Item 1. Financial Statements
Item 1. Financial Statements
NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in millions, except per share data)
September 30,
2024 December 31,
2023
Assets
Current assets:
Cash and cash equivalents $ 349.1 $ 251.1
Available-for-sale debt securities 878.9 780.5
Accounts receivable 481.1 439.3
Inventory
45.8 38.3
Other current assets 121.7 97.8
Total current assets 1,876.6 1,607.0
Deferred tax assets 454.4 362.6
Available-for-sale debt securities 643.9 687.5
Right-of-use assets 257.3 276.5
Equity investments 126.7 161.9
Property and equipment, net 80.0 70.8
Intangible assets, net 34.5 35.5
Other noncurrent assets 61.6 49.6
Total assets $ 3,535.0 $ 3,251.4
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 392.7 $ 448.8
Convertible senior notes — 170.1
Other current liabilities 37.0 35.9
Total current liabilities 429.7 654.8
Noncurrent operating lease liabilities 251.4 258.3
Other noncurrent liabilities 135.0 106.3
Total liabilities 816.1 1,019.4
Stockholders’ equity:
Preferred stock, $ 0.001 par value; 5.0 shares authorized; no shares issued and outstanding
— —
Common stock, $ 0.001 par value; 220.0 shares authorized; 101.2 and 98.7 shares issued and outstanding, respectively
0.1 0.1
Additional paid-in capital 2,623.2 2,382.0
Accumulated other comprehensive income 14.5 7.0
Retained earnings (accumulated deficit) 81.1 ( 157.1 )
Total stockholders’ equity 2,718.9 2,232.0
Total liabilities and stockholders’ equity $ 3,535.0 $ 3,251.4
See accompanying notes to the condensed consolidated financial statements.
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NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
AND COMPREHENSIVE INCOME
(unaudited)
Three Months Ended
September 30, Nine Months Ended
September 30,
(in millions, except per share data) 2024 2023 2024 2023
Revenues:
Net product sales $ 616.6 $ 491.8 $ 1,709.4 $ 1,353.4
Collaboration revenues 5.5 7.0 18.2 18.5
Total revenues 622.1 498.8 1,727.6 1,371.9
Operating expenses:
Cost of revenues 8.0 11.2 24.7 31.2
Research and development 195.0 142.2 545.5 427.5
Acquired in-process research and development 1.0 — 9.5 143.9
Selling, general, and administrative 234.3 204.2 719.4 668.7
Total operating expenses 438.3 357.6 1,299.1 1,271.3
Operating income 183.8 141.2 428.5 100.6
Other income (expense):
Unrealized loss on equity investments ( 16.9 ) ( 40.1 ) ( 35.2 ) ( 0.6 )
Charges associated with convertible senior notes
— — ( 138.4 ) —
Investment income and other, net 23.4 14.5 68.5 33.9
Total other income (expense), net
6.5 ( 25.6 ) ( 105.1 ) 33.3
Income before provision for income taxes
190.3 115.6 323.4 133.9
Provision for income taxes 60.5 32.5 85.2 31.9
Net income $ 129.8 $ 83.1 $ 238.2 $ 102.0
Foreign currency translation adjustments, net of tax 2.9 ( 1.4 ) 2.5 0.7
Unrealized gain on available-for-sale debt securities, net of tax
9.1 0.8 5.0 5.5
Comprehensive income $ 141.8 $ 82.5 $ 245.7 $ 108.2
Earnings per share:
Basic $ 1.28 $ 0.85 $ 2.37 $ 1.05
Diluted $ 1.24 $ 0.82 $ 2.29 $ 1.01
Weighted-average shares outstanding:
Basic 101.1 97.9 100.6 97.5
Diluted 104.3 101.1 104.0 100.6
See accompanying notes to the condensed consolidated financial statements.
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NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited)
Accumulated Other Comprehensive Income (Loss) Retained Earnings (Accumulated Deficit)
Common Stock Additional Paid-In Capital
(in millions) Shares $ Total
Balance at June 30, 2024
100.9 $ 0.1 $ 2,555.3 $ 2.5 $ ( 48.7 ) $ 2,509.2
Net income — — — — 129.8 129.8
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 September 30, 2024
101.2 $ 0.1 $ 2,623.2 $ 14.5 $ 81.1 $ 2,718.9
Balance at June 30, 2023
97.6 $ 0.1 $ 2,241.9 $ ( 1.1 ) $ ( 387.9 ) $ 1,853.0
Net income — — — — 83.1 83.1
Other comprehensive loss, net of tax — — — ( 0.6 ) — ( 0.6 )
Stock-based compensation expense — — 47.8 — — 47.8
Issuances of common stock under stock plans 0.6 — 18.8 — — 18.8
Balance at September 30, 2023
98.2 $ 0.1 $ 2,308.5 $ ( 1.7 ) $ ( 304.8 ) $ 2,002.1
Balance at December 31, 2023
98.7 $ 0.1 $ 2,382.0 $ 7.0 $ ( 157.1 ) $ 2,232.0
Net income — — — — 238.2 238.2
Other comprehensive income, net of tax
— — — 7.5 — 7.5
Stock-based compensation expense — — 129.1 — — 129.1
Issuances of common stock under stock plans 2.5 — 112.1 — — 112.1
Balance at September 30, 2024
101.2 $ 0.1 $ 2,623.2 $ 14.5 $ 81.1 $ 2,718.9
Balance at December 31, 2022
96.5 $ 0.1 $ 2,122.4 $ ( 7.9 ) $ ( 406.8 ) $ 1,707.8
Net income — — — — 102.0 102.0
Other comprehensive income, net of tax — — — 6.2 — 6.2
Stock-based compensation expense — — 156.2 — — 156.2
Issuances of common stock under stock plans 1.7 — 29.9 — — 29.9
Balance at September 30, 2023
98.2 $ 0.1 $ 2,308.5 $ ( 1.7 ) $ ( 304.8 ) $ 2,002.1
See accompanying notes to the condensed consolidated financial statements.
