Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 07, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2022 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
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 | 56,632,541 | |
Entity Shell Company | false | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Trading Symbol | SCTL | |
Entity File Number | 001-36329 | |
Entity Tax Identification Number | 26-1523233 | |
Entity Address, Address Line One | 1 E. Uwchlan Ave, Suite 112 | |
Entity Address, City or Town | Exton | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19341 | |
City Area Code | 770 | |
Local Phone Number | 534-8239 | |
Entity Incorporation, State or Country Code | PA | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Security Exchange Name | NASDAQ | |
Title of 12(b) Security | Common Stock, par value $0.01 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 15,276 | $ 25,217 |
Accounts receivable, net | 14,124 | 11,913 |
Contract asset | 8,934 | 8,565 |
Inventory | 9,470 | 8,917 |
Prepaid expenses and other current assets | 1,889 | 2,917 |
Total current assets | 49,693 | 57,529 |
Property, plant and equipment, net | 51,353 | 51,708 |
Operating lease asset | 5,818 | 5,924 |
Intangible assets, net | 3,612 | 3,833 |
Goodwill | 41,077 | 41,077 |
Other assets | 246 | 246 |
Total assets | 151,799 | 160,317 |
Current liabilities: | ||
Accounts payable | 1,556 | 2,085 |
Current portion of related party debt | 2,039 | 2,039 |
Current portion of operating lease liability | 1,062 | 1,055 |
Accrued expenses and other current liabilities | 6,344 | 12,556 |
Total current liabilities | 11,001 | 17,735 |
Debt, net of current portion | 93,240 | 92,127 |
Related party debt, net of current portion | 3,477 | 3,369 |
Operating lease liability, net of current portion | 4,850 | 4,932 |
Other liabilities | 69 | 90 |
Total liabilities | 112,637 | 118,253 |
Commitments and contingencies (note 7) | ||
Shareholders' equity: | ||
Preferred stock, $0.01 par value. 10,000,000 shares authorized, none issued or outstanding | 0 | 0 |
Common stock, $0.01 par value. 95,000,000 shares authorized, 56,632,541and 46,681,453 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 565 | 467 |
Additional paid-in capital | 288,615 | 287,351 |
Accumulated deficit | (250,018) | (245,754) |
Total shareholders' equity | 39,162 | 42,064 |
Total liabilities and shareholders' equity | $ 151,799 | $ 160,317 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) (Unaudited) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 95,000,000 | 95,000,000 |
Common stock, shares issued | 56,472,086 | 46,681,453 |
Common stock, shares outstanding | 56,472,086 | 46,681,453 |
Consolidated Statements of Oper
Consolidated Statements of Operations (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Income Statement [Abstract] | ||
Revenue | $ 21,194 | $ 16,803 |
Operating expenses: | ||
Cost of sales (excluding amortization of intangible assets) | 16,114 | 14,337 |
Selling, general and administrative | 5,710 | 4,683 |
Amortization of intangible assets | 221 | 646 |
Total operating expenses | 22,045 | 19,666 |
Operating loss | (851) | (2,863) |
Interest expense | (3,413) | (3,898) |
Net loss | $ (4,264) | $ (6,761) |
Earnings Per Share [Abstract] | ||
Loss per share, basic and diluted | $ (0.08) | $ (0.23) |
Weighted average shares outstanding:, basic and diluted | 56,351,178 | 29,737,864 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity or Deficit (Unaudited) - USD ($) $ in Thousands | Total | Common 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 | 28,601,358 | |||
Issuance of common stock, net of costs | 9,340 | $ 22 | 9,318 | |
Issuance of common stock , net of costs , shares | 2,202,420 | |||
Stock-based compensation expense | 3,133 | 3,133 | ||
Vesting of restricted stock units, net | (336) | $ 2 | (338) | |
Vesting of restricted stock units, net , Shares | 209,541 | |||
Net loss | (6,761) | (6,761) | ||
Balance at Mar. 31, 2021 | (8,724) | $ 310 | 232,111 | (241,145) |
Balance, Shares at Mar. 31, 2021 | 31,013,319 | |||
Balance at Dec. 31, 2021 | 42,064 | $ 467 | 287,351 | (245,754) |
Balance, Shares at Dec. 31, 2021 | 46,681,453 | |||
Issuance of common stock, net of costs | (16) | $ 93 | (109) | |
Issuance of common stock , net of costs , shares | 9,302,718 | |||
Stock-based compensation expense | 1,479 | 1,479 | ||
Vesting of restricted stock units, net | $ (101) | $ 5 | (106) | |
Vesting of restricted stock units, net , Shares | 487,695 | |||
Exercise of stock options, net, Shares | 220 | 220 | ||
Net loss | $ (4,264) | (4,264) | ||
Balance at Mar. 31, 2022 | $ 39,162 | $ 565 | $ 288,615 | $ (250,018) |
Balance, Shares at Mar. 31, 2022 | 56,472,086 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (4,264) | $ (6,761) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 1,479 | 3,133 |
Non-cash interest expense | 1,257 | 1,462 |
Depreciation expense | 1,792 | 1,436 |
Amortization of intangible assets | 221 | 646 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (2,211) | (3,395) |
Contract asset | (369) | 336 |
Inventory | (553) | 2,976 |
Prepaid expenses and other assets | 1,134 | 110 |
Accrued interest | (2,274) | 0 |
Accrued payroll | (3,323) | 34 |
Accounts payable, accrued expenses and other liabilities | (969) | (66) |
Net cash used in operating activities | (8,080) | (89) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (1,708) | (1,477) |
Net cash used in investing activities | (1,708) | (1,477) |
Cash flows from financing activities: | ||
Payment of costs for issuance of common stock | (16) | 0 |
Cash portion of $16,160 reduction to debt principal and accrued exit fee | 0 | (10,100) |
Payment of financing costs | (36) | (200) |
Net payments related to vesting of restricted stock units | (101) | (336) |
Net cash used in financing activities | (153) | (10,636) |
Net decrease in cash and cash equivalents | (9,941) | (12,202) |
Cash and cash equivalents, beginning of period | 25,217 | 23,760 |
Cash and cash equivalents, end of period | 15,276 | 11,558 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 4,676 | 2,495 |
Purchases of property, plant and equipment included in accrued expenses and accounts payable | 774 | 132 |
Issuance of common stock to reduce debt principal and accrued exit fees | 0 | 6,060 |
Issuance of common stock to settle interest obligations | $ 0 | $ 3,211 |
Consolidated Statements of Ca_2
Consolidated Statements of Cash Flows (Parenthetical) (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Statement of Cash Flows [Abstract] | ||
Cash portion reduction in debt principal and accrued exit fees | $ 16,160 | $ 16,160 |
Background
Background | 3 Months Ended |
Mar. 31, 2022 | |
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 as Recro Pharma, Inc. Effective March 21, 2022, Recro Pharma, Inc changed its name to Societal CDMO, Inc. to reflect the corporate transformation that had taken place primarily as a result of its acquisition and successful integration of IriSys, LLC (“IriSys”) into the organization. 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 in the area of small molecules. With an expertise in solving complex manufacturing problems, Societal CDMO 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. The Company has determined that it operates in a single segment. The Company has incurred net losses since inception and has an accumulated deficit of $ 250,018 as of March 31, 2022 , which is primarily related to the activities of its former research and development business that was spun-out in 2019. The Company’s future operations are highly dependent on the profitability of its development and manufacturing operations. Management believes that it is probable that the Company will be able to meet its obligations as they become due within at least one year after the date financial statements included herein are issued. |
Summary of Significant Accounti
