Cover Page
Cover Page - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 28, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
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 each class | Common Stock, par value $0.001 per share | |
Trading Symbol(s) | CMRX | |
Name of each exchange on which registered | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 88,583,567 | |
Amendment Flag | false | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Entity Central Index Key | 0001117480 | |
Current Fiscal Year End Date | --12-31 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 15,951 | $ 25,842 |
Short-term investments, available-for-sale | 198,801 | 191,492 |
Accounts receivable | 668 | 1,040 |
Prepaid expenses and other current assets | 9,330 | 9,764 |
Total current assets | 224,750 | 228,138 |
Total long-term investments | 31,322 | 48,626 |
Property and equipment, net of accumulated depreciation | 267 | 227 |
Operating lease right-of-use assets | 1,848 | 1,964 |
Other long-term assets | 346 | 386 |
Total assets | 258,533 | 279,341 |
Current liabilities: | ||
Accounts payable | 2,847 | 3,034 |
Accrued liabilities | 13,584 | 17,381 |
Total current liabilities | 16,431 | 20,415 |
Loan fees | 125 | 250 |
Lease-related obligations | 1,666 | 1,819 |
Total liabilities | 18,222 | 22,484 |
Stockholders’ equity: | ||
Preferred stock, $0.001 par value, 10,000,000 shares authorized at March 31, 2023 and December 31, 2022; no shares issued and outstanding as of March 31, 2023 and December 31, 2022 | 0 | 0 |
Common stock, $0.001 par value, 200,000,000 shares authorized at March 31, 2023 and December 31, 2022; 88,583,567 and 88,054,127 shares issued and outstanding as of March 31, 2023 and December 31, 2022, respectively | 89 | 88 |
Additional paid-in capital | 975,254 | 970,535 |
Accumulated other comprehensive loss, net | (231) | (337) |
Accumulated deficit | (734,801) | (713,429) |
Total stockholders’ equity | 240,311 | 256,857 |
Total liabilities and stockholders’ equity | $ 258,533 | $ 279,341 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 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) | 88,583,567 | 88,054,127 |
Common stock, shares outstanding (in shares) | 88,583,567 | 88,054,127 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Contract and grant revenue | $ 283 | $ 15 |
Cost of goods sold | 0 | 114 |
Gross profit | 283 | (99) |
Operating expenses: | ||
Research and development | 18,822 | 19,040 |
General and administrative | 5,679 | 5,632 |
Total operating expenses | 24,501 | 24,672 |
Loss from operations | (24,218) | (24,771) |
Other income: | ||
Interest income and other, net | 2,846 | 4 |
Net loss | (21,372) | (24,767) |
Other comprehensive loss: | ||
Unrealized gain (loss) on debt investments, net | 106 | (52) |
Comprehensive loss | $ (21,266) | $ (24,819) |
Per share information: | ||
Net loss, basic (in dollars per share) | $ (0.24) | $ (0.28) |
Net loss, diluted (in dollars per share) | $ (0.24) | $ (0.28) |
Weighted-average shares outstanding, basic (in shares) | 88,294,624 | 87,088,804 |
Weighted-average shares outstanding, diluted (in shares) | 88,294,624 | 87,088,804 |
Contract and grant revenue | ||
Contract and grant revenue | $ 234 | $ 0 |
Licensing revenue | ||
Contract and grant revenue | $ 49 | $ 15 |
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, 2021 | $ 68,252 | $ 87 | $ 953,782 | $ (21) | $ (885,596) |
Beginning balance (in shares) at Dec. 31, 2021 | 86,884,266 | ||||
Increase (Decrease) in Stockholders' Equity | |||||
Share-based compensation | 3,708 | 3,708 | |||
Exercise of stock options | 102 | 102 | |||
Exercise of stock options (in shares) | 34,406 | ||||
Employee stock purchase plan purchases | 555 | 555 | |||
Employee stock purchase plan purchases (in shares) | 383,981 | ||||
RSU stock issuance (in shares) | 133,527 | ||||
Comprehensive loss: | |||||
Unrealized loss on investments, net | (52) | (52) | |||
Net loss | (24,767) | (24,767) | |||
Total comprehensive loss | (24,819) | ||||
Ending balance at Mar. 31, 2022 | 47,798 | $ 87 | 958,147 | (73) | (910,363) |
Ending balance (in shares) at Mar. 31, 2022 | 87,436,180 | ||||
Beginning balance at Dec. 31, 2022 | $ 256,857 | $ 88 | 970,535 | (337) | (713,429) |
Beginning balance (in shares) at Dec. 31, 2022 | 88,054,127 | 88,054,127 | |||
Increase (Decrease) in Stockholders' Equity | |||||
Share-based compensation | $ 4,363 | 4,363 | |||
Employee stock purchase plan purchases | 357 | $ 1 | 356 | ||
Employee stock purchase plan purchases (in shares) | 308,000 | ||||
RSU stock issuance (in shares) | 221,440 | ||||
Comprehensive loss: | |||||
Unrealized loss on investments, net | 106 | 106 | |||
Net loss | (21,372) | (21,372) | |||
Total comprehensive loss | (21,266) | ||||
Ending balance at Mar. 31, 2023 | $ 240,311 | $ 89 | $ 975,254 | $ (231) | $ (734,801) |
Ending balance (in shares) at Mar. 31, 2023 | 88,583,567 | 88,583,567 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (21,372) | $ (24,767) |
Adjustments to reconcile net income (loss) to net cash used in operating activities: | ||
Depreciation of property and equipment | 22 | 24 |
Amortization of debt issuance costs | 66 | 33 |
Amortization of discount/premium on investments | (2,096) | 53 |
Share-based compensation | 4,363 | 3,708 |
Gain on sale of investments | 0 | (1) |
Lease-related amortization | (20) | 63 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 371 | 0 |
Inventories | 0 | (646) |
Prepaid expenses and other assets | 441 | (1,002) |
Accounts payable, accrued liabilities and deferred revenue | (4,000) | (912) |
Net cash used in operating activities | (22,225) | (23,447) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (62) | 0 |
Purchases of short-term investments | 0 | (5,258) |
Purchases of long-term investments | (6,803) | 0 |
Proceeds from sales of short-term investments | 0 | 7,699 |
Proceeds from maturities of short-term investments | 19,000 | 51,026 |
Net cash provided by investing activities | 12,135 | 53,467 |
Cash flows from financing activities: | ||
Proceeds from exercise of stock options | 0 | 102 |
Proceeds from employee stock purchase plan | 356 | 556 |
Payments of debt issuance costs | (157) | (118) |
Payment of note payable related to asset acquisition | 0 | (14,000) |
Net cash provided by (used in) financing activities | 199 | (13,460) |
Net (decrease) increase in cash and cash equivalents | (9,891) | 16,560 |
Cash and cash equivalents: | ||
Beginning of period | 25,842 | 15,397 |
End of period | $ 15,951 | $ 31,957 |
The Business and Summary of Sig
The Business and Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2023 | |
