Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 26, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | ACAD | |
Entity Registrant Name | ACADIA PHARMACEUTICALS INC. | |
Entity Central Index Key | 0001070494 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Current Reporting Status | Yes | |
Entity Shell Company | false | |
Entity File Number | 000-50768 | |
Entity Tax Identification Number | 06-1376651 | |
Entity Interactive Data Current | Yes | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity Address, Address Line One | 12830 El Camino Real | |
Entity Address, Address Line Two | Suite 400 | |
Entity Address, City or Town | San Diego | |
Entity Address, State or Province | CA | |
Entity Address, Postal Zip Code | 92130 | |
City Area Code | 858 | |
Local Phone Number | 558-2871 | |
Entity Incorporation, State or Country Code | DE | |
Title of 12(b) Security | Common Stock, par value $0.0001 per share | |
Security Exchange Name | NASDAQ | |
Entity Common Stock, Shares Outstanding | 162,625,379 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Assets | ||
Cash and cash equivalents | $ 290,895 | $ 114,846 |
Investment securities, available-for-sale | 111,978 | 301,977 |
Accounts receivable, net | 65,915 | 62,195 |
Interest and other receivables | 4,335 | 885 |
Inventory | 6,095 | 6,636 |
Prepaid expenses | 23,632 | 21,398 |
Total current assets | 502,850 | 507,937 |
Property and equipment, net | 5,595 | 6,021 |
Operating lease right-of-use assets | 54,151 | 55,573 |
Intangible assets, net | 69,583 | 0 |
Restricted cash | 5,770 | 5,770 |
Long-term inventory | 4,924 | 4,924 |
Other assets | 12,432 | 7,587 |
Total assets | 655,305 | 587,812 |
Liabilities and stockholders’ equity | ||
Accounts payable | 17,422 | 12,746 |
Accrued liabilities | 206,879 | 112,884 |
Total current liabilities | 224,301 | 125,630 |
Operating lease liabilities | 51,441 | 52,695 |
Other long-term liabilities | 5,305 | 9,074 |
Total liabilities | 281,047 | 187,399 |
Commitments and contingencies (Note 9) | ||
Stockholders’ equity: | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized at March 31, 2023 and December 31, 2022; no shares issued and outstanding at March 31, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.0001 par value; 225,000,000 shares authorized at March 31, 2023 and December 31, 2022; 162,384,178 shares and 162,064,872 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively. | 16 | 16 |
Additional paid-in capital | 2,787,034 | 2,770,923 |
Accumulated deficit | (2,412,572) | (2,369,551) |
Accumulated other comprehensive loss | (220) | (975) |
Total stockholders’ equity | 374,258 | 400,413 |
Total liabilities and stockholders’ equity | $ 655,305 | $ 587,812 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 225,000,000 | 225,000,000 |
Common stock, shares issued | 162,384,178 | 162,064,872 |
Common stock, shares outstanding | 162,384,178 | 162,064,872 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenues | ||
Type of Revenue [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember |
Total revenues | $ 118,462 | $ 115,468 |
Operating expenses | ||
Type of Cost, Good or Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember |
Cost of product sales | $ 1,667 | $ 2,950 |
Research and development | 69,144 | 128,855 |
Selling, general and administrative | 101,235 | 96,679 |
Total operating expenses | 172,046 | 228,484 |
Loss from operations | (53,584) | (113,016) |
Interest income, net | 3,800 | 105 |
Other income | 4,845 | 340 |
Loss before income taxes | (44,939) | (112,571) |
Income tax (benefit) expense | (1,918) | 485 |
Net loss | $ (43,021) | $ (113,056) |
Net loss per common share, basic | $ (0.27) | $ (0.70) |
Net loss per common share, diluted | $ (0.27) | $ (0.70) |
Weighted average common shares outstanding, basic | 162,263 | 161,231 |
Weighted average common shares outstanding, diluted | 162,263 | 161,231 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Comprehensive Income [Abstract] | ||
Net loss | $ (43,021) | $ (113,056) |
Other comprehensive income (loss): | ||
Unrealized gain (loss) on investment securities | 757 | (422) |
Foreign currency translation adjustments | (2) | 2 |
Comprehensive loss | $ (42,266) | $ (113,476) |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities | ||
Net loss | $ (43,021) | $ (113,056) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation | 14,705 | 14,963 |
Amortization of premiums and accretion of discounts on investment securities | (2,267) | 447 |
Gain on strategic investment | (4,845) | (339) |
Loss on sale of investment securities | 505 | 0 |
Depreciation | 426 | 516 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (3,720) | 1,653 |
Interest and other receivables | (3,450) | 209 |
Inventory | 481 | 833 |
Prepaid expenses | (2,234) | (1,863) |
Operating lease right-of-use assets | 1,726 | 1,522 |
Accounts payable | 4,676 | 3,892 |
Accrued liabilities | 24,510 | 19,672 |
Operating lease liabilities | (1,656) | (2,117) |
Long-term liabilities | (3,769) | (2,661) |
Net cash used in operating activities | (17,933) | (76,329) |
Cash flows from investing activities | ||
Purchases of investment securities | (66,892) | 0 |
Sale and maturity of investment securities | 259,410 | 131,345 |
Net cash provided by investing activities | 192,518 | 131,345 |
Cash flows from financing activities | ||
Proceeds from issuance of common stock, net of issuance costs | 1,466 | 2,467 |
Net cash provided by financing activities | 1,466 | 2,467 |
Effect of exchange rate changes on cash | (2) | 2 |
Net increase (decrease) in cash, cash equivalents and restricted cash | 176,049 | 57,485 |
Cash, cash equivalents and restricted cash | ||
Beginning of period | 120,616 | 153,205 |
End of period | 296,665 | 210,690 |
Supplemental disclosure of noncash information: | ||
Accrued milestone and contingent payments in connection with asset acquisition | $ 69,583 | $ 0 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Stockholders' Equity (Unaudited) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Other Comprehensive Income (Loss) |
Beginning balance at Dec. 31, 2021 | $ 540,894 | $ 16 | $ 2,694,646 | $ (2,153,576) | $ (192) |
Issuance of common stock from exercise of stock options and units | 2,467 | ||||
Stock-based compensation | 14,912 | ||||
Net loss | (113,056) | (113,056) | |||
Other comprehensive (loss) income | (420) | ||||
Ending balance at Mar. 31, 2022 | 444,797 | 16 | 2,712,025 | (2,266,632) | (612) |
Beginning balance at Dec. 31, 2022 | 400,413 | 16 | 2,770,923 | (2,369,551) | (975) |
Issuance of common stock from exercise of stock options and units | 1,466 | ||||
Stock-based compensation | 14,645 | ||||
Net loss | (43,021) | (43,021) | |||
Other comprehensive (loss) income | 755 | ||||
Ending balance at Mar. 31, 2023 | $ 374,258 | $ 16 | $ 2,787,034 | $ (2,412,572) | $ (220) |
Organization and Business
Organization and Business | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Organization and Business | 1. Organization and Business Acadia Pharmaceuticals Inc. (the Company), based in San Diego, California, is a biopharmaceutical company focused on the development and commercialization of innovative medicines to address unmet medical needs in central nervous system (CNS) disorders and rare diseases. In April 2016, the U.S. Food and Drug Administration (FDA) approved the Company’s first drug, NUPLAZID ® (pimavanserin), for the treatment of hallucinations and delusions associated with Parkinson’s disease psychosis (PDP). NUPLAZID became available for prescription in the United States in May 2016. In March 2023, the FDA approved the Company’s second drug, DAYBUE (trofinetide), for the treatment of Rett syndrome. DAYBUE became available for prescription in the United States in April, 2023. |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | 2. Basis of Presentation and Significant Accounting Policies Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company should be read in conjunction with the audited financial statements and notes thereto as of and for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K (Annual Report) filed with the Securities and Exchange Commission (the SEC). The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, the accompanying financial statements reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair statement of the financial position, results of operations, cash flows, and stockholders’ equity for the interim periods presented. Interim results are not necessarily indicative of results for a full year. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ materially from those estimates. Risk and Uncertainties The global pandemic resulting from the disease known as COVID-19, caused by a novel strain of coronavirus, SARS-CoV-2, has caused national and global economic and financial market disruptions and has adversely impacted the Company’s business. Since the beginning of the pandemic, the growth of sales of NUPLAZID have been negatively impacted by ongoing conditions related to the pandemic. At this time the Company cannot predict the magnitude of the pandemic or the full impact that it may have on the Company’s financial condition, operations, suppliers, and workforce. In addition to the ongoing COVID-19 pandemic, global economic and business activities continue to face widespread macroeconomic uncertainties, including labor shortages, inflation and monetary supply shifts, recession risks, recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures, and potential disruptions from the Russia-Ukraine conflict. The Company continues to actively monitor the impact of these macroeconomic factors on its financial condition, liquidity, operations and workforce. The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected time frame, will depend on future developments, which are uncertain and cannot be predicted; however, any continued or renewed disruption resulting from these factors could negatively impact the Company’s business. Cash, Cash Equivalents and Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated statements of cash flows that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands): March 31, 2023 March 31, 2022 Beginning of End of Beginning of End of Cash and cash equivalents $ 114,846 $ 290,895 $ 147,435 $ 204,920 Restricted cash 5,770 5,770 5,770 5,770 Total cash, cash equivalents and restricted cash shown in $ 120,616 $ 296,665 $ 153,205 $ 210,690 Accounts Receivable Accounts receivable are recorded net of customer allowances for distribution fees, prompt payment discounts, chargebacks, and credit losses. Allowances for distribution fees, prompt payment discounts and chargebacks are based on contractual terms. The Company estimated the current expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about collectability, including historical credit losses, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. The Company has not historically experienced significant credit losses. Based on its assessment, as of March 31, 2023 the Company determined that an allowance for credit loss was not required. License Fees and Royalties The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale. Intangible Assets Finite-lived intangible assets are recorded at cost, net of accumulated amortization, and, if applicable, impairment charges. Amortization of finite-lived intangible assets is recorded over the assets’ estimated useful lives on a straight-line basis or based on the pattern in which economic benefits are consumed, if reliably determinable. We review our finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such intangible assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of intangible the assets exceeds the estimated fair value of the intangible assets. No impairment loss was recorded on intangible assets during the three months ended March 31, 2023 and 2022. |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2023 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 3. Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted average number of common shares outstanding for the period, without consideration for common stock equivalents. Diluted net loss per share is computed by dividing the net loss by the weighted average number of common shares and common stock equivalents outstanding for the period determined using the treasury stock method. For purposes of this calculation, stock options, employee stock purchase plan rights, restricted stock units, and warrants are considered to be common stock equivalents but are not included in the calculations of diluted net loss per share for the periods presented as their effect would be anti-dilutive. The Company incurred net losses for all periods presented and there were no reconciling items for potentially dilutive securities. More specifically, at March 31, 2023 and 2022, stock options, employee stock purchase plan rights, restricted stock units, and warrants totaling approximately 20,764,000 sha res and 17,540,000 shares, respectively, were excluded from the calculation of diluted net loss per share as their effect would have been anti-dilutive. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 4. Stock-Based Compensation The following table summarizes the total stock-based compensation expense included in the Company’s statements of operations for the periods presented (in thousands): Three Months Ended March 31, 2023 2022 Cost of product sales $ 168 $ 323 Research and development 3,972 5,464 Selling, general and administrative 10,565 9,176 $ 14,705 $ 14,963 The fair value of each employee stock option and each employee stock purchase plan right granted is estimated on the grant date under the fair value method using the Black-Scholes valuation model, which requires the Company to make a number of assumptions including the estimated expected life of the award and related volatility. The fair value of restricted stock units is estimated based on the market price of the Company’s common stock on the date of grant. The estimated fair values of stock options, purchase plan rights, and restricted stock units are then expensed over the requisite service period, which is generally the vesting period. For restricted stock units requiring satisfaction of both market and service conditions, the estimated fair values are generally expensed over the longest of the explicit, implicit and derived service periods. Performance-based stock awards vest upon the achievement of certain pre-defined company-specific performance-based criteria. Expense related to these performance-based stock awards is generally recognized ratably over the expected performance period once the pre-defined performance-based criteria for vesting becomes probable. |
Balance Sheet Details
Balance Sheet Details | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Details | 5. Balance Sheet Details Inventory consisted of the following (in thousands): March 31, December 31, Finished goods $ 1,594 $ 1,926 Work in process 4,251 4,427 Raw material 5,174 5,207 $ 11,019 $ 11,560 Reported as: Inventory $ 6,095 $ 6,636 Long-term inventory 4,924 4,924 Total $ 11,019 $ 11,560 Amount reported as long-term inventory consisted of raw materials as of March 31, 2023 and December 31, 2022. The Company has raw materials beyond a one year production plan that help limit the exposures from potential supply interruption. Those raw materials beyond the one year production plan were classified as long-term inventory. Accrued liabilities consisted of the following (in thousands): March 31, December 31, Accrued milestone and contingent payments $ 69,583 $ — Accrued sales allowances 50,137 26,046 Accrued research and development services 33,656 35,048 Accrued compensation and benefits 21,192 28,023 Accrued consulting and professional fees 12,876 11,377 Current portion of lease liabilities 9,173 9,305 Other 10,262 3,085 $ 206,879 $ 112,884 |
Investments
Investments | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | 6. Investments The carrying value and amortized cost of the Company’s investments, summarized by major security type, consisted of the following (in thousands): March 31, 2023 Amortized Unrealized Unrealized Estimated Government sponsored enterprise securities $ 104,852 $ 27 $ ( 231 ) $ 104,648 Municipal bonds 7,360 — ( 30 ) 7,330 $ 112,212 $ 27 $ ( 261 ) $ 111,978 December 31, 2022 Amortized Unrealized Unrealized Estimated U.S. Treasury notes $ 15,956 $ — $ ( 11 ) $ 15,945 Government sponsored enterprise securities 81,216 16 ( 291 ) 80,941 Corporate debt securities 20,873 — ( 98 ) 20,775 Commercial paper 184,923 30 ( 637 ) 184,316 $ 302,968 $ 46 $ ( 1,037 ) $ 301,977 The Company has classified all of its available-for-sale investment securities as current assets on its condensed consolidated balance sheets based on the highly liquid nature of the investment securities and because these investment securities are considered available for use in current operations. The Company has classified all equity securities as other assets on its condensed consolidated balance sheets. At March 31, 2023 and December 31, 2022 , the Company had 17 and 43 available-for-sale investment securities, respectively, in an unrealized loss position. The following table presents gross unrealized losses and fair value for those available-for-sale investment securities that were in an unrealized loss position as of March 31, 2023 and December 31, 2022, aggregated by investment category and length of time that the individual securities have been in a continuous loss position (in thousands): Less Than 12 Months 12 Months or Greater Total Estimated Unrealized Estimated Unrealized Estimated Unrealized March 31, 2023 Government sponsored enterprise securities $ 87,812 $ ( 231 ) $ — $ — $ 87,812 $ ( 231 ) Municipal bonds 7,330 ( 30 ) — — 7,330 ( 30 ) Total $ 95,142 $ ( 261 ) $ — $ — $ 95,142 $ ( 261 ) Less Than 12 Months 12 Months or Greater Total Estimated Unrealized Estimated Unrealized Estimated Unrealized December 31, 2022 U.S. Treasury notes $ 15,945 $ ( 11 ) $ — $ — $ 15,945 $ ( 11 ) Government sponsored enterprise securities 58,254 ( 291 ) — — 58,254 ( 291 ) Corporate debt securities 20,775 ( 98 ) — — 20,775 ( 98 ) Commercial paper 135,200 ( 637 ) — — 135,200 ( 637 ) Total $ 230,174 $ ( 1,037 ) $ — $ — $ 230,174 $ ( 1,037 ) For the three months ended March 31, 2023, the Company made a sale of all of its investments in commercial paper. The proceeds from sales of these securities were $ 183.0 million and net realized losses from the related sales were $ 0.5 million. There were no other sales of available-for-sale investment securities in prior periods. At each reporting date, the Company performs an evaluation of impairment to determine if any unrealized losses are the result of credit losses. Impairment is assessed at the individual security level. Factors considered in determining whether a loss resulted from a credit loss or other factors include the Company’s intent and ability to