Summary of Significant Accounting Principles | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Principles | (2) Summary of significant accounting principles Basis of presentation and principles of consolidation The accompanying unaudited consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information. In accordance with Securities and Exchange Commission's (“SEC”) rules for interim financial statements, certain information required by U.S. GAAP may be condensed or omitted. The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. In the opinion of management, the accompanying consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s results for the interim periods. Operating results for interim periods are not necessarily indicative of the results that may be expected for the full year. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021. 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 and classified 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. 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 lives. 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, packaging, research and development and related services for multiple pharmaceutical companies. Manufacturing Manufacturing 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 customer agreements may have 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. For arrangements that include sales-based profit-sharing where the license for intellectual property is deemed to be the predominant item to which the profit-sharing relates, the Company recognizes revenue when the related sales occur by the commercial partner. For arrangements that include sales-based profit-sharing where the license for intellectual property is not deemed to be the predominant item to which the profit-sharing relates, 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. Research and development Research and development revenue includes services associated with formulation, process development, clinical trials materials services, as well as custom development of manufacturing processes and analytical methods for a customer’s non-clinical, clinical and commercial products. Such revenues are recognized at a point in time or over time depending on the nature and particular facts and circumstances associated with the contract terms. In contracts that specify milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments related to arrangements under which the Company has continuing performance obligations are deferred and recognized over the period of performance. Milestone payments that are not within the Company’s control, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received. In contracts that require revenue recognition over time, the Company utilizes input or output methods, depending on the specifics of the contract, that compare the cumulative work-in-process to date to the most current estimates for the entire performance obligation. Under these contracts, the customer typically owns the product details and process, which have no alternative use. These projects are customized to each customer to meet its specifications and typically only one performance obligation is included. Each project represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of its product as the product is being created or enhanced by the Company’s services and can make changes to its process or specifications upon request. Contract assets represent revenue recognized for performance obligations completed or in process before an unconditional right to payment exists, and therefore invoicing or associated reporting from the customer regarding the computation of the net product sales has not yet occurred. Contract liabilities represent payments received from customers prior to the completion of associated performance obligations. Concentration of credit risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and accounts receivable. The Company manages its cash and cash equivalents based on established guidelines relative to diversification and maturities to maintain safety and liquidity. The Company’s accounts receivable balances are primarily concentrated among three customers. If any of these customers’ receivable balances should be deemed uncollectible, it could have a material adverse effect on the Company’s results of operations and financial condition. The Company is dependent on its relationships with a small number of commercial partners. The Company's three largest customers generated 78 % of its revenues for the three months ended March 31, 2022 . 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. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. A full valuation allowance was recorded as of March 31, 2022 and December 31, 2021. 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 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. 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 debt. 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). To calculate diluted income or loss per share, the numerator and denominator are adjusted to eliminate the income or loss and the dilutive effects on shares, respectively, caused by outstanding common stock options, warrants and unvested restricted stock units, using the treasury stock method, if the inclusion of such instruments would be dilutive. For all periods presented, the Company incurred a net loss. In periods of net loss, the inclusion of dilutive securities would be antidilutive because it would reduce the amount of loss incurred per share. As a result, no additional dilutive shares were included in diluted loss per share, and there were no differences between basic and diluted loss per share. The following table presents the potentially dilutive securities that were excluded from the computations of diluted loss per share: Three months ended March 31, 2022 2021 Restricted stock units 739,148 695,603 Stock options 6,860,892 4,173,680 Warrants 348,664 348,664 Amounts in the table above reflect the common stock equivalents of the noted instruments. Recent accounting pronouncements In March 2020, the FASB issued ASU 2020-04, “Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting” (“ASU 2020-04”). This ASU provides temporary optional expedients and exceptions to the guidance on contract modifications and hedge accounting to ease the financial reporting burdens of the expected market transition from the London Interbank Offered Rate and other interbank offered rates to alternative reference rates. In January 2021, the FASB issued ASU 2021-01, which refines the scope of Topic 848 and clarifies some of its guidance as part of the FASB’s monitoring of global reference rate activities. The new guidance was effective upon issuance, and the Company is allowed to elect to apply the amendments prospectively through December 31, 2022. The Company is currently evaluating the impact this standard will have on its consolidated financial statements. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | (3) Inventory The following table presents the components of inventory: March 31, 2022 December 31, 2021 Raw materials $ 3,588 $ 3,038 Work in process 2,459 3,363 Finished goods 3,423 2,516 Inventory $ 9,470 $ 8,917 |
Property, Plant and Equipment,
Property, Plant and Equipment, Net | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property, Plant and Equipment | (4) Property, plant and equipment, net The following table presents the components of property, plant and equipment: March 31, 2022 December 31, 2021 Land $ 3,263 $ 3,263 Building and improvements 22,874 22,717 Furniture, office and computer equipment 6,229 6,213 Manufacturing equipment 50,327 49,687 Construction in progress 7,480 6,856 Property, plant and equipment, gross 90,173 88,736 Less: accumulated depreciation ( 38,820 ) ( 37,028 ) Property, plant and equipment, net $ 51,353 $ 51,708 Interest expense capitalized to construction in progress was $ 268 in the first quarter of 2022 and $ 65 in the first quarter of 2021. |
Intangible Assets, Net
Intangible Assets, Net | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Intangible Assets, Net | (5) I ntangible assets, net The following table presents the components of other intangible assets: March 31, 2022 December 31, 2021 Gross value Accumulated amortization Carrying value Gross value Accumulated amortization Carrying value Customer relationships $ 18,900 $ 15,807 $ 3,093 $ 18,900 $ 15,685 $ 3,215 Backlog 460 120 340 460 73 387 Trademarks and tradenames 310 131 179 310 79 231 Total $ 19,670 $ 16,058 $ 3,612 $ 19,670 $ 15,837 $ 3,833 The following table presents estimated future amortization of other intangible assets: Twelve months ending March 31, 2023 $ 855 2024 635 2025 486 2026 486 2027 486 Thereafter 664 Total $ 3,612 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2022 | |
