Cover
Cover - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Feb. 24, 2023 | Jun. 30, 2022 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2022 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Transition Report | false | ||
Entity File Number | 001-35867 | ||
Entity Registrant Name | Chimerix, Inc. | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 33-0903395 | ||
Entity Address, Address Line One | 2505 Meridian Parkway | ||
Entity Address, Address Line Two | Suite 100 | ||
Entity Address, City or Town | Durham | ||
Entity Address, State or Province | NC | ||
Entity Address, Postal Zip Code | 27713 | ||
City Area Code | 919 | ||
Local Phone Number | 806-1074 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | CMRX | ||
Security Exchange Name | NASDAQ | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
ICFR Auditor Attestation Flag | true | ||
Entity Shell Company | false | ||
Entity Public Float | $ 111,186,204 | ||
Entity Common Stock, Shares Outstanding | 88,273,567 | ||
Documents Incorporated by Reference | Document Description Portions of the registrant’s notice of annual meeting of stockholders and proxy statement to be filed pursuant to Regulation 14A within 120 days after registrant’s fiscal year end of December 31, 2022 are incorporated by reference into Part III of this report……………………………………………………… | ||
Amendment Flag | false | ||
Document Fiscal Year Focus | 2022 | ||
Document Fiscal Period Focus | FY | ||
Entity Central Index Key | 0001117480 |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2022 | |
Auditor Information [Abstract] | |
Auditor Name | Ernst & Young LLP |
Auditor Firm ID | 42 |
Auditor Location | Raleigh, NC |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 25,842 | $ 15,397 |
Short-term investments, available-for-sale | 191,492 | 72,970 |
Accounts receivable | 1,040 | 0 |
Inventories | 0 | 2,760 |
Prepaid expenses and other current assets | 9,764 | 4,678 |
Total current assets | 228,138 | 95,805 |
Long-term investments | 48,626 | 2,022 |
Property and equipment, net of accumulated depreciation | 227 | 253 |
Operating lease right-of-use assets | 1,964 | 2,404 |
Other long-term assets | 386 | 56 |
Total assets | 279,341 | 100,540 |
Current liabilities: | ||
Accounts payable | 3,034 | 2,788 |
Accrued liabilities | 17,381 | 13,108 |
Note payable | 0 | 14,000 |
Total current liabilities | 20,415 | 29,896 |
Loan Fees | 250 | 0 |
Operating Lease Long-term Liabilities (recorded within Lease-related obligations) | 1,819 | 2,392 |
Total liabilities | 22,484 | 32,288 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized at December 31, 2022 and 2021; no shares issued and outstanding as of December 31, 2022 and 2021 | 0 | 0 |
Common stock, $0.001 par value; 200,000,000 shares authorized at December 31, 2022 and 2021; 88,054,127 and 86,884,266 shares issued and outstanding at December 31, 2022 and 2021, respectively | 88 | 87 |
Additional paid-in capital | 970,535 | 953,782 |
Accumulated other comprehensive loss, net | (337) | (21) |
Accumulated deficit | (713,429) | (885,596) |
Total stockholders’ equity | 256,857 | 68,252 |
Total liabilities and stockholders’ equity | $ 279,341 | $ 100,540 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock, shares issued (in shares) | 88,054,127 | 86,884,266 |
Common stock, shares outstanding (in shares) | 88,054,127 | 86,884,266 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Revenues: | |||
Revenues | $ 33,824,000 | $ 1,979,000 | $ 5,372,000 |
Cost of goods sold | 447,000 | 0 | 0 |
Gross Profit | 33,377,000 | 1,979,000 | 5,372,000 |
Operating expenses: | |||
Research and development | 71,631,000 | 73,817,000 | 36,232,000 |
General and administrative | 22,132,000 | 18,672,000 | 13,656,000 |
Acquired in-process research and development | 0 | 82,890,000 | 0 |
Total operating expenses | 93,763,000 | 175,379,000 | 49,888,000 |
Loss from operations | (60,386,000) | (173,400,000) | (44,516,000) |
Other income (loss): | |||
Interest income and other, net | 2,919,000 | 164,000 | 994,000 |
Gain on sale of business, net | 229,670,000 | 0 | 0 |
Income (loss) before income taxes | 172,203,000 | (173,236,000) | (43,522,000) |
Income tax expense | 36,000 | 0 | 0 |
Net income (loss) | 172,167,000 | (173,236,000) | (43,522,000) |
Other comprehensive income (loss): | |||
Unrealized loss on debt investments, net | (316,000) | (21,000) | (35,000) |
Comprehensive income (loss) | $ 171,851,000 | $ (173,257,000) | $ (43,557,000) |
Per share information: | |||
Net income (loss), basic (in dollars per share) | $ 1.97 | $ (2.04) | $ (0.70) |
Net income (loss), diluted (in dollars per share) | $ 1.94 | $ (2.04) | $ (0.70) |
Weighted-average shares outstanding, basic (in shares) | 87,555,110 | 84,930,255 | 62,183,947 |
Weighted-average shares outstanding, diluted (in shares) | 88,776,147 | 84,930,255 | 62,183,947 |
Procurement revenue | |||
Revenues: | |||
Revenues | $ 31,971,000 | $ 0 | $ 0 |
Contract and grant revenue | |||
Revenues: | |||
Revenues | 942,000 | 1,928,000 | 5,274,000 |
Licensing revenue | |||
Revenues: | |||
Revenues | 536,000 | 51,000 | 98,000 |
Royalty revenue | |||
Revenues: | |||
Revenues | $ 375,000 | $ 0 | $ 0 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-in Capital | Accumulated Other Comprehensive Gain (Loss) | Accumulated Deficit |
Beginning Balance at Dec. 31, 2019 | $ 109,952 | $ 62 | $ 778,693 | $ 35 | $ (668,838) |
Beginning balance (in shares) at Dec. 31, 2019 | 61,590,013 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Share-based compensation | 5,568 | 5,568 | |||
Exercise of stock options | 987 | $ 1 | 986 | ||
Exercise of stock options (in shares) | 409,988 | ||||
Employee stock purchase plan purchases | 426 | 426 | |||
Employee stock purchase plan purchases (in shares) | 337,072 | ||||
RSU stock issuance (in shares) | 478,966 | ||||
Comprehensive loss: | |||||
Unrealized loss on debt investments, net | (35) | (35) | |||
Net income (loss) | (43,522) | (43,522) | |||
Comprehensive income (loss) | (43,557) | ||||
Ending balance (in shares) at Dec. 31, 2020 | 62,816,039 | ||||
Ending Balance at Dec. 31, 2020 | 73,376 | $ 63 | 785,673 | 0 | (712,360) |
Increase (Decrease) in Stockholders' Equity | |||||
Share-based compensation | 12,260 | 12,260 | |||
Exercise of stock options | $ 3,831 | $ 1 | 3,830 | ||
Exercise of stock options (in shares) | 909,997 | 841,775 | |||
Employee stock purchase plan purchases | $ 755 | $ 1 | 754 | ||
Employee stock purchase plan purchases (in shares) | 542,931 | ||||
RSU stock issuance (in shares) | 430,002 | ||||
Issuance of common stock related to asset acquisition | 43,445 | $ 9 | 43,436 | ||
Issuance of common stock related to asset acquisition (in shares) | 8,723,769 | ||||
Issuance of common stock, net of issuance costs | 107,842 | $ 13 | 107,829 | ||
Issuance of common stock, net of issuance costs (in shares) | 13,529,750 | ||||
Comprehensive loss: | |||||
Unrealized loss on debt investments, net | (21) | (21) | |||
Net income (loss) | (173,236) | (173,236) | |||
Comprehensive income (loss) | $ (173,257) | ||||
Ending balance (in shares) at Dec. 31, 2021 | 86,884,266 | 86,884,266 | |||
Ending Balance at Dec. 31, 2021 | $ 68,252 | $ 87 | 953,782 | (21) | (885,596) |
Increase (Decrease) in Stockholders' Equity | |||||
Share-based compensation | 15,285 | 15,285 | |||
Exercise of stock options | $ 608 | 608 | |||
Exercise of stock options (in shares) | 271,079 | 271,079 | |||
Employee stock purchase plan purchases | $ 861 | $ 1 | 860 | ||
Employee stock purchase plan purchases (in shares) | 535,255 | ||||
RSU stock issuance (in shares) | 363,527 | ||||
Comprehensive loss: | |||||
Unrealized loss on debt investments, net | (316) | (316) | |||
Net income (loss) | 172,167 | 172,167 | |||
Comprehensive income (loss) | $ 171,851 | ||||
Ending balance (in shares) at Dec. 31, 2022 | 88,054,127 | 88,054,127 | |||
Ending Balance at Dec. 31, 2022 | $ 256,857 | $ 88 | $ 970,535 | $ (337) | $ (713,429) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities: | |||
Net income (loss) | $ 172,167 | $ (173,236) | $ (43,522) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | |||
Depreciation of property and equipment | 98 | 167 | 402 |
Amortization of debt issuance costs | 233 | 0 | 0 |
Amortization of discount/premium on investments | (1,566) | 846 | (190) |
Share-based compensation | 15,285 | 12,260 | 5,568 |
Fair value of common stock issued related to asset acquisition | 0 | 43,445 | 0 |
Note payable related to asset acquisition | 0 | 14,000 | 0 |
Gain on sale of TEMBEXA | (229,670) | 0 | 0 |
(Gain) on disposition of assets | 0 | 0 | (10) |
(Gain) on sale of investments | (1) | (2) | (4) |
Lease-related amortization | 9 | 301 | (14) |
Changes in operating assets and liabilities: | |||
Accounts receivable | (1,040) | 340 | 893 |
Inventories | (2,467) | (2,760) | 0 |
Prepaid expenses and other assets | (5,419) | (2,352) | 1,025 |
Accounts payable and accrued liabilities | 5,504 | 7,061 | (186) |
Net cash used in operating activities | (46,867) | (99,930) | (36,038) |
Cash flows from investing activities: | |||
Purchases of property and equipment | (71) | (207) | (58) |
Purchases of short-term investments | (183,245) | (105,355) | (73,978) |
Purchases of long-term investments | (57,810) | (9,594) | 0 |
Proceeds from sales of short-term investments | 7,699 | 4,207 | 17,287 |
Proceeds from maturities of short-term investments | 69,480 | 66,858 | 121,452 |
Proceeds from sale of TEMBEXA | 233,984 | 0 | 0 |
Proceeds from sale of property and equipment | 0 | 0 | 10 |
Net cash provided by (used in) investing activities | 70,037 | (44,091) | 64,713 |
Cash flows from financing activities: | |||
Proceeds from exercise of stock options | 608 | 3,831 | 987 |
Proceeds from employee stock purchase plan | 860 | 755 | 426 |
Proceeds from issuance of common stock, net of commissions | 0 | 107,843 | 0 |
Payments of deferred offering costs | (193) | 0 | 0 |
Payment of note payable | (14,000) | 0 | 0 |
Net cash (used in) provided by financing activities | (12,725) | 112,429 | 1,413 |
Net increase (decrease) in cash and cash equivalents | 10,445 | (31,592) | 30,088 |
Beginning of period | 15,397 | 46,989 | 16,901 |
End of period | 25,842 | 15,397 | 46,989 |
Supplemental disclosure of cash flow information | |||
Non-cash purchases of property and equipment | $ 0 | $ 0 | $ 18 |
The Business and Summary of Sig
The Business and Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
The Business and Summary of Significant Accounting Policies | The Business and Summary of Significant Accounting Policies Description of Business Chimerix is a biopharmaceutical company whose mission it is to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. Basis of Presentation The consolidated financial statements include the accounts of the Company, and its wholly owned subsidiaries. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of the Company’s consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. Although these estimates are based on knowledge of current events and actions the Company may undertake in the future, actual results may ultimately differ from these estimates and assumptions. Cash and Cash Equivalents The Company considers any highly liquid instrument with an original maturity of three months or less at acquisition to be a cash equivalent. Cash equivalents consist of money market funds. Investments Investments consist primarily of commercial paper, corporate bonds, and U.S. Treasury securities. The Company invests in high-credit quality investments in accordance with its investment policy which minimizes the probability of loss. Available-for-sale debt securities are carried at fair value as determined by quoted market prices, with the unrealized gains and losses, net of tax, reported as a separate component of stockholders’ equity. Realized gains and losses are determined using the specific identification method and transactions are recorded on a settlement date basis in interest income and other, net. For the year ended December 31, 2022, approximately $1,000 of realized gains were reclassified from accumulated other comprehensive loss, net in the Consolidated Balance Sheets to interest income and other, net in the Consolidated Statements of Operations and Comprehensive Loss. Investments with original maturities beyond three months at the date of purchase and which mature on, or less than twelve months from, the balance sheet date are classified as short-term. Investments with a maturity beyond twelve months from the balance sheet date are classified as long-term. The Company periodically reviews available-for-sale debt securities for other-than-temporary declines in fair value below the cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company evaluates, among other things, the duration and extent to which the fair value of a security is less than its cost; the financial condition of the issuer and any changes thereto; and the Company’s intent to sell, or whether it will more likely than not be required to sell, the security before recovery of its amortized cost basis. The Company does not intend to sell, and is not likely to be required to sell, the available-for-sale debt securities in an unrealized loss position before recovery of the amortized cost bases of the debt securities, which may be maturity. Any such declines in value judged to be other-than-temporary on available-for-sale debt securities are reported in other-than-temporary impairment of investment. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk consist of cash, cash equivalents, short-term investments, and long-term investments. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. Accounts Receivable Accounts receivable at December 31, 2022 consisted of royalties earned on sales of TEMBEXA by Emergent and amounts billed under the Company’s grant agreements and transition services agreement with Emergent. Receivables are recorded as qualifying research activities are conducted and invoices from the Company’s vendors are received. The Company carries its accounts receivable at cost less an allowance for doubtful accounts. On a periodic basis, the Company evaluates its accounts receivable and establishes an allowance based on its history of collections and write-offs and the current status of all receivables. The Company does not accrue interest on trade receivables. If accounts become uncollectible, they will be written off through a charge to the allowance for doubtful accounts. The Company has not recorded a charge to allowance for doubtful accounts as management believes all receivables are fully collectible. Fair Value of Financial Instruments The carrying amounts of certain financial instruments, including accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of such instruments. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company groups assets and liabilities at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. The determination of where an asset or liability falls in the hierarchy requires significant judgment. These levels are: • Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2 — Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly. • Level 3 — Valuations based on inputs that are unobservable and significant to the overall fair value measurement. There was no material re-measurement to fair value of financial assets and liabilities that are not measured at fair value on a recurring basis. For additional information regarding the Company’s investments, please refer to Note 2, "Investments." Below is a table that presents information about certain assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements December 31, 2022 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 17,826 $ 17,826 $ — $ — Commercial paper 4,998 — 4,998 — Total cash equivalents 22,824 17,826 4,998 — Short-term investments U.S. Treasury securities 38,094 25,271 12,823 — Commercial paper 127,517 — 127,517 — Corporate bonds 25,881 — 25,881 — Total short-term investments 191,492 25,271 166,221 — Long-term investments U.S. Treasury securities 48,626 11,685 36,941 — Total long-term investments 48,626 11,685 36,941 — Total assets $ 262,942 $ 54,782 $ 208,160 $ — Fair Value Measurements December 31, 2021 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 11,841 $ 11,841 $ — $ — Total cash equivalents 11,841 11,841 — — Short-term investments U.S. Treasury securities 7,517 2,523 4,994 — Commercial paper 34,887 — 34,887 — Corporate bonds 30,566 — 30,566 — Total short-term investments 72,970 2,523 70,447 — Long-term investments U.S. Treasury securities 2,022 2,022 — — Total long-term investments 2,022 2,022 — — Total assets $ 86,833 $ 16,386 $ 70,447 $ — Inventories The Company considers regulatory approval of product candidates to be uncertain and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. The Company begins capitalization of these inventory related costs once regulatory approval is obtained. The Company primarily uses actual costs to determine its cost basis for inventories. On May 15, 2022, we entered into an Asset Purchase Agreement (the Asset Purchase Agreement) with an affiliate of Emergent BioSolutions Inc. (Emergent BioSolutions) for the sale of our exclusive worldwide rights to brincidofovir, including TEMBEXA® and specified related assets (the Asset Sale). On September 26, 2022, we closed the Asset Sale with Emergent Biodefense Operations Lansing LLC (Emergent), an affiliate of Emergent BioSolutions. Prior to the sale of TEMBEXA to Emergent, the Company’s inventory consisted of TEMBEXA, which was being manufactured for the treatment of smallpox for potential delivery to the Strategic National Stockpile (SNS) for the U.S. government and to other government agencies. TEMBEXA was approved by the FDA on June 4, 2021, at which time the Company began to capitalize inventory costs associated with TEMBEXA. Prior to FDA approval of TEMBEXA, all costs related to the manufacturing of TEMBEXA were charged to research and development expense in the period incurred as there was no alternative future use. The Company valued its inventories at the lower of cost or estimated net realizable value. The Company determined the cost of its inventories, which included amounts related to materials, manufacturing costs, shipping and handling costs on a first-in, first-out (FIFO) basis. Work-in-process included all inventory costs prior to packaging and labelling, including raw material, active product ingredient, and drug product. Finished goods included packaged and labelled products. Title to all inventory was transferred to Emergent upon the close of the Asset Sale (as defined below). Prepaid Expenses and Other Current Assets Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2022 2021 Prepaid research and development expenses $ 3,399 $ 1,726 Interest receivable 643 348 Prepaid insurance 564 450 Other prepaid expenses and current assets 5,158 2,154 Total prepaid expenses and other current assets $ 9,764 $ 4,678 Employee Retention Credit Under the provisions of the extension of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) passed by the United States Congress and signed by the President, the Company is eligible for a refundable employee retention credit subject to certain criteria. The Company recognized a $2.0 million employee retention credit during twelve months ended December 31, 2022 related to labor costs recognized during 2020 and 2021, which is recorded in prepaid expenses and other current assets. For the twelve months ended December 31, 2022, $1.5 million is recorded as a reduction to research and development expenses and $0.5 million is recorded as a reduction to general and administrative expenses. The Company has filed for refunds of the employee retention credits and as of the date of this Annual Report on Form 10-K, it has received $27,000 of refunds and cannot reasonably estimate when it will receive any or all of the remaining refunds. Deferred Loan Costs On January 31, 2022 (the Effective Date), the Company entered into a Loan and Security Agreement (the Loan Agreement), by and between the Company, as borrower, and Silicon Valley Bank, as the lender (the Lender). The Loan Agreement provides for a four-year secured revolving loan facility (the Credit Facility) in an aggregate principal amount of up to $50.0 million. Proceeds from the Credit Facility may be used for working capital and general corporate purposes. The Company has no obligation to draw down any amount under the Credit Facility, and has not drawn down any amount as of December 31, 2022. In September 2022, in connection with the Asset Sale, Silicon Valley Bank and the Company agreed to suspend the availability of future advances under the Loan Agreement until such time the parties mutually agree to amend the Loan Agreement to, among other things, adjust the borrowing base and reset the covenants. Borrowings under the Credit Facility accrue interest at a floating per annum rate of the greater of (i) 1.50% above the Prime Rate (as defined below) and (ii) 4.75%. Prime Rate is defined as the rate of interest per annum published in The Wall Street Journal or any successor publication thereto as the “prime rate”. If such rate of interest from The Wall Street Journal becomes unavailable, the “Prime Rate” shall mean the rate of interest per annum announced by the Lender as its prime rate in effect. In each case, in the event such prime rate is less than zero, such rate shall be deemed to be zero for purposes of the Loan Agreement. The Company must also pay an unused line fee equal to 0.25% per annum on the unused portion of the Credit Facility, payable quarterly in arrears. Upon the termination of the Loan Agreement for any reason prior to the Maturity Date, the Company will be required to pay to the Lender an early termination fee of $0.5 million. The Loan Agreement also requires the Company to pay the Lender a non-refundable commitment fee of $0.5 million, payable in four equal installments beginning on the Effective Date and each anniversary of the Effective Date thereafter until January 31, 2025. As of December 31, 2022, the Company has recorded current deferred loan costs of $0.1 million in prepaid expenses and other current assets and non-current deferred loan costs of $0.3 million in other long-term assets on the Consolidated Balance Sheets. As of December 31, 2022, the Company has recorded a current loan fee liability of $0.2 million in accrued liabilities and a non-current loan fee liability of $0.3 million in loan fees on the Consolidated Balance Sheets. Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three Impairment of Property and Equipment The Company evaluates property and equipment for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If the estimated future cash flows (undiscounted and without interest charges) from the use of an asset are less than the carrying value, a write-down would be recorded to reduce the related asset to its estimated fair value. For the twelve months ended December 31, 2022 and 2021, no such write-downs have occurred. Leases At the inception of an arrangement, we determine if an arrangement is, or contains, a lease based on the unique facts and circumstances present in that arrangement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For arrangements that contain a lease we (i) identify lease and non-lease components, (ii) determine the consideration in the contract, (iii) determine whether the lease is an operating or financing lease; and (iv) recognize lease right-of-use (ROU) assets and liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable and as such, we use our incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. Most leases include options to renew and, or, terminate the lease, which can impact the lease term. The exercise of these options is at our discretion and we do not include any of these options within the expected lease term as we are not reasonably certain we will exercise these options. The current portion of our operating lease liabilities is included in accrued liabilities and the long-term portion is included in lease-related obligations. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): December 31, 2022 2021 Accrued compensation $ 6,438 $ 5,491 Accrued research and development expenses 6,691 4,642 Other accrued liabilities 4,252 2,975 Total accrued liabilities $ 17,381 $ 13,108 Revenue Recognition Policy The Company’s revenues generally consist of (i) procurement revenue - revenue related to sales of TEMBEXA prior to the Asset Sale (ii) contract and grant revenue - revenue generated under federal and private foundation grants and contracts, (iii) licensing revenue - revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements, and (iv) royalty revenue - revenue related to sales of TEMBEXA made by Emergent after the Asset Sale. Revenue is recognized in accordance with the criteria outlined in Accounting Standards Codification (ASC) 606 issued by the Financial Accounting Standards Board (FASB). Following this accounting pronouncement, a five-step approach is applied for recognizing revenue, including (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the entity satisfies a performance obligation. TEMBEXA Procurement Agreements In June 2022, the Company entered into the Supply Agreement and the PHAC Contract, pursuant to which the Company was responsible for supplying TEMBEXA (brincidofovir) treatment courses for use outside of the United States. There are no material performance obligations outside of delivery in the agreements, therefore revenue related to these procurement agreements was recognized when the delivery performance obligation was satisfied. Revenue was recognized based on price per treatment course as outlined in the agreements. For the twelve months ended December 31, 2022, the Company recognized $32.0 million of procurement revenue related to these agreements. The PHAC Contract was assigned to Emergent in November 2022. The remaining deliveries of treatment courses were delivered by Emergent and are subject to the royalty terms of the Asset Purchase Agreement applicable to gross profits outside the United States. The Company recognized approximately $0.4 million of royalty revenue in the twelve months ended December 31, 2022. Emergent Biodefense Operations Lansing LLC On September 26, 2022, the Company completed the Asset Sale to Emergent of the Company’s exclusive worldwide rights to brincidofovir, including TEMBEXA® and specified related assets (the Asset Sale). Emergent paid the Company an upfront cash payment of approximately $238 million upon the closing of the Asset Sale. In addition, pursuant to the Asset Purchase Agreement, the Company is eligible to receive from Emergent: (i) up to an aggregate of approximately $124 million in milestone payments payable upon the exercise of the options under the BARDA Agreement for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA to the U.S. government; (ii) royalty payments equal to 15% of the gross profits from the sales of TEMBEXA made outside of the United States; (iii) royalty payments equal to 20% of the gross profits from the sales of TEMBEXA made in the United States in excess of 1.7 million treatment courses; and (iv) up to an additional $12.5 million upon the achievement of certain other developmental milestones. The effects of recording certain adjustments associated with contingent consideration related to TEMBEXA have been excluded as the Company has made a policy election to account for these amounts when the contingency has been resolved in accordance with Accounting Standards Codification 450, Contingencies . The Company continues to provide operational support to Emergent in furtherance of its obligations under both the Asset Purchase Agreement (and related agreements) and the BARDA Agreement. The BARDA Agreement was novated to Emergent in December 2022. Under the Asset Purchase Agreement, the Company recognized approximately $0.5 million of contract revenue for support provided for the twelve months ended December 31, 2022. Biomedical Advanced Research and Development Authority (BARDA) In February 2011, the Company entered into a contract with BARDA for the advanced development of brincidofovir as a medical countermeasure in the event of a smallpox release. Under the contract, the Company received $72.5 million in expense reimbursement and $4.6 million in fees over the performance of 1 base segment and 4 option segments. Exercise of each option segment was solely at the discretion of BARDA. The Company assessed the services in accordance with the authoritative guidance and concluded that there was a potential of 5 separate contracts (1 base segment and four option segments) were exercised, as well as the base segment. The transaction price for each segment, based on the transaction price as defined in each segment contract, was allocated to the single performance obligation for each contract. The transaction price was recognized over time by measuring the progress toward complete satisfaction of the performance obligation. For reimbursable expenses, this occurred as qualifying research activities were conducted based on invoices from company vendors. For the fixed fee, the progress toward complete satisfaction was estimated based on the costs incurred to date relative to the total estimated costs per the terms of each contract. The Company typically invoiced BARDA monthly as costs were incurred. Any amounts received in advance of performance were recorded as deferred revenue until earned. The base segment and first option segment were completed prior to adoption of ASC 606. The second and third option segments were completed on August 20, 2020. The fourth option segment was completed on September 1, 2021 and the contract has expired in accordance with its terms. Under the BARDA contract, we recognized contract revenue of $1.6 million and $5.3 million during the twelve months ended, December 31, 2021 and 2020, respectively. Grant Revenue Grant revenue under cost-plus-fixed-fee grants from the federal government and private foundations is recognized as allowable costs are incurred and fees are earned. At December 31, 2022, the Company had a deferred revenue balance of $0.2 million related to these grants. Additionally, for the twelve months ended months ended December 31, 2022 and 2021, the Company recognized $0.5 million and $0.4 million, respectively, of grant revenue related to these grants. Ohara Agreement In 2019, Oncoceutics, Inc., a Delaware corporation (Oncoceutics) which was subsequently acquired by the Company in January 2021, entered into a license, development and commercialization agreement with Ohara Pharmaceutical Co., Ltd. for ONC201 in Japan. The Company is entitled to receive up to $2.5 million in nonrefundable regulatory milestone payments. The Company is entitled to double-digit tiered royalties based on the aggregate annual net sales of all products, as defined in the agreement, in Japan. For the twelve months ended months ended December 31, 2022 and 2021, the Company recognized approximately $0.5 million and $47,000, respectively, of license revenue related to this agreement. Research and Development Prepaids and Accruals As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its research and development efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate research and development expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its research and development efforts. The Company determines prepaid and accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of communication of clinical trials, or other services completed. The Company adjusts its rate of research and development expense recognition if actual results differ from its estimates. The Company makes estimates of its prepaid and accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. Through December 31, 2022, there had been no material adjustments to the Company’s prior period estimates of prepaid and accruals for research and development expenses. The Company’s research and development prepaids and accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Research and Development Expenses Major components of research and development costs include cash compensation, stock-based compensation, preclinical studies, clinical trial and related clinical manufacturing, drug development, materials and supplies, legal, regulatory compliance, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Research and development costs, including upfront fees and milestones paid to contract research organizations, are expensed as goods are received or services rendered. Costs incurred in connection with clinical trial activities for which the underlying nature of the activities themselves do not directly relate to active research and development, such as costs incurred for market research and focus groups linked to clinical strategy as well as costs to build the Company’s brand, are not included in research and development costs but are reflected as general and administrative costs. Gain on Sale of Business, Net Emergent Biodefense Operations Lansing LLC The previously mentioned sale of TEMBEXA constitutes a significant disposition of a business, however, the Company determined the disposition does not represent a strategic shift, and accordingly, the Company has not accounted for the disposition as a discontinued operation. The Company recorded a $229.7 million net gain on sale of business in other income (loss) on the Consolidated Statement of Operations and Comprehensive Income (Loss) for the twelve months ended December 31, 2022. Interest Income and Other, Net Interest income and other, net consists primarily of interest earned on our cash, cash equivalents and short-term and long-term investments. Income Taxes Deferred tax assets and liabilities are determined based on differences between the financial and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Valuation allowances are established when the Company determines that it is more likely than not that some portion of a deferred tax asset will not be realized. The Company has incurred operating losses from April 7, 2000 (inception) through December 31, 2021, and therefore has not recorded any current provision for income taxes. For the year ended December 31, 2022, the Company recorded net income and is expecting a small amount of state income tax expense. As such the Company has recorded a provision for current state income taxes. Additionally, the Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement. Accordingly, the Company establishes reserves for uncertain tax positions. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income (GILTI), states that an entity can make an accounting policy election to either recognized deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI as a period expense in the year the tax is incurred. Share-Based Compensation The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, restricted stock units and the employee stock purchase plan purchase rights, based on estimated fair values. The fair value of employee stock options and employee stock purchase plan purchase rights is estimated on the grant date using the Black-Scholes valuation model. The grant-date fair value for restricted stock units is based upon the market price of the Company’s common stock on the date of the grant. The value of the portion of the award that is ultimately expected to vest is recorded as expense over the requisite service periods. For performance-based awards compensation cost is recognized when it is probable that the performance criteria will be met. The Company estimates forfeitures at the time of grant and revises those estimates in subsequent periods if actual forfeitures differ from its estimates. The Company uses historical data to estimate forfeitures and records share-based compensation expense only for those awards that are expected to vest. To the extent that actual forfeitures differ from the Company’s estimates, the difference is recorded as a cumulative adjustment in the period the estimates were revised. For the years ended December 31, 2022, 2021 and 2020, the Company applied a forfeiture rate based on the Company’s historical forfeitures. 401(k) Plan The Company maintains a defined contribution employee retirement plan (401(k) plan). For the years ended December 31, 2022, 2021 and 2020, the Company recognized expenses for matching contributions of $0.5 million, $0.4 million and $0.3 million, respectively. Basic and Dilutive Net Loss Per Share of Common Stock Basic net income (loss) per share of common stock is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period, excluding the dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights. Diluted net income (loss) per share of common stock is computed by dividing net income (loss) by the sum of the weighted-average number of shares of common stock outstanding during the period plus the potential dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. For the twelve months ended December 31, 2022, the diluted per-share computation |
Investments
Investments | 12 Months Ended |
Dec. 31, 2022 | |
Investments [Abstract] | |
