Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2023 | Nov. 01, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Sep. 30, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q3 | |
Entity Registrant Name | Societal CDMO, Inc. | |
Entity Central Index Key | 0001588972 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 104,788,222 | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Trading Symbol | SCTL | |
Entity File Number | 001-36329 | |
Entity Tax Identification Number | 26-1523233 | |
Entity Address, Address Line One | 1 E. Uwchlan Ave, Suite 112 | |
Entity Address, City or Town | Exton | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19341 | |
City Area Code | 770 | |
Local Phone Number | 534-8239 | |
Entity Incorporation, State or Country Code | PA | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Security Exchange Name | NASDAQ | |
Title of 12(b) Security | Common Stock, par value $0.01 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 8,156 | $ 14,995 |
Accounts receivable, net | 14,771 | 15,950 |
Contract assets | 10,076 | 8,724 |
Inventory | 12,279 | 10,301 |
Prepaid expenses and other current assets | 1,688 | 2,848 |
Assets held for sale | 2,815 | 2,768 |
Total current assets | 49,785 | 55,586 |
Property, plant and equipment, net | 51,132 | 50,365 |
Operating lease asset | 5,132 | 5,491 |
Intangible assets, net | 2,408 | 2,928 |
Goodwill | 41,077 | 41,077 |
Other assets | 1,996 | 1,996 |
Total assets | 151,530 | 157,443 |
Current liabilities: | ||
Accounts payable | 2,124 | 1,466 |
Current portion of debt | 9,891 | 7,577 |
Current portion of operating lease liability | 1,099 | 1,079 |
Accrued expenses and other current liabilities | 8,509 | 12,686 |
Total current liabilities | 21,623 | 22,808 |
Debt, net of current portion | 27,444 | 30,967 |
Operating lease liability, net of current portion | 4,270 | 4,584 |
Other liabilities | 39,936 | 39,225 |
Total liabilities | 93,273 | 97,584 |
Commitments and contingencies (note 7) | ||
Shareholders' equity: | ||
Convertible preferred stock, $0.01 par value. 10,000,000 shares authorized, 0 and 450,000 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively | 0 | 4,350 |
Common stock, $0.01 par value. 185,000,000 shares authorized, 104,777,745 and 84,588,868 shares issued and outstanding at September 30, 2023 and December 31,2022, respectively | 1,048 | 846 |
Additional paid-in capital | 335,332 | 320,298 |
Accumulated deficit | (278,123) | (265,635) |
Total shareholders' equity | 58,257 | 59,859 |
Total liabilities and shareholders' equity | $ 151,530 | $ 157,443 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Sep. 30, 2023 | Dec. 31, 2022 |
Statement of Financial Position [Abstract] | ||
Convertible preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Shares of convertible preferred stock issued | 0 | 450,000 |
Preferred stock, shares outstanding | 0 | 450,000 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 185,000,000 | 185,000,000 |
Common stock, shares issued | 104,777,745 | 84,588,868 |
Common stock, shares outstanding | 104,777,745 | 84,588,868 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Statement [Abstract] | ||||
Revenue | $ 23,590,000 | $ 21,589,000 | $ 66,916,000 | $ 65,935,000 |
Operating expenses: | ||||
Cost of sales | 19,870,000 | 16,055,000 | 56,476,000 | 49,639,000 |
Selling, general and administrative | 5,309,000 | 5,075,000 | 15,243,000 | 15,945,000 |
Amortization of intangible assets | 168,000 | 244,000 | 520,000 | 685,000 |
Total operating expenses | 25,347,000 | 21,374,000 | 72,239,000 | 66,269,000 |
Operating (loss) income | (1,757,000) | 215,000 | (5,323,000) | (334,000) |
Interest expense | (2,911,000) | (3,586,000) | (7,370,000) | (10,434,000) |
Interest income | 79,000 | 42,000 | 319,000 | 56,000 |
Loss before income taxes | (4,589,000) | (3,329,000) | (12,374,000) | (10,712,000) |
Income tax expense | 3,000 | 0 | 114,000 | 0 |
Net loss | $ (4,592,000) | $ (3,329,000) | $ (12,488,000) | $ (10,712,000) |
Loss per share, Basic | $ (0.05) | $ (0.06) | $ (0.14) | $ (0.19) |
Loss per share, Diluted | $ (0.05) | $ (0.06) | $ (0.14) | $ (0.19) |
Weighted average shares outstanding, Basic | 100,637,342 | 56,666,473 | 92,021,938 | 56,539,941 |
Weighted average shares outstanding, Diluted | 100,637,342 | 56,666,473 | 92,021,938 | 56,539,941 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity or Deficit (Unaudited) - USD ($) $ in Thousands | Total | Preferred Stock [Member] Convertible Preferred Stock [Member] | Common Stock [Member] | Additional Paid in Capital [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2021 | $ 42,064 | $ 467 | $ 287,351 | $ (245,754) | |
Balance, Shares at Dec. 31, 2021 | 46,681,453 | ||||
Issuance of stock, net of costs, amount | (16) | $ 93 | (109) | ||
Issuance of stock, net of costs, shares | 9,302,718 | ||||
Stock-based compensation expense | 1,479 | 1,479 | |||
Exercise of stock options, net, shares | 220 | ||||
Vesting of restricted stock units, net, amount | (101) | $ 5 | (106) | ||
Vesting of restricted stock units, net , shares | 487,695 | ||||
Net loss | (4,264) | (4,264) | |||
Balance at Mar. 31, 2022 | 39,162 | $ 565 | 288,615 | (250,018) | |
Balance, Shares at Mar. 31, 2022 | 56,472,086 | ||||
Balance at Dec. 31, 2021 | 42,064 | $ 467 | 287,351 | (245,754) | |
Balance, Shares at Dec. 31, 2021 | 46,681,453 | ||||
Net loss | (10,712) | ||||
Balance at Sep. 30, 2022 | 35,234 | $ 567 | 291,133 | (256,466) | |
Balance, Shares at Sep. 30, 2022 | 56,679,389 | ||||
Balance at Mar. 31, 2022 | 39,162 | $ 565 | 288,615 | (250,018) | |
Balance, Shares at Mar. 31, 2022 | 56,472,086 | ||||
Issuance of stock, net of costs, amount | (113) | (113) | |||
Stock-based compensation expense | 1,408 | 1,408 | |||
Vesting of restricted stock units, net, amount | (9) | $ 1 | (10) | ||
Vesting of restricted stock units, net , shares | 172,477 | ||||
Net loss | (3,119) | (3,119) | |||
Balance at Jun. 30, 2022 | 37,329 | $ 566 | 289,900 | (253,137) | |
Balance, Shares at Jun. 30, 2022 | 56,644,563 | ||||
Issuance of stock, net of costs, amount | (14) | (14) | |||
Stock-based compensation expense | 1,260 | 1,260 | |||
Vesting of restricted stock units, net, amount | (12) | $ 1 | (13) | ||
Vesting of restricted stock units, net , shares | 34,826 | ||||
Net loss | (3,329) | (3,329) | |||
Balance at Sep. 30, 2022 | 35,234 | $ 567 | 291,133 | (256,466) | |
Balance, Shares at Sep. 30, 2022 | 56,679,389 | ||||
Balance at Dec. 31, 2022 | 59,859 | $ 4,350 | $ 846 | 320,298 | (265,635) |
Balance, Shares at Dec. 31, 2022 | 450,000 | 84,588,868 | |||
Issuance of stock, net of costs, amount | (36) | $ (18) | (18) | ||
Stock-based compensation expense | 1,044 | 1,044 | |||
Vesting of restricted stock units, net, amount | (207) | $ 3 | (210) | ||
Vesting of restricted stock units, net , shares | 313,450 | ||||
Net loss | (4,684) | (4,684) | |||
Balance at Mar. 31, 2023 | 55,976 | $ 4,332 | $ 849 | 321,114 | (270,319) |
Balance, Shares at Mar. 31, 2023 | 450,000 | 84,902,318 | |||
Balance at Dec. 31, 2022 | 59,859 | $ 4,350 | $ 846 | 320,298 | (265,635) |
Balance, Shares at Dec. 31, 2022 | 450,000 | 84,588,868 | |||
Net loss | (12,488) | ||||
Balance at Sep. 30, 2023 | 58,257 | $ 1,048 | 335,332 | (278,123) | |
Balance, Shares at Sep. 30, 2023 | 104,777,745 | ||||
Balance at Mar. 31, 2023 | 55,976 | $ 4,332 | $ 849 | 321,114 | (270,319) |
Balance, Shares at Mar. 31, 2023 | 450,000 | 84,902,318 | |||
Conversion of preferred stock, amount | $ (4,332) | $ 45 | 4,287 | ||
Conversion of preferred stock, shares | (450,000) | 4,500,000 | |||
Stock-based compensation expense | 1,593 | 1,593 | |||
Vesting of restricted stock units, net, amount | (39) | $ 6 | (45) | ||
Vesting of restricted stock units, net , shares | 644,607 | ||||
Net loss | (3,212) | (3,212) | |||
Balance at Jun. 30, 2023 | 54,318 | $ 900 | 326,949 | (273,531) | |
Balance, Shares at Jun. 30, 2023 | 90,046,925 | ||||
Issuance of stock, net of costs, amount | 7,352 | $ 147 | 7,205 | ||
Issuance of warrants | 37 | 37 | |||
Issuance of stock, net of costs, shares | 14,640,000 | ||||
Stock-based compensation expense | 1,179 | 1,179 | |||
Vesting of restricted stock units, net, amount | (37) | $ 1 | (38) | ||
Vesting of restricted stock units, net , shares | 90,820 | ||||
Net loss | (4,592) | (4,592) | |||
Balance at Sep. 30, 2023 | $ 58,257 | $ 1,048 | $ 335,332 | $ (278,123) | |
Balance, Shares at Sep. 30, 2023 | 104,777,745 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (12,488) | $ (10,712) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 3,816 | 4,147 |
Non-cash interest expense | 1,215 | 3,778 |
Depreciation expense | 6,043 | 5,516 |
Amortization of intangible assets | 520 | 685 |
Deferred income tax expense | 98 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | 1,179 | (5,191) |
Contract assets | (1,352) | (847) |
Inventory | (1,978) | (497) |
Prepaid expenses and other assets | 1,453 | 1,221 |
Accrued interest | 556 | (2,473) |
Accounts payable, accrued expenses and other liabilities | (1,594) | (1,265) |
Net cash used in operating activities | (2,532) | (5,638) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (7,503) | (5,615) |
Net cash used in investing activities | (7,503) | (5,615) |
Cash flows from financing activities: | ||
Proceeds from issuance of stock, net of costs | 7,040 | (143) |
Payment of debt principal | (1,384) | (2,039) |
Payment of financing costs | (2,177) | (83) |
Net payments related to vesting of restricted stock units | (283) | (122) |
Net cash provided by (used in) financing activities | 3,196 | (2,387) |
Net decrease in cash and cash equivalents | (6,839) | (13,640) |
Cash and cash equivalents, beginning of period | 14,995 | 25,217 |
Cash and cash equivalents, end of period | 8,156 | 11,577 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 5,651 | 10,081 |
Purchases of property, plant and equipment included in accrued expenses and accounts payable | 691 | 919 |
Offering costs included in accounts payable and accrued expenses | 251 | 0 |
Deferred financing costs included in accounts payable and accrued expenses | 144 | 35 |
Fair value of warrants issued in connection with financing facility | 37 | 0 |
Assets reclassified as held for sale | $ 0 | $ 2,659 |
Background
Background | 9 Months Ended |
Sep. 30, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Background | (1) Background Societal CDMO, Inc. (the “Company”) was incorporated in the Commonwealth of Pennsylvania on November 15, 2007 . The Company is a bi-coastal contract development and manufacturing organization with capabilities spanning pre-investigational new drug development to commercial manufacturing and packaging for a wide range of therapeutic dosage forms with a primary focus on small molecules. With an expertise in solving complex manufacturing problems, the Company provides therapeutic development, end-to-end regulatory support, clinical and commercial manufacturing, aseptic fill/finish, lyophilization, packaging and logistics services to the global pharmaceutical market. Liquidity and capital resources The Company has incurred net losses since inception, including net losses for the three and nine months ended September 30, 2023, and has an accumulated deficit of $ 278,123 as of September 30, 2023. As of September 30, 2023, the Company’s cash and cash equivalents were $ 8,156 . In August 2023, the Company completed an underwritten public offering in which it raised net proceeds of $7,352 by issuing 14,640,000 shares of the Company’s common stock at a public offering price of $ 0.400 per share and pre-funded warrants to purchase up to 6,110,000 shares of the Company’s common stock. The Company’s future operations are highly dependent on the profitability of its development and manufacturing operations. Management concluded that substantial doubt about its ability to continue as a going concern was raised as of the date of the issuance of these financial statements. However, management concluded that actions taken to date as well as its plans alleviate the substantial doubt that was raised. The Company’s credit agreement with Royal Bank of Canada contains certain financial and other covenants, including quarterly and monthly minimum liquidity requirements, maximum net leverage ratios and minimum fixed charge coverage ratios (see note 8 for details), and includes limitations on, among other things, additional indebtedness, paying dividends in certain circumstances, acquisitions and certain investments. The credit agreement provides for certain mandatory prepayment events, including with respect to the proceeds of asset sales, extraordinary receipts, equity or debt issuances and other specified events, based on the terms of the credit agreement. Any failure to comply with the terms, covenants and conditions of the credit agreement or the debt agreements may result in an event of default under such agreements, which could have a material adverse effect on the business, financial condition and results of operations. The pharmaceutical industry is experiencing a slowdown in clinical development activities resulting from reduced cash funding, and the Company is experiencing higher rates of customer attrition and development program delays that caused management to revise its 2023 earnings and cash projections when it released its second quarter 2023 results in August 2023. As a result of these factors, management took actions to amend its debt agreements in August 2023 to align financial covenants and other terms of the indebtedness with its revised projections. The Company believes that its results of operations will allow it to comply with the amended financial and other covenants and contractual requirements of the agreements for at least the next twelve months. The Company’s ability to comply is subject to the Company’s success in implementing certain cost control measures, including the Company’s strategic reorganization which included a reduction in force, reducing capital expenditures and managing working capital in order to improve its ongoing financial performance and its liquidity position. The Company may extend and or supplement the actions it is taking if it continues to experience adverse conditions described above, among others, that might impact the forecasted performance. If the Company is unable to achieve the results required to comply with the terms of its credit agreement in one or more quarters over the next twelve months, the Company may be required to take specific actions in addition to those described above, including but not limited to, additional cost control measures, or alternatively, seeking an amendment or waiver from its lenders. Obtaining a waiver or an amendment is not within the Company’s control, and if unsuccessful, the lenders may exercise the rights available to them under the credit agreement. |