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: March 31, 2022 December 31, 2021 Payroll and related costs $ 2,394 $ 5,717 Current portion of contract liabilities (see note 10) 1,836 2,308 Property, plant and equipment 426 663 Professional and consulting fees 349 552 Accrued interest 231 2,505 Other 1,108 811 Total $ 6,344 $ 12,556 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | (7) Commitments and contingencies Litigation The Company is involved, from time to time, in various claims and legal proceedings arising in the ordinary course of its business. Except as disclosed below, the Company is not currently a party to any such claims or proceedings that, if decided adversely to it, would either individually or in the aggregate have a material adverse effect on its business, financial condition or results of operations. On May 31, 2018, a securities class action lawsuit (the “Securities Litigation”) was filed against the Company and certain of its officers and directors (collectively, the “Defendants”) in the U.S. District Court for the Eastern District of Pennsylvania (the “Court”) (Case No. 2:18-cv-02279-MMB) that purported to state a claim for alleged violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, as amended, and Rule 10b-5 promulgated thereunder, based on statements made by the Company concerning the New Drug Application (“NDA”) for IV meloxicam. The complaint seeks unspecified damages, interest, attorneys’ fees and other costs. On December 10, 2018, the lead plaintiff filed an amended complaint that asserted the same claims and sought the same relief but included new allegations and named additional officers as defendants. On February 8, 2019, the Company filed a motion to dismiss the amended complaint in its entirety, which the lead plaintiff opposed on April 9, 2019. On May 9, 2019, the Company filed its response and briefing was completed on the motion to dismiss. In response to questions from the Court, the parties submitted supplemental briefs regarding the motion to dismiss the amended complaint during the fall of 2019. On February 18, 2020, the motion to dismiss was granted by the Court without prejudice. On April 25, 2020, the plaintiff filed a second amended complaint. The Company filed a motion to dismiss the second amended complaint on June 18, 2020. The plaintiff filed an opposition to the Company’s motion to dismiss on August 17, 2020. On September 16, 2020, the Company filed a reply in support of its motion to dismiss. On March 1, 2021, the Court denied the Company’s second motion to dismiss. On June 21, 2021, the Defendants filed an answer and affirmative defenses to the second amended complaint. Since then, the parties have been engaged in discovery, which must conclude by April 29, 2022. On September 30, 2021, the plaintiff filed a motion for class certification and appointment of class representative. The Company filed an opposition to the plaintiff’s motion on November 30, 2021. On January 6, 2022, the plaintiff filed a reply in support of the motion for class certification. On March 24, 2022, the plaintiff informed the Court that the parties had reached an agreement-in-principle to settle the Securities Litigation and requested that the Court stay all deadlines. The parties are currently negotiating the terms of a Stipulation and Agreement of Settlement. In connection with the separation of the Company's former acute care research and development business into a new standalone entity named Baudax Bio, Inc. (“Baudax Bio”), Baudax Bio accepted assignment by the Company of all of its obligations in connection with the Securities Litigation and agreed to indemnify it for all liabilities related to the Securities Litigation. Purchase commitments As of March 31, 2022, the Company had outstanding cancelable and non-cancelable purchase commitments in the aggregate amount of $ 8,698 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 named executive officers that provide for, among other things, severance commitments of up to $ 1,303 should the Company terminate the named 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 $ 3,772 in the aggregate if certain events occur following a change in control. |
Debt
Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Debt | (8) Debt The following table presents the components and classification of debt: March 31, 2022 December 31, 2021 Debt principal: Terms loans under Credit Agreement $ 100,000 $ 100,000 Note with former equity holder of IriSys 6,117 6,117 Other 339 339 Debt principal 106,456 106,456 Debt adjustments: Unamortized deferred issuance costs ( 7,835 ) ( 8,896 ) Exit fee accretion 710 669 Unamortized original discount ( 575 ) ( 694 ) Carrying value of debt $ 98,756 $ 97,535 Current portion of related party debt $ 2,039 $ 2,039 Debt, net of current portion 93,240 92,127 Related party debt, net of current portion 3,477 3,369 Carrying value of debt $ 98,756 $ 97,535 The following table presents the future maturity of debt principal: Twelve months ending March 31, 2023 $ 2,039 2024 102,039 2025 2,062 2026 33 2027 40 Thereafter 243 Total debt principal $ 106,456 Term loans under Credit Agreement The Company is currently party to a credit agreement (the “Credit Agreement”) with Athyrium Opportunities III Acquisition LP (“Athyrium”). The Credit Agreement has been fully drawn in the form of $ 48,000 of term A loans and $ 52,000 of term B loans, all of which mature on December 31, 2023 . The term loans under the Credit Agreement bear a rate of interest equal to the three-month LIBOR rate, with a 1 % floor, plus 8.25 % per annum . The term loans require the Company to pay a 1 % exit fee on all repayments. At March 31, 2022 , the aggregate exit fee payable was $ 1,000 , and the cumulative exit fee accreted was $ 710 . The exit fees are being accreted to the carrying amount of the debt using the effective interest method over the term of the loan. In addition, if the Company makes any prepayments prior to maturity, the Company would be subject to prepayment premiums on the term B loans, as a percentage of the amount repaid, of 2.5 %. The Credit Agreement contains certain usual and customary affirmative and negative covenants, as well as financial covenants that the Company will need to satisfy on a monthly and quarterly basis, including maintaining a permitted net leverage ratio (which is the Company’s indebtedness under the Credit Agreement, net of cash and cash equivalents, divided by EBITDA, each as defined in the Credit Agreement) and liquidity amount. As of March 31, 2022 , the Company was in compliance with its covenants under the Credit Agreement. In connection with the Credit Agreement, the Company issued warrants to each of Athyrium and its affiliate, Athyrium Opportunities II Acquisition LP (“Athyrium II”), to purchase an aggregate of 348,664 shares of the Company’s common stock with an exercise price of $ 1.73 per share. See note 9 for additional information. The warrants are exercisable through November 17, 2024 . In connection with the Credit Agreement and amendments made to it over the years, the Company has paid financing costs, has incurred costs to record and subsequently to adjust the value of the warrants described above and has been accreting the exit fee described above. 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 $ 1,137 in the first quarter of 2022 and $ 1,462 in the first quarter of 2021. At March 31, 2022, the overall effective interest rate, including cash paid for interest and non-cash interest expense, was 13.8 % . Note with former equity holder of IriSys In connection with the acquisition of IriSys, the Company issued a subordinated promissory note to a former equity holder of IriSys in the aggregate principal amount of $ 6,117 (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 annual 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 loans under the Credit Agreement with Athyrium. The Note was initially recognized at fair value as part of the consideration paid for the acquisition of IriSys, resulting in an original discount recognized of $ 877 that is being recognized as interest expense using the effective interest method over the term of the Note. At March 31, 2022, the overall effective interest rate, including the amortization of the original discount, was 13.0 % . As of the date the financial statements included herein are issued, the former equity holder of IriSys beneficially owned more than 10% of the Company's common stock and became a related party as a result of the acquisition. The Company has accrued interest of $ 231 through March 31, 2022 that will become payable to the former equity holder of IriSys on the first anniversary of the acquisition. Other In connection with the acquisition of IriSys , the Company assumed a loan with a principal amount of $ 339 . |
Stockholders_ Equity or Deficit