Investments | Investments The following tables summarize the Company’s short-term and long-term debt investments (in thousands): December 31, 2022 Amortized Cost Gross Unrealized Gross Unrealized Estimated Corporate bonds $ 25,906 $ 4 $ (29) $ 25,881 Commercial paper 127,657 36 (176) 127,517 U.S. Treasury securities 86,892 7 (179) 86,720 Total investments $ 240,455 $ 47 $ (384) $ 240,118 December 31, 2021 Amortized Cost Gross Unrealized Gross Unrealized Estimated Corporate bonds $ 30,571 $ 2 $ (7) $ 30,566 Commercial paper 34,890 2 (5) 34,887 U.S. Treasury securities 9,552 — (13) 9,539 Total investments $ 75,013 $ 4 $ (25) $ 74,992 The following tables summarize the Company’s debt investments with unrealized losses, aggregated by investment type and the length of time that individual investments have been in a continuous unrealized loss position (in thousands, except number of securities): December 31, 2022 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 22,905 $ (29) $ — $ — $ 22,905 $ (29) Commercial paper 88,860 (176) — — 88,860 (176) U.S. Treasury securities 67,489 (179) — — 67,489 (179) Total $ 179,254 $ (384) $ — $ — $ 179,254 $ (384) Number of securities with unrealized losses 55 — 55 December 31, 2021 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 28,362 $ (7) $ — $ — $ 28,362 $ (7) Commercial paper 8,991 (5) — — 8,991 (5) U.S. Treasury securities 9,539 (13) — — 9,539 (13) Total $ 46,892 $ (25) $ — $ — $ 46,892 $ (25) Number of securities with unrealized losses 18 — 18 The following table summarizes the scheduled maturity for the Company’s debt investments at December 31, 2022 (in thousands): December 31, 2022 Maturing in one year or less $ 191,492 Maturing after one year through two years 48,626 Total debt investments $ 240,118 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Property and Equipment Property and equipment, net of accumulated depreciation consisted of the following (in thousands): December 31, 2022 2021 Lab equipment $ 2,299 $ 2,341 Leasehold improvements 1,713 1,713 Computer equipment 817 817 Office furniture and equipment 520 520 Property and equipment 5,349 5,391 Less accumulated depreciation (5,122) (5,138) Property and equipment, net of accumulated depreciation $ 227 $ 253 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Leases The Company leases its facilities under long-term operating leases that expire at various dates through 2026. The Company generally has options to renew lease terms on its facilities, which may be exercised at the Company’s sole discretion. In addition, certain lease arrangements may be terminated prior to their original expiration date at the Company’s discretion. The Company evaluates renewal and termination options at the lease commencement date to determine if it is reasonably certain to exercise the option and has concluded on all operating leases that it is not reasonably certain that any options will be exercised. The weighted-average remaining lease term for the Company’s operating leases as of December 31, 2022 was 3.58 years. Expense related to leases is recorded on a straight-line basis over the lease term. Lease expense under operating leases, including common area maintenance fees, totaled approximately $0.7 million and $0.7 million for the twelve months ended December 31, 2022 and 2021, respectively. The discount rate implicit within the Company’s leases is generally not determinable and therefore the Company determines the discount rate based on its incremental borrowing rate based on the information available at commencement date. As of December 31, 2022, the operating lease liabilities reflect a weighted-average discount rate of 7.89%. The following table sets forth the operating lease right-of-use assets and liabilities as of December 31, 2022 (in thousands): Assets Operating Lease Right-of-Use Assets $ 1,964 Liabilities Operating Lease Short-term Liabilities (recorded within Accrued liabilities) $ 573 Operating Lease Long-term Liabilities (recorded within Lease-related obligations) 1,819 Total Operating Lease Liabilities $ 2,392 Operating lease payments over the remainder of the lease terms are as follows (in thousands): Years Ending December 31, As of December 31, 2022 2023 736 2024 759 2025 781 2026 467 Total future minimum rental payments $ 2,743 Less amount of lease payments representing interest 351 Total present value of lease payments $ 2,392 For the twelve months ended December 31, 2022 and 2021, the Company made lease payments of approximately $0.6 million and $0.5 million, respectively, which are included in operating cash flows. Sublease The Company subleased 3,537 square feet of its office space under a non-cancelable operating lease that expired February 2021. For the twelve months ended December 31, 2021, the Company recognized approximately $12,000 of income in Interest income and other, net on the Consolidated Statement of Operations and Comprehensive Loss. As this lease has terminated, there are no future minimum rentals payments to be received. Significance of Revenue Source |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity (Deficit) | Stockholders’ Equity (Deficit) Common Stock The Company’s common stock consists of 200 million authorized shares at December 31, 2022 and 2021, and 88.1 million and 86.9 million shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively. Shares Reserved for Future Issuance The Company has reserved shares of common stock for future issuances as follows: December 31, 2022 2021 For exercise of outstanding common stock options 15,076,365 11,649,594 For delivery upon vesting of outstanding restricted stock units 920,533 896,222 For future equity awards under the 2013 Equity Incentive Plan 1,466,603 2,076,923 For future purchases under the 2013 Employee Stock Purchase Plan 2,186,097 2,298,817 Total shares of common stock reserved for future issuances 19,649,598 16,921,556 Stock Options The Company maintains a 2013 Equity Incentive Plan (the 2013 Plan). The 2013 Plan provides for the grant of incentive stock options (ISOs), nonstatutory stock options (NSOs), stock appreciation rights, restricted stock awards, restricted stock unit (RSU) awards, performance-based stock awards, and other forms of equity compensation (collectively, stock awards), all of which may be granted to employees, including officers, non-employee directors and consultants of the Company and its affiliates. Additionally, the 2013 Plan provides for the grant of performance cash awards. ISOs may be granted only to employees. All other awards may be granted to employees, including officers, and to non-employee directors and consultants. The Company estimates the fair value of its share-based awards to employees, directors and consultants using the Black-Scholes option-pricing model. The Black-Scholes model requires the input of assumptions, including (a) the expected stock price volatility, (b) the calculation of expected term of the award, (c) the risk-free interest rate and (d) expected dividends. For stock options, the Company uses historical volatility data to estimate the volatility of our common stock price and historical exercise data to estimate the expected life. The risk-free interest rates for the periods within the expected life of the option are based on the U.S. Treasury instrument with a life that is similar to the expected life of the option grant. The Company has never paid, and does not expect to pay, dividends in the foreseeable future. The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the stock options granted: Years Ended December 31, 2022 2021 2020 Expected volatility 74.27 % 95.84 % 93.24 % Expected term (in years) 6.0 6.0 6.0 Weighted-average risk-free interest rate 1.91 % 0.71 % 1.24 % Expected dividend yield — % — % — % Weighted-average fair value per option $ 3.33 $ 6.67 $ 1.78 A summary of activity related to the Company’s stock options is as follows: Number of Options Weighted-Average Weighted-Average Total Intrinsic Value Balance, December 31, 2020 8,913,271 $ 5.28 7.52 Granted 3,903,750 8.74 — Exercised (909,997) 4.69 — Forfeited (257,432) 15.12 — Balance, December 31, 2021 11,649,592 $ 6.27 7.65 Granted 4,217,275 5.12 — Exercised (271,079) 2.24 — Forfeited (519,423) 6.93 — Balance, December 31, 2022 15,076,365 $ 6.00 7.32 $ 64,174 Exercisable at December 31, 2022 9,192,591 $ 6.14 6.59 $ 42,393 Vested or expected to vest at December 31, 2022 14,204,938 $ 6.00 7.25 $ 61,673 As of December 31, 2022, there was approximately $19.6 million of total unrecognized compensation cost related to non-vested stock options granted under the 2013 Plan. That compensation cost is expected to be recognized over a weighted-average period of approximately 2.39 years. Other information regarding the Company’s stock options is as follows (in thousands, except per share data): Years Ended December 31, 2022 2021 2020 Weighted-average grant-date fair value per share of options granted $ 3.33 $ 6.67 $ 1.78 Total intrinsic value of options exercised $ 114 $ 3,496 $ 355 Total fair value of shares vested $ 12,721 $ 8,642 $ 4,188 The following table summarizes, at December 31, 2022, by price range: (1) for stock option awards outstanding under the 2013 Plan, the number of stock option awards outstanding, their weighted-average remaining life and their weighted-average exercise price; and (2) for stock option awards exercisable under the 2013 Plan, the number of stock option awards exercisable and their weighted-average exercise price: Outstanding Exercisable Exercise Price Range ($) Number Weighted-Average Remaining Contractual Life (in years) Weighted-Average Exercise Price Number Weighted-Average Exercise Price 1.37 to 2.08 2,418,541 7.42 $ 2.00 1,655,079 $ 2.01 2.09 to 3.13 3,260,545 6.71 2.35 2,707,469 2.34 3.14 to 5.60 1,547,105 5.91 4.64 1,326,771 4.63 5.61 to 7.86 3,918,679 8.98 5.81 1,120,141 6.17 7.87 to 53.74 3,931,495 6.67 12.20 2,383,131 14.14 1.37 to 53.74 15,076,365 7.32 $ 6.00 9,192,591 $ 6.14 Employee Stock Purchase Plan In February 2013, the Company’s board of directors adopted the 2013 Employee Stock Purchase Plan (ESPP), which was subsequently ratified by stockholders and became effective in April 2013. The purpose of the ESPP is to retain the services of new employees and secure the services of new and existing employees while providing incentives for such individuals to exert maximum efforts toward the Company’s success and that of its affiliates. The ESPP is intended to qualify as an “employee stock purchase plan” within the meaning of Section 423 of the Code. The Company has reserved a total of 4,338,936 shares of common stock to be purchased under the ESPP, of which 2,186,097 and 2,298,817 shares remained available for purchase at December 31, 2022 and 2021, respectively. Eligible employees may authorize an amount up to 15% of their salary to purchase common stock at the lower of a 15% discount to the beginning price of their offering period or a 15% discount to the ending price of each six-month purchase interval. The ESPP also provides for an automatic reset feature to start participants on a new twenty-four-month participation period in the event that the common stock market value on a purchase date is less than the common stock value on the first day of the twenty-four month offering period. The Company issued 535,255 and 542,931 shares of common stock pursuant to the ESPP for the years ended December 31, 2022 and 2021, respectively. Compensation expense for purchase rights under the ESPP related to the purchase discount and the “look-back” option were determined using a Black-Scholes option pricing model. The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the ESPP purchase rights: Years Ended December 31, 2022 2021 2020 Expected volatility 104.88 % 97.54 % 75.39 % Expected term (in years) 1.28 0.71 1.28 Weighted-average risk-free interest rate 2.63 % 0.25 % 0.37 % Expected dividend yield — % — % — % Weighted-average option value per share $ 1.97 $ 6.55 $ 0.93 As of December 31, 2022, the Company had a liability of $0.3 million representing employees' contributions to the ESPP. Restricted Stock Units For the years ended December 31, 2022 and 2021, the Company issued RSUs to certain employees and consultants which vest based on service criteria. When vested, the RSU represents the right to be issued the number of shares of the Company’s common stock that is equal to the number of RSUs granted. The grant date fair value for RSUs is based upon the market price of the Company’s common stock on the date of the grant. The fair value is then amortized to compensation expense over the requisite service period or vesting term. For the years ended December 31, 2022 and 2021, the Company issued 363,527 and 430,002 shares of common stock pursuant to the vesting of RSUs, respectively. A summary of activity related to the Company’s RSUs is as follows: Number of Restricted Weighted-Average Grant-Date Fair Value Balance, December 31, 2021 896,222 $ 3.98 Granted 451,250 5.24 Share issuance (363,527) 3.46 Forfeited (63,412) 3.83 Balance, December 31, 2022 920,533 $ 4.82 The total unrecognized compensation cost related to the non-vested RSUs as of December 31, 2022 wa s $3.6 million an d will be recognized over a weighted average period of approxima tely 2.31 years. Stock-based Compensation For awards with only service conditions and graded-vesting features, the Company recognizes compensation expense on a straight-line basis over the requisite service period. Total stock-based compensation expense was as follows (in thousands): Years Ended December 31, 2022 2021 2020 Income Statement Classification: Research and development expense $ 8,267 $ 6,611 $ 2,969 General and administrative expense 7,018 5,649 2,599 Total stock-based compensation expense $ 15,285 $ 12,260 $ 5,568 Cash received from exercises under all share-based payment arrangements for 2022, 2021 and 2020 was $1.5 million, $4.6 million and $1.4 million, respectively. There was no actual tax benefit realized for the tax deductions from exercises of the share-based payment arrangements during 2022, 2021 or 2020. In December 2022, related to the Company’s announcement of a reduction in workforce, further discussed in Note 10, certain vested stock options were modified to extend their exercise period from 90 days to 12 months. In addition, certain outstanding stock option and RSU grants received accelerated vesting as if the service period of the terminated employee continued for up to an additional 12-month period. Related to this, the Company will record expense totaling approximately $1.0 million ratably from the announcement date through the date of termination with approximately $0.4 million of that total being recognized during the twelve months ended December 31, 2022. At-The-Market Equity Offering; Shelf Registration Statement On August 10, 2020, we entered into an Open Market Sale Agreement SM (the Jefferies Sales Agreement) with Jefferies LLC, as agent, pursuant to which we may offer and sell, from time to time through Jefferies, up to $75 million of shares of our common stock. We have not sold any shares of our common stock under the Jefferies Sales Agreement. On May 6, 2021, we filed an automatic shelf registration statement on Form S-3 with the SEC, which was subsequently amended in March 2022 to convert to a non-automatic shelf registration statement. This registration statement enables us to offer for sale, from time to time, in one or more offerings, up to $250 million in the aggregate, of common stock, debt securities, warrants, rights and/or units, and will remain in effect for up to three years from the date it became effective. As of December 31, 2022, no sales have been made under the shelf registration statement. Public Offering of Common Stock On January 20, 2021, the Company entered into an underwriting agreement (the Underwriting Agreement) with Jefferies LLC and Cowen and Company, LLC, as representatives of the several underwriters named therein (collectively, the Underwriters), relating to the issuance and sale of 11,765,000 shares (the Shares) of the Company's common stock. The price to the public in this offering was $8.50 per share, and the Underwriters agreed to purchase the Shares from the Company pursuant to the Underwriting Agreement at a price of $7.99 per share. The net proceeds to the Company from this offering were approximately $107.8 million, including the full exercise of the Underwriters’ option to purchase additional shares, after deducting underwriting discounts and commissions and estimated offering expenses payable by the Company. The offering closed on January 25, 2021. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Income tax expense has been recorded for the period ended December 31, 2022. No income tax expense or benefit has been recorded for the years ended December 31, 2021 or 2020. This is due to the establishment of a valuation allowance against the deferred tax assets generated during those periods. At December 31, 2022, the Company has concluded that it is more likely than not that the Company may not realize the benefit of its deferred tax assets due to its history of losses. Accordingly, the net deferred tax assets have been fully reserved. The provision for income tax expense includes the following as of December 31, 2022, 2021, and 2020: December 31, 2022 2021 2020 Current: Federal $ — $ — $ — State 36 — — Total 36 — — Deferred: Federal — — — State — — — Total — — — Total Tax Expense $ 36 $ — $ — A reconciliation of the difference between the benefit for income taxes and income taxes at the statutory U.S. federal income tax rate is as follows for the years ended December 31, 2022, 2021, and 2020 (in thousands, except percentages): 2022 2021 2020 Amount % of Pretax Amount % of Pretax Amount % of Pretax Income tax benefit at statutory rate $ 36,163 21.0 % $ (36,379) 21.0 % $ (9,140) 21.0 % State income taxes 441 0.2 % (8,060) 4.7 % (138) 0.3 % Research and development credits (3,312) (1.9) % (1,565) 0.9 % (1,088) 2.5 % In process R&D — — % 26,395 (15.2) % — — % Permanent items 1,135 0.7 % 711 (0.4) % 505 (1.2) % Provision to return adjustments 1,091 0.6 % 126 (0.1) % 81 (0.2) % Effect of change in federal tax rate — — % — — % — — % Effect of change in state tax rate 4,405 2.6 % 3,478 (2.0) % 1,139 (2.6) % Removal of excess tax benefit — — % — — % — — % Increase in unrecognized tax benefits 828 0.5 % 439 (0.3) % 272 (0.6) % Current year forfeitures 54 — % 435 (0.3) % 4,026 (9.2) % Change in valuation allowance (40,769) (23.7) % 14,420 (8.3) % 4,343 (10.0) % Net benefit $ 36 — % $ — — % $ — — % The components of deferred tax assets and liabilities at December 31, 2022 and 2021 were as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Domestic net operating loss carryforwards $ 84,147 $ 138,548 Research and development expenses 1,520 1,191 Capitalized Section 174 expenses 12,425 — License fees 11,509 14,131 Research and development credits 20,166 17,738 Capital loss carryforwards 428 484 Accrued bonuses 722 888 Share-based compensation 6,132 4,885 Other 1,333 1,457 Total gross deferred tax assets 138,382 179,322 Valuation allowance (137,936) (178,705) Total deferred tax assets 446 617 Deferred tax liabilities: Right-of-use asset (446) (617) Total deferred tax liabilities (446) (617) Total deferred tax assets and liabilities, net $ — $ — At December 31, 2022, the Company had net operating loss carryforwards for federal and state tax purposes of approximately $394.8 million and $394.4 million, respectively. At December 31, 2021, the Company had net operating loss carryforwards for federal and state tax purposes of approximately $637.9 million and $455.4 million, respectively. Federal losses of $169.5 million begin to expire in 2035 and $225.3 million of the federal losses carryforward indefinitely. State losses of $391.7 million begin to expire in 2024 and $2.7 million of the state losses carryforward indefinitely. The tax benefit in 2022 related to utilization of net operating loss carryforwards is $51.2 million. In addition, the Company has tax credit carryforwards for federal tax purposes of approximately $26.6 million as of December 31, 2022. Of the $26.6 million, $0.1 million expired in 2022. The Company also has capital loss carryforwards for federal tax purposes of $1.9 million, which begin to expire in 2024. The future utilization of net operating loss and tax credit carryforwards may be limited due to changes in ownership. Management has recorded a valuation allowance for all of the deferred tax assets due to the uncertainty of future taxable income. The Company incorporated a subsidiary in the United Kingdom in 2014. However, the subsidiary had zero activity in 2021 and as such, has no undistributed earnings. The Company dissolved the United Kingdom subsidiary in 2021. The Company incorporated a subsidiary in Ireland during 2018. However, the subsidiary had no activity during 2020, 2021 and 2022, and as such, has no undistributed earnings. The Company acquired Oncoceutics, Inc. in 2021 and is including the activity for 2022 in its consolidated financial statements. In general, if the Company experiences a greater than 50% change, by value, in its equity ownership over a three-year period, utilization of its pre-change net operating loss carryforwards is subject to an annual limitation under Section 382 of the Code (and similar state laws). The annual limitation generally is determined by multiplying the value of the Company’s stock at the time of such ownership change (subject to certain adjustments) by the applicable long-term tax-exempt rate. Such limitations may result in expiration of a portion of the net operating loss carryforwards before utilization and may be substantial. The ability of the Company to use its net operating loss carryforwards may be limited or lost if the Company experiences an ownership change under Section 382 of the Code in connection with offerings or as a result of future changes in its stock ownership. Losses from a specific period may be subject to multiple limitations and would generally be limited by the lowest of those limitations. The acquired Oncoceutics net operating losses may be subject to limitations under Section 382, however no study has been completed as of the year ended December 31, 2022. The Company has determined that there may be a future limitation on the Company’s ability to utilize its entire federal R&D credit carryover. Therefore, the Company recognized an uncertain tax benefit associated with the federal R&D credit carryover during the years ended December 31, 2022 and 2021, as follows (in thousands): Balance at December 31, 2020 $ 4,295 Increases related to 2021 391 Increases related to prior periods 48 Balance at December 31, 2021 4,734 Increases related to 2022 828 Increases related to prior periods — Balance at December 31, 2022 $ 5,562 On November 18, 2021, Governor Roy Cooper signed into law the 2021 Appropriations Act which phases out the corporate income tax for North Carolina. The Bill phases out the current 2.5% North Carolina corporate income tax rate over five years starting in 2025, reaching zero by 2030. For tax years beginning on or after January 1, 2025 the rate is 2.25%. The rate decreases to 2% in 2026 and 2027; and to 1% in 2028 and 2029. After 2029, the rate decreases to 0%. As a result of the revised tax rate, the Company adjusted its North Carolina net operating loss deferred tax asset as of December 31, 2021 by applying the revised tax rate, which resulted in a decrease to the deferred tax assets and a corresponding decrease to the valuation allowance of approximately $7.1 million in 2021 and $0.6 million in 2022. The Company has determined that it had no other material uncertain tax benefits for the year ended December 31, 2022. As of December 31, 2022, due to the carry forward of unutilized net operating losses and research and development credits, the Company is subject to U.S. federal and state income tax examinations for the tax years 2002 through 2022. The Company recognizes accrued interest related to unrecognized tax benefits in interest expense and penalties in operating expense. No amounts were accrued for the payment of interest and penalties at December 31, 2022, 2021 and 2020. The Tax Act subjects a “United States shareholder” for U.S. federal income tax purposes to tax GILTI earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income, states that an entity can make an accounting policy election to either recognized deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI in the year the tax is incurred. The Company does not have a GILTI inclusion in 2019, 2020, 2021 or 2022; therefore, no GILTI tax has been recorded for the years ended December 31, 2021 and 2022. |