Summary of Significant Accounti
Summary of Significant Accounting Principles | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Principles | (2) Summary of significant accounting principles Basis of presentation and principles of consolidation The accompanying unaudited consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information. In accordance with Securities and Exchange Commission’s (“SEC”) rules for interim financial statements, certain information required by U.S. GAAP may be condensed or omitted. The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. In the opinion of management, the accompanying consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s results for the interim periods. Operating results for interim periods are not necessarily indicative of the results that may be expected for the full year. The Company has determined that it operates in a single segment. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022. Use of estimates The preparation of financial statements and the notes to the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from such estimates. Cash and cash equivalents Cash and cash equivalents represent cash in banks and highly liquid short-term investments that have maturities of three months or less when acquired. These highly liquid short-term investments are both readily convertible to known amounts of cash and so near to their maturity that they present insignificant risk of changes in value due to changes in interest rates. Accounts receivable, net Accounts receivable generally represent amounts billed for services provided under our customer contracts and are recorded at the invoiced amount net of an allowance for credit losses, if necessary. We apply judgment in assessing the ultimate realization of our receivables, and we estimate an allowance for credit losses based on various factors, such as the aging of our receivables, historical experience, and the financial condition of our customers. The allowance for credit losses was not material as of the balance sheet dates presented. Inventory Inventory is stated at the lower of cost or net realizable value. Included in inventory are raw materials and work-in-process used in the production of commercial products. Items are issued out of inventory using the first-in, first-out method. Adjustments to inventory are determined at the raw materials, work-in-process, and finished good levels to reflect obsolescence or impaired balances. Factors influencing inventory obsolescence include changes in demand, product life cycle, product pricing, physical deterioration and quality concerns. Property, plant and equipment, net Property, plant and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to ten years for furniture, office and computer equipment; six to ten years for manufacturing equipment; 40 years for buildings; and the shorter of the lease term or useful life for leasehold improvements. Repairs and maintenance costs are expensed as incurred. The Company reviews the carrying value of property, plant and equipment for recoverability whenever events occur or changes in circumstances indicate that the carrying amount of individual assets or asset groups may not be recoverable. The Company considers assets to be held for sale when (i) management commits to a plan to sell the asset; (ii) the asset is available for immediate sale in its present condition; (iii) the asset is actively being marketed for sale at a price that is reasonable given the estimate of current market value; and (iv) the sale is probable and will be completed within one year. Upon designation of an asset as held for sale, the Company records the asset’s value at the lower of its carrying value plus selling costs or its estimated net realizable value. Goodwill and intangible assets Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company in a business combination. Goodwill is not amortized but assessed for impairment on an annual basis or more frequently if impairment indicators exist. The impairment analysis for goodwill consists of an optional qualitative assessment potentially followed by a quantitative analysis. If the Company determines that the carrying value of its reporting unit exceeds its fair value, an impairment charge is recorded for the excess. The Company performs its annual goodwill impairment test as of November 30 th , or whenever an event or change in circumstance occurs that would require reassessment of the impairment of goodwill. In performing the evaluation, the Company assesses qualitative factors such as overall financial performance, actual and anticipated changes in industry and market conditions, and competitive environments. As a result of the most recent annual goodwill impairment test, the Company determined that there was no impairment of goodwill. Definite-lived intangible assets are amortized on a straight-line basis over their estimated useful life. The Company is required to review the carrying value of definite-lived intangible assets for recoverability whenever events occur or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. Contingencies The Company’s business exposes it to various contingencies including compliance with regulations, legal exposures and other matters. Loss contingencies are reflected in the financial statements based on management’s assessments of their expected outcome or resolution: • They are recognized as liabilities on the balance sheet if the potential loss is probable and the amount can be reasonably estimated. • They are disclosed if the potential loss is material and considered at least reasonably possible. Significant judgment is required to determine probability and whether the amount can be reasonably estimated. Due to uncertainties related to these matters, accruals are based only on the information available at the time. As additional information becomes available, the Company reassesses potential liabilities and may revise previous estimates. Revenue recognition The Company generates revenues from manufacturing, profit-sharing and development services for multiple pharmaceutical companies. Manufacturing Manufacturing, packaging and other related services revenue is recognized upon transfer of control of a product to a customer, generally upon shipment, based on a transaction price that reflects the consideration the Company expects to be entitled to as specified in the agreement with the commercial partner, which could include variable consideration such as pricing and volume-based adjustments. Profit-sharing In addition to manufacturing and packaging revenue, certain customers who use our technologies are subject to agreements that provide us intellectual property sales-based profit-sharing and/or royalties consideration, collectively referred to as profit-sharing, computed on the net product sales of the commercial partner. Profit-sharing revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. The Company has determined that, in its arrangements, the license for intellectual property is not the predominant item to which the profit-sharing relates, so the Company recognizes revenue upon transfer of control of the manufactured product. In these cases, significant judgment is required to calculate the estimated variable consideration from such profit-sharing using the expected value method based on historical commercial partner pricing and deductions. Estimated variable consideration is partially constrained due to the uncertainty of price adjustments made by the Company’s commercial partners, which are outside of the Company’s control. Factors causing price adjustments by the Company’s commercial partners include increased competition in the products’ markets, mix of volume between the commercial partners’ customers, and changes in government pricing. Development Development revenue includes services associated with formulation, process development, clinical trial materials services, as well as custom development of manufacturing processes and analytical methods for a customer’s non-clinical, clinical and commercial products. Such revenues are recognized at a point in time or over time depending on the nature and particular facts and circumstances associated with the contract terms. In contracts that specify milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments related to arrangements under which the Company has continuing performance obligations are deferred and recognized over the period of performance. Milestone payments that are not within the Company’s control, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received. In contracts that require revenue recognition over time, the Company utilizes input or output methods, depending on the specifics of the contract, that compare the cumulative work-in-process to date to the most current estimates for the entire performance obligation. Under these contracts, the customer typically owns the product details and process, which have no alternative use. These projects are customized to each customer to meet its specifications, and typically only one performance obligation is included. Each project represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of its product as the product is being created or enhanced by the Company’s services and can make changes to its process or specifications upon request. Contract assets represent revenue recognized for performance obligations completed or in process before an unconditional right to payment exists, and therefore invoicing or associated reporting from the customer regarding the computation of the net product sales has not yet occurred. Contract liabilities represent payments received from customers prior to the completion of associated performance obligations. Concentration of credit risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and accounts receivable. The Company manages its cash and cash equivalents based on established guidelines that balance safety and liquidity. The Company’s accounts receivable balances are primarily concentrated among three customers, with balances in the aggregate accounting for 71 % of the balance as of September 30, 2023. If any of these customers’ receivable balances should be deemed uncollectible, it could have a material adverse effect on the Company’s results of operations and financial condition. The Company is dependent on its relationships with a small number of commercial partners. The Company’s three largest customers generated 75 % and 64 % of revenues for the three months ended September 30, 2023 and 2022, respectively, and 75 % and 69 % of its revenues for the nine months ended September 30, 2023 and 2022 , respectively. Stock-based compensation expense The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award. The Company accounts for forfeitures as they occur. Determining the appropriate fair value of stock options requires the use of subjective assumptions, including the expected life of the option and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and/or management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected life of stock options was estimated using the “simplified method,” which is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses the historical volatility of its publicly traded stock in order to estimate future stock price trends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. Upon exercise of stock options or vesting of restricted stock units, the holder may elect to cover tax withholdings by forfeiting shares of an equivalent value. In such cases, the Company issues net new shares to the holder, pays the tax withholding on behalf of the participant and presents the payment similar to a capital distribution: a reduction to additional paid-in-capital and a financing cash outflow in the consolidated financial statements. Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. In assessing the realizability of net deferred tax assets, the Company considers all relevant positive and negative evidence in determining whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the net operating loss carryforwards. A full valuation allowance was recorded as of September 30, 2023 and December 31, 2022. Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the consolidated financial statements. The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company does not anticipate significant changes in the amount of unrecognized income tax benefits over the next year. Leases The Company determines under U.S. GAAP if an arrangement is a lease at inception. The arrangement is a lease if it conveys the right to the Company to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. Options to extend the lease are included in the lease term if the options are reasonably certain to be exercised. Operating lease expense is recognized on a straight-line basis over the lease term. In a sale-leaseback transaction, the Company determines if it relinquished control of the assets to the buyer-lessor. If control is not relinquished, it does not derecognize the asset and does not apply the lease accounting model. Operating lease balances are presented as separate captions on the balance sheets. Finance lease assets are included in property, plant and equipment. Finance lease liabilities are included in other liabilities. Income or loss per share Basic income or loss per share is determined by dividing net income or loss (the numerator) by the weighted average common shares outstanding during the period (the denominator). The denominator includes the weighted average common stock equivalents for warrants priced at $0.0001, as the underlying common shares will be issued for little cash consideration and the conditions for the issuance of the underlying common shares are met when such warrants are issued. To calculate diluted income or loss per share, the numerator and denominator are adjusted to eliminate the income or loss and the dilutive effects on shares, respectively, caused by outstanding common stock options, warrants and unvested restricted stock units, using the treasury stock method, if the inclusion of such instruments would be dilutive. For all periods presented, the Company incurred a net loss. In periods of net loss, the inclusion of dilutive securities would be antidilutive because it would reduce the amount of loss incurred per share. As a result, no additional dilutive shares were included in diluted loss per share, and there were no differences between basic and diluted loss per share. The following table presents the potentially dilutive securities that were excluded from the computations of diluted loss per share: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Restricted stock units 2,702,088 1,717,982 2,834,632 1,461,529 Stock options 8,320,590 8,020,457 7,402,889 7,331,963 Warrants 567,588 348,664 457,280 348,664 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | (3) Inventory The following table presents the components of inventory: September 30, 2023 December 31, 2022 Raw materials $ 6,095 $ 4,318 Work in process 3,618 3,689 Finished goods 2,566 2,294 Inventory $ 12,279 $ 10,301 |
Intangible Assets, Net
Intangible Assets, Net | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets, Net | (4) I ntangible assets, net The following table presents the components of other intangible assets: September 30, 2023 December 31, 2022 Gross value Accumulated amortization Carrying value Gross value Accumulated amortization Carrying value Customer relationships $ 18,900 $ 16,553 $ 2,347 $ 18,900 $ 16,188 $ 2,712 Backlog 460 399 61 460 261 199 Trademarks and tradenames 310 310 — 310 293 17 Total $ 19,670 $ 17,262 $ 2,408 $ 19,670 $ 16,742 $ 2,928 The following table presents estimated future amortization of other intangible assets: Twelve months ending September 30, 2024 $ 547 2025 486 2026 486 2027 486 2028 403 Thereafter — Total $ 2,408 |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment, Net | (5) Property, plant and equipment, net The following table presents the components of property, plant and equipment: September 30, 2023 December 31, 2022 Land $ 604 $ 604 Building and improvements 22,867 22,751 Furniture, office and computer equipment 6,792 6,388 Manufacturing equipment 66,048 58,039 Construction in process 5,305 7,024 Property, plant and equipment, gross 101,616 94,806 Less: accumulated depreciation ( 50,484 ) ( 44,441 ) Property, plant and equipment, net $ 51,132 $ 50,365 Interest expense capitalized to construction in process was $ 137 and $ 419 for the three months ended September 30, 2023 and 2022, respectively, and $ 403 and $ 982 for the nine months ended September 30, 2023 and 2022, respectively. The Company is party to a sale and purchase agreement to sell approximately 121 acres of land adjacent to its Gainesville, Georgia manufacturing campus for expected proceeds of $ 9,075 . The cost of the land has been removed from property, plant and equipment, and together with cumulative closing costs of $ 156 through September 30, 2023 , is currently presented as a held-for-sale asset of $ 2,815 within prepaid expenses and other current assets. The completion of the land sale is subject to customary closing conditions for transactions of this type, including completion of title and environmental due diligence and receipt of certain zoning approvals and permits, which remained to be satisfied at September 30, 2023 . |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | (6) Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following: September 30, 2023 December 31, 2022 Payroll and related costs $ 3,595 $ 4,276 Contract liabilities (see note 11) 1,314 2,211 Professional and consulting fees 851 356 Accrued interest 783 227 Property, plant and equipment 513 934 Accrued transaction costs 50 3,653 Other 1,403 1,029 Total $ 8,509 $ 12,686 Accrued transaction costs include costs incurred related to the refinancing completed in December 2022 which included the sale and subsequent leaseback of the Company’s commercial manufacturing campus located in Gainesville, Georgia (see note 9), the issuance of common and preferred stock, a borrowing of $ 36,900 under a new term loan with Royal Bank of Canada (see note 8) and a one-time cash transaction bonus to certain executive officers and employees. In September 2023, the Company initiated a strategic reorganization, including a reduction in force of 26 then-current employees and nine open positions, and resulted in a charge of $ 1,059 , of which $ 693 was recorded in cost of sales and $ 366 was recorded in selling, general and administrative, primarily related to severance and other related costs. As of September 30, 2023 , $ 545 remains accrued and unpaid and is included in as part of payroll and related costs in the table above. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (7) Commitments and contingencies Litigation The Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its business. The Company is not currently a party to any such claims or proceedings that, if decided adversely to it, would either individually or in the aggregate have a material adverse effect on its business, financial condition or results of operations. On July 2, 2022, a product liability lawsuit was filed against the Company and various other defendants in the State Court of Cobb County, Georgia that claimed injuries and damages caused by Plaintiff Jakob Cuble’s alleged ingestion of, among other things, Focalin XR. The complaint sought compensatory and punitive damages. On April 14, 2023, Plaintiff’s counsel withdrew the case. Purchase commitments As of September 30, 2023, the Company had outstanding cancelable and non-cancelable purchase commitments in the aggregate amount of $ 9,021 related to inventory, capital expenditures and other goods and services. Employment agreements and certain other contingencies The Company has entered into employment agreements with each of its executive officers that provide for, among other things, severance commitments of up to $ 1,393 should the Company terminate the executive officers for convenience or if certain events occur following a change in control. In addition, the Company is subject to other contingencies of up to $ 4,597 in the aggregate if certain events occur following a change in control. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Debt | (8) Debt The following table presents the components and classification of debt: September 30, 2023 December 31, 2022 Debt principal: Term loan under Credit Agreement $ 35,516 $ 36,900 Note with former equity holder of IriSys 4,078 4,078 Other 339 339 Debt principal 39,933 41,317 Debt adjustments: Unamortized deferred issuance costs ( 2,356 ) ( 2,476 ) Unamortized original discount ( 242 ) ( 297 ) Carrying value of debt $ 37,335 $ 38,544 Current portion of debt $ 9,891 $ 7,577 Debt, net of current portion 27,444 30,967 Carrying value of debt $ 37,335 $ 38,544 The following table presents the future maturity of debt principal: Twelve months ending September 30, 2024 $ 9,891 2025 3,498 2026 26,281 2027 44 2028 53 Thereafter 166 Total debt principal $ 39,933 Term loan under Credit Agreement The Company is currently party to a credit agreement (as amended from time to time, the “Credit Agreement”) with Royal Bank of Canada. The Credit Agreement has been fully drawn in the form of a term loan of $ 36,900 . The outstanding principal amount will be repaid in quarterly amounts totaling $ 2,998 and $ 3,459 during the twelve months ending September 30, 2024 and 2025, respectively. The Company is obligated to make a $ 7,500 mandatory principal prepayment upon completion of the sale of certain real property, which is not included in the debt maturity disclosures above. Quarterly principal payments made after the completion of the land sale will be reduced proportionately to the reduction in principal. The final payment of all remaining outstanding principal is due on December 16, 2025. Subject to certain exceptions, the Company is required to make mandatory prepayments with the cash proceeds received in respect of asset sales, certain equity sales, extraordinary receipts, debt issuances, upon a change of control and specified other events. Additionally, the Company is obligated by December 14, 2023 to complete the sale of certain real property adjacent to its Gainesville, Georgia manufacturing campus (see note 5). If that property is not sold by December 14, 2023, the Company will be required to pay a fee of $ 369 and increase each of its quarterly principal payments by $ 231 until that property is sold and any mandatory prepayment is made. Because the Company concluded that the sale of the property is probable to occur in the first half of 2024, an additional $ 2,815 of debt principal has been presented as current, representing the carrying value of the current asset held for sale, and two quarterly principal payment increases of $231 have been included in the debt maturity disclosures above. The Credit Agreement also includes certain financial covenants that the Company will need to satisfy on a quarterly basis, including: (i) maintaining a net leverage ratio less than 3.75 :1.00 through the quarter ending March 31, 2024, stepping down to 2.75 :1.00 for each quarter thereafter; (ii) maintaining a fixed charge coverage ratio of 1.00 :1.00 at September 30, 2023, increasing to 1.05 :1.00 for the last day of each quarter thereafter; (iii) maintaining cash and cash equivalents on hand of no less than: (a) $4,000 on each of September 30, 2023, December 31, 2023 and March 31, 2024 (b) $3,500 on June 30, 2024 (c) $ 4,500 on September 30, 2024 (d) $ 5,000 on each of December 31, 2024, March 31, 2025, June 30, 2025 and September 30, 2025 and (e) $ 1,500 on every other month-end date through maturity. Beginning with the quarter ending December 31, 2023, funded capital expenditures, as defined, cannot exceed $ 9,000 in the aggregate for the preceding twelve-month period. As of September 30, 2023, the Company was in compliance with its covenants under the Credit Agreement. In connection with the Credit Agreement, the Company has paid financing costs. These costs are being recognized in interest expense using the effective interest method over the term of the Credit Agreement, resulting in non-cash interest expense of $ 433 and $ 902 for the three and nine months ended September 30, 2023, respectively. The Credit Agreement bears interest at a floating rate equal to the three-month term Secured Overnight Financing Rate, or SOFR, with an initial floor of 1.00 %, plus an applicable margin that is equal to 4.50 % per annum for the first year, 5.00 % for the second year and 5.50 % for the third year, with quarterly interest payments due until maturity. At September 30, 2023, the overall effective interest rate, including cash paid for interest and non-cash interest expense, was 13.6 % . Historical term loans with Athyrium The Company was previously party to a credit agreement with Athyrium Opportunities III Acquisition LP (“Athyrium Credit Agreement”). The Athyrium Credit Agreement included $ 100,000 of term loans at an interest rate equal to the three-month LIBOR rate plus 8.25 % per annum . During the term of Athyrium Credit Agreement, the Company paid financing costs and accreted an exit fee. These costs were recognized in interest expense using the effective interest method, resulting in non-cash interest expense of $ 1,163 and $ 3,451 for the three and nine months ended September 30, 2022, respectively. The Company repaid the term loans in full using the proceeds from the new Credit Agreement, the sale-leaseback transaction (see note 9) and the issuance of preferred and common stock (see note 10) in December 2022. Note with former equity holder of IriSys In connection with the acquisition of IriSys, LLC (“IriSys”) , the Company issued a subordinated promissory note to a former equity holder of IriSys in the aggregate principal amount of $ 6,117 ( as amended from time to time, the “Note”). The Note is unsecured, has a three-year term, and bears interest at a rate of 6 % per annum. The Note must be repaid in three equal installments through its maturity date, August 13, 2024 . The Note may be prepaid in whole or in part at any time prior to the maturity date. The Note is expressly subordinated in right of payment and priority to the term loan under the Credit Agreement. In August 2023, the Note was amended to defer the due date of the $2,039 payment due on August 12, 2023 of principal, plus accrued interest, to the earlier of (i) June 24, 2024; and (ii) the date on which the Company completes its previously announced sale of certain land at its Gainesville, Georgia location (see note 5). In consideration for the payment deferral, the Company issued a warrant to purchase 100,000 shares of the Company’s common stock, par value $ 0.01 per share at an exercise price of $ 1.00 with a term of three years . In connection with the Note, the Company has paid financing costs. These costs are being recognized as interest expense using the effective interest method over the term of the Note. At September 30, 2023, the overall effective interest rate, including the amortization of the original discount, was 15.3 % . |
