Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2023 | Mar. 13, 2024 | |
Cover [Abstract] | ||
Document Type | 10-K | |
Amendment Flag | false | |
Document Period End Date | Dec. 31, 2023 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | FY | |
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 | 105,690,922 | |
Entity Shell Company | false | |
Entity Public Float | $ 94.3 | |
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 Annual Report | true | |
Document Transition Report | false | |
Security Exchange Name | NASDAQ | |
Title of 12(b) Security | Common Stock, par value $0.01 | |
Entity Well-known Seasoned Issuer | No | |
Entity Voluntary Filers | No | |
ICFR Auditor Attestation Flag | false | |
Document Financial Statement Error Correction [Flag] | false | |
Documents Incorporated by Reference | Portions of the registrant’s proxy statement for the 2024 annual meeting of shareholders, if filed with the Securities and Exchange Commission within 120 days after December 31, 2023, are incorporated by reference into Part III of this Form 10-K, or such Part III information will be provided in an amendment filed on Form 10-K/A within 120 days after December 31, 2023 . | |
Auditor name | KPMG LLP | |
Auditor location | Philadelphia, PA | |
Auditor firm ID | 185 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Current assets: | ||
Cash and cash equivalents | $ 8,095 | $ 14,995 |
Accounts receivable, net | 16,576 | 15,950 |
Contract assets | 12,837 | 8,724 |
Inventory | 10,262 | 10,301 |
Prepaid expenses and other current assets | 2,878 | 2,848 |
Assets held for sale | 2,813 | 2,768 |
Total current assets | 53,461 | 55,586 |
Property, plant and equipment, net | 49,795 | 50,365 |
Operating lease asset | 5,004 | 5,491 |
Intangible assets, net | 2,241 | 2,928 |
Goodwill | 41,077 | 41,077 |
Other assets | 1,896 | 1,996 |
Total assets | 153,474 | 157,443 |
Current liabilities: | ||
Accounts payable | 1,312 | 1,466 |
Current portion of debt | 36,756 | 7,577 |
Current portion of operating lease liability | 1,105 | 1,079 |
Accrued expenses and other current liabilities | 10,814 | 12,686 |
Total current liabilities | 49,987 | 22,808 |
Debt, net of current portion | 339 | 30,967 |
Operating lease liability, net of current portion | 4,153 | 4,584 |
Other liabilities | 40,332 | 39,225 |
Total liabilities | 94,811 | 97,584 |
Commitments and contingencies (note 7) | ||
Shareholders’ deficit: | ||
Convertible preferred stock, $0.01 par value. 10,000,000 shares authorized, 0 and 450,000 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 0 | 4,350 |
Common stock, $0.01 par value. 185,000,000 shares authorized, 104,856,247 and 84,588,868 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively | 1,049 | 846 |
Additional paid-in capital | 336,523 | 320,298 |
Accumulated deficit | (278,909) | (265,635) |
Total shareholders' equity | 58,663 | 59,859 |
Total liabilities and shareholders' equity | $ 153,474 | $ 157,443 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 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 | 104,856,247 | 84,588,868 |
Common stock, shares outstanding | 104,856,247 | 84,588,868 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Statement [Abstract] | |||
Revenue | $ 94,635 | $ 90,214 | $ 75,360 |
Operating expenses: | |||
Cost of sales | 76,497 | 67,076 | 55,537 |
Selling, general and administrative | 21,024 | 21,954 | 18,374 |
Amortization of intangible assets | 687 | 905 | 1,037 |
Total operating expenses | 98,208 | 89,935 | 74,948 |
Operating (loss) income | (3,573) | 279 | 412 |
Interest expense | (9,963) | (14,176) | (15,136) |
Interest income | 394 | 117 | 2 |
(Loss) gain on extinguishment of debt | 0 | (4,996) | 3,352 |
Loss before income taxes | (13,142) | (18,776) | (11,370) |
Income tax expense | 132 | 1,105 | 0 |
Net loss | $ (13,274) | $ (19,881) | $ (11,370) |
Earnings Per Share [Abstract] | |||
Loss per share, basic | $ (0.14) | $ (0.34) | $ (0.26) |
Loss per share, diluted | $ (0.14) | $ (0.34) | $ (0.26) |
Weighted average shares outstanding, basic | 95,229,192 | 57,877,920 | 44,117,473 |
Weighted average shares outstanding, diluted | 95,229,192 | 57,877,920 | 44,117,473 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity (Deficit) - USD ($) $ in Thousands | Total | Convertible preferred stock [Member] | Common Stock [Member] | Preferred Stock [Member] | Preferred Stock [Member] Convertible preferred stock [Member] | Additional Paid in Capital [Member] | Accumulated Deficit [Member] |
Balance at Dec. 31, 2020 | $ (14,100) | $ 286 | $ 219,998 | $ (234,384) | |||
Balance, Shares at Dec. 31, 2020 | 0 | 28,601,358 | |||||
Fair value of shares issuable to former equity holders of IriSys, net of costs | 20,328 | 20,328 | |||||
Issuance of stock, net of costs amount | 41,443 | $ 175 | 41,268 | ||||
Issuance of stock, net of costs, Shares | 17,535,752 | ||||||
Stock-based compensation expense | 6,514 | 6,514 | |||||
Exercise of stock options, net, Shares | 80 | ||||||
Vesting of restricted stock units, net | (751) | $ 6 | (757) | ||||
Vesting of restricted stock units, Shares | 544,263 | ||||||
Net Income (Loss) | (11,370) | (11,370) | |||||
Balance at Dec. 31, 2021 | 42,064 | $ 467 | 287,351 | (245,754) | |||
Balance, Shares at Dec. 31, 2021 | 0 | 46,681,453 | |||||
Issuance of stock, net of costs amount | 32,415 | $ 4,350 | $ 371 | 27,694 | |||
Issuance of stock, net of costs, Shares | 450,000 | 37,144,455 | |||||
Stock-based compensation expense | 5,426 | 5,426 | |||||
Exercise of stock options, net, Shares | 516 | ||||||
Vesting of restricted stock units, net | (165) | $ 8 | (173) | ||||
Vesting of restricted stock units, Shares | 762,444 | ||||||
Net Income (Loss) | (19,881) | (19,881) | |||||
Balance at Dec. 31, 2022 | 59,859 | $ 846 | $ 4,350 | 320,298 | (265,635) | ||
Balance, Shares at Dec. 31, 2022 | 84,588,868 | 450,000 | |||||
Issuance of stock, net of costs amount | 7,334 | $ 147 | $ (18) | $ (18) | 7,187 | ||
Issuance of warrants | 37 | 37 | |||||
Issuance of stock, net of costs, Shares | 14,640,000 | ||||||
Stock-based compensation expense | 5,009 | 5,009 | |||||
Vesting of restricted stock units, net | (284) | $ 11 | (295) | ||||
Conversion of preferred stock | $ (4,332) | $ 45 | 4,287 | ||||
Conversion of preferred stock, Shares | (450,000) | 4,500,000 | |||||
Vesting of restricted stock units, Shares | 1,127,379 | ||||||
Net Income (Loss) | (13,274) | (13,274) | |||||
Balance at Dec. 31, 2023 | $ 58,663 | $ 1,049 | $ 336,523 | $ (278,909) | |||
Balance, Shares at Dec. 31, 2023 | 0 | 104,856,247 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Cash flows from operating activities: | |||
Net loss | $ (13,274) | $ (19,881) | $ (11,370) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 5,009 | 5,426 | 6,514 |
Non-cash interest expense | 2,239 | 4,845 | 5,815 |
Depreciation expense | 8,221 | 7,413 | 6,531 |
Loss on disposal of equipment | 31 | 0 | 0 |
Amortization of intangible assets | 687 | 905 | 1,037 |
Deferred income tax expense | 89 | 1,015 | 0 |
Loss (gain) on extinguishment of debt | 0 | 4,996 | (3,352) |
Changes in operating assets and liabilities: | |||
Accounts receivable | (626) | (4,037) | (1,971) |
Contract assets | (4,113) | (159) | (730) |
Inventory | 39 | (1,384) | 3,380 |
Prepaid expenses and other assets | 493 | 305 | 120 |
Accrued interest | 285 | (2,278) | 2,505 |
Accounts payable, accrued expenses and other liabilities | (85) | (810) | 2,379 |
Net cash (used in) provided by operating activities | (1,005) | (3,644) | 10,858 |
Cash flows from investing activities: | |||
Acquisition of IriSys, net of cash acquired | 0 | 0 | (24,002) |
Purchases of property and equipment | (8,237) | (8,351) | (5,289) |
Net cash used in investing activities | (8,237) | (8,351) | (29,291) |
Cash flows from financing activities: | |||
Proceeds from issuance of stock, net of costs | 6,804 | 33,030 | 32,103 |
Proceeds from issuance of debt | 0 | 36,900 | 0 |
Proceeds from sales-lease back liability | 0 | 37,250 | 0 |
Payment of debt principal | (1,845) | (103,039) | (10,100) |
Payment of financing costs | (2,333) | (2,203) | (1,362) |
Net payments related to vesting of restricted stock units | (284) | (165) | (751) |
Net cash provided by financing activities | 2,342 | 1,773 | 19,890 |
Net (decrease) increase in cash and cash equivalents | (6,900) | (10,222) | 1,457 |
Cash and cash equivalents, beginning of period | 14,995 | 25,217 | 23,760 |
Cash and cash equivalents, end of period | 8,095 | 14,995 | 25,217 |
Supplemental disclosures of cash flow information: | |||
Cash paid for interest | 8,156 | 12,574 | 7,238 |
Purchases of property, plant and equipment included in accrued expenses and accounts payable | 829 | 1,384 | 1,045 |
Fair value of warrants issued in connection with financing facility | 37 | 0 | 0 |
Offering costs included in accounts payable and accrued expenses | 15 | 527 | 0 |
Deferred financing costs included in accounts payable and accrued expenses | 0 | 1,359 | 0 |
Reclassification of deferred financing costs to equity | 0 | 88 | 0 |
Fair value of shares issuable to former equity holders of IriSys | 0 | 0 | 20,931 |
Fair value of note issued to former equity holder of IriSys | 0 | 0 | 5,240 |
Issuance of common stock to reduce debt principal and accrued exit fees | 0 | 0 | 6,060 |
Issuance of common stock to settle interest obligations | $ 0 | $ 0 | $ 3,211 |
Pay vs Performance Disclosure
Pay vs Performance Disclosure - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Pay vs Performance Disclosure | |||
Net Income (Loss) | $ (13,274) | $ (19,881) | $ (11,370) |
Insider Trading Arrangements
Insider Trading Arrangements | 3 Months Ended |
Dec. 31, 2023 | |
Trading Arrangements, by Individual | |
Rule 10b5-1 Arrangement Adopted | false |
Non-Rule 10b5-1 Arrangement Adopted | false |
Rule 10b5-1 Arrangement Terminated | false |
Non-Rule 10b5-1 Arrangement Terminated | false |
Background
Background | 12 Months Ended |
