10-Q 1 nbix-20210930.htm 10-Q nbix-20210930
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2021
OR
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from           to           
Commission file number 0-22705
NEUROCRINE BIOSCIENCES, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of
incorporation or organization)
12780 El Camino Real
San Diego, CA
(Address of principal executive office)
33-0525145
(IRS Employer
Identification No.)
92130
(Zip Code)
(858) 617-7600
(Registrant’s telephone number, including area code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading SymbolName of each exchange on which registered
Common Stock, $0.001 par valueNBIXNasdaq Global Select Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days:  Yes   No
Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).  Yes   No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:
Large accelerated filerAccelerated filer
Non-accelerated filerSmaller reporting company
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes   No
The number of outstanding shares of the registrant’s common stock, par value $0.001 per share, was 94,866,693 as of October 27, 2021.



NEUROCRINE BIOSCIENCES, INC.
TABLE OF CONTENTS


2


Part I. Financial Information
Item 1. Financial Statements
NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited)
(in millions, except per share data)September 30,
2021
December 31,
2020
Assets
Current assets:
Cash and cash equivalents$311.1 $187.1 
Debt securities available-for-sale, at fair value (amortized cost $454.6 million at September 30, 2021 and $612.4 million at December 31, 2020)
454.8 613.9 
Accounts receivable163.8 157.1 
Inventories25.5 28.0 
Other current assets50.5 30.1 
Total current assets1,005.7 1,016.2 
Deferred tax assets310.4 319.4 
Debt securities available-for-sale, at fair value (amortized cost $513.8 million at September 30, 2021 and $226.7 million at December 31, 2020)
513.7 227.1 
Right-of-use assets97.9 82.8 
Equity securities35.3 38.2 
Property and equipment, net51.1 44.6 
Other assets3.2 6.4 
Total assets$2,017.3 $1,734.7 
Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable and accrued liabilities$205.9 $168.7 
Other current liabilities20.0 17.8 
Total current liabilities225.9 186.5 
Convertible senior notes330.7 317.9 
Operating lease liabilities106.4 94.4 
Other long-term liabilities8.3 9.7 
Total liabilities671.3 608.5 
Stockholders’ equity:
Preferred stock, $0.001 par value; 5.0 shares authorized; no shares issued and outstanding at September 30, 2021 and December 31, 2020
  
Common stock, $0.001 par value; 220.0 shares authorized; issued and outstanding shares were 94.8 at September 30, 2021 and 93.5 at December 31, 2020
0.1 0.1 
Additional paid-in capital1,974.0 1,849.7 
Accumulated other comprehensive income0.4 1.8 
Accumulated deficit(628.5)(725.4)
Total stockholders’ equity1,346.0 1,126.2 
Total liabilities and stockholders’ equity$2,017.3 $1,734.7 
See accompanying notes to the condensed consolidated financial statements.

3


NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)
AND COMPREHENSIVE INCOME (LOSS)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions, except per share data)2021202020212020
Revenues:
Net product sales$288.8 $254.1 $786.6 $752.8 
Collaboration revenues7.2 4.4 34.9 45.2 
Total revenues296.0 258.5 821.5 798.0 
Operating expenses:
Cost of sales4.2 2.7 10.2 7.2 
Research and development92.7 69.1 240.7 208.3 
Acquired in-process research and development 118.5 5.0 164.5 
Selling, general and administrative154.6 112.5 426.8 326.8 
Total operating expenses251.5 302.8 682.7 706.8 
Operating income (loss)44.5 (44.3)138.8 91.2 
Other (expense) income:
Interest expense(6.6)(8.5)(19.2)(25.0)
Unrealized loss on equity securities(8.2)(7.0)(7.5)(12.2)
Investment income and other, net0.8 2.7 3.1 11.0 
Total other expense, net(14.0)(12.8)(23.6)(26.2)
Income (loss) before provision for income taxes30.5 (57.1)115.2 65.0 
Provision for income taxes8.0 0.5 18.3 5.6 
Net income (loss)22.5 (57.6)96.9 59.4 
Unrealized (loss) gain on debt securities available-for-sale, net of tax(0.3)(1.4)(1.4)1.8 
Comprehensive income (loss)$22.2 $(59.0)$95.5 $61.2 
Net income (loss) per share, basic$0.24 $(0.62)$1.03 $0.64 
Net income (loss) per share, diluted$0.23 $(0.62)$0.99 $0.61 
Weighted average common shares outstanding, basic94.793.394.593.0
Weighted average common shares outstanding, diluted97.793.397.998.0
See accompanying notes to the condensed consolidated financial statements.