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 accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s audited financial statements and notes thereto included in its Annual Report on Form 10-K for the year ended December 31, 2022. In the opinion of the Company’s management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented have been included. Operating results for the three months ended March 31, 2023 are not necessarily indicative of the results that may be expected for the full year, for any other interim period or for any future year. 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 are tables that present information about certain assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements March 31, 2023 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 13,272 $ 13,272 $ — $ — Total cash equivalents 13,272 13,272 — — Short-term investments U.S. treasury securities 60,747 26,463 34,284 — Commercial paper 115,016 — 115,016 — Corporate bonds 23,038 — 23,038 — Total short-term investments 198,801 26,463 172,338 — Long-term investments U.S. treasury securities 31,322 10,278 21,044 — Total long-term investments 31,322 10,278 21,044 — Total assets $ 243,395 $ 50,013 $ 193,382 $ — 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 $ — 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. 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 was eligible for a refundable employee retention credit subject to certain criteria. The Company recognized a $2.0 million employee retention credit during the three months ended September 30, 2022 related to labor costs recognized during 2020 and 2021, which is recorded in prepaid expenses and other current assets. For the three months ended September 30, 2022, $1.5 million was recorded as a reduction to research and development expenses and $0.5 million was 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 Quarterly Report on Form 10-Q, 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, now a division of First-Citizens Bank & Trust Company, 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 March 31, 2023. In September 2022, in connection with the Asset Sale, the Lender 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 March 31, 2023, 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 March 31, 2023, the Company has recorded a current loan fee liability of $0.2 million in accrued liabilities and a non-current loan fee liability of $0.1 million in loan fees on the Consolidated Balance Sheets. Accrued Liabilities Accrued liabilities consisted of the following (in thousands): March 31, 2023 December 31, 2022 Accrued research and development expenses $ 7,936 $ 6,691 Accrued compensation 3,348 6,438 Other accrued liabilities 2,300 4,252 Total accrued liabilities $ 13,584 $ 17,381 Revenue Recognition Policy The Company’s revenues generally consist of (i) contract and grant revenue—revenue generated under federal and private foundation grants and contracts, (ii) licensing revenue—revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements (iii) royalty revenue—revenue related to sales of TEMBEXA made by Emergent after the Asset Sale, and (iv) procurement revenue—revenue related to sales of TEMBEXA prior to 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. Emergent BioSolutions, Inc. 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 all gross profits associated with the sales of TEMBEXA made outside of the United States during the exclusivity period of TEMBEXA on a market-to-market basis; (iii) royalty payments equal to 20% of future gross profits of TEMBEXA made in the United States associated with volumes above 1.7 million treatment courses of therapy during the exclusivity period of TEMBEXA; and (iv) up to an additional $12.5 million upon the achievement of certain other developmental milestones. The BARDA Agreement was novated to Emergent in December 2022. Under the Asset Purchase Agreement, the Company recognized $0.2 million of contract revenue for expense reimbursement related to support provided to Emergent for the three months ended March 31, 2023. 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 March 31, 2023, the Company has a deferred revenue balance of $0.1 million related to these grants. For the three months ended March 31, 2023, the Company recognized $30,000 of grant revenue and for the three months ended March 31, 2022, the Company recognized no 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 three months ended March 31, 2023 and 2022, the Company recognized approximately $58,000 and $15,000, respectively, of license revenue related to this agreement. TEMBEXA Procurement Agreements Revenue and Royalty Revenue In June 2022, the Company entered into the Supply Agreement and the PHAC Contract (as defined in Note 6 below), 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 three months ended September 30, 2022, the Company recognized $32.0 million of procurement revenue related to these agreements. The remaining deliveries of treatment courses related to the PHAC Contract were delivered by Emergent and were 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 three months ended December 31, 2022. 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 March 31, 2023, 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. Basic and Diluted Net Income (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. 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 three months ended March 31, 2023 and 2022. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. In addition to estimates discussed in other sections of this Quarterly Report on Form 10-Q, the most significant estimates in the Company’s consolidated financial statements relate to the valuation of stock options and the valuation allowance for deferred tax assets resulting from net operating losses. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. Segments The Company operates in only one segment, pharmaceuticals. Impact of Recently Adopted Accounting Standards In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which amends the impairment model by requiring entities to use a forward-looking approach on expected losses to estimate credit losses on certain financial instruments, including trade receivables and available-for-sale debt securities. The new guidance was originally due to become effective for the Company beginning in the first quarter of 2020, however the FASB in November 2019 issued ASU 2019-10 which moved the effective date for smaller reporting companies to the first quarter of 2023. The Company adopted ASU 2016-03 as of January 1, 2023. Given the nature of the Company’s receivables and investment portfolio, adoption of this standard had no impact on the Company's financial position, results of operations or cash flows. |
Investments
Investments | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Investments | Investments The following tables summarize the Company’s debt investments (in thousands): March 31, 2023 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate bonds $ 23,072 $ — $ (34) $ 23,038 U.S. treasury securities 92,152 55 (138) 92,069 Commercial paper 115,130 9 (123) 115,016 Total investments $ 230,354 $ 64 $ (295) $ 230,123 December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value 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 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): March 31, 2023 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 23,038 $ (34) $ — $ — $ 23,038 $ (34) Commercial paper 85,101 (123) — — 85,101 (123) U.S. treasury securities 65,693 (138) — — 65,693 (138) Total $ 173,832 $ (295) $ — $ — $ 173,832 $ (295) Number of securities with unrealized losses 51 — 51 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 The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity sufficient to meet cash flow requirements. The Company places its excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of its credit exposure. In accordance with its policy, the Company is able to invest in marketable debt securities that may consist of U.S. Government and government agency securities, money market and mutual fund investments, certificates of deposits, municipal and corporate notes and bonds, and commercial paper, among others. The Company’s investment policy requires it to purchase high-quality marketable securities with a maximum individual maturity of two years and requires an average portfolio maturity of no more than 12 months. Some of the securities in which the Company invests may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk, the Company schedules its investments with maturities that coincide with expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, the Company does not believe it has a material exposure to interest rate risk arising from its investments. Generally, the Company’s investments are not collateralized. The Company has not realized any significant losses from its investments. The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below 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 cost basis. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Unrealized gains and losses on debt investments are recorded to unrealized gain (loss) on debt investments, net in the Consolidated Statements of Operations and Comprehensive Loss. Realized gains and losses on debt investments are recorded based on specific identification to interest income and other, net in the Consolidated Statements of Operations and Comprehensive Loss. Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the balance sheet date are classified as current investments. Investments with a maturity beyond 12 months from the balance sheet date are classified as long-term investments. At March 31, 2023, the Company believes that the cost of its investments is recoverable in all material respects. The Company recognizes interest income on an accrual basis in interest income in the Consolidated Statements of Operations and Comprehensive Loss. The following table summarizes the scheduled maturity for the Company’s debt investments at March 31, 2023 (in thousands): Maturing in one year or less $ 198,801 Maturing after one year through two years 31,322 Total debt investments $ 230,123 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023 was 3.34 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 $0.2 million and $0.2 million, respectively, for the three months ended March 31, 2023 and 2022. 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 March 31, 2023, 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 March 31, 2023 (in thousands): Assets Operating lease right-of-use assets $ 1,848 Liabilities Operating lease short-term liabilities (recorded within Accrued liabilities) $ (590) Operating lease long-term liabilities (recorded within Lease-related obligations) (1,666) Total operating lease liabilities $ (2,256) Operating lease payments over the remainder of the lease terms are as follows (in thousands): Years Ending December 31, As of March 31, 2023 2023 555 2024 759 2025 781 2026 467 Total future minimum rental payments $ 2,562 Less amount of lease payments representing interest 306 Total present value of lease payments $ 2,256 As of December 31, 2022, operating lease payments over the remainder of the lease terms were 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 three months ended March 31, 2023 and 2022, the Company made lease payments of approximately $0.2 million and $0.1 million, respectively. Significance of Revenue Source The Company was the recipient of federal research contract funds from BARDA, the primary source of the Company’s prior year contract and grant revenue. Periodic audits are required in connection with the Company’s receipt of such funds and certain costs may be questioned as appropriate by BARDA. Accordingly, at March 31, 2023 and December 31, 2022, the Company had recorded a provision for potential refundable amounts of $52,000. |
Equity Transactions and Share-b
Equity Transactions and Share-based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Equity Transactions and Share-based Compensation | Equity Transactions and Share-based Compensation 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. As of March 31, 2023, 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 March 31, 2023, no sales have been made under the shelf registration statement. Stock Options The Company maintains a 2013 Equity Incentive Plan (the 2013 Plan), which provides for the grant of incentive stock options (ISOs), non-statutory 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. The number of shares of common stock reserved for future issuance automatically increased on January 1, 2023, by 4% of the total number of shares of capital stock outstanding on December 31 of the preceding calendar year, or 3.5 million shares. As of March 31, 2023, there was a total of 3.0 million shares reserved for future issuance under the 2013 Plan. The Company issued no shares of common stock pursuant to the exercise of stock options during the three months ended March 31, 2023. The Company issued approximately 34,000 shares of common stock pursuant to the exercise of stock options during the three months ended March 31, 2022. Employee Stock Purchase Plan The Company maintains a 2013 Employee Stock Purchase Plan (ESPP), which provides for the issuance of shares of common stock pursuant to purchase rights granted to the Company’s employees or to employees of any of its designated affiliates. The Company has reserved a total of 4.8 million shares of common stock to be purchased under the ESPP, of which 2.3 million shares remained available for purchase as of March 31, 2023. The number of shares of common stock reserved for issuance automatically increased on January 1, 2023, by an additional 422,535 shares. The ESPP 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. 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 Company issued approximately 308,000 and 384,000 shares of common stock pursuant to the ESPP during the three months ended March 31, 2023 and 2022, respectively. Compensation expense for shares purchased under the ESPP related to the purchase discount and the “look-back” option and were determined using a Black-Scholes option pricing model. Restricted Stock Units The Company has issued RSUs to certain employees 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. The Company issued approximately 221,000 shares of common stock pursuant to the vesting of RSUs during the three months ended March 31, 2023. The Company issued approximately 134,000 shares of common stock pursuant to the vesting of RSUs during the three months ended March 31, 2022. 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 share-based compensation expense recognized related to stock options, the ESPP and RSUs was as follows (in thousands): Three Months Ended March 31, 2023 2022 Research and development expense $ 2,312 $ 1,903 General and administrative expense 2,051 1,805 Total share-based compensation expense $ 4,363 $ 3,708 In December 2022, the Company announced a reduction in workforce. As a result, 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. The Company recorded expense ratably from the announcement date through the date of termination with approximately $0.4 million being recognized during the twelve months ended December 31, 2022 and an additional $0.6 million being recognized during the three months ended March 31, 2023. In January 2023, the Company extended the post-termination exercise period from 90 days to three years for stock option grants made to non-employee members of our Board of Directors. This extension applies to all future grants as well as all then-outstanding grants. Related to this extension, the Company recorded approximately $0.3 million of expense during the three months ended March 31, 2023. |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company estimates an annual effective tax rate of 0.0% for the year ending December 31, 2023 as the Company incurred losses for the three month period ended March 31, 2023 and is forecasting an estimated net loss for both financial statement and tax purposes for the year ending December 31, 2023. Therefore, no federal or state income taxes are expected and none have been recorded at this time. Income taxes have been accounted for using the liability method in accordance with FASB ASC 740. Due to the Company's history of cumulative losses since inception, there is not enough evidence at this time to support that the Company will generate future income of a sufficient amount and nature to utilize the benefits of its net deferred tax assets. Accordingly, the deferred tax assets have been reduced by a full valuation allowance, since the Company cannot currently support that realization of its deferred tax assets is more likely than not. However, the Company feels its deferred tax assets may be used upon the Company becoming profitable. At March 31, 2023, the Company had no unrecognized tax benefits that would reduce the Company’s effective tax rate if recognized. |