Other Liabilities
Other Liabilities | 9 Months Ended |
Sep. 30, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Other Liabilities | (9) Other liabilities At September 30, 2023, other liabilities include a sale-leaseback liability of $ 38,803 and other liabilities of $ 1,133 . Sale-leaseback liability In December 2022 , the Company concurrently entered into sale and lease agreements related to its commercial manufacturing campus in Gainesville, Georgia. The selling price was $ 39,000 , of which $ 1,750 was placed as a lease deposit and classified within other assets, resulting in cash proceeds to the Company of $ 37,250 in 2022. The lease is for an initial term of 20 years with four renewal options of ten years each. Rent under the lease will be payable monthly at a rate of $ 3,510 per year, increasing annually by 3 %, except for the first year where annual base rent will increase by the change in the consumer price index, not to exceed 5 %, if greater. The Company is responsible for the payment of all operating expenses, property taxes and insurance for the property. Pursuant to the terms of the lease, the Company will have a purchase option every ten years and a right of first offer and a right of first refusal to purchase the property should the buyer-lessor intend to sell the property to a third party. The Company determined that it did not relinquish control of the assets to the buyer-lessor. Therefore, the assets were not derecognized, and the selling price was recorded as a financial liability. As of September 30, 2023, the carrying value of the liability was $ 38,803 , which is net of $ 828 of unamortized deferred financing costs. The Company will recognize interest expense at an approximately 11 % imputed rate of interest over a term of 20 years that includes the amortization of the deferred financing costs over the term of the lease. The gross liability balance is scheduled to increase through 2034, at which point it will decrease through the end of lease term on December 31, 2042. |
Shareholders' Equity or Deficit
Shareholders' Equity or Deficit | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Shareholders' Equity or Deficit | (10) Shareholders’ equity or deficit Common stock In May 2023, the Company’s shareholders approved an amendment to the articles of incorporation to increase the number of authorized shares of common stock from 95,000,000 to 185,000,000 . In August 2023, the Company closed an underwritten public offering of 14,640,000 shares of its common stock and pre-funded warrants to purchase 6,110,000 shares of common stock at an exercise price of $ 0.0001 per share for net proceeds to the Company of $ 7,352 , after deducting underwriting discounts and commissions and offering expenses. Convertible preferred stock In December 2022, the Company issued 450,000 shares of Series A Convertible Preferred Stock for proceeds of $ 11.00 per share. Each share was converted into ten shares of common stock automatically in May 2023 upon approval by the Company’s shareholders to increase the number of authorized shares of common stock. As of September 30, 2023 , no preferred stock was issued or outstanding. Warrants The following table presents the warrants outstanding to purchase shares of common stock as of September 30, 2023. All outstanding warrants are equity-classified. Number of shares Exercise price per share Expiration date Athyrium warrants 467,588 $ 1.29 November 17, 2024 IriSys warrants 100,000 1.00 August 13, 2026 Pre-Funded warrants 6,110,000 0.0001 None |
Revenue Recognition
Revenue Recognition | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | (11) Revenue recognition The following table presents changes in contract assets and liabilities: Contract assets Contract liabilities Balance at December 31, 2022 $ 8,724 $ ( 2,211 ) Changes to the beginning balance arising from: Reclassification to receivables as the result of rights to consideration becoming unconditional ( 10,239 ) — Reclassification to revenue as the result of performance obligations satisfied 963 1,586 Changes in estimate 1,651 — Net change to contract balance recognized since beginning of period due to recognition of revenue, amounts billed and changes in estimate 8,977 ( 689 ) Balance at September 30, 2023 $ 10,076 $ ( 1,314 ) Contract assets and contract liabilities are reported at the contract level. Contracts with multiple performance obligation are reported as a net contract asset or contract liability on the consolidated balance sheet. The reclassification to revenue appearing in the contract assets column results from the recognition of revenue on contract liabilities that are presented as a net contract asset at the beginning of the year. The following table disaggregates revenue by timing of revenue recognition: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Point in time $ 18,805 $ 15,565 $ 51,986 $ 51,851 Over time 4,785 6,024 14,930 14,084 Total $ 23,590 $ 21,589 $ 66,916 $ 65,935 The Company’s payment terms for manufacturing revenue and development services are typically 30 to 45 days. Profit-sharing revenue is recorded to accounts receivable in the quarter that the product is sold by the commercial partner upon reporting from the commercial partner and payment terms are generally 45 days after quarter end. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | (12) Stock-based compensation In October 2013, the Company established an equity incentive plan that has been subsequently amended and restated to become the 2018 Amended and Restated Equity Incentive Plan (the “A&R Plan”). At September 30, 2023, a total of 862,334 shares were available for future grants under the A&R Plan. On December 1 st of each year, pursuant to an “evergreen” provision of the A&R Plan, the number of shares available under the A&R Plan may be increased by the board of directors by an amount equal to 5 % of the outstanding common stock on December 1 st of that year. Stock options Stock options are exercisable generally for a period of ten years from the date of grant and generally vest over four years . The following table presents information about the fair value of stock options granted: Nine months ended September 30, 2023 2022 Weighted average grant date fair value $ 0.94 $ 1.02 Assumptions used to determine fair value: Range of expected option life 5.5 - 6.0 years 5.5 - 6.0 years Expected volatility 79 - 84 % 79 - 81 % Risk-free interest rate 3.5 - 4.6 % 1.5 - 4.0 % Expected dividend yield — — No options were exercised in the nine months ended September 30, 2023. The intrinsic value of options exercised was negligible in the nine months ended September 30, 2022. The following table presents information about stock option balances and activity: Number of shares Weighted average exercise price Aggregate intrinsic value Weighted average remaining contractual life Balance, December 31, 2022 8,050,337 $ 3.89 Granted 1,877,109 1.33 Forfeited or expired ( 1,944,253 ) 5.83 Balance, September 30, 2023 7,983,193 2.81 $ 28 7.3 years Exercisable 4,614,058 3.67 — 6.3 years Included in the table above are 972,872 options outstanding as of September 30, 2023 that were granted outside the A&R Plan. The grants were made pursuant to the inducement grant exception in accordance with Nasdaq Listing Rule 5635(c)(4). Restricted stock units Restricted stock units (“RSUs”) vest over six months to four years depending on the purpose of the award and sometimes include performance conditions in addition to service conditions. The fair value of RSUs on the date of grant is measured as the closing price of the Company’s common stock on that date. The weighted average grant-date fair value of RSUs awarded to employees was $ 1.30 in the nine months ended September 30, 2023 and $ 1.32 in the nine months ended September 30, 2022. The fair value of RSUs vested was $ 1,299 and $ 774 in the nine months ended September 30, 2023 and 2022, respectively. The following table presents information about recent RSU activity: Number of shares Weighted average grant date fair value Balance, December 31, 2022 2,061,866 $ 1.71 Granted 2,640,762 1.30 Vested ( 1,284,143 ) 3.19 Forfeited ( 232,540 ) 1.82 Balance, September 30, 2023 3,185,945 2.12 Included in the table above are 73,506 time-based RSUs outstanding at September 30, 2023 that were granted outside of the A&R Plan. The grants were made pursuant to the inducement grant exception in accordance with Nasdaq Listing Rule 5635(c)(4). Other information The following table presents the classification of stock-based compensation expense: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Cost of sales $ 486 $ 428 $ 1,481 $ 1,427 Selling, general and administrative expenses 693 832 2,335 2,720 Total $ 1,179 $ 1,260 $ 3,816 $ 4,147 As of September 30, 2023, there was $ 7,287 of unrecognized compensation expense related to unvested options and RSUs that are expected to vest and will be expensed over a weighted average period of 2.4 years. |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (13) Income taxes The tax provision for interim periods is determined using the estimated annual effective consolidated tax rate, based on the current estimate of full-year earnings before taxes, adjusted for the impact of discrete quarterly items. The provision for income taxes was $ 3 and $ 114 for the three and nine months ended September 30, 2023 , respectively. There was no provision for income taxes for the three or nine months ended September 30, 2022 . The change in effective tax rate from 0 % in the prior periods was due to the utilization of all net operating loss carryforwards without limitations during 2022 in connection with the sale-leaseback transaction (see note 9). |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 9 Months Ended |
Sep. 30, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | (14) Fair value of financial instruments The Company follows the provisions of FASB ASC Topic 820, “ Fair Value Measurements and Disclosures ,” for fair value measurement recognition and disclosure purposes for its financial assets and financial liabilities that are remeasured and reported at fair value each reporting period. The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, short-term investments and certain warrants. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of financial assets and financial liabilities and their placement within the fair value hierarchy. Categorization is based on a three-tier valuation hierarchy, which prioritizes the inputs used in measuring fair value, as follows: • Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; • Level 2: Inputs that are other than quoted prices in active markets for identical assets and liabilities, inputs that are quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are either directly or indirectly observable; and • Level 3: Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. Items measured at fair value on a recurring basis Cash equivalents of $ 4 at September 30, 2023 and $ 6,034 at December 31, 2022 consisted entirely of money market mutual funds whose fair value were determined using Level 1 measurements. Fair value disclosures The Company follows the disclosure provisions of FASB ASC Topic 825, “ Financial Instruments ” (ASC 825), for disclosure purposes for financial assets and financial liabilities that are not measured at fair value. As of September 30, 2023, the financial assets and liabilities recorded on the consolidated balance sheets that are not measured at fair value on a recurring basis include accounts receivable, accounts payable and accrued expenses. The carrying values of these financial assets and liabilities approximate fair value due to their short-term nature. The fair value of long-term debt, where a quoted market price is not available, is evaluated based on, among other factors, interest rates currently available to the Company for debt with similar terms, remaining payments and considerations of the Company’s creditworthiness. The Company determined that the recorded book value of its debt, a level 2 measurement, approximated fair value at September 30, 2023 due to the recent issuances of those instruments and taking into consideration management’s current evaluation of market conditions. |
Leases
Leases | 9 Months Ended |
Sep. 30, 2023 | |
Lessee Disclosure [Abstract] | |