4


NEUROCRINE BIOSCIENCES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
(unaudited)
Accumulated Other Comprehensive Income (Loss)
Common StockAdditional Paid-In CapitalAccumulated Deficit
(in millions)Shares$Total
Balances at June 30, 2021
94.6 $0.1 $1,929.4 $0.7 $(651.0)$1,279.2 
Net income— — — — 22.5 22.5 
Unrealized loss on debt securities available-for-sale, net of tax— — — (0.3)— (0.3)
Share-based compensation expense— — 37.1 — — 37.1 
Issuances of common stock under stock plans0.2 — 7.5 — — 7.5 
Balances at September 30, 2021
94.8 $0.1 $1,974.0 $0.4 $(628.5)$1,346.0 
Balances at June 30, 2020
93.2 $0.1 $1,842.2 $4.6 $(1,015.7)$831.2 
Net loss— — — — (57.6)(57.6)
Unrealized loss on debt securities available-for-sale, net of tax— — — (1.4)— (1.4)
Share-based compensation expense— — 26.7 — — 26.7 
Issuances of common stock under stock plans0.2 — 5.4 — — 5.4 
Balances at September 30, 2020
93.4 $0.1 $1,874.3 $3.2 $(1,073.3)$804.3 
Balance at December 31, 2020
93.5 $0.1 $1,849.7 $1.8 $(725.4)$1,126.2 
Net income— — — — 96.9 96.9 
Unrealized loss on debt securities available-for-sale, net of tax— — — (1.4)— (1.4)
Share-based compensation expense— — 98.6 — — 98.6 
Issuances of common stock under stock plans1.3 — 25.7 — — 25.7 
Balances at September 30, 2021
94.8 $0.1 $1,974.0 $0.4 $(628.5)$1,346.0 
Balance at December 31, 2019
92.3 $0.1 $1,768.1 $1.4 $(1,132.7)$636.9 
Net income— — — — 59.4 59.4 
Unrealized gain on debt securities available-for-sale, net of tax— — — 1.8 — 1.8 
Share-based compensation expense— — 79.0 — — 79.0 
Issuances of common stock under stock plans1.1 — 27.2 — — 27.2 
Balance at September 30, 2020
93.4 $0.1 $1,874.3 $3.2 $(1,073.3)$804.3 
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)20212020
Cash Flows from Operating Activities:
Net income$96.9 $59.4 
Reconciliation of net income to net cash provided by operating activities:
Share-based compensation expense98.6 79.0 
Depreciation7.9 6.4 
Amortization of debt discount12.1 15.2 
Amortization of debt issuance costs0.8 1.0 
Change in fair value of equity security investments7.5 12.2 
Deferred income taxes9.0  
Other7.7 1.7 
Change in operating assets and liabilities:
Accounts receivable(6.7)(30.3)
Inventories2.5 (3.4)
Accounts payable and accrued liabilities37.7 28.1 
Other assets and liabilities, net(21.7)(35.3)
Net cash provided by operating activities252.3 134.0 
Cash Flows from Investing Activities:
Purchases of debt securities available-for-sale(658.7)(399.2)
Sales and maturities of debt securities available-for-sale523.9 557.4 
Purchases of equity securities(4.6) 
Purchases of property and equipment(14.5)(6.4)
Net cash (used in) provided by investing activities(153.9)151.8 
Cash Flows from Financing Activities:
Issuances of common stock under benefit plans25.7 27.2 
Partial repurchase of convertible senior notes(0.1) 
Net cash provided by financing activities25.6 27.2 
Change in cash, cash equivalents and restricted cash124.0 313.0 
Cash, cash equivalents and restricted cash at beginning of period190.3 115.5 
Cash, cash equivalents and restricted cash at end of period$314.3 $428.5 
Supplemental Disclosure:
Non-cash capital expenditures$0.3 $1.1 
Right-of-use assets acquired through operating leases$21.6 $ 
Cash paid for interest$4.3 $5.8 
Cash paid for income taxes$3.4 $0.4 
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
Description of Business. Neurocrine Biosciences, Inc., or Neurocrine Biosciences, the Company, we, our or us, was incorporated in California in 1992 and reincorporated in Delaware in 1996. Neurocrine Continental, Inc., is a Delaware corporation and a wholly owned subsidiary of Neurocrine Biosciences. We also have two wholly owned Irish subsidiaries, Neurocrine Therapeutics, Ltd. and Neurocrine Europe, Ltd., both of which were formed in December 2014 and are inactive.
We are a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. Our diverse portfolio includes United States Food and Drug Administration, or FDA, approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, we have specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie Inc.)
Basis of Presentation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States, or GAAP, for interim financial information and with the instructions of the Securities and Exchange Commission, or 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, 2020, included in our Annual Report on Form 10-K, or the 2020 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, 2020, 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 2020 Form 10-K.
Recently Adopted Accounting Pronouncements.
ASU 2019-12. On January 1, 2021, we adopted Accounting Standards Update, or ASU, 2019-12, Income Taxes (Topic 740): Simplifying the Accounting for Income Taxes, using the modified retrospective transition method. ASU 2019-12 simplifies the accounting for income taxes by removing certain exceptions to the general principles in Topic 740 and amends existing guidance to improve consistent application of Topic 740. The adoption of ASU 2019-12 did not result in a cumulative-effect adjustment to retained earnings. The comparative prior period information continues to be reported under the accounting standards in effect during those periods. The impact of the adoption is expected to be immaterial to our financial position, results of operations, and cash flows on an ongoing basis.
Recently Issued Accounting Pronouncements.
ASU 2020-06. In August 2020, the FASB issued ASU 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging – Contracts in Entity's Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity's Own Equity, which simplifies the accounting for certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts in an entity's own equity. Among other changes, ASU 2020-06 removes the separation models for convertible instruments with cash or beneficial conversion features. Instead, entities will account for convertible debt instruments wholly as debt, unless certain other conditions are met. The adoption of ASU 2020-06 is expected to prospectively reduce reported interest expense and increase reported net income, and result in a reclassification of certain conversion feature balance sheet amounts from stockholders’ equity to liabilities as it relates to the 2.25% convertible senior notes due May 15, 2024, or the 2024 Notes. Additionally, ASU 2020-06 requires the application of the if-converted method to calculate the impact of convertible instruments on diluted earnings per

