Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2022 | May 09, 2022 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2022 | |
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 Boulevard, 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, $0.001 par value | |
Trading Symbol | TRVN | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 165,520,007 | |
Entity Central Index Key | 0001429560 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 48,664 | $ 66,923 |
Inventories | 2,745 | 2,352 |
Prepaid expenses and other current assets | 2,840 | 1,448 |
Total current assets | 54,249 | 70,723 |
Restricted cash | 1,311 | 1,311 |
Property and equipment, net | 1,736 | 1,841 |
Right-of-use lease asset | 4,592 | 4,706 |
Other assets | 2,529 | 1,543 |
Total assets | 64,417 | 80,124 |
Current liabilities: | ||
Accounts payable, net | 2,408 | 4,547 |
Accrued expenses and other current liabilities | 5,703 | 3,847 |
Lease liability | 815 | 792 |
Total current liabilities | 8,926 | 9,186 |
Leases, net of current portion | 6,096 | 6,309 |
Total liabilities | 15,022 | 15,495 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity: | ||
Preferred stock-$0.001 par value; 5,000,000 shares authorized, none issued or outstanding at March 31, 2022 and December 31, 2021 | ||
Common stock-$0.001 par value; 200,000,000 shares authorized at March 31, 2022 and December 31, 2021; 165,520,007 shares issued and outstanding at March 31, 2022 and December 31, 2021 | 165 | 165 |
Additional paid-in capital | 559,721 | 558,566 |
Accumulated deficit | (510,491) | (494,102) |
Total stockholders' equity | 49,395 | 64,629 |
Total liabilities and stockholders' equity | $ 64,417 | $ 80,124 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
Consolidated 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 |
Preferred stock outstanding (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 | 165,520,007 |
Common stock outstanding (in shares) | 165,520,007 | 165,520,007 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenue: | ||
Total revenue | $ 20 | $ 209 |
Operating expenses: | ||
Cost of goods sold | 207 | 163 |
Selling, general and administrative | 11,014 | 7,368 |
Research and development | 5,259 | 2,636 |
Total operating expenses | 16,480 | 10,167 |
Loss from operations | (16,460) | (9,958) |
Other income (expense): | ||
Change in fair value of warrant liability | 3 | |
Other income, net | 45 | 69 |
Interest income | 24 | 48 |
Gain (loss) on foreign currency exchange | 2 | (4) |
Total other income, net | 71 | 116 |
Net loss and comprehensive loss | $ (16,389) | $ (9,842) |
Per share information: | ||
Net loss per share of common stock, basic (in dollars per share) | $ (0.10) | $ (0.06) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.10) | $ (0.06) |
Weighted average common shares outstanding, basic (in shares) | 165,520,007 | 160,508,373 |
Weighted average common shares outstanding, diluted (in shares) | 165,520,007 | 160,508,373 |
Product revenue | ||
Revenue: | ||
Total revenue | $ 209 | |
License revenue | ||
Revenue: | ||
Total revenue | $ 20 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Beginning Balance at Dec. 31, 2020 | $ 160 | $ 546,422 | $ (442,514) | $ 104,068 |
Beginning Balance (in shares) at Dec. 31, 2020 | 159,999,917 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Stock-based compensation expense | 1,111 | 1,111 | ||
Exercise of stock options | 9 | 9 | ||
Exercise of stock options (in shares) | 5,000 | |||
Issuance of common stock, net of issuance costs | $ 1 | 2,791 | 2,792 | |
Issuance of common stock, net of issuance costs (in shares) | 1,219,023 | |||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes | (69) | (69) | ||
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes (in shares) | 49,720 | |||
Net loss | (9,842) | (9,842) | ||
Ending Balance at Mar. 31, 2021 | $ 161 | 550,264 | (452,356) | 98,069 |
Ending Balance (in shares) at Mar. 31, 2021 | 161,273,660 | |||
Beginning Balance at Dec. 31, 2021 | $ 165 | 558,566 | (494,102) | $ 64,629 |
Beginning Balance (in shares) at Dec. 31, 2021 | 165,520,007 | 165,520,007 | ||
Increase (Decrease) in Stockholders' Equity | ||||
Stock-based compensation expense | 1,155 | $ 1,155 | ||
Net loss | (16,389) | (16,389) | ||
Ending Balance at Mar. 31, 2022 | $ 165 | $ 559,721 | $ (510,491) | $ 49,395 |
Ending Balance (in shares) at Mar. 31, 2022 | 165,520,007 | 165,520,007 |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Equity (Parenthetical) - $ / shares | Mar. 31, 2022 | Mar. 31, 2021 |
Common stock, par value (in dollars per share) | $ 0.001 | |
Common Stock | ||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating activities: | ||
Net loss | $ (16,389) | $ (9,842) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 105 | 108 |
Stock-based compensation | 1,155 | 1,111 |
Revaluation of warrant liability | (3) | |
Change in right-of-use asset | 114 | 97 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (2,378) | (2,645) |
Inventories | (393) | |
Operating lease liabilities | (188) | (166) |
Accounts payable, accrued expenses and other liabilities | (283) | (3,073) |
Net cash used in operating activities | (18,257) | (14,413) |
Financing activities: | ||
Proceeds from exercise of common stock options | 9 | |
Proceeds from issuance of common stock, net | 2,792 | |
Payment of employee withholding taxes on vested restricted stock units | (69) | |
Finance lease payments | (2) | (2) |
Net cash (used in) provided by financing activities | (2) | 2,730 |
Net decrease in cash, cash equivalents and restricted cash | (18,259) | (11,683) |
Cash, cash equivalents and restricted cash-beginning of period | 68,234 | 110,713 |
Cash, cash equivalents and restricted cash-end of period | $ 49,975 | $ 99,030 |
Organization and Description of
Organization and Description of the Business | 3 Months Ended |
