| QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
| TRANSITION REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 | |||||
| (State or other jurisdiction of incorporation or organization) | (IRS Employer Identification No.) | |||||||
| Securities registered pursuant to Section 12(b) of the Act: | ||||||||
| Title of each class | Trading symbol(s) | Name of each exchange on which registered | ||||||
| ☒ | Accelerated filer | ☐ | ||||||||||||||||||
| Non-accelerated filer | ☐ | Smaller reporting company | ||||||||||||||||||
| Emerging growth company | ||||||||||||||||||||
Item 3. | ||||||||
| March 31, 2023 | December 31, 2022 | ||||||||||
ASSETS | |||||||||||
Current assets: | |||||||||||
Cash and cash equivalents | $ | $ | |||||||||
Short-term investments | |||||||||||
Accounts receivable | |||||||||||
| Inventory, net | |||||||||||
Other current assets | |||||||||||
Total current assets | |||||||||||
Property, plant and equipment, net | |||||||||||
Operating lease right-of-use assets | |||||||||||
Goodwill | |||||||||||
| Other assets | |||||||||||
Total assets | $ | $ | |||||||||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||||||
Current liabilities: | |||||||||||
Accounts payable | $ | $ | |||||||||
| Accrued expenses | |||||||||||
Operating lease liabilities, current portion | |||||||||||
Total current liabilities | |||||||||||
Operating lease liabilities, less current portion | |||||||||||
| Liabilities related to the sales of future royalties, net | |||||||||||
| Other long-term liabilities | |||||||||||
Total liabilities | |||||||||||
Commitments and contingencies | |||||||||||
Preferred stock, $ | |||||||||||
Common stock, $ | |||||||||||
Capital in excess of par value | |||||||||||
| Accumulated other comprehensive loss | ( | ( | |||||||||
Accumulated deficit | ( | ( | |||||||||
Total stockholders’ equity | |||||||||||
Total liabilities and stockholders’ equity | $ | $ | |||||||||
| Three Months Ended March 31, | |||||||||||
| 2023 | 2022 | ||||||||||
Revenue: | |||||||||||
Product sales | $ | $ | |||||||||
| Non-cash royalty revenue related to the sales of future royalties | |||||||||||
License, collaboration and other revenue | |||||||||||
Total revenue | |||||||||||
Operating costs and expenses: | |||||||||||
Cost of goods sold | |||||||||||
Research and development | |||||||||||
General and administrative | |||||||||||
| Restructuring, impairment, and costs of terminated program | |||||||||||
| Impairment of goodwill | |||||||||||
Total operating costs and expenses | |||||||||||
| Loss from operations | ( | ( | |||||||||
Non-operating income (expense): | |||||||||||
| Change in fair value of development derivative liability | |||||||||||
| Non-cash interest expense on liabilities related to the sales of future royalties | ( | ( | |||||||||
Interest income and other income (expense), net | |||||||||||
Total non-operating income (expense), net | ( | ||||||||||
| Loss before provision for income taxes | ( | ( | |||||||||
| Provision (benefit) for income taxes | ( | ||||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Basic and diluted net loss per share | $ | ( | $ | ( | |||||||
| Weighted average shares outstanding used in computing basic and diluted net loss per share | |||||||||||
| Three Months Ended March 31, | |||||||||||
| 2023 | 2022 | ||||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Other comprehensive income (loss): | |||||||||||
| Net unrealized gain (loss) on available-for-sale investments | ( | ||||||||||
| Net foreign currency translation gain (loss) | ( | ||||||||||
| Other comprehensive income (loss) | ( | ||||||||||
| Comprehensive loss | $ | ( | $ | ( | |||||||
| Common Shares | Par Value | Capital in Excess of Par Value | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total Stockholders’ Equity | ||||||||||||||||||||||||||||||
| Balance at December 31, 2021 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
| Shares issued under equity compensation plans | — | — | — | ||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
| Comprehensive income (loss) | — | — | — | ( | ( | ( | |||||||||||||||||||||||||||||
| Balance at March 31, 2022 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
| Common Shares | Par Value | Capital in Excess of Par Value | Accumulated Other Comprehensive Loss | Accumulated Deficit | Total Stockholders’ Equity | ||||||||||||||||||||||||||||||
| Balance at December 31, 2022 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
| Shares issued under equity compensation plans | — | — | — | ||||||||||||||||||||||||||||||||
| Stock-based compensation | — | — | — | — | |||||||||||||||||||||||||||||||
| Comprehensive income (loss) | — | — | — | ( | ( | ||||||||||||||||||||||||||||||
| Balance at March 31, 2023 | $ | $ | $ | ( | $ | ( | $ | ||||||||||||||||||||||||||||
| Three Months Ended March 31, | |||||||||||
| 2023 | 2022 | ||||||||||
| Cash flows from operating activities: | |||||||||||
| Net loss | $ | ( | $ | ( | |||||||
| Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||
| Non-cash royalty revenue related to the sales of future royalties | ( | ( | |||||||||
| Non-cash interest expense on liabilities related to the sales of future royalties | |||||||||||
| Change in fair value of development derivative liability | ( | ||||||||||
| Non-cash research and development expense | |||||||||||
| Stock-based compensation | |||||||||||
| Depreciation and amortization | |||||||||||
| Deferred income tax expense | ( | ||||||||||
| Impairment of right-of-use assets and property, plant and equipment | |||||||||||
| Impairment of goodwill | |||||||||||
| Amortization of premiums (discounts), net and other non-cash transactions | ( | ||||||||||
| Changes in operating assets and liabilities: | |||||||||||
| Accounts receivable | ( | ||||||||||
| Inventory | ( | ||||||||||
| Operating leases, net | ( | ||||||||||
| Other assets | |||||||||||
| Accounts payable | ( | ||||||||||
| Accrued expenses | |||||||||||
| Net cash used in operating activities | ( | ( | |||||||||
| Cash flows from investing activities: | |||||||||||
| Purchases of investments | ( | ( | |||||||||
| Maturities of investments | |||||||||||
| Purchases of property, plant and equipment | ( | ( | |||||||||
| Net cash provided by investing activities | |||||||||||
| Cash flows from financing activities: | |||||||||||
| Proceeds from shares issued under equity compensation plans | |||||||||||
| Cash receipts from development derivative liability | |||||||||||
| Net cash provided by financing activities | |||||||||||
| Effect of foreign exchange rates on cash and cash equivalents | ( | ||||||||||
| Net increase (decrease) in cash and cash equivalents | ( | ||||||||||
| Cash and cash equivalents at beginning of period | |||||||||||
| Cash and cash equivalents at end of period | $ | $ | |||||||||
| Estimated Fair Value at | |||||||||||
| March 31, 2023 | December 31, 2022 | ||||||||||
| Cash and cash equivalents | $ | $ | |||||||||
| Short-term investments | |||||||||||
| Total cash and investments in marketable securities | $ | $ | |||||||||
| Fair Value Hierarchy Level | March 31, 2023 | December 31, 2022 | ||||||||||||||||||||||||||||||||||||
| Amortized Cost | Gross Unrealized Gains | Gross Unrealized Losses | Fair Value | Fair Value | ||||||||||||||||||||||||||||||||||
| Corporate notes and bonds | 2 | $ | $ | $ | ( | $ | $ | |||||||||||||||||||||||||||||||
| Corporate commercial paper | 2 | ( | ||||||||||||||||||||||||||||||||||||
| Obligations of U.S. government agencies | 2 | |||||||||||||||||||||||||||||||||||||
| Available-for-sale investments | $ | $ | $ | ( | $ | $ | ||||||||||||||||||||||||||||||||
| Money market funds | 1 | |||||||||||||||||||||||||||||||||||||
| Certificates of deposit | 2 | |||||||||||||||||||||||||||||||||||||
| Cash | N/A | |||||||||||||||||||||||||||||||||||||
| Total cash and investments in marketable securities | $ | $ | ||||||||||||||||||||||||||||||||||||
| March 31, 2023 | December 31, 2022 | ||||||||||
| Raw materials | $ | $ | |||||||||
| Work-in-process | |||||||||||
| Finished goods | |||||||||||
| Total inventory | $ | $ | |||||||||
| March 31, 2023 | December 31, 2022 | ||||||||||
| Building and leasehold improvements | $ | $ | |||||||||
| Computer equipment and computer software | |||||||||||
| Manufacturing equipment | |||||||||||
| Laboratory equipment | |||||||||||
| Furniture, fixtures and other | |||||||||||
| Depreciable property, plant and equipment at cost | |||||||||||
| Less: accumulated depreciation | ( | ( | |||||||||
| Depreciable property, plant and equipment, net | |||||||||||
| Construction in process | |||||||||||
| Property, plant and equipment, net | $ | $ | |||||||||
| Three months ended March 31, 2023 | ||||||||
| Goodwill – beginning balance | $ | |||||||
| Impairment of goodwill | ( | |||||||
| Goodwill – ending balance | $ | |||||||
| March 31, 2023 | December 31, 2022 | ||||||||||
| Accrued compensation | $ | $ | |||||||||
| Accrued clinical trial expenses | |||||||||||
| Liability to collaboration partners | |||||||||||
| Accrued contract termination costs | |||||||||||
| Other accrued expenses | |||||||||||
| Total accrued expenses | $ | $ | |||||||||
| Three Months Ended March 31, 2023 | |||||||||||||||||
| 2012 Purchase and Sale Agreement | 2020 Purchase and Sale Agreement | Total | |||||||||||||||
| Liabilities related to the sales of future royalties, net – beginning balance | $ | $ | $ | ||||||||||||||
| Non-cash royalty revenue | ( | ( | ( | ||||||||||||||
| Non-cash interest expense | |||||||||||||||||
| Amortization of transaction costs | |||||||||||||||||
| Liabilities related to the sales of future royalties, net – ending balance | $ | $ | $ | ||||||||||||||