7


share, or EPS, which is expected to result in more dilutive EPS results. ASU 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. We plan to adopt ASU 2020-06 effective January 1, 2022 using the modified retrospective transition method.
2. Significant Collaboration and Licensing Agreements
Takeda Pharmaceutical Company Limited, or Takeda. We entered into an exclusive license agreement with Takeda, which became effective in July 2020, to develop and commercialize certain compounds in Takeda’s early to mid-stage psychiatry pipeline. Specifically, Takeda granted us an exclusive license to (i) luvadaxistat (NBI-1065844/TAK-831) which we are studying in cognitive impairment associated with schizophrenia, (ii) NBI-1065845 (TAK-653) which we are studying in inadequate response to treatment in major depressive disorder, (iii) NBI-1065846 (TAK-041) which we are studying in anhedonia in depression and (iv) four non-clinical stage assets. 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 milestones associated with luvadaxistat and the four non-clinical stage assets, as well as receive royalties on the future net sales of such assets.
With respect to luvadaxistat, Takeda declined to opt-in to a profit-sharing arrangement and instead will be entitled to receive royalties on the future net sales of such asset (in lieu of equally sharing in the operating profits and losses).
With respect to NBI-1065845 and NBI-1065846, Takeda will retain the rights to opt-out of the profit-sharing arrangements pursuant to which Takeda would be entitled to receive royalties on the future net sales of such asset (in lieu of equally sharing in the operating profits and losses). Takeda may elect to exercise such opt-out rights immediately following the completion of the associated second Phase II clinical study or, under certain circumstances related to the development and commercialization activities to be performed by us, before the initiation of a Phase III clinical study for such asset. We and Takeda will equally share in the operating profits and losses associated with NBI-1065845 and NBI-1065846.
Idorsia Pharmaceuticals Ltd., or Idorsia. In May 2020, we entered a collaboration and licensing agreement with Idorsia to license the global rights to NBI-827104 (ACT-709478), a potent, selective, orally active and brain penetrating T-type calcium channel blocker, in clinical development for the treatment of a rare pediatric epilepsy. 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 milestones as well as receive royalties on the future net sales of any collaboration product.
Xenon Pharmaceuticals Inc., or Xenon. In December 2019, we entered into a license and collaboration agreement with Xenon to identify, research, and develop sodium channel inhibitors, including clinical candidate NBI-921352 (XEN901) and three preclinical candidates. 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 milestones as well as receive royalties on the future net sales of any collaboration product.
In September 2021, we received approval of a clinical trial application, or CTA, submitted in the European Union for NBI-921352 for the treatment of focal-onset seizures in adults. In connection with the approval of the CTA for NBI-921352, we paid Xenon a regulatory milestone of $10.0 million, of which we expensed $4.5 million as research and development in the third quarter of 2021, and purchased 0.3 million shares of Xenon’s common stock (at $19.9755 per share) for $5.5 million. The purchased shares were recorded at a fair value of $4.6 million after considering Xenon’s stock price on the measurement date and certain transfer restrictions applicable to the shares. Further, we recorded a charge of $0.9 million to research and development to reflect the premium paid on our purchase of the shares on the measurement date.
Voyager Therapeutics, Inc., or Voyager. We entered into a collaboration and license agreement with Voyager, which became effective in March 2019, to develop and commercialize four programs using Voyager’s proprietary gene therapy platform. The four programs consist of the NBIb-1817 (VY-AADC) for Parkinson’s disease program, the Friedreich’s ataxia program and the rights to two undisclosed programs. In February 2021, we notified Voyager of our termination of the NBIb-1817 for Parkinson’s disease program, which became effective August 2, 2021. The termination does not apply to any other development program other than NBIb-1817 for Parkinson’s disease, and our collaboration and license agreement with Voyager will otherwise continue in effect. Under the terms of the agreement, Voyager may be entitled to receive potential future payments of up to $1.3 billion upon the achievement of certain milestones, as well as receive royalties on the future net sales of any collaboration product.
BIAL – Portela & Ca, S.A., or BIAL. In February 2017, we entered into an exclusive license agreement with BIAL to acquire the United States, or US, and Canada rights to ONGENTYS® (opicapone). Under the terms of the agreement, BIAL may be entitled to receive potential future payments of up to $75.0 million upon the achievement of certain milestones.

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We launched ONGENTYS in the US in September 2020, after receiving FDA approval for ONGENTYS as an adjunctive therapy to levodopa/DOPA decarboxylase inhibitors in adult Parkinson's disease patients in April 2020.
Mitsubishi Tanabe Pharma Corporation, or MTPC. In March 2015, we entered into a collaboration and license agreement with MTPC for the development and commercialization of INGREZZA® (valbenazine) for movement disorders in Japan and other select Asian markets. Under the terms of the agreement, we are entitled to receive royalties on the future worldwide net sales of any collaboration product in select territories in Asia and may also be entitled to receive potential future payments of up to $55.0 million upon the achievement of certain milestones.
In April 2021, MTPC submitted a marketing authorization application, or MAA, with the Ministry of Health and Welfare in Japan for valbenazine for the treatment of tardive dyskinesia. The MTPC submission of the MAA for valbenazine triggered a milestone payment of $15.0 million, which we recognized as milestone revenue in the second quarter of 2021.
We are currently conducting the KINECT-HD study, a placebo-controlled Phase III study of valbenazine in adult Huntington disease patients with chorea. In connection with our performance of the study, we recognized non-cash collaboration revenue of $0.9 million and $3.3 million, respectively, in the three and nine months ended September 30, 2021, and $0.5 million and $1.8 million, respectively, in the three and nine months ended September 30, 2020. As of September 30, 2021, $3.5 million of revenue is being deferred in connection with our continuing performance obligations under the collaboration and will be recognized as non-cash collaboration revenue over the remaining study period using an input method according to costs incurred to-date relative to estimated total costs associated with the study.
AbbVie Inc., or AbbVie. In June 2010, we entered into an exclusive worldwide collaboration with AbbVie to develop and commercialize elagolix and all next-generation gonadotropin-releasing factor antagonists for women’s and men’s health. Under the terms of the agreement, we are entitled to receive royalties on the future worldwide net sales of any collaboration product and may also be entitled to receive potential future payments of up to $366.0 million upon the achievement of certain milestones.
AbbVie launched ORILISSA® (elagolix tablets) in the US and Canada in August and November 2018, respectively. In June 2020, AbbVie launched ORIAHNN® (elagolix, estradiol and norethindrone acetate capsules and elagolix capsules) in the US. We receive royalties at tiered percentage rates on AbbVie net sales of elagolix. We recognized elagolix royalty revenue of $5.9 million and $16.3 million, respectively, in the three and nine months ended September 30, 2021, and $3.9 million and $13.4 million, respectively, in the three and nine months ended September 30, 2020.
3. Debt Securities
The following table summarizes the amortized cost, unrealized gain and loss recognized in accumulated other comprehensive income (loss), and fair value of debt securities available-for-sale, aggregated by major security type and contractual maturity.
September 30,
2021
December 31,
2020
(in millions)Contractual
Maturity
Amortized
Cost