hold the investment until the recovery of its amortized cost basis, the extent to which the fair value is less than the amortized cost basis, the length of time and extent to which fair value has been less than the cost basis, the financial condition of the issuer, any historical failure of the issuer to make scheduled interest or principal payments, any changes to the rating of the security by a rating agency, any adverse legal or regulatory events affecting the issuer or issuer’s industry, any significant deterioration in economic conditions. As of March 31, 2023, the Company did not intend to sell the investments in unrealized loss position and it was unlikely that the Company will be required to sell the investments before the recovery of their amortized cost basis. The Company has not historically experienced significant losses on its investments. Based on its evaluation, the Company determined its year-to-date credit losses related to its available-for-sale securities were immaterial at March 31, 2023 . |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | 7. Fair Value Measurements The Company’s investments include cash equivalents, available-for-sale investment securities consisting of money market funds, municipal bonds , and government sponsored enterprises in accordance with the Company’s investment policy, and equity securities. The Company’s investment policy defines allowable investment securities and establishes guidelines relating to credit quality, diversification, and maturities of its investments to preserve principal and maintain liquidity. All investment securities have a credit rating of at least Aa3/AA- or better, or P-1/A-1 or better, as determined by Moody’s Investors Service or Standard & Poor’s. The Company’s cash equivalents, available-for-sale investment securities and equity securities are classified within the fair value hierarchy as defined by authoritative guidance. The Company’s investment securities and equity securities classified as Level 1 are valued using quoted market prices. The Company obtains the fair value of its Level 2 financial instruments from third-party pricing services. The pricing services utilize industry standard valuation models whereby all significant inputs, including benchmark yields, reported trades, broker/dealer quotes, issuer spreads, bids, offers, or other market-related data, are observable. The Company validates the prices provided by the third-party pricing services by reviewing their pricing methods and matrices, and obtaining market values from other pricing sources. After completing the validation procedures, the Company did not adjust or override any fair value measurements provided by these pricing services as of March 31, 2023 and December 31, 2022. In November 2021, the Company established a plan whereby substantially all full-time employees excluding executive management are eligible to receive a series of cash bonuses based on achievement of certain conditions as described in more detail in Note 8 to the condensed consolidated financial statements included in this quarterly report on Form 10-Q (this Quarterly Report). The Company estimated the fair value of the cash awards using a Monte Carlo simulation, which utilizes level 3 inputs such as volatility, probabilities of success, and other inputs that are not observable in active markets. The cash awards are required to be measured at fair value on a recurring basis each reporting period, with changes in the fair value recognized as compensation cost over the derived service period of the awards. The acquisition related contingent payment is the estimated value of the Rare Pediatric Disease Priority Review Voucher (PRV) owed to Neuren Pharmaceuticals Limited (Neuren) in connection with the asset acquisition as described in more detail in Note 9 to the condensed consolidated financial statements included in this Quarterly Report. The Company estimated the fair value of the contingent payment to be settled in cash using the most recent publicly announced sales of Rare Pediatric Disease PRVs pursuant to the term of the license agreement, which is a Level 3 measurement. The contingent payment is required to be measured at fair value on a recurring basis each reporting period. Changes in the fair value of the contingent payment will be recognized as changes in the estimated value of intangible assets with cumulative adjustment over the amortization period. No contingent payment was paid as of March 31, 2023. The Company has not transferred any investment securities between the classification levels. The recurring fair value measurements of the Company’s financial assets and liabilities measured at March 31, 2023 and December 31, 2022 consisted of the following (in thousands): Fair Value Measurements at March 31, Quoted Prices Significant Significant Assets Money market fund $ 287,113 $ 287,113 $ — $ — Equity securities 12,026 12,026 — — Government sponsored enterprise securities 104,648 — 104,648 — Municipal bonds 7,330 — 7,330 — Total $ 411,117 $ 299,139 $ 111,978 $ — Liabilities Cash awards $ 1,247 $ — $ — $ 1,247 Acquisition related contingent payment 29,583 29,583 Total $ 30,830 $ — $ — $ 30,830 Fair Value Measurements at December 31, Quoted Prices Significant Significant Assets Money market fund $ 72,578 $ 72,578 $ — $ — U.S. Treasury notes 15,945 15,945 — — Equity securities 7,180 7,180 — — Government sponsored enterprise securities 94,803 — 94,803 — Municipal bonds 20,775 — 20,775 — Commercial paper 184,316 — 184,316 — Total $ 395,597 $ 95,703 $ 299,894 $ — Liabilities Cash awards $ 898 $ — $ — $ 898 Total $ 898 $ — $ — $ 898 There was no change in estimated fair value of acquisition related contingent payment during the three months ended March 31, 2023 . Changes in estimated fair value of contingent cash awards during the three months ended March 31, 2023 are as follows (in thousands): |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Equity [Abstract] | |
Stockholders' Equity | 8. Stockholders’ Equity Contingent Cash Awards In November 2021, the Company established a plan whereby substantially all full-time employees excluding executive management are eligible to receive a series of cash bonuses over certain periods based on continued employment and the Company’s stock price reaching a pre-specified target. The maximum potential payout of the cash awards at the grant date was $ 15.1 million. The Company has determined that the cash awards were classified as liabilities pursuant to ASC Topic 718, Compensation –Stock Compensation . The Company estimates the fair value of the awards at each reporting period using a Monte Carlo simulation, which is recognized as compensation cost over the derived service period . Total fair value of the awards at the grant date was $ 4.4 million. The maximum potential payout at March 31, 2023 after adjusting for forfeitures wa s $ 11.6 m illion. The fair value of the awards at March 31, 2023 was approximately $ 2.1 million. During the three months ended March 31, 2023 and 2022, the Company recorded $ 0.3 million and $ 0.9 million compensation cost related to the awards, respectively. 2023 Inducement Plan The Board adopted the Company’s 2023 Inducement Plan (Inducement Plan) on February 1, 2023. The Inducement Plan permits the grant of stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance stock awards and other stock-related awards. Stock awards granted under the Inducement Plan may only be made to individuals who did not previously serve as employees or non-employee directors of the Company or an affiliate of the Company. In addition, stock awards must be approved by either a majority of the Company’s independent directors or the Compensation Committee. The terms of the Inducement Plan are otherwise substantially similar to the Company’s 2010 Equity Incentive Plan. The maximum number of shares of Company common stock that may be issued under the Inducement Plan is 1,750,000 shares. At March 31, 2023, there were 1,344,680 shares available for new grants. |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Collaboration, License and Merger Agreements The Company has entered into various collaboration, licensing and merger agreements which provide the Company with rights to certain know-how, technology and patent rights. The agreements generally include upfront license fees, development and commercial milestone payments upon achievement of certain clinical and commercial development and annual net sales milestones, as well as royalties calculated as a percentage of product revenues, with rates that vary by agreement. As of March 31, 2023, the Company may be required to make milestone payments up to $ 1.6 billion in the aggregate for candidates in its pipeline. In August 2018, the Company entered into a license agreement with Neuren and obtained exclusive North American rights to develop and commercialize trofinetide for Rett syndrome and other indications. Under the terms of the agreement, the Company paid Neuren an upfront license fee of $ 10.0 million and it may be required to pay up to an additional $ 455.0 million in milestone payments based on the achievement of certain development and annual net sales milestones. In addition, the Company will be required to pay Neuren tiered, escalating, double-digit percentage royalties based on net sales. The license agreement was accounted for as an asset acquisition and the upfront cash payment of $ 10.0 million was expensed to research and