Stockholders’ Equity or Deficit | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Stockholders’ Equity or Deficit | (9) Shareholders’ equity or deficit Capital raises The following table presents the Company’s capital raises since its initial public offering in March 2014: Date or period Shares of common stock issued Gross proceeds Offering expenses Net proceeds Initial public offering March 12, 2014 4,312,500 $ 34,500 $ ( 4,244 ) $ 30,256 Private placement July 7, 2015 1,379,311 16,000 ( 1,188 ) 14,812 Underwritten public offering August 19, 2016 1,986,666 14,900 ( 1,533 ) 13,367 Underwritten public offering December 16, 2016 6,670,000 40,020 ( 3,132 ) 36,888 2018 common stock purchase agreement with Aspire Capital Year ended December 31, 2018 1,950,000 16,999 — 16,999 2019 common stock purchase agreement with Aspire Capital Fourth quarter 2020 4,690,972 11,172 ( 78 ) 11,094 Share issuance agreement for amendment 5 to Credit Agreement February 2021 2,202,420 9,338 ( 20 ) 9,318 Underwritten public offering May 12, 2021 15,333,332 34,500 ( 2,397 ) 32,103 Issuance of shares for IriSys acquisition February 2022 9,302,718 20,931 ( 619 ) 20,312 Shares issued As part of the consideration paid for the acquisition of IriSys, the Company issued 9,302,718 shares of its common stock on February 23, 2022. Aspire common stock purchase agreement The Company is currently party to an amended common stock purchase agreement with Aspire Capital Fund LLC (“Aspire Capital”) originally entered into during 2019, and most recently amended in February 2021 (as amended, the “2019 Common Stock Purchase Agreement”). The 2019 Common Stock Purchase Agreement provides that, upon the terms and subject to the conditions and limitations set forth in the agreement, Aspire Capital is committed to purchase, at the Company’s sole election, up to an aggregate value of $ 41,172 in shares of common stock. As of March 31, 2022 , there is availability to issue up to $ 30,000 or 6,199,299 shares of common stock under the 2019 Common Stock Purchase Agreement. Warrants At March 31, 2022 , warrants to purchase 348,664 shares of common stock were outstanding. The warrants are held by Athyrium, equity-classified, exercisable at $ 1.73 per share and expire in November 2024 . See note 8 for additional details. |
Revenue Recognition
Revenue Recognition | 3 Months Ended |
Mar. 31, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue Recognition | (10) Revenue recognition The following table presents changes in contract assets and liabilities: Contract assets Contract liabilities Balance at December 31, 2021 $ 8,565 $ 2,308 Changes to the beginning balance of contract assets arising from: Reclassification to receivables as a result of rights to consideration becoming unconditional ( 7,381 ) — Changes in estimate 1,309 — Contract assets recognized since beginning of period, net of reclassification to receivables and changes in estimates 6,441 — Changes to contract liabilities: Amounts billed in advance of contract performance — 2,754 Revenue recognized — ( 3,226 ) Balance at March 31, 2022 $ 8,934 $ 1,836 The following table disaggregates revenue by timing of revenue recognition: Three months ended March 31, 2022 2021 Point in time $ 16,880 $ 15,147 Over time 4,314 1,656 Total $ 21,194 $ 16,803 The Company’s payment terms for manufacturing revenue and development services are typically 30 to 45 days. Profit-sharing revenue is recorded to accounts receivable in the quarter that the product is sold by the commercial partner upon reporting from the commercial partner and payment terms are generally 45 days after quarter end. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Stock-Based Compensation | (11) 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 March 31, 2022, a total of 1,498,369 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 10 years from the date of grant and generally vest over four years . The following table presents information about the fair value of stock options granted: Three months ended March 31, 2022 2021 Weighted average grant date fair value $ 1.16 $ 2.04 Assumptions used to determine fair value: Range of expected option life 6 years 6 years Expected volatility 79 % 80 - 81 % Risk-free interest rate 1.5 - 2.4 % 0.7 - 1.2 % Expected dividend yield — — The intrinsic value of options exercised was negligible in the first quarter of 2022, and no stock options were exercised in the first quarter of 2021. 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, 2021 5,267,567 $ 6.47 5.7 years Granted 2,918,889 1.70 Exercised ( 220 ) 1.71 Forfeited or expired ( 219,193 ) 4.81 Balance, March 31, 2022 7,967,043 4.77 $ 292 7.0 years Exercisable 3,562,594 7.65 8 4.0 years Included in the table above are 1,034,785 options outstanding as of March 31, 2022 that were granted outside the A&R Plan. The grants were made pursuant to the NASDAQ 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 $ 1.66 in the first quarter of 2022 and $ 3.84 in the first quarter of 2021. The fair value of RSUs vested was $ 414 in the first quarter of 2022 and $ 982 in the first quarter of 2021. The following table presents information about recent RSU activity: Number of shares Weighted average grant date fair value Balance, December 31, 2021 990,065 3.63 Granted 940,090 1.66 Vested ( 250,143 ) 4.74 Forfeited ( 46,133 ) 2.65 Balance, March 31, 2022 1,633,879 2.35 Included in the table above are 114,009 time-based RSUs outstanding at March 31, 2022 that were granted outside of the A&R Plan. The grants were made pursuant to the NASDAQ inducement grant exception in accordance with NASDAQ Listing Rule 5635(c)(4). Other information The following table presents the classification of stock-based compensation expense: Three months ended March 31, 2022 2021 Cost of sales $ 403 $ 1,392 Selling, general and administrative expenses 1,076 1,741 Total $ 1,479 $ 3,133 As of March 31, 2022, there was $ 10,278 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 3.0 years. |
Acquisition of IriSys
Acquisition of IriSys | 3 Months Ended |
Mar. 31, 2022 | |
Business Combinations [Abstract] | |
Acquisition of IriSys | (12) 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 following table presents unaudited supplemental pro forma financial information for the three months ended March 31, 2021 as if the IriSys acquisition had occurred on January 1, 2021: Revenue $ 20,286 Net loss ( 6,282 ) 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, 2021. 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 | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Instruments | (13) 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 $ 14,248 at March 31, 2022 and $ 15,247 at December 31, 2021 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 March 31, 2022, 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 March 31, 2022 due to the recent issuances and amendment of those instruments and taking into consideration management's current evaluation of market conditions. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2022 | |
Lessee Disclosure [Abstract] | |
Leases | (14) Leases The Company is party to two operating leases for development facilities in California and Georgia that end in 2031 and 2025 , respectively, as well as other immaterial operating leases for office space, storage and office equipment. The development facility leases each include options to extend, none of which are included in the lease terms. Short-term and variable lease costs were not material for the periods presented. The development facility leases do not provide an implicit rate, so the Company uses its incremental borrowing rate to discount the lease liabilities. Undiscounted future lease payments for the two development leases, which were the only material noncancelable leases at March 31, 2022, were as follows: Twelve months ended March 31, 2023 $ 1,144 2024 1,172 2025 1,201 2026 1,126 2027 1,104 Thereafter 4,530 Total lease payments 10,277 Less imputed interest ( 4,365 ) Total operating lease liabilities $ 5,912 At March 31, 2022 , the weighted average remaining lease term was 8.5 years, and the weighted average discount rate was 14.1 %. For the first quarter, total lease cost was $ 488 in 2022 and $ 101 in 2021. |
Summary of Significant Accoun_2
Summary of Significant Accounting Principles (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Principles of Consolidation | Basis of presentation and principles of consolidation The accompanying unaudited consolidated financial statements of the Company and its subsidiaries have been prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial information. In accordance with Securities and Exchange Commission's (“SEC”) rules for interim financial statements, certain information required by U.S. GAAP may be condensed or omitted. The Company’s consolidated financial statements include the accounts of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated. In the opinion of management, the accompanying consolidated financial statements include all normal and recurring adjustments (which consist primarily of accruals, estimates and assumptions that impact the financial statements) considered necessary to present fairly the Company’s results for the interim periods. Operating results for interim periods are not necessarily indicative of the results that may be expected for the full year. The accompanying unaudited interim consolidated financial statements should be read in conjunction with the annual audited financial statements and related notes included in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021. |