Mar. 31, 2022 | |
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 commercializing its lead asset, OLINVYK® (oliceridine) injection, or OLINVYK, and 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 its inception, the Company has incurred losses and negative cash flows from operations. At March 31, 2022, the Company had an accumulated deficit of $510.5 million. The Company’s net loss was $16.4 million and $9.8 million for the three months ended March 31, 2022 and 2021, 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, or ASC 205-40, which requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. The Company expects that its existing balance of cash and cash equivalents as of March 31, 2022 is sufficient to fund operations into 2023, but not for more than one year after the date of this filing and therefore management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern. Management’s plans to mitigate this risk include raising additional capital through equity or debt financings, or through strategic transactions. Management’s plans may also include the deferral of certain operating expenses unless and until additional capital is received. However, there can be no assurance that the Company will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to the Company, or that the Company will be successful in deferring certain operating expenses, or that the COVID-19 pandemic will not have an impact on the Company’s ability to raise capital or fund its operations as planned. If the Company is unable to raise sufficient additional capital or defer sufficient operating expenses, the Company may be compelled to reduce the scope of its operations and planned capital expenditures. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying consolidated 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. The consolidated financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s consolidated balance sheets as of March 31, 2022, its results of operations and its comprehensive loss for the three months ended March 31, 2022 and 2021, its consolidated statements of stockholders’ equity for the period from January 1, 2022 to March 31, 2022 and for the period January 1, 2021 to March 31, 2021, and its consolidated statements of cash flows for the three months ended March 31, 2022 and 2021. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and accompanying notes included in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2021. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. The financial data and other information disclosed in these notes related to the three months ended March 31, 2022 and 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period. We have been actively monitoring the novel coronavirus, or COVID-19, situation and its impact globally. Remote working arrangements and travel restrictions imposed by various jurisdictions have had a limited impact on our ability to maintain operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain, including vaccine adoption and effectiveness, the impact of emerging variants of the novel coronavirus, and the actions taken to contain or treat COVID-19. Principles of Consolidation In connection with the royalty-based financing agreement disclosed in Note 10, the Company established three wholly owned subsidiaries, Trevena Royalty Corporation, Trevena SPV1 LLC and Trevena SPV2 LLC to facilitate the financing. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries as of March 31, 2022. All intercompany accounts and transactions have been eliminated in consolidation. Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information, including the potential future effects of COVID-19, the results of which form the basis for making judgements about the carrying values of assets and liabilities and the recording expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. Fair Value of Financial Instruments |
Fair Value of Financial Instrum
Fair Value of Financial Instruments | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value of Financial Instruments | |
Fair Value of Financial Instruments | 3. Fair Value of Financial Instruments ASC 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 and Marketable Securities The following table presents fair value of the Company’s cash, cash equivalents, and marketable securities as of March 31, 2022 and December 31, 2021 (in thousands): March 31, 2022 Adjusted Unrealized Unrealized Cash and Cash Restricted Cost Gains Losses Fair Value Equivalents Cash Cash $ 10,176 $ — $ — $ 10,176 $ 8,865 $ 1,311 Level 1 (1): Money market funds 39,799 — — 39,799 39,799 — Subtotal 39,799 — — 39,799 39,799 — Total $ 49,975 $ — $ — $ 49,975 $ 48,664 $ 1,311 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 (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. 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 consolidated balance sheet. The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers between Level 2 and Level 3 during the three months ended March 31, 2022, or the year ended December 31, 2021. |
Inventories
Inventories | 3 Months Ended |
Mar. 31, 2022 | |
Inventories | |
Inventories | 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. Inventory consists of the following (in thousands): March 31, 2022 December 31, 2021 Finished goods $ 2,880 $ 2,488 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2022 | |
Stockholders' Equity | |