Dec. 31, 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 and has an accumulated deficit of $ 278,909 as of December 31, 2023. As of December 31, 2023, the Company’s cash and cash equivalents were $ 8,095 . For the year-ended December 31, 2023 , the Company reported $ 1,005 of net cash used in operating activities. The Company’s future operations are highly dependent on the profitability of its development and manufacturing operations. The pharmaceutical industry has experienced a slowdown in clinical development activities resulting from reduced cash funding, and the Company has been experiencing higher rates of customer attrition and development program delays which have negatively impacted earnings and cash flows. As a result, management reduced its earnings and cash flow projections during 2023. These factors, and the related impact on debt covenant compliance, continue to impact the Company through the present day and are expected to continue. The Company’s credit agreement with Royal Bank of Canada contains certain financial and other covenants, including 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, incurring additional indebtedness, paying dividends, acquisitions and certain investments. Due to the factors discussed above, there is significant uncertainty as to whether the Company will be able to comply with these covenants in future periods. Further, management concluded that substantial doubt exists about its ability to continue as a going concern as of the date of the issuance of these financial statements. The Company’s conclusion that substantial doubt exists about its ability to continue as a going concern resulted in an explanatory paragraph in the auditor’s report on the Company’s financial statements as of and for the fiscal year ended December 31, 2023, the delivery to the lenders of which pursuant to the credit agreement would result in a default under the credit agreement in effect prior to giving effect to the third amendment to the credit agreement. On March 21, 2024, the Company entered into a third amendment to the credit agreement with Royal Bank of Canada, which extended the deadline until April 30, 2024 for delivery of (i) the audited financial statements for the fiscal year ended December 31, 2023, and (ii) the corresponding audit report without a “going concern” explanatory paragraph. The extension of the deadline to submit these documents effectively delays the default under the amended credit agreement until May 1, 2024. The third amendment also (i) defers the $4,000 quarterly minimum liquidity covenant as of March 31, 2024 until as of April 30, 2024 and (ii) clarified that a $1,500 monthly liquidity covenant was not applicable as of March 31, 2024. This amendment to the credit agreement was made, in part, to provide the Company with flexibility to complete the planned merger, to prevent the explanatory paragraph in the auditor’s report from triggering a default under the credit agreement until May 1, 2024 and to allow certain discretionary cash payments that management intends to make prior to closing the planned merger from potentially triggering a default of the minimum liquidity covenant prior to April 30, 2024. Absent completion of the planned merger before May 1, 2024, which is expected to result in the repayment and termination of the credit agreement, or additional amendments to, or waivers under, the credit agreement, the Company expects that an event of default would be triggered once the audited financial statements are delivered to Royal Bank of Canada under the terms of the amended credit agreement. As a result, the Company has classified the outstanding balance of the loan with Royal Bank of Canada as a current liability in the consolidated balance sheet as of December 31, 2023. Any failure to comply with the other terms, covenants and conditions of the credit agreement or the debt agreements may also 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. An event of default under the Company’s amended credit agreement may constitute an event of default under the Company’s subordinated promissory note with the former equity holders of IriSys and under the lease of the Company’s manufacturing campus in Gainesville, Georgia. Upon the occurrence of an event of default under the subordinated promissory note, the entire unpaid principal amount, all accrued and unpaid interest and any other amounts due automatically accelerate and are due on the date of occurrence of an event of default. Upon the occurrence of an event of default under the lease agreement, remedies available to the lessor generally include, without limitation, terminating such lease agreement, repossessing and reletting the leased property, and recovery of all costs and losses paid or incurred by lessor as a result of such default. The exercise of the aforementioned remedies could have a material adverse effect on the Company’s business, financial condition and results of operations. The Company’s ability to comply with the amended financial covenants and contractual requirements under the Company’s debt agreements is subject to the profitability of the Company’s development and manufacturing operations, maintaining sufficient cash and cash equivalents to satisfy the minimum liquidity financial maintenance covenants, and 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 the Company’s ongoing financial performance and the Company’s liquidity position. However, given the uncertainty associated with the ongoing slowdown in the pharmaceutical industry, the Company may not be successful in undertaking these measures and therefore substantial doubt is not alleviated by management’s plans as of the date of issuance of these financial statements. The Company may extend and/or supplement the actions the Company is taking if the Company continues to experience the adverse conditions described above. If the Company is unable to achieve the results required to comply with the terms of the Company’s 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 additional amendment or waiver from its lenders. Obtaining future credit agreement waivers or amendments to the credit agreement is not within the Company’s control, and if the Company is unsuccessful in doing so and, thereafter, and event of default under the credit agreement occurs, then the lenders may exercise the rights available to them under the credit agreement. On February 28, 2024, the Company entered into an Agreement and Plan of Merger, in connection with which a tender offer was commenced to acquire all of the Company’s issued and outstanding shares of common stock for approximately $ 1.10 per share (see note 19). This information was not considered in the analysis of going concern because neither the completion of the tender offer nor the closing of the merger were within management’s control as of the date of the issuance of these financial statements. These consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles assuming the Company will continue as a going concern. The going concern assumption contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to the carrying amounts and classification of assets, liabilities, and reported expenses that may be necessary if the Company were unable to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Principles | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Principles | (2) Summary of significant accounting principles Basis of presentation and principles of consolidation The accompanying consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). 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. The Company has determined that it operates in a single segment. 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. Business combinations The Company measures the purchase price paid for acquired companies based on fair value and allocates that purchase price to the assets acquired and liabilities assumed based on their estimated fair values. Valuations are performed to assist in determining the fair values of assets acquired and liabilities assumed, which requires management to make estimates and assumptions, in particular with respect to intangible assets. Management makes estimates of fair value based upon assumptions believed to be reasonable. These estimates are based in part on historical experience and information obtained from the acquired companies and expectations of future cash flows. Costs associated with business combinations are expensed as incurred as selling, general and administrative expenses. 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. Development contracts generally do not contain variable consideration, but to the extent they do, the Company includes in the transaction price only amounts that are considered probable of being achieved and estimates the amount to be included using the most likely amount method. In contracts that require revenue recognition over time, the Company utilizes an input method that compares the cumulative achievement of contract tasks 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 69 % of the balance as of December 31, 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 customer contracts generated 70 % of revenues in 2023 . 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 December 31, 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 years 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: Year ended December 31, 2023 2022 2021 Restricted stock units 2,762,057 1,583,469 731,525 Stock options 8,101,217 7,317,274 4,645,109 Warrants 484,857 362,030 348,664 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | (3) Inventory The following table presents the components of inventory: December 31, 2023 December 31, 2022 Raw materials $ 5,337 $ 4,318 Work in process 3,310 3,689 Finished goods 1,615 2,294 Inventory $ 10,262 $ 10,301 |
Intangible Assets, Net
Intangible Assets, Net | 12 Months Ended |
Dec. 31, 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: December 31, 2023 December 31, 2022 Gross value Accumulated amortization Carrying value Gross value Accumulated amortization Carrying value Customer relationships $ 18,900 $ 16,674 $ 2,226 $ 18,900 $ 16,188 $ 2,712 Backlog 460 445 15 460 261 199 Trademarks and tradenames 310 310 — 310 293 17 Total $ 19,670 $ 17,429 $ 2,241 $ 19,670 $ 16,742 $ 2,928 The following table presents estimated future amortization of other intangible assets: Twelve months ending December 31, 2024 $ 501 2025 486 2026 486 2027 486 2028 282 Total $ 2,241 |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 12 Months Ended |
Dec. 31, 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: December 31, 2023 December 31, 2022 Land $ 604 $ 604 Building and improvements 22,913 22,751 Furniture, office and computer equipment 6,845 6,388 Manufacturing equipment 68,002 58,039 Construction in process 3,973 7,024 Property, plant and equipment, gross 102,337 94,806 Less: accumulated depreciation ( 52,542 ) ( 44,441 ) Property, plant and equipment, net $ 49,795 $ 50,365 Interest expense capitalized to construction in process was $ 526 in 2023 and $ 1,195 in 2022. The Company is party to a sale and purchase agreement, as amended, to sell approximately 121 acres of land adjacent to its Gainesville, Georgia manufacturing campus for expected proceeds of $ 8,068 . The cost of the land has been removed from property, plant and equipment, and together with cumulative closing costs o f $ 155 through December 31, 2023, is currently presented as a held-for-sale asset of $ 2,813 w ithin 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 buyers permitting, which remained to be satisfied at December 31, 2023 . |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 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: December 31, 2023 December 31, 2022 Payroll and related costs $ 5,807 $ 4,276 Professional and consulting fees 869 356 Property, plant and equipment 696 934 Contract liabilities (see note 11) 543 2,211 Accrued interest 511 227 Accrued transaction costs 25 3,653 Other 2,363 1,029 Total $ 10,814 $ 12,686 Accrued transaction costs at December 31, 2022 included 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 2023, the Company completed a strategic reorganization, including termination charges of $ 717 , the write-off of certain San Diego assets valued at $ 595 and other related charges of $ 502 . The restructuring actions resulted in a total charge of $ 1,814 , of which $ 1,044 was recorded in cost of sales and $ 769 was recorded in selling, general and administrative expense. As of December 31, 2023, $ 126 of termination costs remain accrued and unpaid and are included in as part of payroll and related costs in the table above. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2023 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (7) Commitments and contingencies 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. From time to time, the Company is involved in discussions with customers regarding ordinary disputes arising out of daily operations. Those types of discussions have increased in frequency following discussions the Company began to have in 2024 to customers of the San Diego facility regarding the Company’s evaluation of certain strategic alternatives. Certain of those customers have responded that they may seek specific contractual remedies from the Company. The Company intends to vigorously assert its rights and protections under its agreements with customers. Based on the current status of the ongoing discussions, the Company does not believe that it will be required to pay any material amounts to resolve these disputes. 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 December 31, 2023, the Company had outstanding cancelable and non-cancelable purchase commitments in the aggregate amount of $ 8,519 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 | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Debt | (8) Debt The following table presents the components and classification of debt: December 31, 2023 December 31, 2022 Debt principal: Term loan under Credit Agreement $ 35,055 $ 36,900 Note with former equity holder of IriSys 4,078 4,078 Other 339 339 Debt principal 39,472 41,317 Debt adjustments: Unamortized deferred issuance costs ( 2,172 ) ( 2,476 ) Unamortized original discount ( 205 ) ( 297 ) Carrying value of debt $ 37,095 $ 38,544 Current portion of debt $ 36,756 $ 7,577 Debt, net of current portion 339 30,967 Carrying value of debt $ 37,095 $ 38,544 The following table presents the future maturity of debt principal: Twelve months ending December 31, 2024 $ 39,149 2025 32 2026 39 2027 46 2028 56 Thereafter 150 Total debt principal $ 39,472 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 is scheduled to be repaid in quarterly amounts totaling $ 3,690 in 2024 and $ 31,365 in 2025 (which is inclusive of the remaining principal balance due at maturity on December 16, 2025). The Company is also obligated to make a $ 7,500 mandatory principal prepayment upon completion of the sale of certain real property. Quarterly principal payments made after the completion of the land sale will be reduced proportionately to the reduction in principal. Substantial doubt exists that the Company will continue as a going concern (see note 1). Absent completion of the planned merger, which is expected to result in the repayment and termination of the credit agreement, or additional amendments to, or waivers under, the credit agreement, the Company expects that an event of default would be triggered once the audited financial statements are delivered to Royal Bank of Canada under the terms of the amended credit agreement. For these reasons, the entire principal balance of the term loan is classified as current and is presented as maturing during the twelve months ending December 31, 2024. 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. The Company paid a fee of $ 369 and is required to increase its remaining quarterly principal payments by $ 231 as a result of not completing the sale of certain real property by a December 2023 deadline. Quarterly principal payment increases of $ 231 have been included in the debt maturity disclosures above . As of December 31, 2023, the Credit Agreement also included 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 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 period of the four fiscal quarters most recently ended. As of December 31, 2023, the Company was in compliance with its financial covenants under the Credit Agreement. See notes 1 and 19 for additional information about subsequent amendments made to certain covenants related to the December 31, 2023 financial information as well as management’s evaluation of forward looking covenant compliance. 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 $ 1,086 in 2023 and $ 35 in 2022. 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 December 31, 2023, the overall effective interest rate, including cash paid for interest and non-cash interest expense, was 13.8 % . 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 $ 4,411 in 2022 and $ 5,558 in 2021 . 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. As a result of fully paying off the terms loans under the Athyrium Credit Agreement, the Company recorded a loss on extinguishment of debt of $ 4,996 primarily for the write-off of the remaining unamortized deferred financing costs. The overall effective interest rate, including cash paid for interest and non-cash interest expense, immediately prior to repayment was 16.4 %. Note with former equity holder of IriSys In connection with the acquisition of IriSys (see note 15), 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 with Royal Bank of Canada. 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 December 31, 2023, the overall effective interest rate, including the amortization of the original discount, was 15.3 % . Other In connection with the acquisition of IriSys (see note 15), the Company assumed a loan with a principal amount of $ 339 . In May 2020, the Company entered into a $ 4,416 promissory note issued under a Federal COVID-19 relief program and shortly after prepaid $ 1,100 of principal to comply with emerging Federal guidance. The note had a two-year term and accrued interest at a rate of 1.0 % per annum, payable upon maturity. In June 2021, the Company received forgiveness of principal and interest on the note and recorded a gain on extinguishment of debt of $ 3,352 , consisting of forgiveness of $ 3,316 of principal and $ 36 of accrued interest. |
Other Liabilities
Other Liabilities | 12 Months Ended |
Dec. 31, 2023 | |
Other Liabilities Disclosure [Abstract] | |
Other Liabilities | (9) Other liabilities At December 31, 2023, other liabilities include a sale-leaseback liability of $ 39,010 and other liabilities of $ 1,322 . 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 December 31, 2023, the carrying value of the liability was $ 39,010 , which is net of $ 820 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 | 12 Months Ended |
Dec. 31, 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 December 31, 2023, no preferred stock was issued or outstanding. Warrants The following table presents the warrants outstanding to purchase shares of common stock as of December 31, 2023: 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 All outstanding warrants are equity-classified. |
Revenue Recognition
Revenue Recognition | 12 Months Ended |
Dec. 31, 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 ( 10,826 ) — Reclassification to revenue as the result of performance obligations satisfied 963 1,809 Changes in estimate 1,416 — Net change to contract balance recognized since beginning of period due to recognition of revenue, amounts billed and changes in estimate 12,560 ( 360 ) Balance at December 31, 2023 $ 12,837 $ ( 762 ) Less: noncurrent portion — 219 Current portion $ 12,837 $ ( 543 ) 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: Year ended December 31, 2023 2022 2021 Point in time $ 73,316 $ 70,325 $ 60,992 Over time 21,319 19,889 14,368 Total $ 94,635 $ 90,214 $ 75,360 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. |
Retirement Plan
Retirement Plan | 12 Months Ended |
Dec. 31, 2023 | |
Retirement Benefits [Abstract] | |
Retirement Plan | (12) Retirement plan The Company has a voluntary 401(k) savings plan in which all employees are eligible to participate. The 401(k) plan features a discretionary employer match. The Company’s current approach is to match 100 % of the employee contributions up to a maximum of 5 % of employee compensation, subject to company performance. Total Company contributions to the 401(k) plan were $ 1,537 for 2023 , $ 1,348 for 2022 and $ 915 for 2021 . |
Stock-Based Compensation
Stock-Based Compensation | 12 Months Ended |
Dec. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Stock-Based Compensation | (13) 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 December 31, 2023, a total of 6,369,829 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 . No options were exercised in 2023. The intrinsic value of options exercised were negligible in 2022 and 2021. The following table presents information about the fair value of stock options granted: Year ended December 31, 2023 2022 2021 Weighted average grant date fair value $ 0.92 $ 1.02 $ 1.77 Assumptions used to determine fair value: Range of expected option life 5.5 - 6.0 years 5.5 - 6.0 years 5.5 - 6.0 years Expected volatility 79 - 85 % 79 - 81 % 79 - 81 % Risk-free interest rate 3.5 - 4.6 % 1.5 - 4.0 % 0.7 - 1.4 % Expected dividend yield — — — 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 1,909,739 1.31 Forfeited or expired ( 2,224,541 ) 5.34 Balance, December 31, 2023 7,735,535 2.83 $ 42 7.3 years Exercisable 4,682,431 3.64 1 6.5 years Included in the table above are 961,005 options outstanding as of December 31, 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 2023, $ 1.32 in 2022 and $ 3.49 in 2021. The fair value of RSUs vested was $ 1,329 in 2023, $ 897 in 2022 and $ 2,663 in 2021. 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 ( 1,365,982 ) 3.17 Forfeited ( 250,496 ) 1.84 Balance, December 31, 2023 3,086,150 2.10 Included in the table above are 40,503 time-based RSUs outstanding at December 31, 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: Year ended December 31, 2023 2022 2021 Cost of sales $ 1,953 $ 1,868 $ 2,797 Selling, general and administrative expenses 3,056 3,558 3,717 Total $ 5,009 $ 5,426 $ 6,514 As of December 31, 2023, there was $ 7,102 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 2.2 years. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | (14) Income taxes All of the Company’s income from continuing operations is domestic. The components of the income tax provision from continuing operations are as follows: Year ended December 31, 2023 2022 2021 Current: Federal $ — $ 33 $ — State 43 57 — Total current 43 90 — Deferred: Federal ( 2,092 ) 1,399 ( 2,396 ) State ( 1,164 ) 4,266 ( 677 ) Total deferred ( 3,256 ) 5,665 ( 3,073 ) Change in valuation allowance 3,345 ( 4,650 ) 3,073 Income tax expense $ 132 $ 1,105 $ — In 2022, the Company entered into a sale-leaseback transaction of its commercial manufacturing campus in Gainesville, Georgia, as discussed further in note 9. This transaction was treated as a sale for federal and state income tax purposes. The sale resulted in a taxable gain of approximately $ 25,350 that was mostly offset with net operating loss carryforwards, as discussed further below. A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2023 2022 2021 U.S. federal statutory income tax rate 21 % 21 % 21 % State taxes, net of federal benefit ( 2 )% 7 % 8 % Change in state tax rate 1 % ( 22 )% ( 2 )% Nondeductible expenses ( 5 )% ( 5 )% ( 1 )% Research and development credits — ( 23 )% 1 % Change in valuation allowance ( 16 )% 16 % ( 27 )% Effective income tax rate ( 1 )% ( 6 )% — In 2022, the Commonwealth of Pennsylvania enacted a reduction to its corporate tax rate from 9.9 % to 8.9 % in 2023. Additionally, the rate will be further reduced by 0.5 % each year until 2031 when the rate will be 4.99 %. This resulted in a revaluation of outstanding state deferred taxes and the significant rate change above. In 2022, the Company also derecognized its deferred tax assets for research and development credits as discussed further below. The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows: December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 35,650 $ 33,352 Interest expense 14,314 12,944 Sale-leaseback 9,448 9,093 Stock-based compensation 5,344 4,681 Other 3,791 3,950 Gross deferred tax asset 68,547 64,020 Valuation allowance ( 54,314 ) ( 50,909 ) Deferred tax assets, net of valuation allowance 14,233 13,111 Deferred tax liabilities: Depreciation ( 11,088 ) ( 10,750 ) Contract assets ( 3,112 ) ( 2,082 ) Other ( 1,197 ) ( 1,294 ) Deferred tax liabilities ( 15,397 ) ( 14,126 ) Net deferred tax liabilities $ ( 1,164 ) $ ( 1,015 ) The net deferred tax liability shown in the table above is recorded in other liabilities on the consolidated balance sheet at December 31, 2023. These net liabilities result from future tax years in which settlements of deferred tax liabilities are forecasted to exceed settlements of deferred tax assets. Beginning December 31, 2022, net operating loss carryforwards that could fully offset such liabilities are no longer available because they were all utilized for the December 2022 sale-leaseback transaction, as discussed further below. The Company continues to maintain a full valuation allowance against its U.S. and state deferred tax assets based on the available positive and negative evidence available. An important aspect of objective negative evidence evaluated was the Company’s historical operating results over the prior three-year period. The Company maintains the valuation allowance as of December 31, 2023 as a result of historical losses, inclusive of discontinued operations, during the most recent three-year period. The Company will re-evaluate the need for a valuation allowance in future periods based on its operating results as a standalone entity. The following table summarizes carryforwards of net operating losses as of December 31, 2023: Amount Expiration Federal net operating losses, 2018 to 2022 133,545 No expiration State net operating losses that expire 111,810 2031 – 2044 State net operating losses that do not expire 35,165 No expiration Under U.S. federal tax law, the utilization of a corporation’s net operating loss and research and development tax credit carryforwards is limited following a greater than 50 % change in ownership during a three-year period. Any unused annual limitation may be carried forward to future years for the balance of the carryforward period. The Company has determined that it experienced ownership changes, as defined by the Act, during the 2008, 2014, 2016 and 2022 tax years; accordingly, the Company’s ability to utilize the aforementioned carryforwards is subject to various annual limitations. As a result of the 2022 ownership change, the Company further determined its research and development tax credits would not be available in future periods, so the related deferred tax assets were written off in 2022. State net operating loss carryforwards may be further limited, including in Pennsylvania, which has a limitation of 40 % of taxable income after modifications and apportionment on state net operating losses utilized in any one year. At December 31, 2023 , the Company had no accrued interest or penalties related to uncertain tax positions, and no amounts have been recognized in the Company’s statements of operations. Due to net operating loss and tax credit carry forwards that remain unutilized, income tax returns for tax years since inception remain subject to examination by the taxing jurisdictions. |
Acquisition of IriSys
Acquisition of IriSys | 12 Months Ended |
Dec. 31, 2023 | |
Business Combinations [Abstract] | |
Acquisition of IriSys | (15) Acquisition of IriSys On August 13, 2021 , the Company acquired all of the units of IriSys pursuant to a unit purchase agreement. IriSys provides contract pharmaceutical product development and manufacturing services, specializing in formulation research and development and good manufacturing practices of clinical trial materials and specialty pharmaceutical products. The acquisition advances the Company’s ongoing growth strategy and leads to key synergies within business development, clinical development and commercial scale-up, as well as a strong cultural alignment and fit between the companies. The aggregate purchase price consideration was comprised of cash consideration, a subordinated promissory note and a contractual obligation to issue 9,302,718 shares of the Company’s common stock, which were issued on February 14, 2022. The following table summarizes the consideration paid: August 13, 2021 Cash paid, net of cash acquired $ 24,002 Net working capital adjustment receivable ( 417 ) Fair value of shares issuable to former equity holders of IriSys 20,931 Fair value of note with former equity holder of IriSys 5,240 Total estimated consideration $ 49,756 The fair value of the shares issuable was determined by using the price of the Company’s common stock on the acquisition date, less a discount for lack of marketability due to the shares being unregistered shares of the Company. The fair value of the note was determined using a discounted cash flow analysis that incorporated an estimate of the market interest rate for debt of similar terms and credit risk on the acquisition date. The Company incurred $ 1,211 in transaction costs related to the acquisition that were expensed as incurred and classified as selling, general and administrative expenses. The following table summarizes the fair values of the assets acquired and liabilities assumed at the date of acquisition: August 13, 2021 Assets acquired: Accounts receivable $ 909 Contract assets 505 Inventory 685 Prepaid expenses and other current assets 91 Property and equipment 9,304 Operating lease asset 5,648 Intangible assets 4,170 Goodwill 36,758 Other assets 146 Total assets acquired $ 58,216 Liabilities assumed: Accounts payable $ 730 Accrued expenses and other current liabilities 1,556 Operating lease liability 5,648 Debt from finance loan 339 Other liabilities 187 Total liabilities assumed $ 8,460 Net assets acquired $ 49,756 The purchase price was allocated to the tangible assets and identifiable intangible assets acquired and liabilities assumed based on their acquisition date estimated fair values. The identifiable intangible assets are subject to amortization on a straight-line basis. The following table presents information about the acquired identifiable intangible assets: Fair value Weighted average amortization period Customer relationships $ 3,400 7.0 years Backlog 460 2.4 years Trademarks and tradenames 310 1.5 years Total $ 4,170 6.1 years The fair value of property, plant and equipment was determined using a cost approach valuation method. The customer relationships and acquired backlog were valued using the multi-period excess earnings method and trademarks and trade names were valued using the relief from royalty method. These methods require several judgments and assumptions to determine the fair value of intangible assets, including revenue growth rates, discount rates, EBITDA margins, and tax rates, among others. These nonrecurring fair value measurements are Level 3 measurements within the fair value hierarchy. Goodwill represents the excess of the purchase price over the net identifiable tangible and intangible assets acquired. The goodwill related to the acquisition was attributable to expected synergies, the value of the assembled workforce as well as the collective experience of the management team with regards to its operations, customers, and industry. The goodwill is deductible for tax purposes. Results for 2021 included revenue of $ 5,955 and net income of $ 440 from IriSys. The following table presents unaudited supplemental pro forma financial information as if the IriSys acquisition had occurred on January 1, 2020: Year ended December 31, 2021 2020 Revenue $ 83,045 $ 78,881 Net income (loss) ( 11,809 ) ( 28,290 ) The pro forma financial information presented above has been prepared by combining the Company’s historical results and the historical results of IriSys and adjusting those results to eliminate historical transaction costs and to reflect the effects of the acquisition as if they occurred on January 1, 2020. The effects of the acquisition on the historical pro forma financial information include additional depreciation and amortization expense from the increase of asset carrying values to fair value, the adoption of new accounting standards, additional interest expense from the issuance of the subordinated promissory note and the elimination of interest expense related to indebtedness of IriSys prior to the acquisition. These results do not purport to be indicative of the results of operations which actually would have resulted had the acquisitions occurred on the date indicated above, or that may result in the future, and do not reflect potential synergies or additional costs following the acquisition. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2023 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | (16) 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 December 31, 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 December 31, 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 December 31, 2023 due to the recent issuances of those instruments and taking into consideration management's current evaluation of market conditions. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2023 | |
Lessee Disclosure [Abstract] | |
Leases | (17) 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 facility leases, which were the only material noncancelable leases at December 31, 2023, were as follows: Twelve months ending December 31, 2024 $ 1,193 2025 1,158 2026 1,097 2027 1,127 2028 1,159 Thereafter 2,521 Total lease payments 8,255 Less imputed interest ( 2,997 ) Total operating lease liabilities $ 5,258 At December 31, 2023, the weighted average remaining lease term was 6.8 years, and the weighted average discount rate was 14.1 % . Total lease cost was $ 1,789 in 2023, $ 1,980 in 2022 and $ 814 in 2021 . |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2023 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | (18) Related Party Transaction s The former equity holder of IriSys beneficially owned more than 10 % of the Company’s common stock and became a related party on August 13, 2021 as a result of the acquisition of IriSys (see note 15). In December 2022, it ceased to meet the definition of a related party following the issuance of additional common stock. |
Subsequent Event
Subsequent Event | 12 Months Ended |