Leases | (15) Leases The Company is party to two operating leases for development facilities in California and Georgia that end in 2031 and 2025 , respectively, as well as other immaterial operating leases for office space, storage and office equipment. The development facility leases each include options to extend, none of which are included in the lease terms. Short-term and variable lease costs were not material for the periods presented. The development facility leases do not provide an implicit rate, so the Company uses its incremental borrowing rate to discount the lease liabilities. Undiscounted future lease payments for the two development leases, which were the only material noncancelable leases at September 30, 2023, were as follows: Twelve months ending September 30, 2024 $ 1,182 2025 1,210 2026 1,084 2027 1,114 2028 1,146 Thereafter 3,011 Total lease payments 8,747 Less imputed interest ( 3,378 ) Total operating lease liabilities $ 5,369 At September 30, 2023, the weighted average remaining lease term was 7.1 years, and the weighted average discount rate was 14.1 % . Total lease cost was $ 549 and $ 525 for the three months ended September 30, 2023 and 2022, respectively, and $ 1,350 and $ 1,498 for the nine months ended September 30, 2023 and 2022 , respectively. |
Summary of Significant Accoun_2
Summary of Significant Accounting Principles (Policies) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of presentation and principles of consolidation The accompanying unaudited consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information. In accordance with Securities and Exchange Commission’s (“SEC”) rules for interim financial statements, certain information required by U.S. GAAP may be condensed or omitted. The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. In the opinion of management, the accompanying consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s results for the interim periods. Operating results for interim periods are not necessarily indicative of the results that may be expected for the full year. The Company has determined that it operates in a single segment. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2022. |
Use of Estimates | Use of estimates The preparation of financial statements and the notes to the financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from such estimates. |
Cash and Cash Equivalents | Cash and cash equivalents Cash and cash equivalents represent cash in banks and highly liquid short-term investments that have maturities of three months or less when acquired. These highly liquid short-term investments are both readily convertible to known amounts of cash and so near to their maturity that they present insignificant risk of changes in value due to changes in interest rates. |
Accounts Receivable, net | Accounts receivable, net Accounts receivable generally represent amounts billed for services provided under our customer contracts and are recorded at the invoiced amount net of an allowance for credit losses, if necessary. We apply judgment in assessing the ultimate realization of our receivables, and we estimate an allowance for credit losses based on various factors, such as the aging of our receivables, historical experience, and the financial condition of our customers. The allowance for credit losses was not material as of the balance sheet dates presented. |
Inventory | Inventory Inventory is stated at the lower of cost or net realizable value. Included in inventory are raw materials and work-in-process used in the production of commercial products. Items are issued out of inventory using the first-in, first-out method. Adjustments to inventory are determined at the raw materials, work-in-process, and finished good levels to reflect obsolescence or impaired balances. Factors influencing inventory obsolescence include changes in demand, product life cycle, product pricing, physical deterioration and quality concerns. |
Property, Plant and Equipment, net | Property, plant and equipment, net Property, plant and equipment are recorded at cost less accumulated depreciation and amortization. Depreciation and amortization are computed using the straight-line method over the estimated useful lives of the assets, which are as follows: three to ten years for furniture, office and computer equipment; six to ten years for manufacturing equipment; 40 years for buildings; and the shorter of the lease term or useful life for leasehold improvements. Repairs and maintenance costs are expensed as incurred. The Company reviews the carrying value of property, plant and equipment for recoverability whenever events occur or changes in circumstances indicate that the carrying amount of individual assets or asset groups may not be recoverable. The Company considers assets to be held for sale when (i) management commits to a plan to sell the asset; (ii) the asset is available for immediate sale in its present condition; (iii) the asset is actively being marketed for sale at a price that is reasonable given the estimate of current market value; and (iv) the sale is probable and will be completed within one year. Upon designation of an asset as held for sale, the Company records the asset’s value at the lower of its carrying value plus selling costs or its estimated net realizable value. |
Goodwill and Intangible Assets | Goodwill and intangible assets Goodwill represents the excess of purchase price over the fair value of net assets acquired by the Company in a business combination. Goodwill is not amortized but assessed for impairment on an annual basis or more frequently if impairment indicators exist. The impairment analysis for goodwill consists of an optional qualitative assessment potentially followed by a quantitative analysis. If the Company determines that the carrying value of its reporting unit exceeds its fair value, an impairment charge is recorded for the excess. The Company performs its annual goodwill impairment test as of November 30 th , or whenever an event or change in circumstance occurs that would require reassessment of the impairment of goodwill. In performing the evaluation, the Company assesses qualitative factors such as overall financial performance, actual and anticipated changes in industry and market conditions, and competitive environments. As a result of the most recent annual goodwill impairment test, the Company determined that there was no impairment of goodwill. Definite-lived intangible assets are amortized on a straight-line basis over their estimated useful life. The Company is required to review the carrying value of definite-lived intangible assets for recoverability whenever events occur or changes in circumstances indicate that the carrying amount of an asset or asset group may not be recoverable. |
Contingencies | Contingencies The Company’s business exposes it to various contingencies including compliance with regulations, legal exposures and other matters. Loss contingencies are reflected in the financial statements based on management’s assessments of their expected outcome or resolution: • They are recognized as liabilities on the balance sheet if the potential loss is probable and the amount can be reasonably estimated. • They are disclosed if the potential loss is material and considered at least reasonably possible. Significant judgment is required to determine probability and whether the amount can be reasonably estimated. Due to uncertainties related to these matters, accruals are based only on the information available at the time. As additional information becomes available, the Company reassesses potential liabilities and may revise previous estimates. |
Revenue Recognition | Revenue recognition The Company generates revenues from manufacturing, profit-sharing and development services for multiple pharmaceutical companies. Manufacturing Manufacturing, packaging and other related services revenue is recognized upon transfer of control of a product to a customer, generally upon shipment, based on a transaction price that reflects the consideration the Company expects to be entitled to as specified in the agreement with the commercial partner, which could include variable consideration such as pricing and volume-based adjustments. Profit-sharing In addition to manufacturing and packaging revenue, certain customers who use our technologies are subject to agreements that provide us intellectual property sales-based profit-sharing and/or royalties consideration, collectively referred to as profit-sharing, computed on the net product sales of the commercial partner. Profit-sharing revenues are generally recognized under the terms of the applicable license, development and/or supply agreement. The Company has determined that, in its arrangements, the license for intellectual property is not the predominant item to which the profit-sharing relates, so the Company recognizes revenue upon transfer of control of the manufactured product. In these cases, significant judgment is required to calculate the estimated variable consideration from such profit-sharing using the expected value method based on historical commercial partner pricing and deductions. Estimated variable consideration is partially constrained due to the uncertainty of price adjustments made by the Company’s commercial partners, which are outside of the Company’s control. Factors causing price adjustments by the Company’s commercial partners include increased competition in the products’ markets, mix of volume between the commercial partners’ customers, and changes in government pricing. Development Development revenue includes services associated with formulation, process development, clinical trial materials services, as well as custom development of manufacturing processes and analytical methods for a customer’s non-clinical, clinical and commercial products. Such revenues are recognized at a point in time or over time depending on the nature and particular facts and circumstances associated with the contract terms. In contracts that specify milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments related to arrangements under which the Company has continuing performance obligations are deferred and recognized over the period of performance. Milestone payments that are not within the Company’s control, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received. In contracts that require revenue recognition over time, the Company utilizes input or output methods, depending on the specifics of the contract, that compare the cumulative work-in-process to date to the most current estimates for the entire performance obligation. Under these contracts, the customer typically owns the product details and process, which have no alternative use. These projects are customized to each customer to meet its specifications, and typically only one performance obligation is included. Each project represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of its product as the product is being created or enhanced by the Company’s services and can make changes to its process or specifications upon request. Contract assets represent revenue recognized for performance obligations completed or in process before an unconditional right to payment exists, and therefore invoicing or associated reporting from the customer regarding the computation of the net product sales has not yet occurred. Contract liabilities represent payments received from customers prior to the completion of associated performance obligations. |
Concentration of Credit Risk | Concentration of credit risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and accounts receivable. The Company manages its cash and cash equivalents based on established guidelines that balance safety and liquidity. The Company’s accounts receivable balances are primarily concentrated among three customers, with balances in the aggregate accounting for 71 % of the balance as of September 30, 2023. If any of these customers’ receivable balances should be deemed uncollectible, it could have a material adverse effect on the Company’s results of operations and financial condition. The Company is dependent on its relationships with a small number of commercial partners. The Company’s three largest customers generated 75 % and 64 % of revenues for the three months ended September 30, 2023 and 2022, respectively, and 75 % and 69 % of its revenues for the nine months ended September 30, 2023 and 2022 , respectively. |
Stock-based Compensation Expense | Stock-based compensation expense The Company measures employee stock-based awards at grant-date fair value and recognizes employee compensation expense on a straight-line basis over the vesting period of the award. The Company accounts for forfeitures as they occur. Determining the appropriate fair value of stock options requires the use of subjective assumptions, including the expected life of the option and expected stock price volatility. The Company uses the Black-Scholes option pricing model to value its stock option awards. The assumptions used in calculating the fair value of stock-based awards represent management’s best estimates and involve inherent uncertainties and the application of management’s judgment. As a result, if factors change and/or management uses different assumptions, stock-based compensation expense could be materially different for future awards. The expected life of stock options was estimated using the “simplified method,” which is based on the average of the vesting tranches and the contractual life of each grant. For stock price volatility, the Company uses the historical volatility of its publicly traded stock in order to estimate future stock price trends. The risk-free interest rate is based on U.S. Treasury notes with a term approximating the expected life of the option. Upon exercise of stock options or vesting of restricted stock units, the holder may elect to cover tax withholdings by forfeiting shares of an equivalent value. In such cases, the Company issues net new shares to the holder, pays the tax withholding on behalf of the participant and presents the payment similar to a capital distribution: a reduction to additional paid-in-capital and a financing cash outflow in the consolidated financial statements. |