Significant Agreements
Significant Agreements | 12 Months Ended |
Dec. 31, 2022 | |
Contractors [Abstract] | |
Significant Agreements | Significant Agreements BARDA 2022 Procurement and Development Contract On August 26, 2022, the Company entered into a procurement contract, as amended, (the BARDA Agreement) with BARDA for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA® to the U.S. government. The BARDA Agreement consists of a five-year base period of performance and a total contract period of performance (base period plus option exercises) of up to ten years (if necessary). Under the terms of the BARDA Agreement, the base period activities are valued at approximately $127 million, consisting of an initial shipment of 319,000 treatment courses of TEMBEXA to be procured and shipped to the Strategic National Stockpile for an aggregate purchase price of approximately $115 million, and reimbursement for certain post-marketing activities of approximately $12 million. The options under the BARDA Agreement, which are exercised at the sole discretion of BARDA, are valued at approximately $553 million (if all such options are exercised during the 10-year contract period), which consists of options to purchase up to an additional 1.381 million treatment courses of TEMBEXA for an aggregate purchase price of approximately $551 million and funding for certain post-marketing activities of approximately $2 million. In connection with the sale of the TEMBEXA franchise to Emergent, the BARDA Agreement was novated to Emergent in December 2022. In accordance with federal regulations, the terms of the novation agreement require that the company guarantee the performance of all obligations transferred to Emergent should Emergent not have the ability to deliver on the terms of the BARDA Agreement. In this instance BARDA may request that we perform the obligations in place of Emergent. Emergent Biodefense Operations Lansing LLC On September 26, 2022, the Company completed the Asset Sale to Emergent of the Company’s exclusive worldwide rights to brincidofovir, including TEMBEXA® and specified related assets (the Asset Sale). Emergent paid the Company an upfront cash payment of approximately $238 million upon the closing of the Asset Sale. In addition, pursuant to the Asset Purchase Agreement, the Company is eligible to receive from Emergent: (i) up to an aggregate of approximately $124 million in milestone payments payable upon the exercise of the options under the BARDA Agreement for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA to the U.S. government; (ii) royalty payments equal to 15% of the gross profits from the sales of TEMBEXA made outside of the United States; (iii) royalty payments equal to 20% of the gross profits from the sales of TEMBEXA made in the United States in excess of 1.7 million treatment courses; and (iv) up to an additional $12.5 million upon the achievement of certain other developmental milestones. The effects of recording certain adjustments associated with contingent consideration related to TEMBEXA have been excluded as the Company has made a policy election to account for these amounts when the contingency has been resolved in accordance with Accounting Standards Codification 450, Contingencies . The Company continues to provide operational support to Emergent in furtherance of its obligations under both the Asset Purchase Agreement (and related agreements) and the BARDA Agreement. The BARDA Agreement was novated to Emergent in December 2022. Under the Asset Purchase Agreement, the Company recognized approximately $0.5 million of contract revenue for support provided for the twelve months ended December 31, 2022. The sale of TEMBEXA constitutes a significant disposition of a business, however, the Company determined the disposition does not represent a strategic shift, and accordingly, the Company has not accounted for the disposition as a discontinued operation. The Company recorded a $229.7 million net gain on sale of business in other income (loss) on the Consolidated Statement of Operations and Comprehensive Income (Loss) for the twelve months ended December 31, 2022. The net gain consists of the following assets and liabilities transferred in accordance with the Asset Purchase Agreement (in thousands): As of September 26, 2022 Up-front cash payment $ 237,987 Liabilities assumed by Emergent 1,423 Inventory transferred to Emergent (5,227) Prepaids transferred to Emergent (511) Transaction costs incurred (4,002) Net gain $ 229,670 TEMBEXA Procurement Agreements In June 2022, the Company entered into a Supply Agreement (the Supply Agreement) with a third-party outside of North America (the Purchaser), pursuant to which the Company was responsible for supplying to the Purchaser, and the Purchaser was responsible for purchasing from the Company, TEMBEXA treatment courses for use in a jurisdiction outside of the United States. Under the terms of the Supply Agreement, the Purchaser paid the Company an aggregate purchase price of approximately $9.3 million, in two equal installments in June 2022 and July 2022. The Company recognized $9.3 million of procurement revenue under the Supply Agreement for the twelve months ended December 31, 2022. Additionally, in June 2022, the Public Health Agency of Canada (PHAC) awarded a Contract (PHAC Contract) to the Company, pursuant to which PHAC agreed to purchase up to approximately $25.3 million (CAD $33.0 million) of TEMBEXA treatment courses for use in Canada. Substantially all of the procurement was delivered and accepted by PHAC in July 2022, completing the performance obligation for those shipments and resulting in $22.6 million of procurement revenue for the twelve months ended December 31, 2022. PHAC assigned the PHAC Contract to Emergent in November 2022. The remaining deliveries of treatment courses were delivered by Emergent and are subject to the royalty terms of the Asset Purchase Agreement applicable to gross profits outside the United States. The Company recognized approximately $0.4 million of royalty revenue in the twelve months ended December 31, 2022. BARDA 2011 Research and Development Contract In February 2011, the Company entered into a contract with BARDA for the advanced development of TEMBEXA as a medical countermeasure in the event of a smallpox release. Under the contract, BARDA agreed to reimburse the Company, plus pay a fixed fee, for the research and development of TEMBEXA as a broad-spectrum therapeutic antiviral for the treatment of smallpox infections. The contract consists of an initial performance period, referred to as the base performance segment, plus up to four extension periods, referred to as option segments, of which all have been exercised. Under the contract, the Company received $72.5 million in expense reimbursement and $4.6 million in fees. The fourth option segment ended on September 1, 2021 and the contract has expired in accordance with its terms. For the years ended December 31, 2021 and 2020, the Company recognized contract revenue under this contract of $1.6 million and $5.3 million, respectively. Ohara Agreement In 2019, Oncoceutics, Inc., a Delaware corporation (Oncoceutics) which was subsequently acquired by the Company in January 2021, entered into a license, development and commercialization agreement with Ohara Pharmaceutical Co., Ltd. for ONC201 in Japan. The Company is entitled to receive up to $2.5 million in nonrefundable regulatory milestone payments. The Company is entitled to double-digit tiered royalties based on the aggregate annual net sales of all products, as defined in the agreement, in Japan. CR Sanjiu Agreement In December 2020, Oncoceutics entered into a license, development and commercialization agreement with China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. (CR Sanjiu). Oncoceutics granted CR Sanjiu an exclusive royalty bearing license to develop and commercialize ONC201 in China, Hong Kong, Macau and Taiwan (CR Sanjiu Territory). The Company is entitled to receive up to $5.0 million in nonrefundable regulatory milestone payments. The Company is entitled to double-digit tiered royalties based on the aggregate annual net sales of all licensed products, as defined in the agreement, in the CR Sanjiu Territory. In May 2022, the Company made the decision to discontinue the development of DSTAT for the treatment of AML. Effective July 12, 2022, the Company terminated the License and Development Agreement with Cantex Pharmaceuticals, Inc. As a result, the Company recorded an accrual of expenses to close-out the DSTAT vendor contracts. As of December 31, 2022, on the Consolidated Balance Sheets, the Company has recorded $1.4 million of contract close-out costs in accrued liabilities offset by a vendor credit of $0.1 million in accounts payable, which included additional expense of $0.8 million recorded to research and development expenses for the twelve months ended December 31, 2022, on the Consolidated Statement of Operations after the decision to discontinue to the DSTAT program. These balances are expected to be fully paid over the first half of 2023. The following table summarizes the contract close-out costs (in thousands) recorded for the twelve months ended December 31, 2022: Contract Close-out Costs Research & development $ 791 General & administrative 8 Total contract close-out expenses $ 799 The following table sets forth the accounts payable and accrual activity for contract close-out costs (in thousands) for the twelve months ended December 31, 2022. Contract Close-out Costs Balance at June 30, 2022 $ 4,539 Revised estimates $ (746) Payments $ (2,482) Balance at December 31, 2022 $ 1,311 |
DSTAT Contract Close-out
DSTAT Contract Close-out | 12 Months Ended |
Dec. 31, 2022 | |
Investments, All Other Investments [Abstract] | |
DSTAT Contract Close-out | Significant Agreements BARDA 2022 Procurement and Development Contract On August 26, 2022, the Company entered into a procurement contract, as amended, (the BARDA Agreement) with BARDA for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA® to the U.S. government. The BARDA Agreement consists of a five-year base period of performance and a total contract period of performance (base period plus option exercises) of up to ten years (if necessary). Under the terms of the BARDA Agreement, the base period activities are valued at approximately $127 million, consisting of an initial shipment of 319,000 treatment courses of TEMBEXA to be procured and shipped to the Strategic National Stockpile for an aggregate purchase price of approximately $115 million, and reimbursement for certain post-marketing activities of approximately $12 million. The options under the BARDA Agreement, which are exercised at the sole discretion of BARDA, are valued at approximately $553 million (if all such options are exercised during the 10-year contract period), which consists of options to purchase up to an additional 1.381 million treatment courses of TEMBEXA for an aggregate purchase price of approximately $551 million and funding for certain post-marketing activities of approximately $2 million. In connection with the sale of the TEMBEXA franchise to Emergent, the BARDA Agreement was novated to Emergent in December 2022. In accordance with federal regulations, the terms of the novation agreement require that the company guarantee the performance of all obligations transferred to Emergent should Emergent not have the ability to deliver on the terms of the BARDA Agreement. In this instance BARDA may request that we perform the obligations in place of Emergent. Emergent Biodefense Operations Lansing LLC On September 26, 2022, the Company completed the Asset Sale to Emergent of the Company’s exclusive worldwide rights to brincidofovir, including TEMBEXA® and specified related assets (the Asset Sale). Emergent paid the Company an upfront cash payment of approximately $238 million upon the closing of the Asset Sale. In addition, pursuant to the Asset Purchase Agreement, the Company is eligible to receive from Emergent: (i) up to an aggregate of approximately $124 million in milestone payments payable upon the exercise of the options under the BARDA Agreement for the delivery of up to 1.7 million treatment courses of tablet and suspension formulations of TEMBEXA to the U.S. government; (ii) royalty payments equal to 15% of the gross profits from the sales of TEMBEXA made outside of the United States; (iii) royalty payments equal to 20% of the gross profits from the sales of TEMBEXA made in the United States in excess of 1.7 million treatment courses; and (iv) up to an additional $12.5 million upon the achievement of certain other developmental milestones. The effects of recording certain adjustments associated with contingent consideration related to TEMBEXA have been excluded as the Company has made a policy election to account for these amounts when the contingency has been resolved in accordance with Accounting Standards Codification 450, Contingencies . The Company continues to provide operational support to Emergent in furtherance of its obligations under both the Asset Purchase Agreement (and related agreements) and the BARDA Agreement. The BARDA Agreement was novated to Emergent in December 2022. Under the Asset Purchase Agreement, the Company recognized approximately $0.5 million of contract revenue for support provided for the twelve months ended December 31, 2022. The sale of TEMBEXA constitutes a significant disposition of a business, however, the Company determined the disposition does not represent a strategic shift, and accordingly, the Company has not accounted for the disposition as a discontinued operation. The Company recorded a $229.7 million net gain on sale of business in other income (loss) on the Consolidated Statement of Operations and Comprehensive Income (Loss) for the twelve months ended December 31, 2022. The net gain consists of the following assets and liabilities transferred in accordance with the Asset Purchase Agreement (in thousands): As of September 26, 2022 Up-front cash payment $ 237,987 Liabilities assumed by Emergent 1,423 Inventory transferred to Emergent (5,227) Prepaids transferred to Emergent (511) Transaction costs incurred (4,002) Net gain $ 229,670 TEMBEXA Procurement Agreements In June 2022, the Company entered into a Supply Agreement (the Supply Agreement) with a third-party outside of North America (the Purchaser), pursuant to which the Company was responsible for supplying to the Purchaser, and the Purchaser was responsible for purchasing from the Company, TEMBEXA treatment courses for use in a jurisdiction outside of the United States. Under the terms of the Supply Agreement, the Purchaser paid the Company an aggregate purchase price of approximately $9.3 million, in two equal installments in June 2022 and July 2022. The Company recognized $9.3 million of procurement revenue under the Supply Agreement for the twelve months ended December 31, 2022. Additionally, in June 2022, the Public Health Agency of Canada (PHAC) awarded a Contract (PHAC Contract) to the Company, pursuant to which PHAC agreed to purchase up to approximately $25.3 million (CAD $33.0 million) of TEMBEXA treatment courses for use in Canada. Substantially all of the procurement was delivered and accepted by PHAC in July 2022, completing the performance obligation for those shipments and resulting in $22.6 million of procurement revenue for the twelve months ended December 31, 2022. PHAC assigned the PHAC Contract to Emergent in November 2022. The remaining deliveries of treatment courses were delivered by Emergent and are subject to the royalty terms of the Asset Purchase Agreement applicable to gross profits outside the United States. The Company recognized approximately $0.4 million of royalty revenue in the twelve months ended December 31, 2022. BARDA 2011 Research and Development Contract In February 2011, the Company entered into a contract with BARDA for the advanced development of TEMBEXA as a medical countermeasure in the event of a smallpox release. Under the contract, BARDA agreed to reimburse the Company, plus pay a fixed fee, for the research and development of TEMBEXA as a broad-spectrum therapeutic antiviral for the treatment of smallpox infections. The contract consists of an initial performance period, referred to as the base performance segment, plus up to four extension periods, referred to as option segments, of which all have been exercised. Under the contract, the Company received $72.5 million in expense reimbursement and $4.6 million in fees. The fourth option segment ended on September 1, 2021 and the contract has expired in accordance with its terms. For the years ended December 31, 2021 and 2020, the Company recognized contract revenue under this contract of $1.6 million and $5.3 million, respectively. Ohara Agreement In 2019, Oncoceutics, Inc., a Delaware corporation (Oncoceutics) which was subsequently acquired by the Company in January 2021, entered into a license, development and commercialization agreement with Ohara Pharmaceutical Co., Ltd. for ONC201 in Japan. The Company is entitled to receive up to $2.5 million in nonrefundable regulatory milestone payments. The Company is entitled to double-digit tiered royalties based on the aggregate annual net sales of all products, as defined in the agreement, in Japan. CR Sanjiu Agreement In December 2020, Oncoceutics entered into a license, development and commercialization agreement with China Resources Sanjiu Medical & Pharmaceutical Co., Ltd. (CR Sanjiu). Oncoceutics granted CR Sanjiu an exclusive royalty bearing license to develop and commercialize ONC201 in China, Hong Kong, Macau and Taiwan (CR Sanjiu Territory). The Company is entitled to receive up to $5.0 million in nonrefundable regulatory milestone payments. The Company is entitled to double-digit tiered royalties based on the aggregate annual net sales of all licensed products, as defined in the agreement, in the CR Sanjiu Territory. In May 2022, the Company made the decision to discontinue the development of DSTAT for the treatment of AML. Effective July 12, 2022, the Company terminated the License and Development Agreement with Cantex Pharmaceuticals, Inc. As a result, the Company recorded an accrual of expenses to close-out the DSTAT vendor contracts. As of December 31, 2022, on the Consolidated Balance Sheets, the Company has recorded $1.4 million of contract close-out costs in accrued liabilities offset by a vendor credit of $0.1 million in accounts payable, which included additional expense of $0.8 million recorded to research and development expenses for the twelve months ended December 31, 2022, on the Consolidated Statement of Operations after the decision to discontinue to the DSTAT program. These balances are expected to be fully paid over the first half of 2023. The following table summarizes the contract close-out costs (in thousands) recorded for the twelve months ended December 31, 2022: Contract Close-out Costs Research & development $ 791 General & administrative 8 Total contract close-out expenses $ 799 The following table sets forth the accounts payable and accrual activity for contract close-out costs (in thousands) for the twelve months ended December 31, 2022. Contract Close-out Costs Balance at June 30, 2022 $ 4,539 Revised estimates $ (746) Payments $ (2,482) Balance at December 31, 2022 $ 1,311 |