Significant Agreements
Significant Agreements | 3 Months Ended |
Mar. 31, 2023 | |
Revenue Recognition [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 over a possible 10-year period. 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 BioSolutions, Inc. 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 period under which the Company was contracted to provide the majority of operational support services to Emergent in furtherance of its obligations under the Asset Purchase Agreement and the BARDA Agreement concluded on March 26, 2023, except for certain services which the parties agreed would continue until the occurrence of a specific event, or in some cases a predetermined end date. The BARDA Agreement was novated to Emergent in December 2022. Under the Asset Purchase Agreement, the Company recognized approximately $0.2 million of contract revenue for support provided for the three months ended March 31, 2023. The sale of TEMBEXA constitutes a significant disposition of a business, however, the Company determined the disposition did not represent a strategic shift, and accordingly, the Company did not account 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) in the third quarter of 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 and July 2022. The Company recognized $9.3 million of procurement revenue under the Supply Agreement for the three months ended September 30, 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 USD $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 three months ended September 2022. Upon the assignment of the PHAC Contract to Emergent, which requires the consent of PHAC, if the remaining deliveries of treatment courses are made by Emergent, they will be subject to the royalty terms of the Asset Purchase Agreement applicable to gross profits outside the United States. 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 three months ended December 31, 2022. 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. Note 7. DSTAT Contract Close-out 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. As a result, the Company recorded an accrual of expenses to close-out the DSTAT vendor contracts. As of March 31, 2023, on the Consolidated Balance Sheets, the Company has recorded $1.1 million of contract close-out costs in accrued liabilities offset by a vendor credit of $0.1 million in accounts payable. 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 in 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 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 The following table sets forth the accounts payable and accrual activity for contract close-out costs (in thousands) for the three months ended March 31, 2023. Contract Close-out Costs Balance at December 31, 2022 $ 1,311 Revised estimates 10 Payments (250) Balance at March 31, 2023 $ 1,071 |
DSTAT Contract Close-out
DSTAT Contract Close-out | 3 Months Ended |
Mar. 31, 2023 | |
Revenue Recognition [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 over a possible 10-year period. 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 BioSolutions, Inc. 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 period under which the Company was contracted to provide the majority of operational support services to Emergent in furtherance of its obligations under the Asset Purchase Agreement and the BARDA Agreement concluded on March 26, 2023, except for certain services which the parties agreed would continue until the occurrence of a specific event, or in some cases a predetermined end date. The BARDA Agreement was novated to Emergent in December 2022. Under the Asset Purchase Agreement, the Company recognized approximately $0.2 million of contract revenue for support provided for the three months ended March 31, 2023. The sale of TEMBEXA constitutes a significant disposition of a business, however, the Company determined the disposition did not represent a strategic shift, and accordingly, the Company did not account 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) in the third quarter of 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 and July 2022. The Company recognized $9.3 million of procurement revenue under the Supply Agreement for the three months ended September 30, 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 USD $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 three months ended September 2022. Upon the assignment of the PHAC Contract to Emergent, which requires the consent of PHAC, if the remaining deliveries of treatment courses are made by Emergent, they will be subject to the royalty terms of the Asset Purchase Agreement applicable to gross profits outside the United States. 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 three months ended December 31, 2022. 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. Note 7. DSTAT Contract Close-out 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. As a result, the Company recorded an accrual of expenses to close-out the DSTAT vendor contracts. As of March 31, 2023, on the Consolidated Balance Sheets, the Company has recorded $1.1 million of contract close-out costs in accrued liabilities offset by a vendor credit of $0.1 million in accounts payable. 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 in 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 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 The following table sets forth the accounts payable and accrual activity for contract close-out costs (in thousands) for the three months ended March 31, 2023. Contract Close-out Costs Balance at December 31, 2022 $ 1,311 Revised estimates 10 Payments (250) Balance at March 31, 2023 $ 1,071 |
Restructuring Costs
Restructuring Costs | 3 Months Ended |
Mar. 31, 2023 | |
Restructuring and Related Activities [Abstract] | |