Unrealized Gain

Unrealized Loss
Fair
Value
Amortized
Cost
Unrealized GainUnrealized LossFair
Value
Commercial paper0 to 1 years$208.6 $ $ $208.6 $82.2 $ $ $82.2 
Corporate debt securities0 to 1 years170.6 0.2  170.8 299.3 1.4  300.7 
Securities of government-sponsored entities0 to 1 years75.4   75.4 230.9 0.1  231.0 
$454.6 $0.2 $ $454.8 $612.4 $1.5 $ $613.9 
Corporate debt securities1 to 2 years$328.6 $0.2 $(0.3)$328.5 $144.8 $0.4 $ $145.2 
Securities of government-sponsored entities1 to 2 years185.2 0.1 (0.1)185.2 81.9 0.1 (0.1)81.9 
$513.8 $0.3 $(0.4)$513.7 $226.7 $0.5 $(0.1)$227.1 
As of September 30, 2021, our security portfolio consisted of 160 securities related to investments in debt securities available-for-sale, of which 82 securities were in an unrealized loss position.
Our investments in corporate debt securities in an unrealized loss position as of September 30, 2021 are of high credit quality (rated A or higher). Unrealized losses on these investments were primarily due to changes in interest rates. 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

9


their amortized cost basis. We did not recognize an allowance for credit losses as of September 30, 2021 or December 31, 2020.
The following table summarizes debt securities available-for-sale in an unrealized loss position for less than 12 months, aggregated by major security type. There were no debt securities available-for-sale in an unrealized loss position for longer than 12 months as of September 30, 2021 or December 31, 2020.
September 30,
2021
December 31,
2020
(in millions)Fair
Value
Unrealized
Loss
Fair
Value
Unrealized
Loss
Corporate Debt Securities$298.5 $(0.3)$ $ 
Securities of government-sponsored entities107.3 (0.1)95.0 (0.1)
$405.8 $(0.4)$95.0 $(0.1)
Accrued interest receivables on debt securities available-for-sale totaled $2.8 million and $3.7 million as of September 30, 2021 and December 31, 2020, respectively. 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 nine months ended September 30, 2021 or 2020.
4. Fair Value Measurements
We record cash equivalents and investments in debt securities available-for-sale and equity securities at fair value based on a fair value hierarchy that distinguishes between assumptions based on market data (observable inputs) and our own assumptions (unobservable inputs). 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.
Investments in debt securities available-for-sale are classified as Level 2 and carried at fair value. We estimate the fair value of debt securities available-for-sale by utilizing third-party pricing services. These pricing services utilize industry standard valuation models, including both income and market-based approaches, for which all significant inputs are observable, either directly or indirectly, to estimate fair value. Such inputs include market pricing based on real-time trade data for similar instruments, issuer credit spreads, benchmark yields, broker/dealer quotes and other observable inputs. We validate valuations obtained from third-party pricing services by understanding the models used, obtaining market values from other pricing sources, and analyzing data in certain instances.
Investments in equity securities of certain companies that are subject to certain holding period restrictions are classified as Level 3 and carried at fair value using an option pricing valuation model. The most significant assumptions within the option pricing valuation model are the stock price volatility, which is based on the historical volatility of similar companies, and the discount for lack of marketability related to the term of the restrictions.
The carrying amounts of accounts receivable and accounts payable and accrued liabilities approximate their fair values due to their short-term maturities.

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Investments, which were measured at fair value on a recurring basis, consisted of the following:
September 30,
2021
December 31,
2020
Fair
Value
Fair Value Measurements UsingFair
Value
Fair Value Measurements Using
(in millions)Level 1Level 2Level 3Level 1Level 2Level 3
Cash and cash equivalents:
Cash and money market funds$311.1 $311.1 $ $ $187.1 $187.1 $ $ 
Restricted cash:
Certificates of deposit3.2 3.2   3.2 3.2 
Debt securities available-for-sale:
Commercial paper208.6  208.6  82.2 82.2 
Corporate debt securities499.3  499.3  445.9 445.9 
Securities of government-sponsored entities260.6  260.6  312.9 312.9 
Equity securities:
Equity securities–biotechnology industry35.3   35.3 38.2 38.2 
$1,318.1 $314.3 $968.5 $35.3 $1,069.5 $190.3 $841.0 $38.2 
The following table presents a reconciliation of equity security investments, which were measured at fair value on a recurring basis using significant unobservable inputs (Level 3):
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions)2021202020212020
Balance at beginning of period$38.9 $50.7 $38.2 $55.9 
Purchases (1)
4.6  4.6  
Unrealized loss included in earnings(8.2)(7.0)(7.5)(12.2)
Balance at end of period$35.3 $43.7 $35.3 $43.7 
_________________________
(1) In September 2021, we purchased 0.3 million shares of Xenon's common stock, valued at $4.6 million on the date of purchase, in connection with the approval of the CTA for NBI-921352.
As of September 30, 2021, the discount for lack of marketability used in the valuation analysis of equity security investments ranged from 2.5% to 7.5% (weighted average of 3.9%). The discount for lack of marketability was weighted by the relative fair value of the instruments. A significant increase (decrease) in the discount for lack of marketability in isolation would result in a significantly lower (higher) fair value measurement. Unrealized gains and losses on equity security investments are included in other income (expense), net.
5. Inventories
Inventories consisted of the following:
(in millions)September 30,
2021
December 31,
2020
Raw materials$13.0 $16.6 
Work in process1.3 2.4 
Finished goods11.2 9.0 
Total inventories$25.5 $28.0 
6. Cash, Cash Equivalents and Restricted Cash
The following table presents a reconciliation of cash, cash equivalents and restricted cash to amounts shown in the condensed consolidated statements of cash flows.
(in millions)September 30,
2021
September 30,
2020
Cash and cash equivalents$311.1 $425.3 
Restricted cash included in other assets3.2 3.2 
Total cash, cash equivalents and restricted cash$314.3 $428.5 