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NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Nine Months Ended
September 30,
(in millions) 2024 2023
Cash flows from operating activities:
Net income
$ 238.2 $ 102.0
Adjustments to reconcile net income to net cash from operating activities:
Stock-based compensation expense 129.1 156.2
Charges associated with convertible senior notes
138.4 —
Impairment charges associated with leased properties 14.0 —
Depreciation 17.3 12.9
Accretion of discount on available-for-sale debt securities, net ( 20.6 ) ( 12.0 )
Amortization of intangible assets 2.7 2.7
Changes in fair values of equity investments 35.2 0.6
Deferred income taxes ( 91.8 ) ( 77.3 )
Other 3.9 ( 0.6 )
Change in operating assets and liabilities:
Accounts receivable ( 41.8 ) ( 67.9 )
Inventory ( 7.5 ) 6.3
Accounts payable and accrued liabilities ( 38.7 ) 147.3
Other assets and liabilities, net ( 25.5 ) ( 3.8 )
Cash flows from operating activities 352.9 266.4
Cash flows from investing activities:
Purchases of available-for-sale debt securities ( 744.3 ) ( 892.7 )
Sales and maturities of available-for-sale debt securities 716.7 681.6
Purchases of equity investments — ( 31.3 )
Capital expenditures ( 30.9 ) ( 22.9 )
Cash flows from investing activities ( 58.5 ) ( 265.3 )
Cash flows from financing activities:
Issuances of common stock under benefit plans 112.1 29.9
Payments to settle convertible senior notes
( 308.8 ) —
Cash flows from financing activities ( 196.7 ) 29.9
Effect of exchange rate changes on cash and cash equivalents 0.3 —
Change in cash, cash equivalents and restricted cash 98.0 31.0
Cash, cash equivalents and restricted cash at beginning of period 259.1 270.7
Cash, cash equivalents and restricted cash at end of period $ 357.1 $ 301.7
Supplemental disclosures:
Accrued capital expenditures
$ 0.8 $ 0.9
Right-of-use assets acquired through operating leases $ 9.0 $ 1.8
Cash paid for interest $ 1.6 $ 1.9
Cash paid for income taxes $ 144.5 $ 5.0
See accompanying notes to the condensed consolidated financial statements.
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NEUROCRINE BIOSCIENCES, INC.
NOTES TO THE CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(unaudited)
1. Organization and Significant Accounting Policies
Basis of Presentation . The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and with the instructions of the Securities and Exchange Commission (SEC) on Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by GAAP for complete financial statements. In the opinion of management, the condensed consolidated financial statements include all adjustments necessary, which are of a normal and recurring nature, for the fair presentation of our financial position and of the results of operations and cash flows for the periods presented. The accompanying unaudited condensed consolidated financial statements include the accounts of Neurocrine Biosciences and our wholly owned subsidiaries. All significant intercompany balances and transactions have been eliminated in consolidation.
These financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto for the year ended December 31, 2023, included in our Annual Report on Form 10-K, or the 2023 Form 10-K, filed with the SEC. The results of operations for the interim period shown in this report are not necessarily indicative of the results that may be expected for any other interim period or the full year. The condensed consolidated balance sheet as of December 31, 2023, has been derived from the audited financial statements as of that date, but does not include all of the information and footnotes required by GAAP for complete financial statements.
There were no significant changes to our significant accounting policies as disclosed in the 2023 Form 10-K.
Recently Issued Accounting Pronouncements Not Yet Adopted.
In November 2023, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires public entities to disclose information about their reportable segments’ significant expenses and other segment items on an interim and annual basis. Public entities with a single reportable segment are required to apply the disclosure requirements in ASU 2023-07, as well as all existing segment disclosures and reconciliation requirements in ASC 280 on an interim and annual basis. ASU 2023-07 is effective for annual reporting periods beginning after December 15, 2023, and for interim reporting periods beginning January 1, 2025, with early adoption permitted. We are currently evaluating the impact that adoption of ASU 2023-07 will have on our financial statement disclosures.
In December 2023, the FASB issued ASU 2023-09, Income Taxes (Topic 740): Improvements to Income Tax Disclosures, which requires public entities, on an annual basis, to provide disclosure of specific categories in the rate reconciliation, as well as disclosure of income taxes paid disaggregated by jurisdiction. ASU 2023-09 is effective for annual reporting periods beginning after December 15, 2024, with early adoption permitted. We are currently evaluating the impact that adoption of ASU 2023-09 will have on our financial statement disclosures.
