Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 15, 2023 | Jun. 30, 2022 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2022 | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | RETA | ||
Entity Registrant Name | Reata Pharmaceuticals, Inc. | ||
Entity Central Index Key | 0001358762 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | Yes | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Large Accelerated Filer | ||
Entity Small Business | false | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 834,215,802 | ||
Title of 12(b) Security | Class A Common Stock, Par Value $0.001 Per Share | ||
Security Exchange Name | NASDAQ | ||
Entity File Number | 001-37785 | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 11-3651945 | ||
Entity Address, Address Line One | 5320 Legacy Drive | ||
Entity Address, City or Town | Plano | ||
Entity Address, State or Province | TX | ||
Entity Address, Postal Zip Code | 75024 | ||
City Area Code | 972 | ||
Local Phone Number | 865-2219 | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
ICFR Auditor Attestation Flag | true | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Location | Dallas, Texas | ||
Auditor Firm ID | 42 | ||
Documents Incorporated by Reference | Portions of the Registrant’s Definitive Proxy Statement relating to the Annual Meeting of Stockholders, scheduled to be held on June 7, 2023 , are incorporated by reference into Part III of this Report. | ||
Common Stock A | |||
Document Information [Line Items] | |||
Entity Common Stock Shares Outstanding | 32,100,478 | ||
Common Stock B | |||
Document Information [Line Items] | |||
Entity Common Stock Shares Outstanding | 4,625,445 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Assets | ||
Cash and cash equivalents | $ 42,312 | $ 590,258 |
Marketable debt securities | 345,202 | 0 |
Prepaid expenses and other current assets | 10,256 | 6,217 |
Total current assets | 397,770 | 596,475 |
Property and equipment, net | 11,179 | 11,604 |
Operating lease right-of-use assets | 105,258 | 126,777 |
Other assets | 284 | 160 |
Total assets | 514,491 | 735,016 |
Liabilities and stockholders’ equity | ||
Accounts payable | 18,706 | 13,505 |
Accrued direct research liabilities | 13,836 | 14,249 |
Other current liabilities | 24,267 | 21,450 |
Operating lease liabilities, current | 2,151 | 3,142 |
Deferred revenue | 0 | 1,648 |
Total current liabilities | 58,960 | 53,994 |
Operating lease liabilities, noncurrent | 117,313 | 132,891 |
Liability related to sale of future royalties, net | 403,913 | 362,142 |
Total noncurrent liabilities | 521,226 | 495,033 |
Commitments and contingencies | ||
Stockholders’ equity: | ||
Additional paid-in capital | 1,501,800 | 1,441,584 |
Accumulated deficit | (1,567,532) | (1,255,631) |
Total stockholders’ equity | (65,695) | 185,989 |
Total liabilities and stockholders’ equity | 514,491 | 735,016 |
Common Stock A | ||
Stockholders’ equity: | ||
Common stock value | 32 | 31 |
Common Stock B | ||
Stockholders’ equity: | ||
Common stock value | $ 5 | $ 5 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Common Stock A | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 500,000,000 | 500,000,000 |
Common stock, shares issued | 31,762,052 | 31,478,197 |
Common stock, shares outstanding | 31,762,052 | 31,478,197 |
Common Stock B | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 4,913,348 | 4,919,249 |
Common stock, shares outstanding | 4,913,348 | 4,919,249 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Collaboration revenue | |||
Collaboration revenue | $ 2,216 | $ 11,490 | $ 9,019 |
Expenses | |||
Research and development | 169,843 | 155,993 | 159,080 |
General and administrative | 109,277 | 99,002 | 75,128 |
Depreciation | 1,130 | 1,203 | 1,136 |
Total expenses | 280,250 | 256,198 | 235,344 |
Other income (expense), net | (33,892) | (53,128) | (43,914) |
Loss before taxes on income | (311,926) | (297,836) | (270,239) |
Benefit from taxes on income | 25 | 450 | 22,487 |
Net loss | $ (311,901) | $ (297,386) | $ (247,752) |
Net loss per share — basic | $ (8.54) | $ (8.19) | $ (7.35) |
Net loss per share — diluted | $ (8.54) | $ (8.19) | $ (7.35) |
Weighted-average number of common shares used in net loss per share — basic | 36,517,928 | 36,321,351 | 33,709,480 |
Weighted-average number of common shares used in net loss per share — diluted | 36,517,928 | 36,321,351 | 33,709,480 |
License and milestone | |||
Collaboration revenue | |||
Collaboration revenue | $ 1,648 | $ 8,040 | $ 4,701 |
Other revenue | |||
Collaboration revenue | |||
Collaboration revenue | $ 568 | $ 3,450 | $ 4,318 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Public Offering | Common Stock A | Common Stock B | Common Stock Common Stock A | Common Stock Common Stock A Public Offering | Common Stock Common Stock B | Additional Paid-In Capital | Additional Paid-In Capital Public Offering | Total Accumulated Deficit |
Balance, value at Dec. 31, 2019 | $ 256,857 | $ 28 | $ 5 | $ 967,317 | $ (710,493) | |||||
Balance, shares at Dec. 31, 2019 | 27,878,550 | 5,318,157 | ||||||||
Compensation expense related to stock-based compensation | 57,633 | 57,633 | ||||||||
Exercise of options, value | $ 17,820 | $ 1 | 17,819 | |||||||
Exercise of options, shares | 616,585 | 616,585 | ||||||||
Issuance of Common Stock, value | $ 55,398 | $ 277,475 | $ 2 | 55,398 | $ 277,473 | |||||
Issuance of Common Stock, shares | 340,793 | 2,000,000 | ||||||||
Conversion of common stock Class B to Class A, value | $ 1 | $ (1) | ||||||||
Conversion of common stock Class B to Class A, shares | 889,811 | (889,811) | ||||||||
Net loss | (247,752) | (247,752) | ||||||||
Balance, value at Dec. 31, 2020 | 417,431 | $ 31 | $ 5 | 1,375,640 | (958,245) | |||||
Balance, shares at Dec. 31, 2020 | 31,109,154 | 5,044,931 | ||||||||
Compensation expense related to stock-based compensation | 56,806 | 56,806 | ||||||||
Exercise of options, value | $ 9,138 | 9,138 | ||||||||
Exercise of options, shares | 234,216 | 234,216 | ||||||||
Issuance of common stock upon vesting of restricted stock units, shares | 9,145 | |||||||||
Conversion of common stock Class B to Class A, shares | 369,043 | (369,043) | ||||||||
Net loss | $ (297,386) | (297,386) | ||||||||
Balance, value at Dec. 31, 2021 | 185,989 | $ 31 | $ 5 | 1,441,584 | (1,255,631) | |||||
Balance, shares at Dec. 31, 2021 | 31,478,197 | 4,919,249 | 31,478,197 | 4,919,249 | ||||||
Compensation expense related to stock-based compensation | 58,731 | 58,731 | ||||||||
Exercise of options, value | $ 1,485 | 1,485 | ||||||||
Exercise of options, shares | 64,953 | 5,159 | 59,794 | |||||||
Issuance of common stock upon vesting of restricted stock units, value | $ 1 | $ 1 | ||||||||
Issuance of common stock upon vesting of restricted stock units, shares | 208,635 | 4,366 | ||||||||
Conversion of common stock Class B to Class A, shares | 70,061 | (70,061) | ||||||||
Net loss | (311,901) | (311,901) | ||||||||
Balance, value at Dec. 31, 2022 | $ (65,695) | $ 32 | $ 5 | $ 1,501,800 | $ (1,567,532) | |||||
Balance, shares at Dec. 31, 2022 | 31,762,052 | 4,913,348 | 31,762,052 | 4,913,348 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities | |||
Net loss | $ (311,901) | $ (297,386) | $ (247,752) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation | 1,130 | 1,203 | 1,136 |
Amortization of debt issuance costs and imputed interest | 0 | 6,563 | 7,545 |
Non-cash interest expense on liability related to sale of future royalty | 41,771 | 46,688 | 21,884 |
Stock-based compensation expense | 58,731 | 56,806 | 57,633 |
Amortization of discount (premium) on marketable debt securities | (3,307) | 0 | 0 |
Loss on extinguishment of debt | 0 | 0 | 11,183 |
Gain on lease termination | 0 | 0 | (1,286) |
Changes in operating assets and liabilities: | |||
Income tax receivable and payable | 42 | 22,217 | (22,217) |
Prepaid expenses, other current assets and other assets | (4,155) | 750 | 222 |
Accounts payable | 5,201 | 8,713 | 2,879 |
Accrued direct research, other current and long-term liabilities | 2,583 | 1,346 | 2,090 |
Operating lease obligations | 7,286 | 439 | (956) |
Payable to collaborators | 0 | (80,000) | (150,000) |
Deferred revenue | (1,648) | (3,040) | (4,701) |
Net cash used in operating activities | (204,267) | (235,701) | (322,340) |
Investing activities | |||
Purchases of property and equipment | (3,270) | (1,329) | (927) |
Purchases of marketable securities | (661,894) | ||
Maturity from marketable securities | 320,000 | ||
Net cash used in investing activities | (345,164) | (1,329) | (927) |
Financing activities | |||
Proceeds from issuance of common stock, net | 0 | 0 | 333,278 |
Payments on deferred offering costs | 0 | 0 | (405) |
Payments on long-term debt | 0 | 0 | (167,170) |
Exercise of options | 1,485 | 9,138 | 17,820 |
Proceeds from sale of future royalties, net | 0 | 0 | 293,570 |
Net cash provided by financing activities | 1,485 | 9,138 | 477,093 |
Net decrease in cash and cash equivalents | (547,946) | (227,892) | 153,826 |
Cash and cash equivalents at beginning of year | 590,258 | 818,150 | 664,324 |
Cash and cash equivalents at end of period | 42,312 | 590,258 | 818,150 |
Supplemental disclosures | |||
Cash paid for interest | 0 | 0 | 8,021 |
Non-cash activity: | |||
Accrued deferred offering cost | 0 | 0 | 102 |
Right-of-use assets obtained in exchange for lease obligations | 4,885 | 124,479 | 4,756 |
Purchases of equipment in accounts payable, accrued direct research, other current, and long-term liabilities | 10 | 295 | 29 |
Acquisition of property and equipment through tenant improvement allowance current, and long-term liabilities | $ 0 | $ 8,702 | $ 2,402 |
Description of Business
Description of Business | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Description of Business | 1. Description of Business Reata Pharmaceuticals, Inc.’s (Reata, the Company, we, us, or our) mission is to identify, develop, and commercialize innovative therapies that change patients’ lives for the better. The Company focuses on small-molecule therapeutics with novel mechanisms of action for the treatment of severe, life-threatening diseases with few or no approved therapies. The Company’s lead programs are omaveloxolone in a rare neurological disease called Friedreich’s ataxia (FA) and bardoxolone methyl (bardoxolone) in rare forms of chronic kidney disease (CKD). Both of the Company’s lead product candidates activate the transcription factor Nrf2 to normalize mitochondrial function, restore redox balance, and resolve inflammation. Because mitochondrial dysfunction, oxidative stress, and inflammation are features of many diseases, the Company believes omaveloxolone, bardoxolone, and our other Nrf2 activators have many potential clinical applications. Reata possesses exclusive, worldwide rights to develop, manufacture, and commercialize omaveloxolone, bardoxolone, and our other Nrf2 activators, excluding certain Asian markets for bardoxolone in certain indications, which are licensed to Kyowa Kirin. In addition, we are developing cemdomespib, the lead product candidate from our Hsp90 modulator program, in neurological indications. We are the exclusive licensee of cemdomespib and have worldwide commercial rights. The Company’s consolidated financial statements include the accounts of all majority-owned subsidiaries. Accordingly, the Company’s share of net earnings and losses from these subsidiaries is included in the consolidated statements of operations. Intercompany profits, transactions, and balances have been eliminated in consolidation. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Risks and Uncertainties The Company has experienced losses and negative operating cash flows for many years since inception and has no marketed drug or other products. The Company’s ability to generate future revenue depends upon the results of its development programs, whose success cannot be guaranteed. The Company may need to raise additional equity capital in the future in order to fund its operations. Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. Investments in Marketable Securities and Cash Equivalents The Company invests excess cash balances in marketable debt securities and classifies its investments as held-to-maturity on facts and circumstances present at the time the Company purchased the securities. At each balance sheet date presented, the Company classified all of its investments in debt securities as held-to maturity and as current assets as they represent the investment of funds available for current operations. The Company’s marketable debt securities are classified as cash equivalents if the original maturity, from the date of purchase, is 90 days or less, and as marketable debt securities if the original maturity, from the date of purchase, is in excess of 90 days. The carrying amount of cash equivalents approximate fair value. As of December 31, 2022 cash and cash equivalents comprise funds in cash, money market accounts, and treasury securities. The Company considers all available evidence to evaluate if an impairment loss exists, and if so, marks the investment to market through a charge to the Company’s consolidated statements of operations and comprehensive loss. The Company did not record any impairment charges related to our marketable debt securities during the year ended December 31, 2022 . Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the following estimated useful lives: Computer equipment 2 - 5 years Software 3 years Laboratory equipment 5 - 7 years Office furniture 5 years Office equipment 5 years Manufacturing equipment 10 years Leasehold improvements are amortized on the straight-line method over the shorter of the lease term or the estimated useful life of the equipment or improvement. Such amortization is recorded as depreciation expenses in the consolidated statements of operations. Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment . Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends, and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company has no t recognized any impairment charges in 2022, 2021, or 2020 . Liability Related to Sale of Future Royalties On June 24, 2020, the Company closed on the Development and Commercialization Funding Agreement with an affiliate of Blackstone Life Sciences, LLC (BXLS), which provided funding for the development and commercialization of bardoxolone for the treatment of CKD caused by Alport syndrome, autosomal dominant polycystic kidney disease (ADPKD), and certain other rare CKD indications in return for future royalties (the Development Agreement). The Company accounted for the Development Agreement as a sale of future revenues resulting in a debt classification, primarily because the Company has significant continuing involvement in generating the future revenue on which the royalties are based. The debt will be amortized under the effective interest rate method and, accordingly, the Company is recognizing non-cash interest expense over the estimated term of the Development Agreement. The liability related to sale of future royalties, and the debt amortization, are based on the Company’s current estimate of future royalties expected to be paid over the estimated term of the Development Agreement. The Company will periodically assess the expected royalty payments and, if materially different than its previous estimate, will prospectively adjust and recognize the related non-cash interest expense. The transaction costs associated with the liability will be amortized to non-cash interest expense over the estimated term of the Development Agreement. For a complete discussion of accounting for Development Agreement, see Note 7, Liability Related to Sale of Future Royalties of Notes to Consolidated Financial Statements contained in this Annual Report on Form 10-K. Fair Value Measurements The Company categorizes its financial instruments measured at fair value into a three-level fair value hierarchy that prioritizes the inputs used in determining the fair value of the asset or liability. The three levels of the fair value hierarchy are as follows: • Level 1 - Financial instruments that have values based on unadjusted quoted prices for identical assets or liabilities in an active market which the Company has the ability to access at the measurement date. • Level 2 - Financial instruments that have values based on quoted market prices in markets where trading occurs infrequently or that have values based on quoted prices of instruments with similar attributes in active markets. • Level 3 - Financial instruments that have values based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. These inputs reflect management’s own assumptions about the assumptions a market participant would use in pricing the asset. Revenue Recognition The Company’s revenue to date has been generated primarily from licensing fees received under its collaborative licensing agreements with AbbVie Inc. (AbbVie) and Kyowa Kirin and reimbursements for expenses from Kyowa Kirin. The terms of the agreements include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones, and royalties on net product sales. Under Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606), an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the promised goods or services in the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as the entity satisfies a performance obligation. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. Licenses of intellectual property: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone payments: At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission by the Company) is included in the transaction price, which is then allocated to each performance obligation. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, and other revenues and earnings in the period of adjustment and in future periods through the end of the performance obligation period. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and where the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. Manufacturing Supply Services: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the licensee and, if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded when the customer obtains control of the goods, which is upon delivery. For a complete discussion of accounting for collaborative licensing agreements, see Note 3, Collaboration Agreements of Notes of Consolidated Financial Statements contained in this Annual Report on Form 10-K. Acquired License Rights All acquired license and sublicense costs that are in-process research and development, which were acquired directly in a transaction other than a business combination that does not have an alternative future use, are expensed as incurred. For a complete discussion of accounting for reacquisition of license rights in 2019, see Note 3, Collaboration Agreements . Research and Development Costs All research and development costs are expensed as incurred, including costs for drug supplies used in research and development or clinical studies, property and equipment acquired specifically for a finite research and development project, and nonrefundable deposits incurred at the initiation of research and development activities. Research and development costs consist principally of costs related to clinical studies managed directly by the Company and through contract research organizations (CROs), manufacture of clinical drug products for clinical studies, preclinical study costs, discovery research expenses, facilities costs, salaries, and related expenses. In December 2017, the Company and Kyowa Kirin entered into the Third Supplement to the Kyowa Kirin Agreement, which allows the Company to begin a portion of the registrational CARDINAL trial in Japan, for which Kyowa Kirin has reimbursed costs incurred of $ 3.0 million as of the end of December 31, 2021. The Company deemed that this was not a material modification to the Kyowa Kirin Agreement because no payment terms or deliverables were changed. The Company’s expenses were reduced by $ 0.5 million for Kyowa Kirin’s share of the study costs for twelve months ended December 31, 2019. No such expenses or credits were recorded in the twelve months ended December 31, 2022 and December 31, 2021. In addition, we have also entered into cost sharing agreement for the FALCON trial and have recorded $ 0.1 million and $ 1.4 million in expenses during the year ended December 31, 2022 and 2021, respectively. No such costs were incurred in the twelve months ended December 31, 2020. The Company bases its expense accruals related to clinical trials on its estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on its behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing costs, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. Included within total accrued direct research liabilities is $ 11.4 million, which was accrued but unbilled, as of December 31, 2022. To date, the Company has not experienced significant changes in its estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, the Company cannot assure that it will not make changes to its estimates in the future as the Company becomes aware of additional information about the status or conduct of its clinical trials and other research activities. Patents Costs associated with filing, prosecuting, enforcing, and maintaining patent rights are expensed as incurred and are classified as general and administrative expenses. Stock-Based Compensation The Company accounts for its stock-based compensation in accordance with ASC 718 Compensation—Stock Compensation (ASC 718). ASC 718 requires companies to measure and recognize compensation expense for all stock option and RSU awards based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes option pricing model to estimate the fair value of stock option awards. The fair value is recognized as expense, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis when the only condition to vesting is continued service. If vesting is subject to a performance condition, recognition is based on the derived service period of the award. Expense for awards with performance conditions is estimated and adjusted on a quarterly basis based upon the assessment of the probability that the performance condition will be met. The Company begins to recognize the value of the performance-based awards when the Company determines the achievement of each performance condition is deemed probable. At the probable date, the Company will record a cumulative expense catch-up, with the remaining amortized over the remaining service period. Use of the Black-Scholes option pricing model requires management to apply judgment under highly subjective assumptions. These assumptions include: • Expected term—The expected term represents the period that the stock-based awards are expected to be outstanding and is based on the average period the stock options are expected to be outstanding and was based on our historical information of the options exercise patterns and post-vesting termination behavior. • Expected volatility—During the first two months of the year, we did not have sufficient trading history to estimate the volatility of our common stock, thus, the expected volatility was estimated based on our own historical volatility since our IPO and the average volatility for comparable publicly traded biopharmaceutical companies. When selecting comparable publicly traded biopharmaceutical companies on which we based our expected stock price volatility, we selected companies with comparable characteristics to us, including enterprise value, risk profiles, position within the industry, and historical share price information sufficient to meet the expected life of the stock-based awards. For the remainder part of the year, the expected volatility was estimated based on our own historical volatility since our IPO. • Risk-free interest rate—The risk-free interest rate is based on the United States Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of option. • Expected dividend—The Company has no plans to pay dividends on its common stock. Therefore, the company used an expected dividend yield of zero. The Company accounts for forfeitures of share-based awards when they occur. Stock option and RSU awards have been granted to non-employees, in connection with research and consulting services provided to the Company, and to employees, under its Second Amended and Restated Long Term Incentive Plan (the LTIP Plan). Equity awards generally vest over terms of four or five years . For employees and non-employees, stock-based compensation expense is recorded ratably through the vesting period for each stock option or tranche of RSU award. In the case of performance-based awards, compensation expense is recognized for awards when achievement of the underlying performance-based targets become probable, which have typically been in the same period as when the targets are achieved. Income Taxes The Company accounts for income taxes and the related accounts under the liability method. Deferred tax assets and liabilities are determined based on differences between the financial statement and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The measurement of a deferred tax asset is reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740, Income Taxes . The Company recognizes a tax benefit for uncertain tax positions if the Company believes it is more likely than not that the position will be upheld on audit based solely on the technical merits of the tax position. The Company evaluates uncertain tax positions after consideration of all available information. As of December 31, 2022 , the interest accrued related to provision for or due to uncertain tax positions was immaterial. Leases At the inception of an arrangement, the Company determines if an arrangement is, or contains, a lease based on the unique facts and circumstances present in that arrangement. Lease assets represent the Company’s right to use an underlying asset for the lease term, and lease liabilities represent the obligation to make lease payments arising from the lease. These assets and liabilities are initially recognized at the lease commencement date based on the present value of lease payments over the lease term calculated using its incremental borrowing rate based on the information available at commencement unless the implicit rate is readily determinable. Lease assets also include upfront lease payments, lease incentives paid, and direct costs incurred and exclude lease incentives received. The lease term used to calculate the lease assets and related lease liabilities includes the options to extend or terminate the lease when it is reasonably certain that the Company will exercise those options. Lease expense for operating leases is recognized on a straight-line basis over the expected lease term as an operating expense while the expense for finance leases is recognized as depreciation expense over the expected lease term unless there is a transfer of title or purchase option reasonably certain of exercise. The Company accounts for each lease component separately from the nonlease components. The depreciable life of lease assets and leasehold improvements is limited by the expected lease term unless there is a transfer of title or purchase option reasonably certain of its exercise. Leases with an initial term of 12 months or less are not recorded on the balance sheet, and the expenses for these short-term leases and operating leases are recognized on a straight-line basis over the lease term. Key assumptions and judgments included in the determination of the lease liability include the discount rate applied to the present value of the future lease payments, and the exercise of renewal options. Our leases do not provide information about the rate implicit in the lease; therefore, we utilize an incremental borrowing rate to calculate the present value of our future lease obligations. The incremental borrowing rate represents the rate of interest we would have to pay on a collateralized borrowing, for an amount equal to the lease payments, over a similar term and in a similar economic environment. Net Income (Loss) per Share Basic and diluted net income (loss) per common share is calculated by dividing net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. The Company’s potentially dilutive shares, which include unvested RSUs and options to purchase common stock, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. For periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions, and other events and circumstances from non-owner sources and includes all components of net income (loss) and other comprehensive income (loss). The other comprehensive income (loss) for the years ended December 31, 2022, 2021, and 2020 was immaterial. |
Collaboration Agreements