Stockholders' Equity | 5. 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 March 31, 2022. The Company also was authorized to issue up to 5,000,000 shares of preferred stock as of March 31, 2022. 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. ATM Programs In April 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. There were no sales under the HCW ATM Program during the three months ended March 31, 2022. As of March 31, 2022, there was approximately $41.9 million remaining available for future issuances under the HCW ATM Program. Registered Direct Offering and Concurrent Warrant Issuance In connection with the Company’s January 2019 securities purchase agreements, the Company issued warrants to purchase 500,000 shares of common stock to certain designees of H.C. Wainwright & Co., LLC. These warrants have a term of five years, are immediately exercisable and have an exercise price of $1.25 per share. As of March 31, 2022, 172,500 of these warrants remain outstanding. 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. 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 of the Company’s equity incentive 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): Three Months Ended March 31, 2022 2021 Research and development $ 275 $ 260 Selling, general and administrative 873 840 Cost of goods sold 7 11 Total stock-based compensation $ 1,155 $ 1,111 Stock Options A summary of stock option activity and related information through March 31, 2022 follows: Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, December 31, 2021 12,449,870 $ 2.67 7.11 Granted 244,950 0.60 Exercised — — Forfeited/Cancelled (435,809) 1.85 Balance, March 31, 2022 12,259,011 $ 2.65 6.97 Vested or expected to vest at March 31, 2022 12,259,011 $ 2.65 6.97 Exercisable at March 31, 2022 7,457,237 $ 3.30 5.66 The aggregate intrinsic value of options exercisable as of March 31, 2022 was zero, based on the difference between the Company’s closing stock price of $0.55 and the exercise price of each stock option. At March 31, 2022, there was $5.5 million of total unrecognized compensation expense related to unvested options that will be recognized over the weighted average remaining vesting period of 2.84 years. 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 common 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 common stock. The per-share weighted-average grant date fair value of the options granted to employees and directors during the three months ended March 31, 2022 and 2021 was estimated at $0.46 and $1.65 per share, respectively, on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions: March 31, 2022 2021 Expected term of options (in years) 6.3 6.2 Risk-free interest rate 1.5 % 0.8 % Expected volatility 92.5 % 97.5 % Dividend yield — % — % 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. As of March 31, 2022, there were 5,918,496 non-vested RSUs with a weighted average grant date fair value of $1.08. For the three months ended March 31, 2022, the Company recorded $0.5 million in stock-based compensation expense related to RSUs, which is reflected in the consolidated statements of operations and comprehensive loss. As of March 31, 2022, there was $5.7 million of total unrecognized compensation expense related to unvested RSUs that will be recognized over the weighted average remaining period of 3.14 years. Shares Available for Future Grant At March 31, 2022, the Company has the following shares available to be granted under its equity incentive plans: Inducement 2013 Plan Plan Available at December 31, 2021 4,178,805 252,500 Authorized 6,620,800 — Granted (244,950) — Shares withheld for taxes not issued — — Forfeited/Cancelled 27,871 — Available at March 31, 2022 10,582,526 252,500 Shares Reserved for Future Issuance At March 31, 2022, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 12,011,511 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 18,931,243 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 6. 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 consolidated statements of operations and comprehensive loss as other income (expense). Supplemental balance sheet information related to leases was as follows (in thousands): March 31, 2022 December 31, 2021 Operating leases: Operating lease right-of-use assets $ 4,592 $ 4,706 Other current lease liabilities 813 788 Operating lease liabilities 6,096 6,309 Total operating lease liabilities $ 6,909 $ 7,097 Finance leases: Property and equipment, at cost $ 45 $ 45 Accumulated depreciation (43) (41) Property and equipment, net 2 4 Other current lease liabilities 2 4 Other long-term liabilities — — Total finance lease liabilities $ 2 $ 4 The components of lease expense were as follows (in thousands): Three Months Ended March 31, 2022 2021 Operating lease costs: Operating lease rental expense $ 327 $ 293 Other income (315) (312) Total operating lease costs $ 12 $ (19) Finance lease costs: Amortization of right-of-use assets 1 2 Interest on lease liabilities — — Total finance lease costs $ 1 $ 2 Supplemental cash flow information related to leases was as follows (in thousands): Three Months Ended March 31, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (70) $ (48) Operating cash flows from finance leases — — Financing cash flows from finance leases (2) (2) Our operating lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2022 (April 1 - December 31) $ 1,053 $ 2 2023 1,425 — 2024 1,450 — 2025 1,474 — 2026 1,498 — 2027 and beyond 2,163 — Total minimum lease payments $ 9,063 $ 2 Interest Expense (2,154) — Lease liability $ 6,909 $ 2 Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2022 (April 1 - December 31) $ 839 2023 1,139 2024 996 Total minimum lease payments $ 2,974 Lease term and discount rates are as follows: Three Months Ended March 31, 2022 2021 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% 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. 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 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 involved facts similar to the consolidated securities lawsuits. The parties agreed to a settlement, which was 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. The litigation is now resolved. |