2. Collaboration and License Agreements
Nxera Pharma UK Limited, or Nxera. In 2021, we entered into a collaboration and license agreement with Nxera (formerly Sosei Heptares) to develop and commercialize certain compounds containing sub-type selective muscarinic M1, M4, or dual M1/M4 receptor agonists, which we have the exclusive rights to develop, manufacture and commercialize worldwide, excluding in Japan, where Nxera retains the rights to develop, manufacture, and commercialize all compounds comprised of M1 receptor agonists, subject to certain exceptions. With respect to such rights retained by Nxera, we retain the rights to opt in to profit sharing arrangements, pursuant to which we and Nxera will equally share in the operating profits and losses for such compounds in Japan. Subject to specified conditions, we may elect to exercise such opt-in rights with respect to each such compound either before initiation of the first proof of concept Phase 2 clinical trial for such compound or following our receipt from Nxera of the top-line data from such clinical trial for such compound. We are responsible for all development, manufacturing, and commercialization costs of any collaboration product.
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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 research and development (R&D) in the second quarter of 2024. In connection with the successful completion of the Phase 2 clinical study for NBI-1117568 in August 2024, we paid Nxera a milestone of $ 35.0 million, which was expensed as R&D in the third quarter of 2024. We expect to advance NBI-1117568 into Phase 3 development in the first half of 2025, which would trigger a milestone of $ 15.0 million payable to Nxera upon initiation of the Phase 3 clinical study.
Under the terms of the agreement, Nxera may be entitled to receive potential future payments of up to $ 2.6 billion upon the achievement of certain event-based milestones and would be entitled to receive royalties on the future net sales of any collaboration product.
Unless earlier terminated, the agreement will continue on a licensed product-by-licensed product and country-by-country basis until the date on which the royalty term for such licensed product has expired in such country. On a licensed product-by-licensed product and country-by-country basis, royalty payments would commence on the first commercial sale of a licensed product and terminate on the later of (i) the expiration of the last patent covering such licensed product in such country, (ii) a number of years from the first commercial sale of such licensed product in such country and (iii) the expiration of regulatory exclusivity for such licensed product in such country.
We may terminate the agreement in its entirety or with respect to one or more targets upon 180 days’ written notice to Nxera during the research collaboration term and upon 90 days’ written notice to Nxera following the expiration of the research collaboration term. Following the expiration of the research collaboration term, Nxera may terminate the agreement on a target-by-target basis in the event that we do not conduct any material development activities outside of Japan with respect to a certain compound or licensed product within the applicable target class for a continuous period of not less than 365 days and do not commence any such activities within 120 days of receiving written notice. Either party may terminate the agreement, subject to specified conditions, (i) in the event of material breach by the other party, subject to a cure period, (ii) if the other party challenges the validity or enforceability of certain intellectual property rights, subject to a cure period, or (iii) if the other party becomes insolvent or takes certain actions related to insolvency.
Takeda Pharmaceutical Company Limited, or Takeda. In 2020, we entered into an exclusive license agreement with Takeda, pursuant to which we acquired the exclusive rights to develop and commercialize certain early to mid-stage psychiatry compounds, including luvadaxistat, NBI-1070770, NBI-1065845, NBI-1065846 and three non-clinical stage compounds. In the third quarter of 2024, we provided Takeda with written notice of termination of the license agreement to develop and commercialize luvadaxistat and NBI-1065846. The termination is anticipated to be effective in April 2025.
NBI-1070770 and the three non-clinical stage compounds have each been designated as a royalty-bearing product. We are responsible for all manufacturing, development and commercialization costs of any royalty-bearing product.
NBI-1065845 is currently designated as a profit-share product, meaning we and Takeda will equally share in the operating profits and losses. Takeda retains the right to opt-out of the profit-sharing arrangement, pursuant to which Takeda would be entitled to receive potential future payments upon the achievement of certain event-based milestones with respect to NBI-1065845 and receive royalties on the future net sales of NBI-1065845 (in lieu of equally sharing in the operating profits and losses). Takeda may elect to exercise the opt-out right for NBI-1065845 immediately following the completion of a second Phase 2 clinical study for NBI-1065845, or, under certain circumstances related to the development and commercialization activities to be performed by us, before the initiation of a Phase 3 clinical study for NBI-1065845.
In connection with the initiation of a Phase 2 clinical study for NBI-1070770 as a potential treatment for major depressive disorder in April 2024, we paid Takeda a milestone of $ 7.5 million, which was expensed as R&D in the second quarter of 2024.
Under the terms of the agreement, Takeda may be entitled to receive potential future payments of up to $ 1.9 billion upon the achievement of certain event-based milestones and would be entitled to receive royalties on the future net sales of any royalty-bearing product.
Unless earlier terminated, the agreement will continue on a licensed product-by-licensed product and country-by-country basis until the date on which, (i) for any royalty-bearing product, the royalty term has expired in such country; and (ii) for any profit-share product, for so long as we continue to develop, manufacture, or commercialize such licensed product. On a licensed product-by-licensed product and country-by-country basis, royalty payments would commence on the first commercial sale of a royalty-bearing product and terminate on the later of (i) the expiration of the last patent covering such royalty-bearing product in such country, (ii) a number of years from the first commercial sale of such royalty-bearing product in such country and (iii) the expiration of regulatory exclusivity for such royalty-bearing product in such country.