Dec. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Event | (19) Subsequent Event On February 28, 2024, the Company entered into an Agreement and Plan of Merger (the “Merger Agreement”) with CoreRx, Inc., (“CoreRx”), and Cane Merger Sub, Inc., a wholly owned subsidiary of CoreRx (“Merger Sub”). Pursuant to the Merger Agreement, and upon the terms and subject to the conditions therein, CoreRx will commence a tender offer, or the Offer, to acquire all of the Company’s issued and outstanding shares of common stock, par value $ 0.01 per share, for approximately $ 1.10 per share of common stock, in cash, subject to any applicable withholding of taxes and without interest. The Offer will initially expire one minute following 11:59 p.m. (Eastern Time) on the date that is 20 business days following the commencement of the Offer, subject to extension under certain circumstances. Following the consummation of the Offer, upon the terms and conditions set forth in the Merger Agreement, Merger Sub will merge with and into the Company, with the Company continuing as the surviving corporation in the Merger and a wholly owned subsidiary of CoreRx. Pursuant to the terms and subject to the conditions of the Merger Agreement, the Merger will be governed by and effected under Section 321(f) of the Pennsylvania Business Corporation Law, with no shareholder vote required to consummate the Merger. As a result of the Merger, the Company will cease to be a publicly traded company. The Merger Agreement includes customary representations, warranties and covenants of the Company, CoreRx and Merger Sub. The Company expects that the outstanding debt under the Credit Agreement and the Note with former equity holder of IriSys will be repaid on or about the closing the Merger Agreement. However, there can be no assurance that the conditions to the completion of the Offer and the Merger will be satisfied or waived, that the Offer and the Merger will be completed on the expected timeframe or at all, or that the Offer and the Merger will be consummated as contemplated by the Merger Agreement. On March 21, 2024, the Company entered into a third amendment to the credit agreement with Royal Bank of Canada, which extended the deadline until April 30, 2024 for delivery of (i) the audited financial statements for the fiscal year ended December 31, 2023, and (ii) the corresponding audit report without a “going concern” explanatory paragraph. The extension of the deadline to submit these documents effectively delays the default under the amended credit agreement until May 1, 2024. The third amendment also (i) defers the $4,000 quarterly minimum liquidity covenant as of March 31, 2024 until as of April 30, 2024 and (ii) clarified that a $1,500 monthly liquidity covenant was not applicable as of March 31, 2024. |
Summary of Significant Accoun_2
Summary of Significant Accounting Principles (Policies) | 12 Months Ended |
Dec. 31, 2023 | |
Accounting Policies [Abstract] | |
Basis of presentation and principles of consolidation | Basis of presentation and principles of consolidation The accompanying consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”). 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. The Company has determined that it operates in a single segment. |
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. |
Business combinations | Business combinations The Company measures the purchase price paid for acquired companies based on fair value and allocates that purchase price to the assets acquired and liabilities assumed based on their estimated fair values. Valuations are performed to assist in determining the fair values of assets acquired and liabilities assumed, which requires management to make estimates and assumptions, in particular with respect to intangible assets. Management makes estimates of fair value based upon assumptions believed to be reasonable. These estimates are based in part on historical experience and information obtained from the acquired companies and expectations of future cash flows. Costs associated with business combinations are expensed as incurred as selling, general and administrative expenses. |
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. Development contracts generally do not contain variable consideration, but to the extent they do, the Company includes in the transaction price only amounts that are considered probable of being achieved and estimates the amount to be included using the most likely amount method. In contracts that require revenue recognition over time, the Company utilizes an input method that compares the cumulative achievement of contract tasks 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 69 % of the balance as of December 31, 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 customer contracts generated 70 % of revenues in 2023 . |
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 December 31, 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 years 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: Year ended December 31, 2023 2022 2021 Restricted stock units 2,762,057 1,583,469 731,525 Stock options 8,101,217 7,317,274 4,645,109 Warrants 484,857 362,030 348,664 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) | 12 Months Ended |
Dec. 31, 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: Year ended December 31, 2023 2022 2021 Restricted stock units 2,762,057 1,583,469 731,525 Stock options 8,101,217 7,317,274 4,645,109 Warrants 484,857 362,030 348,664 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | The following table presents the components of inventory: December 31, 2023 December 31, 2022 Raw materials $ 5,337 $ 4,318 Work in process 3,310 3,689 Finished goods 1,615 2,294 Inventory $ 10,262 $ 10,301 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Components of Other Intangible Assets | The following table presents the components of other intangible assets: December 31, 2023 December 31, 2022 Gross value Accumulated amortization Carrying value Gross value Accumulated amortization Carrying value Customer relationships $ 18,900 $ 16,674 $ 2,226 $ 18,900 $ 16,188 $ 2,712 Backlog 460 445 15 460 261 199 Trademarks and tradenames 310 310 — 310 293 17 Total $ 19,670 $ 17,429 $ 2,241 $ 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 December 31, 2024 $ 501 2025 486 2026 486 2027 486 2028 282 Total $ 2,241 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | The following table presents the components of property, plant and equipment: December 31, 2023 December 31, 2022 Land $ 604 $ 604 Building and improvements 22,913 22,751 Furniture, office and computer equipment 6,845 6,388 Manufacturing equipment 68,002 58,039 Construction in process 3,973 7,024 Property, plant and equipment, gross 102,337 94,806 Less: accumulated depreciation ( 52,542 ) ( 44,441 ) Property, plant and equipment, net $ 49,795 $ 50,365 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following: December 31, 2023 December 31, 2022 Payroll and related costs $ 5,807 $ 4,276 Professional and consulting fees 869 356 Property, plant and equipment 696 934 Contract liabilities (see note 11) 543 2,211 Accrued interest 511 227 Accrued transaction costs 25 3,653 Other 2,363 1,029 Total $ 10,814 $ 12,686 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Debt Disclosure [Abstract] | |
Schedule of Components and Classification of Debt | The following table presents the components and classification of debt: December 31, 2023 December 31, 2022 Debt principal: Term loan under Credit Agreement $ 35,055 $ 36,900 Note with former equity holder of IriSys 4,078 4,078 Other 339 339 Debt principal 39,472 41,317 Debt adjustments: Unamortized deferred issuance costs ( 2,172 ) ( 2,476 ) Unamortized original discount ( 205 ) ( 297 ) Carrying value of debt $ 37,095 $ 38,544 Current portion of debt $ 36,756 $ 7,577 Debt, net of current portion 339 30,967 Carrying value of debt $ 37,095 $ 38,544 |
Schedule of Future Maturities of Debt | The following table presents the future maturity of debt principal: Twelve months ending December 31, 2024 $ 39,149 2025 32 2026 39 2027 46 2028 56 Thereafter 150 Total debt principal $ 39,472 |
Shareholders' Equity or Defic_2
Shareholders' Equity or Deficit (Tables) | 12 Months Ended |
Dec. 31, 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 December 31, 2023: 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) | 12 Months Ended |
Dec. 31, 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 ( 10,826 ) — Reclassification to revenue as the result of performance obligations satisfied 963 1,809 Changes in estimate 1,416 — Net change to contract balance recognized since beginning of period due to recognition of revenue, amounts billed and changes in estimate 12,560 ( 360 ) Balance at December 31, 2023 $ 12,837 $ ( 762 ) Less: noncurrent portion — 219 Current portion $ 12,837 $ ( 543 ) |
Disaggregation of Revenue by Timing of Revenue Recognition | The following table disaggregates revenue by timing of revenue recognition: Year ended December 31, 2023 2022 2021 Point in time $ 73,316 $ 70,325 $ 60,992 Over time 21,319 19,889 14,368 Total $ 94,635 $ 90,214 $ 75,360 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 12 Months Ended |
Dec. 31, 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: Year ended December 31, 2023 2022 2021 Weighted average grant date fair value $ 0.92 $ 1.02 $ 1.77 Assumptions used to determine fair value: Range of expected option life 5.5 - 6.0 years 5.5 - 6.0 years 5.5 - 6.0 years Expected volatility 79 - 85 % 79 - 81 % 79 - 81 % Risk-free interest rate 3.5 - 4.6 % 1.5 - 4.0 % 0.7 - 1.4 % 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 1,909,739 1.31 Forfeited or expired ( 2,224,541 ) 5.34 Balance, December 31, 2023 7,735,535 2.83 $ 42 7.3 years Exercisable 4,682,431 3.64 1 6.5 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 ( 1,365,982 ) 3.17 Forfeited ( 250,496 ) 1.84 Balance, December 31, 2023 3,086,150 2.10 |
Summary of Stock Based Compensation Expense | The following table presents the classification of stock-based compensation expense: Year ended December 31, 2023 2022 2021 Cost of sales $ 1,953 $ 1,868 $ 2,797 Selling, general and administrative expenses 3,056 3,558 3,717 Total $ 5,009 $ 5,426 $ 6,514 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Income Tax Disclosure [Abstract] | |
Components of Income Tax Provision (Benefit) From Continuing Operations | All of the Company’s income from continuing operations is domestic. The components of the income tax provision from continuing operations are as follows: Year ended December 31, 2023 2022 2021 Current: Federal $ — $ 33 $ — State 43 57 — Total current 43 90 — Deferred: Federal ( 2,092 ) 1,399 ( 2,396 ) State ( 1,164 ) 4,266 ( 677 ) Total deferred ( 3,256 ) 5,665 ( 3,073 ) Change in valuation allowance 3,345 ( 4,650 ) 3,073 Income tax expense $ 132 $ 1,105 $ — |
Reconciliation of Statutory U.S. Federal Income Tax Rate to Effective Tax Rate From Continuing Operations | A reconciliation of the statutory U.S. federal income tax rate to the Company’s effective tax rate is as follows: Year ended December 31, 2023 2022 2021 U.S. federal statutory income tax rate 21 % 21 % 21 % State taxes, net of federal benefit ( 2 )% 7 % 8 % Change in state tax rate 1 % ( 22 )% ( 2 )% Nondeductible expenses ( 5 )% ( 5 )% ( 1 )% Research and development credits — ( 23 )% 1 % Change in valuation allowance ( 16 )% 16 % ( 27 )% Effective income tax rate ( 1 )% ( 6 )% — |
Schedule of Tax Effects of Temporary Differences to Significant Portions of Deferred Tax Assets | The tax effects of temporary differences that gave rise to significant portions of the deferred tax assets were as follows: December 31, 2023 2022 Deferred tax assets: Net operating loss carryforwards $ 35,650 $ 33,352 Interest expense 14,314 12,944 Sale-leaseback 9,448 9,093 Stock-based compensation 5,344 4,681 Other 3,791 3,950 Gross deferred tax asset 68,547 64,020 Valuation allowance ( 54,314 ) ( 50,909 ) Deferred tax assets, net of valuation allowance 14,233 13,111 Deferred tax liabilities: Depreciation ( 11,088 ) ( 10,750 ) Contract assets ( 3,112 ) ( 2,082 ) Other ( 1,197 ) ( 1,294 ) Deferred tax liabilities ( 15,397 ) ( 14,126 ) Net deferred tax liabilities $ ( 1,164 ) $ ( 1,015 ) |