Income Taxes | Income taxes Income taxes are accounted for under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax basis, operating losses and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in operations in the period that includes the enactment date. In assessing the realizability of net deferred tax assets, the Company considers all relevant positive and negative evidence in determining whether it is more likely than not that some portion or all of the deferred income tax assets will not be realized. The realization of the gross deferred tax assets is dependent on several factors, including the generation of sufficient taxable income prior to the expiration of the net operating loss carryforwards. A full valuation allowance was recorded as of September 30, 2023 and December 31, 2022. Unrecognized income tax benefits represent income tax positions taken on income tax returns that have not been recognized in the consolidated financial statements. The Company recognizes the benefit of an income tax position only if it is more likely than not (greater than 50%) that the tax position will be sustained upon tax examination, based solely on the technical merits of the tax position. Otherwise, no benefit is recognized. The tax benefits recognized are measured based on the largest benefit that has a greater than 50% likelihood of being realized upon ultimate settlement. The Company does not anticipate significant changes in the amount of unrecognized income tax benefits over the next year. |
Leases | Leases The Company determines under U.S. GAAP if an arrangement is a lease at inception. The arrangement is a lease if it conveys the right to the Company to control the use of identified property, plant, or equipment for a period of time in exchange for consideration. Options to extend the lease are included in the lease term if the options are reasonably certain to be exercised. Operating lease expense is recognized on a straight-line basis over the lease term. In a sale-leaseback transaction, the Company determines if it relinquished control of the assets to the buyer-lessor. If control is not relinquished, it does not derecognize the asset and does not apply the lease accounting model. Operating lease balances are presented as separate captions on the balance sheets. Finance lease assets are included in property, plant and equipment. Finance lease liabilities are included in other liabilities. |
Income or Loss Per Share | Income or loss per share Basic income or loss per share is determined by dividing net income or loss (the numerator) by the weighted average common shares outstanding during the period (the denominator). The denominator includes the weighted average common stock equivalents for warrants priced at $0.0001, as the underlying common shares will be issued for little cash consideration and the conditions for the issuance of the underlying common shares are met when such warrants are issued. To calculate diluted income or loss per share, the numerator and denominator are adjusted to eliminate the income or loss and the dilutive effects on shares, respectively, caused by outstanding common stock options, warrants and unvested restricted stock units, using the treasury stock method, if the inclusion of such instruments would be dilutive. For all periods presented, the Company incurred a net loss. In periods of net loss, the inclusion of dilutive securities would be antidilutive because it would reduce the amount of loss incurred per share. As a result, no additional dilutive shares were included in diluted loss per share, and there were no differences between basic and diluted loss per share. The following table presents the potentially dilutive securities that were excluded from the computations of diluted loss per share: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Restricted stock units 2,702,088 1,717,982 2,834,632 1,461,529 Stock options 8,320,590 8,020,457 7,402,889 7,331,963 Warrants 567,588 348,664 457,280 348,664 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Fair Value Measurement | The Company follows the provisions of FASB ASC Topic 820, “ Fair Value Measurements and Disclosures ,” for fair value measurement recognition and disclosure purposes for its financial assets and financial liabilities that are remeasured and reported at fair value each reporting period. The Company measures certain financial assets and liabilities at fair value on a recurring basis, including cash equivalents, short-term investments and certain warrants. The Company’s assessment of the significance of a particular input to the fair value measurement requires judgment and may affect the valuation of financial assets and financial liabilities and their placement within the fair value hierarchy. Categorization is based on a three-tier valuation hierarchy, which prioritizes the inputs used in measuring fair value, as follows: • Level 1: Observable inputs such as quoted prices (unadjusted) in active markets for identical assets or liabilities; • Level 2: Inputs that are other than quoted prices in active markets for identical assets and liabilities, inputs that are quoted prices for identical or similar assets or liabilities in inactive markets, or other inputs that are either directly or indirectly observable; and • Level 3: Unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions. |
Summary of Significant Accoun_3
Summary of Significant Accounting Principles (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Accounting Policies [Abstract] | |
Schedule of Anti-Dilutive Securities | The following table presents the potentially dilutive securities that were excluded from the computations of diluted loss per share: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Restricted stock units 2,702,088 1,717,982 2,834,632 1,461,529 Stock options 8,320,590 8,020,457 7,402,889 7,331,963 Warrants 567,588 348,664 457,280 348,664 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | The following table presents the components of inventory: September 30, 2023 December 31, 2022 Raw materials $ 6,095 $ 4,318 Work in process 3,618 3,689 Finished goods 2,566 2,294 Inventory $ 12,279 $ 10,301 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Components of Other Intangible Assets | The following table presents the components of other intangible assets: September 30, 2023 December 31, 2022 Gross value Accumulated amortization Carrying value Gross value Accumulated amortization Carrying value Customer relationships $ 18,900 $ 16,553 $ 2,347 $ 18,900 $ 16,188 $ 2,712 Backlog 460 399 61 460 261 199 Trademarks and tradenames 310 310 — 310 293 17 Total $ 19,670 $ 17,262 $ 2,408 $ 19,670 $ 16,742 $ 2,928 |
Schedule of Finite Lived Intangible Assets, Estimated Future Amortization Expense | The following table presents estimated future amortization of other intangible assets: Twelve months ending September 30, 2024 $ 547 2025 486 2026 486 2027 486 2028 403 Thereafter — Total $ 2,408 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | The following table presents the components of property, plant and equipment: September 30, 2023 December 31, 2022 Land $ 604 $ 604 Building and improvements 22,867 22,751 Furniture, office and computer equipment 6,792 6,388 Manufacturing equipment 66,048 58,039 Construction in process 5,305 7,024 Property, plant and equipment, gross 101,616 94,806 Less: accumulated depreciation ( 50,484 ) ( 44,441 ) Property, plant and equipment, net $ 51,132 $ 50,365 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following: September 30, 2023 December 31, 2022 Payroll and related costs $ 3,595 $ 4,276 Contract liabilities (see note 11) 1,314 2,211 Professional and consulting fees 851 356 Accrued interest 783 227 Property, plant and equipment 513 934 Accrued transaction costs 50 3,653 Other 1,403 1,029 Total $ 8,509 $ 12,686 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Components and Classification of Debt | The following table presents the components and classification of debt: September 30, 2023 December 31, 2022 Debt principal: Term loan under Credit Agreement $ 35,516 $ 36,900 Note with former equity holder of IriSys 4,078 4,078 Other 339 339 Debt principal 39,933 41,317 Debt adjustments: Unamortized deferred issuance costs ( 2,356 ) ( 2,476 ) Unamortized original discount ( 242 ) ( 297 ) Carrying value of debt $ 37,335 $ 38,544 Current portion of debt $ 9,891 $ 7,577 Debt, net of current portion 27,444 30,967 Carrying value of debt $ 37,335 $ 38,544 |
Schedule of Future Maturities of Debt | The following table presents the future maturity of debt principal: Twelve months ending September 30, 2024 $ 9,891 2025 3,498 2026 26,281 2027 44 2028 53 Thereafter 166 Total debt principal $ 39,933 |
Shareholders' Equity or Defic_2
Shareholders' Equity or Deficit (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Equity [Abstract] | |
Schedule of Warrants Outstanding to Purchase of Common Stock | The following table presents the warrants outstanding to purchase shares of common stock as of September 30, 2023. All outstanding warrants are equity-classified. Number of shares Exercise price per share Expiration date Athyrium warrants 467,588 $ 1.29 November 17, 2024 IriSys warrants 100,000 1.00 August 13, 2026 Pre-Funded warrants 6,110,000 0.0001 None |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Schedule of Changes in Contract Assets and Liabilities | The following table presents changes in contract assets and liabilities: Contract assets Contract liabilities Balance at December 31, 2022 $ 8,724 $ ( 2,211 ) Changes to the beginning balance arising from: Reclassification to receivables as the result of rights to consideration becoming unconditional ( 10,239 ) — Reclassification to revenue as the result of performance obligations satisfied 963 1,586 Changes in estimate 1,651 — Net change to contract balance recognized since beginning of period due to recognition of revenue, amounts billed and changes in estimate 8,977 ( 689 ) Balance at September 30, 2023 $ 10,076 $ ( 1,314 ) |
Disaggregation of Revenue by Timing of Revenue Recognition | The following table disaggregates revenue by timing of revenue recognition: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Point in time $ 18,805 $ 15,565 $ 51,986 $ 51,851 Over time 4,785 6,024 14,930 14,084 Total $ 23,590 $ 21,589 $ 66,916 $ 65,935 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Fair Value of Stock Options Granted | The following table presents information about the fair value of stock options granted: Nine months ended September 30, 2023 2022 Weighted average grant date fair value $ 0.94 $ 1.02 Assumptions used to determine fair value: Range of expected option life 5.5 - 6.0 years 5.5 - 6.0 years Expected volatility 79 - 84 % 79 - 81 % Risk-free interest rate 3.5 - 4.6 % 1.5 - 4.0 % Expected dividend yield — — |
Summary of Stock Option Activity | The following table presents information about stock option balances and activity: Number of shares Weighted average exercise price Aggregate intrinsic value Weighted average remaining contractual life Balance, December 31, 2022 8,050,337 $ 3.89 Granted 1,877,109 1.33 Forfeited or expired ( 1,944,253 ) 5.83 Balance, September 30, 2023 7,983,193 2.81 $ 28 7.3 years Exercisable 4,614,058 3.67 — 6.3 years |
Summary of Restricted Stock Units Activity | The following table presents information about recent RSU activity: Number of shares Weighted average grant date fair value Balance, December 31, 2022 2,061,866 $ 1.71 Granted 2,640,762 1.30 Vested ( 1,284,143 ) 3.19 Forfeited ( 232,540 ) 1.82 Balance, September 30, 2023 3,185,945 2.12 |
Summary of Stock Based Compensation Expense | The following table presents the classification of stock-based compensation expense: Three months ended September 30, Nine months ended September 30, 2023 2022 2023 2022 Cost of sales $ 486 $ 428 $ 1,481 $ 1,427 Selling, general and administrative expenses 693 832 2,335 2,720 Total $ 1,179 $ 1,260 $ 3,816 $ 4,147 |
Leases - (Tables)
Leases - (Tables) | 9 Months Ended |
Sep. 30, 2023 | |
Lessee Disclosure [Abstract] | |
Schedule of Undiscounted Future Lease Payments for the Development Lease | Undiscounted future lease payments for the two development leases, which were the only material noncancelable leases at September 30, 2023, were as follows: Twelve months ending September 30, 2024 $ 1,182 2025 1,210 2026 1,084 2027 1,114 2028 1,146 Thereafter 3,011 Total lease payments 8,747 Less imputed interest ( 3,378 ) Total operating lease liabilities $ 5,369 |
Background - Additional Informa
Background - Additional Information (Detail) $ in Thousands | 1 Months Ended | 9 Months Ended | |
Aug. 31, 2023 shares | Sep. 30, 2023 USD ($) a | Dec. 31, 2022 USD ($) | |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Entity incorporation date | Nov. 15, 2007 | ||
Accumulated deficit | $ | $ (278,123) | $ (265,635) | |
Cash and cash equivalents | $ | $ 8,156 | $ 14,995 | |
Underwriting Agreement [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Public offering which issued and sold | 14,640,000 | ||