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We may terminate the agreement in its entirety or in one or more (but not all) of the United States, Japan, the European Union and the United Kingdom, or, collectively, the major markets, upon six months ’ written notice to Takeda (i) with respect to all licensed products prior to the first commercial sale of the first licensed product for which first commercial sale occurs, or (ii) with respect to all licensed products in one or more given target classes, as defined in the agreement, prior to the first commercial sale of the first licensed product in such target class for which first commercial sale occurs. We may terminate the agreement in its entirety or in one or more (but not all) of the major markets upon 12 months’ written notice to Takeda (i) with respect to all licensed products following the first commercial sale of the first licensed product for which first commercial sale occurs, or (ii) with respect to all licensed products in one or more given target classes following the first commercial sale of the first licensed product in such target class for which first commercial sale occurs. Takeda may terminate the agreement, subject to specified conditions, (i) if we challenge the validity or enforceability of certain Takeda intellectual property rights or (ii) on a target class-by-target class basis, in the event that we do not conduct any material development or commercialization activities with respect to any licensed product within such target class for a specified continuous period. Subject to a cure period, either party may terminate the agreement in the event of any material breach, solely with respect to the target class of a licensed product to which such material breach relates, or in its entirety in the event of any material breach that relates to all licensed products.
Idorsia Pharmaceuticals Ltd., or Idorsia. In 2020, we entered into a collaboration and license agreement with Idorsia, pursuant to which we acquired the exclusive rights to develop and commercialize NBI-827104, a potent, selective, orally active and brain penetrating T-type calcium channel blocker in clinical development for the treatment of a rare pediatric epilepsy and other potential indications, including essential tremor. We are responsible for all manufacturing, development and commercialization costs of any collaboration product. In the fourth quarter of 2024, we provided Idorsia with written notice of termination of the license agreement to develop and commercialize NBI-827104. The termination is anticipated to be effective in January 2025.
Under the terms of the agreement, Idorsia may be entitled to receive potential future payments of up to $ 1.7 billion upon the achievement of certain event-based milestones and would be entitled to receive royalties on the future net sales of any collaboration product.
We may terminate the agreement, in its entirety or with respect to a particular compound or development candidate, upon 90 days’ written notice to Idorsia. Further, in the event a party commits a material breach and fails to cure such material breach within 90 days after receiving written notice thereof, the non-breaching party may terminate the agreement in its entirety immediately upon written notice to the breaching party.
Xenon Pharmaceuticals Inc., or Xenon. In 2019, we entered into a collaboration and license agreement with Xenon to identify, research and develop sodium channel inhibitors, including NBI-921352 and three preclinical candidates, which compounds we have the exclusive rights to develop and commercialize. We are responsible for all development and manufacturing costs of any collaboration product, subject to certain exceptions.
In connection with entering the agreement in 2019, we purchased approximately 1.4 million shares (at $ 14.196 per share) of Xenon common stock (the 2019 Xenon Shares). The 2019 Xenon Shares were recorded at a fair value of $ 14.1 million after considering Xenon’s stock price and certain transfer restrictions that were applicable to the shares on the measurement date.
In connection with the achievement of a development milestone in 2021, we purchased approximately 0.3 million shares (at $ 19.9755 per share) of Xenon common stock (the 2021 Xenon Shares). The 2021 Xenon Shares were recorded at a fair value of $ 4.6 million after considering Xenon’s stock price and certain transfer restrictions that were applicable to the shares on the measurement date.
In connection with the achievement of a development milestone in 2022, we purchased approximately 0.3 million shares (at $ 31.855 per share) of Xenon common stock (the 2022 Xenon Shares). The 2022 Xenon Shares were recorded at a fair value of $ 7.7 million after considering Xenon’s stock price on the measurement date.
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 would be entitled to receive royalties on the future net sales of any collaboration product. Xenon retains the right to elect to co-develop one product in a major indication, pursuant to which Xenon would receive a mid-single digit percentage increase in royalties earned on the future net sales of such product in the United States and we and Xenon would equally share in the development costs of such product in the applicable indication, except where such development costs relate solely to the regulatory approval of such product outside the United States.
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Unless earlier terminated, the agreement will continue on a licensed product-by-licensed product and country-by-country basis until the expiration of the royalty term for such product in such country. Upon the expiration of the royalty term for a particular licensed product and country, the license obtained by us with respect to such product and country will become fully paid, royalty free, perpetual and irrevocable. We may terminate the agreement upon 90 days’ written notice to Xenon, provided that such unilateral termination will not be effective for certain products until we have used commercially reasonable efforts to complete certain specified clinical studies. Either party may terminate the agreement in the event of a material breach in whole or in part, subject to specified conditions.
Voyager Therapeutics, Inc., or Voyager.
2019 Voyager Agreement. In 2019, we entered into a collaboration and license agreement with Voyager (the 2019 Voyager Agreement), pursuant to which we retain certain rights to develop and commercialize the Friedreich’s ataxia (FA) program and two undisclosed programs. We are responsible for all development and commercialization costs of any collaboration product under the 2019 Voyager Agreement, subject to certain co-development and co-commercialization rights retained by Voyager.
In connection with the 2019 Voyager Agreement, we purchased approximately 4.2 million shares (at $ 11.9625 per share) of Voyager common stock (the 2019 Voyager Shares), which are subject to certain transfer, beneficial ownership, and voting restrictions for a period of up to three years from the effective date of the 2023 Voyager Agreement (defined below). The 2019 Voyager Shares were recorded at a fair value of $ 54.7 million after considering Voyager’s stock price and certain transfer restrictions that were applicable to the shares on the measurement date.
