Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Mar. 29, 2022 | Jun. 30, 2021 | |
Document and Entity Information | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Document Transition Report | false | ||
Entity File Number | 001-36193 | ||
Entity Registrant Name | TREVENA INC | ||
Entity Incorporation, State or Country Code | DE | ||
Entity Tax Identification Number | 26-1469215 | ||
Entity Address, Address Line One | 955 Chesterbrook Blvd. | ||
Entity Address, Address Line Two | Suite 110 | ||
Entity Address, City or Town | Chesterbrook | ||
Entity Address, State or Province | PA | ||
Entity Address, Postal Zip Code | 19087 | ||
City Area Code | 610 | ||
Local Phone Number | 354-8840 | ||
Title of 12(b) Security | Common Stock, par value $0.001 per share | ||
Trading Symbol | TRVN | ||
Security Exchange Name | NASDAQ | ||
Entity Current Reporting Status | Yes | ||
Entity Interactive Data Current | Yes | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Public Float | $ 276 | ||
Entity Common Stock, Shares Outstanding | 165,520,007 | ||
ICFR Auditor Attestation Flag | false | ||
Auditor Name | Ernst & Young LLP | ||
Auditor Firm ID | 42 | ||
Auditor Location | Philadelphia, Pennsylvania | ||
Entity Central Index Key | 0001429560 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Balance Sheets
Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 66,923 | $ 109,403 |
Accounts receivable, net | 71 | |
Inventories | 2,352 | |
Insurance recovery | 9,000 | |
Prepaid expenses and other current assets | 1,448 | 570 |
Total current assets | 70,723 | 119,044 |
Restricted cash | 1,311 | 1,310 |
Property and equipment, net | 1,841 | 2,253 |
Right-of-use lease asset | 4,706 | 5,119 |
Other assets | 1,543 | 13 |
Total assets | 80,124 | 127,739 |
Current liabilities: | ||
Accounts payable, net | 4,547 | 1,693 |
Accrued expenses and other current liabilities | 3,847 | 5,168 |
Estimated settlement liability | 9,000 | |
Lease liability | 792 | 703 |
Total current liabilities | 9,186 | 16,564 |
Leases, net of current portion | 6,309 | 7,101 |
Warrant liability | 6 | |
Total liabilities | 15,495 | 23,671 |
Commitments and contingencies (Note 6) | ||
Stockholders' equity: | ||
Preferred stock - $0.001 par value; 5,000,000 shares authorized, none issued or outstanding at December 31, 2021 and December 31, 2020 | ||
Common stock - $0.001 par value; 200,000,000 shares authorized at December 31, 2021 and December 31, 2020; 165,520,007 and 159,999,917 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively | 165 | 160 |
Additional paid-in capital | 558,566 | 546,422 |
Accumulated deficit | (494,102) | (442,514) |
Total stockholders' equity | 64,629 | 104,068 |
Total liabilities and stockholders' equity | $ 80,124 | $ 127,739 |
Balance Sheets (Parenthetical)
Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Balance Sheets | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock issued (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 200,000,000 | 200,000,000 |
Common stock issued (in shares) | 165,520,007 | 159,999,917 |
Common stock outstanding (in shares) | 165,520,007 | 159,999,917 |
Statements of Operations and Co
Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Revenue: | ||
Total revenue | $ 567 | $ 3,069 |
Operating expenses: | ||
Cost of goods sold | 954 | 182 |
Selling, general and administrative | 38,112 | 19,248 |
Research and development | 13,426 | 13,124 |
Total operating expenses | 52,492 | 32,554 |
Loss from operations | (51,925) | (29,485) |
Other income (expense): | ||
Change in fair value of warrant liability | 6 | (1) |
Other income, net | 172 | 206 |
Interest income | 162 | 240 |
Interest expense | (1) | (29) |
Loss on foreign currency exchange | (2) | |
Total other income, net | 337 | 416 |
Loss before foreign income tax expense | (51,588) | (29,069) |
Foreign income tax expense | (300) | |
Net loss and comprehensive loss | $ (51,588) | $ (29,369) |
Per share information: | ||
Net loss per share of common stock, basic (in dollars per share) | $ (0.32) | $ (0.23) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.32) | $ (0.23) |
Weighted average common shares outstanding, basic (in shares) | 163,293,296 | 127,623,859 |
Weighted average common shares outstanding, diluted (in shares) | 163,293,296 | 127,623,859 |
Product revenue | ||
Revenue: | ||
Total revenue | $ 498 | $ 69 |
License revenue | ||
Revenue: | ||
Total revenue | $ 69 | $ 3,000 |
Statements of Stockholders' Equ
Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2019 | $ 94 | $ 443,129 | $ (413,145) | $ 30,078 |
Beginning Balance (in shares) at Dec. 31, 2019 | 94,213,760 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Stock-based compensation expense | 3,284 | 3,284 | ||
Exercise of stock options | $ 1 | 135 | 136 | |
Exercise of stock options (in shares) | 197,640 | |||
Net exercise of common stock warrant (in shares) | 201,925 | |||
Issuance of common stock, net of issuance costs | $ 64 | 100,946 | 101,010 | |
Issuance of common stock, net of issuance costs (in shares) | 64,344,354 | |||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes | $ 1 | (1,072) | (1,071) | |
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes (in shares) | 1,042,238 | |||
Net loss | (29,369) | (29,369) | ||
Ending Balance at Dec. 31, 2020 | $ 160 | 546,422 | (442,514) | $ 104,068 |
Ending Balance (in shares) at Dec. 31, 2020 | 159,999,917 | 159,999,917 | ||
Increase (Decrease) in Stockholders' Equity | ||||
Stock-based compensation expense | 4,407 | $ 4,407 | ||
Exercise of stock options | 187 | 187 | ||
Exercise of stock options (in shares) | 146,559 | |||
Issuance of common stock, net of issuance costs | $ 4 | 7,944 | 7,948 | |
Issuance of common stock, net of issuance costs (in shares) | 4,277,902 | |||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes | $ 1 | (394) | (393) | |
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes (in shares) | 1,095,629 | |||
Net loss | (51,588) | (51,588) | ||
Ending Balance at Dec. 31, 2021 | $ 165 | $ 558,566 | $ (494,102) | $ 64,629 |
Ending Balance (in shares) at Dec. 31, 2021 | 165,520,007 | 165,520,007 |
Statement of Stockholders' Equi
Statement of Stockholders' Equity (Parenthetical) - $ / shares | Dec. 31, 2021 | Dec. 31, 2020 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common Stock | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Statements of Cash Flows
Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating activities: | ||
Net loss | $ (51,588) | $ (29,369) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 428 | 477 |
Stock-based compensation | 4,407 | 3,284 |
Noncash interest expense on loans | 8 | |
Loss on disposal of assets | 2 | |
Revaluation of warrant liability | (6) | 1 |
Change in right-of-use asset | 413 | 353 |
Changes in operating assets and liabilities: | ||
Accounts receivable, prepaid expenses and other assets | (2,337) | 1,049 |
Inventories | (2,352) | |
Insurance recovery | 9,000 | |
Settlement liability | (9,000) | |
Operating lease liabilities | (695) | (610) |
Accounts payable, accrued expenses and other liabilities | 1,533 | 3,411 |
Net cash used in operating activities | (50,197) | (21,394) |
Investing activities: | ||
Purchases of property and equipment | (16) | (27) |
Maturities of marketable securities | 3,500 | |
Net cash (used in) provided by investing activities | (16) | 3,473 |
Financing activities: | ||
Proceeds from exercise of common stock options | 187 | 136 |
Proceeds from issuance of common stock, net | 7,948 | 101,010 |
Payment of employee withholding taxes on vested restricted stock units | (393) | (1,071) |
Finance lease payments | (8) | (10) |
Repayments of loans payable, net | (5,045) | |
Net cash provided by financing activities | 7,734 | 95,020 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (42,479) | 77,099 |
Cash, cash equivalents and restricted cash-beginning of period | 110,713 | 33,614 |
Cash, cash equivalents and restricted cash-end of period | $ 68,234 | 110,713 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | $ 19 |
Organization and Description of
Organization and Description of the Business | 12 Months Ended |
Dec. 31, 2021 | |
Organization and Description of the Business | |
Organization and Description of the Business | 1. Organization and Description of the Business Trevena, Inc., or the Company, was incorporated in Delaware as Parallax Therapeutics, Inc. on November 9, 2007. The Company began operations in December 2007, and its name was changed to Trevena, Inc. on January 3, 2008. The Company is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients affected by central nervous system, or CNS, disorders. The Company operates in one segment and has its principal office in Chesterbrook, Pennsylvania. Since commencing operations in 2007, the Company has devoted substantially all of its financial resources and efforts to research and development, including nonclinical studies and clinical trials. The Company has never been profitable. In late 2017, the Company submitted a new drug application, or NDA, for OLINVYK™ (OLINVYK) injection, or OLINVYK, to the United States Food and Drug Administration, or the FDA. In August 2020, the FDA approved the NDA for OLINVYK and the Company initiated commercial launch of OLINVYK in the first quarter of 2021. Since the Company’s inception, the Company has incurred losses and negative cash flows from operations. At December 31, 2021, the Company had an accumulated deficit of $494.1 million. The Company’s net loss was $51.6 million and $29.4 million for the years ended December 31, 2021 and 2020, respectively. The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements—Going Concern |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the ASC and Accounting Standards Updates, or ASUs, of the FASB. The Company’s functional currency is the U.S. dollar. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management used significant estimates in the following areas, among others: stock-based compensation expense, the determination of the fair value of stock-based awards, the fair value of common stock warrants, the accounting for research and development costs, accrued expenses and the recoverability of the Company’s net deferred tax assets and related valuation allowance. The financial data and other information disclosed in these notes are not necessarily indicative of the results to be expected for any future year or period. The Company bases its estimates on historical experience and also on assumptions that it believes are reasonable, however, actual results could significantly differ from those results. Cash, Cash Equivalents and Marketable Securities The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents are valued at cost, which approximates their fair market value. The Company maintains a portion of its cash and cash equivalent balances in money market mutual funds that may invest substantially all of their assets in U.S. government agency securities and U.S. Treasury securities. Restricted Cash The Company maintains $1.3 million as collateral under a letter of credit for the Company’s facility lease obligations in Chesterbrook, Pennsylvania. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its balance sheet. Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, restricted cash, accounts payable and accrued expenses approximate their fair values, given their short-term nature. The Company had no loans payable at December 31, 2021 or 2020. Certain of the Company’s common stock warrants are carried at fair value, as disclosed in Note 3. The Company has evaluated the estimated fair value of financial instruments using available market information and management’s estimates. The use of different market assumptions and/or estimation methodologies could have a significant effect on the estimated fair value amounts. See Note 3 for additional information. Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents, and restricted cash. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has no off-balance sheet concentrations of credit risk such as foreign currency exchange contracts, option contracts or other hedging arrangements. Property and Equipment Property and equipment consists of computer and laboratory equipment, software, office equipment, furniture, manufacturing equipment and leasehold improvements and is recorded at cost. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred. Upon disposal, retirement or sale, the related cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations. Property and equipment are depreciated on a straight-line basis over their estimated useful lives. The Company uses a life of three years for computer equipment and five years for laboratory equipment, office equipment, furniture, manufacturing equipment and software. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset. The Company reviews long-lived assets when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the book values of the assets to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the projected discounted future net cash flows arising from the assets. No impairment losses were recorded during the years ended December 31, 2021 or 2020. Leases At the commencement of a lease, the Company recognizes a liability to make lease payments and an asset representing the right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term, including variable fees that are known or subject to a minimum floor. The lease liability includes lease component fees, while non-lease component fees are expensed as incurred for all asset classes. When a contract excludes an implicit rate, the Company utilizes an incremental borrowing rate based on information available at the lease commencement date including lease term and geographic region. The initial valuation of the right-of-use, or ROU, asset includes the initial measurement of the lease liability, lease payments made in advance of the lease commencement date, and initial direct costs incurred by the Company and excludes lease incentives. Leases with an initial term of 12 months or less are classified as short-term leases and are not recorded on the balance sheet. The lease expense for short-term leases is recognized on a straight-line basis over the lease term. The Company tests for impairment of the ROU assets whenever circumstances indicate that the carrying amount of the asset may not be recoverable. Common Stock Warrants Freestanding warrants that are related to the purchase of common stock are classified as liabilities and recorded at fair value regardless of the timing of the redemption feature or the redemption price or the likelihood of redemption. These warrants are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the statements of operations and comprehensive loss. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrants. The warrants are classified as Level 3 liabilities. The value of these warrants was immaterial as of December 31, 2021 and 2020. In addition, in connection with entering into loan agreements, the Company has issued warrants to purchase shares of the Company’s common stock. These detachable warrant instruments qualify for equity classification and have been allocated upon the relative fair value of the base instrument and the warrant. See Note 7 and Note 8 for additional information. Revenue In accordance with FASB’s ASC 606, Revenue from Contracts with Customers, or ASC 606, the Company recognizes revenue when customers obtain control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: (i) (ii) (iii) (iv) (v) The Company applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. See Note 9 and Note 10, respectively, for a full discussion of the Company’s product revenue and license revenue. Research and Development Research and development costs are charged to expense as incurred. Research and development costs include, but are not limited to, personnel expenses, clinical trial supplies, fees for clinical trial services, manufacturing costs, consulting costs, and allocated overhead. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company may account for these expenses according to the progress of the trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2021 and 2020, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. Stock-Based Compensation The Company has equity incentive plans under which various types of equity-based awards including, but not limited to, incentive stock options, non-qualified stock options, and restricted stock unit awards, may be granted to employees, non-employee directors, and non-employee consultants. At December 31, 2021, the Company had two stock-based compensation plans, which are more fully described in Note 8. The Company also has an inducement plan under which various types of equity-based awards, including non-qualified stock options and restricted stock awards, may be granted to new employees. The Company has applied the fair value recognition provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation — Stock Compensation, to account for stock-based compensation for employees. The Company recognizes compensation expense for all stock-based awards based on the estimated grant-date fair values. For restricted stock unit awards to employees, the fair value is based on the closing price of the Company’s common stock on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends and has no current intention of paying cash dividends. The Company elected an accounting policy to record forfeitures as they occur. For stock awards that vest based on performance conditions (e.g., achievement of certain milestones), expense is recognized when it is probable that the conditions will be met. See Note 8 for a discussion of the assumptions used by the Company in determining the grant date fair value of options granted under the Black-Scholes option pricing model, as well as a summary of the stock option activity under the Company’s stock-based compensation plan for all years presented. Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not taken any uncertain tax position or recorded any reserves, interest or penalties. Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Comprehensive income (loss) was equal to the net loss for years ended December 31, 2020 and 2021. Basic and Diluted Net Loss Per Share of Common Stock The Company’s basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per common share is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for all periods presented. Recently Adopted Accounting Standards In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes, which removed certain exceptions to the general principles of the accounting for income taxes and also improves consistent application of and simplification of other areas when accounting for income taxes. The effective date for this standard was January 1, 2021. The Company adopted this standard on January 1, 2021. There was no impact to the Company’s financial statements or related disclosures upon the adoption. |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments ASC Topic 820, Fair Value Measurement, ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following: Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access. Level 2—Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly. Level 3—Valuations based on inputs that are unobservable and significant to the overall fair value measurement. To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. Cash, Cash Equivalents, Restricted Cash, and Marketable Securities The following table presents the Company’s cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2021 and 2020 (in thousands): December 31, 2021 Adjusted Unrealized Unrealized Cash and Cash Restricted Cost Gains Losses Fair Value Equivalents Cash Cash $ 9,459 $ — $ — $ 9,459 $ 8,148 $ 1,311 Level 1 (1): Money market funds 58,775 — — 58,775 58,775 — Subtotal 58,775 — — 58,775 58,775 — Total $ 68,234 $ — $ — $ 68,234 $ 66,923 $ 1,311 December 31, 2020 Adjusted Unrealized Unrealized Cash and Cash Restricted Cost Gains Losses Fair Value Equivalents Cash Cash $ 6,100 $ — $ — $ 6,100 $ 4,790 $ 1,310 Level 1 (1): Money market funds 104,613 — — 104,613 104,613 — Subtotal 104,613 — — 104,613 104,613 — Total $ 110,713 $ — $ — $ 110,713 $ 109,403 $ 1,310 (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. The Company classifies investments available to fund current operations as current assets on its balance sheets. As of December 31, 2021 and 2020, the Company did not hold any investment securities exceeding a one-year maturity. The Company maintains $1.3 million as collateral under a letter of credit for the Company’s facility lease obligations in Chesterbrook, Pennsylvania. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its balance sheet. Accretion of bond discount on marketable securities is included in other income as a separate component of other income (expense) on the statement of operations and comprehensive loss. Interest income on marketable securities is recorded as interest income on the statement of operations and comprehensive loss. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. The Company does not hold material Level 3 securities, and therefore, there were no transfers in or out of Level 3 in the hierarchy during the years ended December 31, 2021 or 2020. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2021 | |
Inventories, net | |
Inventories, net | 4. Inventories Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method for all inventories. Inventory includes the cost of API, raw materials and third-party contract manufacturing and packaging services. Indirect overhead costs associated with production and distribution are recorded as period costs in the period incurred. OLINVYK was approved by the FDA in August 2020. Prior to FDA approval, all manufacturing costs for OLINVYK were expensed to research and development. Upon FDA approval, manufacturing costs for OLINVYK manufactured for commercial sale have been capitalized as inventory cost. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense. The Company periodically evaluates the carrying value of inventory on hand using the same lower of cost or net realizable value approach as that used to initially value the inventory. Valuation adjustments may be required for slow-moving or obsolete inventory or in any situations where market conditions have caused net realizable value to fall below the carrying cost of the inventory. |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2021 | |
Property and Equipment, net | |
Property and Equipment, net | 5. Property and Equipment, net Property and equipment consisted of the following (in thousands): Estimated Useful December 31, Life in Years 2021 2020 Computers and software 3 5 $ 476 $ 476 Office equipment and furniture 5 721 721 Manufacturing equipment 5 10 10 Leasehold improvements 10 3,082 3,082 Leased assets 5 45 45 Total property and equipment 4,334 4,334 Less accumulated depreciation and amortization (2,493) (2,081) Property and equipment, net $ 1,841 $ 2,253 Depreciation and amortization expense was $0.4 million and $0.5 million for the years ended December 31, 2021 and 2020, respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses and Other Current Liabilities | |
Accrued Expenses and Other Current Liabilities | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Compensation and benefits $ 2,132 $ 2,919 Commercial expenses 107 605 Legal expenses 124 784 Clinical trial expenses 550 — Pharmaceutical development expenses 161 413 Credit balances to customers 87 — Accrued purchases 271 — Other accrued expenses and other current liabilities 415 447 Total accrued expenses and other current liabilities $ 3,847 $ 5,168 |
Loans Payable
Loans Payable | 12 Months Ended |
Dec. 31, 2021 | |
Loans Payable. | |
Loans Payable | 7. Loans Payable In September 2014, the Company entered into a loan and security agreement with Oxford Finance LLC and Pacific Western Bank (formerly Square 1 Bank) (together, the lenders), pursuant to which the lenders agreed to lend the Company up to $35.0 million in a three-tranche series of term loans (Term Loans A, B, and C). In September 2014, December 2015 and March 2017, the Company incurred borrowings under the agreement in the aggregate initial principal amount of $28.5 million. Term Loans A and B accrued interest at 6.5% per annum and Term Loan C accrued interest at 6.98% per annum. The Company was required to make payments of interest only on borrowings under the loan agreement on a monthly basis through and including January 1, 2018; payments of principal in equal monthly installments and accrued interest began on January 1, 2018 and continued until the loan matured on March 1, 2020. On March 2, 2020, the Company made its final payment under the loan and security agreement with the lenders. Upon the last payment date of the amounts borrowed under the agreement, the Company was required to pay a final payment fee of $1.9 million, equal to 6.6% of the aggregate amounts borrowed. In connection with entering into the agreement, the Company issued to the lenders and the placement agent warrants to purchase an aggregate of 7,678 shares of Trevena’s common stock. Warrants exercisable for an aggregate of 5,728 shares remain outstanding as of December 31, 2021. These warrants were exercisable upon issuance and have an exercise price of $5.8610 per share. The warrants may be exercised on a cashless basis and will terminate on the earlier of September 19, 2024 or the closing of a merger or consolidation transaction in which the Company is not the surviving entity. In connection with the draw of Term Loan B, the Company issued to the lenders and the placement agent additional warrants to purchase an aggregate of 34,961 shares of the Company’s common stock. These warrants have substantially the same terms as those noted above, have an exercise price of $10.6190 per share and an expiration date of December 23, 2025. In connection with draw of Term Loan C, the Company issued to the lenders and placement agent additional warrants to purchase an aggregate of 62,241 shares of the Company’s common stock. These warrants have substantially the same terms as those noted above and have an exercise price of $3.6150 per share and an expiration date of March 31, 2027. These detachable warrant instruments have qualified for equity classification and have been allocated upon the relative fair value of the base instrument and the warrants, according to the guidance of ASC 470-20-25-2. As of December 31, 2021 and December 31, 2020, there are no borrowings outstanding attributable to Term Loans A, B, or C. No million related to the issuance of its term loans. Per ASU 2015 03, Interest-Imputation of Interest, debt discount and debt issuance costs are to be presented as a contra-liability to the debt on the balance sheet. These costs were amortized to interest expense over the life of the loans using the effective interest method. Immaterial amounts of debt discount and debt issuance cost were amortized to interest expense during the year ended December 31, 2020. |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity | |
Stockholders' Equity | 8. Stockholders’ Equity Equity Offerings Under its certificate of incorporation, the Company was authorized to issue up to 200,000,000 shares of common stock as of December 31, 2021 and December 31, 2020. The Company also was authorized to issue up to 5,000,000 shares of preferred stock as of December 31, 2021 and December 31, 2020. The Company is required, at all times, to reserve and keep available out of its authorized but unissued shares of common stock sufficient shares to effect the conversion of the shares of the preferred stock and all outstanding stock options and warrants. Registered Underwritten Public Offering ATM Programs On April 17, 2019, the Company entered into a Common Stock Sales Agreement with H.C. Wainwright & Co., LLC, or Wainwright, pursuant to which the Company may offer and sell through Wainwright, from time to time at the Company’s sole discretion, shares of its common stock, having an aggregate offering price of up to $50.0 million, or the HCW ATM Program. Sales of the shares of common stock are deemed to be “at-the-market offerings,” as defined in Rule 415 under the Securities Act. In December 2020, the Company and Wainwright entered into Amendment No. 1 to Common Stock Sales Agreement, or the Amendment, to amend the Common Stock Sales Agreement to, among other things, update the reference to the registration statement pursuant to which the shares of common stock may be sold and to include an additional $50.0 million of shares of common stock in the HCW ATM Program. For the year ended December 31, 2021, the Company issued and sold approximately 4.3 million shares of common stock under the HCW ATM Program. The net offering proceeds to the Company in 2021 for sales under the HCW ATM Program were approximately $7.9 million after deducting related expenses, including commissions. As of December 31, 2021, there was approximately $41.9 million remaining available for future issuances under the HCW ATM Program. Registered Direct Offering and Concurrent Warrant Issuance In January 2019, the Company entered into securities purchase agreements with two institutional investors wherein the Company agreed to sell to the investors an aggregate of 10,000,000 shares of its common stock, at an offering price of $1.00 per share, in a registered direct offering. The net proceeds to the Company from the offering were $9.2 million, after deducting fees and the expenses of the placement agent. Pursuant to a letter agreement dated January 28, 2019, the Company engaged Wainwright to act as its exclusive placement agent in connection with the issuance and sale of the shares. The Company paid Wainwright 7.0% of the aggregate gross proceeds in the offering and $50,000 for certain expenses, and it issued warrants to purchase 500,000 shares of common stock to certain designees of Wainwright. These warrants have a term of five years, are immediately exercisable and have an exercise price of $1.25 per share. During the year ended December 31, 2020, 327,500 of these warrants were exercised in a cashless exercise for 201,925 common shares. The warrants are classified as equity and were recorded at fair value as of the date of issuance on the Company’s Consolidated Balance Sheets and no further adjustments to their valuation are made. The letter agreement also includes indemnification obligations of the Company and other provisions customary for transactions of this nature. Equity Incentive Plans In 2008, the Company adopted the 2008 Equity Incentive Plan, as amended on February 29, 2008, January 7, 2010, July 8, 2010, December 10, 2010, June 23, 2011 and June 17, 2013, collectively, the 2008 Plan, that authorized the Company to grant restricted stock and stock options to eligible employees, directors and consultants to the Company. In 2013, the Company adopted the 2013 Equity Incentive Plan, as amended on May 14, 2014, collectively, 2013 Plan. The 2013 Plan became effective upon the Company’s entry into the underwriting agreement related to its IPO in January 2014 and, as of such date, no further grants were permitted under the 2008 Plan. The 2013 Plan provides for the grant of incentive stock options, nonqualified stock options, stock appreciation rights, restricted stock awards, restricted stock unit awards, performance-based stock awards and other forms of equity compensation (collectively, stock awards), all of which may be granted to employees, including officers, non-employee directors and consultants of the Company. Additionally, the 2013 Plan provides for the grant of cash and stock-based performance awards. The 2013 Plan contains an “evergreen” provision, pursuant to which the number of shares of common stock available for issuance under the plan automatically increases on January 1 of each year beginning in 2015. On December 15, 2016, the Company adopted the Trevena, Inc. Inducement Plan, or the Inducement Plan, effective January 1, 2017, pursuant to which the Company reserved 500,000 shares of the Company’s common stock for issuance under the Inducement Plan. The Plan provides for nonqualified stock options and restricted stock unit awards. The only persons eligible to receive grants of awards under the Inducement Plan are individuals who satisfy the standards for inducement grants under Nasdaq Marketplace Rule 5635(c)(4) and the related guidance under Nasdaq IM 5635-1, including individuals who were not previously an employee or director of the Company or are following a bona fide period of non-employment, in each case as an inducement material to such individual’s agreement to enter into employment with the Company. Under all Plans, the amount, terms of grants and exercisability provisions are determined by the board of directors or its designee. The term of the options may be up to 10 years, and options are exercisable in cash or as otherwise determined by the board of directors or its designee. Vesting generally occurs over a period of not greater than four years. For performance-based stock awards, the Company recognizes expense when achievement of the performance condition is probable, over the requisite service period. The estimated grant-date fair value of the Company’s share-based awards is amortized on a straight-line basis over the awards’ service periods. Share-based compensation expense recognized was as follows (in thousands): Year Ended December 31, 2021 2020 Research and development $ 1,066 $ 781 Selling, general and administrative 3,303 2,497 Cost of goods sold 38 6 Total stock-based compensation $ 4,407 $ 3,284 Stock Options A summary of stock option activity and related information from January 1, 2020 through December 31, 2021 follows: Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, January 1, 2020 7,568,304 $ 3.40 7.01 Granted 2,477,486 1.90 Exercised (197,640) 0.68 Forfeited/Cancelled (283,631) 3.33 Balance, December 31, 2020 9,564,519 $ 3.07 7.17 Granted 3,747,642 1.60 Exercised (146,559) 1.28 Forfeited/Cancelled (715,732) 2.81 Balance, December 31, 2021 12,449,870 $ 2.67 7.11 Vested or expected to vest at December 31, 2021 12,449,870 $ 2.67 7.11 Exercisable at December 31, 2021 7,073,223 $ 3.39 5.72 The aggregate intrinsic value of the options exercisable as of December 31, 2021 was zero, based on the difference between the Company’s closing stock price of $0.58 and the exercise price of each stock option. The Company uses the Black-Scholes option-pricing model to estimate the fair value of stock options at the grant date. The Black-Scholes model requires the Company to make certain estimates and assumptions, including estimating the fair value of the Company’s common stock, assumptions related to the expected price volatility of the Company’s stock, the period during which the options will be outstanding, the rate of return on risk-free investments and the expected dividend yield for the Company’s stock. The per-share weighted average grant date fair value of the options granted to employees and directors during the years ended December 31, 2021 and 2020 was estimated at $1.25 and $1.48 per share, respectively, on the date of grant using the Black-Scholes option-pricing model with the following weighted average assumptions: Year Ended December 31, 2021 2020 Expected term of options (in years) 6.2 6.1 Risk-free interest rate 1.0 % 0.6 % Expected volatility 98.0 % 97.3 % Dividend yield — % — % The weighted average valuation assumptions were determined as follows: ● Risk-free interest rate: The Company based the risk-free interest rate on the interest rate payable on U.S. Treasury securities in effect at the time of grant for a period that is commensurate with the assumed expected option term. ● Expected term of options: Due to its lack of sufficient historical data, the Company estimates the expected life of its employee stock options using the “simplified” method, as prescribed in Staff Accounting Bulletin No. 107. ● Expected stock price volatility: The Company estimates the expected volatility based on the actual historical volatility of the Company’s stock price using daily closing prices over a period equal to the expected term of the associated award. ● Expected annual dividend yield: The Company estimated the expected dividend yield based on consideration of its historical dividend experience and future dividend expectations. The Company has not historically declared or paid dividends to stockholders. Moreover, it does not intend to pay dividends in the future, but instead expects to retain any earnings to invest in the continued growth of the business. Accordingly, the Company assumed an expected dividend yield of 0.0% . The Company elects to record forfeitures upon occurrence, rather than utilizing an estimate. As of December 31, 2021, there was $6.0 million of total unrecognized compensation expense related to unvested stock options that will be recognized over the weighted average remaining period of 2.97 years. Restricted Stock Units RSU-related expense is recognized on a straight-line basis over the vesting period. Upon vesting, these awards may be settled on a net-exercise basis to cover any required withholding tax with the remaining amount converted into an equivalent number of shares of common stock. There were 466,059 shares of common stock underlying vested RSUs that were withheld during the year ended December 31, 2021, based on the value of the RSU awards as determined by the Company’s closing stock price on the applicable vesting date. The shares withheld for taxes are again available for issuance under the plan. Weighted Average Number of Grant Date Awards Fair Value Non-vested at January 1, 2020 2,945,585 $ 0.73 Granted 2,536,850 2.11 Vested (1,519,493) 0.71 Forfeited/Cancelled (191,600) 0.69 Non-vested at December 31, 2020 3,771,342 $ 1.66 Granted 4,358,462 0.70 Vested (1,561,688) 1.20 Forfeited (649,620) 1.64 Non-vested at December 31, 2021 5,918,496 $ 1.08 For the years ended December 31, 2021 and 2020, the Company recorded $1.8 million and $1.1 million, respectively, in stock-based compensation expense related to RSUs, which is reflected in the statements of operations and comprehensive loss. As of December 31, 2021, there was $6.2 million of total unrecognized compensation expense related to unvested RSUs that will be recognized over the weighted average remaining period of 3.38 years. Shares Available for Future Grant At December 31, 2021, the Company has the following shares available to be granted: Inducement 2013 Plan Plan Available at December 31, 2020 4,053,501 252,500 Authorized 6,399,997 — Granted (8,106,104) — Shares withheld for taxes not issued 466,059 — Forfeited/Cancelled 1,365,352 — Available at December 31, 2021 4,178,805 252,500 Shares Reserved for Future Issuance At December 31, 2021, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 12,202,370 Restricted stock units outstanding under 2013 Plan 5,918,496 Stock options outstanding under Inducement Plan 247,500 Shares reserved for future issuance under Inducement Plan 252,500 Shares reserved for future issuance under 2013 Employee Stock Purchase Plan 225,806 Warrants outstanding 275,430 Total shares of common stock reserved for future issuance 19,122,102 |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 9. Commitments and Contingencies Leases The Company leases office space in Chesterbrook, Pennsylvania and equipment. The Company’s principal office is located at 955 Chesterbrook Boulevard, Chesterbrook, Pennsylvania, where the Company currently leases approximately 8,231 square feet of developed office space on the first floor and 40,565 square feet of developed office space on the second floor. The lease term for this space extends through May 2028. On October 11, 2018, the Company entered into an agreement with The Vanguard Group, Inc., or Vanguard, whereby Vanguard agreed to sublease the 40,565 square feet of space on the second floor for an initial term of 37 months. On October 2, 2020, Vanguard notified the Company that they exercised the first option to extend the sublease term for three years through November 30, 2024. Vanguard has a second option to extend the sublease term for an additional three years through November 30, 2027. The sublease provides for rent abatement for the first month of the term; thereafter, the rent payable to the Company by Vanguard under the sublease is (i) $0.50 less during months 2 through 13 of the sublease and (ii) in month 14 and thereafter of the sublease, $1.00 less than the base rent payable by the Company under its master lease with Chesterbrook Partners, L.P. Vanguard also is responsible for paying to the Company all tenant energy costs, annual operating costs, and annual tax costs attributable to the subleased space during the term of the sublease. Rent expense and associated sublease income are recorded in the Company’s statements of operations and comprehensive loss as other income (expense). Supplemental balance sheet information related to leases was as follows (in thousands): December 31, 2021 December 31, 2020 Operating leases: Operating lease right-of-use assets $ 4,706 $ 5,119 Other current lease liabilities 788 696 Operating lease liabilities 6,309 7,097 Total operating lease liabilities $ 7,097 $ 7,793 Finance leases: Property and equipment, at cost $ 45 $ 45 Accumulated depreciation (41) (34) Property and equipment, net 4 11 Other current lease liabilities 4 7 Other long-term liabilities — 4 Total finance lease liabilities $ 4 $ 11 The components of lease expense were as follows (in thousands): Year Ended December 31, 2021 2020 Operating lease costs: Operating lease rental expense $ 1,228 $ 1,256 Other income (1,186) (1,195) Total operating lease costs $ 42 $ 61 Finance lease costs: Amortization of right-of-use assets 7 9 Interest on lease liabilities 1 1 Total finance lease costs $ 8 $ 10 Supplemental cash flow information related to leases was as follows (in thousands): Year Ended December 31, 2021 2020 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (265) $ (179) Operating cash flows from finance leases — — Financing cash flows from finance leases (8) (10) Our lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2022 $ 1,401 $ 4 2023 1,425 — 2024 1,450 — 2025 1,474 — 2026 and beyond 3,661 — Total minimum lease payments $ 9,411 $ 4 Interest Expense (2,314) — Lease