Common stock public offering price | 0.4 | ||
Pre-funded warrants to purchase | 6,110,000 | ||
Land [Member] | |||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||
Area Of Land | a | 121 |
Summary of Significant Accoun_4
Summary of Significant Accounting Principles - Additional Information (Detail) - Customer | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Accounts Receivable [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Number of customers | 3 | |||
Accounts Receivable [Member] | Customer Concentration Risk [Member] | Cash [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Concentration risk percentage | 71% | |||
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | Cash [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Concentration risk percentage | 75% | 64% | 75% | 69% |
Furniture and Office Equipment [Member] | Minimum [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Property, plant and equipment estimated useful lives | 3 years | 3 years | ||
Furniture and Office Equipment [Member] | Maximum [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Property, plant and equipment estimated useful lives | 10 years | 10 years | ||
Manufacturing Equipment [Member] | Minimum [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Property, plant and equipment estimated useful lives | 6 years | 6 years | ||
Manufacturing Equipment [Member] | Maximum [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Property, plant and equipment estimated useful lives | 10 years | 10 years | ||
Buildings [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Property, plant and equipment estimated useful lives | 40 years | 40 years | ||
Leasehold Improvements [Member] | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ||||
Property, Plant, and Equipment, Useful Life, Term, Description [Extensible Enumeration] | us-gaap:UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMember | us-gaap:UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMember |
Summary of Significant Accoun_5
Summary of Significant Accounting Principles - Schedule of Anti-Dilutive Securities (Detail) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Restricted Stock Units [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of diluted weighted average shares outstanding | 2,702,088 | 1,717,982 | 2,834,632 | 1,461,529 |
Stock options [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of diluted weighted average shares outstanding | 8,320,590 | 8,020,457 | 7,402,889 | 7,331,963 |
Warrants [Member] | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of diluted weighted average shares outstanding | 567,588 | 348,664 | 457,280 | 348,664 |
Inventory - Components of Inven
Inventory - Components of Inventory (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 6,095 | $ 4,318 |
Work in process | 3,618 | 3,689 |
Finished goods | 2,566 | 2,294 |
Inventory | $ 12,279 | $ 10,301 |
Intangible Assets , Net - Summa
Intangible Assets , Net - Summary of Components of Other Intangible Assets (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | $ 19,670 | $ 19,670 |
Accumulated amortization | 17,262 | 16,742 |
Carrying value | 2,408 | 2,928 |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | 18,900 | 18,900 |
Accumulated amortization | 16,553 | 16,188 |
Carrying value | 2,347 | 2,712 |
Backlog [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | 460 | 460 |
Accumulated amortization | 399 | 261 |
Carrying value | 61 | 199 |
Trademarks and Trade Names [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | 310 | 310 |
Accumulated amortization | $ 310 | 293 |
Carrying value | $ 17 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Finite Lived Intangible Assets, Estimated Future Amortization Expense (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2024 | $ 547 | |
2025 | 486 | |
2026 | 486 | |
2027 | 486 | |
2028 | 403 | |
Thereafter | 0 | |
Carrying value | $ 2,408 | $ 2,928 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 101,616 | $ 94,806 |
Less: accumulated depreciation | (50,484) | (44,441) |
Property, plant and equipment, net | 51,132 | 50,365 |
Land [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 604 | 604 |
Buildings and Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 22,867 | 22,751 |
Furniture, Office & Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 6,792 | 6,388 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 66,048 | 58,039 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 5,305 | $ 7,024 |
Property, Plant and Equipment_4
Property, Plant and Equipment, Net - Additional Information (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) a | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) a | Sep. 30, 2022 USD ($) | |
Property, Plant and Equipment [Line Items] | ||||
Interest Expense | $ 2,911 | $ 3,586 | $ 7,370 | $ 10,434 |
Construction in Progress [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Interest Expense | $ 137 | $ 419 | $ 403 | $ 982 |
Land [Member] | ||||
Property, Plant and Equipment [Line Items] | ||||
Area Of Land | a | 121 | 121 | ||
Proceeds from Sale of property plant and equipment | $ 9,075 | |||
Carrying value of other assets | $ 2,815 | 2,815 | ||
Cumulative closing costs | $ 156 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Payroll and related costs | $ 3,595 | $ 4,276 |
Contract liabilities | 1,314 | 2,211 |
Professional and consulting fees | 851 | 356 |
Accrued interest | 783 | 227 |
Property, plant and equipment | 513 | 934 |
Accrued transaction costs | 50 | 3,653 |
Other | 1,403 | 1,029 |
Total | $ 8,509 | $ 12,686 |
Accrued Expenses and Other Cu_4
Accrued Expenses and Other Current Liabilities - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | Dec. 31, 2022 | |
Severance and other related costs | $ 1,059 | ||||
Accrued and unpaid severance costs | 545 | ||||
Cost of sales | $ 19,870 | $ 16,055 | 56,476 | $ 49,639 | |
Selling, general and administrative | 5,309 | $ 5,075 | 15,243 | $ 15,945 | |
Cost Of Sales [Member] | |||||
Cost of sales | 693 | ||||
Selling General And Administrative Expenses [Member] | |||||
Selling, general and administrative | 366 | ||||
Term loans under Credit Agreement [Member] | |||||
New term loan | $ 36,900 | $ 36,900 | |||
Term loans under Credit Agreement [Member] | Georgia [Member] | |||||
New term loan | $ 36,900 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | Sep. 30, 2023 USD ($) |
Executive Officer [Member] | |
Supply Commitment [Line Items] | |
Potential severance commitments arrangement consideration | $ 1,393 |
Other Contingencies | 4,597 |
Purchase Commitment [Member] | |
Supply Commitment [Line Items] | |
Purchase commitment non cancelable and cancelable | $ 9,021 |
Debt - Schedule of Components a
Debt - Schedule of Components and Classification of Debt (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Debt principal | $ 39,933 | $ 41,317 |
Unamortized deferred issuance costs | (2,356) | (2,476) |
Unamortized original discount | (242) | (297) |
Carrying value of debt | 37,335 | 38,544 |
Current portion of debt | 9,891 | 7,577 |
Debt, net of current portion | 27,444 | 30,967 |
Carrying value of debt | 37,335 | 38,544 |
Term loans under Credit Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Debt principal | 35,516 | 36,900 |
Current portion of debt | 2,815 | |
Note With Former [Member] | ||
Debt Instrument [Line Items] | ||
Debt principal | 4,078 | 4,078 |
Other [Member] | ||
Debt Instrument [Line Items] | ||
Debt principal | $ 339 | $ 339 |
Debt - Schedule of Future Matur
Debt - Schedule of Future Maturities of Debt (Detail) $ in Thousands | Sep. 30, 2023 USD ($) |
Debt Disclosure [Abstract] | |
2024 | $ 9,891 |
2025 | 3,498 |
2026 | 26,281 |
2027 | 44 |
2028 | 53 |
Thereafter | 166 |
Total debt principal | $ 39,933 |
Debt - Additional Information (
Debt - Additional Information (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) $ / shares | Sep. 30, 2022 USD ($) | Aug. 31, 2023 $ / shares shares | Dec. 31, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) | |
Debt Instrument [Line Items] | |||||||
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 | $ 0.01 | ||||
Long term debt, maturity, year two | $ 9,891 | $ 9,891 | |||||
Long term debt, maturity, year three | 3,498 | 3,498 | |||||
Cash and cash equivalents | 8,156 | 8,156 | $ 14,995 | ||||
Capital expenditure | 691 | $ 919 | |||||
Carrying value of debt | 37,335 | 37,335 | 38,544 | ||||
Current portion of debt | $ 9,891 | 9,891 | $ 7,577 | ||||
Non-cash interest expense | $ 1,215 | 3,778 | |||||
Athyrium Opportunities I I I Acquisition Limited Partnership Credit Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit agreement | $ 100,000 | ||||||
Term loan interest rate, Description | an interest rate equal to the three-month LIBOR rate plus 8.25% per annum | ||||||
Non-cash interest expense | $ 1,163 | $ 3,451 | |||||
Athyrium Opportunities I I I Acquisition Limited Partnership Credit Agreement [Member] | LIBOR [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Term loan variable interest rate | 8.25% | ||||||
Note With Former [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, maturity date | Aug. 13, 2024 | Aug. 13, 2024 | |||||
Number of shares | shares | 100,000 | ||||||
Common stock, par value | $ / shares | $ 0.01 | ||||||
Warrant, exercise price per share | $ / shares | $ 1 | ||||||
Carrying value of debt | $ 6,117 | $ 6,117 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 6% | 6% | |||||
Debt Instrument, Interest Rate, Basis for Effective Rate | 15.3 | ||||||
Long-term debt term | 3 years | 3 years | 3 years | ||||
Term loans under Credit Agreement [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Credit agreement | $ 36,900 | $ 36,900 | |||||
Long term debt, maturity, year two | 2,998 | 2,998 | |||||
Long term debt, maturity, year three | 3,459 | $ 3,459 | |||||
Repayment Terms | The outstanding principal amount will be repaid in quarterly amounts totaling $2,998 and $3,459 during the twelve months ending September 30, 2024 and 2025, respectively. The Company is obligated to make a $7,500 mandatory principal prepayment upon completion of the sale of certain real property, which is not included in the debt maturity disclosures above. Quarterly principal payments made after the completion of the land sale will be reduced proportionately to the reduction in principal. The final payment of all remaining outstanding principal is due on December 16, 2025. | ||||||
Repayment of debt within 12 months of credit agreement closing upon the sale of real property | $ 7,500 | ||||||
Cash and cash equivalents end of next twelve month | 4,500 | $ 4,500 | |||||
Minimum fixed charge ratio | 1 | ||||||
Term loan interest rate, Description | interest at a floating rate equal to the three-month term Secured Overnight Financing Rate, or SOFR, with an initial floor of 1.00%, plus an applicable margin that is equal to 4.50% per annum for the first year, 5.00% for the second year and 5.50% for the third year, with quarterly interest payments due until maturity. | ||||||
Debt instrument, early repayment terms | Subject to certain exceptions, the Company is required to make mandatory prepayments with the cash proceeds received in respect of asset sales, certain equity sales, extraordinary receipts, debt issuances, upon a change of control and specified other events. Additionally, the Company is obligated by December 14, 2023 to complete the sale of certain real property adjacent to its Gainesville, Georgia manufacturing campus (see note 5). If that property is not sold by December 14, 2023, the Company will be required to pay a fee of $369 and increase each of its quarterly principal payments by $231 until that property is sold and any mandatory prepayment is made. Because the Company concluded that the sale of the property is probable to occur in the first half of 2024, an additional $2,815 of debt principal has been presented as current, representing the carrying value of the current asset held for sale, and two quarterly principal payment increases of $231 have been included in the debt maturity disclosures above. | ||||||
Fee on debt instrument | 369 | ||||||
Increase in qauterly repayments | $ 231 | ||||||
Current portion of debt | $ 2,815 | $ 2,815 | |||||
Effective interest rate | 13.60% | 13.60% | |||||
Non-cash interest expense | $ 433 | $ 902 | |||||
Term loans under Credit Agreement [Member] | Maximum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Cash and cash equivalents end of year 2 | 5,000 | $ 5,000 | |||||
Minimum fixed charge ratio | 1.05 | ||||||
Maximum leverage ratio | 3.75 | ||||||
Capital expenditure | $ 9,000 | ||||||
Term loans under Credit Agreement [Member] | Minimum [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Cash and cash equivalents | $ 1,500 | $ 1,500 | |||||
Maximum leverage ratio | 2.75 | ||||||
Term loans under Credit Agreement [Member] | Debt Instrument, Redemption, Period One [Member] | Floor [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Term loan variable interest rate | 1% | ||||||
Term loans under Credit Agreement [Member] | Debt Instrument, Redemption, Period One [Member] | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Term loan variable interest rate | 4.50% | ||||||
Term loans under Credit Agreement [Member] | Debt Instrument, Redemption, Period Two [Member] | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Term loan variable interest rate | 5% | ||||||
Term loans under Credit Agreement [Member] | Debt Instrument, Redemption, Period Three [Member] | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate [Member] | |||||||
Debt Instrument [Line Items] | |||||||