In connection with the selection of a development candidate under the FA program pursuant to our collaboration with Voyager, we expensed a milestone of $ 5.0 million as R&D in the first quarter of 2024.
Under the terms of the 2019 Voyager Agreement, Voyager may be entitled to receive potential future payments of up to $ 1.3 billion upon the achievement of certain event-based milestones and would be 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.
Unless terminated earlier, the 2019 Voyager Agreement will continue in effect until the expiration of the last to expire royalty term with respect to any collaboration product under the agreement or the last expiration or termination of any exercised co-development and co-commercialization rights by Voyager as provided for in the 2019 Voyager Agreement. We may terminate the 2019 Voyager Agreement upon 180 days’ written notice to Voyager prior to the first commercial sale of any collaboration product under the 2019 Voyager Agreement or upon one year after the date of notice if such notice is provided after the first commercial sale of any collaboration product under the 2019 Voyager Agreement.
2023 Voyager Agreement. In 2023, we entered into a collaboration and license agreement with Voyager (the 2023 Voyager Agreement), pursuant to which we acquired the global rights to the gene therapy products directed to the gene that encodes glucosylceramidase beta 1 (GBA1) for the treatment of Parkinson's disease and other diseases associated with GBA1 (the GBA1 Program), and three gene therapy programs directed to rare central nervous system (CNS) targets, each enabled by Voyager's next-generation TRACER TM capsids. With respect to collaboration products subject to the GBA1 Program, we are responsible for all development and commercialization costs of any such products, including in the U.S., where Voyager retains certain co-development and co-commercialization rights. Voyager may elect to exercise such rights, pursuant to which we and Voyager would equally share in the operating profits and losses of such products in the U.S. (in lieu of Voyager being entitled to receive potential future payments of certain event-based milestones upon their achievement in the U.S. and receive royalties on the future net sales of such products in the U.S.), following Voyager’s receipt of the top-line data from a first clinical trial Parkinson’s disease. However, if we and Voyager elect to focus on an indication other than Parkinson’s disease prior to Voyager’s receipt of top-line data from a first clinical trial for Parkinson’s disease, then Voyager may elect to exercise such co-development and co-commercialization rights after the later of: (i) Voyager’s receipt of top-line data from the first clinical trial of a product that is the subject of the GBA1 Program or (ii) the date we and Voyager decide not to pursue Parkinson’s disease as an indication for development under the GBA1 Program. Irrespective of Voyager’s election to exercise such rights, Voyager may be entitled to receive potential future payments upon the achievement of certain event-based milestones outside the U.S. and would be entitled to receive royalties on the future net sales of any such product outside the U.S. With respect to collaboration products subject to the three gene therapy programs directed to rare CNS targets, we are responsible for all development and commercialization costs for any such products.
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In connection with the 2023 Voyager Agreement, we paid Voyager $ 175.0 million upfront, including a purchase of approximately 4.4 million shares (at $ 8.88 per share) of Voyager common stock (the 2023 Voyager Shares), which are subject to certain transfer, beneficial ownership, and voting restrictions for a period of up to three years from the effective date of the 2023 Voyager Agreement. We accounted for the transaction as an asset acquisition as the set of acquired assets did not constitute a business. In addition, as part of the collaboration, Jude Onyia, Ph.D., Chief Scientific Officer of Neurocrine Biosciences, was appointed to Voyager's board of directors. Dr. Onyia (or another individual designated by us) will be nominated for election to Voyager's board of directors annually for a maximum duration of 10 years from the effective date of the 2023 Voyager Agreement. As a result, our equity investment in Voyager became subject to the equity method of accounting, and Voyager became a related party, following our purchase of the 2023 Voyager Shares, after which, together with the 2019 Voyager Shares, we owned approximately 19.9 % of the voting stock of Voyager. 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. The 2023 Voyager Shares were recorded at a fair value of $ 31.3 million after considering Voyager’s stock price on the measurement date. The remaining $ 143.9 million of the purchase price, which includes certain transaction-related costs, was expensed as in-process research and development in the first quarter of 2023 as the license had no foreseeable alternative future use.
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 would be 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.
Unless terminated earlier, the 2023 Voyager Agreement will continue in effect until the expiration of the last to expire royalty term with respect to any collaboration product under the 2023 Voyager Agreement or the last expiration or termination of any exercised co-development and co-commercialization rights by Voyager as provided for in the 2023 Voyager Agreement. We may terminate the 2023 Voyager Agreement upon 180 days’ written notice to Voyager prior to the first commercial sale of any collaboration product under the 2023 Voyager Agreement or upon one year after the date of notice if such notice is provided after the first commercial sale of any collaboration product under the 2023 Voyager Agreement.
Mitsubishi Tanabe Pharma Corporation, or MTPC. In 2015, we out-licensed the rights to valbenazine in Japan and other select Asian markets to MTPC. In 2020, we entered into a commercial supply agreement with MTPC, pursuant to which we supply MTPC with valbenazine drug product for commercial use in such markets. MTPC is responsible for all development, manufacturing and commercialization costs of valbenazine in such markets.
MTPC launched DYSVAL ® (valbenazine) in Japan for the treatment of tardive dyskinesia in June 2022 and subsequently in other select Asian markets, where it is marketed as REMLEAS ® (valbenazine). We receive royalties at tiered percentage rates on MTPC net sales of valbenazine.