Restructuring Costs | Restructuring Costs In December 2022, the Company made the decision to restructure its operations, which included a reduction in workforce of 20 full-time employees. During the three months ended December 31, 2022, the Company recorded expense for one-time employee termination benefits of $1.9 million, which included a ratable share of the total stock compensation expense that resulted from the modifications of stock option agreements of employees. The total amount of stock compensation expense related to the reduction in workforce equals $1.0 million of which $0.4 million was recorded in the fourth quarter of 2022. The following table summarizes the restructuring charges (in thousands) recorded for the three months ended December 31, 2022: Employee Termination Benefits Research and development $ 1,768 General and administrative 86 Total restructuring expenses $ 1,854 The following table sets forth the accrual activity for employee termination benefits (in thousands) for the three months ended March 31, 2023: Employee Termination Benefits Balance at December 31, 2022 $ 1,442 Revised estimates (73) Payments (641) Balance at March 31, 2023 $ 728 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023, 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) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of PresentationThe accompanying unaudited consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. The accompanying unaudited consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (GAAP) for interim financial information, the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s audited financial statements and notes thereto included in its Annual Report on Form 10-K for the year ended December 31, 2022. In the opinion of the Company’s management, all adjustments, consisting of normal recurring adjustments, necessary for a fair presentation of its financial position, operating results and cash flows for the periods presented have been included. Operating results for the three months ended March 31, 2023 are not necessarily indicative of the results that may be expected for the full year, for any other interim period or for any future year. |
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. |
Revenue Recognition | Revenue Recognition Policy The Company’s revenues generally consist of (i) contract and grant revenue—revenue generated under federal and private foundation grants and contracts, (ii) licensing revenue—revenue related to non-refundable upfront fees, royalties and milestone payments earned under license agreements (iii) royalty revenue—revenue related to sales of TEMBEXA made by Emergent after the Asset Sale, and (iv) procurement revenue—revenue related to sales of TEMBEXA prior to 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 March 31, 2023, 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. |
Basic and Diluted Net Income (Loss) Per Share of Common Stock | Basic and Diluted Net Income (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. 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 three months ended March 31, 2023 and 2022. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses, and related disclosure of contingent assets and liabilities. In addition to estimates discussed in other sections of this Quarterly Report on Form 10-Q, the most significant estimates in the Company’s consolidated financial statements relate to the valuation of stock options and the valuation allowance for deferred tax assets resulting from net operating losses. These estimates are based on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from those estimates. |
Segments | SegmentsThe Company operates in only one segment, pharmaceuticals. |
Impact of Recently Adopted Accounting Standards | Impact of Recently Adopted Accounting Standards In June 2016, the FASB issued ASU 2016-13, Financial Instruments-Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments , which amends the impairment model by requiring entities to use a forward-looking approach on expected losses to estimate credit losses on certain financial instruments, including trade receivables and available-for-sale debt securities. The new guidance was originally due to become effective for the Company beginning in the first quarter of 2020, however the FASB in November 2019 issued ASU 2019-10 which moved the effective date for smaller reporting companies to the first quarter of 2023. The Company adopted ASU 2016-03 as of January 1, 2023. Given the nature of the Company’s receivables and investment portfolio, adoption of this standard had no impact on the Company's financial position, results of operations or cash flows. |
The Business and Summary of S_3
The Business and Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Certain Assets Measured at Fair Value on a Recurring Basis | Below are tables that present information about certain assets measured at fair value on a recurring basis (in thousands): Fair Value Measurements March 31, 2023 Total Quoted Prices in Significant Other Significant Cash equivalents Money market funds $ 13,272 $ 13,272 $ — $ — Total cash equivalents 13,272 13,272 — — Short-term investments U.S. treasury securities 60,747 26,463 34,284 — Commercial paper 115,016 — 115,016 — Corporate bonds 23,038 — 23,038 — Total short-term investments 198,801 26,463 172,338 — Long-term investments U.S. treasury securities 31,322 10,278 21,044 — Total long-term investments 31,322 10,278 21,044 — Total assets $ 243,395 $ 50,013 $ 193,382 $ — 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 $ — |
Schedule of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): March 31, 2023 December 31, 2022 Accrued research and development expenses $ 7,936 $ 6,691 Accrued compensation 3,348 6,438 Other accrued liabilities 2,300 4,252 Total accrued liabilities $ 13,584 $ 17,381 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Short-Term and Long-Term Investments | The following tables summarize the Company’s debt investments (in thousands): March 31, 2023 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value Corporate bonds $ 23,072 $ — $ (34) $ 23,038 U.S. treasury securities 92,152 55 (138) 92,069 Commercial paper 115,130 9 (123) 115,016 Total investments $ 230,354 $ 64 $ (295) $ 230,123 December 31, 2022 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value 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 |
Summary of Investments with Unrealized Losses, Aggregated by Investment Type and the Length of Time | 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): March 31, 2023 Less than 12 Months Greater than 12 Months Total Fair Value Unrealized Loss Fair Value Unrealized Loss Fair Value Unrealized Loss Corporate bonds $ 23,038 $ (34) $ — $ — $ 23,038 $ (34) Commercial paper 85,101 (123) — — 85,101 (123) U.S. treasury securities 65,693 (138) — — 65,693 (138) Total $ 173,832 $ (295) $ — $ — $ 173,832 $ (295) Number of securities with unrealized losses 51 — 51 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 |
Summary of the Scheduled Maturity of Company Investments | The following table summarizes the scheduled maturity for the Company’s debt investments at March 31, 2023 (in thousands): Maturing in one year or less $ 198,801 Maturing after one year through two years 31,322 Total debt investments $ 230,123 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023 (in thousands): Assets Operating lease right-of-use assets $ 1,848 Liabilities Operating lease short-term liabilities (recorded within Accrued liabilities) $ (590) Operating lease long-term liabilities (recorded within Lease-related obligations) (1,666) Total operating lease liabilities $ (2,256) |
Operating Lease Maturity | Operating lease payments over the remainder of the lease terms are as follows (in thousands): Years Ending December 31, As of March 31, 2023 2023 555 2024 759 2025 781 2026 467 Total future minimum rental payments $ 2,562 Less amount of lease payments representing interest 306 Total present value of lease payments $ 2,256 As of December 31, 2022, operating lease payments over the remainder of the lease terms were 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 |
Equity Transactions and Share_2
Equity Transactions and Share-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Schedule of Employee and Non-Employee Share-Based Compensation Expense Recognized Related to Stock Options, the ESPP and RSUs | Total share-based compensation expense recognized related to stock options, the ESPP and RSUs was as follows (in thousands): Three Months Ended March 31, 2023 2022 Research and development expense $ 2,312 $ 1,903 General and administrative expense 2,051 1,805 Total share-based compensation expense $ 4,363 $ 3,708 |