Oncoceutics Acquisition
Oncoceutics Acquisition | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Oncoceutics Acquisition | Oncoceutics Acquisition On January 7, 2021, we entered into an agreement to acquire Oncoceutics, a privately-held, clinical-stage biotechnology company developing imipridones, a novel potential class of compounds. As consideration for the acquisition, the Company (a) paid an upfront cash payment of approximately $25.0 million, (b) issued an aggregate of 8,723,769 shares of the Company's common stock, (c) made an additional cash payment of $14.0 million upon the one year anniversary of the closing of the acquisition, and (d) agreed to make contingent payments up to an aggregate of $360.0 million based on the achievement of certain development, regulatory and commercialization events, as well as additional tiered royalty payments based upon future net sales of ONC201 and ONC206 products, subject to certain reductions, and a contingent payment in the event we receive any proceeds from the sale of a rare pediatric disease priority review voucher based on the Oncoceutics products. Pursuant to the merger agreement we have certain diligence obligations with respect to further development and commercialization of the Oncoceutics product candidates. The promissory note totaling $14.0 million was paid to the Oncoceutics' shareholders in January 2022. A $20.0 million milestone payment was paid and expensed to research and development expenses in the fourth quarter of 2021 related to the achievement of the 20% ORR, evaluated by BICR, of ONC201 in recurrent H3 K27M-mutant glioma patients success milestone. The Company accounted for the Oncoceutics acquisition as an asset acquisition as the majority of the value of the assets acquired related to the ONC201 acquired in-process research and development (IPR&D) asset. In accordance with Accounting Standards Codification (ASC) Subtopic 730-10-25, Accounting for Research and Development Costs, the up-front payments to acquire a new drug compound, are immediately expensed as acquired IPR&D and future milestone payments are expensed to research and development expenses when paid or payable in transactions other than a business combination provided that the drug has not achieved regulatory approval for marketing and, absent obtaining such approval, has no alternative future use. Therefore, the portion of the purchase price that was allocated to the IPR&D assets acquired was immediately expensed. Other assets acquired and liabilities assumed, were recorded at fair value. The following represents the consideration paid and purchase price allocation for the acquisition of Oncoceutics (in thousands, except for per share data): Cash $ 23,836 One-year closing anniversary payment 14,000 Shares common stock issued as consideration 8,723,769 Stock price per share on effective date 4.98 Value of estimated common stock consideration 43,445 Total consideration $ 81,281 Net assets acquired $ (1,310) IPR&D assets expensed 82,591 Total purchase price allocated $ 81,281 Transaction costs expensed to IPR&D (1) $ 299 Total IPR&D expensed $ 82,890 |
Restructuring Costs
Restructuring Costs | 12 Months Ended |
Dec. 31, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Costs | Restructuring CostsIn December 2022, the Company made the decision to restructure its operations, which included a reduction in workforce of 20 full-time employees. The Company recorded expense for one-time employee termination benefits of $1.9 million, during the twelve months ended December 31, 2022, which includes $0.4 million of the total $1.0 million of stock compensation expense related to modifications of stock option agreements of employees included in the reduction in workforce that will be expenses ratably from the announcement date through the date of termination. As of December 31, 2022, the Company had a severance accrual balance of $1.4 million. The following table summarizes the restructuring charges (in thousands) recorded for the twelve months ended December 31, 2022: Employee Termination Benefits Research and development $ 1,768 General and administrative 86 Total restructuring expenses $ 1,854 |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2022 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent EventsThe Company has evaluated subsequent events through the issuance date of these financial statements to ensure that this filing includes appropriate disclosure of events both recognized in the financial statements as of December 31, 2022, and events which occurred subsequently but were not recognized in the financial statements. |
The Business and Summary of S_2
The Business and Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The consolidated financial statements include the accounts of the Company, and its wholly owned subsidiaries. The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP). The preparation of the Company’s consolidated financial statements requires estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities in the consolidated financial statements and accompanying notes. Although these estimates are based on knowledge of current events and actions the Company may undertake in the future, actual results may ultimately differ from these estimates and assumptions. |
Cash and Cash Equivalents | Cash and Cash Equivalents The Company considers any highly liquid instrument with an original maturity of three months or less at acquisition to be a cash equivalent. Cash equivalents consist of money market funds. |
Investments | Investments Investments consist primarily of commercial paper, corporate bonds, and U.S. Treasury securities. The Company invests in high-credit quality investments in accordance with its investment policy which minimizes the probability of loss. Available-for-sale debt securities are carried at fair value as determined by quoted market prices, with the unrealized gains and losses, net of tax, reported as a separate component of stockholders’ equity. Realized gains and losses are determined using the specific identification method and transactions are recorded on a settlement date basis in interest income and other, net. For the year ended December 31, 2022, approximately $1,000 of realized gains were reclassified from accumulated other comprehensive loss, net in the Consolidated Balance Sheets to interest income and other, net in the Consolidated Statements of Operations and Comprehensive Loss. Investments with original maturities beyond three months at the date of purchase and which mature on, or less than twelve months from, the balance sheet date are classified as short-term. Investments with a maturity beyond twelve months from the balance sheet date are classified as long-term. |
Concentration of Credit Risk | Concentration of Credit RiskFinancial instruments that potentially subject the Company to concentrations of credit risk consist of cash, cash equivalents, short-term investments, and long-term investments. The Company is exposed to credit risk, subject to federal deposit insurance, in the event of default by the financial institutions holding its cash and cash equivalents to the extent of amounts recorded on the balance sheets. |
Accounts Receivable | Accounts Receivable Accounts receivable at December 31, 2022 consisted of royalties earned on sales of TEMBEXA by Emergent and amounts billed under the Company’s grant agreements and transition services agreement with Emergent. Receivables are recorded as |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of certain financial instruments, including accounts receivable, accounts payable and accrued expenses approximate their fair values due to the short-term nature of such instruments. For assets and liabilities recorded at fair value, it is the Company’s policy to maximize the use of observable inputs and minimize the use of unobservable inputs when developing fair value measurements, in accordance with the fair value hierarchy. Fair value measurements for assets and liabilities where there exists limited or no observable market data are based primarily upon estimates and are often calculated based on the economic and competitive environment, the characteristics of the asset or liability and other factors. Therefore, fair value measurements cannot be determined with precision and may not be realized in an actual sale or immediate settlement of the asset or liability. Additionally, there may be inherent weaknesses in any calculation technique and changes in the underlying assumptions used, including discount rates and estimates of future cash flows, could significantly affect the calculated current or future fair values. The Company utilizes fair value measurements to record fair value adjustments to certain assets and liabilities and to determine fair value disclosures. The Company groups assets and liabilities at fair value in three levels, based on the markets in which the assets and liabilities are traded and the reliability of the assumptions used to determine fair value. The determination of where an asset or liability falls in the hierarchy requires significant judgment. These levels are: • Level 1 — Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. • Level 2 — Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active, and models for which all significant inputs are observable, either directly or indirectly. • Level 3 — Valuations based on inputs that are unobservable and significant to the overall fair value measurement. There was no material re-measurement to fair value of financial assets and liabilities that are not measured at fair value on a recurring basis. For additional information regarding the Company’s investments, please refer to Note 2, "Investments." |
Inventories | Inventories The Company considers regulatory approval of product candidates to be uncertain and product manufactured prior to regulatory approval may not be sold unless regulatory approval is obtained. As such, the manufacturing costs for product candidates incurred prior to regulatory approval are not capitalized as inventory but are expensed as research and development costs. The Company begins capitalization of these inventory related costs once regulatory approval is obtained. The Company primarily uses actual costs to determine its cost basis for inventories. On May 15, 2022, we entered into an Asset Purchase Agreement (the Asset Purchase Agreement) with an affiliate of Emergent BioSolutions Inc. (Emergent BioSolutions) for the sale of our exclusive worldwide rights to brincidofovir, including TEMBEXA® and specified related assets (the Asset Sale). On September 26, 2022, we closed the Asset Sale with Emergent Biodefense Operations Lansing LLC (Emergent), an affiliate of Emergent BioSolutions. Prior to the sale of TEMBEXA to Emergent, the Company’s inventory consisted of TEMBEXA, which was being manufactured for the treatment of smallpox for potential delivery to the Strategic National Stockpile (SNS) for the U.S. government and to other government agencies. TEMBEXA was approved by the FDA on June 4, 2021, at which time the Company began to capitalize inventory costs associated with TEMBEXA. Prior to FDA approval of TEMBEXA, all costs related to the manufacturing of TEMBEXA were charged to research and development expense in the period incurred as there was no alternative future use. The Company valued its inventories at the lower of cost or estimated net realizable value. The Company determined the cost of its inventories, which included amounts related to materials, manufacturing costs, shipping and handling costs on a first-in, first-out (FIFO) basis. Work-in-process included all inventory costs prior to packaging and labelling, including raw material, active product ingredient, and drug product. Finished goods included packaged and labelled products. Title to all inventory was transferred to Emergent upon the close of the Asset Sale (as defined below). |
Property and Equipment | Property and Equipment Property and equipment are stated at cost, less accumulated depreciation. Depreciation is determined on a straight-line basis over the estimated useful lives of the assets, which generally range from three |
Impairment of Property and Equipment | Impairment of Property and EquipmentThe Company evaluates property and equipment for impairment whenever events or changes in circumstances indicate that the carrying value of an asset may not be recoverable. If the estimated future cash flows (undiscounted and without interest charges) from the use of an asset are less than the carrying value, a write-down would be recorded to reduce the related asset to its estimated fair value. |
Leases | Leases At the inception of an arrangement, we determine if an arrangement is, or contains, a lease based on the unique facts and circumstances present in that arrangement. Lease classification, recognition, and measurement are then determined at the lease commencement date. For arrangements that contain a lease we (i) identify lease and non-lease components, (ii) determine the consideration in the contract, (iii) determine whether the lease is an operating or financing lease; and (iv) recognize lease right-of-use (ROU) assets and liabilities. Lease liabilities and their corresponding ROU assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable and as such, we use our incremental borrowing rate based on the information available at the lease commencement date, which represents an internally developed rate that would be incurred to borrow, on a collateralized basis, over a similar term, an amount equal to the lease payments in a similar economic environment. Most leases include options to renew and, or, terminate the lease, which can impact the lease term. The exercise of these options is at our discretion and we do not include any of these options within the expected lease term as we are not reasonably certain we will exercise these options. |
Revenue Recognition | Revenue Recognition Policy The Company’s revenues generally consist of (i) procurement revenue - revenue related to sales of TEMBEXA prior to the Asset Sale (ii) contract and grant revenue - revenue generated under federal and private foundation grants and contracts, (iii) licensing revenue - revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements, and (iv) royalty revenue - revenue related to sales of TEMBEXA made by Emergent after the Asset Sale. Revenue is recognized in accordance with the criteria outlined in Accounting Standards Codification (ASC) 606 issued by the Financial Accounting Standards Board (FASB). Following this accounting pronouncement, a five-step approach is applied for recognizing revenue, including (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to the performance obligations in the contract; and (5) recognize revenue when, or as, the entity satisfies a performance obligation. |
Research and Development Prepaids and Accruals | Research and Development Prepaids and Accruals As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its research and development efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate research and development expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of its research and development efforts. The Company determines prepaid and accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of communication of clinical trials, or other services completed. The Company adjusts its rate of research and development expense recognition if actual results differ from its estimates. The Company makes estimates of its prepaid and accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. Through December 31, 2022, there had been no material adjustments to the Company’s prior period estimates of prepaid and accruals for research and development expenses. The Company’s research and development prepaids and accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. |
Research and Development Expenses | Research and Development Expenses Major components of research and development costs include cash compensation, stock-based compensation, preclinical studies, clinical trial and related clinical manufacturing, drug development, materials and supplies, legal, regulatory compliance, and fees paid to consultants and other entities that conduct certain research and development activities on the Company’s behalf. Research and development costs, including upfront fees and milestones paid to contract research organizations, are expensed as goods are received or services rendered. Costs incurred in connection with clinical trial activities for which the underlying nature of the activities themselves do not directly relate to active research and development, such as costs incurred for market research and focus groups linked to clinical strategy as well as costs to build the Company’s brand, are not included in research and development costs but are reflected as general and administrative costs. |
Interest Income and Other, Net | Interest Income and Other, Net Interest income and other, net consists primarily of interest earned on our cash, cash equivalents and short-term and long-term investments. |
Income Taxes | Income Taxes Deferred tax assets and liabilities are determined based on differences between the financial and tax reporting bases of assets and liabilities and are measured using enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. Valuation allowances are established when the Company determines that it is more likely than not that some portion of a deferred tax asset will not be realized. The Company has incurred operating losses from April 7, 2000 (inception) through December 31, 2021, and therefore has not recorded any current provision for income taxes. For the year ended December 31, 2022, the Company recorded net income and is expecting a small amount of state income tax expense. As such the Company has recorded a provision for current state income taxes. Additionally, the Company recognizes the tax benefit from an uncertain tax position only if it is more likely than not that the tax position will be sustained on examination by the taxing authorities based on the technical merits of the position. The tax benefit recognized in the financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement. Accordingly, the Company establishes reserves for uncertain tax positions. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income (GILTI), states that an entity can make an accounting policy election to either recognized deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI as a period expense in the year the tax is incurred. |