liability $ 7,097 $ 4 Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2022 1,118 2023 1,139 2024 996 2025 — 2026 and beyond — Total minimum lease payments $ 3,253 Weighted average lease term and discount rates are as follows: Year Ended December 31, 2021 2020 Weighted average remaining lease term (years) Operating leases 6 7 Finance leases — 1 Weighted average discount rate Operating leases 9.2% 9.2% Finance leases 6.5% 6.5% The Company had no deferred rent at December 31, 2021 or 2020 related to its facility leases. Legal Proceedings In October and November 2018, the Company and certain current and former officers and directors were sued in three purported class actions filed in the U.S. District Court for the Eastern District of Pennsylvania, or the EDPA, alleging violations of the federal securities laws. In January 2019, the three lawsuits were consolidated into one action, and on May 29, 2019, the District Court appointed a group of five individual investors as lead plaintiffs. A consolidated amended complaint was filed on August 2, 2019, alleging, among other things, that the Company and two former officers made false and misleading statements regarding the Company’s business, operations, and prospects, including certain statements made relating to the Company’s End-of-Phase 2 meeting with the FDA, and certain statements concerning top-line results from the Company’s Phase 3 studies. The plaintiffs sought, among other remedies, unspecified damages, attorneys’ fees and other costs, and unspecified equitable or injunctive relief. On August 28, 2020, the EDPA granted in part and denied in part the defendants’ motion to dismiss. On October 2, 2020, the Company and the individual defendants filed their answer to the amended complaint, denying all liability. On February 11, 2021, the parties agreed in principle to a settlement of $8.5 million, all of which was to be paid by the Company’s insurance carriers, subject to approval by the Court. The Court issued its preliminary approval of the settlement on May 3, 2021 and finally approved the settlement on August 2, 2021. The Company and the individual defendants did not acknowledge any wrongdoing as part of the settlement. The Company recorded the $8.5 million estimated settlement liability and the $8.5 million estimated insurance recovery in its 2020 financial statements. As expected, the $8.5 million was paid by the Company’s insurance carriers, and the litigation is now resolved. The Company continues to believe that the claims were without merit. In December 2018, a shareholder derivative action was filed on behalf of the Company and against certain current and former officers and directors in the EDPA, and in February 2019, two additional, similar shareholder derivative actions were filed in the U.S. District Court for the District of Delaware. A fourth similar shareholder derivative action was filed in the EDPA in September 2019, and a fifth, similar derivative action was filed in the EDPA in November 2019. A similar sixth derivative action was filed in the EDPA in September 2020. These cases, which involved facts similar to the consolidated securities lawsuits, asserted claims against the individual defendants for, among other things, breach of fiduciary duty, waste of corporate assets, violations of the federal securities laws, and unjust enrichment, and they make a number of demands, including for monetary damages and other equitable and injunctive relief. The parties agreed to a settlement, which was preliminarily approved by the Court on May 27, 2021, and finally approved by the Court on August 2, 2021. The individual defendants did not acknowledge any wrongdoing as part of the settlement. The Company agreed to make certain corporate governance changes, and a monetary payment of $500,000 was made to plaintiffs’ counsel, all of which was funded by the Company’s insurance carriers. The Company recorded in the fourth quarter of 2020 an estimated liability of $0.5 million and a corresponding insurance recovery of the same amount. As expected, the $0.5 million was paid by the Company’s insurance carriers, and the litigation is now resolved. |
Product Revenue
Product Revenue | 12 Months Ended |
Dec. 31, 2021 | |
Product Revenue | |
Product Revenue | 10. Product Revenue Performance Obligation The Company’s performance obligation is the supply of finished pharmaceutical products to its customers. The Company’s customers consist of major wholesale distributors. The Company’s customer contracts generally consist of both a master agreement, which is signed by the Company and its customer, and a customer submitted purchase order, which is governed by the terms and conditions of the master agreement. Revenue is recognized when the Company transfers control of its products to the customer, which occurs at a point-in-time, upon delivery. The Company offers standard payment terms to its customers and has elected the practical expedient to not adjust the promised amount of consideration for the effects of a significant financing, since the period between when the Company transfers the product to the customer and when the customer pays for that product is one year or less. Taxes collected from customers relating to product revenue and remitted to governmental authorities are excluded from revenues. The consideration amounts due from customers as a result of product revenue are subject to variable consideration. The Company offers standard product warranties which provide assurance that the product will function as expected and in accordance with specifications. Customers cannot purchase warranties separately and these warranties do not give rise to a separate performance obligation. The Company permits the return of product under certain circumstances, mainly upon at or near product expiration, instances of shipping errors or where product is damaged in transit. The Company accrues for the customer’s right to return as part of its variable consideration. See below for further details. Variable Consideration The Company includes an estimate of variable consideration in its transaction price at the time of sale when control of the product transfers to the customer. Variable consideration includes distributor chargebacks, prompt payment (cash) discounts, distribution service fees and product returns. The Company assesses whether or not an estimate of its variable consideration is constrained and has determined that the constraint does not apply, since it is probable that a significant reversal in the amount of cumulative revenue will not occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. The Company’s estimates for variable consideration are adjusted as required at each reporting period for specific known developments that may result in a change in the amount of total consideration it expects to receive. Distributor Chargebacks When a product that is subject to a contractual price agreement is sold to a third party, the difference between the price paid to the Company by the wholesaler and the price under the specific contract is charged back to the Company by the wholesaler. Utilizing this information, the Company estimates a chargeback percentage for each product and records an allowance for chargebacks as a reduction to revenue when the Company records sales of the products. We reduce the chargeback allowance when a chargeback request from a wholesaler is processed. Reserves for distributor chargebacks are included in accounts receivable, net on the consolidated balance sheet. Prompt Payment (Cash) Discounts The Company provides customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The Company’s prompt payment discount reserves are based on actual net sales and contractual discount rates. Reserves for prompt payment discounts are included in accounts receivable, net on the consolidated balance sheet. Distribution Service Fees The Company pays distribution service fees to its customers based on a fixed percentage of the product price. These fees are not in exchange for a distinct good or service and therefore are recognized as a reduction of the transaction price. The Company reserves for these fees based on actual net sales, contractual fee rates negotiated with the customer and the mix of the products in the distribution channel that remain subject to fees. Reserves for distribution service fees are included in accounts receivable, net on the consolidated balance sheet. Product Returns Generally, the Company’s customers have the right to return any unopened product during the eighteen 18 six 6 twelve 12 Six 6 two forty-eight 48 The Company recognizes the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since the returns primarily consist of expired and short dated products that will not be resold, the Company does not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due to the anticipated return). Accrued product return estimates are recorded in accrued expenses and other current liabilities on the consolidated balance sheet. Concentration of Revenue The Company’s three customers account for 100% of total product revenue for the year ended December 31, 2021. Sales-Related Deductions The following table presents a rollforward of the major categories of sales-related deductions included in trade receivable allowances for the year ended December 31, 2021 (in thousands): Sales Discounts Chargebacks Fee for Service Balance, January 1, 2021 $ 2 $ 5 $ 10 Provision related to current period sales 14 37 83 Adjustment related to prior period sales — — — Credit or payments made during the period (15) (1) (48) Balance, December 31, 2021 $ 1 $ 41 $ 45 As of December 31, 2021, the Company does not have any outstanding accounts receivable and, as a result, the sales allowance of $87,000 has been included with accrued expenses and other current liabilities on the Company’s balance sheet. |
License Revenue
License Revenue | 12 Months Ended |
Dec. 31, 2021 | |
License Revenue | |
License Revenue | 11. License Revenue License and Commercialization Agreement with Pharmbio Korea Inc. In April 2018, the Company entered into an exclusive license agreement with Pharmbio Korea Inc., or Pharmbio, for the development and commercialization of OLINVYK for the management of moderate to severe acute pain in South Korea. Under the terms of the agreement, the Company received an upfront, non-refundable cash payment of $3.0 million (less applicable withholding taxes of $0.5 million) in June 2018, and will receive a cash commercial milestone of up to $0.5 million if OLINVYK is approved in South Korea and tiered royalties on product sales in South Korea ranging from high single digits to 20%, less applicable withholding taxes. As part of the agreement, the Company also granted Pharmbio an option to manufacture OLINVYK, on a non-exclusive basis, for the development and commercialization of the product in South Korea, subject to a separate arrangement to be entered into if Pharmbio exercises the option. The license agreement is terminable by Pharmbio for any reason upon 180 days written notice. In accordance with the terms of the agreement, Pharmbio is solely responsible for all development and regulatory activities in South Korea. The parties have formed a Joint Development Committee with equal representation from the Company and Pharmbio to provide overall coordination and oversight of the development of OLINVYK in South Korea. The parties also agreed to form a Joint Manufacturing and Commercialization Committee at least six months prior to the anticipated date of regulatory approval of OLINVYK in South Korea to provide overall coordination and oversight of the manufacture and commercialization of OLINVYK in South Korea. License Agreement with Jiangsu Nhwa Pharmaceutical Co. Ltd. In April 2018, the Company also entered into an exclusive license agreement with Jiangsu Nhwa Pharmaceutical Co. Ltd., or Nhwa, for the development and commercialization of OLINVYK for the management of moderate to severe acute pain in China. Under the terms of this agreement, the Company received an upfront, non-refundable cash payment of $2.5 million (less applicable withholding taxes of $0.3 million) in July 2018. In August 2020, the Company received a milestone payment of $3.0 million (less applicable withholding taxes of $0.3 million), that became payable by Nhwa upon FDA approval of OLINVYK. The Company is also eligible to receive a cash milestone payment of $3.0 million, subject to Chinese withholding taxes, upon regulatory approval of OLINVYK in China, up to an additional $6.0 million of commercialization milestone payments based on product sales levels in China, and a ten percent royalty on all net product sales in China, less applicable withholding taxes. As part of the agreement, the Company also granted Nhwa an option to manufacture OLINVYK, on an exclusive basis in China, for the development and commercialization of the product in China. In the second quarter of 2018, Nhwa elected to exercise this manufacturing option and the Company and Nhwa expect to enter into a separate agreement for such services. The license agreement is terminable by Nhwa for any reason upon 180 days written notice. In accordance with the terms of the agreement, Nhwa is solely responsible for all development and regulatory activities in China. The parties have formed a Joint Development Committee with equal representation from the Company and Nhwa to provide overall coordination and oversight of the development of OLINVYK in China. The parties also agreed to form a Joint Manufacturing and Commercialization Committee at least six months prior to the anticipated date of regulatory approval of OLINVYK in China to provide overall coordination and oversight of the manufacture and commercialization of OLINVYK in China. For the year ended December 31, 2021 and 2020, license revenue in the accompanying statements of operations and comprehensive loss is comprised of the following: Year Ended Year Ended December 31, 2021 2020 Pharmbio Korea Inc. $ — $ — Jiangsu Nhwa Pharmaceutical Co. Ltd. 69 3,000 Total license revenues $ 69 $ 3,000 License revenue recorded for the year ended December 31, 2021 consisted of |