Under the terms of our license agreement with MTPC, we may be entitled to receive potential future payments of up to $ 30.0 million upon the achievement of certain sales-based milestones and are entitled to receive royalties at tiered percentage rates on future MTPC net sales of valbenazine for the longer of 10 years or the life of the related patent rights. MTPC may terminate the agreement upon 180 days’ written notice to us. In such event, all out-licensed product rights would revert to us.
AbbVie Inc., or AbbVie. In 2010, we out-licensed the global rights to elagolix to AbbVie. AbbVie is responsible for all development and commercialization costs of elagolix.
AbbVie launched ORILISSA ® (elagolix tablets) in the U.S. for the treatment of moderate to severe pain associated with endometriosis in August 2018 and ORIAHNN ® (elagolix, estradiol and norethindrone acetate capsules and elagolix capsules) in the U.S. for the treatment of heavy menstrual bleeding due to uterine fibroids in June 2020. We receive royalties at tiered percentage rates on AbbVie net sales of elagolix and recognized elagolix royalty revenue of $ 3.3 million and $ 4.2 million, respectively, for the third quarter of 2024 and 2023 and $ 9.8 million and $ 12.0 million, respectively, for the first nine months of 2024 and 2023.
Under the terms of our license agreement with AbbVie, we may be entitled to receive potential future payments of up to $ 366.0 million upon the achievement of certain event-based milestones and are entitled to receive royalties at tiered percentage rates on future AbbVie net sales of elagolix for the longer of 10 years or the life of the related patent rights. AbbVie may terminate the agreement upon 180 days’ written notice to us. In such event, all out-licensed product rights would revert to us.
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3. Available-for-Sale Debt Securities
The following table presents a summary of available-for-sale debt securities, aggregated by major security type and contractual maturity.
September 30,
2024 December 31,
2023
(in millions) Contractual
Maturity Amortized
Cost Unrealized
Gain Unrealized
Loss Fair
Value Amortized
Cost Unrealized
Gain Unrealized
Loss Fair
Value
Commercial paper 0 to 1 years $ 37.3 $ — $ — $ 37.3 $ 53.5 $ — $ — $ 53.5
Corporate debt securities 0 to 1 years 531.4 1.0 ( 0.1 ) 532.3 382.1 0.1 ( 1.0 ) 381.2
Securities of government-sponsored entities 0 to 1 years 308.7 0.6 — 309.3 346.1 0.2 ( 0.5 ) 345.8
$ 877.4 $ 1.6 $ ( 0.1 ) $ 878.9 $ 781.7 $ 0.3 $ ( 1.5 ) $ 780.5
Corporate debt securities 1 to 3 years $ 488.9 $ 6.2 $ ( 0.1 ) $ 495.0 $ 483.5 $ 2.9 $ ( 0.4 ) $ 486.0
Securities of government-sponsored entities 1 to 3 years 148.2 0.8 ( 0.1 ) 148.9 201.1 0.5 ( 0.1 ) 201.5
$ 637.1 $ 7.0 $ ( 0.2 ) $ 643.9 $ 684.6 $ 3.4 $ ( 0.5 ) $ 687.5
Unrealized losses on available-for-sale debt securities were primarily due to changes in interest rates. These investments 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 recovery of their amortized cost basis. No allowance for credit losses was recognized as of September 30, 2024 or December 31, 2023.
The following table presents available-for-sale debt securities that were in an unrealized loss position as of September 30, 2024, aggregated by major security type and length of time in a continuous loss position.
Less Than 12 Months 12 Months or Longer Total
(in millions) Fair
Value Unrealized
Loss Fair
Value Unrealized
Loss Fair
Value Unrealized
Loss
Corporate debt securities $ 125.9 $ ( 0.1 ) $ 49.1 $ ( 0.1 ) $ 175.0 $ ( 0.2 )
Securities of government-sponsored entities $ 84.8 $ ( 0.1 ) $ — $ — $ 84.8 $ ( 0.1 )
The following table presents available-for-sale debt securities that were in an unrealized loss position as of December 31, 2023, aggregated by major security type and length of time in a continuous loss position.
Less Than 12 Months 12 Months or Longer Total
(in millions) Fair
Value Unrealized
Loss Fair
Value Unrealized
Loss Fair
Value Unrealized
Loss
Corporate debt securities $ 265.1 $ ( 0.4 ) $ 183.8 $ ( 1.0 ) $ 448.9 $ ( 1.4 )
Securities of government-sponsored entities $ 214.6 $ ( 0.2 ) $ 16.7 $ ( 0.4 ) $ 231.3 $ ( 0.6 )
Accrued interest receivables on available-for-sale debt securities totaled $ 13.5 million and $ 11.2 million, respectively, as of September 30, 2024 and December 31, 2023. We do not measure an allowance for credit losses for accrued interest receivables. For the purposes of identifying and measuring an impairment, accrued interest is excluded from both the fair value and amortized cost basis of the debt security. Uncollectible accrued interest receivables associated with an impaired debt security are reversed against interest income upon identification of the impairment. No accrued interest receivables were written off during the first nine months of 2024 or 2023.
4. Fair Value Measurements
The fair value hierarchy consists of the following three levels:
Level 1 – Quoted prices (unadjusted) in active markets for identical assets or liabilities.