Significant Agreements (Tables)
Significant Agreements (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue Recognition [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) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue Recognition [Abstract] | |
Schedule of Accrual Activities for Contract Close-out Cost | The following table summarizes the contract close-out costs (in thousands) recorded in 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 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 The following table sets forth the accounts payable and accrual activity for contract close-out costs (in thousands) for the three months ended March 31, 2023. Contract Close-out Costs Balance at December 31, 2022 $ 1,311 Revised estimates 10 Payments (250) Balance at March 31, 2023 $ 1,071 |
Restructuring Costs (Tables)
Restructuring Costs (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Restructuring and Related Activities [Abstract] | |
Restructuring and Related Costs | The following table summarizes the restructuring charges (in thousands) recorded for the three months ended December 31, 2022: Employee Termination Benefits Research and development $ 1,768 General and administrative 86 Total restructuring expenses $ 1,854 |
Schedule of Restructuring Reserve by Type of Cost | The following table sets forth the accrual activity for employee termination benefits (in thousands) for the three months ended March 31, 2023: Employee Termination Benefits Balance at December 31, 2022 $ 1,442 Revised estimates (73) Payments (641) Balance at March 31, 2023 $ 728 |
The Business and Summary of S_4
The Business and Summary of Significant Accounting Policies - Assets and Liabilities Measured at Fair Value on a Recurring Basis (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | $ 198,801 | $ 191,492 |
Total long-term investments | 31,322 | 48,626 |
Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 13,272 | 22,824 |
Short-term investments, available-for-sale | 198,801 | 191,492 |
Total long-term investments | 31,322 | 48,626 |
Total assets | 243,395 | 262,942 |
Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 13,272 | 17,826 |
Short-term investments, available-for-sale | 26,463 | 25,271 |
Total long-term investments | 10,278 | 11,685 |
Total assets | 50,013 | 54,782 |
Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 0 | 4,998 |
Short-term investments, available-for-sale | 172,338 | 166,221 |
Total long-term investments | 21,044 | 36,941 |
Total assets | 193,382 | 208,160 |
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 |
Total long-term investments | 0 | 0 |
Total assets | 0 | 0 |
U.S. treasury securities | Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 60,747 | 38,094 |
Total long-term investments | 31,322 | 48,626 |
U.S. treasury securities | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 26,463 | 25,271 |
Total long-term investments | 10,278 | 11,685 |
U.S. treasury securities | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 34,284 | 12,823 |
Total long-term investments | 21,044 | 36,941 |
U.S. treasury securities | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Total long-term investments | 0 | 0 |
Commercial paper | Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 115,016 | 127,517 |
Commercial paper | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Commercial paper | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 115,016 | 127,517 |
Commercial paper | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Corporate bonds | Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 23,038 | 25,881 |
Corporate bonds | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Corporate bonds | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 23,038 | 25,881 |
Corporate bonds | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment | ||
Short-term investments, available-for-sale | 0 | 0 |
Money market funds | Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 13,272 | 17,826 |
Money market funds | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 13,272 | 17,826 |
Money market funds | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 0 | 0 |
Money market funds | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | $ 0 | 0 |
Commercial paper | Fair value, measurements, recurring | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 4,998 | |
Commercial paper | Fair value, measurements, recurring | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 0 | |
Commercial paper | Fair value, measurements, recurring | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | 4,998 | |
Commercial paper | Fair value, measurements, recurring | Significant Unobservable Inputs (Level 3) | ||
Fair Value, Separate Account Investment | ||
Cash equivalents | $ 0 |
The Business and Summary of S_5
The Business and Summary of Significant Accounting Policies - Employee Retention Credit (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Sep. 30, 2022 | Mar. 31, 2022 | |
Business and Summary of Significant Accounting Policies | |||
Employee retention credit | $ 2,000 | ||
Research and development | $ 18,822 | $ 19,040 | |
General and administrative | 5,679 | $ 5,632 | |
Proceeds from tax refund | $ 27 | ||
Scenario, Adjustment | |||
Business and Summary of Significant Accounting Policies | |||
Research and development | (1,500) | ||
General and administrative | $ (500) |
The Business and Summary of S_6
The Business and Summary of Significant Accounting Policies - Deferred Loan Costs (Details) | Jan. 31, 2022 USD ($) installment | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) |
Business and Summary of Significant Accounting Policies | |||
Non-current loan fee liability | $ 125,000 | $ 250,000 | |
Revolving Credit Facility | |||
Business and Summary of Significant Accounting Policies | |||
Debt instrument, term | 4 years | ||
Aggregate principal amount | $ 50,000,000 | ||
Debt instrument, interest rate, stated percentage | 4.75% | ||
Line of credit facility, unused capacity, commitment fee percentage | 0.25% | ||
Debt instrument, early termination fee | $ 500,000 | ||
Debt instrument, unused borrowing capacity, fee | $ 500,000 | ||
Number of installment payments (installment) | installment | 4 | ||
Current deferred loan costs | 100,000 | ||
Noncurrent deferred loan costs | 300,000 | ||
Loan fee liability | 200,000 | ||
Non-current loan fee liability | $ 100,000 | ||
Revolving Credit Facility | Prime Rate | |||
Business and Summary of Significant Accounting Policies | |||
Debt instrument, basis spread on variable rate | 1.50% |
The Business and Summary of S_7
The Business and Summary of Significant Accounting Policies - Schedule of Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accounting Policies [Abstract] | ||
Accrued research and development expenses | $ 7,936 | $ 6,691 |
Accrued compensation | 3,348 | 6,438 |
Other accrued liabilities | 2,300 | 4,252 |
Total accrued liabilities | $ 13,584 | $ 17,381 |
The Business and Summary of S_8
The Business and Summary of Significant Accounting Policies - Narrative (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | |||||
Sep. 26, 2022 USD ($) treatment | Jul. 31, 2022 USD ($) | Mar. 31, 2023 USD ($) segment | Dec. 31, 2022 USD ($) | Sep. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2019 USD ($) | |
Business and Summary of Significant Accounting Policies | |||||||
Contract and grant revenue | $ 283 | $ 15 | |||||
Number of segments | segment | 1 | ||||||
Ohara Pharmaceutical Co., Ltd. | |||||||
Business and Summary of Significant Accounting Policies | |||||||