| Fair Value Hierarchy Level | Three Months Ended March 31, 2022 | |||||||||||||
| Fair value at beginning of period | 3 | $ | ||||||||||||
| Non-cash research and development expense | ||||||||||||||
| Cash receipts from SFJ | ||||||||||||||
| Change in the fair value of development derivative liability | ( | |||||||||||||
| Fair value at end of period | 3 | $ | ||||||||||||
| Three Months Ended March 31, | ||||||||||||||
| 2023 | 2022 | |||||||||||||
| Clinical trial expense, other third-party and employee costs for the wind down of the bempegaldesleukin program | $ | |||||||||||||
| Contract termination and other restructuring costs | ||||||||||||||
| Restructuring, impairment and costs of terminated program | $ | $ | ||||||||||||
| Three Months Ended March 31, 2023 | ||||||||
| Severance and benefit expense | $ | |||||||
| Impairment of right-of-use assets and property, plant and equipment | ||||||||
| Contract termination and other restructuring costs | ||||||||
| Restructuring, impairment and costs of terminated program | $ | |||||||
| Three Months Ended March 31, 2023 | ||||||||||||||||||||
| 2023 Restructuring Plan | 2022 Restructuring Plan | Total | ||||||||||||||||||
| Liability balance as of December 31, 2022 | $ | $ | $ | |||||||||||||||||
| Expense recognized during the period | ||||||||||||||||||||
| Payments during the period | ( | ( | ||||||||||||||||||
| Liability balance as of March 31, 2023 | $ | $ | $ | |||||||||||||||||
| Three Months Ended March 31, 2023 | |||||||||||||||||
| Property, Plant and Equipment | Operating Lease Right-of-Use Assets | Total | |||||||||||||||
| Net book value of impaired facilities before write-off | $ | $ | $ | ||||||||||||||
| Less: Fair value of impaired facilities — Level 3 of Fair Value Hierarchy | ( | ( | ( | ||||||||||||||
| Impairment expense for facilities | |||||||||||||||||
| Impairment of other property, plant and equipment | — | ||||||||||||||||
| Total impairment of right-of-use assets and property, plant and equipment | $ | $ | $ | ||||||||||||||
| Three Months Ended March 31, | |||||||||||
| 2023 | 2022 | ||||||||||
Cost of goods sold | $ | $ | |||||||||
Research and development | |||||||||||
General and administrative | |||||||||||
| Total stock-based compensation | $ | $ | |||||||||
| Three Months Ended March 31, | $ Change 2023 vs. 2022 | % Change 2023 vs. 2022 | |||||||||||||||||||||
| 2023 | 2022 | ||||||||||||||||||||||
| Revenue: | |||||||||||||||||||||||
| Product sales | $ | 4,718 | $ | 5,688 | $ | (970) | (17) | % | |||||||||||||||
| Non-cash royalty revenue related to sales of future royalties | 16,861 | 17,561 | (700) | (4) | % | ||||||||||||||||||
| License, collaboration and other revenue | 15 | 1,573 | (1,558) | (99) | % | ||||||||||||||||||
| Total revenue | 21,594 | 24,822 | (3,228) | (13) | % | ||||||||||||||||||
| Operating costs and expenses: | |||||||||||||||||||||||
| Cost of goods sold | 7,060 | 5,315 | 1,745 | 33 | % | ||||||||||||||||||
| Research and development | 30,469 | 107,253 | (76,784) | (72) | % | ||||||||||||||||||
| General and administrative | 21,081 | 27,339 | (6,258) | (23) | % | ||||||||||||||||||
| Restructuring, impairment and costs of terminated program | 21,193 | 1,475 | 19,718 | 1,337 | % | ||||||||||||||||||
| Impairment of goodwill | 76,501 | — | 76,501 | n/m | |||||||||||||||||||
| Total operating costs and expenses | 156,304 | 141,382 | 14,922 | 11 | % | ||||||||||||||||||
| Loss from operations | (134,710) | (116,560) | (18,150) | 16 | % | ||||||||||||||||||
| Non-operating income (expense): | |||||||||||||||||||||||
| Change in fair value of development derivative liability | — | 33,427 | (33,427) | (100) | % | ||||||||||||||||||
| Non-cash interest expense on liability related to sale of future royalties | (6,405) | (7,529) | 1,124 | (15) | % | ||||||||||||||||||
| Interest income and other income (expense), net | 4,034 | 395 | 3,639 | 921 | % | ||||||||||||||||||
| Total non-operating income (expense), net | (2,371) | 26,293 | (28,664) | (109) | % | ||||||||||||||||||
| Loss before provision for income taxes | (137,081) | (90,267) | (46,814) | 52 | % | ||||||||||||||||||
| Provision (benefit) for income taxes | (63) | 126 | (189) | (150) | % | ||||||||||||||||||
| Net loss | $ | (137,018) | $ | (90,393) | $ | (46,625) | 52 | % | |||||||||||||||
| n/m - not meaningful | |||||||||||||||||||||||
| Three Months Ended March 31, | ||||||||||||||
| 2023 | 2022 | |||||||||||||
| Clinical trial expense, other third-party and employee costs for the wind down of the bempegaldesleukin program | $ | 1,598 | $ | — | ||||||||||
| Severance and benefit expense | 5,483 | — | ||||||||||||
| Impairment of right-of-use assets and property, plant and equipment | 13,200 | — | ||||||||||||
| Contract termination and other restructuring costs | 912 | 1,475 | ||||||||||||
| Restructuring, impairment and other costs of terminated program | $ | 21,193 | $ | 1,475 | ||||||||||
Exhibit Number | Description of Documents | ||||||||||
3.1(1) | |||||||||||
3.2(2) | |||||||||||
3.3(3) | |||||||||||
3.4(4) | |||||||||||
3.5(5) | |||||||||||
| 10.1(6) | |||||||||||
31.1(6) | |||||||||||
31.2(6) | |||||||||||
32.1* | |||||||||||
101.SCH(6) | Inline XBRL Taxonomy Extension Schema Document. | ||||||||||
101.CAL(6) | Inline XBRL Taxonomy Extension Calculation Linkbase Document. | ||||||||||
101.LAB(6) | Inline XBRL Taxonomy Extension Label Linkbase Document. | ||||||||||
101.PRE(6) | Inline XBRL Taxonomy Extension Presentation Linkbase Document. | ||||||||||
101.DEF(6) | Inline XBRL Taxonomy Extension Definition Linkbase Document. | ||||||||||
104(6) | Cover Page Interactive Data File (formatted as inline XBRL with applicable taxonomy extension information contained in Exhibits 101). | ||||||||||
| By: | /s/ SANDRA GARDINER | |||||||
| Sandra Gardiner Interim Chief Financial Officer (Principal Financial Officer) | ||||||||
| Date: May 9, 2023 | ||||||||




| CLIENT: | FLG: | ||||
| Nektar Therapeutics, Inc., | FLG Partners, LLC, | ||||
| a Delaware corporation. | a California limited liability company. | ||||
| By: Mark. A. Wilson | By: U. Heather Ogan | ||||
| Signed: /s/ Mark A. Wilson | Signed: /s/ U. Heather Ogan | ||||
| Title: Chief Legal Officer | Title: Administrative Partner | ||||
| Address: 455 Mission Bay Blvd South, Suite 100, | Effective Date: April 7, 2023. | ||||
| San Francisco, California 94158 | |||||
| Email: mwilson@nektar.com | |||||

Date: May 9, 2023 | /s/ HOWARD W. ROBIN | |||||||
| Howard W. Robin Chief Executive Officer, President and Director | ||||||||
Date: May 9, 2023 | /s/ SANDRA GARDINER | |||||||
| Sandra Gardiner Interim Chief Financial Officer (Principal Financial Officer) | ||||||||
Date: May 9, 2023 | ||||||||
| /s/ HOWARD W. ROBIN | /s/ SANDRA GARDINER | |||||||
Howard W. Robin Chief Executive Officer, President and Director | Sandra Gardiner Interim Chief Financial Officer (Principal Financial Officer) | |||||||
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares |
Mar. 31, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Statement of Financial Position [Abstract] | ||
| Preferred stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
| Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
| Preferred stock, shares designated (in shares) | 0 | 0 |
| Preferred stock, shares outstanding (in shares) | 0 | 0 |
| Common stock, par value (in dollars per share) | $ 0.0001 | $ 0.0001 |
| Common stock, shares authorized (in shares) | 300,000,000 | 300,000,000 |
| Common stock, shares outstanding (in shares) | 189,235,000 | 188,560,000 |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Statement of Comprehensive Income [Abstract] | ||
| Net loss | $ (137,018) | $ (90,393) |
| Other comprehensive income (loss): | ||
| Net unrealized gain (loss) on available-for-sale investments | 1,087 | (2,091) |
| Net foreign currency translation gain (loss) | 139 | (284) |
| Other comprehensive income (loss) | 1,226 | (2,375) |
| Comprehensive loss | $ (135,792) | $ (92,768) |
Organization and Summary of Significant Accounting Policies |
3 Months Ended |
|---|---|
Mar. 31, 2023 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| Organization and Summary of Significant Accounting Policies | Organization and Summary of Significant Accounting Policies Organization We are a research-based biopharmaceutical company headquartered in San Francisco, California and incorporated in Delaware. We (individually or with a partner) are developing a pipeline of drug candidates that utilize our advanced polymer conjugate technology platforms, which are designed to enable the development of new molecular entities that target known mechanisms of action. Our research and development pipeline of new investigational drugs includes investigational treatments in the field of immunotherapy. Our research and development activities have required significant ongoing investment to date and are expected to continue to require significant investment. As a result, we expect to continue to incur substantial losses and negative cash flows from operations in the future. We have financed our operations primarily through cash generated from licensing, collaboration and manufacturing agreements and financing transactions. As of March 31, 2023, we had approximately $456.8 million in cash and investments in marketable securities. Results of Clinical Trial Programs and the Restructuring Plans In March and April 2022, we announced that our registrational trials of bempegaldesleukin in combination with Opdivo® in metastatic melanoma, renal cell carcinoma and locally advanced or metastatic urothelial cancer under our Strategic Collaboration Agreement with Bristol-Myers Squibb Company (BMS) did not meet their primary endpoints. Based on these results, in April 2022, we announced our decisions to