Collaboration Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaboration Agreements | 3. Collaboration Agreements Subsequent to the 2019 reacquisition of certain rights originally licensed to AbbVie (see “AbbVie” below), the Company’s collaboration revenue and deferred revenue have been generated primarily from licensing fees and reimbursements for expenses received under our exclusive license with Kyowa Kirin Agreement (as defined below). Kyowa Kirin In December 2009, the Company entered into an exclusive license agreement with Kyowa Kirin to develop and commercialize bardoxolone in the licensed territory (the Kyowa Kirin Agreement). The terms of the agreement include a payment to the Company of a nonrefundable, up-front license fee of $ 35.0 million and additional development and commercial milestone payments. As of December 31, 2022, the Company has received $ 50.0 million related to regulatory development milestone payments from Kyowa Kirin and has the potential in the future to achieve another $ 47.0 million from regulatory milestones and $ 140.0 million from commercial milestones. The Company also has the potential to achieve tiered royalties ranging from the low teens to the low 20 percent range, depending on the country of sale and the amount of annual net sales, on net sales by Kyowa Kirin in the licensed territory. The Company is participating on a joint steering committee with Kyowa Kirin to oversee the development and commercialization activities related to bardoxolone. Any future milestones and royalties received are subject to mid to lower single digit percent declining tiered commissions to certain consultants as compensation for negotiations of the Kyowa Kirin Agreement. The Company regularly evaluates its remaining performance obligation under the Kyowa Kirin Agreement. Accordingly, revenue may fluctuate from period to period due to changes to its estimated performance obligation period and variable considerations. The Company began recognizing revenue related to the up-front payment upon execution of the Kyowa Kirin Agreement as the Company's period of performance began. In March 2021, the Company’s performance obligation period under the Kyowa Kirin Agreement was extended to and completed in June 2022. On July 27, 2021, Kyowa Kirin submitted a New Drug Application (NDA) in Japan to the Ministry of Health, Labour and Welfare for bardoxolone for improvement of renal function in patients with Alport syndrome. Based on this submission, the Company earned a $ 5.0 million milestone payment, variable consideration previously considered constrained, under the Kyowa Kirin Agreement. As a result, the Company recorded $ 4.7 million in collaboration revenue, a cumulative catch-up for the portion of this milestone that was satisfied in prior periods, and $ 0.3 million in deferred revenue that was recognized over the remaining performance obligation period. Under the Kyowa Kirin Agreement, we did not recognize any deferred revenue subsequent to June 30, 2022. AbbVie In September 2010, the Company entered into a license agreement with AbbVie (the AbbVie License Agreement) for an exclusive license to develop and commercialize bardoxolone in the Licensee Territory (as defined in the AbbVie License Agreement). In December 2011, the Company entered into a collaboration agreement with AbbVie (the Collaboration Agreement) to jointly research, develop, and commercialize the Company’s portfolio of second and later generation oral Nrf2 activators. In October 2019, the Company and AbbVie entered into an Amended and Restated License Agreement (the Reacquisition Agreement) pursuant to which the Company reacquired the development, manufacturing, and commercialization rights concerning its proprietary Nrf2 activator product platform originally licensed to AbbVie in the AbbVie License Agreement and the Collaboration Agreement. In exchange for such rights, the Company agreed to pay AbbVie $ 330.0 million, all of which has subsequently been paid. Additionally, the Company will pay AbbVie an escalating, low single-digit royalty on worldwide net sales, on a product-by-product basis, of omaveloxolone and certain other Nrf2 activators. The execution of the Reacquisition Agreement ended our performance obligations under the Collaboration Agreement. The Company recognized interest expense related to the Reacquisition Agreement of approximately $ 6.6 million and $ 6.5 million during twelve months ended December 31, 2021 and 2020 , respectively. As of December 31, 2021, the Company has fully satisfied its payable to AbbVie, therefore no interest expense was recognized during the twelve months ended December 31, 2022. |
Marketable Debt Securities
Marketable Debt Securities | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Debt Securities | 4. Marketable Debt Securities During the year ended December 31, 2022, the Company invested its excess cash balances in marketable debt securities and, at each balance sheet date presented, the Company classified all of its investments in debt securities as held-to-maturity and as current assets as they mature within 12 months and represent the investment of funds available for current operations. The following tables summarize our marketable debt securities (in thousands), as of December 31, 2022: Amortized Gross Gross Fair Value (1) Marketable debt securities: U.S. treasury securities 345,202 8 ( 423 ) 344,787 Total $ 345,202 $ 8 $ ( 423 ) $ 344,787 (1) The fair value was determined using the three-tier fair value hierarchy for disclosure in accordance with Accounting Standards Codification 820-10. The Company's investments in marketable securities are classified within Level 2 of the fair value hierarchy. The Company uses quoted prices for similar assets sourced from certain third-party pricing services. The third-party pricing services generally utilize industry standard valuation models for which all significant inputs are observable, either directly or indirectly, to estimate the price or fair value of the securities. The primary input generally includes reported trades of or quotes on the same or similar securities. The Company does not make additional judgments or assumptions made to the pricing data sourced from the third-party pricing services. |
Other Income (Expense), Net
Other Income (Expense), Net | 12 Months Ended |
Dec. 31, 2022 | |
Other Income and Expenses [Abstract] | |
Other Income (Expense), Net | . Other Income (Expense), Net Years Ended December 31 2022 2021 2020 (in thousands) Other income (expense), net Investment income $ 5,990 $ 177 $ 2,769 Interest expense — ( 6,563 ) ( 14,895 ) Non-cash interest expense on liability ( 41,771 ) ( 46,688 ) ( 21,884 ) Other income (expense) 1,889 ( 54 ) 1,279 Loss on extinguishment of debt — — ( 11,183 ) Total other income (expense), net $ ( 33,892 ) $ ( 53,128 ) $ ( 43,914 ) Investment Income Investment income consists primarily of interest generated from our cash and cash equivalents and marketable securities. Interest Expense Interest expense consists primarily of the interest on our borrowing activities under our loan agreements and the imputed interest from the amount due to AbbVie under the Reacquisition Agreement. Non-Cash Interest Expense on Liability Related to Sale of Future Royalties Non-cash interest expense consists of recognition of interest expense based on the Company’s current estimate of future royalties expected to be paid over the estimated term of the Development Agreement. Other income (expense) Other income (expense) consists primarily of gains and losses on foreign currency exchange, sales of assets, lease termination and employee retention credit. In the twelve months ended December 31, 2022, other income included $ 2.1 million, related to the employee retention credit (ERC) under the CARE S Act. Other income of $ 1.3 million recorded in the twelve months ended December 31, 2020, related to a gain on the Company’s lease termination due to the bankruptcy filing of its lessor. Loss on Extinguishment of Debt In June 2020, the Company paid off the Term Loans and recorded a loss on the extinguishment of debt of $ 11.2 million, which consisted primarily of prepayment fees, exit fees and unamortized debt issuance costs. |
Term Loan
Term Loan | 12 Months Ended |
Dec. 31, 2022 | |
Debt Disclosure [Abstract] | |
Term Loan | 6. Term Loan On October 9, 2019, the Company entered into the First Amendment to the Amended and Restated Loan and Security Agreement (the Amended Restated Loan Agreement), under which it borrowed $ 155.0 million as of December 20, 2019. On June 24, 2020, the Company paid off the total outstanding balance of the term loans under the Term Loans prior to the maturity date. The payoff consisted of (i) the outstanding principal balance of $ 155.0 million, (ii) exit fees of $ 6.7 million, which were partially accrued up to the date of repayment, (iii) prepayment fees of $ 5.4 million, and (iv) accrued and unpaid interest of $ 1.0 million. At the time of payoff, all liabilities and obligations under the Amended Restated Loan Agreement were terminated. The Company recognized approximately $ 8.3 million in interest expense for the twelve months ended December 31, 2020. No interest expense was recognized in 2022 and 2021, as the term loan was paid off in June 2020. |
Liability Related to Sale of Fu
Liability Related to Sale of Future Royalties | 12 Months Ended |
Dec. 31, 2022 | |
Liability Related To Sale Of Future Royalties [Abstract] | |
Liability Related to Sale of Future Royalties | 7. Liability Related to Sale of Future Royalties On June 24, 2020, the Company closed on the Development Agreement. The Development Agreement included a $ 300.0 million payment by an affiliate of BXLS in return for various percentage royalty payments on worldwide net sales of bardoxolone, once approved in the United States or certain specified European countries, by Reata and its licensees, other than Kyowa Kirin. The royalty percentage will initially be in the mid-single digits and, in future years, can vary between higher-mid single digit percentages to low-single digit percentages depending on various milestones, including indication approval dates, cumulative royalty payments, and cumulative net sales. Pursuant to the Development Agreement, we have granted BXLS a security interest in substantially all of our assets. After a bardoxolone product approval has been obtained by the Company, the Company is obligated to make certain minimum cumulative payment amounts in 2025 through 2033, but only until BXLS has achieved certain internal rate of return target. In addition, concurrent with the Development Agreement, the Company entered into a common stock purchase agreement (the Purchase Agreement) with affiliates of BXLS to sell an aggregate of 340,793 shares of the Company’s Class A common stock at $ 146.72 per share for a total of $ 50.0 million. The Company concluded that there were two units of accounting for the consideration received, comprised of the liability related to the sale of future royalties and the common shares. The Company allocated the $ 300.0 million from the Development Agreement and $ 50.0 million from the Purchase Agreement between the two units of accounting on a relative fair value basis at the time of the transaction. The Company allocated $ 294.5 million, which includes $ 0.8 million in transaction costs incurred, in transaction consideration to the liability, and $ 55.5 million to the common shares. The Company determined the fair value of the common shares based on the closing stock price on the June 24, 2020, the closing date of the Development Agreement. At inception, the effective interest rate under the Development Agreement, including transaction costs, was approximately 13.8 %. During the first quarter of 2022, the Company reassessed the expected royalty payments and lowered our previous estimate of future sales for which royalties will be paid. Accordingly, we have prospectively adjusted and recognized lower non-cash interest expense using a 10.9 % effective interest rate, as of December 31, 2022. The following table shows the activity within the liability related to sale of future royalties for the twelve months ended December 31, 2022: Liability Related to Sale of (in thousands) Balance at December 31, 2021 $ 362,928 Non-cash interest expense recognized 41,706 Balance at December 31, 2022 404,634 Less: Unamortized transaction cost ( 721 ) Carrying value at December 31, 2022 $ 403,913 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 8. Property and Equipment Property and equipment consisted of the following as of December 31: 2022 2021 (in thousands) Computer equipment and software $ 3,997 $ 3,748 Laboratory equipment 6,828 6,389 Office furniture 2,005 1,990 Office and other equipment 399 399 Leasehold improvements 14,020 14,127 Manufacturing equipment 223 213 27,472 26,866 Less: accumulated depreciation ( 16,293 ) ( 15,262 ) Property and equipment, net $ 11,179 $ 11,604 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Leases | 9. Leases The Company’s headquarters are located in Plano, Texas, where it leases approximately 122,000 square feet of office space, with lease terms extending through December 31, 2023 . The Company leases additional office and laboratory space of approximately 34,890 square feet located in Irving, Texas, with lease terms extending through October 31, 2024 , with an option to extend for a fixed 12-month period. The Company has an additional lease of a single-tenant, build-to-suit building of approximately 327,400 square feet of office and laboratory space located in Plano, Texas with an initial lease term of 16 years. The Company entered into the lease agreement on October 15, 2019 (the 2019 Lease Agreement), and at the Company’s option , it may renew the lease for two consecutive five-year renewal periods or one ten-year renewal period . On December 15, 2021, the Company obtained control of the space, and, accordingly, the Company recorded related right-of-use assets and the lease liabilities during the fourth quarter of 2021. The Company recorded the liability associated with the 2019 Lease Agreement at the present value of the lease payments not yet paid, using the discount rate as of the commencement date. As the discount rate implicit in the 2019 Lease Agreement was not readily determinable, the Company utilized its incremental borrowing rate. The renewals are not assumed in the determination of the lease term, since they are not deemed to be reasonably assured at the inception of the lease. At inception, the Company recorded $ 124.5 million as a right-of-use asset, which represented a lease liability of $ 133.2 million, net of $ 8.7 million of lease incentives recognized. During the fourth quarter of 2022, our landlord provided a revised summary of project costs that directly impacted our future lease payments. The revision in project costs reduced our future lease payments owed under the 2019 Lease Agreement; therefore, we reversed $ 19.8 million of the right-of-use asset and $ 19.3 million of the lease liability in the fourth quarter for the period ended December 31, 2022. For the year ended December 31, 2022, the Company paid $ 9.5 million for amounts included in the measurement of lease liabilities. For the years ended December 31, 2022, 2021 and 2020, the Company recorded total rent expense of $ 17.3 million, $ 3.6 million, and $ 3.4 million, respectively. Supplemental balance sheet and other information related to the Company’s operating leases is as follows: As of December 31 2022 2021 Weighted-average remaining lease term (in years) 15.2 15.7 Weighted-average discount rate 6.5 % 6.6 % Maturities of lease liabilities by fiscal year for the Company’s operating leases: As of December 31, 2022 (in thousands) 2023 (1) $ 9,686 2024 6,457 2025 11,777 2026 12,007 2027 12,241 Thereafter 143,829 Total lease payments (1) 195,997 Less: Imputed interest ( 76,537 ) Present value of lease liabilities $ 119,460 (1) Above table assumes one year rent abatement is applied beginning in June 2023 following United States Food and Drug Administration (FDA) approval of omaveloxolone. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 10. Income Taxes On March 27, 2020, the United States enacted the Coronavirus Aid, Relief, and Economic Security Act (the CARES Act). The CARES Act is an emergency economic stimulus package that includes spending and tax breaks to strengthen the U.S. economy and to provide assistance to individuals, families, and businesses affected by the coronavirus disease (COVID-19). Accordingly, under the provisions of the CARES Act, in March 2020, the Company recognized tax benefits and receivables totaling $ 22.2 million associated with the ability to carryback an applicable prior year’s net operating losses to a preceding year, which had previously been fully reserved by its valuation allowance. During the second quarter of 2021, the Company received a total of $ 22.9 million from the IRS, comprising $ 22.2 million of the income tax receivable plus $ 0.7 million in interest. The CARES Act also provided for an employee retention credit, which is a refundable tax credit against certain employment taxes. The Company qualified for the tax credit in the first and second quarter of 2021. The Company filed for this credit in the fourth quarter of 2022, as a result, the Company accrued a benefit of $ 2.1 million related to the ERC in Other income (expense), net on the Consolidated Statements of Operations. The following table reconciles the Company’s effective income tax rate from continuing operations to the federal statutory tax rate of 21 %: Years Ended December 31 2022 2021 2020 U.S. federal income taxes 21 % 21 % 21 % Federal and state tax credits 4 5 12 Stock-based compensation ( 1 ) ( 0 ) 4 NOL carryback rate differential — — 1 Foreign rate differential ( 6 ) ( 3 ) ( 2 ) Change in valuation allowance ( 19 ) ( 23 ) ( 28 ) Other 1 — — Recorded federal income tax benefit — % — % 8 % Deferred tax assets and liabilities reflect the net effects of net operating loss, tax credit carryovers and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Significant components of the Company’s net deferred tax assets as of December 31 are as follows (in thousands): 2022 2021 Deferred tax assets: Federal and state tax credits $ 115,064 $ 102,590 Net operating loss 119,431 101,463 Accrued royalties 85,299 79,458 Intellectual property 53,892 60,753 Lease Liability 25,229 29,847 Stock-based compensation 29,037 23,677 Deferred revenue — 362 Compensation accruals 3,264 884 Section 174 capitalization 16,394 — Other 615 538 Deferred tax assets before valuation allowance 448,225 399,572 Less: Valuation allowance ( 424,052 ) ( 369,215 ) Net deferred income tax assets 24,173 30,357 Deferred tax liabilities: Right-of-use assets ( 22,229 ) ( 27,817 ) Other ( 1,779 ) ( 2,424 ) Net deferred tax assets $ 165 $ 116 Deferred tax assets are regularly reviewed for recoverability by jurisdiction and valuation allowances are established based on historical and projected future taxable losses and the expected timing of the reversals of existing temporary differences. For the majority of its deferred tax assets, the Company cannot currently conclude that it is more likely than not that they will be utilized. Therefore, the Company has recorded valuation allowances against these deferred tax assets for 2022. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income (including reversals of deferred tax liabilities) during the periods in which those temporary differences will become deductible. The valuation allowance increased by $ 54.8 million and $ 68.3 million in 2022 and 2021, respectively. As of December 31, 2022 , the Company had United States federal accumulated net operating losses of $ 363.8 million. The Company has United States federal accumulated net operating losses of $ 59.7 million expiring in 2037. Under the Tax Cuts and Jobs Act of 2017 (the 2017 Tax Act), the remaining $ 304.1 million will be carried forward indefinitely but is limited to 80 % of our taxable income in any annual period. As of December 31, 2022 , the Company had net operating losses in Switzerland of $ 358.8 million with expiration starting in 2028. As of December 31, 2022, the Company has federal orphan drug tax credit, federal research and development tax credit, and state research and development tax credit carryforwards of $ 86.7 million, $ 20.7 million, and $ 7.5 million, respectively, with federal orphan drug and federal research and development tax credits expiring between years 2024 and 2042 , of which $ 0.1 million expires in 2024 and the remainder begins expiring in 2030 . The Company's federal income tax returns for 2013, and 2019 through 2021 remain open to examination by the IRS. |
Licenses
Licenses | 12 Months Ended |
Dec. 31, 2022 | |
License Agreements [Abstract] | |
Licenses | 11. Licenses The proprietary rights and technical information covered by various patent and patent applications, which are discussed in more detail below, have been licensed by the Company from third parties, including stockholders. These licenses will continue for the life of the respective patent or until terminated by either party. Certain agreements call for the payment of royalties on product sales over the life of the patents. The term of all agreements is through the useful lives of the licensed patents or for a period of 15 to 20 years for technology rights, for which there are no applicable patent rights. Bardoxolone and Nrf2 Activators In July 2004, the Company entered into an exclusive technology and patent license agreement (the 2004 CDDO License Agreement) with two academic institutions for certain patents and patent applications, known as the CDDO Patents. The Company has the right to sublicense these patents. In the event of a sublicense, the terms of the contract require the Company to pay the licensors sublicense fees based on a percentage of total compensation received that varies depending on the phase of development of a drug candidate as of the time of the sublicense. The Company agreed to pay a royalty on net sales of any products developed as a result of the license, an annual license fee, and various milestone fees, and issued shares of its common stock as consideration for the license. In July 2012, the Company amended the 2004 CDDO License Agreement, which provides, among other terms, that the Company will pay to the licensors a low single-digit royalty on net sales of certain Nrf2 activator compounds, including omaveloxolone, that are claimed in certain patents and patent applications that are wholly owned by or licensed to the Company. In 2021, the Company paid a development milestone and sublicense payments of $ 0.6 million under the agreement, no such milestones were paid during the twelve months ended December 31, 2022. In August 2021, the Company amended the 2004 CDDO License Agreement. This amendment, among other terms, provides consent to an internal restructuring by the Company of certain of its intellectual property rights, facilitates the potential monetization by the Trustees of Dartmouth College (Dartmouth) of their rights to royalties under the license, clarifies the applicability of certain running royalty payment obligations with respect to certain compounds, and specifies the dispute resolution procedure regarding the ongoing dispute between the Company and Licensors as to whether the Company is obligated under the 2012 amendment to the 2004 CDDO License Agreement to pay the licensors a low single-digit royalty on sales of products containing bardoxolone. In January 2009, the Company filed a patent application claiming the use of bardoxolone and related compounds in treating CKD, endothelial dysfunction, cardiovascular disease (CVD), and related disorders. Several of the original inventors of these compounds at an academic institution were named as co-inventors on this application, along with several company employees. Consequently, the Company and Dartmouth are co-owners of this patent application. In December 2009, the Company entered into an agreement with Dartmouth that provides the Company with an exclusive worldwide license to the academic institution’s rights in these applications and any resulting patents (the 2009 License Agreement). The Company agreed to pay a low single-digit royalty on product sales that occur after the effective term of the original patents, a sublicense fee, an annual license fee, and various milestone fees. In 2021, the Company paid a development milestone and sublicense payments of $ 0.4 million under the agreement, no such milestones were paid during the twelve months ended December 31, 2022. In August 2021, the Company amended the 2009 License Agreement. These amendments, among other terms, provides consent to an internal restructuring by the Company of certain of its intellectual property rights, facilitates the potential monetization by Dartmouth of its rights to royalties under the 2009 License Agreement, clarifies that there is no minimum royalty provision, and adds provisions regarding the defense of certain patent rights. Other Technologies The Company has an exclusive technology and patent license agreement with the University of Kansas and the University of Kansas Medical Center (the University of Kansas) for certain patents and patent applications related to small molecule modulators of heat shock proteins, including cemdomespib. The Company has the right to sublicense this patent. In the event of a sublicense, the terms of the contract require the Company to pay the licensors sublicense fees based on a percentage of total compensation received that varies depending on the phase of development of a drug candidate as of the time of the sublicense. The Company paid non-refundable license issue fees and agreed to pay royalties on net sales of any products developed as a result of the license, annual license fees, various milestone fees, including reimbursement of sunk-in patent expenses, and fees for sponsored research performed by the University of Kansas as consideration for the license. |
Convertible Preferred Stock
Convertible Preferred Stock | 12 Months Ended |
Dec. 31, 2022 | |
Equity [Abstract] | |
Convertible Preferred Stock | 12. Convertible Preferred Stock Under our Thirteenth Amended and Restated Certificate of Incorporation, the Company has 100,000,000 undesignated shares of convertible preferred stock. As of December 31, 2022 and 2021 , there were no shares of convertible preferred stock issued and outstanding. |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | 13. Stock-Based Compensation The LTIP Plan provides for awards of RSUs, nonstatutory stock options, incentive stock options within the meaning of Section 422 of the Internal Revenue Code of 1986, as amended (the Code), and other incentive awards and rights to purchase shares of the Company’s common stock. As of December 31, 2022, a total of 2,402,710 shares of common stock are reserved for future grant under the LTIP Plan. As of December 31, 2022 , 1,151,656 RSUs and stock options to purchase 6,009,199 shares are outstanding under the LTIP Plan. In 2022, the stockholders approved the Reata Pharmaceuticals, Inc. 2022 Employee Stock Purchase Plan (the "ESPP"), pursuant to which 500,000 shares of common stock were authorized for issuance. Under the ESPP, each offering period is twelve months, with two six-month purchase periods, at the end of each purchase period the employees may purchase shares of common stock through payroll deductions made over the term of the purchase period. The per-share purchase price at the end of each purchase period is equal to the lesser of 85 % of the closing price of the Company's common stock at the beginning of the offering period or the purchase date. As of December 31, 2022, the Company has not issued any common stock in relation to the ESPP. The Company recorded approximately $ 0.1 million in compensation expense related to the ESPP. The Company recognizes stock-based compensation expense for awards with service-based vesting conditions as an expense using the straight-line method. In the case of performance-based awards, compensation expense is recognized for awards when achievement of the underlying performance-based targets become probable, which have typically been in the same period as when the targets are achieved. The following table summarizes time-based and performance-based stock compensation expense reflected in the consolidated statements of operations: Years Ended December 31 2022 2021 2020 (in thousands) Research and development $ 27,722 $ 23,566 $ 28,114 General and administrative 31,009 33,240 29,519 Total stock compensation expense $ 58,731 $ 56,806 $ 57,633 Restricted Stock Units RSUs, including service-based and performance-based awards, were granted under the LTIP Plan. The fair value of these RSUs is equal to the closing price of the Company’s common stock at the date of grant multiplied by the number of shares subject to the RSU awards with forfeitures accounted for as they occur. The vesting is subject to the satisfaction of service requirements or the satisfaction of achieving certain performance targets. The following table summarizes RSUs as of December 31, 2022, and changes during the year ended December 31, 2022 under the LTIP Plan: Number of Weighted-Average Outstanding at January 1, 2022 809,145 $ 66.91 Granted 783,775 27.57 Vested ( 216,507 ) 50.15 Forfeited ( 224,757 ) 55.69 Outstanding at December 31, 2022 1,151,656 $ 45.45 As of December 31, 2022, total unrecognized compensation expense of $ 28.1 million related to service-based RSU and performance-based RSU awards that were deemed probable of vesting is expected to be recognized over a weighted average of 2.3 years, which excludes the unvested performance-based RSUs that were deemed not probable of vesting as of December 31, 2022, constituting of 244,500 shares with unrecognized stock-based compensation expense of $ 15.9 million. Stock Options Stock options, including service-based and performance-based awards, were granted under the LTIP Plan. The Company estimates stock awards fair value on the date of grant using the Black-Scholes valuation, with the vesting being subject to service requirements' satisfaction or achieving certain performance targets. The Company accounts for forfeitures when they occur. The following table summarizes stock option activity as of December 31, 2022, and changes during the year ended December 31, 2022, under the LTIP Plan and standalone option agreements: Number of Weighted- Outstanding at January 1, 2022 4,743,180 $ 86.06 Granted 1,938,874 27.86 Exercised ( 64,953 ) 22.96 Forfeited ( 425,880 ) 96.41 Expired ( 182,022 ) 129.23 Outstanding at December 31, 2022 6,009,199 $ 65.92 Exercisable at December 31, 2022 3,433,108 $ 61.04 As of December 31, 2022, total unrecognized compensation expense of $ 54.9 million related to stock options is expected to be recognized over a weighted average of 2.72 years, which excludes the unvested performance-based stock options that were deemed not probable of vesting as of December 31, 2022, constituting 952,700 shares with unrecognized stock-based compensation expense of $ 54.2 million. At December 31, 2022, 6,009,199 stock options are fully vested or are expected to vest and have a weighted-average outstanding term of 6.8 years and a weighted-average exercise price of $ 65.92 . Exercisable stock options have a weighted-average outstanding remaining term of 5.4 years. The total intrinsic value (the difference between market value and exercise prices of in-the-money options) of all outstanding options at December 31, 2022, 2021, and 2020, was $ 45.0 million , $ 8.6 million, and $ 269.4 million, respectively. The total intrinsic value of exercisable options at December 31, 2022, 2021, and 2020, was $ 28.7 million, $ 8.6 million, and $ 185.7 million, respectively. In 2022, 2021, and 2020, 64,953 , 234,216 , and 616,585 options were exercised, respectively. The total intrinsic value of options exercised was $ 0.7 million, $ 21.2 million and $ 68.6 million for the years ended December 31, 2022, 2021 and 2020, respectively. For the year ended December 31, 2022 we received $ 1.5 million in cash from stock option exercises. Fair Value Estimates The Company’s determination of the fair value of stock-based payment awards on the date of grant using the Black-Scholes option pricing model is affected by many factors, including the stock price and a number of subjective variables. These variables include, but are not limited to, the Company’s stock price volatility over the expected term of the awards and estimates of the expected option term. The weighted-average assumptions used in the Black-Scholes option pricing model were as follows: Years Ended December 31 2022 2021 2020 Dividend yield — % — % — % Volatility 73.36 % 69.71 % 73.46 % Risk-free interest rate 2.33 % 0.69 % 1.44 % Expected term of options (in years) 5.67 5.65 5.86 Weighted average grant date fair value $ 17.92 $ 120.97 $ 196.96 Expected volatility is based on the Company’s own historical volatility since its IPO and benchmarked public companies during fiscal years 2022, 2021 and 2020. The risk-free interest rate, ranging from 1.3 % to 4.25 % during the year ended December 31, 2022 , is based on the United States Treasury yield curve in effect at the time of grant for periods corresponding with the expected life of the options. The expected term of options represents the weighted-average period of time that options granted are expected to be outstanding based on historical data. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2022 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plans | 14. Employee Benefit Plans In 2010, we adopted an Employee Investment Plan, qualified under Section 401(k) of the Code, which is a retirement savings plan covering substantially all of our U.S. employees (the Plan). The Plan is administered under the “safe harbor” provision of ERISA. Under the Plan, an eligibl e employee may elect to contribute a percentage of their salary on a pre-tax basis, subject to federal statutory limitations. Beginning in January 2019, the Company implemented a discretionary employer matching contribution of $ 1.00 for every $ 1.00 contributed by a participating employee up to $ 7,000 and $ 6,000 annually in 2022 and 2021 , respectively, which such matching contributions become fully vested after four years of service. The Company recorded expense of $ 2.1 million, $ 1.7 million and $ 1.1 million for the twelve months ended December 31, 2022, 2021 and 2020 , respectively, which includes the Company’s contributions and administrative costs. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 15. Commitments and Contingencies Litigation From time to time, the Company is a party to legal proceedings in the course of its business, including the matters described below. The outcome of any such legal proceedings, regardless of the merits, is inherently uncertain. In addition, litigation and related matters are costly and may divert the attention of our management and other resources that would otherwise be engaged in other activities. If the Company were unable to prevail in any such legal proceedings, its business, results of operations, liquidity and financial condition could be adversely affected. The Company recognizes accruals for litigations to the extent that it can conclude that a loss is both probable and reasonably estimable and recognizes legal expenses as incurred. Bardoxolone Securities Litigation In late 2021 and early 2022, certain putative stockholders of the Company filed complaints in the United States District Court for the Eastern District of Texas alleging violations of the federal securities laws against the Company and certain of its executives, including its Chief Executive Officer; its Chief Operating Officer, Chief Financial Officer, and President; and its Chief Innovation Officer (in one of the suits). On April 22, 2022, the suits were consolidated and a lead plaintiff was appointed. On June 21, 2022, the lead plaintiff filed a complaint against the Company, the aforementioned executives, certain current and former member of the Company’s Board of Directors, and underwriters in connection with secondary offerings of Company stock in 2019 and 2020. The complaint alleges, among other things, that the Company made false and misleading statements regarding the sufficiency of the Phase 2 and Phase 3 CARDINAL studies to support an NDA for bardoxolone in the treatment of CKD caused by Alport syndrome, and the Company’s interactions with the FDA concerning potential approval for bardoxolone. The complaint asserts claims under the Securities Act of 1933 and the Securities Exchange Act of 1934 (Exchange Act). The plaintiffs seek, among other things, a class action designation, an award of damages, and costs and expenses, including attorney fees and expert fees. The Company believes that the allegations contained in the complaint are without merit and intends to defend the case. The Company cannot predict at this point the length of time that this action will be ongoing or the liability, if any, which may arise therefrom. Derivative Lawsuit On May 6, 2022, an alleged stockholder of the Company filed a derivative action in the Court of Chancery of the State of Delaware against certain current and former directors of the Company and naming the Company as a nominal defendant. The plaintiff asserts claims in the complaint of breach of fiduciary duty and unjust enrichment concerning the alleged payment of excessive compensation to the non-employee directors of the Company between fiscal years 2019 and 2021. The plaintiff seeks, among other things, an order awarding damages and costs and expenses, including attorneys and expert fees, and directing the Board of Directors to reform and improve its corporate governance and internal procedures relating to the award of non-employee director compensation. The parties have agreed to a stipulation of compromise and settlement, which was approved by the Court of Chancery in January 2023. Pursuant to the terms of the stipulation of compromise and settlement, all claims were dismissed. At December 31, 2022 the Company recorded a liability for the amount settled in payment of plaintiff’s attorneys’ fees and expenses, which has no material impact on the Company. Indemnifications ASC 460, Guarantees, requires that, upon issuance of a guarantee, the guarantor must recognize a liability for the fair value of the obligations it assumes under that guarantee. As permitted under Delaware law and in accordance with the Company’s bylaws, officers and directors are indemnified for certain events or occurrences, subject to certain limits, while the officer or director is or was serving in such capacity. The maximum amount of potential future indemnification is unlimited; however, the Company has obtained director and officer insurance that limits its exposure and may enable recoverability of a portion of any future amounts paid. The Company believes the fair value for these indemnification obligations is minimal. Accordingly, the Company has no t recognized any liabilities relating to these obligations as of December 31, 2022 . The Company has certain agreements with licensors, licensees, collaborators, and vendors that contain indemnification provisions. In such provisions, the Company typically agrees to indemnify the licensor, licensee, collaborator, or vendor against certain types of third-party claims. The Company accrues for known indemnification issues when a loss is probable and can be reasonably estimated. There were no accruals for expenses related to indemnification issues for any period presented. |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 16. Net Loss per Share The computation of basic and diluted net loss per share attributable to common stockholders of the Company for the years ended December 31 is summarized in the following table: Years Ended December 31 2022 2021 2020 Numerator Net loss (in thousands) $ ( 311,901 ) $ ( 297,386 ) $ ( 247,752 ) Denominator Weighted-average number of common shares 36,517,928 36,321,351 33,709,480 Dilutive potential common shares — — — Weighted-average number of common shares 36,517,928 36,321,351 33,709,480 Net loss per share — basic and diluted $ ( 8.54 ) $ ( 8.19 ) $ ( 7.35 ) The number of weighted average stock options and RSUs that were not included in the diluted earnings per share calculation because the effect would have been anti-dilutive represented 7,160,855 , 5,552,325 , and 4,414,820 shares for the years ended 2022, 2021, and 2020 , respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Risks and Uncertainties | Risks and Uncertainties The Company has experienced losses and negative operating cash flows for many years since inception and has no marketed drug or other products. The Company’s ability to generate future revenue depends upon the results of its development programs, whose success cannot be guaranteed. The Company may need to raise additional equity capital in the future in order to fund its operations. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ from those estimates. |
Investments in Marketable Securities and Cash Equivalents | Investments in Marketable Securities and Cash Equivalents The Company invests excess cash balances in marketable debt securities and classifies its investments as held-to-maturity on facts and circumstances present at the time the Company purchased the securities. At each balance sheet date presented, the Company classified all of its investments in debt securities as held-to maturity and as current assets as they represent the investment of funds available for current operations. The Company’s marketable debt securities are classified as cash equivalents if the original maturity, from the date of purchase, is 90 days or less, and as marketable debt securities if the original maturity, from the date of purchase, is in excess of 90 days. The carrying amount of cash equivalents approximate fair value. As of December 31, 2022 cash and cash equivalents comprise funds in cash, money market accounts, and treasury securities. The Company considers all available evidence to evaluate if an impairment loss exists, and if so, marks the investment to market through a charge to the Company’s consolidated statements of operations and comprehensive loss. The Company did not record any impairment charges related to our marketable debt securities during the year ended December 31, 2022 . |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is computed using the straight-line method over the following estimated useful lives: Computer equipment 2 - 5 years Software 3 years Laboratory equipment 5 - 7 years Office furniture 5 years Office equipment 5 years Manufacturing equipment 10 years Leasehold improvements are amortized on the straight-line method over the shorter of the lease term or the estimated useful life of the equipment or improvement. Such amortization is recorded as depreciation expenses in the consolidated statements of operations. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets The Company periodically evaluates its long-lived assets for potential impairment in accordance with ASC Topic 360, Property, Plant and Equipment . Potential impairment is assessed when there is evidence that events or changes in circumstances indicate that the carrying amount of an asset may not be recovered. Recoverability of these assets is assessed based on undiscounted expected future cash flows from the assets, considering a number of factors, including past operating results, budgets and economic projections, market trends, and product development cycles. If impairments are identified, assets are written down to their estimated fair value. The Company has no t recognized any impairment charges in 2022, 2021, or 2020 . |
Liability Related to Sale of Future Royalties | Liability Related to Sale of Future Royalties On June 24, 2020, the Company closed on the Development and Commercialization Funding Agreement with an affiliate of Blackstone Life Sciences, LLC (BXLS), which provided funding for the development and commercialization of bardoxolone for the treatment of CKD caused by Alport syndrome, autosomal dominant polycystic kidney disease (ADPKD), and certain other rare CKD indications in return for future royalties (the Development Agreement). The Company accounted for the Development Agreement as a sale of future revenues resulting in a debt classification, primarily because the Company has significant continuing involvement in generating the future revenue on which the royalties are based. The debt will be amortized under the effective interest rate method and, accordingly, the Company is recognizing non-cash interest expense over the estimated term of the Development Agreement. The liability related to sale of future royalties, and the debt amortization, are based on the Company’s current estimate of future royalties expected to be paid over the estimated term of the Development Agreement. The Company will periodically assess the expected royalty payments and, if materially different than its previous estimate, will prospectively adjust and recognize the related non-cash interest expense. The transaction costs associated with the liability will be amortized to non-cash interest expense over the estimated term of the Development Agreement. For a complete discussion of accounting for Development Agreement, see Note 7, Liability Related to Sale of Future Royalties of Notes to Consolidated Financial Statements contained in this Annual Report on Form 10-K. |
Fair Value Measurements | Fair Value Measurements The Company categorizes its financial instruments measured at fair value into a three-level fair value hierarchy that prioritizes the inputs used in determining the fair value of the asset or liability. The three levels of the fair value hierarchy are as follows: • Level 1 - Financial instruments that have values based on unadjusted quoted prices for identical assets or liabilities in an active market which the Company has the ability to access at the measurement date. • Level 2 - Financial instruments that have values based on quoted market prices in markets where trading occurs infrequently or that have values based on quoted prices of instruments with similar attributes in active markets. • Level 3 - Financial instruments that have values based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. These inputs reflect management’s own assumptions about the assumptions a market participant would use in pricing the asset. |