development in the third quarter of 2018 as there is no alternative use for the asset. In connection with the FDA approval of DAYBUE in March 2023, the Company is required to make a milestone payment of $ 40.0 million to Neuren following the first commercial sale of DAYBUE pursuant to the license agreement. As of March 31, 2023, the Company has not paid the $ 40.0 million milestone payment and will pay it within 60 days after its first commercial sale of DAYBUE in the U.S. The Company capitalized the $ 40.0 million milestone payment as an intangible asset as it was deemed probable of occurring as of March 31, 2023 and will begin amortizing it on a straight-line basis over the estimated useful life upon the first commercial sale. In addition, the Company was granted a Rare Pediatric Disease PRV following the FDA approval of DAYBUE. Pursuant to the license agreement, the Company is required to pay Neuren one third of the value of the PRV at at the time of sale or use of the PRV. If the PRV is sold, the amount to be paid will be the sale value net applicable fees. If the PRV is not sold but used by the Company, the amount to be paid will be the average price of most recent three publicly announced sales of Rare Pediatric Disease PRVs immediately preceding the issuance of the PRV to the Company. The Company capitalized the $ 29.6 million for the estimated PRV value owed to Neuren as an intangible asset and will amortize it on a straight-line basis over the estimated useful life. In January 2022, the Company entered into a license and collaboration agreement with Stoke Therapeutics, Inc. (Stoke) to discover, develop and commercialize novel RNA-based medicines for the potential treatment of severe and rare genetic neurodevelopmental diseases of the CNS. The collaboration includes SYNGAP1 syndrome, Rett syndrome (MECP2), and an undisclosed neurodevelopmental target. For the SYNGAP1 program, the two companies will jointly share global research, development and commercialization responsibilities and share 50/50 in all worldwide costs and future profits . In addition, Stoke is eligible to receive potential development, regulatory, first commercial sales and sales milestones. For the MECP2 program and the undisclosed neurodevelopmental program, the Company acquired an exclusive worldwide license to develop and commercialize MECP2 program and the undisclosed neurodevelopmental program. Stoke will lead research and pre-clinical development activities, while the Company will lead clinical development and commercialization activities. The Company will fund research and pre-clinical development activities related to these two targets and Stoke is eligible to receive potential development, regulatory, first commercial sales and sales milestones as well as tiered royalty payments on worldwide sales starting in the mid-single digit range and escalating to the mid-teens based on revenue levels. Under the terms of the agreement, the Company paid Stoke a $ 60.0 million upfront payment which was accounted for as an asset acquisition and was expensed to research and development in the first quarter of 2022 as there is no alternative use for the asset. The Company may be required to pay up to an additional $ 907.5 million in milestones as well as royalties on future sales. Corporate Credit Card Program In connection with the Company’s credit card program, the Company established a letter of credit for $ 2.0 million, which has automatic annual extensions and is fully secured by restricted cash. Fleet Program In connection with the Company’s fleet program, the Company established a letter of credit for $ 0.4 million, which has automatic annual extensions and is fully secured by restricted cash. Legal Proceedings Patent Infringement On July 24, 2020, the Company filed complaints against (i) Aurobindo Pharma Limited and its affiliate Aurobindo Pharma USA, Inc. and (ii) Teva Pharmaceuticals USA, Inc. and its affiliate Teva Pharmaceutical Industries Ltd., and on July 30, 2020, the Company filed complaints against (i) Hetero Labs Limited and its affiliates Hetero Labs Limited Unit-V and Hetero USA Inc., (ii) MSN Laboratories Private Ltd. and its affiliate MSN Pharmaceuticals, Inc., and (iii) Zydus Pharmaceuticals (USA) Inc. and its affiliate Cadila Healthcare Limited. These complaints, which were filed in the United States District Court for the District of Delaware, allege infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID (Pimavanserin I Cases). The cases have been assigned to the Honorable Richard G. Andrews. On September 1, 2020, Aurobindo filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On September 22, 2020, the Company filed its answer to Aurobindo’s counterclaims. On August 31, 2020, Teva filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On September 21, 2020, the Company filed its answer to Teva’s counterclaims. On October 5, 2020, Hetero filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On October 26, 2020, the Company filed its answer to Hetero’s counterclaims. On September 30, 2020, MSN filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On November 5, 2020, the Company filed its first amended complaint against MSN in the United States District Court for the District of Delaware, alleging infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID. On November 19, 2020, MSN filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On December 10, 2020, the Company filed its answer to MSN’s counterclaims. On November 2, 2020, Zydus filed its answer and counterclaims seeking declaratory judgments of noninfringement and invalidity. On November 23, 2020, the Company filed its answer to Zydus’s counterclaims. On December 8, 2020, the parties’ joint proposed scheduling order was entered by Judge Andrews. On April 7, 2021, the Company filed its first amended complaints against Hetero and Teva and its second amended complaint against MSN, to include an additional Orange Book-listed patent covering NUPLAZID. On April 8, 2021, the Company filed its first amended complaint against Zydus and on April 9, 2021, the Company filed its first amended complaint against Aurobindo. On April 20, 2021, MSN filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On April 21, 2021, Teva filed its answer, affirmative defenses, and counterclaims to the Company’s first amended complaint, seeking declaratory judgments of noninfringement and invalidity. On April 22, 2021, Zydus filed its answer, affirmative defenses, and counterclaims to the Company’s first amended complaint, seeking declaratory judgments of noninfringement and invalidity. On April 22, 2021, Aurobindo filed its answer, affirmative defenses, and counterclaims to the Company’s first amended complaint, seeking declaratory judgments of noninfringement and invalidity. On May 11, 2021, the Company filed its answer to MSN’s counterclaims. On May 12, the Company filed its answer to Teva’s counterclaims. On May 13, the Company filed its answer to Zydus’s counterclaims and its answer to Aurobindo’s counterclaims. A joint trial in the matters is scheduled for May 15, 2023. The Company entered into an agreement effective April 22, 2021 with Hetero settling all claims and counterclaims in the litigation. The agreement allows Hetero to launch its generic pimavanserin product on February 27, 2038, subject to certain triggers for earlier launch. The Hetero case was dismissed by joint agreement on May 3, 2021. On August 27, 2021, the Company filed its second amended complaint against Zydus to include an additional Orange Book-listed patent covering NUPLAZID. On September 10, 2021, Zydus filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity. Also on September 10, 2021, the parties filed their Joint Claim Construction Chart. On October 1, 2021, the Company filed its answer to Zydus’s counterclaims. On November 30, 2021, the Company filed a stipulation and proposed order to dismiss two of its Orange Book-listed patents covering NUPLAZID against Teva, which was ordered by the Court on December 1, 2021. On January 28, 2022, the parties filed their Joint Claim Construction Brief and Appendix. On February 23, 2022, the Court heard oral argument on claim construction. On April 6, 2022, the Court issued a Memorandum Opinion construing several terms at issue, adopting the Company’s construction on two terms, Defendants’ construction on two terms, and one agreed-upon construction. On February 28, 2022, the Company filed a stipulation and proposed order to dismiss one patent against MSN, which was ordered by the Court on March 1, 2022. On March 10, 2022, the Company filed a stipulation and proposed order to dismiss one patent against Teva, which was ordered by the Court on March 10, 2022. On March 22, 2022, the Company filed a stipulation and proposed order to dismiss seven patents against Aurobindo, which was ordered by the Court on March 22, 2022. On March 30, 2022, the Company filed a stipulation and proposed order to dismiss two patents against Zydus, which was ordered by the Court on March 31, 2022. On April 22, 2022, the Company filed a stipulation and proposed order of non-infringement against Aurobindo regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 22, 2022. On April 26, 2022, the Company filed a stipulation and proposed order of non-infringement against MSN regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 26, 2022. On April 26, 2022, the Company filed a stipulation and proposed order of non-infringement