discontinue all development of bempegaldesleukin in combination with checkpoint inhibitors, including these trials, our registrational trial in adjuvant melanoma under our BMS Collaboration Agreement, and our Phase 2/3 study of bempegaldesleukin in combination with Keytruda® in squamous cell cancer of the head and neck under our Co-Development Agreement with SFJ Pharmaceuticals. See Note 5 for additional information regarding our BMS Collaboration Agreement and Co-Development Agreement with SFJ Pharmaceuticals. Pursuant to the Strategic Collaboration Agreement, we and BMS continue our efforts to wind down the bempegaldesleukin program. In April 2022, we also announced new strategic reorganization and cost restructuring plans (together, the 2022 Restructuring Plan), pursuant to which we we completed an approximately 70% reduction of our workforce during 2022 and sold our research facility in India in December 2022. On February 23, 2023, we announced the topline data from the Phase 2 study of rezpegaldesleukin in adult patients with systemic lupus erythematosus (SLE) (Phase 2 Lupus Study) under our collaboration agreement with Eli Lilly and Company (Lilly). Lilly notified us that it does not intend to advance rezpegaldesleukin into Phase 3 development for SLE. On April 27, 2023, we announced that we would be regaining the full rights to rezpegaldesleukin from Lilly. Based on the positive results from a Phase 1b study in which rezpegaldesleukin reduced atopic dermatitis symptoms, we plan to initiate a Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis in 2023. We will also explore other auto-immune indications for the development of rezpegaldesleukin. Pursuant to plans approved by our Board of Directors (the Board) on March 29, 2023, we announced on April 17, 2023, a new strategic reprioritization and cost restructuring plan (the 2023 Restructuring Plan). Under the 2023 Restructuring Plan, we are reducing our San Francisco-based workforce by approximately 60%, which is expected to be substantially completed by June 2023. We have incurred and expect to incur significant costs resulting from the 2022 and 2023 Restructuring Plans. See Note 6 for additional information on the effect on our Condensed Consolidated Financial Statements. Basis of Presentation and Principles of Consolidation Our Condensed Consolidated Financial Statements include the financial position, results of operations and cash flows of Nektar Therapeutics and our wholly-owned subsidiaries. We have eliminated all intercompany accounts and transactions in consolidation. We prepared our Condensed Consolidated Financial Statements following the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, we may condense or omit certain footnotes or other financial information that are normally required by U.S. generally accepted accounting principles (GAAP) for annual periods. In the opinion of management, these financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of our financial position and operating results. Our Condensed Consolidated Financial Statements are denominated in U.S. dollars. Accordingly, changes in exchange rates between the applicable foreign currency and the U.S. dollar will affect the translation of each foreign subsidiary’s financial results into U.S. dollars for purposes of reporting our consolidated financial results. We include translation gains and losses in accumulated other comprehensive loss in the stockholders’ equity section of our Condensed Consolidated Balance Sheets. To date, such cumulative currency translation adjustments have not been significant to our consolidated financial position. Our comprehensive loss consists of our net loss plus our foreign currency translation gains and losses and unrealized gains and losses on available-for-sale securities. There were no significant reclassifications out of accumulated other comprehensive loss to the statements of operations during the three months ended March 31, 2023 and 2022. The accompanying Condensed Consolidated Financial Statements are unaudited. The Condensed Consolidated Balance Sheet data as of December 31, 2022 was derived from the audited consolidated financial statements which are included in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on February 28, 2023. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and the accompanying notes to those financial statements. Revenue, expenses, assets, and liabilities can vary during each quarter of the year. The results and trends in these interim Condensed Consolidated Financial Statements are not necessarily indicative of the results to be expected for the full year or any other period. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Accounting estimates and assumptions are inherently uncertain. Actual results could differ materially from those estimates and assumptions. As appropriate, we assess estimates each period, update them to reflect current information, and generally reflect any changes in estimates in the period first identified. Significant Concentrations Our customers are primarily pharmaceutical companies that are located in the U.S. and Europe and with whom we have multi-year arrangements. Our accounts receivable balance contains billed and unbilled trade receivables from product sales, milestones (to the extent that they have been achieved and are due from the counterparty), and other contingent payments, as well as reimbursable costs from collaborative research and development agreements. We generally do not require collateral from our customers. We perform a regular review of our customers’ credit risk and payment histories, including payments made after period end. Historically, we have not experienced credit losses from our accounts receivable. We have not recorded reserves for credit losses for the three months ended March 31, 2023 and 2022, nor have recorded such an allowance as of March 31, 2023 or December 31, 2022. We are dependent on our suppliers and contract manufacturers to provide raw materials and drugs of appropriate quality and reliability and to meet applicable contract and regulatory requirements. In certain cases, we rely on single sources of supply of one or more critical materials. Consequently, in the event that supplies are delayed or interrupted for any reason, our ability to develop and produce our drug candidates, our ability to supply comparator drugs for our clinical trials, or our ability to meet our supply obligations could be significantly impaired, which could have a material adverse effect on our business, financial condition and results of operations. For our available-for-sale securities, we have significant concentrations of issuers in the banking and financial services industries. While our investment policy requires that we only invest in highly-rated securities and limit our exposure to any single issuer, various factors may materially affect the financial condition of issuers. Additionally, pursuant to our investment policy, we may sell securities before maturity if the issuer’s credit rating has been downgraded below our minimum credit rating requirements, which may result in a loss on the sale. Accordingly, if various factors result in downgrades below our minimum credit rating requirements and if we decide to sell these securities, we may experience losses on such sales. Restructuring We recognize restructuring charges related to reorganization plans that have been committed to by management when liabilities have been incurred. In connection with these activities, we record restructuring charges at fair value for: •contractual or other employee termination benefits provided that the obligations result from services already rendered based on rights that vest or accumulated when the payment of benefits becomes probable and the amount can be reasonably estimated, •one-time employee termination benefits on the communication date from management to the employees provided that management has committed to a plan of termination, the plan identifies the employees and their expected termination dates, the details of termination benefits are complete, and it is unlikely that changes to the plan will be made or the plan will be withdrawn, •contract termination costs when we cancel the contract in accordance with its terms, and •costs to be incurred over the remaining contract term without economic benefit to us at the cease-use date. For one-time employee terminations benefits, we recognize the liability in full on the communication date when future services are not required or amortize the liability ratably over the service period, if required. The fair value of termination benefits reflects our estimates of expected utilization of certain Company-funded post-employment benefits. See Note 6 for additional information on the severance expense that we recognized for employees terminated in connection with our reductions-in-force. Impairment of Goodwill Goodwill is assessed for impairment on an annual basis and whenever events and circumstances indicate that it may be impaired. Factors that may indicate potential impairment and trigger an impairment test include, but are not limited to, current economic, market and geopolitical conditions, including a significant, sustained decline in our stock price and market capitalization compared to the net book value; an adverse change in legal factors, business climate or operational performance of the business; or significant changes in the ability of the reporting unit to generate positive cash flows for our strategic business objectives. If the carrying value of the reporting unit, including goodwill, exceeds the reporting unit’s fair value, we will recognize a goodwill impairment loss, and we will write down goodwill such that