Net Loss Per Common Share
Net Loss Per Common Share | 12 Months Ended |
Dec. 31, 2021 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 12. Net Loss Per Common Share The following table sets forth the computation of basic and diluted net loss per share for the periods indicated (in thousands, except share and per share data): Year Ended December 31, 2021 2020 Basic and diluted net loss per common share calculation: Net loss $ (51,588) $ (29,369) Weighted average common shares outstanding 163,293,296 127,623,859 Net loss per share of common stock - basic and diluted $ (0.32) $ (0.23) The following outstanding securities at December 31, 2021 and 2020 have been excluded from the computation of diluted weighted shares outstanding, as they would have been anti-dilutive: December 31, 2021 2020 Options outstanding 12,449,870 9,564,519 RSUs outstanding 5,918,496 3,771,342 Warrants 275,430 295,591 Total 18,643,796 13,631,452 |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Income Taxes | 13. Income Taxes The income tax provision for the years ended December 31, 2021 and 2020 are as follows (in thousands): December 31, 2021 2020 Current: Foreign $ — $ 300 Federal — — State — — Total — 300 Deferred Foreign — — Federal — — State — — Total — — Total income tax provision (benefit) $ — $ 300 Deferred tax assets and liabilities reflect the net effects of net operating losses, or NOLs, and tax credit carryovers and temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax purposes. Realization of the deferred tax assets is contingent on future taxable income and based upon the level of historical losses, management has concluded that the deferred tax assets do not meet the more-likely-than-not threshold for realizability. Accordingly, a full valuation allowance continues to be recorded against the Company's deferred tax assets as of December 31, 2021 and 2020. The Company’s valuation allowance increased by $14.4 million and $5.9 million for the years ended December 31, 2021 and 2020, respectively. Significant components of the Company’s net deferred tax assets as of December 31, 2021 and 2020 are as follows (in thousands): December 31, 2021 2020 Deferred tax assets: NOLs $ 40,810 $ 25,949 Research and development credits 15,575 14,920 Research and development expenses capitalized for tax purposes 93,254 93,812 Equity-based compensation 3,960 4,130 Deferred rent 691 772 Depreciation 312 246 Other temporary differences 657 730 Total deferred tax assets 155,259 140,559 Deferred tax liabilities: Prepaid expenses (381) (119) Total deferred tax liabilities (381) (119) Net deferred tax assets 154,878 140,440 Less valuation allowance (154,878) (140,440) Net deferred tax asset $ — $ — A reconciliation of income tax expense computed at the statutory federal income tax rate to income taxes as reflected in the financial statements is as follows: December 31, 2021 2020 Percent of pre-tax income: U.S. federal statutory income tax rate 21.0 % 21.0 % Permanent Differences (0.2) % 1.0 % State taxes, net of federal benefit 7.2 % 4.8 % Research and development credit 1.3 % 2.6 % Withholding Tax — % (1.0) % Stock compensation (1.4) % (6.9) % Other 0.1 % (2.3) % Change in valuation allowance (28.0) % (20.2) % Effective income tax rate — % (1.0) % As of December 31, 2021, the Company had U.S. federal and state NOLs of $141.8 million and $139.7 million, respectively, that begin to expire starting in 2027. As of December 31, 2021, the Company had federal research and development tax credit carryforwards of $15.6 million that begin to expire in 2027. Net operating loss and tax credit carryforwards may become subject to annual limitations in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined by Sections 382 and 383 of the Internal Revenue Code as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The Company files income tax returns in the U.S., the Commonwealth of Pennsylvania and various other states. Tax years for 2018 and thereafter are open and potentially subject to examination by the federal and state taxing authorities. The Company is currently not under examination by the Internal Revenue Service or any other jurisdictions for any tax years. To the extent the Company utilizes any tax attributes from a tax period that may otherwise be closed due to statute expiration, the Internal Revenue Service, state tax authorities, or other governing parties may still adjust the tax attributes upon their examination of the future period in which the attribute was utilized. There are no uncertain tax positions recorded for any federal or state positions. The Company’s policy is to record interest and penalties related to tax matters in income tax expense. |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2021 | |
Employee Benefit Plan | |
Employee Benefit Plan | 14. Employee Benefit Plan The Company sponsors a 401(k) defined contribution plan for its employees. Employee contributions are voluntary. The Company matches employee contributions in an amount equal to 100% of the first 3% of eligible compensation and 50% of the next 2% of eligible compensation, and such employer contributions are immediately vested. During the years ended December 31, 2021 and 2020, the Company provided matching contributions of $0.3 million and $0.2 million, respectively. |
Subsequent Events
Subsequent Events | 12 Months Ended |
Dec. 31, 2021 | |
Subsequent Events | |
Subsequent Events | 15. Subsequent Events On March 30, 2022, the Company entered into a royalty-based financing with R-Bridge Healthcare Fund, an affiliate of CBC Group, or the R-Bridge Financing. In connection with this financing, the Company will receive an upfront amount of $15.0 million, plus $15.0 million upon first commercial sale of OLINVYK in China. The Company will also receive an additional $10.0 million upon achievement of either a commercial or financing milestone. The R-Bridge Financing will be repaid through assignment to R-Bridge of all royalties from the Company’s license with its partner in China, Jiangsu Nhwa Pharmaceutical, or Nhwa, and through a 4% net revenue interest in U.S. net sales of OLINVYK. This U.S. revenue interest will be capped at $10.0 million if Chinese approval occurs by year-end 2023. In the event Chinese approval does not occur by that time, the U.S. revenue interest will increase to 7% and will continue until certain combined totals of U.S. revenue interest and Chinese royalties are repaid. The Company retains all milestones from our partnership with Nhwa, including a $3.0 million milestone on Chinese approval. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the ASC and Accounting Standards Updates, or ASUs, of the FASB. The Company’s functional currency is the U.S. dollar. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Management used significant estimates in the following areas, among others: stock-based compensation expense, the determination of the fair value of stock-based awards, the fair value of common stock warrants, the accounting for research and development costs, accrued expenses and the recoverability of the Company’s net deferred tax assets and related valuation allowance. The financial data and other information disclosed in these notes are not necessarily indicative of the results to be expected for any future year or period. The Company bases its estimates on historical experience and also on assumptions that it believes are reasonable, however, actual results could significantly differ from those results. |
Cash and Cash Equivalents and Marketable Securities | Cash, Cash Equivalents and Marketable Securities The Company considers all highly liquid investments that have maturities of three months or less when acquired to be cash equivalents. Cash equivalents are valued at cost, which approximates their fair market value. The Company maintains a portion of its cash and cash equivalent balances in money market mutual funds that may invest substantially all of their assets in U.S. government agency securities and U.S. Treasury securities. |
Restricted Cash | Restricted Cash The Company maintains $1.3 million as collateral under a letter of credit for the Company’s facility lease obligations in Chesterbrook, Pennsylvania. The Company has recorded this deposit and accumulated interest thereon as restricted cash on its balance sheet. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, restricted cash, accounts payable and accrued expenses approximate their fair values, given their short-term nature. The Company had no loans payable at December 31, 2021 or 2020. Certain of the Company’s common stock warrants are carried at fair value, as disclosed in Note 3. The Company has evaluated the estimated fair value of financial instruments using available market information and management’s estimates. The use of different market assumptions and/or estimation methodologies could have a significant effect on the estimated fair value amounts. See Note 3 for additional information. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the Company to concentrations of credit risk are primarily cash, cash equivalents, and restricted cash. The Company’s investment policy includes guidelines on the quality of the institutions and financial instruments and defines allowable investments that the Company believes minimizes the exposure to concentration of credit risk. The Company has no off-balance sheet concentrations of credit risk such as foreign currency exchange contracts, option contracts or other hedging arrangements. |
Property and Equipment | Property and Equipment Property and equipment consists of computer and laboratory equipment, software, office equipment, furniture, manufacturing equipment and leasehold improvements and is recorded at cost. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred. Upon disposal, retirement or sale, the related cost and accumulated depreciation are removed from the accounts and any resulting gain or loss is included in the results of operations. Property and equipment are depreciated on a straight-line basis over their estimated useful lives. The Company uses a life of three years for computer equipment and five years for laboratory equipment, office equipment, furniture, manufacturing equipment and software. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the asset. The Company reviews long-lived assets when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparison of the book values of the assets to future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value, which is measured based on the projected discounted future net cash flows arising from the assets. No impairment losses were recorded during the years ended December 31, 2021 or 2020. |
Leases | Leases At the commencement of a lease, the Company recognizes a liability to make lease payments and an asset representing the right to use the underlying asset during the lease term. The lease liability is measured at the present value of lease payments over the lease term, including variable fees that are known or subject to a minimum floor. The lease liability includes lease component fees, while non-lease component fees are expensed as incurred for all asset classes. When a contract excludes an implicit rate, the Company utilizes an incremental borrowing rate based on information available at the lease commencement date including lease term and geographic region. The initial valuation of the right-of-use, or ROU, asset includes the initial measurement of the lease liability, lease payments made in advance of the lease commencement date, and initial direct costs incurred by the Company and excludes lease incentives. Leases with an initial term of 12 months or less are classified as short-term leases and are not recorded on the balance sheet. The lease expense for short-term leases is recognized on a straight-line basis over the lease term. The Company tests for impairment of the ROU assets whenever circumstances indicate that the carrying amount of the asset may not be recoverable. |
Common Stock Warrants | Common Stock Warrants Freestanding warrants that are related to the purchase of common stock are classified as liabilities and recorded at fair value regardless of the timing of the redemption feature or the redemption price or the likelihood of redemption. These warrants are subject to re-measurement at each balance sheet date and any change in fair value is recognized as a component of change in fair value of warrant liability in the statements of operations and comprehensive loss. The Company will continue to adjust the liability for changes in fair value until the earlier of the exercise or expiration of the warrants. The warrants are classified as Level 3 liabilities. The value of these warrants was immaterial as of December 31, 2021 and 2020. In addition, in connection with entering into loan agreements, the Company has issued warrants to purchase shares of the Company’s common stock. These detachable warrant instruments qualify for equity classification and have been allocated upon the relative fair value of the base instrument and the warrant. See Note 7 and Note 8 for additional information. |
Revenue | Revenue In accordance with FASB’s ASC 606, Revenue from Contracts with Customers, or ASC 606, the Company recognizes revenue when customers obtain control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines are within the scope of ASC 606, it performs the following five steps: (i) (ii) (iii) (iv) (v) The Company applies the five-step model to contracts when it determines that it is probable it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract and determines those that are performance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. See Note 9 and Note 10, respectively, for a full discussion of the Company’s product revenue and license revenue. |