Product Revenue
Product Revenue | 3 Months Ended |
Mar. 31, 2022 | |
Product Revenue | |
Product Revenue | 7. 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. Sales-Related Deductions The following table presents a rollforward of the major categories of sales-related deductions included in trade receivable allowances for the three months ended March 31, 2022 (in thousands): Sales Discounts Chargebacks Fee for Service Balance, January 1, 2022 $ 1 $ 41 $ 45 Provision related to current period sales — — — Adjustment related to prior period sales — — — Credit or payments made during the period — — — Balance, March 31, 2022 $ 1 $ 41 $ 45 |
License Revenue
License Revenue | 3 Months Ended |
Mar. 31, 2022 | |
License Revenue | |
License Revenue | 8. 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. 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 three months ended March 31, 2022 and 2021, license revenue in the accompanying consolidated statements of operations and comprehensive loss is comprised of the following: Three Months Ended March 31, 2022 2021 Pharmbio Korea Inc. $ 20 $ — Jiangsu Nhwa Pharmaceutical Co. Ltd. — — Total license revenues $ 20 $ — |
Net Loss Per Common Share
Net Loss Per Common Share | 3 Months Ended |
Mar. 31, 2022 | |
Net Loss Per Common Share | |
Net Loss Per Common Share | 9. 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): Three Months Ended March 31, 2022 2021 Basic and diluted net loss per common share calculation: Net loss $ (16,389) $ (9,842) Weighted average common shares outstanding 165,520,007 160,508,373 Net loss per share of common stock - basic and diluted $ (0.10) $ (0.06) The following outstanding securities at March 31, 2022 and 2021 have been excluded from the computation of diluted weighted shares outstanding, as they would have been anti-dilutive: March 31, 2022 2021 Options outstanding 12,259,011 10,350,543 RSUs outstanding 5,918,496 3,696,342 Warrants 275,430 295,591 Total 18,452,937 14,342,476 |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2022 | |
Subsequent Events | |
Subsequent Events | 10. Subsequent Events In April 2022, the Company received the first $15.0 million tranche from its royalty-based loan agreement with an affiliate of R-Bridge Healthcare Fund, or the R-Bridge Financing. The R-Bridge Financing calls for an initial $15.0 million tranche within 15 days of the closing of the deal. The Company will receive an additional $10.0 million upon achievement of either a financing or commercial milestone and an additional $15.0 million upon the first commercial sale of OLINVYK® in China, subject to customary bring down conditions and deliverables. R-Bridge Healthcare Fund is an affiliate of CBC Group, one of Asia’s largest and most active healthcare-dedicated investment firms focusing in three core areas: pharmaceutical & biotech, medtech, and healthcare services. The R-Bridge Financing is secured by and repaid with proceeds from (i) royalties from the Company’s license agreement with its partner in China, Jiangsu Nhwa Pharmaceutical Co. Ltd. (Nhwa), and (ii) a revenue interest based on the Company’s U.S. net sales of OLINVYK in an initial amount of 4% of such net sales. This U.S. revenue interest will be capped at $10.0 million if Chinese approval of OLINVYK 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 paid. The Company retains all milestones from its partnership with Nhwa, including a $3.0 million milestone on Chinese approval of OLINVYK. In connection with the Company’s R-Bridge Financing, the Company issued a warrant to purchase 5,000,000 shares of common stock. This warrant has a term of 3 years, is immediately exercisable and has an exercise price of $0.82 per share. It was issued in April 2022 upon receipt of the first $15.0 million tranche. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Summary of Significant Accounting Policies | |
Basis of Presentation | Basis of Presentation The accompanying consolidated 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. The consolidated financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s consolidated balance sheets as of March 31, 2022, its results of operations and its comprehensive loss for the three months ended March 31, 2022 and 2021, its consolidated statements of stockholders’ equity for the period from January 1, 2022 to March 31, 2022 and for the period January 1, 2021 to March 31, 2021, and its consolidated statements of cash flows for the three months ended March 31, 2022 and 2021. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and accompanying notes included in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2021. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. The financial data and other information disclosed in these notes related to the three months ended March 31, 2022 and 2021 are not necessarily indicative of the results to be expected for the year ending December 31, 2022, any other interim periods, or any future year or period. We have been actively monitoring the novel coronavirus, or COVID-19, situation and its impact globally. Remote working arrangements and travel restrictions imposed by various jurisdictions have had a limited impact on our ability to maintain operations. The full extent to which the COVID-19 pandemic will directly or indirectly impact our business, results of operations and financial condition will depend on future developments that are highly uncertain, including vaccine adoption and effectiveness, the impact of emerging variants of the novel coronavirus, and the actions taken to contain or treat COVID-19. |