the carrying value of the reporting unit equals its fair value, provided that we cannot reduce goodwill below zero. See Note 6 for additional information regarding the impairment charges we recorded in connection with our goodwill. Long-Lived Asset Impairment We assess the impairment of long-lived assets whenever events or changes in business circumstances indicate that the carrying amounts of the assets may not be fully recoverable. In the case of property, plant and equipment and right-of-use assets for our leases, we determine whether there has been an impairment by comparing the carrying value of the asset to the anticipated undiscounted net cash flows associated with the asset. If such cash flows are less than the carrying value, we write down the asset to its fair value, which may be measured as anticipated net cash flows associated with the asset, discounted at a rate that we believe a market participant would utilize to reflect the risks associated with the cash flows, such as credit risk. See Note 6 for additional information regarding the impairment charges we recorded in connection with our leased facilities and certain property and equipment. Net Loss per Share For all periods presented in the Condensed Consolidated Statements of Operations, the net loss available to common stockholders is equal to the reported net loss. We calculate basic net loss per share based on the weighted-average number of common shares outstanding during the periods presented. For the three months ended March 31, 2023 and 2022, basic and diluted net loss per share are the same due to our net losses and the requirement to exclude potentially dilutive securities which would have an antidilutive effect on net loss per share. We excluded shares underlying the weighted average outstanding stock options, restricted stock units (RSUs) and performance stock units (PSUs), which totaled 22.8 million and 22.3 million for the three months ended March 31, 2023 and 2022, respectively.
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Cash and Investments in Marketable Securities |
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| Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Cash and Investments in Marketable Securities | Cash and Investments in Marketable Securities Cash and investments in marketable securities, including cash equivalents, are as follows (in thousands):
Our portfolio of cash and investments in marketable securities includes (in thousands):
For the three months ended March 31, 2023 and 2022, there were no transfers between Level 1 and Level 2 of the fair value hierarchy. At December 31, 2022, our gross unrealized losses totaled $1.8 million, and our gross unrealized gains were insignificant.
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Condensed Consolidated Financial Statement Details |
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| Inventory Disclosure [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Condensed Consolidated Financial Statement Details | Condensed Consolidated Financial Statement Details Inventory Inventory consists of the following (in thousands):
We manufacture finished goods inventory upon receipt of firm purchase orders, and we may manufacture certain intermediate work-in-process materials and purchase raw materials based on purchase forecasts from our collaboration partners. We include direct materials, direct labor, and manufacturing overhead in inventory and determine cost on a first-in, first-out basis for raw materials and on a specific identification basis for work-in-process and finished goods. We value inventory at the lower of cost or net realizable value, and we write down defective or excess inventory to net realizable value based on historical experience or projected usage. We expense inventory related to our research and development activities as manufactured by us or when purchased. Property, Plant and Equipment Property, plant and equipment consists of the following (in thousands):
As a result of the decrease in the fair value of our single reporting unit during the three months ended March 31, 2023, we recorded a non-cash impairment charge of $3.5 million for property, plant and equipment, which we report in restructuring, impairment and costs of terminated program in our Condensed Consolidated Statement of Operations. See Note 6 for additional information. Goodwill The following is a reconciliation of the changes in our goodwill for the three months ended March 31, 2023 (in thousands):
As a result of the decrease in the fair value of our single reporting unit during the three months ended March 31, 2023, we recorded a non-cash goodwill impairment charge of $76.5 million, which we report as impairment of goodwill in our Condensed Consolidated Statement of Operations. We had previously recognized goodwill primarily from our acquisitions of Shearwater Corp. and Aerogen, Inc. in 2001 and 2005, respectively. See Note 6 for additional information. Accrued Expenses Accrued expenses consist of the following (in thousands):
Liabilities Related to the Sales of Future Royalties In 2012 and 2020, we sold to RPI Finance Trust (RPI) and entities managed by Healthcare Royalty Management, LLC (collectively, HCR), respectively, our rights to receive royalties under our license and manufacturing agreements with certain pharmaceutical partners under the 2012 Purchase and Sale Agreement and the 2020 Purchase and Sale Agreement, respectively. We account for these transactions as debt and recognize non-cash royalty revenue and non-cash interest expense to amortize the proceeds over the lives of the respective arrangements. We periodically update our prospective non-cash interest rate based on our estimates of future royalties. As of March 31, 2023, our imputed interest rates for the arrangements with RPI and HCR were 10% and 20%, respectively. The following is a reconciliation of the changes in our liabilities related to the sales of future royalties for the three months ended March 31, 2023 (in thousands):
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Commitments and Contingencies |
3 Months Ended |
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Mar. 31, 2023 | |
| Commitments and Contingencies Disclosure [Abstract] | |
| Commitments and Contingencies | Commitments and Contingencies Legal Matters From time to time, we are involved in lawsuits, arbitrations, claims, investigations and proceedings, consisting of intellectual property, commercial, employment and other matters, which arise in the ordinary course of business. We make provisions for liabilities when it is both probable that a liability has been incurred and the amount of the loss can be reasonably estimated. Such provisions are reviewed at least quarterly and adjusted to reflect the impact of settlement negotiations, judicial and administrative rulings, advice of legal counsel, and other information and events pertaining to a particular case. Litigation is inherently unpredictable. If any unfavorable ruling were to occur in any specific period, there exists the possibility of a material adverse impact on the results of our operations for that period and on our cash flows and liquidity. On May 2, 2023, we and our directors were named in a putative class action complaint filed in the Court of Chancery of the State of Delaware. The plaintiff in this complaint alleges section 13 of our bylaws relating to stockholder action without meeting violates Delaware law and is therefore void. Upon service of this complaint, we will have twenty days to reply. We have recorded no liability for any litigation matters in our Consolidated Balance Sheets at either March 31, 2023 or December 31, 2022. Indemnifications in Connection with Commercial Agreements As part of our collaboration agreements with our partners related to the license, development, manufacture and supply of drugs and PEGylation materials based on our proprietary technologies and drug candidates, we generally agree to defend, indemnify and hold harmless our partners from and against third party liabilities arising out of the agreement, including product liability (with respect to our activities) and infringement of intellectual property to the extent the intellectual property is developed by us and licensed to our partners. The term of these indemnification obligations is generally perpetual commencing after execution of the agreement. There is generally no limitation on the potential amount of future payments we could be required to make under these indemnification obligations. From time to time, we enter into other strategic agreements such as divestitures and financing transactions pursuant to which we are required to make representations and warranties and undertake to perform or comply with certain covenants. For example, we made certain intellectual property representations in connection with our RPI and HCR transactions, however, the time limitation we have to indemnify RPI with respect to any breach of these intellectual property-based representations and warranties has passed. In the event it is determined that we breached certain of the representations and warranties or covenants made by us in any such agreements or certain express indemnification provisions are applicable, we could incur substantial indemnification liabilities depending on the timing, nature, and amount of any such claims. To date, we have not incurred any costs to defend lawsuits or settle claims related to these indemnification obligations, nor any breaches of representations or warranties or covenants. Because the aggregate amount of any potential indemnification obligation is not a stated amount, we cannot reasonably estimate the overall maximum amount of any such obligations.