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7. Leases
We have operating leases for our office and laboratory facilities, including our corporate headquarters, with terms that expire from 2024 through 2031. 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 operating lease right-of-use, or ROU, assets or operating lease liabilities. In connection with our operating leases, in lieu of a cash security deposits, Wells Fargo Bank, N.A., issued letters of credit on our behalf, which are secured by deposits totaling $3.2 million.
The following table presents supplemental operating lease information.
Nine Months Ended
September 30,
(in millions, except weighted average data)20212020
Operating lease cost$11.2 $7.4 
Cash paid for amounts included in the measurement of operating lease liabilities$9.1 $6.4 
September 30,
2021
September 30,
2020
Weighted average remaining lease term
9.0 years10.5 years
Weighted average discount rate5.3 %5.8 %
The following table presents approximate future minimum lease payments under operating leases.
(in millions)September 30,
2021
Year ending December 31, 2021 (3 months remaining)
$3.5 
Year ending December 31, 2022
16.8 
Year ending December 31, 2023
17.5 
Year ending December 31, 2024
17.0 
Year ending December 31, 2025
15.5 
Thereafter85.4 
Total operating lease payments155.7 
Less accreted interest33.8 
Total operating lease liabilities121.9 
Less current operating lease liabilities included in other current liabilities15.5 
Noncurrent operating lease liabilities$106.4 
8. Convertible Senior Notes
On May 2, 2017, we completed a private placement of $517.5 million in aggregate principal amount of the 2024 Notes and entered into an indenture agreement, or the 2024 Indenture, with respect to the 2024 Notes. In November 2020, we entered into separate, privately negotiated transactions with certain holders of the 2024 Notes to repurchase $136.2 million aggregate principal amount of the 2024 Notes for an aggregate repurchase price of $186.9 million in cash. At September 30, 2021, $381.2 million aggregate principal amount of the 2024 Notes remained outstanding. Interest on the 2024 Notes is due semi-annually on May 15 and November 15 of each year.
Pursuant to the terms of the 2024 notes, we could not redeem the 2024 Notes prior to May 15, 2021. On or after May 15, 2021, we may redeem for cash all or part of the 2024 Notes if the last reported sale price (as defined in the 2024 Indenture) of our common stock has been at least 130% of the conversion price then in effect (equal to $98.70 as of September 30, 2021) for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading-day period ending on, and including, the trading day immediately before the date which we provide notice of redemption.
Holders of the 2024 Notes may convert the 2024 Notes at any time prior to the close of business on the business day immediately preceding May 15, 2024, only under the following circumstances:
(i)during any calendar quarter (and only during such calendar quarter), if the last reported sale price of our common stock for at least 20 trading days (whether or not consecutive) during a period of 30 consecutive trading days ending on the last trading day of the immediately preceding calendar quarter is greater than 130% of the conversion price (equal to $98.70 as of September 30, 2021) on each applicable trading day;

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(ii)during the five business-day period immediately after any five consecutive trading-day period (the measurement period) in which the trading price (as defined in the 2024 Indenture) per $1,000 principal amount of the 2024 Notes for each trading day of the measurement period was less than 98% of the product of the last reported sale price of our common stock and the conversion rate on each such trading day;
(iii)upon the occurrence of specified corporate events, including a merger or a sale of all or substantially all of our assets; or
(iv)if we call the 2024 Notes for redemption, until the close of business on the business day immediately preceding the redemption date.
On or after January 15, 2024, until the close of business on the scheduled trading day immediately preceding May 15, 2024, holders may convert their 2024 Notes at any time.
Upon conversion, holders will receive the principal amount of their 2024 Notes and any excess conversion value, calculated based on the per share volume-weighted average price for each of the 30 consecutive trading days during the observation period (as more fully described in the 2024 Indenture). For both the principal and excess conversion value, holders may receive cash, shares of our common stock or a combination of cash and shares of our common stock, at our option.
It is our intent and policy to settle conversions through combination settlement, which essentially involves repayment of an amount of cash equal to the “principal portion” and delivery of the “share amount” in excess of the principal portion in shares of common stock or cash. In general, for each $1,000 in principal, the “principal portion” of cash upon settlement is defined as the lesser of $1,000, and the conversion value during the 25-day observation period as described in the 2024 Indenture. The conversion value is the sum of the daily conversion value which is the product of the effective conversion rate divided by 25 days and the daily volume weighted average price, or VWAP, of our common stock. The “share amount” is the cumulative “daily share amount” during the observation period, which is calculated by dividing the daily VWAP into the difference between the daily conversion value (i.e., conversion rate x daily VWAP) and $1,000.
The initial conversion rate for the 2024 Notes is 13.1711 shares of common stock per $1,000 principal amount, which is equivalent to an initial conversion price of approximately $75.92 per share of our common stock. At the initial conversion rate, settlement of the 2024 Notes for shares of our common stock would approximate 5.0 million shares. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. The initial conversion price of the 2024 Notes represented a premium of approximately 42.5% to the closing sale price of $53.28 per share of our common stock on the Nasdaq Global Select Market on April 26, 2017, the date that we priced the private offering of the 2024 Notes.
In the event of conversion, holders would forgo all future interest payments, any unpaid accrued interest and the possibility of further stock price appreciation. Upon the receipt of conversion requests, the settlement of the 2024 Notes will be paid pursuant to the terms of the 2024 Indenture. In the event that all of the 2024 Notes are converted, we would be required to repay the $381.2 million in principal value and any conversion premium in any combination of cash and shares of our common stock, at our option.
If we undergo a fundamental change, as defined in the 2024 Indenture, subject to certain conditions, holders of the 2024 Notes may require us to repurchase for cash all or part of their 2024 Notes at a repurchase price equal to 100% of the principal amount of the 2024 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. In addition, if a ‘‘make-whole fundamental change’’ (as defined in the 2024 Indenture) occurs prior to January 15, 2024, we will, in certain circumstances, increase the conversion rate for a holder who elects to convert its notes in connection with the make-whole fundamental change.
The 2024 Notes are our general unsecured obligations that rank senior in right of payment to all of our indebtedness that is expressly subordinated in right of payment to the 2024 Notes, and equal in right of payment to our unsecured indebtedness.
While the 2024 Notes are currently classified as a long-term liability, the future convertibility and associated balance sheet classification will be monitored at each quarterly reporting date and analyzed dependent upon market prices of our common stock during the prescribed measurement periods. In the event that we have the election to redeem the 2024 Notes or the holders of the 2024 Notes have the election to convert the 2024 Notes at any time during the prescribed measurement period, the 2024 Notes would then be considered a current obligation and classified as such.
We are required to separately account for the liability and equity components of the 2024 Notes as they may be settled entirely or partially in cash upon conversion in a manner that reflects our economic interest cost. The liability component of the instrument was valued in a manner that reflects the market interest rate for a similar nonconvertible instrument at the date