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 and classified 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 and Equipment | 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. |
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 lives. 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, packaging, research and development and related services for multiple pharmaceutical companies. Manufacturing Manufacturing 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 customer agreements may have 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. For arrangements that include sales-based profit-sharing where the license for intellectual property is deemed to be the predominant item to which the profit-sharing relates, the Company recognizes revenue when the related sales occur by the commercial partner. For arrangements that include sales-based profit-sharing where the license for intellectual property is not deemed to be the predominant item to which the profit-sharing relates, 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. Research and development Research and development revenue includes services associated with formulation, process development, clinical trials materials services, as well as custom development of manufacturing processes and analytical methods for a customer’s non-clinical, clinical and commercial products. Such revenues are recognized at a point in time or over time depending on the nature and particular facts and circumstances associated with the contract terms. In contracts that specify milestones, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments related to arrangements under which the Company has continuing performance obligations are deferred and recognized over the period of performance. Milestone payments that are not within the Company’s control, such as submission for approval to regulators by a commercial partner or approvals from regulators, are not considered probable of being achieved until those submissions are submitted by the customer or approvals are received. In contracts that require revenue recognition over time, the Company utilizes input or output methods, depending on the specifics of the contract, that compare the cumulative work-in-process to date to the most current estimates for the entire performance obligation. Under these contracts, the customer typically owns the product details and process, which have no alternative use. These projects are customized to each customer to meet its specifications and typically only one performance obligation is included. Each project represents a distinct service that is sold separately and has stand-alone value to the customer. The customer also retains control of its product as the product is being created or enhanced by the Company’s services and can make changes to its process or specifications upon request. Contract assets represent revenue recognized for performance obligations completed or in process before an unconditional right to payment exists, and therefore invoicing or associated reporting from the customer regarding the computation of the net product sales has not yet occurred. Contract liabilities represent payments received from customers prior to the completion of associated performance obligations. |
Concentration of Credit Risk | Concentration of credit risk Financial instruments that potentially subject the Company to significant concentration of credit risk consist primarily of cash, cash equivalents and accounts receivable. The Company manages its cash and cash equivalents based on established guidelines relative to diversification and maturities to maintain safety and liquidity. The Company’s accounts receivable balances are primarily concentrated among three customers. If any of these customers’ receivable balances should be deemed uncollectible, it could have a material adverse effect on the Company’s results of operations and financial condition. The Company is dependent on its relationships with a small number of commercial partners. The Company's three largest customers generated 78 % of its revenues for the three months ended March 31, 2022 . |
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. A valuation allowance is recorded to the extent it is more likely than not that some portion or all of the deferred tax assets will not be realized. A full valuation allowance was recorded as of March 31, 2022 and December 31, 2021. 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 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. 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 debt. |
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). To calculate diluted income or loss per share, the numerator and denominator are adjusted to eliminate the income or loss and the dilutive effects on shares, respectively, caused by outstanding common stock options, warrants and unvested restricted stock units, using the treasury stock method, if the inclusion of such instruments would be dilutive. For all periods presented, the Company incurred a net loss. In periods of net loss, the inclusion of dilutive securities would be antidilutive because it would reduce the amount of loss incurred per share. As a result, no additional dilutive shares were included in diluted loss per share, and there were no differences between basic and diluted loss per share. The following table presents the potentially dilutive securities that were excluded from the computations of diluted loss per share: Three months ended March 31, 2022 2021 Restricted stock units 739,148 695,603 Stock options 6,860,892 4,173,680 Warrants 348,664 348,664 Amounts in the table above reflect the common stock equivalents of the noted instruments. |
Recently Accounting Pronouncements | Recent accounting pronouncements In March 2020, the FASB issued ASU 2020-04, “Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting” (“ASU 2020-04”). This ASU provides temporary optional expedients and exceptions to the guidance on contract modifications and hedge accounting to ease the financial reporting burdens of the expected market transition from the London Interbank Offered Rate and other interbank offered rates to alternative reference rates. In January 2021, the FASB issued ASU 2021-01, which refines the scope of Topic 848 and clarifies some of its guidance as part of the FASB’s monitoring of global reference rate activities. The new guidance was effective upon issuance, and the Company is allowed to elect to apply the amendments prospectively through December 31, 2022. The Company is currently evaluating the impact this standard will have on its consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Principles (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Schedule of Anti-Dilutive Securities | The following table presents the potentially dilutive securities that were excluded from the computations of diluted loss per share: Three months ended March 31, 2022 2021 Restricted stock units 739,148 695,603 Stock options 6,860,892 4,173,680 Warrants 348,664 348,664 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Components of Inventory | The following table presents the components of inventory: March 31, 2022 December 31, 2021 Raw materials $ 3,588 $ 3,038 Work in process 2,459 3,363 Finished goods 3,423 2,516 Inventory $ 9,470 $ 8,917 |
Property, Plant and Equipment_2
Property, Plant and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of Property, Plant and Equipment | property, plant and equipment: March 31, 2022 December 31, 2021 Land $ 3,263 $ 3,263 Building and improvements 22,874 22,717 Furniture, office and computer equipment 6,229 6,213 Manufacturing equipment 50,327 49,687 Construction in progress 7,480 6,856 Property, plant and equipment, gross 90,173 88,736 Less: accumulated depreciation ( 38,820 ) ( 37,028 ) Property, plant and equipment, net $ 51,353 $ 51,708 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Summary of Components of Other Intangible Assets | The following table presents the components of other intangible assets: March 31, 2022 December 31, 2021 Gross value Accumulated amortization Carrying value Gross value Accumulated amortization Carrying value Customer relationships $ 18,900 $ 15,807 $ 3,093 $ 18,900 $ 15,685 $ 3,215 Backlog 460 120 340 460 73 387 Trademarks and tradenames 310 131 179 310 79 231 Total $ 19,670 $ 16,058 $ 3,612 $ 19,670 $ 15,837 $ 3,833 |
Schedule of Finite Lived Intangible Assets, Estimated Future Amortization Expense | The following table presents estimated future amortization of other intangible assets: Twelve months ending March 31, 2023 $ 855 2024 635 2025 486 2026 486 2027 486 Thereafter 664 Total $ 3,612 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Summary of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consist of the following: March 31, 2022 December 31, 2021 Payroll and related costs $ 2,394 $ 5,717 Current portion of contract liabilities (see note 10) 1,836 2,308 Property, plant and equipment 426 663 Professional and consulting fees 349 552 Accrued interest 231 2,505 Other 1,108 811 Total $ 6,344 $ 12,556 |