Revenue Recognition | Revenue Recognition The Company’s revenue to date has been generated primarily from licensing fees received under its collaborative licensing agreements with AbbVie Inc. (AbbVie) and Kyowa Kirin and reimbursements for expenses from Kyowa Kirin. The terms of the agreements include non-refundable upfront fees, funding of research and development activities, payments based upon achievement of milestones, and royalties on net product sales. Under Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers (Topic 606), an entity recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of Topic 606, the entity performs the following five steps: (i) identify the promised goods or services in the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price, including the constraint on variable consideration; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when or as the entity satisfies a performance obligation. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when or as the performance obligation is satisfied. Licenses of intellectual property: If a license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. Milestone payments: At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission by the Company) is included in the transaction price, which is then allocated to each performance obligation. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration, and other revenues and earnings in the period of adjustment and in future periods through the end of the performance obligation period. Royalties: For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and where the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). To date, the Company has not recognized any royalty revenue resulting from any of its licensing arrangements. Manufacturing Supply Services: Arrangements that include a promise for future supply of drug substance or drug product for either clinical development or commercial supply at the customer’s discretion are generally considered options. The Company assesses if these options provide a material right to the licensee and, if so, they are accounted for as separate performance obligations. If the Company is entitled to additional payments when the customer exercises these options, any additional payments are recorded when the customer obtains control of the goods, which is upon delivery. For a complete discussion of accounting for collaborative licensing agreements, see Note 3, Collaboration Agreements of Notes of Consolidated Financial Statements contained in this Annual Report on Form 10-K. |
Acquired License Rights | Acquired License Rights All acquired license and sublicense costs that are in-process research and development, which were acquired directly in a transaction other than a business combination that does not have an alternative future use, are expensed as incurred. For a complete discussion of accounting for reacquisition of license rights in 2019, see Note 3, Collaboration Agreements . |
Research and Development Costs | Research and Development Costs All research and development costs are expensed as incurred, including costs for drug supplies used in research and development or clinical studies, property and equipment acquired specifically for a finite research and development project, and nonrefundable deposits incurred at the initiation of research and development activities. Research and development costs consist principally of costs related to clinical studies managed directly by the Company and through contract research organizations (CROs), manufacture of clinical drug products for clinical studies, preclinical study costs, discovery research expenses, facilities costs, salaries, and related expenses. In December 2017, the Company and Kyowa Kirin entered into the Third Supplement to the Kyowa Kirin Agreement, which allows the Company to begin a portion of the registrational CARDINAL trial in Japan, for which Kyowa Kirin has reimbursed costs incurred of $ 3.0 million as of the end of December 31, 2021. The Company deemed that this was not a material modification to the Kyowa Kirin Agreement because no payment terms or deliverables were changed. The Company’s expenses were reduced by $ 0.5 million for Kyowa Kirin’s share of the study costs for twelve months ended December 31, 2019. No such expenses or credits were recorded in the twelve months ended December 31, 2022 and December 31, 2021. In addition, we have also entered into cost sharing agreement for the FALCON trial and have recorded $ 0.1 million and $ 1.4 million in expenses during the year ended December 31, 2022 and 2021, respectively. No such costs were incurred in the twelve months ended December 31, 2020. The Company bases its expense accruals related to clinical trials on its estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on its behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing costs, the Company estimates the time period over which services will be performed and the level of effort to be expended in each period. Included within total accrued direct research liabilities is $ 11.4 million, which was accrued but unbilled, as of December 31, 2022. To date, the Company has not experienced significant changes in its estimates of accrued research and development expenses after a reporting period. However, due to the nature of estimates, the Company cannot assure that it will not make changes to its estimates in the future as the Company becomes aware of additional information about the status or conduct of its clinical trials and other research activities. |
Patents | Patents Costs associated with filing, prosecuting, enforcing, and maintaining patent rights are expensed as incurred and are classified as general and administrative expenses. |
Stock-Based Compensation | Stock-Based Compensation The Company accounts for its stock-based compensation in accordance with ASC 718 Compensation—Stock Compensation (ASC 718). ASC 718 requires companies to measure and recognize compensation expense for all stock option and RSU awards based on the estimated fair value of the award on the grant date. The Company uses the Black-Scholes option pricing model to estimate the fair value of stock option awards. The fair value is recognized as expense, over the requisite service period, which is generally the vesting period of the respective award, on a straight-line basis when the only condition to vesting is continued service. If vesting is subject to a performance condition, recognition is based on the derived service period of the award. Expense for awards with performance conditions is estimated and adjusted on a quarterly basis based upon the assessment of the probability that the performance condition will be met. The Company begins to recognize the value of the performance-based awards when the Company determines the achievement of each performance condition is deemed probable. At the probable date, the Company will record a cumulative expense catch-up, with the remaining amortized over the remaining service period. Use of the Black-Scholes option pricing model requires management to apply judgment under highly subjective assumptions. These assumptions include: • Expected term—The expected term represents the period that the stock-based awards are expected to be outstanding and is based on the average period the stock options are expected to be outstanding and was based on our historical information of the options exercise patterns and post-vesting termination behavior. • Expected volatility—During the first two months of the year, we did not have sufficient trading history to estimate the volatility of our common stock, thus, the expected volatility was estimated based on our own historical volatility since our IPO and the average volatility for comparable publicly traded biopharmaceutical companies. When selecting comparable publicly traded biopharmaceutical companies on which we based our expected stock price volatility, we selected companies with comparable characteristics to us, including enterprise value, risk profiles, position within the industry, and historical share price information sufficient to meet the expected life of the stock-based awards. For the remainder part of the year, the expected volatility was estimated based on our own historical volatility since our IPO. • Risk-free interest rate—The risk-free interest rate is based on the United States Treasury zero coupon issues in effect at the time of grant for periods corresponding with the expected term of option. • Expected dividend—The Company has no plans to pay dividends on its common stock. Therefore, the company used an expected dividend yield of zero. The Company accounts for forfeitures of share-based awards when they occur. Stock option and RSU awards have been granted to non-employees, in connection with research and consulting services provided to the Company, and to employees, under its Second Amended and Restated Long Term Incentive Plan (the LTIP Plan). Equity awards generally vest over terms of four or five years . For employees and non-employees, stock-based compensation expense is recorded ratably through the vesting period for each stock option or tranche of RSU award. In the case of performance-based awards, compensation expense is recognized for awards when achievement of the underlying performance-based targets become probable, which have typically been in the same period as when the targets are achieved. |
Income Taxes | Income Taxes The Company accounts for income taxes and the related accounts under the liability method. Deferred tax assets and liabilities are determined based on differences between the financial statement and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The measurement of a deferred tax asset is reduced, if necessary, by a valuation allowance if it is more likely than not that some portion or all of the deferred tax asset will not be realized. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740, Income Taxes . The Company recognizes a tax benefit for uncertain tax positions if the Company believes it is more likely than not that the position will be upheld on audit based solely on the technical merits of the tax position. The Company evaluates uncertain tax positions after consideration of all available information. As of December 31, 2022 , the interest accrued related to provision for or due to uncertain tax positions was immaterial. |
Leases | Leases At the inception of an arrangement, the Company determines if an arrangement is, or contains, a lease based on the unique facts and circumstances present in that arrangement. Lease assets represent the Company’s right to use an underlying asset for the lease term, and lease liabilities represent the obligation to make lease payments arising from the lease. These assets and liabilities are initially recognized at the lease commencement date based on the present value of lease payments over the lease term calculated using its incremental borrowing rate based on the information available at commencement unless the implicit rate is readily determinable. Lease assets also include upfront lease payments, lease incentives paid, and direct costs incurred and exclude lease incentives received. The lease term used to calculate the lease assets and related lease liabilities includes the options to extend or terminate the lease when it is reasonably certain that the Company will exercise those options. Lease expense for operating leases is recognized on a straight-line basis over the expected lease term as an operating expense while the expense for finance leases is recognized as depreciation expense over the expected lease term unless there is a transfer of title or purchase option reasonably certain of exercise. The Company accounts for each lease component separately from the nonlease components. The depreciable life of lease assets and leasehold improvements is limited by the expected lease term unless there is a transfer of title or purchase option reasonably certain of its exercise. Leases with an initial term of 12 months or less are not recorded on the balance sheet, and the expenses for these short-term leases and operating leases are recognized on a straight-line basis over the lease term. Key assumptions and judgments included in the determination of the lease liability include the discount rate applied to the present value of the future lease payments, and the exercise of renewal options. Our leases do not provide information about the rate implicit in the lease; therefore, we utilize an incremental borrowing rate to calculate the present value of our future lease obligations. The incremental borrowing rate represents the rate of interest we would have to pay on a collateralized borrowing, for an amount equal to the lease payments, over a similar term and in a similar economic environment. |
Net Income (Loss) per Share | Net Income (Loss) per Share Basic and diluted net income (loss) per common share is calculated by dividing net income (loss) attributable to common stockholders by the weighted average number of common shares outstanding during the period, without consideration for common stock equivalents. The Company’s potentially dilutive shares, which include unvested RSUs and options to purchase common stock, are considered to be common stock equivalents and are only included in the calculation of diluted net loss per share when their effect is dilutive. For periods in which the Company reports a net loss attributable to common stockholders, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions, and other events and circumstances from non-owner sources and includes all components of net income (loss) and other comprehensive income (loss). The other comprehensive income (loss) for the years ended December 31, 2022, 2021, and 2020 was immaterial. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Depreciation Property and Equipment | Depreciation is computed using the straight-line method over the following estimated useful lives: Computer equipment 2 - 5 years Software 3 years Laboratory equipment 5 - 7 years Office furniture 5 years Office equipment 5 years Manufacturing equipment 10 years Leasehold improvements are amortized on the straight-line method over the shorter of the lease term or the estimated useful life of the equipment or improvement. Such amortization is recorded as depreciation expenses in the consolidated statements of operations. |
Marketable Debt Securities (Tab
Marketable Debt Securities (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Marketable Debt Securities | The following tables summarize our marketable debt securities (in thousands), as of December 31, 2022: Amortized Gross Gross Fair Value (1) Marketable debt securities: U.S. treasury securities 345,202 8 ( 423 ) 344,787 Total $ 345,202 $ 8 $ ( 423 ) $ 344,787 (1) The fair value was determined using the three-tier fair value hierarchy for disclosure in accordance with Accounting Standards Codification 820-10. The Company's investments in marketable securities are classified within Level 2 of the fair value hierarchy. The Company uses quoted prices for similar assets sourced from certain third-party pricing services. The third-party pricing services generally utilize industry standard valuation models for which all significant inputs are observable, either directly or indirectly, to estimate the price or fair value of the securities. The primary input generally includes reported trades of or quotes on the same or similar securities. The Company does not make additional judgments or assumptions made to the pricing data sourced from the third-party pricing services. |