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of issuance. The initial carrying value of the liability component of $368.3 million was calculated using a 7.5% assumed borrowing rate. The equity component of $149.2 million, representing the conversion option, was determined by deducting the fair value of the liability component from the par value of the 2024 Notes and was recorded in additional paid-in capital on the consolidated balance sheet at the issuance date. That equity component is treated as a discount on the liability component of the 2024 Notes, which is amortized over the seven-year term of the 2024 Notes using the effective interest rate method. The equity component is not re-measured as long as it continues to meet the conditions for equity classification. At September 30, 2021, the remaining period over which the discount on the liability component will be amortized was approximately 2.6 years.
We allocated the total transaction costs of approximately $14.7 million related to the issuance of the 2024 Notes to the liability and equity components of the 2024 Notes based on their relative values. Transaction costs attributable to the liability component are amortized to interest expense over the seven-year term of the 2024 Notes, and transaction costs attributable to the equity component are netted with the equity component in stockholders’ equity.
The 2024 Notes do not contain any financial or operating covenants or any restrictions on the payment of dividends, the issuance of other indebtedness or the issuance or repurchase of securities by us. The 2024 Indenture contains customary events of default with respect to the 2024 Notes, including that upon certain events of default, 100% of the principal and accrued and unpaid interest on the 2024 Notes will automatically become due and payable.
The 2024 Notes, net of discounts and deferred financing costs, consisted of the following:
(in millions)September 30,
2021
December 31,
2020
Principal$381.2 $381.3 
Deferred financing costs(3.2)(4.0)
Debt discount, net(47.3)(59.4)
Net carrying amount$330.7 $317.9 
The 2024 Notes were recorded at the estimated value of a similar non-convertible instrument on the date of issuance and accretes to the face value of the 2024 Notes over their seven-year term. The fair value of the 2024 Notes, which was estimated utilizing market quotations from an over-the-counter trading market (Level 2), was $497.7 million at September 30, 2021 and $514.3 million at December 31, 2020.
9. Net Income (Loss) Per Share
Net income (loss) per share was calculated as follows:
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions, except per share data)2021202020212020
Net income (loss) - basic and diluted$22.5 $(57.6)$96.9 $59.4 
Weighted-average common shares outstanding:
Basic94.7 93.3 94.5 93.0 
Effect of dilutive securities:
Stock options1.8  1.9 2.5 
Restricted stock (1)
0.2  0.3 0.5 
2024 Notes (2)
1.0  1.1 2.0 
Diluted97.7 93.3 97.9 98.0 
Net income (loss) per share:
Basic$0.24 $(0.62)$1.03 $0.64 
Diluted$0.23 $(0.62)$0.99 $0.61 
Shares excluded from diluted per share amounts because their effect would have been anti-dilutive4.5 10.9 4.0 2.3 
_________________________
(1) In August 2021, our board of directors approved an equity grant in the form of restricted stock units, or RSUs, to our full-time employees other than our executive officers, consisting of approximately 0.5 million RSUs, which will vest over a period of two years.