against Teva regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on April 27, 2022. On May 10, 2022, the Company filed its second amended complaint against Teva to include an additional Orange Book-listed patent covering NUPLAZID. On May 18, 2022, the Company filed a stipulation and proposed order of non-infringement against Zydus regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID, which was ordered by the Court on May 19, 2022. On May 24, 2022, Teva filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 1, 2022, the Company filed its second amended complaint against Aurobindo alleging infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 2, 2022, the Company filed its third amended complaint against Zydus alleging infringement of certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 14, 2022, the Company filed its answer to Teva’s counterclaims. June 15, 2022, Aurobindo filed its answer, affirmative defenses, and counterclaims to the Company’s second amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On June 16, 2022, Zydus filed its answer, affirmative defenses, and counterclaims to the Company’s third amended complaint, seeking declaratory judgments of noninfringement and invalidity regarding certain of the Company’s Orange Book-listed patents covering NUPLAZID. On July 6, 2022, the Company filed its answer to Aurobindo’s counterclaims. On September 7, 2022, the consolidated cases were reassigned to the Honorable Judge Gregory B. Williams. On September 30, 2022, the Company filed a stipulation and proposed order to stay the claims currently asserted against Teva and for Teva to be bound by the result of the litigation rendered against the remaining Defendants, which was ordered by the Court on October 4, 2022. On October 21, 2022, the Company filed complaints against Aurobindo, MSN and Zydus in the United States District Court for the District of Delaware alleging infringement of an additional Orange Book-listed patent covering NUPLAZID (Pimavanserin II Cases). On March 29, 2023, following Aurobindo’s conversion of various patent certifications from Paragraph IV certifications to Paragraph III certifications in connection with the Pimavanserin I Case, the Company filed a stipulation and proposed order in the Pimavanserin I Case to dismiss the remaining asserted patents against Aurobindo. This stipulation was ordered by the Court on March 30, 2023. The Company entered into an agreement, effective March 31, 2023, with Zydus settling all claims and counterclaims in the Pimavanserin I Cases and Pimavanserin II Cases. The agreement allows Zydus to launch its generic pimavanserin 10 mg products on September 23, 2036 and 34 mg products on February 27, 2038, subject to certain triggers for earlier launch. On April 4, 2023, the Company filed a stipulation and proposed order to dismiss all claims and counterclaims between the Company and Zydus in the Pimavanserin I Cases and Pimavanserin II Cases, which was ordered by the Court on April 5, 2023. In connection with the Pimavanserin I Cases, only MSN remains as an active defendant. On April 6, 2023, the Company and MSN filed a stipulation and proposed order requesting adjournment of the final pre-trial conference and trial, and requesting resolution of the remaining issue – MSN’s validity challenge of the sole patent in suit – through summary judgment briefing by the parties, which was ordered by the Court on April 10, 2023. Briefing is scheduled to be completed on June 28, 2023. Securities Class Action On April 19, 2021, a purported stockholder of the Company filed a putative securities class action complaint (captioned Marechal v. Acadia Pharmaceuticals, Inc., Case No. 21-cv-0762) in the U.S. District Court for the Southern District of California against the Company and certain of the Company’s current executive officers. On September 29, 2021, the Court issued an order designating lead plaintiff and lead counsel. On December 10, 2021, lead plaintiff filed an amended complaint. The amended complaint generally alleges that defendants violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 by failing to disclose that the materials submitted in support of its sNDA seeking approval of pimavanserin for the treatment of hallucinations and delusions associated with dementia-related psychosis contained statistical and design deficiencies and that the FDA was unlikely to approve the sNDA in its current form. The amended complaint seeks unspecified monetary damages and other relief. Defendants filed a motion to dismiss the amended complaint on February 15, 2022. On September 27, 2022, the Court issued an order denying Defendants’ motion to dismiss. Defendants filed their answer to the amended complaint on October 19, 2022, and filed a motion for reconsideration on October 25, 2022. On February 2, 2023, the Court issued an order denying the motion for reconsideration. On March 17, 2023, the Court issued a scheduling order, setting an August 21, 2023, deadline for lead plaintiff to file a motion for class certification, and setting a fact-discovery cutoff of December 15, 2023. The parties are currently engaged in discovery. Management currently believes that none of the foregoing claims or other actions pending against the Company as of March 31, 2023 is likely to have, individually or in the aggregate, a material adverse effect on the Company’s business, liquidity, financial position, or results of operations. Given the unpredictability inherent in litigation, however, the Company cannot predict the outcome of these matters. The Company is unable to estimate possible losses or ranges of losses that may result from these matters, and therefore it has not accrued any amounts in connection with these matters other than attorneys’ fees incurred to date . |
Leases
Leases | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Leases | 10. Leases The Company leases facilities and certain equipment under noncancelable operating leases with remaining lease terms of 0.8 years to 8.2 years , some of which include options to extend for up to two five-year terms. These optional periods were not considered in the determination of the right-of-use asset or the lease liability as the Company did not consider it reasonably certain that it would exercise such options. The operating lease costs were as follows (in thousands): Three Months Ended March 31, 2023 2022 Operating lease cost $ 2,181 $ 2,110 Supplemental cash flow information related to the Company’s leases were as follows (in thousands): Three Months Ended March 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 2,370 $ 2,190 Right-of-use assets obtained in exchange for operating lease obligations: 304 1,440 The balance sheet classification of the Company’s lease liabilities was as follows (in thousands): March 31, December 31, Operating lease liabilities Current portion included in accrued liabilities $ 9,173 $ 9,305 Operating lease liabilities 51,441 52,695 Total operating lease liabilities $ 60,614 $ 62,000 Maturities of lease liabilities were as follows (in thousands): Operating Leases Remainder of 2023 $ 7,127 Years ending December 31, 2024 9,228 2025 9,308 2026 8,672 2027 8,389 Thereafter 28,691 Total lease payments 71,415 Less: Imputed interest ( 10,801 ) Total operating lease liabilities $ 60,614 Operating lease liabilities are based on the net present value of the remaining lease payments over the remaining lease term. In determining the present value of lease payments, the Company uses its incremental borrowing rate based on the information available at the lease commencement date. As of March 31, 2023, the weighted average remaining lease term was 7.7 years and the weighted average discount rate used to determine the operating lease liability was 4.4 % . In the fourth quarter of 2018, the Company entered into an agreement to lease the 4 th and 5 th floors of corporate office space in San Diego, California with total minimum lease payments of $ 50.4 million over an initial term of 10 years and 9 months . In February 2020, the Company entered into the first amendment to the lease agreement to lease the 2 nd floor of corporate office space in San Diego, California with total minimum lease payments of $ 25.3 million over an initial term of approximately 10 years and 7 months. In March 2020, the Company entered into the second amendment to the lease agreement which increased the total minimum lease payments of the original corporate office space to $ 51.4 million. In the third quarter of 2020, the lease for the 4 th and 5 th floors of corporate office space commenced and the Company capitalized a right of use asset and related lease liability of $ 40.3 million. In the first quarter of 2021 , the lease for the 2 nd floor of corporate office space commenced and the Company capitalized a right of use asset and related lease liability of $ 19.2 million. In connection with this lease and the amendment , the Company established a letter of credit for $ 3.1 million, which has automatic annual extensions and is fully secured by restricted cash. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 11. Income Taxes For the three months ended March 31, 2023 and March 31, 2022, the Company recognized an income tax benefit of $ 1.9 million on a pre-tax loss of $ 44.9 million and income tax expense of $ 0.5 million on a pre-tax loss of $ 112.6 million, respectively, resulting in effective tax rates of 4.3 % and - 0.4 %, respectively. The effective tax rate for the three months ended March 31, 2023 varies from the U.S. federal statutory tax rate of 21 % due to federal and state income tax expense as a result of current taxable income, offset by valuation allowance. The effective tax rate for the three months ended March 31, 2022 varies from the U.S. federal statutory tax rate of 21 % due to state income tax expense as a result of current taxable income, offset by valuation allowance. |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying unaudited condensed consolidated financial statements of the Company should be read in conjunction with the audited financial statements and notes thereto as of and for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K (Annual Report) filed with the Securities and Exchange Commission (the SEC). The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the United States (GAAP) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, since they are interim statements, the accompanying financial statements do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of management, the accompanying financial statements reflect all adjustments (consisting of normal recurring adjustments) that are necessary for a fair statement of the financial position, results of operations, cash flows, and stockholders’ equity for the interim periods presented. Interim results are not necessarily indicative of results for a full year. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Actual results could differ materially from those estimates. |
Risk and Uncertainties | Risk and Uncertainties The global pandemic resulting from the disease known as COVID-19, caused by a novel strain of coronavirus, SARS-CoV-2, has caused national and global economic and financial market disruptions and has adversely impacted the Company’s business. Since the beginning of the pandemic, the growth of sales of NUPLAZID have been negatively impacted by ongoing conditions related to the pandemic. At this time the Company cannot predict the magnitude of the pandemic or the full impact that it may have on the Company’s financial condition, operations, suppliers, and workforce. In addition to the ongoing COVID-19 pandemic, global economic and business activities continue to face widespread macroeconomic uncertainties, including labor shortages, inflation and monetary supply shifts, recession risks, recent and potential future disruptions in access to bank deposits or lending commitments due to bank failures, and potential disruptions from the Russia-Ukraine conflict. The Company continues to actively monitor the impact of these macroeconomic factors on its financial condition, liquidity, operations and workforce. The extent of the impact of these factors on the Company’s operational and financial performance, including its ability to execute its business strategies and initiatives in the expected time frame, will depend on future developments, which are uncertain and cannot be predicted; however, any continued or renewed disruption resulting from these factors could negatively impact the Company’s business. |
Cash, Cash Equivalents and Restricted Cash | Cash, Cash Equivalents and Restricted Cash The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated statements of cash flows that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands): March 31, 2023 March 31, 2022 Beginning of End of Beginning of End of Cash and cash equivalents $ 114,846 $ 290,895 $ 147,435 $ 204,920 Restricted cash 5,770 5,770 5,770 5,770 Total cash, cash equivalents and restricted cash shown in $ 120,616 $ 296,665 $ 153,205 $ 210,690 |
Accounts Receivable | Accounts Receivable Accounts receivable are recorded net of customer allowances for distribution fees, prompt payment discounts, chargebacks, and credit losses. Allowances for distribution fees, prompt payment discounts and chargebacks are based on contractual terms. The Company estimated the current expected credit losses of its accounts receivable by assessing the risk of loss and available relevant information about collectability, including historical credit losses, existing contractual payment terms, actual payment patterns of its customers, individual customer circumstances, and reasonable and supportable forecast of economic conditions expected to exist throughout the contractual life of the receivable. The Company has not historically experienced significant credit losses. Based on its assessment, as of March 31, 2023 the Company determined that an allowance for credit loss was not required. |
License Fees and Royalties | License Fees and Royalties The Company expenses amounts paid to acquire licenses associated with products under development when the ultimate recoverability of the amounts paid is uncertain and the technology has no alternative future use when acquired. Acquisitions of technology licenses are charged to expense or capitalized based upon management’s assessment regarding the ultimate recoverability of the amounts paid and the potential for alternative future use. The Company has determined that technological feasibility for its product candidates is reached when the requisite regulatory approvals are obtained to make the product available for sale. |
Intangible Assets | Intangible Assets Finite-lived intangible assets are recorded at cost, net of accumulated amortization, and, if applicable, impairment charges. Amortization of finite-lived intangible assets is recorded over the assets’ estimated useful lives on a straight-line basis or based on the pattern in which economic benefits are consumed, if reliably determinable. We review our finite-lived intangible assets for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. If such intangible assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of intangible the assets exceeds the estimated fair value of the intangible assets. No impairment loss was recorded on intangible assets during the three months ended March 31, 2023 and 2022. |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated statements of cash flows that sum to the total of the same such amounts shown in the condensed consolidated statements of cash flows (in thousands): March 31, 2023 March 31, 2022 Beginning of End of Beginning of End of Cash and cash equivalents $ 114,846 $ 290,895 $ 147,435 $ 204,920 Restricted cash 5,770 5,770 5,770 5,770 Total cash, cash equivalents and restricted cash shown in $ 120,616 $ 296,665 $ 153,205 $ 210,690 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Stock-based Compensation Expense Included in Statements of Operations | The following table summarizes the total stock-based compensation expense included in the Company’s statements of operations for the periods presented (in thousands): Three Months Ended March 31, 2023 2022 Cost of product sales $ 168 $ 323 Research and development 3,972 5,464 Selling, general and administrative 10,565 9,176 $ 14,705 $ 14,963 |
Balance Sheet Details (Tables)
Balance Sheet Details (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Inventory | Inventory consisted of the following (in thousands): March 31, December 31, Finished goods $ 1,594 $ 1,926 Work in process 4,251 4,427 Raw material 5,174 5,207 $ 11,019 $ 11,560 Reported as: Inventory $ 6,095 $ 6,636 Long-term inventory 4,924 4,924 Total $ 11,019 $ 11,560 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): March 31, December 31, Accrued milestone and contingent payments $ 69,583 $ — Accrued sales allowances 50,137 26,046 Accrued research and development services 33,656 35,048 Accrued compensation and benefits 21,192 28,023 Accrued consulting and professional fees 12,876 11,377 Current portion of lease liabilities 9,173 9,305 Other 10,262 3,085 $ 206,879 $ 112,884 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Carrying Value and Amortized Cost of Company Investments Summarized by Major Security Type | The carrying value and amortized cost of the Company’s investments, summarized by major security type, consisted of the following (in thousands): March 31, 2023 Amortized Unrealized Unrealized Estimated Government sponsored enterprise securities $ 104,852 $ 27 $ ( 231 ) $ 104,648 Municipal bonds 7,360 — ( 30 ) 7,330 $ 112,212 $ 27 $ ( 261 ) $ 111,978 December 31, 2022 Amortized Unrealized Unrealized Estimated U.S. Treasury notes $ 15,956 $ — $ ( 11 ) $ 15,945 Government sponsored enterprise securities 81,216 16 ( 291 ) 80,941 Corporate debt securities 20,873 — ( 98 ) 20,775 Commercial paper 184,923 30 ( 637 ) 184,316 $ 302,968 $ 46 $ ( 1,037 ) $ 301,977 |