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License and Collaboration Agreements |
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| License And Collaboration Agreements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| License and Collaboration Agreements | License and Collaboration Agreements We have entered into various collaboration agreements including license agreements and collaborative research, development and commercialization agreements with various pharmaceutical and biotechnology companies. Under these collaboration arrangements, we are entitled to receive license fees, upfront payments, milestone and other contingent payments, royalties, sales milestone payments, and payments for the manufacture and supply of our proprietary PEGylation materials and/or reimbursement for research and development activities. We generally include our costs of performing these services in research and development expense, except for costs for product sales to our collaboration partners which we include in cost of goods sold. We analyze our agreements to determine whether we should account for the agreements within the scope of ASC 808, and, if so, we analyze whether we should account for any elements under ASC 606. Eli Lilly and Company (Lilly): Rezpegaldesleukin (previously referred to as NKTR-358) On July 23, 2017, we entered into a worldwide license agreement (the Lilly Agreement) with Eli Lilly and Company (Lilly) to co-develop rezpegaldesleukin, a novel immunological drug candidate that we invented, pursuant to which we received an initial payment of $150.0 million and were eligible for up to $250.0 million in additional development and regulatory milestones. The Lilly Agreement provided that, during Phase 1B and Phase 2 development, we would share development costs wherein 75% of the costs are borne by Lilly and 25% of the costs are borne by us. On February 23, 2023, we announced the topline data from the Phase 2 study of rezpegaldesleukin in adult patients with systemic lupus erythematosus (SLE) (Phase 2 Lupus Study). Although the Phase 2 Lupus Study did not meet its primary endpoint, patients who received the middle dose within the modified intent-to-treat population, defined as all patients who were randomized and received at least one dose of rezpegaldesleukin, demonstrated improvement in SLEDAI-2K score as compared to placebo. Nonetheless, Lilly notified us that it does not intend to advance rezpegaldesleukin into Phase 3 development for SLE. On April 23, 2023, Nektar received from Lilly a notice of-at will termination of the Lilly Agreement. On April 27, 2023, we announced that we would regain full rights to rezpegaldesleukin from Lilly. Based on the positive results from a Phase 1b study in which rezpegaldesleukin reduced atopic dermatitis symptoms, we plan to initiate a Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis in 2023. We will also explore other auto-immune indications for the development of rezpegaldesleukin. Bristol-Myers Squibb Company (BMS): Bempegaldesleukin, also referred to as NKTR-214 Effective April 3, 2018, we entered into a Strategic Collaboration Agreement (the BMS Collaboration Agreement) and a Share Purchase Agreement with BMS. Pursuant to the BMS Collaboration Agreement, we and BMS have jointly developed bempegaldesleukin in combination with BMS’s Opdivo®. The parties share the internal and external development costs for bempegaldesleukin in combination regimens based on each party’s relative ownership interest in the compounds included in the regimens. In accordance with the agreement, the parties share development costs for bempegaldesleukin in combination with Opdivo®, 67.5% of costs to BMS and 32.5% to Nektar. The parties share costs for the manufacturing and pre-commercial costs of bempegaldesleukin, 35% of the costs to BMS and 65% to Nektar. Upon the effective date of the BMS Collaboration Agreement in April 2018, BMS paid us a non-refundable upfront cash payment of $1.0 billion and purchased 8,284,600 shares of our common stock pursuant to the Share Purchase Agreement for total additional cash consideration of $850.0 million. In 2020, we received additional non-refundable milestone payments of $50.0 million. As discussed in Note 1, in April 2022, we announced that BMS and we decided to discontinue all development of bempegaldesleukin in combination with Opdivo®. The decision to terminate the program does not affect the cost-sharing provisions under the BMS Collaboration Agreement. Pursuant to the BMS Collaboration Agreement, we and BMS continue our efforts to wind down the bempegaldesleukin program. We determined that the BMS Collaboration Agreement falls within the scope of ASC 808. Based on the cost sharing percentages described above, we recognized BMS’ reimbursement of our expenses as a reduction of research and development expense and our reimbursement of BMS’ expenses as research and development expense. As discussed in Note 6, beginning in the second quarter of 2022, we began reporting clinical trial, other third-party costs and employee costs for the wind down of the bempegaldesleukin program in restructuring and costs of terminated program. The net reimbursement payable to BMS for the three months ended March 31, 2023 was not significant. For the three months ended March 31, 2022, we recorded $24.9 million for the net reimbursement from BMS as a reduction of research and development expense. SFJ Pharmaceuticals On February 12, 2021, we entered into a Co-Development Agreement (the SFJ Agreement) with SFJ Pharmaceuticals XII, L.P., a SFJ Pharmaceuticals Group company (SFJ), pursuant to which SFJ would pay up to $150.0 million to support a Phase 2/3 study of bempegaldesleukin in combination with Keytruda® (pembrolizumab) in metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (the SCCHN Clinical Trial). SFJ had primary responsibility for the clinical trial management of the SCCHN Clinical Trial, and we were the sponsor of the SCCHN Clinical Trial. The SFJ Agreement provided for us to pay up to $637.5 million in Success Payments in the event of FDA approval of bempegaldesleukin in up to three indications. We accounted for the SFJ Agreement as a derivative liability, which we remeasured to fair value at each reporting date. We recorded increases to the liability for non-cash research and development expense as SFJ conducted the SCCHN Clinical Trial and for cash receipts from SFJ to us to support our internal costs of conducting the trial. We presented the gain (loss) from the remeasurement as change in fair value of development derivative liability in our Condensed Consolidated Statements of Operations. As of March 31, 2022, due to the negative results of the metastatic melanoma trial and initial discussions with SFJ, we concluded that it was remote that SFJ and we would continue the SCCHN Clinical Trial. Accordingly, the fair value of the development derivative liability was reduced to zero as of March 31, 2022, and we recognized a corresponding gain in change in fair value of development derivative liability. In April 2022, we announced that SFJ and we agreed to discontinue the SCCHN Clinical Trial. Accordingly, SFJ will not be entitled to any Success Payments, and SFJ has the responsibility to wind down the SCCHN Clinical Trial at its sole cost. SFJ has no right to seek reimbursement from us for any costs incurred for the SCCHN Clinical Trial. The following table presents the change in the derivative liability for the three months ended March 31, 2022:
Other We have other collaboration agreements that have resulted in commercialized products for our collaborations partners. Under these agreements, we may sell our proprietary PEGylation materials for use in these products, and we are entitled to receive royalties based on net sales of these products as well as sales milestones. As discussed in Note 3, we have sold our rights to receive royalties from these other collaboration agreements. Our non-cash royalty revenue, which totaled $16.9 million and $17.6 million for the three months ended March 31, 2023 and 2022, respectively, represents revenue for granting licenses which we had satisfied in prior periods. Additionally, we have a collaboration agreement for a product under development, under which we are entitled to up to a total of $40.0 million of regulatory milestones, as well as sales milestones upon achievement of annual sales targets and royalties based on net sales of commercialized products, if any. However, given the current phase of development of the potential product under this collaboration agreement, we cannot estimate the probability or timing of achieving these milestones, and, therefore, have excluded all development milestones from the transaction price for this agreement.