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(2) Convertible debt instruments that may be settled entirely or partly in cash (such as the 2024 Notes) may, in certain circumstances where the borrower has the ability and intent to settle in cash, be accounted for under the treasury stock method. We issued the 2024 Notes with a combination settlement feature, which we have the ability and intent to use upon conversion of the 2024 Notes, to settle the principal amount of debt for cash and the excess of the principal portion in shares of our common stock. As a result, of the approximately 5.0 million shares underlying the 2024 Notes, only the shares required to settle the excess of the principal portion are considered under the treasury stock method.
10. Legal Proceedings
In the second quarter of 2021, we received notices from (i) Teva Pharmaceuticals Development, Inc., (ii) Lupin Limited, (iii) Crystal Pharmaceutical (Suzhou) Co. Ltd., and (iv) Zydus Pharmaceuticals (USA) Inc. (each an “ANDA Filer”) that each company had filed an abbreviated new drug application, or ANDA, with the FDA seeking approval of a generic version of INGREZZA. The ANDAs each contained a Paragraph IV Patent Certification alleging that certain of our patents covering INGREZZA are invalid and/or will not be infringed by each ANDA Filer’s manufacture, use or sale of the medicine for which the ANDA was submitted. We filed suit in the U.S. District Court for the District of Delaware in July 2021 against (i) Teva Pharmaceuticals, Inc. and its affiliates Teva Pharmaceuticals Development, Inc., Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries Ltd., (ii) Lupin Limited and its affiliates Lupin Pharmaceuticals, Inc., and Lupin Atlantis Holdings S.A., (iii) Crystal Pharmaceutical (Suzhou) Co., Ltd., and its affiliate Crystal Pharmatech Co., Ltd., and (iv) Zydus Pharmaceuticals (USA) Inc. and its affiliates Zydus Worldwide DMCC, Cadila Healthcare Limited d/b/a Zydus Cadila and Zydus Healthcare (USA) LLC. We also filed suit in the U.S. District Court for the District of New Jersey in July 2021 against Zydus Pharmaceuticals (USA) Inc. and its affiliates Zydus Worldwide DMCC, Cadila Healthcare Limited d/b/a Zydus Cadila and Zydus Healthcare (USA) LLC seeking to prevent any ANDA Filer from selling a generic version of INGREZZA.

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations section contains forward-looking statements, which involve risks and uncertainties. Our actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors, including those set forth in Part II, Item 1A under the caption “Risk Factors.” The interim financial statements and this Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the financial statements and notes thereto for the year ended December 31, 2020 and the related Management’s Discussion and Analysis of Financial Condition and Results of Operations, which are contained in our Annual Report on Form 10-K for the year ended December 31, 2020 and our Quarterly Report on Form 10-Q for the nine months ended September 30, 2021.
Overview
We are a neuroscience-focused, biopharmaceutical company dedicated to discovering, developing and delivering life-changing treatments for people with serious, challenging and under-addressed neurological, endocrine and psychiatric disorders. Our diverse portfolio includes United States Food and Drug Administration, or FDA, approved treatments for tardive dyskinesia, Parkinson’s disease, endometriosis*, uterine fibroids* and clinical programs in multiple therapeutic areas. For nearly three decades, we have specialized in targeting and interrupting disease-causing mechanisms involving the interconnected pathways of the nervous and endocrine systems. (*in collaboration with AbbVie Inc.)
We launched INGREZZA® (valbenazine) in the United States, or US, in May 2017 as the first FDA-approved drug for the treatment of tardive dyskinesia. In September 2020, we launched ONGENTYS® (opicapone) for Parkinson's disease in the US, leveraging our existing INGREZZA commercial infrastructure. INGREZZA net product sales represent the significant majority of our total net product sales.
Our partner AbbVie Inc., or AbbVie, launched ORILISSA® (elagolix tablets) in the US and Canada in August and November 2018, respectively. In June 2020, AbbVie launched ORIAHNN® (elagolix, estradiol and norethindrone acetate capsules and elagolix capsules) in the US. We receive royalties at tiered percentage rates on AbbVie net sales of elagolix.
Pipeline Updates:
NBI-921352 (XEN901):
In September 2021, we received approval of a clinical trial application, or CTA, submitted in the European Union for NBI-921352 for the treatment of focal-onset seizures in adults. In connection with the approval of the CTA for NBI-921352, we paid Xenon a regulatory milestone of $10.0 million, of which we expensed $4.5 million as research and development in the third quarter of 2021, and purchased 0.3 million shares of Xenon’s common stock (at $19.9755 per share) for $5.5 million. The purchased shares were recorded at a fair value of $4.6 million after considering Xenon’s stock price on the measurement date and certain transfer restrictions applicable to the shares. Further, we recorded a charge of $0.9 million to research and development to reflect the premium paid on our purchase of the shares on the measurement date.
COVID-19
The global COVID-19 pandemic has dramatically changed the ways in which we live and interact with one another. While we adapt to this new shared reality, our mission remains unchanged: to discover and develop life-changing treatments for people with serious, challenging and under-addressed disorders.
Although the initial impact of the COVID-19 pandemic has subsided, we are uncertain how more transmissible variants may impact our business. We remain committed to (1) prioritizing the safety, health and well-being of patients and their caregivers, healthcare providers and our employees; (2) ensuring patients with tardive dyskinesia are well supported and have continued uninterrupted access to INGREZZA, for which we have not experienced and currently do not expect any supply disruption; and (3) advancing ongoing clinical studies.
Most of our field-based employees have resumed in-person interactions, and certain of our office-based employees began to return to the office, in each case on a voluntary basis and in accordance with location-specific guidance. We are planning for a larger-scale return of our workforce to our offices before the end of 2021 and have developed flexible work arrangement guidelines to help balance business needs, employee health, well-being and safety and the evolving work environment.
Most hospitals, community mental health facilities, physicians’ offices, pharmacies, and other healthcare facilities have relaxed their policies that limited access of patients and our employees to such facilities and limited the ability of patients, pharmacies, and prescribers to interact with each other. However, we anticipate these policies may change from time to time as communities grapple with local or regional outbreaks. The ultimate impact of the COVID-19 pandemic, including any