Summary of Gross Unrealized Losses and Fair Value of Available-For-Sale Investment Securities in Unrealized Loss Position | The following table presents gross unrealized losses and fair value for those available-for-sale investment securities that were in an unrealized loss position as of March 31, 2023 and December 31, 2022, aggregated by investment category and length of time that the individual securities have been in a continuous loss position (in thousands): Less Than 12 Months 12 Months or Greater Total Estimated Unrealized Estimated Unrealized Estimated Unrealized March 31, 2023 Government sponsored enterprise securities $ 87,812 $ ( 231 ) $ — $ — $ 87,812 $ ( 231 ) Municipal bonds 7,330 ( 30 ) — — 7,330 ( 30 ) Total $ 95,142 $ ( 261 ) $ — $ — $ 95,142 $ ( 261 ) Less Than 12 Months 12 Months or Greater Total Estimated Unrealized Estimated Unrealized Estimated Unrealized December 31, 2022 U.S. Treasury notes $ 15,945 $ ( 11 ) $ — $ — $ 15,945 $ ( 11 ) Government sponsored enterprise securities 58,254 ( 291 ) — — 58,254 ( 291 ) Corporate debt securities 20,775 ( 98 ) — — 20,775 ( 98 ) Commercial paper 135,200 ( 637 ) — — 135,200 ( 637 ) Total $ 230,174 $ ( 1,037 ) $ — $ — $ 230,174 $ ( 1,037 ) |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements of Cash Equivalents, Available-For-Sale Investment Securities and Equity Securities | The recurring fair value measurements of the Company’s financial assets and liabilities measured at March 31, 2023 and December 31, 2022 consisted of the following (in thousands): Fair Value Measurements at March 31, Quoted Prices Significant Significant Assets Money market fund $ 287,113 $ 287,113 $ — $ — Equity securities 12,026 12,026 — — Government sponsored enterprise securities 104,648 — 104,648 — Municipal bonds 7,330 — 7,330 — Total $ 411,117 $ 299,139 $ 111,978 $ — Liabilities Cash awards $ 1,247 $ — $ — $ 1,247 Acquisition related contingent payment 29,583 29,583 Total $ 30,830 $ — $ — $ 30,830 Fair Value Measurements at December 31, Quoted Prices Significant Significant Assets Money market fund $ 72,578 $ 72,578 $ — $ — U.S. Treasury notes 15,945 15,945 — — Equity securities 7,180 7,180 — — Government sponsored enterprise securities 94,803 — 94,803 — Municipal bonds 20,775 — 20,775 — Commercial paper 184,316 — 184,316 — Total $ 395,597 $ 95,703 $ 299,894 $ — Liabilities Cash awards $ 898 $ — $ — $ 898 Total $ 898 $ — $ — $ 898 |
Schedule of Changes in Estimated Fair Value of Contingent Cash Awards | Changes in estimated fair value of contingent cash awards during the three months ended March 31, 2023 are as follows (in thousands): Balance as of December 31, 2022 $ 898 Vesting of awards 169 Expense forfeited ( 19 ) Change in fair value 199 Balance as of March 31, 2023 $ 1,247 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Summary of Operating Lease Costs | The operating lease costs were as follows (in thousands): Three Months Ended March 31, 2023 2022 Operating lease cost $ 2,181 $ 2,110 |
Supplemental Cash Flow Information Related to the Company's Leases | Supplemental cash flow information related to the Company’s leases were as follows (in thousands): Three Months Ended March 31, 2023 2022 Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 2,370 $ 2,190 Right-of-use assets obtained in exchange for operating lease obligations: 304 1,440 |
Summary of Balance Sheet Classification of Lease Liabilities | The balance sheet classification of the Company’s lease liabilities was as follows (in thousands): March 31, December 31, Operating lease liabilities Current portion included in accrued liabilities $ 9,173 $ 9,305 Operating lease liabilities 51,441 52,695 Total operating lease liabilities $ 60,614 $ 62,000 |
Summary of Maturities of Lease Liabilities | Maturities of lease liabilities were as follows (in thousands): Operating Leases Remainder of 2023 $ 7,127 Years ending December 31, 2024 9,228 2025 9,308 2026 8,672 2027 8,389 Thereafter 28,691 Total lease payments 71,415 Less: Imputed interest ( 10,801 ) Total operating lease liabilities $ 60,614 |
Basis of Presentation and Sig_4
Basis of Presentation and Significant Accounting Policies - Schedule of Reconciliation of Cash, Cash Equivalents and Restricted Cash (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Cash, Cash Equivalents, Restricted Cash, and Restricted Cash Equivalents, Including Disposal Group and Discontinued Operations [Abstract] | ||||
Cash and cash equivalents | $ 290,895 | $ 114,846 | $ 204,920 | $ 147,435 |
Restricted cash | 5,770 | 5,770 | 5,770 | 5,770 |
Total cash, cash equivalents and restricted cash shown in the condensed consolidated statements of cash flows | $ 296,665 | $ 120,616 | $ 210,690 | $ 153,205 |
Basis of Presentation and Sig_5
Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Accounting Policies [Abstract] | |||
Impairment of intangible assets | $ 0 | $ 0 | |
Intangible assets, net | $ 69,583 | $ 0 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Earnings Per Share [Abstract] | ||
Antidilutive securities to purchase common stock | 20,764,000 | 17,540,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock-based Compensation Expense Included in Statements of Operations (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 14,705 | $ 14,963 |
Cost of Product Sales [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 168 | 323 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | 3,972 | 5,464 |
Selling, General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
Stock-based compensation expense | $ 10,565 | $ 9,176 |
Balance Sheet Details - Schedul
Balance Sheet Details - Schedule of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Finished goods | $ 1,594 | $ 1,926 |
Work in process | 4,251 | 4,427 |
Raw material | 5,174 | 5,207 |
Inventory | 11,019 | 11,560 |
Short term inventory | 6,095 | 6,636 |
Long-term inventory | $ 4,924 | $ 4,924 |
Balance Sheet Details - Sched_2
Balance Sheet Details - Schedule of Accrued Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Accrued milestone and contingent payments | $ 69,583 | $ 0 |
Accrued sales allowances | 50,137 | 26,046 |
Accrued research and development services | 33,656 | 35,048 |
Accrued compensation and benefits | 21,192 | 28,023 |
Accrued consulting and professional fees | 12,876 | 11,377 |
Current portion of lease liabilities | 9,173 | 9,305 |
Other | 10,262 | 3,085 |
Accrued liabilities | $ 206,879 | $ 112,884 |
Investments - Carrying Value an
Investments - Carrying Value and Amortized Cost of Company's Investments Summarized by Major Security Type (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Estimated Fair Value | $ 111,978 | $ 301,977 |
Debt and equity securities, Amortized Cost | 112,212 | 302,968 |
Debt and equity securities, Unrealized Gains | 27 | 46 |
Debt and equity securities, Unrealized Losses | (261) | (1,037) |
Debt and equity securities, Estimated Fair Value | 111,978 | 301,977 |
US Treasury Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Amortized Cost | 15,956 | |
Debt securities, Unrealized Gains | 0 | |
Debt securities, Unrealized Losses | (11) | |
Debt securities, Estimated Fair Value | 15,945 | |
US Government Sponsored Enterprises Debt Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Amortized Cost | 104,852 | 81,216 |
Debt securities, Unrealized Gains | 27 | 16 |
Debt securities, Unrealized Losses | (231) | (291) |
Debt securities, Estimated Fair Value | 104,648 | 80,941 |
Municipal bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Amortized Cost | 7,360 | |
Debt securities, Unrealized Gains | 0 | |
Debt securities, Unrealized Losses | (30) | |
Debt securities, Estimated Fair Value | $ 7,330 | |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Amortized Cost | 20,873 | |
Debt securities, Unrealized Gains | 0 | |
Debt securities, Unrealized Losses | (98) | |
Debt securities, Estimated Fair Value | 20,775 | |
Commercial paper | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Debt securities, Amortized Cost | 184,923 | |
Debt securities, Unrealized Gains | 30 | |
Debt securities, Unrealized Losses | (637) | |
Debt securities, Estimated Fair Value | $ 184,316 |
Investments - Additional Inform
Investments - Additional Information (Detail) $ in Millions | 3 Months Ended | |
Mar. 31, 2023 USD ($) Security | Dec. 31, 2022 Security | |
Marketable Securities [Line Items] | ||
Number of available-for-sale investment securities in unrealized loss position | Security | 17 | 43 |
Proceeds from sale of available-for-sale securities | $ 183 | |
Available-for-sale securities, realized gain loss | $ 0.5 |
Investments - Summary of Gross
Investments - Summary of Gross Unrealized Losses and Fair Value of Available-For-Sale Investment Securities in Unrealized Loss Position (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | $ 95,142 | $ 230,174 |
Less Than 12 Months, Unrealized Losses | (261) | (1,037) |
Total, Estimated Fair Value | 95,142 | 230,174 |
Total, Unrealized Losses | (261) | (1,037) |
US Treasury Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | 15,945 | |
Less Than 12 Months, Unrealized Losses | (11) | |
Total, Estimated Fair Value | 15,945 | |
Total, Unrealized Losses | (11) | |
US Government Sponsored Enterprises Debt Securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | 87,812 | 58,254 |
Less Than 12 Months, Unrealized Losses | (231) | (291) |
Total, Estimated Fair Value | 87,812 | 58,254 |
Total, Unrealized Losses | (231) | (291) |
Municipal bonds | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | 7,330 | |
Less Than 12 Months, Unrealized Losses | (30) | |
Total, Estimated Fair Value | 7,330 | |
Total, Unrealized Losses | $ (30) | |
Corporate debt securities | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | 20,775 | |
Less Than 12 Months, Unrealized Losses | (98) | |
Total, Estimated Fair Value | 20,775 | |
Total, Unrealized Losses | (98) | |
Commercial paper | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Less Than 12 Months, Estimated Fair Value | 135,200 | |
Less Than 12 Months, Unrealized Losses | (637) | |
Total, Estimated Fair Value | 135,200 | |
Total, Unrealized Losses | $ (637) |
Fair Value Measurements - Fair
Fair Value Measurements - Fair Value Measurements of Cash Equivalents, Available-For-Sale Investment Securities and Equity Securities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | $ 411,117 | $ 395,597 |
Financial Instruments, Financial Liabilities, Balance Sheet Groupings [Abstract] | ||