Summary of Carryforward of Net Operating Losses | The following table summarizes carryforwards of net operating losses as of December 31, 2023: Amount Expiration Federal net operating losses, 2018 to 2022 133,545 No expiration State net operating losses that expire 111,810 2031 – 2044 State net operating losses that do not expire 35,165 No expiration |
Acquisition of IriSys (Tables)
Acquisition of IriSys (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Business Combinations [Abstract] | |
Schedule of Business Acquisition of Purchase Price Consideration | The following table summarizes the consideration paid: August 13, 2021 Cash paid, net of cash acquired $ 24,002 Net working capital adjustment receivable ( 417 ) Fair value of shares issuable to former equity holders of IriSys 20,931 Fair value of note with former equity holder of IriSys 5,240 Total estimated consideration $ 49,756 |
Schedule of Fair Values of the Assets Acquired and Liabilities Assumed | The following table summarizes the fair values of the assets acquired and liabilities assumed at the date of acquisition: August 13, 2021 Assets acquired: Accounts receivable $ 909 Contract assets 505 Inventory 685 Prepaid expenses and other current assets 91 Property and equipment 9,304 Operating lease asset 5,648 Intangible assets 4,170 Goodwill 36,758 Other assets 146 Total assets acquired $ 58,216 Liabilities assumed: Accounts payable $ 730 Accrued expenses and other current liabilities 1,556 Operating lease liability 5,648 Debt from finance loan 339 Other liabilities 187 Total liabilities assumed $ 8,460 Net assets acquired $ 49,756 |
Schedule of Intangible Assets Acquired | The following table presents information about the acquired identifiable intangible assets: Fair value Weighted average amortization period Customer relationships $ 3,400 7.0 years Backlog 460 2.4 years Trademarks and tradenames 310 1.5 years Total $ 4,170 6.1 years |
Schedule of Supplemental Pro Forma Financial Information | The following table presents unaudited supplemental pro forma financial information as if the IriSys acquisition had occurred on January 1, 2020: Year ended December 31, 2021 2020 Revenue $ 83,045 $ 78,881 Net income (loss) ( 11,809 ) ( 28,290 ) |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2023 | |
Lessee Disclosure [Abstract] | |
Schedule of Undiscounted Future Lease Payments for the Development Lease | Undiscounted future lease payments for the two development facility leases, which were the only material noncancelable leases at December 31, 2023, were as follows: Twelve months ending December 31, 2024 $ 1,193 2025 1,158 2026 1,097 2027 1,127 2028 1,159 Thereafter 2,521 Total lease payments 8,255 Less imputed interest ( 2,997 ) Total operating lease liabilities $ 5,258 |
Background - Additional Informa
Background - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Aug. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | Feb. 28, 2024 | |
Restructuring Cost and Reserve [Line Items] | |||||
Entity incorporation date | Nov. 15, 2007 | ||||
Accumulated deficit | $ 278,909 | $ 265,635 | |||
Cash and cash equivalents | 8,095 | 14,995 | |||
Net cash used in operating activities | $ (1,005) | $ (3,644) | $ 10,858 | ||
Common stock value per share | $ 0.01 | $ 0.01 | |||
Accounts receivable, net | $ 16,576 | $ 15,950 | |||
Contract assets | 12,837 | 8,724 | |||
Inventory | 10,262 | 10,301 | |||
Prepaid expenses and other current assets | 2,878 | 2,848 | |||
Right of use asset | 5,004 | 5,491 | |||
Net Intangible Assets, Definite-lived | 2,241 | 2,928 | |||
Property, plant and equipment, net | $ 49,795 | $ 50,365 | |||
Subsequent Event [Member] | CoreRx, Inc. [Member] | |||||
Restructuring Cost and Reserve [Line Items] | |||||
Common stock value per share | $ 0.01 | ||||
Cash [Member] | Subsequent Event [Member] | CoreRx, Inc. [Member] | |||||
Restructuring Cost and Reserve [Line Items] | |||||
Common stock value per share | $ 1.1 | ||||
Underwriting Agreement [Member] | |||||
Restructuring Cost and Reserve [Line Items] | |||||
Public offering which issued and sold | 14,640,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Principles - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2023 Customer | |
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 | 69% |
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | Cash [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Concentration risk percentage | 70% |
Furniture and Office Equipment [Member] | Minimum | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 3 years |
Furniture and Office Equipment [Member] | Maximum | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 10 years |
Manufacturing Equipment [Member] | Minimum | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 6 years |
Manufacturing Equipment [Member] | Maximum | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 10 years |
Buildings [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 40 years |
Leasehold Improvements [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment useful life | us-gaap:UsefulLifeShorterOfTermOfLeaseOrAssetUtilityMember |
Summary of Significant Accoun_5
Summary of Significant Accounting Principles - Schedule of Anti-Dilutive Securities (Detail) - shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
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 | 2,762,057 | 1,583,469 | 731,525 |
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 | 8,101,217 | 7,317,274 | 4,645,109 |
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 | 484,857 | 362,030 | 348,664 |
Inventory - Components of Inven
Inventory - Components of Inventory (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 5,337 | $ 4,318 |
Work in process | 3,310 | 3,689 |
Finished goods | 1,615 | 2,294 |
Inventory | $ 10,262 | $ 10,301 |
Intangible Assets, Net - Summar
Intangible Assets, Net - Summary of Components of Other Intangible Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | $ 19,670 | $ 19,670 |
Accumulated amortization | 17,429 | 16,742 |
Carrying value | 2,241 | 2,928 |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | 18,900 | 18,900 |
Accumulated amortization | 16,674 | 16,188 |
Carrying value | 2,226 | 2,712 |
Backlog [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | 460 | 460 |
Accumulated amortization | 445 | 261 |
Carrying value | 15 | 199 |
Trademarks and Tradenames [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | 310 | 310 |
Accumulated amortization | 310 | 293 |
Carrying value | $ 0 | $ 17 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Finite Lived Intangible Assets, Estimated Future Amortization Expense (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2024 | $ 501 | |
2025 | 486 | |
2026 | 486 | |
2027 | 486 | |
2028 | 282 | |
Carrying value | $ 2,241 | $ 2,928 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 102,337 | $ 94,806 |
Less: accumulated depreciation | (52,542) | (44,441) |
Property, plant and equipment, net | 49,795 | 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 | 22,913 | 22,751 |
Furniture, Office & Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 6,845 | 6,388 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 68,002 | 58,039 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 3,973 | $ 7,024 |
Property, Plant and Equipment_4
Property, Plant and Equipment, Net - Additional Information (Detail) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 USD ($) a | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Property, Plant and Equipment [Line Items] | |||
Interest Expense | $ 9,963 | $ 14,176 | $ 15,136 |
Construction in Progress [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Interest Expense | $ 526 | $ 1,195 | |
Land [Member] | |||
Property, Plant and Equipment [Line Items] | |||
Area Of Land | a | 121 | ||
Proceeds from Sale of property plant and equipment | $ 8,068 | ||
Carrying value of other assets | 2,813 | ||
Cumulative closing costs | $ 155 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Payables and Accruals [Abstract] | ||
Payroll and related costs | $ 5,807 | $ 4,276 |
Professional and consulting fees | 869 | 356 |
Property, plant and equipment | 696 | 934 |
Contract liabilities (see note 11) | 543 | 2,211 |
Accrued interest | 511 | 227 |
Accrued transaction costs | 25 | 3,653 |
Other | 2,363 | 1,029 |
Total | $ 10,814 | $ 12,686 |
Accrued expenses and other cu_4
Accrued expenses and other current liabilities - Additional Information (Detail) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Nov. 30, 2023 | Sep. 30, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Write-off of assests | $ 2,813 | $ 2,768 | |||
Severance and other related costs | 1,814 | ||||
Accrued and unpaid severance costs | 126 | ||||
Cost of Goods and Services Sold | 76,497 | 67,076 | $ 55,537 | ||
Selling, general and administrative | 21,024 | 21,954 | $ 18,374 | ||
Cost of Sales [Member] | |||||
Cost of Goods and Services Sold | 1,044 | ||||
Selling General and Administrative Expenses [Member] | |||||
Selling, general and administrative | 769 | ||||
Term Loan Under Credit Agreement [Member] | |||||
New term loan | $ 36,900 | ||||
Gainesville, Georgia [Member] | Term Loan Under Credit Agreement [Member] | |||||
New term loan | $ 36,900 | ||||
San Diego [Member] | |||||
Write-off of assests | $ 595 | $ 595 | |||
Other restructuring and related charges | 502 | 502 | |||
Severance and other related costs | $ 717 | $ 717 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | Dec. 31, 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 | $ 8,519 |
Debt - Components and Classific
Debt - Components and Classification of Debt (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Instrument [Line Items] | ||
Debt principal | $ 39,472 | $ 41,317 |
Unamortized deferred issuance costs | (2,172) | (2,476) |
Unamortized original discount | (205) | (297) |
Carrying value of debt | 37,095 | 38,544 |
Current portion of debt | 36,756 | 7,577 |
Debt, net of current portion | 339 | 30,967 |
Term Loan Under Credit Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Debt principal | 35,055 | 36,900 |
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 Maturities o
Debt - Schedule of Maturities of Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Debt Disclosure [Abstract] | ||
2024 | $ 39,149 | |
2025 | 32 | |
2026 | 39 | |
2027 | 46 | |
2028 | 56 | |
Thereafter | 150 | |
Total debt principal | $ 39,472 | $ 41,317 |
Debt - Additional Information (
Debt - Additional Information (Detail) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||||
May 31, 2020 USD ($) | Dec. 31, 2023 USD ($) $ / shares | Dec. 31, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) | Aug. 31, 2023 $ / shares shares | Aug. 12, 2023 USD ($) | |
Debt Instrument [Line Items] | ||||||
Common stock, par value | $ / shares | $ 0.01 | $ 0.01 | ||||
Long term debt, maturity, year one | $ 39,149 | |||||
Long term debt, maturity, year two | 32 | |||||
Long term debt, maturity, year three | 39 | |||||
Cash and cash equivalents | 8,095 | $ 14,995 | ||||