License agreement, nonrefundable regulatory milestone payment to be received | $ 2,500 | ||||||
Emergent | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Up-front cash payment | $ 237,987 | ||||||
SymBio Pharmaceuticals | Scenario, Plan | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Deferred revenue | 12,500 | ||||||
Emergent Biodefense Operations Lansing LLC | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Revenue recognized | $ 200 | ||||||
Grant | Oncoceutics, Inc. | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Deferred revenue | 100 | ||||||
Contract and grant revenue | 30 | 0 | |||||
Licensing | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Contract and grant revenue | 49 | 15 | |||||
Licensing | Ohara Pharmaceutical Co., Ltd. | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Contract and grant revenue | $ 58 | $ 15 | |||||
TEMBEXA | PHAC | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Contract and grant revenue | $ 22,600 | $ 32,000 | |||||
TEMBEXA | Emergent | Base Period | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Up-front cash payment | $ 238,000 | ||||||
Quantity royalty rate, trigger (treatments) | treatment | 1,700,000 | ||||||
TEMBEXA | Emergent | Base Period | Non- United States | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Gross profit royalty rate (percent) | 15% | ||||||
TEMBEXA | Emergent | Base Period | United States | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Gross profit royalty rate (percent) | 20% | ||||||
Royalty | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Contract and grant revenue | $ 400 | ||||||
BARDA | Emergent | Base Period | |||||||
Business and Summary of Significant Accounting Policies | |||||||
Maximum milestone proceeds upon the exercise of options | $ 124,000 |
Investments - Summary of Availa
Investments - Summary of Available-for-Sale securities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Schedule of Investments | ||
Amortized Cost | $ 230,354 | $ 240,455 |
Gross Unrealized Gains | 64 | 47 |
Gross Unrealized Losses | (295) | (384) |
Estimated Fair Value | 230,123 | 240,118 |
Corporate bonds | ||
Schedule of Investments | ||
Amortized Cost | 23,072 | 25,906 |
Gross Unrealized Gains | 0 | 4 |
Gross Unrealized Losses | (34) | (29) |
Estimated Fair Value | 23,038 | 25,881 |
U.S. treasury securities | ||
Schedule of Investments | ||
Amortized Cost | 92,152 | 86,892 |
Gross Unrealized Gains | 55 | 7 |
Gross Unrealized Losses | (138) | (179) |
Estimated Fair Value | 92,069 | 86,720 |
Commercial paper | ||
Schedule of Investments | ||
Amortized Cost | 115,130 | 127,657 |
Gross Unrealized Gains | 9 | 36 |
Gross Unrealized Losses | (123) | (176) |
Estimated Fair Value | $ 115,016 | $ 127,517 |
Investments - Summary of Invest
Investments - Summary of Investments with Unrealized Losses, Aggregated by Investment Type and the Length of Time (Details) $ in Thousands | Mar. 31, 2023 USD ($) security | Dec. 31, 2022 USD ($) security |
Debt Securities, Available-for-sale | ||
Fair value, less than 12 months | $ 173,832 | $ 179,254 |
Unrealized loss, less than 12 months | (295) | (384) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 173,832 | 179,254 |
Unrealized loss, total | $ (295) | $ (384) |
Number of securities with unrealized losses, less than 12 months | security | 51 | 55 |
Number of securities with unrealized losses, greater than 12 months | security | 0 | 0 |
Number of securities with unrealized losses, total | security | 51 | 55 |
Corporate bonds | ||
Debt Securities, Available-for-sale | ||
Fair value, less than 12 months | $ 23,038 | $ 22,905 |
Unrealized loss, less than 12 months | (34) | (29) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 23,038 | 22,905 |
Unrealized loss, total | (34) | (29) |
Commercial paper | ||
Debt Securities, Available-for-sale | ||
Fair value, less than 12 months | 85,101 | 88,860 |
Unrealized loss, less than 12 months | (123) | (176) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 85,101 | 88,860 |
Unrealized loss, total | (123) | (176) |
U.S. treasury securities | ||
Debt Securities, Available-for-sale | ||
Fair value, less than 12 months | 65,693 | 67,489 |
Unrealized loss, less than 12 months | (138) | (179) |
Fair value, greater than 12 months | 0 | 0 |
Unrealized loss, greater than 12 months | 0 | 0 |
Fair value, total | 65,693 | 67,489 |
Unrealized loss, total | $ (138) | $ (179) |
Investments - Schedule of Inves
Investments - Schedule of Investment Maturity (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Debt Securities, Available-for-sale, Maturity, Allocated and Single Maturity Date, Fair Value | ||
Maturing in one year or less | $ 198,801 | |
Maturing after one year through two years | 31,322 | |
Total debt investments | $ 230,123 | $ 240,118 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Weighted average remaining lease term | 3 years 4 months 2 days | ||
Rent expense under non-cancelable operating leases | $ 200 | $ 200 | |
Weighted average discount rate | 7.89% | ||
Lease payments | $ 200 | $ 100 | |
BARDA | Refundable Agreements | |||
Disaggregation of Revenue | |||
Provision for refundable amounts | $ 52 | $ 52 |
Commitments and Contingencies_2
Commitments and Contingencies - Operating Lease Right-of-Use Assets and Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Assets | ||
Operating lease right-of-use assets | $ 1,848 | $ 1,964 |
Liabilities | ||
Operating lease short-term liabilities (recorded within Accrued liabilities) | (590) | |
Operating lease long-term liabilities (recorded within Lease-related obligations) | (1,666) | (1,819) |
Total present value of lease payments | $ (2,256) | $ (2,392) |
Operating lease, liability, current, statement of financial position [extensible list] | Accrued Liabilities, Current |
Commitments and Contingencies_3
Commitments and Contingencies - Maturity Analysis of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Lessee, Operating Lease, Liability, Payment, Due | ||
Year one | $ 555 | $ 736 |
Year two | 759 | 759 |
Year three | 781 | 781 |
Year four | 467 | 467 |
Total future minimum rental payments | 2,562 | 2,743 |
Less amount of lease payments representing interest | 306 | 351 |
Total present value of lease payments | $ 2,256 | $ 2,392 |
Equity Transactions and Share_3
Equity Transactions and Share-based Compensation - Narrative (Details) - USD ($) | 3 Months Ended | 12 Months Ended | ||||
Jan. 01, 2023 | Mar. 31, 2023 | Dec. 31, 2022 | Mar. 31, 2022 | Dec. 31, 2022 | Aug. 10, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Shares issued for restricted stock units (in shares) | 221,000 | 134,000 | ||||
One-time employee termination benefits | $ 600,000 | $ 1,854,000 | $ 400,000 | |||
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 | |||||
The 2013 Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Evergreen option provision, equity increase | 4% | |||||
Additional shares authorized (in shares) | 3,500,000 | |||||
Number of shares reserved for future issuance (in shares) | 3,000,000 | |||||
Shares issued pursuant to the exercise of stock options (in shares) | 0 | 34,000 | ||||
The 2013 Employee Stock Purchase Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award | ||||||
Additional shares authorized (in shares) | 422,535 | |||||
Number of shares reserved for future issuance (in shares) | 2,300,000 | |||||
Number of shares authorized to be granted (in shares) | 4,800,000 | |||||
Participation term | 24 months | |||||
Percentage of pay that employee can contribute, maximum | 15% | |||||
Discounted purchase price from market price, offering date | 15% | |||||
Discounted purchase price from market price, purchase date | 15% | |||||