Other Income (Expense), Net (Ta
Other Income (Expense), Net (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Other Income and Expenses [Abstract] | |
Summary of Other Income (Expense), Net | Years Ended December 31 2022 2021 2020 (in thousands) Other income (expense), net Investment income $ 5,990 $ 177 $ 2,769 Interest expense — ( 6,563 ) ( 14,895 ) Non-cash interest expense on liability ( 41,771 ) ( 46,688 ) ( 21,884 ) Other income (expense) 1,889 ( 54 ) 1,279 Loss on extinguishment of debt — — ( 11,183 ) Total other income (expense), net $ ( 33,892 ) $ ( 53,128 ) $ ( 43,914 ) |
Liability Related to Sale of _2
Liability Related to Sale of Future Royalties (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Liability Related To Sale Of Future Royalties [Abstract] | |
Schedule of Activity Within Liability Related to Sale of Future Royalties | The following table shows the activity within the liability related to sale of future royalties for the twelve months ended December 31, 2022: Liability Related to Sale of (in thousands) Balance at December 31, 2021 $ 362,928 Non-cash interest expense recognized 41,706 Balance at December 31, 2022 404,634 Less: Unamortized transaction cost ( 721 ) Carrying value at December 31, 2022 $ 403,913 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment consisted of the following as of December 31: 2022 2021 (in thousands) Computer equipment and software $ 3,997 $ 3,748 Laboratory equipment 6,828 6,389 Office furniture 2,005 1,990 Office and other equipment 399 399 Leasehold improvements 14,020 14,127 Manufacturing equipment 223 213 27,472 26,866 Less: accumulated depreciation ( 16,293 ) ( 15,262 ) Property and equipment, net $ 11,179 $ 11,604 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Leases [Abstract] | |
Summary of Supplemental Balance Sheet and Other Information Related to Operating Leases | Supplemental balance sheet and other information related to the Company’s operating leases is as follows: As of December 31 2022 2021 Weighted-average remaining lease term (in years) 15.2 15.7 Weighted-average discount rate 6.5 % 6.6 % |
Schedule of Maturities of Lease Liabilities | Maturities of lease liabilities by fiscal year for the Company’s operating leases: As of December 31, 2022 (in thousands) 2023 (1) $ 9,686 2024 6,457 2025 11,777 2026 12,007 2027 12,241 Thereafter 143,829 Total lease payments (1) 195,997 Less: Imputed interest ( 76,537 ) Present value of lease liabilities $ 119,460 (1) Above table assumes one year rent abatement is applied beginning in June 2023 following United States Food and Drug Administration (FDA) approval of omaveloxolone. |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of Effective Income Tax Rate from Continuing Operations to Federal Statutory Tax Rate | The following table reconciles the Company’s effective income tax rate from continuing operations to the federal statutory tax rate of 21 %: Years Ended December 31 2022 2021 2020 U.S. federal income taxes 21 % 21 % 21 % Federal and state tax credits 4 5 12 Stock-based compensation ( 1 ) ( 0 ) 4 NOL carryback rate differential — — 1 Foreign rate differential ( 6 ) ( 3 ) ( 2 ) Change in valuation allowance ( 19 ) ( 23 ) ( 28 ) Other 1 — — Recorded federal income tax benefit — % — % 8 % |
Significant Components of Net Deferred Tax Assets | Significant components of the Company’s net deferred tax assets as of December 31 are as follows (in thousands): 2022 2021 Deferred tax assets: Federal and state tax credits $ 115,064 $ 102,590 Net operating loss 119,431 101,463 Accrued royalties 85,299 79,458 Intellectual property 53,892 60,753 Lease Liability 25,229 29,847 Stock-based compensation 29,037 23,677 Deferred revenue — 362 Compensation accruals 3,264 884 Section 174 capitalization 16,394 — Other 615 538 Deferred tax assets before valuation allowance 448,225 399,572 Less: Valuation allowance ( 424,052 ) ( 369,215 ) Net deferred income tax assets 24,173 30,357 Deferred tax liabilities: Right-of-use assets ( 22,229 ) ( 27,817 ) Other ( 1,779 ) ( 2,424 ) Net deferred tax assets $ 165 $ 116 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Summary of Time Based and Performance-Based Stock Compensation Expense | The following table summarizes time-based and performance-based stock compensation expense reflected in the consolidated statements of operations: Years Ended December 31 2022 2021 2020 (in thousands) Research and development $ 27,722 $ 23,566 $ 28,114 General and administrative 31,009 33,240 29,519 Total stock compensation expense $ 58,731 $ 56,806 $ 57,633 |
Summary of Restricted Stock Units | The following table summarizes RSUs as of December 31, 2022, and changes during the year ended December 31, 2022 under the LTIP Plan: Number of Weighted-Average Outstanding at January 1, 2022 809,145 $ 66.91 Granted 783,775 27.57 Vested ( 216,507 ) 50.15 Forfeited ( 224,757 ) 55.69 Outstanding at December 31, 2022 1,151,656 $ 45.45 |
Summary of Stock Option Activity | The following table summarizes stock option activity as of December 31, 2022, and changes during the year ended December 31, 2022, under the LTIP Plan and standalone option agreements: Number of Weighted- Outstanding at January 1, 2022 4,743,180 $ 86.06 Granted 1,938,874 27.86 Exercised ( 64,953 ) 22.96 Forfeited ( 425,880 ) 96.41 Expired ( 182,022 ) 129.23 Outstanding at December 31, 2022 6,009,199 $ 65.92 Exercisable at December 31, 2022 3,433,108 $ 61.04 |
Weighted Average Assumptions in Black-Scholes Pricing Model | The weighted-average assumptions used in the Black-Scholes option pricing model were as follows: Years Ended December 31 2022 2021 2020 Dividend yield — % — % — % Volatility 73.36 % 69.71 % 73.46 % Risk-free interest rate 2.33 % 0.69 % 1.44 % Expected term of options (in years) 5.67 5.65 5.86 Weighted average grant date fair value $ 17.92 $ 120.97 $ 196.96 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Net Loss per Share | The computation of basic and diluted net loss per share attributable to common stockholders of the Company for the years ended December 31 is summarized in the following table: Years Ended December 31 2022 2021 2020 Numerator Net loss (in thousands) $ ( 311,901 ) $ ( 297,386 ) $ ( 247,752 ) Denominator Weighted-average number of common shares 36,517,928 36,321,351 33,709,480 Dilutive potential common shares — — — Weighted-average number of common shares 36,517,928 36,321,351 33,709,480 Net loss per share — basic and diluted $ ( 8.54 ) $ ( 8.19 ) $ ( 7.35 ) |
Summary of Estimated Useful Liv
Summary of Estimated Useful Lives of Property and Equipment (Details) | 12 Months Ended |
Dec. 31, 2022 | |
Computer equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 2 years |
Computer equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Software | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 3 years |
Laboratory equipment | Minimum | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Laboratory equipment | Maximum | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 7 years |
Office furniture | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Office equipment | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 5 years |
Manufacturing equipment | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Useful Life | 10 years |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | 12 Months Ended | |||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Significant Accounting Policies [Line Items] | ||||
Asset impairment charges | $ 0 | $ 0 | $ 0 | |
Research and development | $ 169,843,000 | 155,993,000 | 159,080,000 | |
Minimum | ||||
Significant Accounting Policies [Line Items] | ||||
Equity vesting terms | 4 years | |||
Maximum | ||||
Significant Accounting Policies [Line Items] | ||||
Equity vesting terms | 5 years | |||
Collaborative Arrangement | ||||
Significant Accounting Policies [Line Items] | ||||
Unbilled research and development expense accrued | $ 11,400,000 | |||
Kyowa Kirin Agreement | License Agreement Terms | ||||
Significant Accounting Policies [Line Items] | ||||
Reduction in research and development expense | 0 | 0 | $ 500,000 | |
Kyowa Kirin Agreement | Clinical Development Milestones | License Agreement Terms | ||||
Significant Accounting Policies [Line Items] | ||||
Reduction in research and development expense | 3,000,000 | |||
FALCON Cost Sharing Agreement | ||||
Significant Accounting Policies [Line Items] | ||||
Research and development | $ 100,000 | $ 1,400,000 | $ 0 |
Collaboration Agreements - Addi
Collaboration Agreements - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
Jul. 27, 2021 | Dec. 31, 2009 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Oct. 31, 2019 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Decrease in revenue recognition | $ 1,648 | $ 3,040 | $ 4,701 | |||
Collaboration revenue | 2,216 | 11,490 | 9,019 | |||
Interest expense | 0 | 6,563 | 14,895 | |||
Kyowa Kirin Agreement | License Agreement Terms | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Upfront license fee received | $ 35,000 | |||||
Collaboration revenue, milestone payments received | 50,000 | |||||
Collaboration revenue, potential milestone payments | 47,000 | |||||
Collaboration revenue, additional potential commercial milestone payments | 140,000 | |||||
Collaboration agreement earned milestone payment | $ 5,000 | |||||
Collaboration revenue | 4,700 | |||||
Deferred Revenue | $ 300 | |||||
AbbVie | ||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | ||||||
Payable to collaborators | $ 330,000 | |||||
Interest expense | $ 0 | $ 6,600 | $ 6,500 |
Marketable Debt Securities - Su
Marketable Debt Securities - Summary of Marketable Debt Securities (Details) $ in Thousands | Dec. 31, 2022 USD ($) | |
Marketable Securities [Line Items] | ||
Marketable Debt Securities, Amortized Cost | $ 345,202 | |
Marketable Debt Securities, Unrealized Gains | 8 | |
Marketable Debt Securities, Unrealized Loss | (423) | |
Marketable Debt Securities, Fair Value | 344,787 | [1] |
U.S. Treasury Securities | ||
Marketable Securities [Line Items] | ||
Marketable Debt Securities, Amortized Cost | 345,202 | |
Marketable Debt Securities, Unrealized Gains | 8 | |
Marketable Debt Securities, Unrealized Loss | (423) | |
Marketable Debt Securities, Fair Value | $ 344,787 | [1] |
[1] The fair value was determined using the three-tier fair value hierarchy for disclosure in accordance with Accounting Standards Codification 820-10. The Company's investments in marketable securities are classified within Level 2 of the fair value hierarchy. The Company uses quoted prices for similar assets sourced from certain third-party pricing services. The third-party pricing services generally utilize industry standard valuation models for which all significant inputs are observable, either directly or indirectly, to estimate the price or fair value of the securities. The primary input generally includes reported trades of or quotes on the same or similar securities. The Company does not make additional judgments or assumptions made to the pricing data sourced from the third-party pricing services. |
Other Income (Expense), Net - S
Other Income (Expense), Net - Summary of Other Income (Expense), Net (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Other income (expense), net | ||||
Investment income | $ 5,990 | $ 177 | $ 2,769 | |
Interest expense | 0 | (6,563) | (14,895) | |
Non-cash interest expense on liability related to sale of future royalty | (41,771) | (46,688) | (21,884) | |
Other income (expense) | 1,889 | (54) | 1,279 | |
Loss on extinguishment of debt | $ 11,200 | 0 | 0 | 11,183 |
Total other income (expense), net | $ (33,892) | $ (53,128) | $ (43,914) |
Other Income (Expense), Net - A
Other Income (Expense), Net - Additional Information (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Jun. 30, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Other Income and Expenses [Abstract] | ||||
Other income related to employee retention credit | $ 2,100 | |||
Other income (expense) | 1,889 | $ (54) | $ 1,279 | |
Loss on extinguishment of debt | $ 11,200 | $ 0 | $ 0 | $ 11,183 |
Term Loan - Additional Informat
Term Loan - Additional Information (Details) - Amended Restated Loan Agreement - Term Loan - USD ($) $ in Millions | 12 Months Ended | ||||
Jun. 24, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 20, 2019 | |
Debt Instrument [Line Items] | |||||
Loan principal amount | $ 155 | ||||
Repayment of outstanding principal amount | $ 155 | ||||
Debt instrument, exit fee | 6.7 | ||||
Debt instrument, prepayment fee | 5.4 | ||||
Debt instrument, accrued and unpaid interest | $ 1 | ||||
Interest expense recognized | $ 0 | $ 0 | $ 8.3 |
Liability Related to Sale of _3
Liability Related to Sale of Future Royalties - Additional Information (Details) $ / shares in Units, $ in Thousands | 12 Months Ended | |||
Jun. 24, 2020 USD ($) Account $ / shares shares | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | |
Liability Related To Sale Of Future Royalties [Line Items] | ||||
Proceeds from issuance of common stock, net | $ 0 | $ 0 | $ 333,278 | |
Number of units of accounting related to consideration received | Account | 2 | |||
Liability related to sale of future royalties, net | $ 294,500 | |||
Transaction cost of liability related to sale of future royalties | 800 | |||
Transaction consideration allocated to common shares | $ 55,500 | |||
Effective interest rate including transaction costs | 13.80% | |||
Non cash interest expense recognized percentage | 10.90% | |||
Development Agreement | ||||
Liability Related To Sale Of Future Royalties [Line Items] | ||||
Proceeds from royalty agreement | $ 300,000 | |||
Purchase Agreement | ||||
Liability Related To Sale Of Future Royalties [Line Items] | ||||
Proceeds from issuance of common stock, net | 50,000 | |||
Purchase Agreement | Common Stock A | BXLS | ||||
Liability Related To Sale Of Future Royalties [Line Items] | ||||
Proceeds from issuance of common stock, net | $ 50,000 | |||
Issuance of common stock | shares | 340,793 | |||
Shares issued, price per share | $ / shares | $ 146.72 |
Liability Related to Sale of _4
Liability Related to Sale of Future Royalties - Schedule of Activity Within Liability Related to Sale of Future Royalties (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Liability Related To Sale Of Future Royalties [Abstract] | |
Liability related to sale of future royalties, Balance at December 31, 2021 | $ 362,928 |
Non-cash interest expense recognized | 41,706 |
Liability related to sale of future royalties, Balance at December 31, 2022 | 404,634 |
Less: Unamortized transaction cost | (721) |
Liability related to sale of future royalties, Carrying values at December 31, 2022 | $ 403,913 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross, Total | $ 27,472 | $ 26,866 |