Principles of Consolidation | Principles of Consolidation In connection with the royalty-based financing agreement disclosed in Note 10, the Company established three wholly owned subsidiaries, Trevena Royalty Corporation, Trevena SPV1 LLC and Trevena SPV2 LLC to facilitate the financing. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries as of March 31, 2022. All intercompany accounts and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information, including the potential future effects of COVID-19, the results of which form the basis for making judgements about the carrying values of assets and liabilities and the recording expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments |
Fair Value of Financial Instr_2
Fair Value of Financial Instruments (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value of Financial Instruments | |
Schedule of cash, cash equivalents and marketable securities | The following table presents fair value of the Company’s cash, cash equivalents, and marketable securities as of March 31, 2022 and December 31, 2021 (in thousands): March 31, 2022 Adjusted Unrealized Unrealized Cash and Cash Restricted Cost Gains Losses Fair Value Equivalents Cash Cash $ 10,176 $ — $ — $ 10,176 $ 8,865 $ 1,311 Level 1 (1): Money market funds 39,799 — — 39,799 39,799 — Subtotal 39,799 — — 39,799 39,799 — Total $ 49,975 $ — $ — $ 49,975 $ 48,664 $ 1,311 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 (1) The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities. |
Inventories (Tables)
Inventories (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Inventories | |
Schedule of Inventory | Inventory consists of the following (in thousands): March 31, 2022 December 31, 2021 Finished goods $ 2,880 $ 2,488 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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): Three Months Ended March 31, 2022 2021 Research and development $ 275 $ 260 Selling, general and administrative 873 840 Cost of goods sold 7 11 Total stock-based compensation $ 1,155 $ 1,111 |
Summary of stock option activity | Options Outstanding Weighted Average Weighted Remaining Average Contractual Number of Exercise Term Shares Price (in years) Balance, December 31, 2021 12,449,870 $ 2.67 7.11 Granted 244,950 0.60 Exercised — — Forfeited/Cancelled (435,809) 1.85 Balance, March 31, 2022 12,259,011 $ 2.65 6.97 Vested or expected to vest at March 31, 2022 12,259,011 $ 2.65 6.97 Exercisable at March 31, 2022 7,457,237 $ 3.30 5.66 |
Schedule of weighted-average assumptions: | March 31, 2022 2021 Expected term of options (in years) 6.3 6.2 Risk-free interest rate 1.5 % 0.8 % Expected volatility 92.5 % 97.5 % Dividend yield — % — % |
Schedule of shares available to be granted under equity incentive plans | At March 31, 2022, the Company has the following shares available to be granted under its equity incentive plans: Inducement 2013 Plan Plan Available at December 31, 2021 4,178,805 252,500 Authorized 6,620,800 — Granted (244,950) — Shares withheld for taxes not issued — — Forfeited/Cancelled 27,871 — Available at March 31, 2022 10,582,526 252,500 |
Schedule of shares of common stock reserved/available | At March 31, 2022, the Company has reserved the following shares of common stock for issuance: Stock options outstanding under 2013 Plan 12,011,511 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 18,931,243 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies. | |
Schedule of balance sheet information related to leases | Supplemental balance sheet information related to leases was as follows (in thousands): March 31, 2022 December 31, 2021 Operating leases: Operating lease right-of-use assets $ 4,592 $ 4,706 Other current lease liabilities 813 788 Operating lease liabilities 6,096 6,309 Total operating lease liabilities $ 6,909 $ 7,097 Finance leases: Property and equipment, at cost $ 45 $ 45 Accumulated depreciation (43) (41) Property and equipment, net 2 4 Other current lease liabilities 2 4 Other long-term liabilities — — Total finance lease liabilities $ 2 $ 4 |
Schedule of components of lease expense | The components of lease expense were as follows (in thousands): Three Months Ended March 31, 2022 2021 Operating lease costs: Operating lease rental expense $ 327 $ 293 Other income (315) (312) Total operating lease costs $ 12 $ (19) Finance lease costs: Amortization of right-of-use assets 1 2 Interest on lease liabilities — — Total finance lease costs $ 1 $ 2 |
Schedule of supplemental cash flow information | Supplemental cash flow information related to leases was as follows (in thousands): Three Months Ended March 31, 2022 2021 Cash paid for amounts included in the measurement of lease liabilities Operating cash flows from operating leases $ (70) $ (48) Operating cash flows from finance leases — — Financing cash flows from finance leases (2) (2) |
Schedule of maturities of operating lease liabilities | Our operating lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2022 (April 1 - December 31) $ 1,053 $ 2 2023 1,425 — 2024 1,450 — 2025 1,474 — 2026 1,498 — 2027 and beyond 2,163 — Total minimum lease payments $ 9,063 $ 2 Interest Expense (2,154) — Lease liability $ 6,909 $ 2 |
Schedule of maturities of financing lease liabilities | Our operating lease liabilities will mature, as follows (in thousands): Operating Leases Financing Leases 2022 (April 1 - December 31) $ 1,053 $ 2 2023 1,425 — 2024 1,450 — 2025 1,474 — 2026 1,498 — 2027 and beyond 2,163 — Total minimum lease payments $ 9,063 $ 2 Interest Expense (2,154) — Lease liability $ 6,909 $ 2 |
Schedule of expected sublease inflows | Per the terms of our sublease, we expect the following inflows (in thousands): Sublease 2022 (April 1 - December 31) $ 839 2023 1,139 2024 996 Total minimum lease payments $ 2,974 |
Schedule of weighted average lease term and discount rates | Three Months Ended March 31, 2022 2021 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) | 3 Months Ended |
Mar. 31, 2022 | |
Product Revenue | |