Share-Based Compensation | Share-Based Compensation The Company measures and recognizes compensation expense for all share-based payment awards made to employees and directors, including employee stock options, restricted stock units and the employee stock purchase plan purchase rights, based on estimated fair values. The fair value of employee stock options and employee stock purchase plan purchase rights is estimated on the grant date using the Black-Scholes valuation model. The grant-date fair value for restricted stock units is based upon the market price of the Company’s common stock on the date of the grant. The value of the portion of the award that is ultimately expected to vest is recorded as expense over the requisite service periods. For performance-based awards compensation cost is recognized when it is probable that the performance criteria will be met. The Company estimates forfeitures at the time of grant and revises those estimates in subsequent periods if actual forfeitures differ from its estimates. The Company uses historical data to estimate forfeitures and records share-based compensation expense only for those awards that are expected to vest. To the extent that actual forfeitures differ from the Company’s estimates, the difference is recorded as a cumulative adjustment in the period the estimates were revised. For the years ended December 31, 2022, 2021 and 2020, the Company applied a forfeiture rate based on the Company’s historical forfeitures. |
401(k) Plan | 401(k) PlanThe Company maintains a defined contribution employee retirement plan (401(k) plan). |
Basic and Dilutive Net Loss Per Share of Common Stock | Basic and Dilutive Net Loss Per Share of Common Stock Basic net income (loss) per share of common stock is computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding during the period, excluding the dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights. Diluted net income (loss) per share of common stock is computed by dividing net income (loss) by the sum of the weighted-average number of shares of common stock outstanding during the period plus the potential dilutive effects of non-vested restricted stock, stock options, and employee stock purchase plan purchase rights outstanding during the period calculated in accordance with the treasury stock method, but are excluded if their effect is anti-dilutive. For the twelve months ended December 31, 2022, the diluted per-share computations reflect the number of additional common stock outstanding that would have been outstanding if the potentially dilutive common stock had been issued. Because the impact of these items is anti-dilutive during the periods of net loss, there was no difference between basic and diluted loss per share of common stock for the twelve months ended December 31, 2021 and 2020. |
Segments | SegmentsThe Company operates in only one segment, pharmaceuticals. |
Impact of Recently Issued Accounting Standards | Impact of Recently Issued Accounting Standards In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments |
The Business and Summary of S_3
The Business and Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Accounting Policies [Abstract] | |
Assets and Liabilities Measured at Fair Value on a Recurring Basis | Below is a table that presents information about certain assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements December 31, 2022 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 17,826 $ 17,826 $ — $ — Commercial paper 4,998 — 4,998 — Total cash equivalents 22,824 17,826 4,998 — Short-term investments U.S. Treasury securities 38,094 25,271 12,823 — Commercial paper 127,517 — 127,517 — Corporate bonds 25,881 — 25,881 — Total short-term investments 191,492 25,271 166,221 — Long-term investments U.S. Treasury securities 48,626 11,685 36,941 — Total long-term investments 48,626 11,685 36,941 — Total assets $ 262,942 $ 54,782 $ 208,160 $ — Fair Value Measurements December 31, 2021 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 11,841 $ 11,841 $ — $ — Total cash equivalents 11,841 11,841 — — Short-term investments U.S. Treasury securities 7,517 2,523 4,994 — Commercial paper 34,887 — 34,887 — Corporate bonds 30,566 — 30,566 — Total short-term investments 72,970 2,523 70,447 — Long-term investments U.S. Treasury securities 2,022 2,022 — — Total long-term investments 2,022 2,022 — — Total assets $ 86,833 $ 16,386 $ 70,447 $ — |
Schedule of Prepaid and Other Current Assets | Prepaid expenses and other current assets consisted of the following (in thousands): December 31, 2022 2021 Prepaid research and development expenses $ 3,399 $ 1,726 Interest receivable 643 348 Prepaid insurance 564 450 Other prepaid expenses and current assets 5,158 2,154 Total prepaid expenses and other current assets $ 9,764 $ 4,678 |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): December 31, 2022 2021 Accrued compensation $ 6,438 $ 5,491 Accrued research and development expenses 6,691 4,642 Other accrued liabilities 4,252 2,975 Total accrued liabilities $ 17,381 $ 13,108 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments [Abstract] | |
Summary of Short-term and Long-term Investments | The following tables summarize the Company’s short-term and long-term debt investments (in thousands): December 31, 2022 Amortized Cost Gross Unrealized Gross Unrealized Estimated Corporate bonds $ 25,906 $ 4 $ (29) $ 25,881 Commercial paper 127,657 36 (176) 127,517 U.S. Treasury securities 86,892 7 (179) 86,720 Total investments $ 240,455 $ 47 $ (384) $ 240,118 December 31, 2021 Amortized Cost Gross Unrealized Gross Unrealized Estimated Corporate bonds $ 30,571 $ 2 $ (7) $ 30,566 Commercial paper 34,890 2 (5) 34,887 U.S. Treasury securities 9,552 — (13) 9,539 Total investments $ 75,013 $ 4 $ (25) $ 74,992 |
Debt Securities, Available-for-Sale, Unrealized Loss Position, Fair Value | The following tables summarize the Company’s debt investments with unrealized losses, aggregated by investment type and the length of time that individual investments have been in a continuous unrealized loss position (in thousands, except number of securities): December 31, 2022 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 22,905 $ (29) $ — $ — $ 22,905 $ (29) Commercial paper 88,860 (176) — — 88,860 (176) U.S. Treasury securities 67,489 (179) — — 67,489 (179) Total $ 179,254 $ (384) $ — $ — $ 179,254 $ (384) Number of securities with unrealized losses 55 — 55 December 31, 2021 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 28,362 $ (7) $ — $ — $ 28,362 $ (7) Commercial paper 8,991 (5) — — 8,991 (5) U.S. Treasury securities 9,539 (13) — — 9,539 (13) Total $ 46,892 $ (25) $ — $ — $ 46,892 $ (25) Number of securities with unrealized losses 18 — 18 |
Summary of the Scheduled Maturity of Company Investments | The following table summarizes the scheduled maturity for the Company’s debt investments at December 31, 2022 (in thousands): December 31, 2022 Maturing in one year or less $ 191,492 Maturing after one year through two years 48,626 Total debt investments $ 240,118 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Summary of Property and Equipment, net | Property and equipment, net of accumulated depreciation consisted of the following (in thousands): December 31, 2022 2021 Lab equipment $ 2,299 $ 2,341 Leasehold improvements 1,713 1,713 Computer equipment 817 817 Office furniture and equipment 520 520 Property and equipment 5,349 5,391 Less accumulated depreciation (5,122) (5,138) Property and equipment, net of accumulated depreciation $ 227 $ 253 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Operating Lease Right-of-Use Assets and Liabilities | The following table sets forth the operating lease right-of-use assets and liabilities as of December 31, 2022 (in thousands): Assets Operating Lease Right-of-Use Assets $ 1,964 Liabilities Operating Lease Short-term Liabilities (recorded within Accrued liabilities) $ 573 Operating Lease Long-term Liabilities (recorded within Lease-related obligations) 1,819 Total Operating Lease Liabilities $ 2,392 |
Operating Lease Maturity | Operating lease payments over the remainder of the lease terms are as follows (in thousands): Years Ending December 31, As of December 31, 2022 2023 736 2024 759 2025 781 2026 467 Total future minimum rental payments $ 2,743 Less amount of lease payments representing interest 351 Total present value of lease payments $ 2,392 |
Stockholders' Equity (Deficit)
Stockholders' Equity (Deficit) (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Stockholders' Equity Note [Abstract] | |
Schedule of Shares Reserved for Future Issuance | The Company has reserved shares of common stock for future issuances as follows: December 31, 2022 2021 For exercise of outstanding common stock options 15,076,365 11,649,594 For delivery upon vesting of outstanding restricted stock units 920,533 896,222 For future equity awards under the 2013 Equity Incentive Plan 1,466,603 2,076,923 For future purchases under the 2013 Employee Stock Purchase Plan 2,186,097 2,298,817 Total shares of common stock reserved for future issuances 19,649,598 16,921,556 |
Schedule of Fair Value Assumptions, Stock Options | The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the stock options granted: Years Ended December 31, 2022 2021 2020 Expected volatility 74.27 % 95.84 % 93.24 % Expected term (in years) 6.0 6.0 6.0 Weighted-average risk-free interest rate 1.91 % 0.71 % 1.24 % Expected dividend yield — % — % — % Weighted-average fair value per option $ 3.33 $ 6.67 $ 1.78 |
Summary of Activity Related to Stock Options | A summary of activity related to the Company’s stock options is as follows: Number of Options Weighted-Average Weighted-Average Total Intrinsic Value Balance, December 31, 2020 8,913,271 $ 5.28 7.52 Granted 3,903,750 8.74 — Exercised (909,997) 4.69 — Forfeited (257,432) 15.12 — Balance, December 31, 2021 11,649,592 $ 6.27 7.65 Granted 4,217,275 5.12 — Exercised (271,079) 2.24 — Forfeited (519,423) 6.93 — Balance, December 31, 2022 15,076,365 $ 6.00 7.32 $ 64,174 Exercisable at December 31, 2022 9,192,591 $ 6.14 6.59 $ 42,393 Vested or expected to vest at December 31, 2022 14,204,938 $ 6.00 7.25 $ 61,673 |
Schedule of Other Information Regarding Stock Options | Other information regarding the Company’s stock options is as follows (in thousands, except per share data): Years Ended December 31, 2022 2021 2020 Weighted-average grant-date fair value per share of options granted $ 3.33 $ 6.67 $ 1.78 Total intrinsic value of options exercised $ 114 $ 3,496 $ 355 Total fair value of shares vested $ 12,721 $ 8,642 $ 4,188 |
Schedule of Share-based Compensation, Shares Authorized | The following table summarizes, at December 31, 2022, by price range: (1) for stock option awards outstanding under the 2013 Plan, the number of stock option awards outstanding, their weighted-average remaining life and their weighted-average exercise price; and (2) for stock option awards exercisable under the 2013 Plan, the number of stock option awards exercisable and their weighted-average exercise price: Outstanding Exercisable Exercise Price Range ($) Number Weighted-Average Remaining Contractual Life (in years) Weighted-Average Exercise Price Number Weighted-Average Exercise Price 1.37 to 2.08 2,418,541 7.42 $ 2.00 1,655,079 $ 2.01 2.09 to 3.13 3,260,545 6.71 2.35 2,707,469 2.34 3.14 to 5.60 1,547,105 5.91 4.64 1,326,771 4.63 5.61 to 7.86 3,918,679 8.98 5.81 1,120,141 6.17 7.87 to 53.74 3,931,495 6.67 12.20 2,383,131 14.14 1.37 to 53.74 15,076,365 7.32 $ 6.00 9,192,591 $ 6.14 |
Schedule of Fair Value Assumptions, Employee Stock Purchase Plan | The following table illustrates the assumptions for the Black-Scholes model used in determining the fair value of the ESPP purchase rights: Years Ended December 31, 2022 2021 2020 Expected volatility 104.88 % 97.54 % 75.39 % Expected term (in years) 1.28 0.71 1.28 Weighted-average risk-free interest rate 2.63 % 0.25 % 0.37 % Expected dividend yield — % — % — % Weighted-average option value per share $ 1.97 $ 6.55 $ 0.93 |
Summary of Activity Related to Restricted Stock Units | A summary of activity related to the Company’s RSUs is as follows: Number of Restricted Weighted-Average Grant-Date Fair Value Balance, December 31, 2021 896,222 $ 3.98 Granted 451,250 5.24 Share issuance (363,527) 3.46 Forfeited (63,412) 3.83 Balance, December 31, 2022 920,533 $ 4.82 |
Schedule of Employee Service Share-based Compensation, Allocation of Recognized Period Costs | For awards with only service conditions and graded-vesting features, the Company recognizes compensation expense on a straight-line basis over the requisite service period. Total stock-based compensation expense was as follows (in thousands): Years Ended December 31, 2022 2021 2020 Income Statement Classification: Research and development expense $ 8,267 $ 6,611 $ 2,969 General and administrative expense 7,018 5,649 2,599 Total stock-based compensation expense $ 15,285 $ 12,260 $ 5,568 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Income Tax Disclosure [Abstract] | |
Schedule of Components of Income Tax Expense | The provision for income tax expense includes the following as of December 31, 2022, 2021, and 2020: December 31, 2022 2021 2020 Current: Federal $ — $ — $ — State 36 — — Total 36 — — Deferred: Federal — — — State — — — Total — — — Total Tax Expense $ 36 $ — $ — |
Reconciliation of the Difference between the Benefit for Income Taxes and Income Taxes at the Statutory U.S. Federal Income Tax Rate | A reconciliation of the difference between the benefit for income taxes and income taxes at the statutory U.S. federal income tax rate is as follows for the years ended December 31, 2022, 2021, and 2020 (in thousands, except percentages): 2022 2021 2020 Amount % of Pretax Amount % of Pretax Amount % of Pretax Income tax benefit at statutory rate $ 36,163 21.0 % $ (36,379) 21.0 % $ (9,140) 21.0 % State income taxes 441 0.2 % (8,060) 4.7 % (138) 0.3 % Research and development credits (3,312) (1.9) % (1,565) 0.9 % (1,088) 2.5 % In process R&D — — % 26,395 (15.2) % — — % Permanent items 1,135 0.7 % 711 (0.4) % 505 (1.2) % Provision to return adjustments 1,091 0.6 % 126 (0.1) % 81 (0.2) % Effect of change in federal tax rate — — % — — % — — % Effect of change in state tax rate 4,405 2.6 % 3,478 (2.0) % 1,139 (2.6) % Removal of excess tax benefit — — % — — % — — % Increase in unrecognized tax benefits 828 0.5 % 439 (0.3) % 272 (0.6) % Current year forfeitures 54 — % 435 (0.3) % 4,026 (9.2) % Change in valuation allowance (40,769) (23.7) % 14,420 (8.3) % 4,343 (10.0) % Net benefit $ 36 — % $ — — % $ — — % |
Components of Deferred Tax Assets and Liabilities | The components of deferred tax assets and liabilities at December 31, 2022 and 2021 were as follows (in thousands): December 31, 2022 2021 Deferred tax assets: Domestic net operating loss carryforwards $ 84,147 $ 138,548 Research and development expenses 1,520 1,191 Capitalized Section 174 expenses 12,425 — License fees 11,509 14,131 Research and development credits 20,166 17,738 Capital loss carryforwards 428 484 Accrued bonuses 722 888 Share-based compensation 6,132 4,885 Other 1,333 1,457 Total gross deferred tax assets 138,382 179,322 Valuation allowance (137,936) (178,705) Total deferred tax assets 446 617 Deferred tax liabilities: Right-of-use asset (446) (617) Total deferred tax liabilities (446) (617) Total deferred tax assets and liabilities, net $ — $ — |
Summary of Uncertain Tax Benefit | Therefore, the Company recognized an uncertain tax benefit associated with the federal R&D credit carryover during the years ended December 31, 2022 and 2021, as follows (in thousands): Balance at December 31, 2020 $ 4,295 Increases related to 2021 391 Increases related to prior periods 48 Balance at December 31, 2021 4,734 Increases related to 2022 828 Increases related to prior periods — Balance at December 31, 2022 $ 5,562 |
Commitment and Contingencies (T
Commitment and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule Of Net Gain From The Sales Of Assets | The net gain consists of the following assets and liabilities transferred in accordance with the Asset Purchase Agreement (in thousands): As of September 26, 2022 Up-front cash payment $ 237,987 Liabilities assumed by Emergent 1,423 Inventory transferred to Emergent (5,227) Prepaids transferred to Emergent (511) Transaction costs incurred (4,002) Net gain $ 229,670 |
DSTAT Contract Close-out (Table
DSTAT Contract Close-out (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Investments, All Other Investments [Abstract] | |
Schedule Of Contract Close-Out Costs | The following table summarizes the contract close-out costs (in thousands) recorded for the twelve months ended December 31, 2022: Contract Close-out Costs Research & development $ 791 General & administrative 8 Total contract close-out expenses $ 799 The following table sets forth the accounts payable and accrual activity for contract close-out costs (in thousands) for the twelve months ended December 31, 2022. Contract Close-out Costs Balance at June 30, 2022 $ 4,539 Revised estimates $ (746) Payments $ (2,482) Balance at December 31, 2022 $ 1,311 |
Oncoceutics Acquisition (Tables
Oncoceutics Acquisition (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Business Combination and Asset Acquisition [Abstract] | |
Asset Acquisition | The following represents the consideration paid and purchase price allocation for the acquisition of Oncoceutics (in thousands, except for per share data): Cash $ 23,836 One-year closing anniversary payment 14,000 Shares common stock issued as consideration 8,723,769 Stock price per share on effective date 4.98 Value of estimated common stock consideration 43,445 Total consideration $ 81,281 Net assets acquired $ (1,310) IPR&D assets expensed 82,591 Total purchase price allocated $ 81,281 Transaction costs expensed to IPR&D (1) $ 299 Total IPR&D expensed $ 82,890 |
Restructuring Costs (Tables)
Restructuring Costs (Tables) | 12 Months Ended |
Dec. 31, 2022 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Costs | The following table summarizes the restructuring charges (in thousands) recorded for the twelve months ended December 31, 2022: Employee Termination Benefits Research and development $ 1,768 General and administrative 86 Total restructuring expenses $ 1,854 |
The Business and Summary of S_4
The Business and Summary of Significant Accounting Policies (Narrative) (Details) | 1 Months Ended | 12 Months Ended | ||||||||||
Sep. 26, 2022 USD ($) | Aug. 26, 2022 USD ($) treatment | Jan. 31, 2022 USD ($) installment | Jul. 31, 2022 USD ($) | Feb. 28, 2011 USD ($) | Feb. 28, 2011 segment | Feb. 28, 2011 contract | Feb. 28, 2011 extension | Dec. 31, 2022 USD ($) segment | Dec. 31, 2021 USD ($) shares | Dec. 31, 2020 USD ($) shares | Dec. 31, 2019 USD ($) | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Interest income and other, net | $ 2,919,000 | $ 164,000 | $ 994,000 | |||||||||
Accumulated other comprehensive loss, net | 337,000 | 21,000 | ||||||||||
Employee retention credit | 2,000,000 | |||||||||||
Research and development | (71,631,000) | (73,817,000) | (36,232,000) | |||||||||
General and administrative expenses | (22,132,000) | (18,672,000) | (13,656,000) | |||||||||
Proceeds from tax refund | 27,000 | |||||||||||
Loan Fees | 250,000 | 0 | ||||||||||
Impairment of long-lived assets | 0 | 0 | ||||||||||
Revenues | 33,824,000 | 1,979,000 | 5,372,000 | |||||||||
Up-front cash payment | 233,984,000 | 0 | 0 | |||||||||
Gain on sale of business, net | 229,670,000 | 0 | 0 | |||||||||
Defined contribution plan, cost recognized | $ 500,000 | $ 400,000 | $ 300,000 | |||||||||
Antidilutive shares excluded from earnings per share calculation (in shares) | shares | 4,672,859 | 1,162,161 | ||||||||||
Number of operating segments | segment | 1 | |||||||||||
BARDA | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Revenues | $ 1,600,000 | $ 5,300,000 | ||||||||||
Number of base segments | segment | 1 | |||||||||||
Number of option segments | 4 | 4 | ||||||||||
Number of contracts | contract | 5 | |||||||||||