Less: accumulated depreciation | (16,293) | (15,262) |
Property and equipment, net | 11,179 | 11,604 |
Computer equipment and software | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross, Total | 3,997 | 3,748 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross, Total | 6,828 | 6,389 |
Office furniture | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross, Total | 2,005 | 1,990 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross, Total | 399 | 399 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross, Total | 14,020 | 14,127 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property, Plant and Equipment, Gross, Total | $ 223 | $ 213 |
Leases - Additional Information
Leases - Additional Information (Details) $ in Thousands | 12 Months Ended | ||||
Oct. 15, 2019 ft² | Dec. 31, 2022 USD ($) ft² | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Dec. 15, 2021 USD ($) | |
Lessee Lease Description [Line Items] | |||||
Operating lease right-of-use asset | $ 105,258 | $ 126,777 | |||
Operating lease liability | 119,460 | ||||
Cash paid for amounts included in the measurement of lease liabilities | 9,500 | ||||
Operating lease, expense | $ 17,300 | $ 3,600 | $ 3,400 | ||
Plano Texas | |||||
Lessee Lease Description [Line Items] | |||||
Operating lease, existence of option to extend | true | ||||
Operating lease, option to extend | extending through December 31, 2023 | ||||
Lease expiration date | Dec. 31, 2023 | ||||
Plano Texas | Office Space | |||||
Lessee Lease Description [Line Items] | |||||
Area of real estate property | ft² | 122,000 | ||||
Plano Texas | Office And Laboratory Space | 2019 Lease Agreement | |||||
Lessee Lease Description [Line Items] | |||||
Area of real estate property | ft² | 327,400 | ||||
Operating lease, existence of option to extend | true | ||||
Renewal lease term, option one | two consecutive five-year renewal periods | ||||
Lease initial term | 16 years | ||||
Renewal lease term, option two | one ten-year renewal period | ||||
Operating lease right-of-use asset | $ 124,500 | ||||
Operating lease right-of-use asset reversed | $ 19,800 | ||||
Operating lease liability | 133,200 | ||||
Operating lease liability reversed | $ 19,300 | ||||
Lease Incentive, net | $ 8,700 | ||||
Irving Texas | |||||
Lessee Lease Description [Line Items] | |||||
Operating lease, existence of option to extend | true | ||||
Operating lease, option to extend | extending through October 31, 2024 | ||||
Lease expiration date | Oct. 31, 2024 | ||||
Operating lease, renewal Term | 12 months | ||||
Irving Texas | Office And Laboratory Space | |||||
Lessee Lease Description [Line Items] | |||||
Area of real estate property | ft² | 34,890 |
Leases - Summary of Supplementa
Leases - Summary of Supplemental Balance Sheet and Other Information Related to Operating Leases (Details) | Dec. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Weighted-average remaining lease term (in years) | 15 years 2 months 12 days | 15 years 8 months 12 days |
Weighted-average discount rate | 6.50% | 6.60% |
Leases - Schedule of Maturities
Leases - Schedule of Maturities of Lease Liabilities (Details) $ in Thousands | Dec. 31, 2022 USD ($) | |
Leases [Abstract] | ||
2023 | $ 9,686 | [1] |
2024 | 6,457 | |
2025 | 11,777 | |
2026 | 12,007 | |
2027 | 12,241 | |
Thereafter | 143,829 | |
Total lease payments | 195,997 | [1] |
Less: Imputed interest | (76,537) | |
Present value of lease liabilities | $ 119,460 | |
[1] Above table assumes one year rent abatement is applied beginning in June 2023 following United States Food and Drug Administration (FDA) approval of omaveloxolone. |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||
Dec. 31, 2022 | Jun. 30, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 | |
Income Tax Disclosure [Line Items] | ||||||
Income tax receivable as per CARES Act | $ 22,900 | $ 22,200 | ||||
Federal statutory tax rate | 21% | 21% | 21% | |||
Income tax received | 22,200 | |||||
Income tax, interest | $ 700 | |||||
Increase in valuation allowance | $ 54,800 | $ 68,300 | ||||
Federal accumulated net operating losses | $ 363,800 | $ 363,800 | ||||
Operating loss carry forwards limit percentage | 80% | |||||
Federal research and development tax credit carryforwards | 20,700 | $ 20,700 | ||||
Federal orphan drug tax credit carryforwards | 86,700 | 86,700 | ||||
Deferred tax assets state research and development tax credit carryforwards | 7,500 | 7,500 | ||||
Federal and state tax credits | 115,064 | $ 115,064 | $ 102,590 | |||
Tax credit carryforwards remainder expiration beginning year | 2030 | |||||
Other Income (Expense), Net | ||||||
Income Tax Disclosure [Line Items] | ||||||
Accrued benefit related to employee retention credit | 2,100 | |||||
Fiscal Year After 2037 | ||||||
Income Tax Disclosure [Line Items] | ||||||
Federal accumulated net operating losses | 304,100 | $ 304,100 | ||||
Expiring 2037 | ||||||
Income Tax Disclosure [Line Items] | ||||||
Federal accumulated net operating losses | 59,700 | 59,700 | ||||
Expiring 2028 | ||||||
Income Tax Disclosure [Line Items] | ||||||
Federal accumulated net operating losses | 358,800 | $ 358,800 | ||||
Earliest Tax Year | ||||||
Income Tax Disclosure [Line Items] | ||||||
Tax credit carryforwards expiration year | 2024 | |||||
Latest Tax Year | ||||||
Income Tax Disclosure [Line Items] | ||||||
Tax credit carryforwards expiration year | 2042 | |||||
Expiring 2024 | ||||||
Income Tax Disclosure [Line Items] | ||||||
Federal and state tax credits | $ 100 | $ 100 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Effective Income Tax Rate from Continuing Operations to Federal Statutory Tax Rate (Details) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal income taxes | 21% | 21% | 21% |
Federal and state tax credits | 4% | 5% | 12% |
Stock-based compensation | (1.00%) | 0% | 4% |
NOL carryback rate differential | 0% | 0% | 1% |
Foreign rate differential | (6.00%) | (3.00%) | (2.00%) |
Change in valuation allowance | (19.00%) | (23.00%) | (28.00%) |
Other | 1% | 0% | 0% |
Recorded federal income tax benefit | 0% | 0% | 8% |
Income Taxes - Significant Comp
Income Taxes - Significant Components of Net Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Federal and state tax credits | $ 115,064 | $ 102,590 |
Net operating loss | 119,431 | 101,463 |
Accrued royalties | 85,299 | 79,458 |
Intellectual property | 53,892 | 60,753 |
Lease Liability | 25,229 | 29,847 |
Stock-based compensation | 29,037 | 23,677 |
Deferred revenue | 0 | 362 |
Compensation accruals | 3,264 | 884 |
Section 174 capitalization | 16,394 | 0 |
Other | 615 | 538 |
Deferred tax assets before valuation allowance | 448,225 | 399,572 |
Less: Valuation allowance | (424,052) | (369,215) |
Net deferred income tax assets | 24,173 | 30,357 |
Deferred tax liabilities: | ||
Right-of-use assets | (22,229) | (27,817) |
Other | (1,779) | (2,424) |
Net deferred tax assets | $ 165 | $ 116 |
Licenses - Additional Informati
Licenses - Additional Information (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
License Agreements [Line Items] | ||
Term of agreements | The term of all agreements is through the useful lives of the licensed patents or for a period of 15 to 20 years for technology rights, for which there are no applicable patent rights. | |
2004 CDDO License Agreement | ||
License Agreements [Line Items] | ||
Development milestone and sublicense payments | $ 0 | $ 600,000 |
2009 Method of Use License Agreement | ||
License Agreements [Line Items] | ||
Development milestone and sublicense payments | $ 0 | $ 400,000 |
Minimum | ||
License Agreements [Line Items] | ||
Term of agreements | 15 years | |
Maximum | ||
License Agreements [Line Items] | ||
Term of agreements | 20 years |
Convertible Preferred Stock - A
Convertible Preferred Stock - Additional Information (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Undesignated Preferred Stock | ||
Class of Stock [Line Items] | ||
Convertible preferred stock | 100,000,000 | |
Convertible Preferred Stock | ||
Class of Stock [Line Items] | ||
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Compensation expense | $ 58,731,000 | $ 56,806,000 | $ 57,633,000 |
Stock options to purchase shares outstanding | 6,009,199 | 4,743,180 | |
Stock Option, Weighted-average exercise price | $ 65.92 | ||
Exercisable Stock, Weighted-average outstanding | 5 years 4 months 24 days | ||
Total intrinsic value of outstanding options | $ 45,000,000 | $ 8,600,000 | 269,400,000 |
Total intrinsic value of exercisable options | $ 28,700,000 | $ 8,600,000 | $ 185,700,000 |
Exercise of options, shares | 64,953 | 234,216 | 616,585 |
Total intrinsic value of options exercised | $ 700,000 | $ 21,200,000 | $ 68,600 |
Exercise of options | $ 1,485,000 | $ 9,138,000 | $ 17,820,000 |
Risk free interest rate, Minimum | 1.30% | ||
Risk free interest rate, Maximum | 4.25% | ||
Service Based Restricted Stock Unit (RSUs) and Performance-based (RSUs) | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unrecognized compensation expense | $ 28,100,000 | ||
Unrecognized compensation expense, recognition period | 2 years 3 months 18 days | ||
Performance-based RSUs | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unrecognized compensation expense | $ 15,900,000 | ||
Performance-based stock options deemed not probable of vesting | 244,500 | ||
Stock Options | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unrecognized compensation expense | $ 54,900,000 | ||
Unrecognized compensation expense, recognition period | 2 years 8 months 19 days | ||
Weighted-average years, vested and expected to vest | 6 years 9 months 18 days | ||
Performance-based Stock Options | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unrecognized compensation expense | $ 54,200,000 | ||
Performance-based stock options deemed not probable of vesting | 952,700 | ||
LTIP Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock reserved for future grant | 2,402,710 | ||
LTIP Plan | Restricted Stock Unit (RSUs) | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Shares of restricted stock outstanding | 1,151,656 | ||
2022 Employee Stock Purchase Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
common stock, shares authorized issuance | 500,000 | ||
Percentage of closing price of common stock | 85% | ||
Compensation expense | $ 100,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Time Based and Performance-Based Stock Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total stock compensation expense | $ 58,731 | $ 56,806 | $ 57,633 |
Research and development | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total stock compensation expense | 27,722 | 23,566 | 28,114 |
General and administrative | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Total stock compensation expense | $ 31,009 | $ 33,240 | $ 29,519 |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Units (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Weighted-Average Grant Date Fair Value | |
Weighted-Average Grant Date Fair Value - Beginning balance | $ 120.97 |
Weighted-Average Grant Date Fair Value - Ending balance | $ 17.92 |
Restricted Stock Unit (RSUs) | |
Number RSUs | |
Number RSUs - Beginning balance | shares | 809,145 |
Number RSUs, Granted | shares | 783,775 |
Number RSUs, Vested | shares | (216,507) |
Number RSUs, Forfeited | shares | (224,757) |
Number RSUs - Ending balance | shares | 1,151,656 |
Weighted-Average Grant Date Fair Value | |
Weighted-Average Grant Date Fair Value - Beginning balance | $ 66.91 |
Weighted-Average Grant Date Fair Value, Granted | 27.57 |
Weighted-Average Grant Date Fair Value, Vested | 50.15 |
Weighted-Average Grant Date Fair Value, Forfeited | 55.69 |
Weighted-Average Grant Date Fair Value - Ending balance | $ 45.45 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Option Activity (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Options, Abstract | |||
Number of Options, Outstanding - Beginning balance | 4,743,180 | ||
Number of Options, Granted | 1,938,874 | ||
Number of Options, Exercised | (64,953) | (234,216) | (616,585) |
Number of Options, Forfeited | (425,880) | ||
Number of Options, Expired | (182,022) | ||
Number of Options, Outstanding - Ending balance | 6,009,199 | 4,743,180 | |
Number of Options, Exercisable | 3,433,108 | ||
Weighted Average Price, Abstract | |||
Weighted-Average Price, Outstanding - Beginning balance | $ 86.06 | ||
Weighted-Average Price, Granted | 27.86 | ||
Weighted-Average Price, Exercised | 22.96 | ||
Weighted-Average Price, Forfeited | 96.41 | ||
Weighted-Average Price, Expired | 129.23 | ||
Weighted-Average Price, Outstanding - Ending balance | 65.92 | $ 86.06 | |
Weighted-Average Price, Exercisable | $ 61.04 |
Stock-Based Compensation - Weig
Stock-Based Compensation - Weighted Average Assumptions in Black-Scholes Pricing Model (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-Based Payment Arrangement [Abstract] | |||
Dividend yield | 0% | 0% | 0% |
Volatility | 73.36% | 69.71% | 73.46% |
Risk-free interest rate | 2.33% | 0.69% | 1.44% |
Expected term of options (in years) | 5 years 8 months 1 day | 5 years 7 months 24 days | 5 years 10 months 9 days |
Weighted average grant date fair value | $ 17.92 | $ 120.97 | $ 196.96 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Retirement Benefits [Abstract] | |||
Defined benefit plan, description | we adopted an Employee Investment Plan, qualified under Section 401(k) of the Code, which is a retirement savings plan covering substantially all of our U.S. employees (the Plan). | ||
Defined contribution plan employer discretionary contribution amount | $ 1,000 | $ 1,000 | |
Maximum employee contributions to the plan | $ 7,000,000 | $ 6,000,000 | |
Period of matching contributions to vest | 4 years | 4 years | |
Defined contribution plan including contributions and administrative costs expenses | $ 2,100,000 | $ 1,700,000 | $ 1,100 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Liabilities relating to indemnification, description | Accordingly, the Company has not recognized any liabilities relating to these obligations as of December 31, 2022 |
Liabilities recognized related to indemnification | $ 0 |
Accrual expenses related to indemnification | $ 0 |
Net Loss per Share - Computatio
Net Loss per Share - Computation of Basic and Diluted Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator | |||
Net loss | $ (311,901) | $ (297,386) | $ (247,752) |
Denominator | |||
Weighted-average number of common shares used in net loss per share — basic | 36,517,928 | 36,321,351 | 33,709,480 |
Dilutive potential common shares | 0 | 0 | 0 |
Weighted-average number of common shares used in net loss per share — diluted | 36,517,928 | 36,321,351 | 33,709,480 |
Net loss per share — basic | $ (8.54) | $ (8.19) | $ (7.35) |
Net loss per share — diluted | $ (8.54) | $ (8.19) | $ (7.35) |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Details) - shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |||
Weighted average anti-dilutive shares excludes from computation of earnings per share | 7,160,855 | 5,552,325 | 4,414,820 |