Research and Development | Research and Development Research and development costs are charged to expense as incurred. Research and development costs include, but are not limited to, personnel expenses, clinical trial supplies, fees for clinical trial services, manufacturing costs, consulting costs, and allocated overhead. Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as subject enrollment, clinical site activations or information provided to the Company by its vendors with respect to their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the pattern of costs incurred, and are reflected in the financial statements as prepaid or accrued research and development expense, as the case may be. As part of the process of preparing its financial statements, the Company is required to estimate its expenses resulting from its obligations under contracts with vendors, clinical research organizations and consultants, and under clinical site agreements in connection with conducting clinical trials. The financial terms of these contracts are subject to negotiations, which vary from contract to contract and may result in payment flows that do not match the periods over which materials or services are provided under such contracts. The Company’s objective is to reflect the appropriate trial expenses in its financial statements by matching those expenses with the period in which services are performed and efforts are expended. The Company may account for these expenses according to the progress of the trial as measured by subject progression and the timing of various aspects of the trial. The Company determines accrual estimates through financial models taking into account discussion with applicable personnel and outside service providers as to the progress or state of consummation of trials, or the services completed. During the course of a clinical trial, the Company adjusts its clinical expense recognition if actual results differ from its estimates. The Company makes estimates of its accrued expenses as of each balance sheet date based on the facts and circumstances known to it at that time. The Company’s clinical trial accruals are dependent upon the timely and accurate reporting of contract research organizations and other third-party vendors. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of the status and timing of services performed relative to the actual status and timing of services performed may vary and may result in it reporting amounts that are too high or too low for any particular period. For the years ended December 31, 2021 and 2020, there were no material adjustments to the Company’s prior period estimates of accrued expenses for clinical trials. |
Stock-Based Compensation | Stock-Based Compensation The Company has equity incentive plans under which various types of equity-based awards including, but not limited to, incentive stock options, non-qualified stock options, and restricted stock unit awards, may be granted to employees, non-employee directors, and non-employee consultants. At December 31, 2021, the Company had two stock-based compensation plans, which are more fully described in Note 8. The Company also has an inducement plan under which various types of equity-based awards, including non-qualified stock options and restricted stock awards, may be granted to new employees. The Company has applied the fair value recognition provisions of Financial Accounting Standards Board Accounting Standards Codification Topic 718, Compensation — Stock Compensation, to account for stock-based compensation for employees. The Company recognizes compensation expense for all stock-based awards based on the estimated grant-date fair values. For restricted stock unit awards to employees, the fair value is based on the closing price of the Company’s common stock on the date of grant. The value of the portion of the award that is ultimately expected to vest is recognized as expense on a straight-line basis over the requisite service period. The fair value of stock options is determined using the Black-Scholes option pricing model. The Company utilizes a dividend yield of zero based on the fact that the Company has never paid cash dividends and has no current intention of paying cash dividends. The Company elected an accounting policy to record forfeitures as they occur. For stock awards that vest based on performance conditions (e.g., achievement of certain milestones), expense is recognized when it is probable that the conditions will be met. See Note 8 for a discussion of the assumptions used by the Company in determining the grant date fair value of options granted under the Black-Scholes option pricing model, as well as a summary of the stock option activity under the Company’s stock-based compensation plan for all years presented. |
Income Taxes | Income Taxes Income taxes are recorded in accordance with ASC Topic 740, Income Taxes The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position, as well as consideration of the available facts and circumstances. To date, the Company has not taken any uncertain tax position or recorded any reserves, interest or penalties. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Comprehensive income (loss) was equal to the net loss for years ended December 31, 2020 and 2021. |
Basic and Diluted Net Loss Per Share of Common Stock | Basic and Diluted Net Loss Per Share of Common Stock The Company’s basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per common share is computed by giving effect to all potential dilutive common stock equivalents outstanding for the period. Because the impact of these items is anti-dilutive during periods of net loss, there was no difference between basic and diluted net loss per share of common stock for all periods presented. |
Recently Adopted Accounting Standards | Recently Adopted Accounting Standards In December 2019, the FASB issued ASU 2019-12, Simplifying the Accounting for Income Taxes, which removed certain exceptions to the general principles of the accounting for income taxes and also improves consistent application of and simplification of other areas when accounting for income taxes. The effective date for this standard was January 1, 2021. The Company adopted this standard on January 1, 2021. There was no impact to the Company’s financial statements or related disclosures upon the adoption. |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value of Financial Instruments | |
Schedule of cash, cash equivalents and marketable securities | The following table presents the Company’s cash, cash equivalents, restricted cash, and marketable securities as of December 31, 2021 and 2020 (in thousands): December 31, 2021 Adjusted Unrealized Unrealized Cash and Cash Restricted Cost Gains Losses Fair Value Equivalents Cash Cash $ 9,459 $ — $ — $ 9,459 $ 8,148 $ 1,311 Level 1 (1): Money market funds 58,775 — — 58,775 58,775 — Subtotal 58,775 — — 58,775 58,775 — Total $ 68,234 $ — $ — $ 68,234 $ 66,923 $ 1,311 December 31, 2020 Adjusted Unrealized Unrealized Cash and Cash Restricted Cost Gains Losses Fair Value Equivalents Cash Cash $ 6,100 $ — $ — $ 6,100 $ 4,790 $ 1,310 Level 1 (1): Money market funds 104,613 — — 104,613 104,613 — Subtotal 104,613 — — 104,613 104,613 — Total $ 110,713 $ — $ — $ 110,713 $ 109,403 $ 1,310 (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property and Equipment, net | |
Schedule of property and equipment | Property and equipment consisted of the following (in thousands): Estimated Useful December 31, Life in Years 2021 2020 Computers and software 3 5 $ 476 $ 476 Office equipment and furniture 5 721 721 Manufacturing equipment 5 10 10 Leasehold improvements 10 3,082 3,082 Leased assets 5 45 45 Total property and equipment 4,334 4,334 Less accumulated depreciation and amortization (2,493) (2,081) Property and equipment, net $ 1,841 $ 2,253 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Compensation and benefits $ 2,132 $ 2,919 Commercial expenses 107 605 Legal expenses 124 784 Clinical trial expenses 550 — Pharmaceutical development expenses 161 413 Credit balances to customers 87 — Accrued purchases 271 — Other accrued expenses and other current liabilities 415 447 Total accrued expenses and other current liabilities $ 3,847 $ 5,168 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Stockholders' Equity | |
Schedule of share-based compensation expense recognized | The estimated grant-date fair value of the Company’s share-based awards is amortized on a straight-line basis over the awards’ service periods. Share-based compensation expense recognized was as follows (in thousands): Year Ended December 31, 2021 2020 Research and development $ 1,066 $ 781 Selling, general and administrative 3,303 2,497 Cost of goods sold 38 6 Total stock-based compensation $ 4,407 $ 3,284 |
Summary of stock option activity | Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, January 1, 2020 7,568,304 $ 3.40 7.01 Granted 2,477,486 1.90 Exercised (197,640) 0.68 Forfeited/Cancelled (283,631) 3.33 Balance, December 31, 2020 9,564,519 $ 3.07 7.17 Granted 3,747,642 1.60 Exercised (146,559) 1.28 Forfeited/Cancelled (715,732) 2.81 Balance, December 31, 2021 12,449,870 $ 2.67 7.11 Vested or expected to vest at December 31, 2021 12,449,870 $ 2.67 7.11 Exercisable at December 31, 2021 7,073,223 $ 3.39 5.72 |
Schedule of weighted-average assumptions: | Year Ended December 31, 2021 2020 Expected term of options (in years) 6.2 6.1 Risk-free interest rate 1.0 % 0.6 % Expected volatility 98.0 % 97.3 % Dividend yield — % — % |
Schedule of changes in the status of non-vested RSU | Weighted Average Number of Grant Date Awards Fair Value Non-vested at January 1, 2020 2,945,585 $ 0.73 Granted 2,536,850 2.11 Vested (1,519,493) 0.71 Forfeited/Cancelled (191,600) 0.69 Non-vested at December 31, 2020 3,771,342 $ 1.66 Granted 4,358,462 0.70 Vested (1,561,688) 1.20 Forfeited (649,620) 1.64 Non-vested at December 31, 2021 5,918,496 $ 1.08 |
Schedule of shares available to be granted under equity incentive plans | At December 31, 2021, the Company has the following shares available to be granted: Inducement 2013 Plan Plan Available at December 31, 2020 4,053,501 252,500 Authorized 6,399,997 — Granted (8,106,104) — Shares withheld for taxes not issued 466,059 — Forfeited/Cancelled 1,365,352 — Available at December 31, 2021 4,178,805 252,500 |
Schedule of shares of common stock reserved/available | At December 31, 2021, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 12,202,370 Restricted stock units outstanding under 2013 Plan 5,918,496 Stock options outstanding under Inducement Plan 247,500 Shares reserved for future issuance under Inducement Plan 252,500 Shares reserved for future issuance under 2013 Employee Stock Purchase Plan 225,806 Warrants outstanding 275,430 Total shares of common stock reserved for future issuance 19,122,102 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies. | |
Schedule of balance sheet information related to leases | Supplemental balance sheet information related to leases was as follows (in thousands): December 31, 2021 December 31, 2020 Operating leases: Operating lease right-of-use assets $ 4,706 $ 5,119 Other current lease liabilities 788 696 Operating lease liabilities 6,309 7,097 Total operating lease liabilities $ 7,097 $ 7,793 Finance leases: Property and equipment, at cost $ 45 $ 45 Accumulated depreciation (41) (34) Property and equipment, net 4 11 Other current lease liabilities 4 7 Other long-term liabilities — 4 Total finance lease liabilities $ 4 $ 11 |
Schedule of components of lease expense | The components of lease expense were as follows (in thousands): Year Ended December 31, 2021 2020 Operating lease costs: Operating lease rental expense $ 1,228 $ 1,256 Other income (1,186) (1,195) Total operating lease costs $ 42 $ 61 Finance lease costs: Amortization of right-of-use assets 7 9 Interest on lease liabilities 1 1 Total finance lease costs $ 8 $ 10 |
Schedule of supplemental cash flow information | Supplemental cash flow information related to leases was as follows (in thousands): Year Ended December 31, 2021 2020 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (265) $ (179) Operating cash flows from finance leases — — Financing cash flows from finance leases (8) (10) |
Schedule of maturities of operating lease liabilities | Our lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2022 $ 1,401 $ 4 2023 1,425 — 2024 1,450 — 2025 1,474 — 2026 and beyond 3,661 — Total minimum lease payments $ 9,411 $ 4 Interest Expense (2,314) — Lease liability $ 7,097 $ 4 |
Schedule of maturities of financing lease liabilities | Our lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2022 $ 1,401 $ 4 2023 1,425 — 2024 1,450 — 2025 1,474 — 2026 and beyond 3,661 — Total minimum lease payments $ 9,411 $ 4 Interest Expense (2,314) — Lease liability $ 7,097 $ 4 |
Schedule of expected sublease inflows | Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2022 1,118 2023 1,139 2024 996 2025 — 2026 and beyond — Total minimum lease payments $ 3,253 |
Schedule of weighted average lease term and discount rates | Year Ended December 31, 2021 2020 Weighted average remaining lease term (years) Operating leases 6 7 Finance leases — 1 Weighted average discount rate Operating leases 9.2% 9.2% Finance leases 6.5% 6.5% |
Product Revenue (Tables)
Product Revenue (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Product Revenue | |
Schedule of major categories of sales-related deductions included in trade receivable allowances | The following table presents a rollforward of the major categories of sales-related deductions included in trade receivable allowances for the year ended December 31, 2021 (in thousands): Sales Discounts Chargebacks Fee for Service Balance, January 1, 2021 $ 2 $ 5 $ 10 Provision related to current period sales 14 37 83 Adjustment related to prior period sales — — — Credit or payments made during the period (15) (1) (48) Balance, December 31, 2021 $ 1 $ 41 $ 45 |
License Revenue (Tables)
License Revenue (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Product Revenue | |
Schedule of license revenue | Year Ended Year Ended December 31, 2021 2020 Pharmbio Korea Inc. $ — $ — Jiangsu Nhwa Pharmaceutical Co. Ltd. 69 3,000 Total license revenues $ 69 $ 3,000 |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Net Loss Per Common Share | |