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Restructuring, Impairment and Costs of Terminated Program, and Impairment of Goodwill |
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| Restructuring and Related Activities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Restructuring, Impairment and Costs of Terminated Program, and Impairment of Goodwill | Restructuring, Impairment and Costs of Terminated Program, and Impairment of Goodwill Restructuring, Impairment and Costs of Terminated Program In connection with our 2022 and 2023 Restructuring Plans, we report the following costs in restructuring, impairment and costs of terminated program: •Clinical trial expense, other third-party costs and employee costs for the wind down of the bempegaldesleukin program, net of the reimbursement from BMS, initiated in 2022; •Severance and related benefit costs pursuant to the 2022 and 2023 Restructuring Plans; •Non-cash impairment of right-of-use assets and property, plant and equipment; and •Contract termination and other costs associated with these plans. In prior periods through March 31, 2022, we reported the clinical trial costs, other third-party costs and employee costs related to the bempegaldesleukin program primarily in research and development expense. Beginning in the second quarter of 2022, we began reporting clinical trial, other third-party costs and employee costs for the wind down of the bempegaldesleukin program in restructuring, impairment and costs of terminated program. 2022 Restructuring Plan As discussed in Note 1, because our registrational trials in bempegaldesleukin did not meet their primary endpoints, we decided to discontinue all development of bempegaldesleukin and wind down the clinical trials studying bempegaldesleukin. In April 2022, we announced the 2022 Restructuring Plan pursuant to which we completed an approximately 70% reduction of our workforce during 2022. We also sold our research facility in India in December 2022 and decided to sublease certain of our leased premises in San Francisco, CA, including our office leased space on Third St. and portions of our office and laboratory space on Mission Bay Blvd. South. Restructuring, impairment and other costs of terminated program pertaining to the 2022 Restructuring Plan includes the following (in thousands):
For the three months ended March 31, 2022, restructuring, impairment and other costs primarily include cancellation fees for certain manufacturing activities for bempegaldesleukin. Through March 31, 2023, we have recognized $11.8 million cumulatively for contract termination and other costs for the 2022 Restructuring Plan. 2023 Restructuring Plan As discussed in Note 1, pursuant to plans approved by our Board in March 2023, we announced the 2023 Restructuring Plan to further reduce our San Francisco-based workforce by approximately 60%, which is expected to be substantially completed by June 2023. Restructuring, impairment and other costs of terminated program pertaining to the 2023 Restructuring Plan includes the following (in thousands):
Severance and Benefit Expense Employees affected by the reduction in force under the 2022 and 2023 Restructuring Plans are entitled to receive severance payments and certain Company funded benefits. The restructuring charges are recorded at fair value. For the 2022 Restructuring Plan, we recognized severance and benefit expense in full for employees who had no requirements for future service when the 2022 Restructuring Plan was approved by the Board in April 2022. We recognized severance and benefit expense for employees who were required to render services to receive their severance and benefits ratably over the service period. This service period began on the communication date in April 2022 and was completed for all employees during 2022. We recognized $30.9 million in total severance and benefit expense during 2022 and paid the remaining liability of $3.3 million in January 2023. For the 2023 Restructuring Plan, we recognized a liability of $5.5 million of severance and benefit expense as of March 31, 2023, reflecting severance and benefits which the employees had vested into and for which payment was probable and reasonably estimable as of March 31, 2023. We expect to recognize an additional $1.9 million for severance and benefit expense for the 2023 Restructuring Plan, primarily in the second quarter of 2023. The following table provides details regarding the severance and benefit expense for the three months ended March 31, 2023 pursuant to the 2023 Restructuring Plan and a reconciliation of the severance and benefits liability for the three months ended March 31, 2023, which we report within accrued expenses on our Condensed Consolidated Balance Sheet (in thousands):
Impairment of Long-Lived Assets and Goodwill During the three months ended March 31, 2023, our stock price and resulting market capitalization experienced a significant, sustained decline. Accordingly, we assessed our long-lived assets, including our property, plant and equipment, right-of-use assets and goodwill, for impairment. As part of our impairment analysis, we first assessed which long-lived assets have identifiable cash flows that are largely independent of the cash flows of other groups of assets. We concluded that the long-lived assets associated with our leased spaces that we had previously decided to sublease under our 2022 Restructuring Plan continue to have cash flows that are independent of our entity-wide group. We concluded that these assets, for which we had recognized impairment charges during 2022, were recoverable based on estimated sublease income and therefore did not record any impairment charges for these long-lived assets for the three months ended March 31, 2023. We evaluated our remaining long-lived assets for impairment and performed a recoverability test using the undiscounted cash flows approach. We concluded that our net assets were not recoverable within the remaining useful lives. Accordingly, we estimated the fair value of the asset or asset group based on discounted future cash flows of the asset or asset group using a discount rate commensurate with the related risk. For the operating lease asset related to our Mission Bay facility, we estimated the fair value based on market participant assumptions, including the length of time to enter into a sublease, sublease payments, tenant improvement allowances and broker commissions, which we evaluated using current real estate trends and market conditions. We discounted the sublease income using the estimated borrowing rate of a market participant subtenant, which we estimated to be 7.9%. As a result of this analysis, we recorded a non-cash impairment charge of $11.5 million. We also recorded an additional non-cash impairment charge of $1.7 million for certain laboratory equipment. We report the aggregate non-cash impairment charge of $13.2 million in restructuring, impairment and costs of terminated program in our Condensed Consolidated Statement of Operations. The following table presents a reconciliation of the non-cash impairment charge we recorded for these long-lived assets for the three months ended March 31, 2023 (in thousands):
After we recorded the non-cash impairment charges for our long-lived assets, we next assessed goodwill for impairment. We had previously recognized goodwill primarily from our acquisitions of Shearwater Corp. and Aerogen, Inc. in 2001 and 2005, respectively. Accordingly, in accordance with ASC 350-20 Goodwill and ASC 820-10 Fair Value Measurement, we measured the fair value of our reporting unit utilizing both income and market approaches for our entity-wide asset impairment analysis. Based on this analysis, we wrote off all of our goodwill, resulting in a non-cash impairment charge of $76.5 million during the three months ended March 31, 2023, which we reported as impairment of goodwill in our Condensed Consolidated Statements of Operations.
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Stock-Based Compensation |
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| Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Stock-Based Compensation | Stock-Based CompensationWe recognized total stock-based compensation expense in our Condensed Consolidated Statements of Operations as follows (in thousands):
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Organization and Summary of Significant Accounting Policies (Policies) |
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Mar. 31, 2023 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| Organization | Organization We are a research-based biopharmaceutical company headquartered in San Francisco, California and incorporated in Delaware. We (individually or with a partner) are developing a pipeline of drug candidates that utilize our advanced polymer conjugate technology platforms, which are designed to enable the development of new molecular entities that target known mechanisms of action. Our research and development pipeline of new investigational drugs includes investigational treatments in the field of immunotherapy. Our research and development activities have required significant ongoing investment to date and are expected to continue to require significant investment. As a result, we expect to continue to incur substantial losses and negative cash flows from operations in the future. We have financed our operations primarily through cash generated from licensing, collaboration and manufacturing agreements and financing transactions.