Schedule of major categories of sales-related deductions included in trade receivable allowances | Sales Discounts Chargebacks Fee for Service Balance, January 1, 2022 $ 1 $ 41 $ 45 Provision related to current period sales — — — Adjustment related to prior period sales — — — Credit or payments made during the period — — — Balance, March 31, 2022 $ 1 $ 41 $ 45 |
License Revenue (Tables)
License Revenue (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Product Revenue | |
Schedule of license revenue | Three Months Ended March 31, 2022 2021 Pharmbio Korea Inc. $ 20 $ — Jiangsu Nhwa Pharmaceutical Co. Ltd. — — Total license revenues $ 20 $ — |
Net Loss Per Common Share (Tabl
Net Loss Per Common Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
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): Three Months Ended March 31, 2022 2021 Basic and diluted net loss per common share calculation: Net loss $ (16,389) $ (9,842) Weighted average common shares outstanding 165,520,007 160,508,373 Net loss per share of common stock - basic and diluted $ (0.10) $ (0.06) |
Schedule of outstanding securities excluded from the computation of diluted weighted shares outstanding as they would have been anti-dilutive | March 31, 2022 2021 Options outstanding 12,259,011 10,350,543 RSUs outstanding 5,918,496 3,696,342 Warrants 275,430 295,591 Total 18,452,937 14,342,476 |
Organization and Description _2
Organization and Description of the Business (Details) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2022USD ($)segment | Mar. 31, 2021USD ($) | Dec. 31, 2021USD ($) | |
Organization and Description of the Business | |||
Number of operating segments | segment | 1 | ||
Accumulated deficit | $ 510,491 | $ 494,102 | |
Net loss | $ 16,389 | $ 9,842 |
Fair Value of Financial Instr_3
Fair Value of Financial Instruments (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Fair value | ||
Transfers between Level 2 and Level 3 | $ 0 | $ 0 |
Letter of credit collateral | 1,300 | |
Adjusted cost | ||
Fair value | ||
Cash | 10,176 | 9,459 |
Total | 49,975 | 68,234 |
Fair Value | ||
Fair value | ||
Cash | 10,176 | 9,459 |
Total | 49,975 | 68,234 |
Cash and Cash Equivalents | Fair Value | ||
Fair value | ||
Cash | 8,865 | 8,148 |
Total | 48,664 | 66,923 |
Restricted Cash | Fair Value | ||
Fair value | ||
Cash | 1,311 | 1,311 |
Total | 1,311 | 1,311 |
Level 1 | Adjusted cost | ||
Fair value | ||
Investments | 39,799 | 58,775 |
Level 1 | Fair Value | ||
Fair value | ||
Investments | 39,799 | 58,775 |
Level 1 | Money market mutual funds | Adjusted cost | ||
Fair value | ||
Investments | 39,799 | 58,775 |
Level 1 | Money market mutual funds | Fair Value | ||
Fair value | ||
Investments | 39,799 | 58,775 |
Level 1 | Cash and Cash Equivalents | Fair Value | ||
Fair value | ||
Investments | 39,799 | 58,775 |
Level 1 | Cash and Cash Equivalents | Money market mutual funds | Fair Value | ||
Fair value | ||
Investments | $ 39,799 | $ 58,775 |
Inventories - Schedule Of Inven
Inventories - Schedule Of Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Inventories | ||
Finished goods | $ 2,880 | $ 2,488 |
Inventory reserve | $ 100 | $ 100 |
Stockholders' Equity - Equity O
Stockholders' Equity - Equity Offerings (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |||||
Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Apr. 30, 2019 | Jan. 31, 2019 | |
Stockholders' Equity | ||||||
Common stock authorized (in shares) | 200,000,000 | 200,000,000 | ||||
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 | ||||
Net proceeds from the offering | $ 2,792 | |||||
Warrants outstanding (in shares) | 275,430 | |||||
Wainwright | ||||||
Stockholders' Equity | ||||||
Warrants to purchase shares of common stock | 500,000 | |||||
Warrants term | 5 years | |||||
Exercise price (in dollars per share) | $ 1.25 | |||||
Warrants outstanding (in shares) | 172,500 | |||||
At-the-market sales facility - April 17, 2019 agreement | Wainwright | Maximum | ||||||
Stockholders' Equity | ||||||
Offering amount | $ 50,000 | |||||
At-the-market sales facility - December 31, 2020 agreement | Wainwright | ||||||
Stockholders' Equity | ||||||
Offering amount | $ 50,000 | |||||
HCW ATM Program | ||||||
Stockholders' Equity | ||||||
Net proceeds from the offering | $ 0 | |||||
Stock available for further issuance | $ 41,900 |
Stockholders' Equity - Equity I
Stockholders' Equity - Equity Incentive Plans (Details) - USD ($) $ in Thousands | Dec. 15, 2016 | Mar. 31, 2022 | Mar. 31, 2021 |
Equity Incentive Plans | |||
Stock-based compensation | $ 1,155 | $ 1,111 | |
Research and Development Expense | |||
Equity Incentive Plans | |||
Stock-based compensation | 275 | 260 | |
General and Administrative Expense | |||
Equity Incentive Plans | |||
Stock-based compensation | 873 | 840 | |
Cost of goods sold | |||
Equity Incentive Plans | |||
Stock-based compensation | $ 7 | $ 11 | |
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) - $ / shares | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Number of Shares | ||
Balance at the beginning of the period (in shares) | 12,449,870 | |
Granted (in shares) | 244,950 | |
Forfeited/Cancelled (in shares) | (435,809) | |
Balance at the end of the period (in shares) | 12,259,011 | 12,449,870 |
Vested or expected to vest at the end of the period (in shares) | 12,259,011 | |
Exercisable at the end of the period (in shares) | 7,457,237 | |
Weighted-Average Exercise Price | ||
Balance at the beginning of the period (in dollars per share) | $ 2.67 | |
Granted (in dollars per share) | 0.60 | |
Forfeited/Cancelled (in dollars per share) | 1.85 | |
Balance at the end of the period (in dollars per share) | 2.65 | $ 2.67 |
Vested or expected to vest at the end of the period (in dollars per share) | 2.65 | |
Exercisable at the end of the period (in dollars per share) | 3.30 | |