Emergent BioSolutions, Inc. | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Up-front cash payment | $ 237,987,000 | |||||||||||
Gain on sale of business, net | $ 229,670,000 | $ 229,700,000 | ||||||||||
Revenue recognized | 500,000 | |||||||||||
Ohara Pharmaceutical Co., Ltd. | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
License agreement, nonrefundable regulatory milestone payment to be received | $ 2,500,000 | |||||||||||
TEMBEXA | Emergent BioSolutions, Inc. | Base Period | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Up-front cash payment | $ 238,000,000 | |||||||||||
Quantity royalty rate, trigger (treatments) | treatment | 1,700,000 | |||||||||||
TEMBEXA | Emergent BioSolutions, Inc. | Base Period | Non- United States | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Gross profit royalty rate (percent) | 15% | |||||||||||
TEMBEXA | Emergent BioSolutions, Inc. | Base Period | Federal | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Gross profit royalty rate (percent) | 20% | |||||||||||
Expense Reimbursement | BARDA | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Revenues | $ 72,500,000 | |||||||||||
Fees | BARDA | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Revenues | $ 4,600,000 | |||||||||||
Grant | Oncoceutics, Inc. | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Revenues | 500,000 | 400,000 | ||||||||||
Contract with customer, asset, after allowance for credit loss | 200,000 | |||||||||||
Royalty revenue | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Revenues | 375,000 | 0 | 0 | |||||||||
Contract and grant revenue | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Revenues | 942,000 | 1,928,000 | 5,274,000 | |||||||||
Licensing revenue | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Revenues | 536,000 | 51,000 | $ 98,000 | |||||||||
Licensing revenue | Ohara Pharmaceutical Co., Ltd. | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Revenues | 500,000 | $ 47,000 | ||||||||||
Public Health Agency Of Canada | TEMBEXA | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Revenues | $ 22,600,000 | $ 32,000,000 | ||||||||||
Minimum | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Property and equipment, useful life | 3 years | |||||||||||
Maximum | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Property and equipment, useful life | 5 years | |||||||||||
Revolving Credit Facility | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Debt instrument, term | 4 years | |||||||||||
Loan and security agreement, maximum capacity | $ 50,000,000 | |||||||||||
Debt instrument, interest rate, stated percentage | 4.75% | |||||||||||
Line of credit facility, unused capacity, commitment fee percentage | 25% | |||||||||||
Debt instrument, early termination fee | $ 500,000 | |||||||||||
Commitment fee | $ 500,000 | |||||||||||
Number of installment payments (installment) | installment | 4 | |||||||||||
Deferred loan cost, current | $ 100,000 | |||||||||||
Deferred loan cost, non-current | 300,000 | |||||||||||
Loan fees liability, current | 200,000 | |||||||||||
Loan Fees | 300,000 | |||||||||||
Revolving Credit Facility | Prime Rate | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Debt instrument, basis spread on variable rate | 1.50% | |||||||||||
Scenario, Adjustment | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Interest income and other, net | 1,000 | |||||||||||
Accumulated other comprehensive loss, net | 1,000 | |||||||||||
Research and development | 1,500,000 | |||||||||||
General and administrative expenses | $ 500,000 | |||||||||||
Scenario, Plan | SymBio Pharmaceuticals | ||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||||||||||
Contract with customer, asset, after allowance for credit loss | $ 12,500,000 |
The Business and Summary of S_5
The Business and Summary of Significant Accounting Policies (Assets and Liabilities Measured at Fair Value on a Recurring Basis) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | $ 191,492 | $ 72,970 |
Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 22,824 | 11,841 |
Short-term investments, available-for-sale | 191,492 | 72,970 |
Long-term investments | 48,626 | 2,022 |
Total assets | 262,942 | 86,833 |
Fair value, measurements, recurring | U.S. Treasury securities | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 38,094 | 7,517 |
Long-term investments | 48,626 | 2,022 |
Fair value, measurements, recurring | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 127,517 | 34,887 |
Fair value, measurements, recurring | Corporate bonds | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 25,881 | 30,566 |
Fair value, measurements, recurring | Money market funds | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 17,826 | 11,841 |
Fair value, measurements, recurring | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 4,998 | |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 17,826 | 11,841 |
Short-term investments, available-for-sale | 25,271 | 2,523 |
Long-term investments | 11,685 | 2,022 |
Total assets | 54,782 | 16,386 |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | U.S. Treasury securities | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 25,271 | 2,523 |
Long-term investments | 11,685 | 2,022 |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Corporate bonds | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market funds | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 17,826 | 11,841 |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 0 | |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 4,998 | 0 |
Short-term investments, available-for-sale | 166,221 | 70,447 |
Long-term investments | 36,941 | 0 |
Total assets | 208,160 | 70,447 |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | U.S. Treasury securities | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 12,823 | 4,994 |
Long-term investments | 36,941 | 0 |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 127,517 | 34,887 |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | Corporate bonds | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 25,881 | 30,566 |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | Money market funds | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 0 | 0 |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 4,998 | |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 0 | 0 |
Short-term investments, available-for-sale | 0 | 0 |
Long-term investments | 0 | 0 |
Total assets | 0 | 0 |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | U.S. Treasury securities | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Long-term investments | 0 | 0 |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | Corporate bonds | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | Money market funds | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 0 | $ 0 |
Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | Commercial paper | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | $ 0 |
The Business and Summary of S_6
The Business and Summary of Significant Accounting Policies (Schedule of Prepaid and Other Current Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Prepaid Expense and Other Assets, Current | ||
Prepaid research and development expenses | $ 3,399 | $ 1,726 |
Interest receivable | 643 | 348 |
Prepaid insurance | 564 | 450 |
Other prepaid expenses and current assets | 5,158 | 2,154 |
Total prepaid expenses and other current assets | $ 9,764 | $ 4,678 |
The Business and Summary of S_7
The Business and Summary of Significant Accounting Policies (Schedule of Accrued Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Accrued Liabilities, Current | ||
Accrued compensation | $ 6,438 | $ 5,491 |
Accrued research and development expenses | 6,691 | 4,642 |
Other accrued liabilities | 4,252 | 2,975 |
Total accrued liabilities | $ 17,381 | $ 13,108 |
Investments - Summary of Availa
Investments - Summary of Available-for-Sale Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Schedule of Investments | ||
Amortized Cost | $ 240,455 | $ 75,013 |
Gross Unrealized Gains | 47 | 4 |
Gross Unrealized Losses | (384) | (25) |
Estimated Fair Value | 240,118 | 74,992 |
Corporate bonds | ||
Schedule of Investments | ||
Amortized Cost | 25,906 | 30,571 |
Gross Unrealized Gains | 4 | 2 |
Gross Unrealized Losses | (29) | (7) |
Estimated Fair Value | 25,881 | 30,566 |
Commercial paper | ||
Schedule of Investments | ||
Amortized Cost | 127,657 | 34,890 |
Gross Unrealized Gains | 36 | 2 |
Gross Unrealized Losses | (176) | (5) |
Estimated Fair Value | 127,517 | 34,887 |
U.S. Treasury securities | ||
Schedule of Investments | ||
Amortized Cost | 86,892 | 9,552 |
Gross Unrealized Gains | 7 | 0 |
Gross Unrealized Losses | (179) | (13) |
Estimated Fair Value | $ 86,720 | $ 9,539 |
Investments - Summary of Invest
Investments - Summary of Investments with Unrealized Losses, Aggregated by Investment Type and the Length of Time (Details) $ in Thousands | Dec. 31, 2022 USD ($) security | Dec. 31, 2021 USD ($) security |
Schedule of Investments | ||
Fair value, less than 12 months | $ 179,254 | $ 46,892 |
Unrealized loss, less than 12 months | (384) | (25) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 179,254 | 46,892 |
Unrealized loss, total | $ (384) | $ (25) |
Number of securities with unrealized losses, less than 12 months | security | 55 | 18 |
Number of securities with unrealized losses, greater than 12 months | security | 0 | 0 |
Number of securities with unrealized losses, total | security | 55 | 18 |
Corporate bonds | ||
Schedule of Investments | ||
Fair value, less than 12 months | $ 22,905 | $ 28,362 |
Unrealized loss, less than 12 months | (29) | (7) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 22,905 | 28,362 |
Unrealized loss, total | (29) | (7) |
Commercial paper | ||
Schedule of Investments | ||
Fair value, less than 12 months | 88,860 | 8,991 |
Unrealized loss, less than 12 months | (176) | (5) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 88,860 | 8,991 |
Unrealized loss, total | (176) | (5) |
U.S. Treasury securities | ||
Schedule of Investments | ||
Fair value, less than 12 months | 67,489 | 9,539 |
Unrealized loss, less than 12 months | (179) | (13) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 67,489 | 9,539 |
Unrealized loss, total | $ (179) | $ (13) |
Investments - Available for Sal
Investments - Available for Sale Securities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Investments [Abstract] | ||
Maturing in one year or less | $ 191,492 | |
Maturing after one year through two years | 48,626 | |
Total debt investments | $ 240,118 | $ 74,992 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment, Net | ||
Property and equipment | $ 5,349 | $ 5,391 |
Less accumulated depreciation | (5,122) | (5,138) |
Property and equipment, net of accumulated depreciation | 227 | 253 |
Lab equipment | ||
Property, Plant and Equipment, Net | ||
Property and equipment | 2,299 | 2,341 |
Leasehold improvements | ||
Property, Plant and Equipment, Net | ||
Property and equipment | 1,713 | 1,713 |
Computer equipment | ||
Property, Plant and Equipment, Net | ||
Property and equipment | 817 | 817 |
Office furniture and equipment | ||
Property, Plant and Equipment, Net | ||
Property and equipment | $ 520 | $ 520 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) ft² | |
Commitments and Contingencies Disclosure [Abstract] | ||
Weighted average remaining lease term | 3 years 6 months 29 days | |
Lease expense under operating leases | $ 700 | $ 700 |
Weighted average discount rate | 7.89% | |
Lease payments | $ 600 | $ 500 |
Area of sublease space (in sq ft) | ft² | 3,537 | |
Sublease income | $ 12 | |
BARDA | Refundable Agreements | ||
Disaggregation of Revenue | ||
Provision for refundable amounts | $ 100 | $ 100 |
Commitments and Contingencies_2
Commitments and Contingencies - Operating Lease Right-of-Use Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
ASSETS | ||
Operating Lease Right-of-Use Assets | $ 1,964 | $ 2,404 |
Liabilities | ||
Operating Lease Short-term Liabilities (recorded within Accrued liabilities) | 573 | |
Operating Lease Long-term Liabilities (recorded within Lease-related obligations) | 1,819 | $ 2,392 |
Total Operating Lease Liabilities | $ 2,392 | |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Liability | Liability |
Commitments and Contingencies_3
Commitments and Contingencies - Maturity Analysis of Operating Lease Liabilities (Details) $ in Thousands | Dec. 31, 2022 USD ($) |
Years Ending December 31, | |
2023 | $ 736 |
2024 | 759 |
2025 | 781 |
2026 | 467 |
Total future minimum rental payments | 2,743 |
Less amount of lease payments representing interest | 351 |
Total Operating Lease Liabilities | $ 2,392 |
Stockholders' Equity (Deficit_2
Stockholders' Equity (Deficit) (Narrative) (Details) - USD ($) | 1 Months Ended | 12 Months Ended | ||||||
Jan. 20, 2021 | Dec. 31, 2022 | Apr. 30, 2019 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2022 | Aug. 10, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Common stock, shares authorized (in shares) | 200,000,000 | 200,000,000 | 200,000,000 | |||||
Common stock, shares issued (in shares) | 88,054,127 | 88,054,127 | 86,884,266 | |||||
Common stock, shares outstanding (in shares) | 88,054,127 | 88,054,127 | 86,884,266 | |||||
Shares reserved for future issuance (in shares) | 19,649,598 | 19,649,598 | 16,921,556 | |||||
Liability | $ 17,381,000 | $ 17,381,000 | $ 13,108,000 | |||||
Proceeds from exercise of all share-based payment arrangements | 1,500,000 | 4,600,000 | $ 1,400,000 | |||||
Anticipated severance cost | 1,000,000 | 1,000,000 | ||||||
Tax benefit from share-based payment arrangements | 0 | $ 0 | $ 0 | |||||
One-time employee termination benefits | $ 400,000 | $ 1,854,000 | ||||||
Employee stock option | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Shares reserved for future issuance (in shares) | 15,076,365 | 15,076,365 | 11,649,594 | |||||
Restricted stock units (RSUs) | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Unrecognized compensation costs, period of recognition | 2 years 3 months 21 days | |||||||
Shares reserved for future issuance (in shares) | 920,533 | 920,533 | 896,222 | |||||
Shares issued pursuant to vesting of RSUs (in shares) | 363,527 | 430,002 | ||||||
Unrecognized compensation costs | $ 3,600,000 | $ 3,600,000 | ||||||
Public Offering | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Sale of common stock, amount authorized | $ 250,000,000 | $ 75,000,000 | ||||||
Sales of stock, authorization term | 3 years | |||||||
Public Stock Offering | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Common stock sold (in shares) | 11,765,000 | |||||||
Common stock sold (in dollars per share) | $ 8.50 | |||||||
Sale of common stock, net offering proceeds | $ 107,800,000 | |||||||
Underwriter's Option | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Common stock sold (in dollars per share) | $ 7.99 | |||||||
Year One | Chief Executive Officer | Employee stock option | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Vesting percentage | 25% | |||||||
Year Two | Chief Executive Officer | Employee stock option | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Vesting percentage | 25% | |||||||
Year Three | Chief Executive Officer | Employee stock option | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Vesting percentage | 25% | |||||||
Year Four | Chief Executive Officer | Employee stock option | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Vesting percentage | 25% | |||||||
The 2013 Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Unrecognized compensation costs | $ 19,600,000 | $ 19,600,000 | ||||||
Unrecognized compensation costs, period of recognition | 2 years 4 months 20 days | |||||||
Shares reserved for future issuance (in shares) | 1,466,603 | 1,466,603 | 2,076,923 | |||||
The 2013 Employee Stock Purchase Plan | ||||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||||
Number of shares available for grant (in shares) | 4,338,936 | 4,338,936 | ||||||
Shares reserved for future issuance (in shares) | 2,186,097 | 2,186,097 | 2,298,817 | |||||
Percentage of pay that employee can contribute, maximum | 15% | 15% | ||||||
Discount from market price, entry date | 15% | |||||||
Discount from market price, purchase date | 15% | |||||||
Employee stock purchase plan, purchase period | 6 months | |||||||
Employee stock purchase plan, automatic reset participation period | 24 months | |||||||
Employee stock purchase plan purchases (in shares) | 535,255 | 542,931 | ||||||
Liability | $ 300,000 | $ 300,000 |
Stockholders' Equity (Deficit_3
Stockholders' Equity (Deficit) (Schedule of Shares Reserved for Future Issuance) (Details) - shares | Dec. 31, 2022 | Dec. 31, 2021 |
Share-based Compensation Arrangement by Share-based Payment Award | ||
Shares reserved for future issuance (in shares) | 19,649,598 | 16,921,556 |
The 2013 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Shares reserved for future issuance (in shares) | 1,466,603 | 2,076,923 |
The 2013 Employee Stock Purchase Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Shares reserved for future issuance (in shares) | 2,186,097 | 2,298,817 |
Employee stock option | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Shares reserved for future issuance (in shares) | 15,076,365 | 11,649,594 |
Restricted stock units (RSUs) | ||
Share-based Compensation Arrangement by Share-based Payment Award | ||
Shares reserved for future issuance (in shares) | 920,533 | 896,222 |
Stockholders' Equity (Deficit_4
Stockholders' Equity (Deficit) (Assumption Used to Determine the Fair Value of Options Granted) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Weighted-average fair value per option (in dollars per share) | $ 3.33 | $ 6.67 | $ 1.78 |
Employee stock option | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Expected volatility | 74.27% | 95.84% | 93.24% |
Expected term (in years) | 6 years | 6 years | 6 years |
Weighted-average risk-free interest rate | 1.91% | 0.71% | 1.24% |
Expected dividend yield | 0% | 0% | 0% |
Weighted-average fair value per option (in dollars per share) | $ 3.33 | $ 6.67 | $ 1.78 |
Stockholders' Equity (Deficit_5
Stockholders' Equity (Deficit) (Summary of Activity Related to Stock Options) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Options Outstanding | |||
Beginning balance (in shares) | 11,649,592 | 8,913,271 | |
Granted (in shares) | 4,217,275 | 3,903,750 | |
Exercised (in shares) | (271,079) | (909,997) | |
Forfeited (in shares) | (519,423) | (257,432) | |
Ending balance (in shares) | 15,076,365 | 11,649,592 | 8,913,271 |
Exercisable (in shares) | 9,192,591 | ||
Vested and expected to vest (in shares) | 14,204,938 | ||
Weighted-Average Exercise Price | |||
Beginning balance (in dollars per share) | $ 6.27 | $ 5.28 | |
Granted (in dollars per share) | 5.12 | 8.74 | |
Exercised (in dollars per share) | 2.24 | 4.69 | |
Forfeited (in dollars per share) | 6.93 | 15.12 | |
Ending balance (in dollars per share) | 6 | $ 6.27 | $ 5.28 |
Exercisable (in dollars per share) | 6.14 | ||
Vested or expected to vest (in dollars per share) | $ 6 | ||
Additional Disclosure | |||
Weighted-average remaining contractual life (in years) | 7 years 3 months 25 days | 7 years 7 months 24 days | 7 years 6 months 7 days |
Weighted-average remaining contractual life (in years), Exercisable | 6 years 7 months 2 days | ||
Weighted-average remaining contractual life (in years), Vested or expected to vest | 7 years 3 months | ||
Total intrinsic value of options outstanding | $ 64,174 | ||
Total intrinsic value of options exercisable | 42,393 | ||
Total intrinsic value of options vested or expected to vest | $ 61,673 |
Stockholders' Equity (Deficit_6
Stockholders' Equity (Deficit) (Schedule of other information regarding stock options) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Stockholders' Equity Note [Abstract] | |||
Weighted-average fair value per option (in dollars per share) | $ 3.33 | $ 6.67 | $ 1.78 |