Term loan variable interest rate | 5.50% |
Other Liabilities - Additional
Other Liabilities - Additional Information (Detail) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2023 | Dec. 31, 2022 | |
Accelerated Share Repurchases [Line Items] | ||
Sale Leaseback Liability | $ 38,803 | |
Other Liabilities | $ 39,936 | $ 39,225 |
Sale lease back transaction description of assets | In December 2022, the Company concurrently entered into sale and lease agreements related to its commercial manufacturing campus in Gainesville, Georgia. The selling price was $39,000, of which $1,750 was placed as a lease deposit and classified within other assets, resulting in cash proceeds to the Company of $37,250 in 2022. The lease is for an initial term of 20 years with four renewal options of ten years each. Rent under the lease will be payable monthly at a rate of $3,510 per year, increasing annually by 3%, except for the first year where annual base rent will increase by the change in the consumer price index, not to exceed 5%, if greater. The Company is responsible for the payment of all operating expenses, property taxes and insurance for the property. Pursuant to the terms of the lease, the Company will have a purchase option every ten years and a right of first offer and a right of first refusal to purchase the property should the buyer-lessor intend to sell the property to a third party. | |
Sale lease back transaction date | December 2022 | |
Lease Deposit | $ 1,750 | |
Lessee,lease, description | The lease is for an initial term of 20 years with four renewal options of ten years each. Rent under the lease will be payable monthly at a rate of $3,510 per year, increasing annually by 3%, except for the first year where annual base rent will increase by the change in the consumer price index, not to exceed 5%, if greater. | |
Lessee, lease, renewal term | 10 years | |
Proceeds from sales-lease back liability | $ 37,250 | |
Lease initial term | 20 years | |
Annual base rent under the lease | $ 3,510 | |
Percentage of increase in rent amount | 3% | |
Company recognized liability | $ 38,803 | |
Unamortized deferred financing costs | $ 828 | |
Imputed rate of interest | 11% | |
Term of contract under recognize interest expense | 20 years | |
Description of sale leaseback liability, gross liability period | The gross liability balance is scheduled to increase through 2034, at which point it will decrease through the end of lease term on December 31, 2042. | |
Maximum [Member] | ||
Accelerated Share Repurchases [Line Items] | ||
Percentage of increase in rent amount | 5% | |
Gainesville, Georgia | ||
Accelerated Share Repurchases [Line Items] | ||
Other Liabilities | $ 1,133 | |
Selling price | $ 39,000 |
Shareholders' Equity or Defic_3
Shareholders' Equity or Deficit - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | |||
Aug. 31, 2023 | Sep. 30, 2023 | May 17, 2023 | Dec. 31, 2022 | |
Schedule Of Capitalization Equity [Line Items] | ||||
Increase in number of authorized shares of common stock | 185,000,000 | 185,000,000 | ||
Shares of convertible preferred stock issued | 0 | 450,000 | ||
Preferred stock, shares outstanding | 0 | 450,000 | ||
Convertible preferred stock, par value | $ 0.01 | $ 0.01 | ||
Proceeds from issuance of common stock underwriting discounts and commissions and estimated offering expenses | $ 7,352 | |||
Underwriting Agreement [Member] | ||||
Schedule Of Capitalization Equity [Line Items] | ||||
Public offering which issued and sold | 14,640,000 | |||
Common stock public offering price | 0.4 | |||
Minimum [Member] | ||||
Schedule Of Capitalization Equity [Line Items] | ||||
Increase in number of authorized shares of common stock | 95,000,000 | |||
Maximum [Member] | ||||
Schedule Of Capitalization Equity [Line Items] | ||||
Increase in number of authorized shares of common stock | 185,000,000 | |||
Preferred Class A [Member] | ||||
Schedule Of Capitalization Equity [Line Items] | ||||
Shares of convertible preferred stock issued | 0 | 450,000 | ||
Preferred stock, shares outstanding | 0 | |||
Convertible preferred stock, par value | $ 11 | |||
Equity [Member] | Athyrium Opportunities II Acquisition LP [Member] | Warrants, Exercise Price $1.29, Expiring on November 2024 [Member] | ||||
Schedule Of Capitalization Equity [Line Items] | ||||
Warrants outstanding to purchase shares, Number of Shares | 467,588 | |||
Warrant, exercise price per share | $ 1.29 | |||
Equity [Member] | Irisys LLC [Member] | Warrants, Exercise Price $1.00, Expiring on August 2026 [Member] | ||||
Schedule Of Capitalization Equity [Line Items] | ||||
Warrants outstanding to purchase shares, Number of Shares | 100,000 | |||
Warrant, exercise price per share | $ 1 | |||
Equity [Member] | Pre Funded Warrants [Member] | ||||
Schedule Of Capitalization Equity [Line Items] | ||||
Warrants outstanding to purchase shares, Number of Shares | 6,110,000 | 6,110,000 | ||
Warrant, exercise price per share | $ 0.0001 | $ 0.0001 |
Shareholders' Equity or Defic_4
Shareholders' Equity or Deficit - Schedule of Warrants Outstanding to Purchase Shares of Common Stock (Detail) - Equity [Member] - $ / shares | Sep. 30, 2023 | Aug. 31, 2023 |
Athyrium warrants | Warrants, Exercise Price $1.29, Expiring on November 2024 [Member] | ||
Schedule of Capitalization, Equity [Line Items] | ||
Number of shares | 467,588 | |
Exercise price per share | $ 1.29 | |
IriSys warrants | Warrants Exercise Price One Per Share and Expiration Date August 2026 [Member] | ||
Schedule of Capitalization, Equity [Line Items] | ||
Number of shares | 100,000 | |
Exercise price per share | $ 1 | |
Pre-Funded warrants | ||
Schedule of Capitalization, Equity [Line Items] | ||
Number of shares | 6,110,000 | 6,110,000 |
Exercise price per share | $ 0.0001 | $ 0.0001 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Changes in Contract Assets and Liabilities (Detail) $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) | |
Contract with Customer Asset | |
Balance at December 31, 2022 | $ 8,724 |
Changes to the beginning balance of contract assets arising from: | |
Reclassification to receivables as a result of rights to consideration becoming unconditional | (10,239) |
Reclassification to revenue as the result of performance obligations satisfied | 963 |
Changes in estimate | 1,651 |
Net change to contract balance recognized since beginning of period due to recognition of revenue, amounts billed and changes in estimate | 8,977 |
Balance at September 30, 2023 | 10,076 |
Contract with Customer, Liability | |
Balance at December 31, 2022 | (2,211) |
Changes to the beginning balance of contract liabilities arising from : | |
Reclassification to revenue as the result of performance obligations satisfied | 1,586 |
Net change to contract balance recognized since beginning of period due to recognition of revenue, amounts billed and changes in estimate | (689) |
Balance at September 30, 2023 | $ (1,314) |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue by Timing of Revenue Recognition (Detail) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Disaggregation Of Revenue [Line Items] | ||||
Revenue | $ 23,590 | $ 21,589 | $ 66,916 | $ 65,935 |
Point In Time [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue | 18,805 | 15,565 | 51,986 | 51,851 |
Over Time [Member] | ||||
Disaggregation Of Revenue [Line Items] | ||||
Revenue | $ 4,785 | $ 6,024 | $ 14,930 | $ 14,084 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 9 Months Ended | |
Dec. 31, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock options exercisable period | 10 years | ||
Stock options vest period | 4 years | ||
Weighted average grant date fair value | $ 0.94 | $ 1.02 | |
Number of options, exercised | $ 0 | ||
Number of options, Granted | 972,872 | ||
Unrecognized compensation expense related to unvested options and time-based RSUs, expected to vest | $ 7,287 | ||
Unrecognized compensation expense related to unvested options, weighted average period | 2 years 4 months 24 days | ||
Stock Options Granted Outside Plan [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Number of shares, Granted | 73,506 | ||
Restricted Stock Units [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted average grant date fair value | $ 1.3 | $ 1.32 | |
Number of shares, Granted | 2,640,762 | ||
Fair value vested | $ 1,299 | $ 774 | |
Restricted Stock Units [Member] | Minimum [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock options vest period | 6 months | ||
Restricted Stock Units [Member] | Maximum [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock options vest period | 4 years | ||
A&R Plan [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Percentage of outstanding common stock | 5% | ||
2013 Equity Incentive Plan [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Shares available for future grants | 862,334 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options Granted (Detail) - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted average grant date fair value | $ 0.94 | $ 1.02 |
Assumptions used to determine fair value: | ||
Expected dividend yield | 0% | 0% |
Minimum [Member] | ||
Assumptions used to determine fair value: | ||
Range of expected option life | 5 years 6 months | 5 years 6 months |
Expected volatility | 79% | 79% |
Risk-free interest rate | 3.50% | 1.50% |
Maximum [Member] | ||
Assumptions used to determine fair value: | ||
Range of expected option life | 6 years | 6 years |
Expected volatility | 84% | 81% |
Risk-free interest rate | 4.60% | 4% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 9 Months Ended |
Sep. 30, 2023 USD ($) $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | |
Number of shares, Beginning balance | shares | 8,050,337 |
Number of shares, Granted | shares | 1,877,109 |
Number of shares, Exercisable | shares | 4,614,058 |
Number of shares, Forfeited or expired | shares | (1,944,253) |
Number of shares, Ending balance | shares | 7,983,193 |
Weighted average exercise price, Beginning balance | $ / shares | $ 3.89 |
Weighted average exercise price, Granted | $ / shares | 1.33 |
Weighted average exercise price, Forfeited or expired | $ / shares | 5.83 |
Weighted average exercise price, Ending balance | $ / shares | 2.81 |
Weighted average exercise price, Exercisable | $ / shares | $ 3.67 |
Aggregate intrinsic value | $ | $ 28 |
Aggregate intrinsic value, Exercisable | $ | $ 0 |
Weighted average remaining contractual life | 7 years 3 months 18 days |
Weighted average remaining contractual life, Exercisable | 6 years 3 months 18 days |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - $ / shares | 9 Months Ended | |
Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted average grant date fair value, Granted | $ 0.94 | $ 1.02 |
Restricted Stock Units [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares, Beginning balance | 2,061,866 | |
Number of shares, Granted | 2,640,762 | |
Number of shares, Vested | (1,284,143) | |
Number of shares, Forfeited | (232,540) | |
Number of shares, Ending balance | 3,185,945 | |
Weighted average grant date fair value, Beginning balance | $ 1.71 | |
Weighted average grant date fair value, Granted | 1.3 | $ 1.32 |
Weighted average grant date fair value, Vested | 3.19 | |
Weighted average grant date fair value, Forfeited | 1.82 | |
Weighted average grant date fair value, Ending balance | $ 2.12 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Based Compensation Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock based compensation expense | $ 1,179 | $ 1,260 | $ 3,816 | $ 4,147 |
Cost Of Sales [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock based compensation expense | 486 | 428 | 1,481 | 1,427 |
Selling General And Administrative Expenses [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock based compensation expense | $ 693 | $ 832 | $ 2,335 | $ 2,720 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 | Sep. 30, 2022 | Sep. 30, 2023 | Sep. 30, 2022 | |
Income Tax Disclosure [Abstract] | ||||
Provision for income taxes | $ 3,000 | $ 0 | $ 114,000 | $ 0 |
Effective income tax rate | 0% |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) $ in Thousands | Sep. 30, 2023 | Dec. 31, 2022 |
Money Market Mutual Funds [Member] | Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis Valuation Techniques [Line Items] | ||
Cash equivalents | $ 4 | $ 6,034 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2023 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2023 USD ($) Lease | Sep. 30, 2022 USD ($) | |
Lessee Lease Description [Line Items] | ||||
Number of Operating Lease | 2 | |||
Number of Development Lease | 2 | |||
Operating lease, weighted average remaining term | 7 years 1 month 6 days | 7 years 1 month 6 days | ||
Operating lease, weighted average discount rate percent | 14.10% | 14.10% | ||
Total operating lease, cost | $ | $ 549 | $ 525 | $ 1,350 | $ 1,498 |
California [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease, option to extend | The development facility leases each include options to extend, none of which are included in the lease terms. | |||
Operating lease expiration year | 2031 | |||
Georgia [Member] | ||||
Lessee Lease Description [Line Items] | ||||
Operating lease expiration year | 2025 |
Leases - Schedule of Undiscount
Leases - Schedule of Undiscounted Future Lease Payments for the Development Lease (Detail) $ in Thousands | Sep. 30, 2023 USD ($) |
Lessee Disclosure [Abstract] | |
2024 | $ 1,182 |
2025 | 1,210 |
2026 | 1,084 |
2027 | 1,114 |
2028 | 1,146 |
Thereafter | 3,011 |
Total lease payments | 8,747 |
Less imputed interest | (3,378) |
Total operating lease liabilities | $ 5,369 |