Debt (Tables)
Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
components and classification of debt | The following table presents the components and classification of debt: March 31, 2022 December 31, 2021 Debt principal: Terms loans under Credit Agreement $ 100,000 $ 100,000 Note with former equity holder of IriSys 6,117 6,117 Other 339 339 Debt principal 106,456 106,456 Debt adjustments: Unamortized deferred issuance costs ( 7,835 ) ( 8,896 ) Exit fee accretion 710 669 Unamortized original discount ( 575 ) ( 694 ) Carrying value of debt $ 98,756 $ 97,535 Current portion of related party debt $ 2,039 $ 2,039 Debt, net of current portion 93,240 92,127 Related party debt, net of current portion 3,477 3,369 Carrying value of debt $ 98,756 $ 97,535 |
Schedule of Maturities of Debt | The following table presents the future maturity of debt principal: Twelve months ending March 31, 2023 $ 2,039 2024 102,039 2025 2,062 2026 33 2027 40 Thereafter 243 Total debt principal $ 106,456 |
Stockholders_ Equity or Defic_2
Stockholders’ Equity or Deficit (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Summary of Capital Raises Since its Initial Public Offreing | The following table presents the Company’s capital raises since its initial public offering in March 2014: Date or period Shares of common stock issued Gross proceeds Offering expenses Net proceeds Initial public offering March 12, 2014 4,312,500 $ 34,500 $ ( 4,244 ) $ 30,256 Private placement July 7, 2015 1,379,311 16,000 ( 1,188 ) 14,812 Underwritten public offering August 19, 2016 1,986,666 14,900 ( 1,533 ) 13,367 Underwritten public offering December 16, 2016 6,670,000 40,020 ( 3,132 ) 36,888 2018 common stock purchase agreement with Aspire Capital Year ended December 31, 2018 1,950,000 16,999 — 16,999 2019 common stock purchase agreement with Aspire Capital Fourth quarter 2020 4,690,972 11,172 ( 78 ) 11,094 Share issuance agreement for amendment 5 to Credit Agreement February 2021 2,202,420 9,338 ( 20 ) 9,318 Underwritten public offering May 12, 2021 15,333,332 34,500 ( 2,397 ) 32,103 Issuance of shares for IriSys acquisition February 2022 9,302,718 20,931 ( 619 ) 20,312 |
Revenue Recognition (Tables)
Revenue Recognition (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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, 2021 $ 8,565 $ 2,308 Changes to the beginning balance of contract assets arising from: Reclassification to receivables as a result of rights to consideration becoming unconditional ( 7,381 ) — Changes in estimate 1,309 — Contract assets recognized since beginning of period, net of reclassification to receivables and changes in estimates 6,441 — Changes to contract liabilities: Amounts billed in advance of contract performance — 2,754 Revenue recognized — ( 3,226 ) Balance at March 31, 2022 $ 8,934 $ 1,836 |
Disaggregation of Revenue by Timing of Revenue Recognition | The following table disaggregates revenue by timing of revenue recognition: Three months ended March 31, 2022 2021 Point in time $ 16,880 $ 15,147 Over time 4,314 1,656 Total $ 21,194 $ 16,803 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Share-based Payment Arrangement [Abstract] | |
Fair Value of Stock Options Granted | The following table presents information about the fair value of stock options granted: Three months ended March 31, 2022 2021 Weighted average grant date fair value $ 1.16 $ 2.04 Assumptions used to determine fair value: Range of expected option life 6 years 6 years Expected volatility 79 % 80 - 81 % Risk-free interest rate 1.5 - 2.4 % 0.7 - 1.2 % 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, 2021 5,267,567 $ 6.47 5.7 years Granted 2,918,889 1.70 Exercised ( 220 ) 1.71 Forfeited or expired ( 219,193 ) 4.81 Balance, March 31, 2022 7,967,043 4.77 $ 292 7.0 years Exercisable 3,562,594 7.65 8 4.0 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, 2021 990,065 3.63 Granted 940,090 1.66 Vested ( 250,143 ) 4.74 Forfeited ( 46,133 ) 2.65 Balance, March 31, 2022 1,633,879 2.35 |
Summary of Stock Based Compensation Expense | The following table presents the classification of stock-based compensation expense: Three months ended March 31, 2022 2021 Cost of sales $ 403 $ 1,392 Selling, general and administrative expenses 1,076 1,741 Total $ 1,479 $ 3,133 |
Acquisition of IriSys (Tables)
Acquisition of IriSys (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Business Combinations [Abstract] | |
Schedule of Supplemental Pro Forma Financial Information | The following table presents unaudited supplemental pro forma financial information for the three months ended March 31, 2021 as if the IriSys acquisition had occurred on January 1, 2021: Revenue $ 20,286 Net loss ( 6,282 ) |
Leases - (Tables)
Leases - (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Lessee Disclosure [Abstract] | |
Schedule of Undiscounted Future Lease Payments for the Development Lease | Undiscounted future lease payments for the two development leases, which were the only material noncancelable leases at March 31, 2022, were as follows: Twelve months ended March 31, 2023 $ 1,144 2024 1,172 2025 1,201 2026 1,126 2027 1,104 Thereafter 4,530 Total lease payments 10,277 Less imputed interest ( 4,365 ) Total operating lease liabilities $ 5,912 |
Background - Additional Informa
Background - Additional Information (Detail) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022USD ($)Segment | Dec. 31, 2021USD ($) | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Entity incorporation date | Nov. 15, 2007 | |
Accumulated deficit | $ | $ 250,018 | $ 245,754 |
Number of operating segment | Segment | 1 |
Summary of Significant Accoun_4
Summary of Significant Accounting Principles - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2022Customer | |
Accounts Receivable [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Number of customers | 3 |
Sales Revenue, Net [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Number of customers | 3 |
Sales Revenue, Net [Member] | Customer Concentration Risk [Member] | Cash [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Concentration risk percentage | 78.00% |
Furniture and Office Equipment [Member] | Minimum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 3 years |
Furniture and Office Equipment [Member] | Maximum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 10 years |
Manufacturing Equipment [Member] | Minimum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 6 years |
Manufacturing Equipment [Member] | Maximum [Member] | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |
Property, plant and equipment estimated useful lives | 10 years |
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 | the shorter of the lease term or useful life |
Summary of Significant Accoun_5
Summary of Significant Accounting Principles - Schedule of Anti-Dilutive Securities (Detail) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 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 | 739,148 | 695,603 |
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 | 6,860,892 | 4,173,680 |
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 | 348,664 | 348,664 |
Inventory - Components of Inven
Inventory - Components of Inventory (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 3,588 | $ 3,038 |
Work in process | 2,459 | 3,363 |
Finished goods | 3,423 | 2,516 |
Inventory | $ 9,470 | $ 8,917 |
Property, Plant and Equipment_3
Property, Plant and Equipment, Net - Schedule of Property, Plant and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 90,173 | $ 88,736 |
Less: accumulated depreciation | (38,820) | (37,028) |
Property, plant and equipment, net | 51,353 | 51,708 |
Land [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 3,263 | 3,263 |
Buildings and Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 22,874 | 22,717 |
Furniture, Office & Computer Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 6,229 | 6,213 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | 50,327 | 49,687 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property, plant and equipment | $ 7,480 | $ 6,856 |
Property, Plant and Equipment_4
Property, Plant and Equipment, Net - Additional Information (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Property, Plant and Equipment [Line Items] | ||
Interest Expense | $ 3,413 | $ 3,898 |
Construction in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Interest Expense | $ 268 | $ 65 |
Intangible Assets , Net - Summa