Level 2 – Quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability.
Level 3 – Unobservable inputs that reflect our own assumptions about the assumptions that market participants would use in pricing the asset or liability when there is little, if any, market activity for the asset or liability at the measurement date.
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The following table presents a summary of certain financial assets, which were measured at fair value on a recurring basis.
September 30,
2024 December 31,
2023
Fair
Value Leveling Fair
Value Leveling
(in millions) Level 1 Level 2 Level 1 Level 2
Cash and cash equivalents $ 349.1 $ 349.1 $ — $ 251.1 $ 251.1 $ —
Available-for-sale debt securities 1,522.8 — 1,522.8 1,468.0 — 1,468.0
Equity investments 126.7 126.7 — 161.9 161.9 —
$ 1,998.6 $ 475.8 $ 1,522.8 $ 1,881.0 $ 413.0 $ 1,468.0
5. Other Balance Sheet Details
Inventory consisted of the following:
(in millions) September 30,
2024 December 31,
2023
Raw materials $ 23.7 $ 21.5
Work in process 10.6 9.7
Finished goods 11.5 12.3
45.8 43.5
Less inventory reserves
— ( 5.2 )
Total inventory
$ 45.8 $ 38.3
Accounts payable and accrued liabilities consisted of the following:
(in millions) September 30,
2024 December 31,
2023
Sales rebates and reserves $ 138.9 $ 139.3
Accrued employee related costs 77.1 86.2
Current branded prescription drug fee 42.7 45.7
Accrued development costs 38.3 44.3
Accounts payable and other accrued liabilities 95.7 133.3
Total accounts payable and accrued liabilities $ 392.7 $ 448.8
Other noncurrent liabilities consisted of the following:
(in millions) September 30,
2024 December 31,
2023
Noncurrent income taxes payable
$ 134.9 $ 96.0
Other noncurrent liabilities
0.1 10.3
Total other noncurrent liabilities $ 135.0 $ 106.3
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) September 30,
2024 September 30,
2023
Cash and cash equivalents $ 349.1 $ 293.7
Restricted cash included in other noncurrent assets
8.0 8.0
Total cash, cash equivalents, and restricted cash $ 357.1 $ 301.7
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6. Goodwill and Intangible Assets
The following table presents the changes in the carrying amount of goodwill. Goodwill is included in other noncurrent assets in our condensed consolidated balance sheets.
(in millions)
Balance as of December 31, 2023
$ 5.8
Foreign currency translation adjustments 0.3
Balance as of September 30, 2024
$ 6.1
The following table presents information relating to our recognized intangible assets.
September 30,
2024 December 31,
2023
(dollars in millions) Useful Life Gross Carrying Amount Accumulated Amortization Net
Carrying Amount Gross Carrying Amount Accumulated Amortization Net
Carrying Amount
Developed product rights 10 years $ 37.9 $ 7.3 $ 30.6 $ 35.9 $ 4.0 $ 31.9
Acquired IPR&D Indefinite $ 3.9 $ — 3.9 $ 3.6 $ — 3.6
Total intangible assets, net $ 34.5 $ 35.5
The following table presents approximate future annual amortization expense for our finite-lived intangible assets as of September 30, 2024.
(in millions)
2024 (3 months remaining)
$ 0.9
2025
$ 3.8
2026
$ 3.8
2027
$ 3.8
2028
$ 3.8
Thereafter $ 14.5
7. Leases
Our operating leases that have commenced have terms that expire beginning 2025 through 2036 and consist of office space and research and development laboratories, including our corporate headquarters. Certain of these lease agreements contain clauses for renewal at our option. As we were not reasonably certain to exercise any of these renewal options at commencement of the associated leases, no such options were recognized as part of our right-of-use (ROU) assets or operating lease liabilities.
The following table presents supplemental operating lease information for operating leases that have commenced.
Nine Months Ended
September 30,
(in millions, except weighted average data) 2024 2023
Operating lease cost $ 27.9 $ 12.3
Sublease income ( 1.3 ) ( 0.3 )
Net operating lease cost $ 26.6 $ 12.0
Cash paid for amounts included in the measurement of operating lease liabilities $ 24.0 $ 13.4
September 30,
2024 September 30,
2023
Weighted average remaining lease term
10.3 years 7.2 years
Weighted average discount rate 5.0 % 5.4 %
Restricted cash related to letters of credit issued in lieu of cash security deposits $ 7.8 $ 7.8
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The following table presents approximate future non-cancelable minimum lease payments under operating leases and sublease income as of September 30, 2024.
(in millions) Operating
Leases (1)
Sublease
Income
2024 (3 months remaining)
$ 9.0 $ ( 0.8 )
2025
35.4 ( 3.5 )
2026
34.9 ( 3.5 )
2027
35.8 ( 3.5 )
2028
36.6 ( 3.5 )
Thereafter 220.4 ( 8.8 )
Total operating lease payments (sublease income) 372.1 $ ( 23.6 )
Less accreted interest 85.9
Total operating lease liabilities 286.2
Less current operating lease liabilities included in other current liabilities 34.8
Noncurrent operating lease liabilities $ 251.4
_________________________
(1) Amounts presented in the table above exclude $ 5.6 million for 2025, $ 22.6 million for 2026, $ 23.3 million for 2027, $ 24.0 million for 2028 and $ 214.4 million thereafter of approximate non-cancelable future minimum lease payments under an operating lease related to our new campus facility that has not yet commenced.