Schedule of computation of basic and diluted net loss per share | The following table sets forth the computation of basic and diluted net loss per share for the periods indicated (in thousands, except share and per share data): Year Ended December 31, 2021 2020 Basic and diluted net loss per common share calculation: Net loss $ (51,588) $ (29,369) Weighted average common shares outstanding 163,293,296 127,623,859 Net loss per share of common stock - basic and diluted $ (0.32) $ (0.23) |
Schedule of outstanding securities excluded from the computation of diluted weighted shares outstanding as they would have been anti-dilutive | December 31, 2021 2020 Options outstanding 12,449,870 9,564,519 RSUs outstanding 5,918,496 3,771,342 Warrants 275,430 295,591 Total 18,643,796 13,631,452 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Taxes | |
Schedule of income tax provision | The income tax provision for the years ended December 31, 2021 and 2020 are as follows (in thousands): December 31, 2021 2020 Current: Foreign $ — $ 300 Federal — — State — — Total — 300 Deferred Foreign — — Federal — — State — — Total — — Total income tax provision (benefit) $ — $ 300 |
Schedule of significant components of the Company's deferred tax assets | Significant components of the Company’s net deferred tax assets as of December 31, 2021 and 2020 are as follows (in thousands): December 31, 2021 2020 Deferred tax assets: NOLs $ 40,810 $ 25,949 Research and development credits 15,575 14,920 Research and development expenses capitalized for tax purposes 93,254 93,812 Equity-based compensation 3,960 4,130 Deferred rent 691 772 Depreciation 312 246 Other temporary differences 657 730 Total deferred tax assets 155,259 140,559 Deferred tax liabilities: Prepaid expenses (381) (119) Total deferred tax liabilities (381) (119) Net deferred tax assets 154,878 140,440 Less valuation allowance (154,878) (140,440) Net deferred tax asset $ — $ — |
Schedule of reconciliation of income tax expense computed at the statutory federal income tax rate to income taxes as reflected in the financial statements | December 31, 2021 2020 Percent of pre-tax income: U.S. federal statutory income tax rate 21.0 % 21.0 % Permanent Differences (0.2) % 1.0 % State taxes, net of federal benefit 7.2 % 4.8 % Research and development credit 1.3 % 2.6 % Withholding Tax — % (1.0) % Stock compensation (1.4) % (6.9) % Other 0.1 % (2.3) % Change in valuation allowance (28.0) % (20.2) % Effective income tax rate — % (1.0) % |
Organization and Description _2
Organization and Description of the Business (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021USD ($)segment | Dec. 31, 2020USD ($) | |
Organization and Description of the Business | ||
Number of operating segments | segment | 1 | |
Accumulated deficit | $ 494,102 | $ 442,514 |
Net loss | $ 51,588 | $ 29,369 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Details) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2021USD ($)segmentitem$ / shares | Dec. 31, 2020USD ($)$ / shares | |
Fair Value of Financial Instruments | ||
Loans payable | $ 0 | $ 0 |
Property and Equipment | ||
Impairment of property and equipment | $ 0 | $ 0 |
Segment Information | ||
Number of operating segments | segment | 1 | |
Stock-Based Compensation | ||
Number of stock-based compensation plans | item | 2 | |
Dividend yield | 0.00% | |
Basic and diluted net loss per common share calculation: | ||
Difference between basic and diluted net loss per share of Common Stock (in dollars per share) | $ / shares | $ 0 | $ 0 |
Chesterbrook, Pennsylvania | ||
Restricted Cash | ||
Letter of credit collateral | $ 1.3 | |
Computer equipment | ||
Property and Equipment | ||
Estimated useful life | P3Y | |
Laboratory equipment, office equipment, furniture and software | ||
Property and Equipment | ||
Estimated useful life | P5Y |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair value | ||
Transfers between Level 2 and Level 3 | $ 0 | $ 0 |
Adjusted cost | ||
Fair value | ||
Cash | 9,459 | 6,100 |
Total | 68,234 | 110,713 |
Fair Value | ||
Fair value | ||
Cash | 9,459 | 6,100 |
Total | 68,234 | 110,713 |
Chesterbrook, Pennsylvania | ||
Fair value | ||
Letter of credit collateral | 1,300 | |
Cash and Cash Equivalents | Fair Value | ||
Fair value | ||
Cash | 8,148 | 4,790 |
Total | 66,923 | 109,403 |
Restricted Cash | Fair Value | ||
Fair value | ||
Cash | 1,311 | 1,310 |
Total | 1,311 | 1,310 |
Level 1 | Adjusted cost | ||
Fair value | ||
Investments | 58,775 | 104,613 |
Level 1 | Fair Value | ||
Fair value | ||
Investments | 58,775 | 104,613 |
Level 1 | Money market mutual funds | Adjusted cost | ||
Fair value | ||
Investments | 58,775 | 104,613 |
Level 1 | Money market mutual funds | Fair Value | ||
Fair value | ||
Investments | 58,775 | 104,613 |
Level 1 | Cash and Cash Equivalents | Fair Value | ||
Fair value | ||
Investments | 58,775 | 104,613 |
Level 1 | Cash and Cash Equivalents | Money market mutual funds | Fair Value | ||
Fair value | ||
Investments | $ 58,775 | $ 104,613 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Property and Equipment | ||
Total property and equipment | $ 4,334 | $ 4,334 |
Accumulated depreciation | (2,493) | (2,081) |
Property and equipment, net | 1,841 | 2,253 |
Depreciation and amortization expense | 428 | 477 |
Computers and software | ||
Property and Equipment | ||
Property and equipment, gross | $ 476 | 476 |
Computers and software | Minimum | ||
Property and Equipment | ||
Estimated useful life | P3Y | |
Computers and software | Maximum | ||
Property and Equipment | ||
Estimated useful life | P5Y | |
Office equipment and furniture | ||
Property and Equipment | ||
Estimated useful life | P5Y | |
Property and equipment, gross | $ 721 | 721 |
Manufacturing equipment | ||
Property and Equipment | ||
Estimated useful life | P5Y | |
Property and equipment, gross | $ 10 | 10 |
Leasehold improvements | ||
Property and Equipment | ||
Estimated useful life | P10Y | |
Property and equipment, gross | $ 3,082 | 3,082 |
Leased assets | ||
Property and Equipment | ||
Estimated useful life | P5Y | |
Leased assets | $ 45 | $ 45 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Accrued Expenses and Other Current Liabilities | ||
Compensation and benefits | $ 2,132 | $ 2,919 |
Commercial expenses | 107 | 605 |
Legal expenses | 124 | 784 |
Clinical trial expenses | 550 | |
Pharmaceutical development expenses | 161 | 413 |
Credit balances to customers | 87 | |
Accrued purchases | 271 | |
Other accrued expenses and other current liabilities | 415 | 447 |
Total accrued expenses and other current liabilities | $ 3,847 | $ 5,168 |
Loans Payable (Details)
Loans Payable (Details) $ / shares in Units, $ in Thousands | Mar. 02, 2020USD ($) | Sep. 30, 2014USD ($)tranche$ / sharesshares | Dec. 31, 2021USD ($)shares | Dec. 31, 2020USD ($) | Sep. 30, 2020$ / sharesshares | Mar. 31, 2017USD ($) | Dec. 31, 2015$ / sharesshares |
Long Term Debt | |||||||
Interest expense | $ 1 | $ 29 | |||||
Loan and security agreement | |||||||
Long Term Debt | |||||||
Maximum amount available | $ 35,000 | ||||||
Debt number of tranches | tranche | 3 | ||||||
Gross proceeds | $ 28,500 | ||||||
Final payment fee | $ 1,900 | ||||||
Final payment fee percentage | 6.60% | ||||||
Term Loan A | Common Stock | Warrants | |||||||
Long Term Debt | |||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | shares | 7,678 | 5,728 | |||||
Exercise price | $ / shares | $ 5.8610 | ||||||
Term Loan B | Common Stock | Warrants | |||||||
Long Term Debt | |||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | shares | 34,961 | ||||||
Exercise price | $ / shares | $ 10.6190 | ||||||
Term Loan C | |||||||
Long Term Debt | |||||||
Interest rate (as a percent) | 6.98% | ||||||
Term Loan C | Common Stock | Warrants | |||||||
Long Term Debt | |||||||
Number of shares that can be purchased upon exercise of warrants (in shares) | shares | 62,241 | ||||||
Exercise price | $ / shares | $ 3.6150 | ||||||
Term Loans A and B | |||||||
Long Term Debt | |||||||
Interest rate (as a percent) | 6.50% | ||||||
Term Loans A, B, and C | |||||||
Long Term Debt | |||||||
Aggregate principal balance outstanding | $ 0 | 0 | |||||
Interest expense | $ 0 | $ 20 | |||||
Debt discount and debt issuance costs | $ 1,000 |
Stockholders' Equity - Equity O
Stockholders' Equity - Equity Offerings (Details) | Jan. 28, 2019USD ($)$ / sharesshares | Aug. 31, 2020USD ($)$ / sharesshares | Jan. 31, 2019USD ($)Institution$ / sharesshares | Dec. 31, 2021USD ($)shares | Dec. 31, 2020USD ($)shares | Apr. 17, 2019USD ($) |
Stockholders' Equity | ||||||
Common stock authorized (in shares) | shares | 200,000,000 | 200,000,000 | ||||
Preferred stock authorized (in shares) | shares | 5,000,000 | 5,000,000 | ||||
Net proceeds from the offering | $ | $ 7,948,000 | $ 101,010,000 | ||||
Issuance of common stock, net of issuance costs | $ | $ 7,948,000 | $ 101,010,000 | ||||
Wainwright | ||||||
Stockholders' Equity | ||||||
Percentage of aggregate gross proceeds paid | 7.00% | |||||
Expenses paid | $ | $ 50,000 | |||||
Warrants to purchase shares of common stock | shares | 500,000 | |||||
Warrants term | 5 years | |||||
Exercise price (in dollars per share) | $ / shares | $ 1.25 | |||||
Number of warrants exercised in a cashless exercise | shares | 327,500 | |||||
Common shares issued in conversion of warrants | shares | 201,925 | |||||
At-the-market sales facility - April 17, 2019 agreement | Maximum | ||||||
Stockholders' Equity | ||||||
Offering amount | $ | $ 50,000,000 | $ 50,000,000 | ||||
Private Placement | ||||||
Stockholders' Equity | ||||||
Issuance of common stock (in shares) | shares | 10,000,000 | |||||
Offering price (in dollars per share) | $ / shares | $ 1 | |||||
Issuance of common stock, net of issuance costs | $ | $ 9,200,000 | |||||
Number of institutional investors | Institution | 2 | |||||
Public Offering | ||||||
Stockholders' Equity | ||||||
Issuance of common stock (in shares) | shares | 25,000,000 | |||||
Offering price (in dollars per share) | $ / shares | $ 2.30 | |||||
Issuance of common stock, net of issuance costs | $ | $ 53,700,000 | |||||
Time period for full exercise of option to purchase additional shares | 30 days | |||||
HCW ATM Program | ||||||
Stockholders' Equity | ||||||
Issuance of common stock (in shares) | shares | 4,300,000 | |||||
Net proceeds from the offering | $ | $ 7,900,000 | |||||
Stock available for further issuance | $ | $ 41,900,000 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Incentive Plans (Details) - USD ($) $ in Thousands | Dec. 15, 2016 | Dec. 31, 2021 | Dec. 31, 2020 |
Equity Incentive Plans | |||
Stock-based compensation | $ 4,407 | $ 3,284 | |
Research and Development Expense | |||
Equity Incentive Plans | |||
Stock-based compensation | 1,066 | 781 | |
General and Administrative Expense | |||
Equity Incentive Plans | |||
Stock-based compensation | 3,303 | 2,497 | |
Cost of goods sold | |||
Equity Incentive Plans | |||
Stock-based compensation | $ 38 | $ 6 | |
Maximum | |||
Equity Incentive Plans | |||
Term of award | 10 years | ||
Vesting period | 4 years | ||
Inducement Plan | |||
Equity Incentive Plans | |||
Authorized (in shares) | 500,000 |
Stockholders' Equity - Options
Stockholders' Equity - Options Outstanding (Details) - Employee Stock Option - $ / shares | 12 Months Ended | ||
Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 | |
Number of Shares | |||
Balance at the beginning of the period (in shares) | 9,564,519 | 7,568,304 | |
Granted (in shares) | 3,747,642 | 2,477,486 | |
Exercised (in shares) | (146,559) | (197,640) | |
Forfeited/Cancelled (in shares) | (715,732) | (283,631) | |
Balance at the end of the period (in shares) | 12,449,870 | 9,564,519 | 7,568,304 |
Vested or expected to vest at the end of the period (in shares) | 12,449,870 | ||
Exercisable at the end of the period (in shares) | 7,073,223 | ||
Weighted-Average Exercise Price | |||
Balance at the beginning of the period (in dollars per share) | $ 3.07 | $ 3.40 | |
Granted (in dollars per share) | 1.60 | 1.90 | |
Exercised (in dollars per share) | 1.28 | 0.68 | |
Forfeited/Cancelled (in dollars per share) | (2.81) | (3.33) | |
Balance at the end of the period (in dollars per share) | 2.67 | $ 3.07 | $ 3.40 |
Vested or expected to vest at the end of the period (in dollars per share) | 2.67 | ||
Exercisable at the end of the period (in dollars per share) | 3.39 | ||
Closing price of Company's stock (in dollars per share) | $ 0.58 | ||
Weighted Average Remaining Contractual Term | |||
Options Outstanding at the end of the period | 7 years 1 month 9 days | 7 years 2 months 1 day | 7 years 3 days |
Vested or expected to vest at the end of the period | 7 years 1 month 9 days | ||
Exercisable at the end of the period | 5 years 8 months 19 days |
Stockholders' Equity - Assumpti
Stockholders' Equity - Assumptions Used (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Stockholders' Equity | ||
Dividend yield | 0.00% | |
Employee Stock Option | ||
Stockholders' Equity | ||
Weighted average grant date fair value (in dollars per share) | $ 1.25 | $ 1.48 |
Expected term of options (in years) | 6 years 2 months 12 days | 6 years 1 month 6 days |
Risk-free interest rate (as a percent) | 1.00% | 0.60% |
Expected volatility (as a percent) | 98.00% | 97.30% |
Dividend yield | 0.00% | 0.00% |
Unrecognized compensation expense | $ 6 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 2 years 11 months 19 days |
Stockholders' Equity - Non-vest
Stockholders' Equity - Non-vested RSUs (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Weighted Average Grant Date Fair Value | ||
Stock-based compensation | $ 4,407 | $ 3,284 |
Restricted Stock Units | ||
Number of Shares | ||
Non-vested at beginning of period (in shares) | 3,771,342 | 2,945,585 |
Granted (in shares) | 4,358,462 | 2,536,850 |
Vested (in shares) | (1,561,688) | (1,519,493) |
Forfeited/Cancelled | (649,620) | (191,600) |
Non-vested at end of period (in shares) | 5,918,496 | 3,771,342 |
Weighted Average Grant Date Fair Value | ||
Non-vested at beginning of period (in dollars per share) | $ 1.66 | $ 0.73 |
Granted (in dollars per share) | 0.70 | 2.11 |
Vested (in dollars per share) | 1.20 | 0.71 |
Forfeited (in dollars per share) | 1.64 | 0.69 |
Non-vested at end of period (in dollars per share) | $ 1.08 | $ 1.66 |