Financial liabilities, fair value disclosure | 30,830 | 898 |
Money market fund | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 287,113 | 72,578 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 299,139 | 95,703 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market fund | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 287,113 | 72,578 |
Significant Other Observable Inputs (Level 2) | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 111,978 | 299,894 |
Significant Unobservable Inputs (Level 3) | ||
Financial Instruments, Financial Liabilities, Balance Sheet Groupings [Abstract] | ||
Financial liabilities, fair value disclosure | 30,830 | 898 |
U.S. Treasury notes | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 15,945 | |
U.S. Treasury notes | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 15,945 | |
Equity securities | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 12,026 | 7,180 |
Equity securities | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 12,026 | 7,180 |
US Government Sponsored Enterprises Debt Securities [Member] | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 104,648 | 94,803 |
US Government Sponsored Enterprises Debt Securities [Member] | Significant Other Observable Inputs (Level 2) | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 104,648 | 94,803 |
Municipal bonds | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 7,330 | 20,775 |
Municipal bonds | Significant Other Observable Inputs (Level 2) | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 7,330 | 20,775 |
Commercial paper | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 184,316 | |
Commercial paper | Significant Other Observable Inputs (Level 2) | ||
Financial Instruments, Financial Assets, Balance Sheet Groupings [Abstract] | ||
Investments, fair value disclosure | 184,316 | |
Cash awards | Cash | ||
Financial Instruments, Financial Liabilities, Balance Sheet Groupings [Abstract] | ||
Financial liabilities, fair value disclosure | 1,247 | 898 |
Cash awards | Significant Unobservable Inputs (Level 3) | Cash | ||
Financial Instruments, Financial Liabilities, Balance Sheet Groupings [Abstract] | ||
Financial liabilities, fair value disclosure | 1,247 | $ 898 |
Acquisition related contingent payment | ||
Financial Instruments, Financial Liabilities, Balance Sheet Groupings [Abstract] | ||
Financial liabilities, fair value disclosure | 29,583 | |
Acquisition related contingent payment | Significant Unobservable Inputs (Level 3) | ||
Financial Instruments, Financial Liabilities, Balance Sheet Groupings [Abstract] | ||
Financial liabilities, fair value disclosure | $ 29,583 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Changes in Estimated Fair Value of Contingent Cash Awards (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Fair Value Disclosures [Abstract] | |
Balance as of December 31, 2022 | $ 898 |
Vesting of Awards | 169 |
Expense forfeited | (19) |
Change in fair value | 199 |
Balance as of March 31, 2023 | $ 1,247 |
Stockholders' Equity - Addition
Stockholders' Equity - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | 3 Months Ended | ||
Nov. 30, 2021 | Mar. 31, 2023 | Mar. 31, 2022 | Nov. 02, 2021 | |
Class of Stock [Line Items] | ||||
Maximum amount paid as cash awards to employees | $ 11.6 | $ 15.1 | ||
Fair value of awards | $ 4.4 | 2.1 | ||
Compensation cost related to the awards | $ 0.3 | $ 0.9 | ||
2023 Inducement Plan [Member] | ||||
Class of Stock [Line Items] | ||||
Shares granted | 1,344,680 | |||
Maximum [Member] | 2023 Inducement Plan [Member] | ||||
Class of Stock [Line Items] | ||||
Shares issued, shares | 1,750,000 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Jan. 31, 2022 | Aug. 31, 2018 | Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2018 | Dec. 31, 2022 | Dec. 31, 2021 | |
Other Commitments [Line Items] | |||||||
Gain (loss) on strategic investment | $ 4,845 | $ 339 | |||||
Research and development | 69,144 | 128,855 | |||||
Restricted cash | 5,770 | $ 5,770 | $ 5,770 | $ 5,770 | |||
Letter of Credit | Corporate Credit Card Program | |||||||
Other Commitments [Line Items] | |||||||
Restricted cash | 2,000 | ||||||
Letter of Credit | Fleet Program | |||||||
Other Commitments [Line Items] | |||||||
Restricted cash | 400 | ||||||
Stoke Therapeutics, Inc. [Member] | Research and Development [Member] | |||||||
Other Commitments [Line Items] | |||||||
Collaborative Arrangements Upfront Consideration And Transaction Payment | $ 60,000 | ||||||
Mile stone payments payable | 907,500 | ||||||
Upfront consideration and transaction costs | $ 60,000 | ||||||
Collaboration Agreement, Cost Splits Description | For the SYNGAP1 program, the two companies will jointly share global research, development and commercialization responsibilities and share 50/50 in all worldwide costs and future profits | ||||||
License Agreements | North America | |||||||
Other Commitments [Line Items] | |||||||
Mile stone payments payable | 40,000 | ||||||
Upfront payment | 40,000 | ||||||
License Agreements | Neuren | North America | |||||||
Other Commitments [Line Items] | |||||||
Upfront license fee | $ 10,000 | ||||||
Milestone payment as intangible asset | 40,000 | ||||||
PRV liability | 29,600 | ||||||
License Agreements | Neuren | Research and Development [Member] | North America | |||||||
Other Commitments [Line Items] | |||||||
Upfront payment | $ 10,000 | ||||||
Maximum | |||||||
Other Commitments [Line Items] | |||||||
Mile stone payments payable | $ 1,600,000 | ||||||
Maximum | License Agreements | Neuren | North America | |||||||
Other Commitments [Line Items] | |||||||
Mile stone payments payable | $ 455,000 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||||
Mar. 31, 2023 USD ($) Term | Mar. 31, 2021 USD ($) | Sep. 30, 2021 | Dec. 31, 2022 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Sep. 30, 2020 USD ($) | Mar. 31, 2020 USD ($) | Feb. 29, 2020 USD ($) | Dec. 31, 2018 USD ($) | |
Lessee Lease Description [Line Items] | ||||||||||
Operating lease, description | The Company leases facilities and certain equipment under noncancelable operating leases with remaining lease terms of 0.8 years to 8.2 years, some of which include options to extend for up to two five-year terms. | |||||||||
Operating lease, option to extend | true | |||||||||
Operating lease, options to extend | some of which include options to extend for up to two five-year terms. | |||||||||
Weighted average remaining lease term | 7 years 8 months 12 days | |||||||||
Weighted average discount rate | 4.40% | |||||||||
Capitalization of lease liability | $ 19,200 | $ 40,300 | ||||||||
Restricted cash | $ 5,770 | $ 5,770 | $ 5,770 | $ 5,770 | ||||||
Corporate Office Space Lease Agreement | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating leases arrangement term | 10 years 7 months | 10 years 9 months | ||||||||
Corporate Office Space Lease Agreement | Letter of Credit | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Restricted cash | $ 3,100 | |||||||||
California | Corporate Office Space Lease Agreement | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Minimum lease payment amount | $ 51,400 | $ 25,300 | $ 50,400 | |||||||
Lease commencement period | first quarter of 2021 | |||||||||
Minimum [Member] | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating lease remaining lease term | 9 months 18 days | |||||||||
Maximum | ||||||||||
Lessee Lease Description [Line Items] | ||||||||||
Operating lease remaining lease term | 8 years 2 months 12 days | |||||||||
Number of renewal option terms | Term | 2 | |||||||||
Operating lease, renewal term | 5 years |
Leases - Summary of Operating L
Leases - Summary of Operating Lease Costs (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Lease, Cost [Abstract] | ||
Operating lease cost | $ 2,181 | $ 2,110 |
Leases - Supplemental Cash Flow
Leases - Supplemental Cash Flow Information Related to the Company's Leases (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Lease, Cost [Abstract] | ||
Operating cash flows from operating leases | $ 2,370 | $ 2,190 |
Right-of-use assets obtained in exchange for operating lease obligations: | $ 304 | $ 1,440 |
Leases - Summary of Balance She
Leases - Summary of Balance Sheet Classification of Lease Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Current portion of lease liabilities | $ 9,173 | $ 9,305 |
Operating Lease Liability Current Statement Of Financial Position Extensible List | Accrued liabilities | Accrued liabilities |
Operating lease liabilities | $ 51,441 | $ 52,695 |
Total operating lease liabilities | $ 60,614 | $ 62,000 |
Leases - Summary of Maturities
Leases - Summary of Maturities of Lease Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Operating Lease Liabilities [Abstract] | ||
Remainder of 2023 | $ 7,127 | |
2024 | 9,228 | |
2025 | 9,308 | |
2026 | 8,672 | |
2027 | 8,389 | |
Thereafter | 28,691 | |
Total lease payments | 71,415 | |
Less: | ||
Imputed interest | (10,801) | |
Total operating lease liabilities | $ 60,614 | $ 62,000 |
Income Taxes (Additional Inform
Income Taxes (Additional Information) (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Income Tax Disclosure [Abstract] | ||
Income tax (benefit) expense | $ (1,918) | $ 485 |
Loss before income taxes | $ (44,939) | $ (112,571) |
Effective Income Tax Rate Reconciliation, at Federal Statutory Income Tax Rate, Percent | 21% | 21% |
Effective Income Tax Rate Reconciliation, Deduction, Percent, Total | 4.30% | 0.40% |