Intangible Assets , Net - Summary of Components of Other Intangible Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | $ 19,670 | $ 19,670 |
Accumulated amortization | 16,058 | 15,837 |
Carrying value | 3,612 | 3,833 |
Customer Relationships [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | 18,900 | 18,900 |
Accumulated amortization | 15,807 | 15,685 |
Carrying value | 3,093 | 3,215 |
Backlog [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | 460 | 460 |
Accumulated amortization | 120 | 73 |
Carrying value | 340 | 387 |
Trademarks and Trade Names [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross value | 310 | 310 |
Accumulated amortization | 131 | 79 |
Carrying value | $ 179 | $ 231 |
Intangible Assets, Net - Schedu
Intangible Assets, Net - Schedule of Finite Lived Intangible Assets, Estimated Future Amortization Expense (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Goodwill and Intangible Assets Disclosure [Abstract] | ||
2023 | $ 855 | |
2024 | 635 | |
2025 | 486 | |
2026 | 486 | |
2027 | 486 | |
Thereafter | 664 | |
Net Intangible Assets, Definite-lived | $ 3,612 | $ 3,833 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Payroll and related costs | $ 2,394 | $ 5,717 |
Current portion of contract liabilities (see note 10) | 1,836 | 2,308 |
Property, plant and equipment | 426 | 663 |
Professional and consulting fees | 349 | 552 |
Accrued interest | 231 | 2,505 |
Other | 1,108 | 811 |
Total | $ 6,344 | $ 12,556 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) $ in Thousands | Mar. 31, 2022USD ($) |
Executive Officer [Member] | |
Supply Commitment [Line Items] | |
Potential severance commitments arrangement consideration | $ 1,303 |
Other Contingencies | 3,772 |
Purchase Commitment [Member] | |
Supply Commitment [Line Items] | |
Purchase commitment non cancelable and cancelable | $ 8,698 |
Debt - components and classific
Debt - components and classification of debt (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||
Debt principal | $ 106,456 | $ 106,456 |
Unamortized deferred issuance costs | (7,835) | (8,896) |
Exit fee accretion | 710 | 669 |
Unamortized original discount | (575) | (694) |
Carrying value of debt | 98,756 | 97,535 |
Current portion of related party debt | 2,039 | 2,039 |
Debt, net of current portion | 93,240 | 92,127 |
Related party debt, net of current portion | 3,477 | 3,369 |
Carrying value of debt | 98,756 | 97,535 |
Term loans under Credit Agreement [Member] | ||
Debt Instrument [Line Items] | ||
Debt principal | 100,000 | 100,000 |
Exit fee accretion | 710 | |
Note With Former [Member] | ||
Debt Instrument [Line Items] | ||
Debt principal | 6,117 | 6,117 |
Other [Member] | ||
Debt Instrument [Line Items] | ||
Debt principal | $ 339 | $ 339 |
Debt - Schedule of Future Matur
Debt - Schedule of Future Maturities of Debt (Detail) $ in Thousands | Mar. 31, 2022USD ($) |
Debt Instrument [Line Items] | |
2023 | $ 2,039 |
2024 | 102,039 |
2025 | 2,062 |
2026 | 33 |
2027 | 40 |
Thereafter | 243 |
Total debt | $ 106,456 |
Debt - Additional Information (
Debt - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Nov. 17, 2017 | |
Debt Instrument [Line Items] | ||||
Carrying value of debt | $ 98,756 | $ 97,535 | ||
Debt instrument, exit fee | 710 | 669 | ||
Non-cash interest expense | 1,257 | $ 1,462 | ||
Debt principal | $ 106,456 | 106,456 | ||
Athyrium Opportunities II Acquisition LP [Member] | Seven Year Warrant [Member] | ||||
Debt Instrument [Line Items] | ||||
Purchase common stock with warrant issue | 348,664 | |||
Warrant, exercise price per share | $ 1.73 | |||
Warrants, exercisable date | Nov. 17, 2024 | |||
Athyrium Opportunities I I I Acquisition Limited Partnership Credit Agreement [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, maturity date | Dec. 31, 2023 | |||
Debt instrument exit fee | $ 1,000 | |||
Term loan interest rate, Description | interest equal to the three-month LIBOR rate, with a 1% floor, plus 8.25% per annum | |||
Exit fee percentage | 1.00% | |||
Debt instrument, covenant description | The Credit Agreement contains certain usual and customary affirmative and negative covenants, as well as financial covenants that the Company will need to satisfy on a monthly and quarterly basis, including maintaining a permitted net leverage ratio (which is the Company’s indebtedness under the Credit Agreement, net of cash and cash equivalents, divided by EBITDA, each as defined in the Credit Agreement) and liquidity amount. As of March 31, 2022, the Company was in compliance with its covenants under the Credit Agreement. | |||
Debt instrument, early repayment terms | if the Company makes any prepayments prior to maturity, the Company would be subject to prepayment premiums on the term B loans, as a percentage of the amount repaid, of 2.5%. | |||
Athyrium Opportunities I I I Acquisition Limited Partnership Credit Agreement [Member] | Floor [Member] | ||||
Debt Instrument [Line Items] | ||||
Term loan variable interest rate | 1.00% | |||
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 | 13.80% | |||
Note With Former [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, maturity date | Aug. 13, 2024 | |||
Carrying value of debt | $ 6,117 | |||
Debt Instrument, Interest Rate, Stated Percentage | 6.00% | |||
Unamortized original discount | $ 877 | |||
Debt Instrument, Interest Rate, Basis for Effective Rate | 13.0 | |||
Accrued Interest | $ 231 | |||
Others [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt principal | 339 | |||
Term loans under Credit Agreement [Member] | ||||
Debt Instrument [Line Items] | ||||
Debt instrument, exit fee | 710 | |||
Non-cash interest expense | 1,137 | $ 1,462 | ||
Debt principal | 100,000 | $ 100,000 | ||
A Term Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Credit agreement | 48,000 | |||
B Term Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Credit agreement | $ 52,000 | |||
Debt instrument minimum prepayment penalty percentage thereafter | 2.50% |
Shareholders Equity or Deficit
Shareholders Equity or Deficit - Summary of Capital Raises Since its Initial Public Offreing (Detail) - USD ($) $ in Thousands | May 12, 2021 | Dec. 16, 2016 | Aug. 19, 2016 | Jul. 07, 2015 | Mar. 12, 2014 | Dec. 31, 2018 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2020 |
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock, net of costs amount | $ (16) | $ 9,340 | |||||||
Irisys [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock , net of costs , shares | 9,302,718 | ||||||||
Gross proceeds on sale of common stock in initial public offering | $ 20,931 | ||||||||
Payments on underwriting discounts, commissions and offering costs | (619) | ||||||||
Issuance of common stock, net of costs amount | $ 20,312 | ||||||||
Amendment6 Member | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock , net of costs , shares | 2,202,420 | ||||||||
Gross proceeds on sale of common stock in initial public offering | $ 9,338 | ||||||||
Payments on underwriting discounts, commissions and offering costs | (20) | ||||||||
Issuance of common stock, net of costs amount | $ 9,318 | ||||||||
Initial Public Offering [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock , net of costs , shares | 4,312,500 | ||||||||
Gross proceeds on sale of common stock in initial public offering | $ 34,500 | ||||||||
Payments on underwriting discounts, commissions and offering costs | (4,244) | ||||||||
Issuance of common stock, net of costs amount | $ 30,256 | ||||||||
Private Placement [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock , net of costs , shares | 1,379,311 | ||||||||
Gross proceeds on sale of common stock in initial public offering | $ 16,000 | ||||||||
Payments on underwriting discounts, commissions and offering costs | (1,188) | ||||||||
Issuance of common stock, net of costs amount | $ 14,812 | ||||||||
Underwriters Public Offering [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock , net of costs , shares | 15,333,332 | 6,670,000 | 1,986,666 | ||||||
Gross proceeds on sale of common stock in initial public offering | $ 34,500 | $ 40,020 | $ 14,900 | ||||||
Payments on underwriting discounts, commissions and offering costs | (2,397) | (3,132) | (1,533) | ||||||
Issuance of common stock, net of costs amount | $ 32,103 | $ 36,888 | $ 13,367 | ||||||
2018 Common Stock Purchase Agreement [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock , net of costs , shares | 1,950,000 | ||||||||
Gross proceeds on sale of common stock in initial public offering | $ 16,999 | ||||||||
Issuance of common stock, net of costs amount | $ 16,999 | ||||||||
2019 Common Stock Purchase Agreement [Member] | |||||||||
Schedule Of Capitalization Equity [Line Items] | |||||||||
Issuance of common stock , net of costs , shares | 4,690,972 | ||||||||
Gross proceeds on sale of common stock in initial public offering | $ 11,172 | ||||||||