Total intrinsic value of options exercised | $ 114 | $ 3,496 | $ 355 |
Total fair value of shares vested | $ 12,721 | $ 8,642 | $ 4,188 |
Stockholders' Equity (Deficit_7
Stockholders' Equity (Deficit) (Schedule of Share-based Compensation, Shares Authorized) (Details) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
1.37 to 2.08 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in dollars per share) | $ 1.37 |
Share-based compensation, upper range limit (in dollars per share) | $ 2.08 |
Share-based compensation, number of outstanding options (in shares) | shares | 2,418,541 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 7 years 5 months 1 day |
Share-based compensation, outstanding options, weighted average exercise price (in dollars per share) | $ 2 |
Share-based compensation, number of exercisable options (in shares) | shares | 1,655,079 |
Share-based compensation, exercisable options, weighted average exercise price (in dollars per share) | $ 2.01 |
2.09 to 3.13 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in dollars per share) | 2.09 |
Share-based compensation, upper range limit (in dollars per share) | $ 3.13 |
Share-based compensation, number of outstanding options (in shares) | shares | 3,260,545 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 6 years 8 months 15 days |
Share-based compensation, outstanding options, weighted average exercise price (in dollars per share) | $ 2.35 |
Share-based compensation, number of exercisable options (in shares) | shares | 2,707,469 |
Share-based compensation, exercisable options, weighted average exercise price (in dollars per share) | $ 2.34 |
3.14 to 5.60 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in dollars per share) | 3.14 |
Share-based compensation, upper range limit (in dollars per share) | $ 5.60 |
Share-based compensation, number of outstanding options (in shares) | shares | 1,547,105 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 5 years 10 months 28 days |
Share-based compensation, outstanding options, weighted average exercise price (in dollars per share) | $ 4.64 |
Share-based compensation, number of exercisable options (in shares) | shares | 1,326,771 |
Share-based compensation, exercisable options, weighted average exercise price (in dollars per share) | $ 4.63 |
5.61 to 7.86 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in dollars per share) | 5.61 |
Share-based compensation, upper range limit (in dollars per share) | $ 7.86 |
Share-based compensation, number of outstanding options (in shares) | shares | 3,918,679 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 8 years 11 months 23 days |
Share-based compensation, outstanding options, weighted average exercise price (in dollars per share) | $ 5.81 |
Share-based compensation, number of exercisable options (in shares) | shares | 1,120,141 |
Share-based compensation, exercisable options, weighted average exercise price (in dollars per share) | $ 6.17 |
1.37 to 53.74 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in dollars per share) | 7.87 |
Share-based compensation, upper range limit (in dollars per share) | $ 53.74 |
Share-based compensation, number of outstanding options (in shares) | shares | 3,931,495 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 6 years 8 months 1 day |
Share-based compensation, outstanding options, weighted average exercise price (in dollars per share) | $ 12.20 |
Share-based compensation, number of exercisable options (in shares) | shares | 2,383,131 |
Share-based compensation, exercisable options, weighted average exercise price (in dollars per share) | $ 14.14 |
1.37 to 53.74 | |
Share-based Compensation Arrangement by Share-based Payment Award | |
Share-based compensation, lower range limit (in dollars per share) | 1.37 |
Share-based compensation, upper range limit (in dollars per share) | $ 53.74 |
Share-based compensation, number of outstanding options (in shares) | shares | 15,076,365 |
Share-based compensation, outstanding options, weighted average remaining contractual term | 7 years 3 months 25 days |
Share-based compensation, outstanding options, weighted average exercise price (in dollars per share) | $ 6 |
Share-based compensation, number of exercisable options (in shares) | shares | 9,192,591 |
Share-based compensation, exercisable options, weighted average exercise price (in dollars per share) | $ 6.14 |
Stockholders' Equity (Deficit_8
Stockholders' Equity (Deficit) (Schedule of Share-Based Compensation) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award | |||
Weighted-average fair value per option (in dollars per share) | $ 3.33 | $ 6.67 | $ 1.78 |
The 2013 Employee Stock Purchase Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Expected volatility | 104.88% | 97.54% | 75.39% |
Expected term (in years) | 1 year 3 months 10 days | 8 months 15 days | 1 year 3 months 10 days |
Weighted-average risk-free interest rate | 2.63% | 0.25% | 0.37% |
Expected dividend yield | 0% | 0% | 0% |
Weighted-average fair value per option (in dollars per share) | $ 1.97 | $ 6.55 | $ 0.93 |
Stockholders' Equity (Deficit_9
Stockholders' Equity (Deficit) (Summary of Activity Related to Restricted Stock Units) (Details) - Restricted stock units (RSUs) | 12 Months Ended |
Dec. 31, 2022 $ / shares shares | |
Number of Restricted Stock Units Outstanding | |
Beginning balance (in shares) | shares | 896,222 |
Granted (in shares) | shares | 451,250 |
Shares issuance (in shares) | shares | (363,527) |
Forfeited (in shares) | shares | (63,412) |
Ending balance (in shares) | shares | 920,533 |
Weighted-Average Grant-Date Fair Value | |
Beginning balance (in dollars per share) | $ / shares | $ 3.98 |
Granted (in dollars per share) | $ / shares | 5.24 |
Shares issuance (in dollars per share) | $ / shares | 3.46 |
Forfeited (in dollars per share) | $ / shares | 3.83 |
Ending balance (in dollars per share) | $ / shares | $ 4.82 |
Stockholders' Equity (Defici_10
Stockholders' Equity (Deficit) (Schedule of Allocation of Recognized Period Costs) (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 | |||
Allocated share-based compensation expense | $ 15,285 | $ 12,260 | $ 5,568 |
Research and development expense | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Allocated share-based compensation expense | 8,267 | 6,611 | 2,969 |
General and administrative expense | |||
Share-based Compensation Arrangement by Share-based Payment Award | |||
Allocated share-based compensation expense | $ 7,018 | $ 5,649 | $ 2,599 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Operating Loss Carryforwards | |||
Income tax expense | $ 36,000 | $ 0 | $ 0 |
Operating loss carryforwards | 51,200,000 | ||
Tax credit carryforward | 26,600,000 | ||
Tax credit carryforward expired amount | 100,000 | ||
Capital loss carryforward subject to expiration | 1,900,000 | ||
Decrease in deferred tax asset | 600,000 | 7,100,000 | |
Decrease in deferred tax asset valuation allowance | 600,000 | 7,100,000 | |
Penalties and interest accrued | 0 | 0 | $ 0 |
United Kingdom | |||
Operating Loss Carryforwards | |||
Undisturbed foreign earnings | 0 | ||
Federal | |||
Operating Loss Carryforwards | |||
Operating loss carryforwards | 394,800,000 | 637,900,000 | |
Operating loss carryforwards, subject to expiration | 169,500,000 | ||
Operating loss carryforwards, not subject to expiration | 225,300,000 | ||
State | |||
Operating Loss Carryforwards | |||
Operating loss carryforwards | 394,400,000 | $ 455,400,000 | |
Operating loss carryforwards, subject to expiration | 391,700,000 | ||
Operating loss carryforwards, not subject to expiration | $ 2,700,000 |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Income Tax Expense (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Current: | |||
Federal | $ 0 | $ 0 | $ 0 |
State | 36,000 | 0 | 0 |
Total | 36,000 | 0 | 0 |
Deferred: | |||
Federal | 0 | 0 | 0 |
State | 0 | 0 | 0 |
Total | 0 | 0 | 0 |
Net benefit | $ 36,000 | $ 0 | $ 0 |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of the Difference between the Benefit for Income Taxes and Income Taxes at the Statutory U.S. Federal Income Tax Rate) (Alternate) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Amount | |||
Income tax benefit at statutory rate | $ 36,163,000 | $ (36,379,000) | $ (9,140,000) |
State income taxes | 441,000 | (8,060,000) | (138,000) |
Research and development credits | (3,312,000) | (1,565,000) | (1,088,000) |
In process R&D | 0 | 26,395,000 | 0 |
Permanent items | 1,135,000 | 711,000 | 505,000 |
Provision to return adjustments | 1,091,000 | 126,000 | 81,000 |
Effect of change in federal tax rate | 0 | 0 | 0 |
Effect of change in state tax rate | 4,405,000 | 3,478,000 | 1,139,000 |
Removal of excess tax benefit | 0 | 0 | 0 |
Increase in unrecognized tax benefits | 828,000 | 439,000 | 272,000 |
Current year forfeitures | 54,000 | 435,000 | 4,026,000 |
Change in valuation allowance | (40,769,000) | 14,420,000 | 4,343,000 |
Net benefit | $ 36,000 | $ 0 | $ 0 |
% of Pretax Earnings | |||
Income tax benefit at statutory rate | 21% | 21% | 21% |
State income taxes | 0.20% | 4.70% | 0.30% |
Research and development credits | (1.90%) | 0.90% | 2.50% |
In process R&D | 0% | (15.20%) | 0% |
Permanent items | 0.70% | (0.40%) | (1.20%) |
Provision to return adjustments | 0.60% | (0.10%) | (0.20%) |
Effect of change in federal tax rate | 0% | 0% | 0% |
Effect of change in state tax rate | 2.60% | (2.00%) | (2.60%) |
Removal of excess tax benefit | 0% | 0% | 0% |
Increase in unrecognized tax benefits | 0.50% | (0.30%) | (0.60%) |
Current year forfeitures | 0% | (0.30%) | (9.20%) |
Change in valuation allowance | (23.70%) | (8.30%) | (10.00%) |
Net benefit | 0% | 0% | 0% |
Income Taxes (Components of Def
Income Taxes (Components of Deferred Tax Assets and Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2022 | Dec. 31, 2021 |
Deferred tax assets: | ||
Domestic net operating loss carryforwards | $ 84,147 | $ 138,548 |
Research and development expenses | 1,520 | 1,191 |
Capitalized Section 174 expenses | 12,425 | 0 |
License fees | 11,509 | 14,131 |
Research and development credits | 20,166 | 17,738 |
Capital loss carryforwards | 428 | 484 |
Accrued bonuses | 722 | 888 |
Share-based compensation | 6,132 | 4,885 |
Other | 1,333 | 1,457 |
Total gross deferred tax assets | 138,382 | 179,322 |
Valuation allowance | (137,936) | (178,705) |
Total deferred tax assets | 446 | 617 |
Deferred tax liabilities: | ||
Right-of-use asset | (446) | (617) |
Total deferred tax liabilities | (446) | (617) |
Total deferred tax assets and liabilities, net | $ 0 | $ 0 |
Income Taxes (Summary of Uncert
Income Taxes (Summary of Uncertain Tax Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2022 | Dec. 31, 2021 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns | ||
Beginning balance | $ 4,734 | $ 4,295 |
Increase related to current year tax positions | 828 | 391 |
Increases related to prior periods | 0 | 48 |
Ending balance | $ 5,562 | $ 4,734 |
Significant Agreements (Narrati
Significant Agreements (Narratives) (Details) $ in Thousands, $ in Millions | 1 Months Ended | 12 Months Ended | ||||||||||
Sep. 26, 2022 USD ($) | Aug. 26, 2022 USD ($) treatment | Jun. 23, 2022 USD ($) installment | Jul. 31, 2022 USD ($) | Feb. 28, 2011 USD ($) | Feb. 28, 2011 segment | Feb. 28, 2011 extension | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | Dec. 31, 2020 USD ($) | Jun. 23, 2022 CAD ($) | Dec. 31, 2019 USD ($) | |
Long-term Purchase Commitment | ||||||||||||
Up-front cash payment | $ 233,984 | $ 0 | $ 0 | |||||||||
Gain on sale of business, net | 229,670 | 0 | 0 | |||||||||
Revenues | 33,824 | 1,979 | 5,372 | |||||||||
TEMBEXA | Purchaser | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Revenues | 9,300 | |||||||||||
TEMBEXA | Public Health Agency Of Canada | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Revenues | $ 22,600 | 32,000 | ||||||||||
TEMBEXA | Scenario, Plan | Purchaser | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Deferred revenue | $ 9,300 | |||||||||||
Number of payment installments | installment | 2 | |||||||||||
TEMBEXA | Scenario, Plan | Public Health Agency Of Canada | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Deferred revenue | $ 25,300 | $ 33 | ||||||||||
Royalty revenue | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Revenues | 375 | 0 | 0 | |||||||||
BARDA | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Revenues | $ 1,600 | 5,300 | ||||||||||
Number of option segments | 4 | 4 | ||||||||||
BARDA | TEMBEXA | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Base performance, contract term | 5 years | |||||||||||
Amount of additional courses at the discretion of customer, gross value | $ 553,000 | |||||||||||
Amount of additional courses at the discretion of customer | treatment | 1,381,000 | |||||||||||
Amount of additional courses at the discretion of customer, net of marketing cost | $ 551,000 | |||||||||||
Reimbursable marketing cost upon the exercise of options | $ 2,000 | |||||||||||
BARDA | TEMBEXA | Base Period | Scenario, Plan | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Contractual treatment commitment (treatment) | treatment | 319,000 | |||||||||||
Deferred revenue | $ 127,000 | |||||||||||
BARDA | TEMBEXA | Maximum | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Contractual treatment commitment (treatment) | treatment | 1,700,000 | |||||||||||
Significant agreements, contract term | 10 years | |||||||||||
BARDA | Expense Reimbursement | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Revenues | $ 72,500 | |||||||||||
BARDA | Fees | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Revenues | $ 4,600 | |||||||||||
National Stockpile | TEMBEXA | Base Period | Scenario, Plan | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Deferred revenue | $ 115,000 | |||||||||||
National Stockpile | Expense Reimbursement | Base Period | Scenario, Plan | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Reimbursable marketing expenses | 12,000 | |||||||||||
Emergent BioSolutions, Inc. | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Up-front cash payment | $ 237,987 | |||||||||||
Gain on sale of business, net | $ 229,670 | $ 229,700 | ||||||||||
Emergent BioSolutions, Inc. | TEMBEXA | Base Period | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Up-front cash payment | $ 238,000 | |||||||||||
Quantity royalty rate, trigger (treatments) | treatment | 1,700,000 | |||||||||||
Emergent BioSolutions, Inc. | TEMBEXA | Base Period | Non- United States | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Gross profit royalty rate (percent) | 15% | |||||||||||
Emergent BioSolutions, Inc. | TEMBEXA | Base Period | Federal | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Gross profit royalty rate (percent) | 20% | |||||||||||
Emergent BioSolutions, Inc. | BARDA | Base Period | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Maximum milestone proceeds upon the exercise of options | $ 124,000 | |||||||||||
SymBio Pharmaceuticals | Scenario, Plan | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Contract with customer, asset, after allowance for credit loss | $ 12,500 | |||||||||||
Ohara Pharmaceutical Co., Ltd. | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
License agreement, nonrefundable regulatory milestone payment to be received | $ 2,500 | |||||||||||
Sanjiu Medical & Pharmaceutical Co., Ltd. | Oncoceutics, Inc. | ||||||||||||
Long-term Purchase Commitment | ||||||||||||
Payment to be received upon achievement of milestones | $ 5,000 |
Significant Agreements - Schedu
Significant Agreements - Schedule Of Net Gain From The Sales Of Assets (Details) - USD ($) $ in Thousands | 12 Months Ended | |||
Sep. 26, 2022 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Long-term Purchase Commitment | ||||
Up-front cash payment | $ 233,984 | $ 0 | $ 0 | |
Net gain | 229,670 | $ 0 | $ 0 | |
Emergent BioSolutions, Inc. | ||||
Long-term Purchase Commitment | ||||
Up-front cash payment | $ 237,987 | |||
Liabilities assumed by Emergent | 1,423 | |||
Inventory transferred to Emergent | (5,227) | |||
Prepaids transferred to Emergent | (511) | |||
Transaction costs incurred | (4,002) | |||
Net gain | $ 229,670 | $ 229,700 |
DSTAT Contract Close-out (Detai
DSTAT Contract Close-out (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Dec. 31, 2022 | Jun. 30, 2022 | |
Schedule of Investments | ||
Contract close out liability | $ 1,311 | $ 4,539 |
Contract close out liability, adjustments | 746 | |
Accrued Liabilities | ||
Schedule of Investments | ||
Contract close out liability | 1,400 | |
Accounts Payable | ||
Schedule of Investments | ||
Contract close out liability | $ (100) |
DSTAT Contract Close-out (Contr
DSTAT Contract Close-out (Contract Close-out Cost Income Statement Location) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2022 USD ($) | |
Schedule of Investments | |
Total contract close-out expenses | $ 799 |
Research and development expense | |
Schedule of Investments | |
Total contract close-out expenses | 791 |
General and administrative expense | |
Schedule of Investments | |
Total contract close-out expenses | $ 8 |
DSTAT Contract Close-out (Sched
DSTAT Contract Close-out (Schedule of Accrual Activities for Contract Close-out Cost) (Details) $ in Thousands | 6 Months Ended |
Dec. 31, 2022 USD ($) | |
Contract Close-out Costs | |
Balance at June 30, 2022 | $ 4,539 |
Revised estimates | (746) |
Payments | (2,482) |
Balance at December 31, 2022 | $ 1,311 |
Oncoceutics Acquisition - Narra
Oncoceutics Acquisition - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||
Jan. 07, 2021 | Dec. 31, 2021 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Asset Acquisition | |||||
Acquired in-process research and development | $ 0 | $ 82,890 | $ 0 | ||
Oncoceutics, Inc. | |||||
Asset Acquisition | |||||
Cash payment for acquisition | $ 25,000 | ||||
Number of shares issued for acquisition (in shares) | 8,723,769 | ||||
One-year closing anniversary payment | $ 14,000 | ||||
Contingent consideration for acquisition | 360,000 | ||||
Acquired in-process research and development | $ 82,591 | $ 20,000 |
Oncoceutics Acquisition - Consi
Oncoceutics Acquisition - Consideration Paid and Purchase Price Allocation (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||
Jan. 07, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | |
Asset Acquisition | ||||||
IPR&D assets expensed | $ 0 | $ 82,890 | $ 0 | |||
Oncoceutics, Inc. | ||||||
Asset Acquisition | ||||||
Cash | $ 23,836 | |||||
One-year closing anniversary payment | $ 14,000 | |||||
Shares common stock issued as consideration (in shares) | 8,723,769 | |||||
Stock price per share on effective date (in dollars per share) | $ 4.98 | |||||
Value of estimated common stock consideration | $ 43,445 | |||||
Total consideration | 81,281 | |||||
Net assets acquired | (1,310) | |||||
IPR&D assets expensed | 82,591 | $ 20,000 | ||||
Total purchase price allocated | 81,281 | |||||
Transaction costs expensed to IPR&D | 299 | |||||
Transaction costs expensed to IPR&D | $ 82,890 | |||||
Transaction expenses | $ 600 |
Restructuring Costs (Details)
Restructuring Costs (Details) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Dec. 31, 2022 USD ($) | May 31, 2019 employee | Dec. 31, 2022 USD ($) | |
Restructuring Cost and Reserve | |||
Reduction in workforce | employee | 20 | ||
One-time employee termination benefits | $ 400 | $ 1,854 | |
Anticipated severance cost | 1,000 | 1,000 | |
Severance Accrual Balance | |||
Restructuring Cost and Reserve | |||
Accrual balance | $ 1,400 | $ 1,400 |
Restructuring Costs - Summary o
Restructuring Costs - Summary of Restructuring Charges (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended |
Dec. 31, 2022 | Dec. 31, 2022 | |
Restructuring Cost and Reserve | ||
Employee Termination Benefits | $ 400 | $ 1,854 |
Research and development expense | ||
Restructuring Cost and Reserve | ||
Employee Termination Benefits | 1,768 | |
General and administrative expense | ||
Restructuring Cost and Reserve | ||
Employee Termination Benefits | $ 86 |