Closing price of Company's stock (in dollars per share) | $ 0.55 | |
Weighted Average Remaining Contractual Term | ||
Options Outstanding at the end of the period | 6 years 11 months 19 days | 7 years 1 month 9 days |
Vested or expected to vest at the end of the period | 6 years 11 months 19 days | |
Exercisable at the end of the period | 5 years 7 months 28 days |
Stockholders' Equity - Option_2
Stockholders' Equity - Options Other Info (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Options outstanding | ||
Closing price of Company's stock (in dollars per share) | $ 0.55 | |
Employee Stock Option | ||
Options outstanding | ||
Unrecognized compensation expense | $ 5.5 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 2 years 10 months 2 days | |
Per-share weighted-average grant date fair value of options granted (in dollars per share) | $ 0.46 | $ 1.65 |
Employee Stock Option | Weighted-average | ||
Weighted-average assumptions: | ||
Expected term of options (in years) | 6 years 3 months 18 days | 6 years 2 months 12 days |
Risk-free interest rate (as a percent) | 1.50% | 0.80% |
Expected volatility (as a percent) | 92.50% | 97.50% |
Stockholders' Equity - Non-vest
Stockholders' Equity - Non-vested RSUs (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Weighted Average Grant Date Fair Value | ||
Stock-based compensation | $ 1,155 | $ 1,111 |
Restricted Stock Units | ||
Number of Shares | ||
Non-vested at end of period (in shares) | 5,918,496 | |
Weighted Average Grant Date Fair Value | ||
Non-vested at end of period (in dollars per share) | $ 1.08 | |
Stock-based compensation | $ 500 | |
Unrecognized compensation expense | $ 5,700 | |
Weighted average remaining period for recognition of unrecognized compensation expense | 3 years 1 month 20 days |
Stockholder's Equity - Shares R
Stockholder's Equity - Shares Reserved for Future Grant and Issuance (Details) - shares | Dec. 15, 2016 | Mar. 31, 2022 | Dec. 31, 2021 |
Shares Reserved for Future Issuance | |||
Stock options outstanding (in shares) | 12,259,011 | 12,449,870 | |
Warrants outstanding (in shares) | 275,430 | ||
Total shares of common stock reserved for future issuance (in shares) | 18,931,243 | ||
2013 plan | |||
Shares Available for Future Grant | |||
Balance at the beginning of the period (in shares) | 4,178,805 | ||
Authorized (in shares) | 6,620,800 | ||
Granted (in shares) | (244,950) | ||
Forfeited/Cancelled (in shares) | 27,871 | ||
Balance at the end of the period (in shares) | 10,582,526 | ||
Shares Reserved for Future Issuance | |||
Shares available for future issuance (in shares) | 10,582,526 | 4,178,805 | |
Inducement Plan | |||
Shares Available for Future Grant | |||
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 | ||
Shares Reserved for Future Issuance | |||
Shares available for future issuance (in shares) | 252,500 | 252,500 | |
2013 Employee Stock Purchase Plan | |||
Shares Available for Future Grant | |||
Balance at the end of the period (in shares) | 225,806 | ||
Shares Reserved for Future Issuance | |||
Shares available for future issuance (in shares) | 225,806 | ||
Employee Stock Option | 2013 plan | |||
Shares Reserved for Future Issuance | |||
Stock options outstanding (in shares) | 12,011,511 | ||
Employee Stock Option | Inducement Plan | |||
Shares Reserved for Future Issuance | |||
Stock options outstanding (in shares) | 247,500 | ||
Restricted Stock Units | 2013 plan | |||
Shares Reserved for Future Issuance | |||
Stock options outstanding (in shares) | 5,918,496 |
Commitments and Contingencies -
Commitments and Contingencies - Leases (Details) - Chesterbrook, Pennsylvania | Oct. 02, 2020 | Oct. 11, 2018ft²$ / ft² | Mar. 31, 2022USD ($) |
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 | ||
Sublease Agreements | Vanguard Group, Inc | |||
Leases | |||
Number of square feet of space being subleased on second floor | ft² | 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 | Mar. 31, 2022 | Dec. 31, 2021 |
Leases | ||
Operating lease right-of-use assets | $ 4,592 | $ 4,706 |
Operating lease liabilities - Current | $ 813 | $ 788 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Lease Liability Current | Lease Liability Current |
Operating lease liabilities - Noncurrent | $ 6,096 | $ 6,309 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease Liability Noncurrent | Lease Liability Noncurrent |
Lease Liability | $ 6,909 | $ 7,097 |
Property and equipment, net | 1,736 | 1,841 |
Finance lease liabilities - Current | $ 2 | $ 4 |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Lease Liability Current | Lease Liability Current |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease Liability Noncurrent | Lease Liability Noncurrent |
Lease Liability | $ 2 | $ 4 |
Finance leased assets | ||
Leases | ||
Property and equipment, at cost | 45 | 45 |
Accumulated depreciation | (43) | (41) |
Property and equipment, net | $ 2 | $ 4 |
Commitments and Contingencies_3
Commitments and Contingencies - Components of lease expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Operating lease costs: | ||
Operating lease rental expense | $ 327 | $ 293 |
Other income | (315) | (312) |
Total operating lease costs | 12 | (19) |
Finance lease costs: | ||
Amortization of right-of-use assets | 1 | 2 |
Total finance lease costs | $ 1 | $ 2 |
Commitments and Contingencies_4
Commitments and Contingencies - Cash flow information (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Commitments and Contingencies. | ||
Operating cash flows from operating leases | $ (70) | $ (48) |
Financing cash flows from finance leases | $ (2) | $ (2) |
Commitments and Contingencies_5
Commitments and Contingencies - Lease liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Operating Leases | ||
2022 (April 1 - December 31) | $ 1,053 | |
2023 | 1,425 | |
2024 | 1,450 | |