Purchase interval | 6 months | |||||
Shares issued pursuant to employee stock purchase plan (in shares) | 308,000 | 384,000 |
Equity Transactions and Share_4
Equity Transactions and Share-based Compensation - Schedule of Share-based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount | ||
Total share-based compensation expense | $ 4,363 | $ 3,708 |
Independent Members Of Board | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount | ||
Total share-based compensation expense | 300 | |
Research and development expense | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount | ||
Total share-based compensation expense | 2,312 | 1,903 |
General and administrative expense | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount | ||
Total share-based compensation expense | $ 2,051 | $ 1,805 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2023 | Mar. 31, 2023 | |
Income Tax Contingency | ||
Unrecognized tax benefits | $ 0 | |
Scenario, Forecast | ||
Income Tax Contingency | ||
Estimated annual effective tax rate | 0% |
Significant Agreements (Details
Significant Agreements (Details) $ in Thousands, $ in Millions | 1 Months Ended | 3 Months Ended | ||||||||||
Sep. 26, 2022 USD ($) treatment | Aug. 26, 2022 USD ($) treatment | Jun. 23, 2022 USD ($) installment | Jul. 31, 2022 USD ($) | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Sep. 30, 2022 USD ($) | Mar. 31, 2022 USD ($) | Jun. 30, 2022 USD ($) | Jun. 23, 2022 CAD ($) | Dec. 31, 2020 USD ($) | Dec. 31, 2019 USD ($) | |
Schedule of Investments | ||||||||||||
Contract and grant revenue | $ 283 | $ 15 | ||||||||||
TEMBEXA | Purchaser | ||||||||||||
Schedule of Investments | ||||||||||||
Deferred revenue | $ 9,300 | |||||||||||
Number of payment installments | installment | 2 | |||||||||||
Contract and grant revenue | $ 9,300 | |||||||||||
TEMBEXA | PHAC | ||||||||||||
Schedule of Investments | ||||||||||||
Contract and grant revenue | $ 22,600 | 32,000 | ||||||||||
TEMBEXA | Scenario, Plan | Purchaser | ||||||||||||
Schedule of Investments | ||||||||||||
Deferred revenue | $ 9,300 | |||||||||||
TEMBEXA | Scenario, Plan | PHAC | ||||||||||||
Schedule of Investments | ||||||||||||
Deferred revenue | $ 25,300 | $ 33 | ||||||||||
Royalty | ||||||||||||
Schedule of Investments | ||||||||||||
Contract and grant revenue | $ 400 | |||||||||||
BARDA | TEMBEXA | ||||||||||||
Schedule of Investments | ||||||||||||
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 | ||||||||||||
Schedule of Investments | ||||||||||||
Contractual treatment commitment (treatment) | treatment | 319,000 | |||||||||||
Deferred revenue | $ 127,000 | |||||||||||
BARDA | TEMBEXA | Maximum | ||||||||||||
Schedule of Investments | ||||||||||||
Contractual treatment commitment (treatment) | treatment | 1,700,000 | |||||||||||
Contract term (years) | 10 years | |||||||||||
Emergent | ||||||||||||
Schedule of Investments | ||||||||||||
Up-front cash payment | $ 237,987 | |||||||||||
Gain (loss) on sale of assets | 229,670 | $ 229,700 | ||||||||||
Emergent | TEMBEXA | Base Period | ||||||||||||
Schedule of Investments | ||||||||||||
Up-front cash payment | $ 238,000 | |||||||||||
Quantity royalty rate, trigger (treatments) | treatment | 1,700,000 | |||||||||||
Emergent | TEMBEXA | Base Period | Non- United States | ||||||||||||
Schedule of Investments | ||||||||||||
Gross profit royalty rate (percent) | 15% | |||||||||||
Emergent | TEMBEXA | Base Period | United States | ||||||||||||
Schedule of Investments | ||||||||||||
Gross profit royalty rate (percent) | 20% | |||||||||||
Emergent | BARDA | Base Period | ||||||||||||
Schedule of Investments | ||||||||||||
Maximum milestone proceeds upon the exercise of options | $ 124,000 | |||||||||||
SymBio Pharmaceuticals | Scenario, Plan | ||||||||||||
Schedule of Investments | ||||||||||||
Deferred revenue | $ 12,500 | |||||||||||
Emergent Biodefense Operations Lansing LLC | ||||||||||||
Schedule of Investments | ||||||||||||
Revenue recognized | $ 200 | |||||||||||
Ohara Pharmaceutical Co., Ltd. | ||||||||||||
Schedule of Investments | ||||||||||||
License agreement, nonrefundable regulatory milestone payment to be received | $ 2,500 | |||||||||||
CR Sanjui | Scenario, Plan | Oncoceutics, Inc. | ||||||||||||
Schedule of Investments | ||||||||||||
Deferred revenue | $ 5,000 | |||||||||||
National Stockpile | TEMBEXA | Base Period | Scenario, Plan | ||||||||||||
Schedule of Investments | ||||||||||||
Deferred revenue | $ 115,000 | |||||||||||
National Stockpile | Expense reimbursement | Base Period | Scenario, Plan | ||||||||||||
Schedule of Investments | ||||||||||||
Reimbursable marketing expenses | $ 12,000 |
Significant Agreements- Schedul
Significant Agreements- Schedule of Assets and Liabilities Transferred in Accordance with Asset Purchase Agreement (Details) - Emergent - USD ($) $ in Thousands | 3 Months Ended | |
Sep. 26, 2022 | Sep. 30, 2022 | |
Schedule of Investments | ||
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 - Narr
DSTAT Contract Close-out - Narratives (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | Jun. 30, 2022 | |
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations | |||
Contract close out liability | $ 1,071 | $ 1,311 | $ 4,539 |
Revised estimates | (10) | $ 746 | |
Accrued Liabilities | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations | |||
Contract close out liability | 1,100 | ||
Accounts Payable | |||
Income Statement, Balance Sheet and Additional Disclosures by Disposal Groups, Including Discontinued Operations | |||
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 ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative | |
Contract close out cost | $ 799 |
Research and development expense | |
Collaborative Arrangement and Arrangement Other than Collaborative | |
Contract close out cost | 791 |
General and administrative expense | |
Collaborative Arrangement and Arrangement Other than Collaborative | |
Contract close out cost | $ 8 |
DSTAT Contract Close-out- Sched
DSTAT Contract Close-out- Schedule of Accrual Activities for Contract Close-out Cost (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended |
Mar. 31, 2023 | Dec. 31, 2022 | |
Accrual Activities for Contract Close-out Cost | ||
Balance at June 30, 2022 | $ 1,311 | $ 4,539 |
Revised estimates | 10 | (746) |
Payments | (250) | (2,482) |
Balance at December 31, 2022 | $ 1,071 | $ 1,311 |
Restructuring Costs (Details)
Restructuring Costs (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |
Dec. 31, 2022 USD ($) employee | Mar. 31, 2023 USD ($) | Dec. 31, 2022 USD ($) | Dec. 31, 2022 USD ($) | |
Restructuring and Related Activities [Abstract] | ||||
Reduction in workforce | employee | 20 | |||
One-time employee termination benefits | $ 600 | $ 1,854 | $ 400 | |
Anticipated severance cost | $ 1,000 | 1,000 | 1,000 | |
Severance accrual balance | $ 1,442 | $ 728 | $ 1,442 | $ 1,442 |
Restructuring Costs - Summary o
Restructuring Costs - Summary of Restructuring Charges (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2022 | |
Restructuring Cost and Reserve | |||
Total restructuring expenses | $ 600 | $ 1,854 | $ 400 |
Research and development expense | |||
Restructuring Cost and Reserve | |||
Total restructuring expenses | 1,768 | ||
General and administrative expense | |||
Restructuring Cost and Reserve | |||
Total restructuring expenses | $ 86 |
Restructuring Costs - Accrual A
Restructuring Costs - Accrual Activity for Restructuring Accrual (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Restructuring Reserve | |
Balance at December 31, 2022 | $ 1,442 |
Revised estimates | (73) |
Payments | (641) |
Balance at March 31, 2023 | $ 728 |