Capital expenditure | 829 | 1,384 | $ 1,045 | |||
Carrying value of debt | 37,095 | 38,544 | ||||
Non-cash interest expense | 2,239 | 4,845 | 5,815 | |||
Current portion of debt | 36,756 | 7,577 | ||||
Debt principal | 39,472 | 41,317 | ||||
Gain on extinguishment of debt | $ 0 | (4,996) | 3,352 | |||
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 | $ 4,411 | 5,558 | ||||
Gain on extinguishment of debt | $ 4,996 | |||||
Athyrium Opportunities I I I Acquisition Limited Partnership Credit Agreement [Member] | LIBOR [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Term loan variable interest rate | 8.25% | |||||
Athyrium Second Amendment Credit Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Effective interest rate | 16.40% | |||||
Note With Former Member of IriSys [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, maturity date | Aug. 13, 2024 | |||||
Number of shares | shares | 100,000 | |||||
Common stock, par value | $ / shares | $ 0.01 | |||||
Carrying value of debt | $ 6,117 | |||||
Exercise price per share | $ / shares | $ 1 | |||||
Debt instrument, face amount | $ 2,039 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 6% | |||||
Long-term debt term | 3 years | 3 years | ||||
Debt Instrument, Interest Rate, Basis for Effective Rate | 15.3 | |||||
Others [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt principal | $ 339 | |||||
Term Loan Under Credit Agreement [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Credit agreement | 36,900 | |||||
Long term debt, maturity, year one | 3,690 | |||||
Long term debt, maturity, year two | $ 31,365 | |||||
Repayment Terms | The outstanding principal amount is scheduled to be repaid in quarterly amounts totaling $3,690 in 2024 and $31,365 in 2025 (which is inclusive of the remaining principal balance due at maturity on December 16, 2025). The Company is also obligated to make a $7,500 mandatory principal prepayment upon completion of the sale of certain real property. Quarterly principal payments made after the completion of the land sale will be reduced proportionately to the reduction in principal.Substantial doubt exists that the Company will continue as a going concern (see note 1). Absent completion of the planned merger, which is expected to result in the repayment and termination of the credit agreement, or additional amendments to, or waivers under, the credit agreement, the Company expects that an event of default would be triggered once the audited financial statements are delivered to Royal Bank of Canada under the terms of the amended credit agreement. For these reasons, the entire principal balance of the term loan is classified as current and is presented as maturing during the twelve months ending December 31, 2024. | |||||
Repayment of debt within 12 months of credit agreement closing upon the sale of real property | $ 7,500 | |||||
Minimum fixed charge ratio | 1 | |||||
Cash and cash equivalents during the period | $ 4,000 | |||||
Cash and cash equivalents during next year of first quarter | 4,000 | |||||
Cash and cash equivalents after six months | 3,500 | |||||
Cash and cash equivalents end of next twelve month | $ 4,500 | |||||
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. The Company paid a fee of $369 and is required to increase its remaining quarterly principal payments by $231 as a result of not completing the sale of certain real property by a December 2023 deadline. Quarterly principal payment increases of $231 have been included in the debt maturity disclosures above | |||||
Debt instrument fee | $ 369 | |||||
Increase in qauterly repayments | $ 231 | |||||
Effective interest rate | 13.80% | |||||
Non-cash interest expense | $ 1,086 | $ 35 | ||||
Debt principal | 35,055 | $ 36,900 | ||||
Term Loan Under Credit Agreement [Member] | Maximum | ||||||
Debt Instrument [Line Items] | ||||||
Capital expenditure | $ 9,000 | |||||
Minimum fixed charge ratio | 1.05 | |||||
Maximum leverage ratio | 3.75 | |||||
Cash and cash equivalents end of year 2 | $ 5,000 | |||||
Cash and cash equivalents at next two years of first quarter | 5,000 | |||||
Cash and cash equivalents at next two years of second quarter | 5,000 | |||||
Cash and cash equivalents at next two year of third quarter | 5,000 | |||||
Term Loan Under Credit Agreement [Member] | Minimum | ||||||
Debt Instrument [Line Items] | ||||||
Cash and cash equivalents | $ 1,500 | |||||
Maximum leverage ratio | 2.75 | |||||
Term Loan Under Credit Agreement [Member] | First Year [Member] | Floor [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Term loan variable interest rate | 1% | |||||
Term Loan Under Credit Agreement [Member] | First Year [Member] | SOFR [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Term loan variable interest rate | 4.50% | |||||
Term Loan Under Credit Agreement [Member] | Second Year [Member] | SOFR [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Term loan variable interest rate | 5% | |||||
Term Loan Under Credit Agreement [Member] | Third Year [Member] | SOFR [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Term loan variable interest rate | 5.50% | |||||
Federal COVID 19 Relief Program [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 4,416 | |||||
Debt Instrument, Interest Rate, Stated Percentage | 1% | |||||
Long-term debt term | 2 years | |||||
Repayments of Long-term Debt | $ 1,100 | |||||
Gain on extinguishment of debt | 3,352 | |||||
Debt forgiveness | 3,316 | |||||
Accrued interest | $ 36 |
Other Liabilities - Additional
Other Liabilities - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Accelerated Share Repurchases [Line Items] | |||
Sale leaseback liability | $ 39,010 | ||
Other liabilities | $ 40,332 | $ 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 | ||
Proceeds from sales-lease back liability | $ 0 | $ 37,250 | $ 0 |
Lease initial term | 20 years | ||
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 | ||
Annual base rent under the lease | $ 3,510 | ||
Percentage of increase in rent amount | 3% | ||
Company recognized liability | $ 39,010 | ||
Unamortized deferred financing costs | $ 820 | ||
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 | $ 1,322 | ||
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 | Dec. 31, 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 | |||
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 $6.84, 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] | 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 | Dec. 31, 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) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2023 | Dec. 31, 2022 | |
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 the result of rights to consideration becoming unconditional | (10,826) | |
Reclassification to revenue as the result of performance obligations satisfied | 963 | |
Changes in estimate | 1,416 | |
Net change to contract balance recognized since beginning of period due to recognition of revenue, amounts billed and changes in estimate | 12,560 | |
Balance at December 31, 2023 | 12,837 | |
Current portion | 12,837 | $ 8,724 |
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 | 1,809 | |
Net change to contract balance recognized since beginning of period due to recognition of revenue, amounts billed and changes in estimate | (360) | |
Balance at December 31, 2023 | (762) | |
Less: noncurrent portion | 219 | |
Current portion | $ (543) | $ (2,211) |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue by Timing of Revenue Recognition (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | |||
Revenue | $ 94,635 | $ 90,214 | $ 75,360 |
Point In Time [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Revenue | 73,316 | 70,325 | 60,992 |
Over Time [Member] | |||
Disaggregation Of Revenue [Line Items] | |||
Revenue | $ 21,319 | $ 19,889 | $ 14,368 |
Retirement Plan - Additional In
Retirement Plan - Additional Information (Detail) - 401(k) Plan [Member] - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Defined Contribution Plan Disclosure [Line Items] | |||
Defined contribution plan, employer matching contribution, percent of match | 100% | ||
Defined contribution plan, maximum annual contributions per employee, percent | 5% | ||
Contributions by employer | $ 1,537 | $ 1,348 | $ 915 |
Defined contribution plan, description | The Company has a voluntary 401(k) savings plan in which all employees are eligible to participate. The 401(k) plan features a discretionary employer match. The Company’s current approach is to match 100% of the employee contributions up to a maximum of 5% of employee compensation, subject to company performance. Total Company contributions to the 401(k) plan were $1,537 for 2023, $1,348 for 2022 and $915 for 2021 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
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 | $ 0.92 | $ 1.02 | $ 1.77 | |
Number of options, exercised | $ 0 | |||
Unrecognized compensation expense related to unvested options and time-based RSUs, expected to vest | $ 7,102 | $ 7,102 | ||
Unrecognized compensation expense related to unvested options, weighted average period | 2 years 2 months 12 days | |||
Stock Options Granted Outside Plan [Member] | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Number of options, Granted | 961,005 | |||
Number of shares, Granted | 40,503 | |||
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 | $ 3.49 | |
Number of shares, Granted | 2,640,762 | |||
Share based compensation Number of shares cancelled | 250,496 | |||
Fair value vested | $ 1,329 | $ 897 | $ 2,663 | |
Restricted Stock Units [Member] | Minimum | ||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||
Stock options vest period | 6 months | |||
Restricted Stock Units [Member] | Maximum | ||||
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 | 6,369,829 | 6,369,829 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options Granted (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted average grant date fair value | $ 0.92 | $ 1.02 | $ 1.77 |
Assumptions used to determine fair value: | |||
Expected dividend yield | 0% | 0% | 0% |
Minimum [Member] | |||
Assumptions used to determine fair value: | |||
Range of expected option life | 5 years 6 months | 5 years 6 months | 5 years 6 months |
Expected volatility | 79% | 79% | 79% |
Risk-free interest rate | 3.50% | 1.50% | 0.70% |
Maximum [Member] | |||
Assumptions used to determine fair value: | |||
Range of expected option life | 6 years | 6 years | 6 years |
Expected volatility | 85% | 81% | 81% |
Risk-free interest rate | 4.60% | 4% | 1.40% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) $ / shares shares | |
Share-Based Payment Arrangement [Abstract] | |
Number of shares, Beginning balance | shares | 8,050,337 |
Number of shares, Granted | shares | 1,909,739 |
Number of shares, Forfeited or expired | shares | (2,224,541) |
Number of shares, Ending balance | shares | 7,735,535 |
Number of shares, Exercisable | shares | 4,682,431 |
Weighted average exercise price, Beginning balance | $ / shares | $ 3.89 |
Weighted average exercise price, Granted | $ / shares | 1.31 |
Weighted average exercise price, Forfeited or expired | $ / shares | 5.34 |
Weighted average exercise price, Ending balance | $ / shares | 2.83 |
Weighted average exercise price, Exercisable | $ / shares | $ 3.64 |
Aggregate intrinsic value | $ | $ 42 |