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| Results of Clinical Trial Programs and the Restructuring Plans | Results of Clinical Trial Programs and the Restructuring Plans In March and April 2022, we announced that our registrational trials of bempegaldesleukin in combination with Opdivo® in metastatic melanoma, renal cell carcinoma and locally advanced or metastatic urothelial cancer under our Strategic Collaboration Agreement with Bristol-Myers Squibb Company (BMS) did not meet their primary endpoints. Based on these results, in April 2022, we announced our decisions to discontinue all development of bempegaldesleukin in combination with checkpoint inhibitors, including these trials, our registrational trial in adjuvant melanoma under our BMS Collaboration Agreement, and our Phase 2/3 study of bempegaldesleukin in combination with Keytruda® in squamous cell cancer of the head and neck under our Co-Development Agreement with SFJ Pharmaceuticals. See Note 5 for additional information regarding our BMS Collaboration Agreement and Co-Development Agreement with SFJ Pharmaceuticals. Pursuant to the Strategic Collaboration Agreement, we and BMS continue our efforts to wind down the bempegaldesleukin program. In April 2022, we also announced new strategic reorganization and cost restructuring plans (together, the 2022 Restructuring Plan), pursuant to which we we completed an approximately 70% reduction of our workforce during 2022 and sold our research facility in India in December 2022. On February 23, 2023, we announced the topline data from the Phase 2 study of rezpegaldesleukin in adult patients with systemic lupus erythematosus (SLE) (Phase 2 Lupus Study) under our collaboration agreement with Eli Lilly and Company (Lilly). Lilly notified us that it does not intend to advance rezpegaldesleukin into Phase 3 development for SLE. On April 27, 2023, we announced that we would be regaining the full rights to rezpegaldesleukin from Lilly. Based on the positive results from a Phase 1b study in which rezpegaldesleukin reduced atopic dermatitis symptoms, we plan to initiate a Phase 2b study of rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis in 2023. We will also explore other auto-immune indications for the development of rezpegaldesleukin. Pursuant to plans approved by our Board of Directors (the Board) on March 29, 2023, we announced on April 17, 2023, a new strategic reprioritization and cost restructuring plan (the 2023 Restructuring Plan). Under the 2023 Restructuring Plan, we are reducing our San Francisco-based workforce by approximately 60%, which is expected to be substantially completed by June 2023. We have incurred and expect to incur significant costs resulting from the 2022 and 2023 Restructuring Plans. See Note 6 for additional information on the effect on our Condensed Consolidated Financial Statements.
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| Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation Our Condensed Consolidated Financial Statements include the financial position, results of operations and cash flows of Nektar Therapeutics and our wholly-owned subsidiaries. We have eliminated all intercompany accounts and transactions in consolidation. We prepared our Condensed Consolidated Financial Statements following the requirements of the Securities and Exchange Commission (SEC) for interim reporting. As permitted under those rules, we may condense or omit certain footnotes or other financial information that are normally required by U.S. generally accepted accounting principles (GAAP) for annual periods. In the opinion of management, these financial statements include all normal and recurring adjustments that we consider necessary for the fair presentation of our financial position and operating results. Our Condensed Consolidated Financial Statements are denominated in U.S. dollars. Accordingly, changes in exchange rates between the applicable foreign currency and the U.S. dollar will affect the translation of each foreign subsidiary’s financial results into U.S. dollars for purposes of reporting our consolidated financial results. We include translation gains and losses in accumulated other comprehensive loss in the stockholders’ equity section of our Condensed Consolidated Balance Sheets. To date, such cumulative currency translation adjustments have not been significant to our consolidated financial position. Our comprehensive loss consists of our net loss plus our foreign currency translation gains and losses and unrealized gains and losses on available-for-sale securities. There were no significant reclassifications out of accumulated other comprehensive loss to the statements of operations during the three months ended March 31, 2023 and 2022. The accompanying Condensed Consolidated Financial Statements are unaudited. The Condensed Consolidated Balance Sheet data as of December 31, 2022 was derived from the audited consolidated financial statements which are included in our Annual Report on Form 10-K for the year ended December 31, 2022 filed with the SEC on February 28, 2023. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the consolidated financial statements and the accompanying notes to those financial statements. Revenue, expenses, assets, and liabilities can vary during each quarter of the year. The results and trends in these interim Condensed Consolidated Financial Statements are not necessarily indicative of the results to be expected for the full year or any other period.
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| Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. generally accepted accounting principles (GAAP) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenue and expenses during the reporting period. Accounting estimates and assumptions are inherently uncertain. Actual results could differ materially from those estimates and assumptions. As appropriate, we assess estimates each period, update them to reflect current information, and generally reflect any changes in estimates in the period first identified.
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| Significant Concentrations | Significant ConcentrationsOur customers are primarily pharmaceutical companies that are located in the U.S. and Europe and with whom we have multi-year arrangements. Our accounts receivable balance contains billed and unbilled trade receivables from product sales, milestones (to the extent that they have been achieved and are due from the counterparty), and other contingent payments, as well as reimbursable costs from collaborative research and development agreements. We are dependent on our suppliers and contract manufacturers to provide raw materials and drugs of appropriate quality and reliability and to meet applicable contract and regulatory requirements. In certain cases, we rely on single sources of supply of one or more critical materials. Consequently, in the event that supplies are delayed or interrupted for any reason, our ability to develop and produce our drug candidates, our ability to supply comparator drugs for our clinical trials, or our ability to meet our supply obligations could be significantly impaired, which could have a material adverse effect on our business, financial condition and results of operations. For our available-for-sale securities, we have significant concentrations of issuers in the banking and financial services industries. While our investment policy requires that we only invest in highly-rated securities and limit our exposure to any single issuer, various factors may materially affect the financial condition of issuers. Additionally, pursuant to our investment policy, we may sell securities before maturity if the issuer’s credit rating has been downgraded below our minimum credit rating requirements, which may result in a loss on the sale. Accordingly, if various factors result in downgrades below our minimum credit rating requirements and if we decide to sell these securities, we may experience losses on such sales.
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| Restructuring | Restructuring We recognize restructuring charges related to reorganization plans that have been committed to by management when liabilities have been incurred. In connection with these activities, we record restructuring charges at fair value for: •contractual or other employee termination benefits provided that the obligations result from services already rendered based on rights that vest or accumulated when the payment of benefits becomes probable and the amount can be reasonably estimated, •one-time employee termination benefits on the communication date from management to the employees provided that management has committed to a plan of termination, the plan identifies the employees and their expected termination dates, the details of termination benefits are complete, and it is unlikely that changes to the plan will be made or the plan will be withdrawn, •contract termination costs when we cancel the contract in accordance with its terms, and •costs to be incurred over the remaining contract term without economic benefit to us at the cease-use date. For one-time employee terminations benefits, we recognize the liability in full on the communication date when future services are not required or amortize the liability ratably over the service period, if required. The fair value of termination benefits reflects our estimates of expected utilization of certain Company-funded post-employment benefits. See Note 6 for additional information on the severance expense that we recognized for employees terminated in connection with our reductions-in-force.
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| Impairment of Goodwill | Impairment of Goodwill Goodwill is assessed for impairment on an annual basis and whenever events and circumstances indicate that it may be impaired. Factors that may indicate potential impairment and trigger an impairment test include, but are not limited to, current economic, market and geopolitical conditions, including a significant, sustained decline in our stock price and market capitalization compared to the net book value; an adverse change in legal factors, business climate or operational performance of the business; or significant changes in the ability of the reporting unit to generate positive cash flows for our strategic business objectives. If the carrying value of the reporting unit, including goodwill, exceeds the reporting unit’s fair value, we will recognize a goodwill impairment loss, and we will write down goodwill such that the carrying value of the reporting unit equals its fair value, provided that we cannot reduce goodwill below zero. See Note 6 for additional information regarding the impairment charges we recorded in connection with our goodwill.
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| Long-Lived Asset Impairment | Long-Lived Asset Impairment We assess the impairment of long-lived assets whenever events or changes in business circumstances indicate that the carrying amounts of the assets may not be fully recoverable. In the case of property, plant and equipment and right-of-use assets for our leases, we determine whether there has been an impairment by comparing the carrying value of the asset to the anticipated undiscounted net cash flows associated with the asset. If such cash flows are less than the carrying value, we write down the asset to its fair value, which may be measured as anticipated net cash flows associated with the asset, discounted at a rate that we believe a market participant would utilize to reflect the risks associated with the cash flows, such as credit risk. See Note 6 for additional information regarding the impairment charges we recorded in connection with our leased facilities and certain property and equipment.