Stock-based compensation | $ 1,800 | $ 1,100 |
Unrecognized compensation expense | $ 6,200 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 3 years 4 months 17 days | |
Shares of common stock underlying vested RSUs withheld | 466,059 |
Stockholders' Equity - Availabl
Stockholders' Equity - Available for Grant (Details) - shares | Dec. 15, 2016 | Dec. 31, 2021 |
2013 plan | ||
Stockholders' Equity | ||
Balance at the beginning of the period (in shares) | 4,053,501 | |
Authorized (in shares) | 6,399,997 | |
Granted (in shares) | (8,106,104) | |
Shares withheld for taxes not issued (in shares) | 466,059 | |
Forfeited/Cancelled (in shares) | 1,365,352 | |
Balance at the end of the period (in shares) | 4,178,805 | |
Inducement Plan | ||
Stockholders' Equity | ||
Balance at the beginning of the period (in shares) | 252,500 | |
Authorized (in shares) | 500,000 | |
Balance at the end of the period (in shares) | 252,500 |
Stockholders' Equity - Shares A
Stockholders' Equity - Shares Available for Future Issuance (Details) | Dec. 31, 2021shares |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 19,122,102 |
Warrants | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 275,430 |
2013 plan | Employee Stock Option | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 12,202,370 |
2013 plan | Restricted Stock Units | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 5,918,496 |
2013 plan | Employee Stock Purchase Plan | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 225,806 |
Inducement Plan | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 252,500 |
Inducement Plan | Employee Stock Option | |
Stockholders' Equity | |
Total shares of common stock reserved for future issuance (in shares) | 247,500 |
Commitments and Contingencies -
Commitments and Contingencies - Leases (Details) - Chesterbrook, Pennsylvania $ in Millions | Oct. 02, 2020 | Oct. 11, 2018ft²$ / ft² | Dec. 31, 2021USD ($)ft² | Dec. 31, 2020USD ($) |
Leases | ||||
Number of square feet of space leased on the first floor | 8,231 | |||
Number of square feet of space leased on the second floor | 40,565 | |||
Deferred rent | $ | $ 0 | $ 0 | ||
Sublease Agreements | Vanguard Group, Inc | ||||
Leases | ||||
Number of square feet of space being subleased on second floor | 40,565 | |||
Initial term of sublease | 37 months | |||
Term of optional sublease extension | 3 years | |||
Term of second optional sublease extension | 3 years | |||
Amount per square foot less for rent during months 2 to 13 | $ / ft² | 0.50 | |||
Amount per square foot for rent after month 14 | $ / ft² | 1 |
Commitments and Contingencies_2
Commitments and Contingencies - Balance sheet information related to leases (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Leases | ||
Operating lease right-of-use assets | $ 4,706 | $ 5,119 |
Operating lease liabilities - Current | $ 788 | $ 696 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Lease Liability Current | Lease Liability Current |
Operating lease liabilities - Noncurrent | $ 6,309 | $ 7,097 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease Liability Noncurrent | Lease Liability Noncurrent |
Lease Liability | $ 7,097 | $ 7,793 |
Property and equipment, at cost | 4,334 | 4,334 |
Accumulated depreciation | (2,493) | (2,081) |
Property and equipment, net | 1,841 | 2,253 |
Finance lease liabilities - Current | $ 4 | $ 7 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Lease Liability Current | Lease Liability Current |
Finance lease liabilities - Noncurrent | $ 4 | |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease Liability Noncurrent | Lease Liability Noncurrent |
Lease Liability | $ 4 | $ 11 |
Finance leased assets | ||
Leases | ||
Property and equipment, at cost | 45 | 45 |
Accumulated depreciation | (41) | (34) |
Property and equipment, net | $ 4 | $ 11 |
Commitments and Contingencies_3
Commitments and Contingencies - Components of lease expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Operating lease costs: | ||
Operating lease rental expense | $ 1,228 | $ 1,256 |
Other income | (1,186) | (1,195) |
Total operating lease costs | 42 | 61 |
Finance lease costs: | ||
Amortization of right-of-use assets | 7 | 9 |
Interest on lease liabilities | 1 | 1 |
Total finance lease costs | $ 8 | $ 10 |
Commitments and Contingencies_4
Commitments and Contingencies - Cash flow information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Commitments and Contingencies. | ||
Operating cash flows from operating leases | $ (265) | $ (179) |
Financing cash flows from finance leases | $ (8) | $ (10) |
Commitments and Contingencies_5
Commitments and Contingencies - Lease liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Operating Leases | ||
2022 | $ 1,401 | |
2023 | 1,425 | |
2024 | 1,450 | |
2025 | 1,474 | |
2026 and beyond | 3,661 | |
Total minimum lease payments | 9,411 | |
Interest Expense | (2,314) | |
Lease Liability | 7,097 | $ 7,793 |
Financing Leases | ||
2022 | 4 | |
Total minimum lease payments | 4 | |
Lease Liability | 4 | $ 11 |
Sublease | ||
2022 | 1,118 | |
2023 | 1,139 | |
2024 | 996 | |
Total minimum lease payments | $ 3,253 |
Commitments and Contingencies_6
Commitments and Contingencies - Lease term and discount rates (Details) | Dec. 31, 2021 | Dec. 31, 2020 |
Commitments and Contingencies. | ||
Weighted average remaining lease term - Operating leases | 6 years | 7 years |
Weighted average remaining lease term - Finance leases | 1 year | |
Weighted average discount rate - Operating leases | 9.20% | 9.20% |
Weighted average discount rate - Finance leases | 6.50% | 6.50% |
Commitments and Contingencies_7
Commitments and Contingencies - Legal Proceedings (Details) | Feb. 11, 2021USD ($) | Aug. 02, 2019item | May 29, 2019item | Feb. 28, 2019item | Jan. 31, 2019item | Nov. 30, 2018item | Dec. 31, 2020USD ($) | Dec. 31, 2020USD ($) | Aug. 02, 2021USD ($) |
Legal Proceedings | |||||||||
Estimated settlement liability | $ 9,000,000 | $ 9,000,000 | |||||||
Insurance recovery | 9,000,000 | 9,000,000 | |||||||
Class Actions In Eastern District Of Pennsylvania | |||||||||
Legal Proceedings | |||||||||
Number of claims | item | 3 | 3 | |||||||
Number of claims after consolidation | item | 1 | ||||||||
Number of investors appointed | item | 5 | ||||||||
Number of former officers | item | 2 | ||||||||
Monetary payment to be made to the plaintiff | $ 8,500,000 | ||||||||
Estimated settlement liability | 8,500,000 | 8,500,000 | |||||||
Insurance recovery | 8,500,000 | 8,500,000 | |||||||
Settlement amount paid by insurance carriers | 8,500,000 | ||||||||
Shareholder Derivative Actions | |||||||||
Legal Proceedings | |||||||||
Number of claims | item | 2 | ||||||||
Estimated settlement liability | 500,000 | $ 500,000 | |||||||
Insurance recovery | $ 500,000 | ||||||||
Settlement amount paid by insurance carriers | $ 500,000 |
Product Revenue (Details)
Product Revenue (Details) | 12 Months Ended |
Dec. 31, 2021USD ($)item | |
Sales Discounts | |
Balance | $ 2,000 |
Provision related to current period sales | 14,000 |
Credit or payments made during the period | (15,000) |
Balance | 1,000 |
Chargebacks | |
Balance | 5,000 |
Provision related to current period sales | 37,000 |
Credit or payments made during the period | (1,000) |
Balance | 41,000 |
Fee for Service | |
Balance | 10,000 |
Provision related to current period sales | 83,000 |
Credit or payments made during the period | (48,000) |
Balance | 45,000 |
Sales allowance included with accrued expenses and other current liabilities. | $ 87,000 |
Product revenue | Revenue Benchmark | Customer Concentration Risk | |
Revenue | |
Number of customers | item | 3 |
Concentration risk percentage | 100.00% |
OLINVYK | |
Product Returns | |
Time period that customers have right to return unopened product | 18 months |
Time period prior to labeled expiration date that customers have right to return unopened product | 6 months |
Time period after labeled expiration date that customers have right to return unopened product | 12 months |
Time period after product launch that customers have right to return product from initial purchase | 6 months |
Product shelf life | 48 months |
OLINVYK | Minimum | |
Product Returns | |
Time period to evaluate historical sales | 2 years |
OLINVYK | Maximum | |
Product Returns | |
Time period to evaluate historical sales | 3 years |
License Revenue (Details)
License Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Aug. 31, 2020 | Apr. 30, 2018 | Dec. 31, 2021 | Dec. 31, 2020 | |
Licensing Arrangements | ||||
Total revenue | $ 567 | $ 3,069 | ||
Pharmbio Korea Inc | ||||
Licensing Arrangements | ||||
Upfront payment | $ 3,000 | |||
Withholding taxes | $ 500 | |||
Time period for written notice to terminate license agreement | 180 days | |||
Pharmbio Korea Inc | Minimum | ||||
Licensing Arrangements | ||||
Time period to form a committee prior to the anticipated date of regulatory approval | 6 months | |||
Pharmbio Korea Inc | Maximum | ||||
Licensing Arrangements | ||||
Commercialization milestone payments | $ 500 | |||
Royalties on product sales, percentage | 20.00% | |||
Jiangsu Nhwa Pharmaceutical Co Ltd | Minimum | ||||
Licensing Arrangements | ||||
Time period to form a committee prior to the anticipated date of regulatory approval | 6 months | |||
Jiangsu Nhwa Pharmaceutical Co Ltd | Licensing agreements for development and commercialization | ||||
Licensing Arrangements | ||||
Upfront payment | $ 3,000 | $ 2,500 | ||
Withholding taxes | $ 300 | $ 300 | ||
Time period for written notice to terminate license agreement | 180 days | |||
Milestone payment upon regulatory approval in China | $ 3,000 | |||
Milestone payment upon sales targets reached in China | $ 6,000 | |||
Royalty percentage on net product sales in China after milestones met | 10.00% | |||
License revenue | ||||
Licensing Arrangements | ||||
Total revenue | $ 69 | 3,000 | ||
License revenue | Jiangsu Nhwa Pharmaceutical Co Ltd | ||||
Licensing Arrangements | ||||
Total revenue | $ 100 | $ 3,000 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Basic and diluted net loss per common share calculation: | ||
Net loss | $ (51,588) | $ (29,369) |
Weighted average common shares outstanding, basic (in shares) | 163,293,296 | 127,623,859 |
Weighted average common shares outstanding, diluted (in shares) | 163,293,296 | 127,623,859 |
Net loss per share of common stock, basic (in dollars per share) | $ (0.32) | $ (0.23) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.32) | $ (0.23) |
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 18,643,796 | 13,631,452 |
Employee Stock Option | ||
Basic and diluted net loss per common share calculation: | ||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 12,449,870 | 9,564,519 |
Restricted Stock Units | ||
Basic and diluted net loss per common share calculation: | ||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 5,918,496 | 3,771,342 |
Warrants | ||
Basic and diluted net loss per common share calculation: | ||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 275,430 | 295,591 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Taxes | ||
Increase in valuation allowance | $ 14.4 | $ 5.9 |
Income Taxes - Income Tax Provi
Income Taxes - Income Tax Provision (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Current: | |
Foreign | $ 300 |
Total | 300 |
Total income tax provision (benefit) | $ 300 |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
NOLs | $ 40,810 | $ 25,949 |
Research and development credits | 15,575 | 14,920 |
Research and development expenses capitalized for tax purposes | 93,254 | 93,812 |
Equity-based compensation | 3,960 | 4,130 |
Deferred rent | 691 | 772 |
Depreciation | 312 | 246 |
Other temporary differences | 657 | 730 |
Total deferred tax assets | 155,259 | 140,559 |
Deferred tax liabilities: | ||
Prepaid expenses | (381) | (119) |
Total deferred tax liabilities | (381) | (119) |
Net deferred tax assets | 154,878 | 140,440 |
Less valuation allowance | (154,878) | (140,440) |
Net deferred tax asset | $ 0 | $ 0 |
Income Taxes - Effective Tax Ra
Income Taxes - Effective Tax Rate Reconciliation (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Percent of pre-tax income: | ||
U.S. federal statutory income tax rate | 21.00% | 21.00% |
Permanent Differences | (0.20%) | 1.00% |
State taxes, net of federal benefit | 7.20% | 4.80% |
Research and development credit | 1.30% | 2.60% |
Withholding Tax | 0.00% | (1.00%) |
Stock compensation | (1.40%) | (6.90%) |
Other | 0.10% | (2.30%) |
Change in valuation allowance | (28.00%) | (20.20%) |
Effective income tax rate | 0.00% | (1.00%) |
U.S. federal | ||
Operating loss carryforwards | ||
Net operating loss carryforwards | $ 141.8 | |
State Jurisdiction | ||
Operating loss carryforwards | ||
Tax credit carryforwards | 139.7 | |
Research Tax Credit Carryforward | U.S. federal | ||
Operating loss carryforwards | ||
Tax credit carryforwards | $ 15.6 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - USD ($) $ in Millions | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Employee Benefit Plan | ||
Employer matching contribution for employee's contributions of the first 3% of eligible compensation | 100.00% | |
Percentage of eligible compensation, matched 100% by employer | 3.00% | |
Employer matching contribution for employee's contributions of the next 2% of eligible compensation | 50.00% | |
Percentage of eligible compensation, matched 50% by employer | 2.00% | |
Company's matching contributions to the plan | $ 0.3 | $ 0.2 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent event - R-Bridge Financing - China $ in Millions | Mar. 29, 2022USD ($) |
Subsequent Event | |
Upfront payment | $ 15 |
Milestone payment upon first commercial sale in China | 15 |
Commercialization milestone payments | $ 10 |
Jiangsu Nhwa Pharmaceutical Co Ltd | |
Subsequent Event | |
Net revenue interest in U.S. net sales (as a percent) | 4.00% |
Cap of U.S. revenue interest if Chinese approval occurs by year-end 2023 | $ 10 |
Net revenue interest in U.S. net sales if approval target is not reached (as a percent) | 7.00% |
Milestone payment upon regulatory approval in China | $ 3 |