Aggregate intrinsic value, Exercisable | $ | $ 1 |
Weighted average remaining contractual life | 7 years 3 months 18 days |
Weighted average remaining contractual life, Exercisable | 6 years 6 months |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - $ / shares | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Weighted average grant date fair value, Granted | $ 0.92 | $ 1.02 | $ 1.77 |
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 | (1,365,982) | ||
Number of shares, Forfeited | (250,496) | ||
Number of shares, Ending balance | 3,086,150 | 2,061,866 | |
Weighted average grant date fair value, Beginning balance | $ 1.71 | ||
Weighted average grant date fair value, Granted | 1.3 | $ 1.32 | $ 3.49 |
Weighted average grant date fair value, Vested | 3.17 | ||
Weighted average grant date fair value, Forfeited | 1.84 | ||
Weighted average grant date fair value, Ending balance | $ 2.1 | $ 1.71 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Based Compensation Expenses (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock based compensation expense | $ 5,009 | $ 5,426 | $ 6,514 |
Cost of Sales [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock based compensation expense | 1,953 | 1,868 | 2,797 |
Selling General and Administrative Expenses [Member] | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Stock based compensation expense | $ 3,056 | $ 3,558 | $ 3,717 |
Income Taxes - Components of In
Income Taxes - Components of Income Tax Provision (Benefit) From Continuing Operations (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Current: | |||
Federal | $ 33 | ||
State | $ 43 | 57 | |
Total current | 43 | 90 | |
Deferred: | |||
Federal | (2,092) | 1,399 | $ (2,396) |
State | (1,164) | 4,266 | (677) |
Total deferred | (3,256) | 5,665 | (3,073) |
Change in valuation allowance | 3,345 | (4,650) | 3,073 |
Income tax expense | $ 132 | $ 1,105 | $ 0 |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Statutory U.S. Federal Income Tax Rate to Effective Tax Rate From Continuing Operations (Detail) | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |||
U.S. federal statutory income tax rate | 21% | 21% | 21% |
State taxes, net of federal benefit | (2.00%) | 7% | 8% |
Change in state tax rate | 1% | (22.00%) | (2.00%) |
Nondeductible expenses | (5.00%) | (5.00%) | (1.00%) |
Research and development credits | 0% | (23.00%) | 1% |
Change in valuation allowance | (16.00%) | 16% | (27.00%) |
Effective income tax rate | (1.00%) | (6.00%) | 0% |
Income Taxes - Schedule of Tax
Income Taxes - Schedule of Tax Effects of Temporary Differences to Significant Portions of Deferred Tax Assets (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 |
Income Tax Disclosure [Abstract] | ||
Net operating loss carryforwards | $ 35,650 | $ 33,352 |
Interest expense | 14,314 | 12,944 |
Sales Leaseback | 9,448 | 9,093 |
Stock-based compensation | 5,344 | 4,681 |
Other | 3,791 | 3,950 |
Gross deferred tax asset | 68,547 | 64,020 |
Valuation allowance | (54,314) | (50,909) |
Deferred tax assets, net of valuation allowance | 14,233 | 13,111 |
Depreciation | (11,088) | (10,750) |
Contract assets | (3,112) | (2,082) |
Other | (1,197) | (1,294) |
Deferred tax liabilities | (15,397) | (14,126) |
Net deferred tax liabilities | $ (1,164) | $ (1,015) |
Income Taxes - Summary of Carry
Income Taxes - Summary of Carryforward of Net Operating Losses (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses, Expiration period | State net operating loss carryforwards may be further limited, including in Pennsylvania, which has a limitation of 40% of taxable income after modifications and apportionment on state net operating losses utilized in any one year. |
Federal [Member] | Tax Year 2018 To 2022 | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses | $ 133,545 |
Net operating losses, Expiration period | No expiration |
State [Member] | Limited | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses | $ 111,810 |
Net operating losses, Expiration period start | 2031 |
Net operating losses, Expiration period end | 2044 |
State [Member] | Unlimited | |
Operating Loss Carryforwards [Line Items] | |
Net operating losses | $ 35,165 |
Net operating losses, Expiration period | No expiration |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Income Taxes [Line Items] | |||
Operating loss and research and development tax credit carryforwards percentage of change in ownership | 50% | ||
Operating loss and research and development tax credit carryforwards percentage of change in ownership period | 3 years | ||
Taxable gain on sale for federal and state income tax purposes | $ 25,350 | ||
Percentage of limitation on taxable income after modification and apportionment | 40% | ||
Net operating loss carryforwards, limitation | State net operating loss carryforwards may be further limited, including in Pennsylvania, which has a limitation of 40% of taxable income after modifications and apportionment on state net operating losses utilized in any one year. | ||
Accrued interest or penalties related to uncertain tax positions | $ 0 | ||
Recognized amounts of interest or penalties related to uncertain tax positions | $ 0 | ||
Income tax examination | Due to net operating loss and tax credit carry forwards that remain unutilized, income tax returns for tax years since inception remain subject to examination by the taxing jurisdictions. | ||
Reduction in corporate tax rate | 1% | (22.00%) | (2.00%) |
PENNSYLVANIA | |||
Income Taxes [Line Items] | |||
Reduction in corporate tax rate | 4.99% | ||
Income Tax Rate Deduction, Percent | 0.50% | ||
Maximum [Member] | PENNSYLVANIA | |||
Income Taxes [Line Items] | |||
Reduction in corporate tax rate | 9.90% | ||
Minimum [Member] | PENNSYLVANIA | |||
Income Taxes [Line Items] | |||
Reduction in corporate tax rate | 8.90% |
Acquisition of IriSys (Addition
Acquisition of IriSys (Additional Information) (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Aug. 13, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Business Acquisition [Line Items] | ||||
Indefinite-lived intangible assets fair value | $ 4,170 | |||
Net loss | (13,274) | $ (19,881) | $ (11,370) | |
Customer Relationships [Member] | ||||
Business Acquisition [Line Items] | ||||
Indefinite-lived intangible assets fair value | $ 3,400 | |||
Irisys LLC [Member] | ||||
Business Acquisition [Line Items] | ||||
Date of acquisition agreement | Aug. 13, 2021 | |||
Number of share issued for acquisition | 9,302,718 | |||
Business acquisition transaction costs | $ 1,211 | |||
Revenues | 5,955 | |||
Net loss | $ 440 |
Acquisition of IriSys - Schedul
Acquisition of IriSys - Schedule of Business Acquisition of Purchase Price Consideration (Detail) - USD ($) $ in Thousands | 12 Months Ended | |||
Aug. 13, 2021 | Dec. 31, 2023 | Dec. 31, 2022 | Dec. 31, 2021 | |
Business Acquisition [Line Items] | ||||
Cash paid, net of cash acquired | $ 0 | $ 0 | $ 24,002 | |
Net working capital adjustment receivable | $ (417) | |||
Irisys LLC [Member] | ||||
Business Acquisition [Line Items] | ||||
Cash paid, net of cash acquired | 24,002 | |||
Fair value of forward equity issuance | 20,931 | |||
Fair value of note with former members of IriSys | 5,240 | |||
Total estimated consideration | $ 49,756 |
Acquisition of IriSys - Sched_2
Acquisition of IriSys - Schedule of Provisional Fair Values of the Assets Acquired and Liabilities Assumed (Detail) - USD ($) $ in Thousands | Dec. 31, 2023 | Dec. 31, 2022 | Aug. 13, 2021 |
Assets acquired: | |||
Operating lease asset | $ 5,004 | $ 5,491 | |
Irisys LLC [Member] | |||
Assets acquired: | |||
Accounts receivable | $ 909 | ||
Contract assets | 505 | ||
Inventory | 685 | ||
Prepaid expenses and other current assets | 91 | ||
Property and equipment | 9,304 | ||
Operating lease asset | 5,648 | ||
Intangible assets | 4,170 | ||
Goodwill | 36,758 | ||
Other assets | 146 | ||
Total assets acquired | 58,216 | ||
Liabilities assumed: | |||
Accounts payable | 730 | ||
Accrued expenses and other current liabilities | 1,556 | ||
Operating lease liability | 5,648 | ||
Debt from finance loan | 339 | ||
Other liabilities | 187 | ||
Total liabilities assumed | 8,460 | ||
Net assets acquired | $ 49,756 |
Acquisition of IriSys - Sched_3
Acquisition of IriSys - Schedule of Intangible Assets Acquired (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2023 USD ($) | |
Acquired Finite-Lived Intangible Assets [Line Items] | |
Intangible asset amortized remaining term | 6 years 1 month 6 days |
Indefinite-lived intangible assets fair value | $ 4,170 |
Customer Relationships [Member] | |
Acquired Finite-Lived Intangible Assets [Line Items] | |
Intangible asset amortized remaining term | 7 years |
Indefinite-lived intangible assets fair value | $ 3,400 |
Backlog [Member] | |
Acquired Finite-Lived Intangible Assets [Line Items] | |
Intangible asset amortized remaining term | 2 years 4 months 24 days |
Indefinite-lived intangible assets fair value | $ 460 |
Trademark and tradenames [Member] | |
Acquired Finite-Lived Intangible Assets [Line Items] | |
Intangible asset amortized remaining term | 1 year 6 months |
Indefinite-lived intangible assets fair value | $ 310 |
Acquisition of IriSys - Sched_4
Acquisition of IriSys - Schedule of Supplemental Pro Forma Financial Information (Detail) - Irisys LLC [Member] - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Business Acquisition [Line Items] | ||
Revenue | $ 83,045 | $ 78,881 |
Net income (loss) | $ (11,809) | $ (28,290) |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) $ in Thousands | Dec. 31, 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 | 12 Months Ended | ||
Dec. 31, 2023 USD ($) Lease | Dec. 31, 2022 USD ($) | Dec. 31, 2021 USD ($) | |
Lessee Lease Description [Line Items] | |||
Number of operating lease | 2 | ||
Number of development lease | 2 | ||
Operating lease, weighted average remaining term | 6 years 9 months 18 days | ||
Operating lease, weighted average discount rate percent | 14.10% | ||
Total operating lease, cost | $ | $ 1,789 | $ 1,980 | $ 814 |
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 | ||
Gainesville, 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 | Dec. 31, 2023 USD ($) |
Lessee Disclosure [Abstract] | |
2024 | $ 1,193 |
2025 | 1,158 |
2026 | 1,097 |
2027 | 1,127 |
2028 | 1,159 |
Thereafter | 2,521 |
Total lease payments | 8,255 |
Less imputed interest | (2,997) |
Total operating lease liabilities | $ 5,258 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) | 12 Months Ended |
Dec. 31, 2023 | |
Irisys LLC [Member] | |
Related Party Transaction [Line Items] | |
common stock owned percentage | 10 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Details) - $ / shares | Feb. 28, 2024 | Dec. 31, 2023 | Dec. 31, 2022 |
Subsequent Event [Line Items] | |||
Common stock value per share | $ 0.01 | $ 0.01 | |
CoreRx, Inc. [Member] | Subsequent Event [Member] | |||
Subsequent Event [Line Items] | |||
Common stock value per share | $ 0.01 | ||
Description of merger offer expiration | The Offer will initially expire one minute following 11:59 p.m. (Eastern Time) on the date that is 20 business days following the commencement of the Offer, subject to extension under certain circumstances. | ||
CoreRx, Inc. [Member] | Subsequent Event [Member] | Cash [Member] | |||
Subsequent Event [Line Items] | |||
Common stock value per share | $ 1.1 |