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| Net Loss per Share | Net Loss per Share For all periods presented in the Condensed Consolidated Statements of Operations, the net loss available to common stockholders is equal to the reported net loss. We calculate basic net loss per share based on the weighted-average number of common shares outstanding during the periods presented. For the three months ended March 31, 2023 and 2022, basic and diluted net loss per share are the same due to our net losses and the requirement to exclude potentially dilutive securities which would have an antidilutive effect on net loss per share. |
| Inventory | We value inventory at the lower of cost or net realizable value, and we write down defective or excess inventory to net realizable value based on historical experience or projected usage. We expense inventory related to our research and development activities as manufactured by us or when purchased. |
Cash and Investments in Marketable Securities (Tables) |
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| Fair Value Disclosures [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Cash and Investments in Marketable Securities, Including Cash Equivalents | Cash and investments in marketable securities, including cash equivalents, are as follows (in thousands):
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| Schedule of Portfolio of Cash and Investments in Marketable Securities | Our portfolio of cash and investments in marketable securities includes (in thousands):
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Condensed Consolidated Financial Statement Details (Tables) |
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| Schedule of Inventory | Inventory consists of the following (in thousands):
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| Schedule of Property, Plant and Equipment | Property, plant and equipment consists of the following (in thousands):
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| Schedule of Goodwill | The following is a reconciliation of the changes in our goodwill for the three months ended March 31, 2023 (in thousands):
|
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| Schedule of Liability Related to Sale of Potential Future Royalties | The following is a reconciliation of the changes in our liabilities related to the sales of future royalties for the three months ended March 31, 2023 (in thousands):
|
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| Schedule of Accrued Expenses | Accrued Expenses Accrued expenses consist of the following (in thousands):
|
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License and Collaboration Agreements (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| License And Collaboration Agreements [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Derivative Liabilities at Fair Value | The following table presents the change in the derivative liability for the three months ended March 31, 2022:
|
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Restructuring, Impairment and Costs of Terminated Program, and Impairment of Goodwill (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Restructuring and Related Activities [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Restructuring, Impairment and Other Costs of Terminated Program | Restructuring, impairment and other costs of terminated program pertaining to the 2022 Restructuring Plan includes the following (in thousands):
The following table provides details regarding the severance and benefit expense for the three months ended March 31, 2023 pursuant to the 2023 Restructuring Plan and a reconciliation of the severance and benefits liability for the three months ended March 31, 2023, which we report within accrued expenses on our Condensed Consolidated Balance Sheet (in thousands):
|
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Stock-Based Compensation (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2023 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Share-Based Payment Arrangement [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Schedule of Stock-Based Compensation Expense | We recognized total stock-based compensation expense in our Condensed Consolidated Statements of Operations as follows (in thousands):
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) shares in Millions |
1 Months Ended | 3 Months Ended | ||
|---|---|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2023 |
Mar. 31, 2022 |
Dec. 31, 2022 |
|
| Organization And Summary Of Significant Accounting Policies [Line Items] | ||||
| Cash and investments in marketable securities | $ 456,827,000 | $ 456,827,000 | $ 504,977,000 | |
| Accounts receivable, credit loss expense (reversal) | $ 0 | $ 0 | ||
| Stock Options, RSUs And PSUs | ||||
| Organization And Summary Of Significant Accounting Policies [Line Items] | ||||
| Potentially dilutive securities (in shares) | 22.8 | 22.3 | ||
| Employee Severance | 2023 Restructuring Plan | ||||
| Organization And Summary Of Significant Accounting Policies [Line Items] | ||||
| Workforce termination, percentage | 60.00% | |||
Cash and Investments in Marketable Securities - Cash and Investments in Marketable Securities, Including Cash Equivalents (Detail) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Estimated Fair Value at | ||
| Cash and cash equivalents | $ 76,955 | $ 88,227 |
| Short-term investments | 379,872 | 416,750 |
| Total cash and investments in marketable securities | $ 456,827 | $ 504,977 |
Cash and Investments in Marketable Securities - Additional Information (Detail) $ in Millions |
Dec. 31, 2022
USD ($)
|
|---|---|
| Fair Value Disclosures [Abstract] | |
| Gross unrealized losses | $ 1.8 |
Condensed Consolidated Financial Statement Details - Schedule of Inventory (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Inventory Disclosure [Abstract] | ||
| Raw materials | $ 2,234 | $ 2,575 |
| Work-in-process | 13,167 | 10,749 |
| Finished goods | 4,834 | 5,878 |
| Total inventory | $ 20,235 | $ 19,202 |
Condensed Consolidated Financial Statement Details - Narrative (Details) $ in Thousands |
3 Months Ended | |
|---|---|---|
|
Mar. 31, 2023
USD ($)
|
Mar. 31, 2022
USD ($)
|
|
| Goodwill [Line Items] | ||
| Impairment of goodwill | $ 76,501 | $ 0 |
| 2012 Purchase and Sale Agreement | ||
| Goodwill [Line Items] | ||
| Royalties liability discount rate | 0.10 | |
| 2020 Purchase and Sale Agreement | ||
| Goodwill [Line Items] | ||
| Royalties liability discount rate | 0.20 | |
Condensed Consolidated Financial Statement Details - Schedule of Goodwill (Details) - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Goodwill [Roll Forward] | ||
| Goodwill – beginning balance | $ 76,501 | |
| Impairment of goodwill | (76,501) | $ 0 |
| Goodwill – ending balance | 0 | |
| Impairment of goodwill | $ 76,501 | $ 0 |
Condensed Consolidated Financial Statement Details - Schedule of Accrued Expenses (Details) - USD ($) $ in Thousands |
Mar. 31, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Inventory Disclosure [Abstract] | ||
| Accrued compensation | $ 14,888 | $ 9,582 |
| Accrued clinical trial expenses | 7,739 | 12,262 |
| Liability to collaboration partners | 3,495 | 3,808 |
| Accrued contract termination costs | 3,461 | 3,902 |
| Other accrued expenses | 7,827 | 7,003 |
| Total accrued expenses | $ 37,410 | $ 36,557 |
Commitments and Contingencies (Detail) - USD ($) |
Mar. 31, 2023 |
Dec. 31, 2022 |
|---|---|---|
| Commitments and Contingencies Disclosure [Abstract] | ||
| Liability for litigation | $ 0 | $ 0 |
License and Collaboration Agreements - Fair Value of Derivative Liabilities (Details) - Fair Value, Level 3 - Development Derivative Liability $ in Thousands |
3 Months Ended |
|---|---|
|
Mar. 31, 2022
USD ($)
| |
| Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items] | |
| Fair value at beginning of period | $ 27,726 |
| Non-cash research and development expense | 4,951 |
| Cash receipts from SFJ | 750 |
| Change in the fair value of development derivative liability | (33,427) |
| Fair value at end of period | $ 0 |
Restructuring, Impairment and Costs of Terminated Program, and Impairment of Goodwill - Restructuring Reserve Rollforward (Details) - Employee Severance - USD ($) $ in Thousands |
1 Months Ended | 3 Months Ended | 12 Months Ended |
|---|---|---|---|
Jan. 31, 2023 |
Mar. 31, 2023 |
Dec. 31, 2022 |
|
| Restructuring Reserve [Roll Forward] | |||
| Restructuring reserve, beginning balance | $ 3,299 | $ 3,299 | |
| Expense recognized during the period | 5,483 | $ 30,900 | |
| Payments during the period | (3,300) | (3,299) | |
| Restructuring reserve, ending balance | 5,483 | 3,299 | |
| 2023 Restructuring Plan | |||
| Restructuring Reserve [Roll Forward] | |||
| Restructuring reserve, beginning balance | 0 | 0 | |
| Expense recognized during the period | 5,483 | ||
| Payments during the period | 0 | ||
| Restructuring reserve, ending balance | 5,483 | 0 | |
| 2022 Restructuring Plan | |||
| Restructuring Reserve [Roll Forward] | |||
| Restructuring reserve, beginning balance | $ 3,299 | 3,299 | |
| Expense recognized during the period | 0 | ||
| Payments during the period | (3,299) | ||
| Restructuring reserve, ending balance | $ 0 | $ 3,299 |
Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands |
3 Months Ended | |
|---|---|---|
Mar. 31, 2023 |
Mar. 31, 2022 |
|
| Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
| Total stock-based compensation | $ 10,019 | $ 20,961 |
| Cost of goods sold | ||
| Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
| Total stock-based compensation | 812 | 669 |
| Research and development | ||
| Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
| Total stock-based compensation | 4,146 | 12,041 |
| General and administrative | ||
| Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||
| Total stock-based compensation | $ 5,061 | $ 8,251 |
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