2025 | 1,474 | |
2026 | 1,498 | |
2027 and beyond | 2,163 | |
Total minimum lease payments | 9,063 | |
Interest Expense | (2,154) | |
Lease Liability | 6,909 | $ 7,097 |
Financing Leases | ||
2021 (October 1 - December 31) | 2 | |
Total minimum lease payments | 2 | |
Lease Liability | 2 | $ 4 |
Sublease | ||
2022 (April 1 - December 31) | 839 | |
2023 | 1,139 | |
2024 | 996 | |
Total minimum lease payments | $ 2,974 |
Commitments and Contingencies_6
Commitments and Contingencies - Lease term and discount rates (Details) | Mar. 31, 2022 | Mar. 31, 2021 |
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 ($) | Feb. 28, 2019item | Nov. 30, 2018item | Dec. 31, 2020USD ($) | Aug. 02, 2021USD ($) |
Class Actions In Eastern District Of Pennsylvania | Pending Litigation | |||||
Legal Proceedings | |||||
Number of claims | item | 3 | ||||
Number of claims after consolidation | item | 1 | ||||
Monetary payment to be made to the plaintiff | $ 8,500,000 | ||||
Class Actions In Eastern District Of Pennsylvania | Settled Litigation | |||||
Legal Proceedings | |||||
Estimated settlement liability | $ 8,500,000 | ||||
Insurance recovery | 8,500,000 | ||||
Settlement amount paid by insurance carriers | 8,500,000 | ||||
Shareholder Derivative Actions | Pending Litigation | |||||
Legal Proceedings | |||||
Number of claims | item | 2 | ||||
Shareholder Derivative Actions | Settled Litigation | |||||
Legal Proceedings | |||||
Estimated settlement liability | $ 500,000 | ||||
Insurance recovery | $ 500,000 |
Product Revenue (Details)
Product Revenue (Details) | 3 Months Ended |
Mar. 31, 2022USD ($) | |
Sales Discounts | |
Balance | $ 1,000 |
Provision related to current period sales | |
Balance | 1,000 |
Chargebacks | |
Balance | 41,000 |
Provision related to current period sales | |
Balance | 41,000 |
Fee for Service | |
Balance | 45,000 |
Provision related to current period sales | |
Balance | 45,000 |
Sales allowance included with accrued expenses and other current liabilities. | $ 87,000 |
License Revenue (Details)
License Revenue (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | |||
Aug. 31, 2020 | Jul. 31, 2018 | Jun. 30, 2018 | Mar. 31, 2022 | Mar. 31, 2021 | |
Licensing Arrangements | |||||
Total revenue | $ 20 | $ 209 | |||
Pharmbio Korea Inc | Licensing agreements for development and commercialization | |||||
Licensing Arrangements | |||||
Upfront payment | $ 3,000 | ||||
Commercialization milestone payments | $ 500 | ||||
Time period for written notice to terminate license agreement | 180 days | ||||
Pharmbio Korea Inc | Licensing agreements for development and commercialization | Minimum | |||||
Licensing Arrangements | |||||
Time period to form a committee prior to the anticipated date of regulatory approval | 6 months | ||||
Pharmbio Korea Inc | Licensing agreements for development and commercialization | Maximum | |||||
Licensing Arrangements | |||||
Royalties on product sales, percentage | 20.00% | ||||
Jiangsu Nhwa Pharmaceutical Co Ltd | Licensing agreements for development and commercialization | |||||
Licensing Arrangements | |||||
Upfront payment | $ 2,500 | ||||
Withholding taxes | $ 300 | $ 300 | |||
Time period for written notice to terminate license agreement | 180 days | ||||
Milestone payment upon regulatory approval | $ 3,000 | ||||
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% | ||||
Jiangsu Nhwa Pharmaceutical Co Ltd | Licensing agreements for development and commercialization | Minimum | |||||
Licensing Arrangements | |||||
Time period to form a committee prior to the anticipated date of regulatory approval | 6 months | ||||
License revenue | |||||
Licensing Arrangements | |||||
Total revenue | 20 | ||||
License revenue | Licensing agreements for development and commercialization | |||||
Licensing Arrangements | |||||
Withholding taxes | $ 500 | ||||
License revenue | Pharmbio Korea Inc | |||||
Licensing Arrangements | |||||
Total revenue | $ 20 |
Net Loss Per Common Share (Deta
Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Basic and diluted net loss per common share calculation: | ||
Net loss | $ (16,389) | $ (9,842) |
Weighted average common shares outstanding, basic (in shares) | 165,520,007 | 160,508,373 |
Weighted average common shares outstanding, diluted (in shares) | 165,520,007 | 160,508,373 |
Net loss per share of common stock, basic (in dollars per share) | $ (0.10) | $ (0.06) |
Net loss per share of common stock, diluted (in dollars per share) | $ (0.10) | $ (0.06) |
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 18,452,937 | 14,342,476 |
Employee Stock Option | ||
Basic and diluted net loss per common share calculation: | ||
Outstanding securities excluded from computation of diluted weighted shares outstanding (in shares) | 12,259,011 | 10,350,543 |
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 | 3,696,342 |
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 |
Subsequent Events (Details)
Subsequent Events (Details) - Subsequent event - R-Bridge Financing $ / shares in Units, $ in Millions | 1 Months Ended |
Apr. 30, 2022USD ($)area$ / sharesshares | |
Royalty Based Loan Agreement | |
Subsequent Event | |
Upfront payment | $ 15 |
Commercialization milestone payments | $ 10 |
Debt instrument, first tranche call from closing of the deal, time period | 15 days |
Number of firm's core areas | area | 3 |
Warrants to purchase shares of common stock | shares | 5,000,000 |
Warrants term | 3 years |
Exercise price | $ / shares | $ 0.82 |
Royalty Based Loan Agreement - First Tranche | |
Subsequent Event | |
Proceeds from royalty-based loan agreement | $ 15 |
China | Royalty Based Loan Agreement | |
Subsequent Event | |
Milestone payment upon first commercial sale in China | $ 15 |
Jiangsu Nhwa Pharmaceutical Co Ltd | China | |
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 |