New Campus Facility. On February 8, 2022, we entered into a lease agreement for a four-building campus facility currently under construction in San Diego, California, including a six-year option for the construction of a fifth building. This campus facility, comprised of office space and research and development laboratories, now serves as our corporate headquarters.
The construction of the campus facility is phased. The first phase of construction, consisting of two buildings relating to office space, was completed in December 2023 and resulted in the recognition of ROU assets and operating lease liabilities totaling $ 199.0 million and $ 189.8 million, respectively. The second phase of construction, consisting of two buildings relating to laboratory space, is scheduled for completion by the end of 2024.
As we continue to occupy our new campus facility, certain of our existing leased properties will be marketed for sublease when we determine there is excess leased capacity. Certain of these subleases contain both lease and non-lease components. Sublease income is recognized as an offset to operating expense on a straight-line basis over the lease term. Income related to non-lease components is recognized in operating expenses as a reduction to costs we incur in relation to the primary lease.
Impairment of ROU Assets. ROU assets are reviewed for impairment when indicators of impairment are present. ROU assets are tested for impairment individually or as part of an asset group if the cash flows related to the ROU asset are not independent from the cash flows of other assets and liabilities. An asset group is the unit of accounting for long-lived assets to be held and used, which represents the lowest level for which identifiable cash flows are largely independent of the cash flows of other groups of assets and liabilities.
Corporate ROU assets that are actively being marketed for sublease in connection with excess leased capacity are tested for impairment individually when the cash flows related to the ROU asset are determined to be independent from the cash flows of other assets and liabilities. Corporate ROU assets are otherwise tested for impairment on a consolidated level with consideration given to all cash flows of the company as corporate functions do not generate cash flows and are funded by revenue-producing activities at lower levels of the entity.
In the second quarter of 2024, we reassessed the asset groupings for corporate ROU assets that are actively being marketed for sublease in connection with leased office space that has been vacated as we continue to occupy our new campus facility. For asset groups where impairment was triggered, we used discounted cash flow models (an income approach) with Level 3 inputs to estimate the fair values of the asset groups and recognized corresponding 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. The significant assumptions used in the discounted cash flows models included projected sublease income over the remaining lease term, expected downtime prior to the commencement of executed or future subleases, and discount rates that reflected a market participant's assumptions in valuing the asset groups.
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8. Convertible Senior Notes
On May 2, 2017, we completed a private placement of $ 517.5 million in aggregate principal amount of 2.25 % fixed-rate convertible senior notes due May 15, 2024 (the 2024 Notes) and entered into the 2017 Indenture with respect to the 2024 Notes. Interest on the 2024 Notes was due semi-annually on May 15 and November 15 of each year.
In 2020, we repurchased $ 136.2 million in aggregate principal amount of the 2024 Notes for an aggregate repurchase price of $ 186.9 million in cash. In 2022, we repurchased $ 210.8 million in aggregate principal amount of the 2024 Notes for an aggregate repurchase price of $ 279.0 million in cash.
On or after January 15, 2024, holders of the 2024 Notes had the ability to convert the 2024 Notes at any time until the close of business on the scheduled trading day immediately preceding May 15, 2024. In January 2024, we provided notice to the holders of the 2024 Notes electing to settle all conversions of the 2024 Notes which occur on or after January 15, 2024 in cash. Consequently, the embedded conversion option of the 2024 Notes (the conversion feature) required bifurcation and separate accounting from the 2024 Notes as it no longer qualified for the equity scope exception under ASC 815, Derivatives and Hedging. Upon bifurcation of the conversion feature, we recorded a derivative liability at a fair value of $ 126.6 million (Level 3) and a corresponding debt discount that was accreted over the remaining term of the 2024 Notes using the straight-line method. Subsequent changes in the fair value of the derivative liability and accretion of the associated debt discount were recorded in other income (expense), net in our condensed consolidated statements of income.
During the second quarter of 2024, holders of the 2024 Notes converted $ 169.8 million in aggregate principal amount of the 2024 Notes for $ 308.2 million in cash, reflecting a conversion premium of $ 138.4 million calculated based on the per share volume-weighted average price (VWAP) for each of the 30 consecutive trading days during the observation period (as more fully described in the 2017 Indenture). 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 nine months of 2024.
(in millions)
Accretion of debt discount associated with derivative liability $ 126.6
Change in fair value of derivative liability 9.6
Loss on extinguishment of convertible senior notes 2.2
Charges associated with convertible senior notes $ 138.4
9. Earnings per Share
Earnings per share were calculated as follows:
Three Months Ended
September 30, Nine Months Ended
September 30,
(in millions, except per share data) 2024 2023 2024 2023
Net income - basic and diluted $ 129.8 $ 83.1 $ 238.2 $ 102.0
Weighted-average common shares outstanding:
Basic 101.1 97.9 100.6 97.5
Effect of dilutive securities 3.2 3.2 3.4 3.1
Diluted 104.3 101.1 104.0 100.6
Earnings per share:
Basic $ 1.28 $ 0.85 $ 2.37 $ 1.05
Diluted $ 1.24 $ 0.82 $ 2.29 $ 1.01
Shares excluded from diluted per share amounts because their effect would have been anti-dilutive 1.7 4.4 1.9 5.2
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