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lasting effects on our revenue and the way we conduct our business, is highly uncertain and subject to continued change. We recognize that this pandemic will continue to present unique challenges for us throughout 2021, and potentially into 2022.
Results of Operations for the Three and Nine Months Ended September 30, 2021 and 2020
Revenues.
Net Product Sales by Sales Product.
 Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions)
2021202020212020
INGREZZA net product sales$286.5 $254.0 $780.9 $752.7 
ONGENTYS net product sales2.3 0.1 5.7 0.1 
Total net product sales$288.8 $254.1 $786.6 $752.8 
Compared with the comparable period last year, the increase in INGREZZA net product sales for the three months ended September 30, 2021 was primarily driven by record total prescriptions reflecting higher customer demand and increased commercial activities.
Collaboration Revenues by Category.
 Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions)
2021202020212020
Elagolix royalty revenue$5.9 $3.9 $16.3 $13.4 
Milestone revenue— — 15.0 30.0 
Other collaboration revenues
1.3 0.5 3.6 1.8 
Total collaboration revenues$7.2 $4.4 $34.9 $45.2 
Collaboration revenues for the nine months ended September 30, 2021 primarily reflect the achievement of a $15.0 million milestone associated with MTPC's MAA submission for valbenazine for the treatment of tardive dyskinesia in Japan.
Collaboration revenues for the nine months ended September 30, 2020 primarily reflect the achievement of a $30.0 million milestone associated with AbbVie’s receipt of FDA approval for ORIAHNN for uterine fibroids in May 2020.
Operating Expenses.
Cost of Sales.
 Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions)
2021202020212020
Cost of sales$4.2 $2.7 $10.2 $7.2 
Research and Development, or R&D.
We support our drug discovery and development efforts through the commitment of significant resources to discovery, R&D programs and business development opportunities. Costs are reflected in the applicable development stage based upon the program status when incurred. Therefore, the same program could be reflected in different development stages in the same reporting period. For several of our programs, the R&D activities are part of our collaborative and other relationships.
R&D expense categories consist of the following:
Late Stage. Consist of costs incurred for product candidates in Phase II registrational studies and all subsequent activities.
Early Stage. Consist of costs incurred for product candidates after the approval of an investigational new drug application by the applicable regulatory agency through Phase II non-registrational studies.
Research and Discovery. Consist of costs incurred prior to the approval of an investigational new drug application by the applicable regulatory agency.
Milestones. Consist of costs incurred for development and/or regulatory milestones in connection with our collaborative arrangements.

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Payroll and Benefits. Consist of costs incurred for salaries and wages, payroll taxes, benefits and share-based compensation associated with employees involved in R&D activities. Share-based compensation may fluctuate from period to period based on factors that are not within our control, such as our stock price on the dates share-based grants are issued.
Facilities and Other. Consist of indirect costs incurred for the benefit of multiple programs, including depreciation, information technology, and facility-based expenses, such as rent expense.
The following table presents R&D expense by category.
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions)2021202020212020
Late stage$15.8 $15.3 $41.9 $41.4 
Early stage13.9 9.8 27.8 20.0 
Research and discovery14.8 11.7 35.9 31.6 
Milestones5.4 — 5.4 20.0 
Payroll and benefits32.4 24.8 97.0 73.9 
Facilities and other10.4 7.5 32.7 21.4 
Total R&D expense$92.7 $69.1 $240.7 $208.3 
Late Stage. Compared with the comparable periods last year, late-stage R&D expense for the three and nine months ended September 30, 2021 primarily reflects decreased investment associated with our termination of the NBIb-1817 program for Parkinson’s disease in February 2021, offset by continued investment in our Phase III programs in congenital adrenal hyperplasia for adults and pediatric patients and our Phase III Huntington Disease trial.
Early Stage. Compared with the comparable periods last year, early-stage R&D expense for the three and nine months ended September 30, 2021 primarily reflects continued enrollment of our Phase II programs in epileptic encephalopathy with continuous spike and wave during sleep, or CSWS, and essential tremor and our initiation of Phase II programs in focal-onset seizure in adults and SCN8A developmental epileptic encephalopathy, or SCN8A-DEE.
Milestones. R&D expense for the three and nine months ended September 30, 2021 reflects $5.4 million associated with our receipt of approval for the NBI-921352 CTA in September 2021. For the nine months ended September 30, 2020, R&D expense reflects $20.0 million associated with our receipt of FDA approval for ONGENTYS for Parkinson’s disease in April 2020.
Payroll and benefits. Compared with the comparable periods last year, payroll and benefits R&D expense for the three and nine months ended September 30, 2021 reflects higher personnel expenses primarily driven by increased headcount. Payroll and benefits R&D expense for the nine months ended September 30, 2021 also reflects a non-cash share-based compensation charge of $6.4 million related to the modification of certain share-based awards.
Acquired In-Process Research and Development, or IPR&D.
 Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions)
2021202020212020
IPR&D expense$— $118.5 $5.0 $164.5 
IPR&D expense for the three and nine months ended September 30, 2020 reflects $118.5 million of upfront fees paid pursuant to our exclusive license agreement with Takeda Pharmaceutical Company Limited, or Takeda. IPR&D expense for the nine months ended September 30, 2020 also reflects $46.0 million of upfront fees paid pursuant to our collaboration and license agreement with Idorsia.
Selling, General and Administrative, or SG&A.
 Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions)
2021202020212020
SG&A expense$154.6 $112.5 $426.8 $326.8 
Compared with the comparable periods last year, SG&A expense for the three and nine months ended September 30, 2021 primarily reflects increased investment to support our commercial initiatives, including the May 2021 launch of our INGREZZA direct-to-consumer advertising campaign, "TD Spotlight".

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Other Expense, Net.
Three Months Ended
September 30,
Nine Months Ended
September 30,
(in millions)2021202020212020
Interest expense$(6.6)$(8.5)$(19.2)$(25.0)
Unrealized loss on equity securities(8.2)(7.0)(7.5)(12.2)
Investment income and other, net0.8 2.7 3.1 11.0 
Total other expense, net$(14.0)$(12.8)$(23.6)$(26.2)
Compared to the comparable periods last year, other expense, net, for the three and nine months ended September 30, 2021 reflects periodic fluctuations in unrealized losses recognized to adjust our equity investments in Voyager and Xenon to fair value and decreased interest expense resulting from the November 2020 repurchase of $136.2 million aggregate principal amount of the 2.25% convertible senior notes due May 15, 2024, or the 2024 Notes, for an aggregate repurchase price of $186.9 million in cash.
Provision for Income Taxes.
Three Months Ended
September 30,