Payments on underwriting discounts, commissions and offering costs | (78) | ||||||||
Issuance of common stock, net of costs amount | $ 11,094 |
Shareholders Equity or Defici_2
Shareholders Equity or Deficit - Additional Information (Detail) - $ / shares | Feb. 13, 2021 | Mar. 31, 2022 |
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 | 348,664 | |
Warrant, exercise price per share | $ 1.73 | |
Warrants outstanding to purchase shares, Expiration dates | 2024-11 | |
Irisys [Member] | ||
Schedule Of Capitalization Equity [Line Items] | ||
Number of share issued for acquisition | 9,302,718 | |
Issuance of common stock , net of costs , shares | 9,302,718 | |
Aspire Capital | ||
Schedule Of Capitalization Equity [Line Items] | ||
Purchase commitment of common stock, Shares | 41,172 | |
Aspire Capital | Maximum [Member] | ||
Schedule Of Capitalization Equity [Line Items] | ||
Issuance of common stock , net of costs , shares | 6,199,299 | |
Aspire Capital | Minimum [Member] | ||
Schedule Of Capitalization Equity [Line Items] | ||
Issuance of common stock , net of costs , shares | 30,000 |
Revenue Recognition - Schedule
Revenue Recognition - Schedule of Changes in Contract Assets and Liabilities (Detail) $ in Thousands | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Changes to the beginning balance of contract assets arising from: | |
Reclassification to receivables as a result of rights to consideration becoming unconditional | $ (7,381) |
Changes in estimate | 1,309 |
Contract assets recognized since beginning of period, net of reclassification to receivables and changes in estimates | 6,441 |
Balance at December 31, 2021 | 8,565 |
Balance at March 31, 2022 | 8,934 |
Changes to contract liabilities: | |
Amounts billed in advance of contract performance | 2,754 |
Revenue recognized | (3,226) |
Contract assets, Revenue recognized | 0 |
Balance at December 31, 2021 | 2,308 |
Balance at March 31, 2022 | $ 1,836 |
Revenue Recognition - Disaggreg
Revenue Recognition - Disaggregation of Revenue by Timing of Revenue Recognition (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Disaggregation Of Revenue [Line Items] | ||
Revenue | $ 21,194 | $ 16,803 |
Point In Time [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Revenue | 16,880 | 15,147 |
Over Time [Member] | ||
Disaggregation Of Revenue [Line Items] | ||
Revenue | $ 4,314 | $ 1,656 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | ||||
Dec. 31, 2022 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | Mar. 31, 2022 | Mar. 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 | $ 1.16 | $ 2.04 | ||||
Intrinsic value of options exercised | $ 0 | |||||
Unrecognized compensation expense related to unvested options and time-based RSUs, expected to vest | $ 10,278 | |||||
Unrecognized compensation expense related to unvested options, weighted average period | 3 years | |||||
Stock Options Granted Outside Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Number of options, Granted | 1,034,785 | |||||
Number of shares. Granted | 114,009 | |||||
Restricted Stock Units [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Weighted average grant date fair value | $ 1.66 | $ 3.84 | ||||
Number of shares. Granted | 940,090 | |||||
Fair value vested | $ 414 | $ 982 | ||||
Restricted Stock Units [Member] | Minimum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options vest period | 6 months | |||||
Restricted Stock Units [Member] | Maximum [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Stock options vest period | 4 years | |||||
A&R Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Percentage of outstanding common stock | 5.00% | 5.00% | 5.00% | |||
A&R Plan [Member] | Forecast [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Percentage of outstanding common stock | 5.00% | |||||
2013 Equity Incentive Plan [Member] | ||||||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||||||
Shares available for future grants | 1,498,369 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Stock Options Granted (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted average grant date fair value | $ 1.16 | $ 2.04 |
Assumptions used to determine fair value: | ||
Range of expected option life | 6 years | 6 years |
Expected volatility | 79.00% | |
Expected dividend yield | 0.00% | 0.00% |
Minimum [Member] | ||
Assumptions used to determine fair value: | ||
Expected volatility | 80.00% | |
Risk-free interest rate | 1.50% | 0.70% |
Maximum [Member] | ||
Assumptions used to determine fair value: | ||
Expected volatility | 81.00% | |
Risk-free interest rate | 2.40% | 1.20% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | ||
Number of shares, Beginning balance | 5,267,567 | |
Number of shares, Granted | 2,918,889 | |
Number of shares, Exercised | (220) | |
Number of shares, Forfeited or expired | (219,193) | |
Number of shares, Ending balance | 7,967,043 | 5,267,567 |
Number of shares, Exercisable | 3,562,594 | |
Weighted average exercise price, Beginning balance | $ 6.47 | |
Weighted average exercise price, Granted | 1.70 | |
Weighted average exercise price, Exercised | 1.71 | |
Weighted average exercise price, Forfeited or expired | 4.81 | |
Weighted average exercise price, Ending balance | 4.77 | $ 6.47 |
Weighted average exercise price, Exercisable | $ 7.65 | |
Aggregate intrinsic value | $ 292 | |
Aggregate intrinsic value, Exercisable | $ 8 | |
Weighted average remaining contractual life | 7 years | 5 years 8 months 12 days |
Weighted average remaining contractual life, Exercisable | 4 years |
Stock-Based Compensation - Su_2
Stock-Based Compensation - Summary of Restricted Stock Units Activity (Detail) - $ / shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Weighted average grant date fair value | $ 1.16 | $ 2.04 |
Restricted Stock Units [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Number of shares, Beginning balance | 990,065 | |
Number of shares. Granted | 940,090 | |
Number of shares, Vested | (250,143) | |
Number of shares, Forfeited | (46,133) | |
Number of shares, Ending balance | 1,633,879 | |
Number of shares, beginning balance | $ 3.63 | |
Weighted average grant date fair value | 1.66 | $ 3.84 |
Number of shares, Vested | 4.74 | |
Number of shares, Forfeited | 2.65 | |
Number of shares, ending balance | $ 2.35 |
Stock-Based Compensation - Su_3
Stock-Based Compensation - Summary of Stock Based Compensation Expenses (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | $ 1,479 | $ 3,133 |
Cost Of Sales [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | 403 | 1,392 |
Selling General And Administrative Expenses [Member] | ||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | ||
Stock based compensation expense | $ 1,076 | $ 1,741 |
Acquisition of IriSys - Additio
Acquisition of IriSys - Additional information (Detail) | Aug. 13, 2021 |
Irisys LLC [Member] | |
Business Acquisition [Line Items] | |
Date of acquisition agreement | Aug. 13, 2021 |
Acquisition of IriSys - Schedul
Acquisition of IriSys - Schedule of Supplemental Pro Forma Financial Information (Detail) - Irisys LLC [Member] $ in Thousands | 3 Months Ended |
Mar. 31, 2021USD ($) | |
Business Acquisition [Line Items] | |
Revenue | $ 20,286 |
Net loss | $ 6,282 |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments - Additional Information (Detail) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
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 | $ 14,248 | $ 15,247 |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022USD ($)Lease | Mar. 31, 2021USD ($) | |
Lessee Lease Description [Line Items] | ||
Number of Operating Lease | 2 | |
Number of Development Lease | 2 | |
Operating lease, weighted average remaining term | 8 years 6 months | |
Operating lease, weighted average discount rate percent | 14.10% | |
Total operating lease, cost | $ | $ 488 | $ 101 |
California [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease, option to extend | The development facility leases each include options to extend, none of which are included in the lease terms. | |
Operating lease expiration year | 2031 | |
Georgia [Member] | ||
Lessee Lease Description [Line Items] | ||
Operating lease expiration year | 2025 |
Leases - Schedule of Undiscount
Leases - Schedule of Undiscounted Future Lease Payments for the Development Lease (Detail) $ in Thousands | Mar. 31, 2022USD ($) |
Lessee Disclosure [Abstract] | |
2023 | $ 1,144 |
2024 | 1,172 |
2025 | 1,201 |
2026 | 1,126 |
2027 | 1,104 |
Thereafter | 4,530 |
Total lease payments | 10,277 |
Less imputed interest | (4,365) |
Total operating lease liabilities | $ 5,912 |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - shares | Mar. 31, 2022 | Dec. 31, 2021 |
Subsequent Event [Line Items] | ||
Increase in number of authorized shares of common stock | 95,000,000 | 95,000,000 |