Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 04, 2021 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-36554 | |
Entity Registrant Name | Ocular Therapeutix, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 20-5560161 | |
Entity Address, Address Line One | 24 Crosby Drive | |
Entity Address, City or Town | Bedford | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 01730 | |
City Area Code | 781 | |
Local Phone Number | 357-4000 | |
Title of 12(b) Security | Common Stock, $0.0001 par value per share | |
Trading Symbol | OCUL | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 76,582,927 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001393434 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 191,860 | $ 228,057 |
Accounts receivable, net | 18,734 | 12,252 |
Inventory | 1,112 | 1,201 |
Prepaid expenses and other current assets | 4,817 | 4,650 |
Total current assets | 216,523 | 246,160 |
Property and equipment, net | 7,042 | 8,095 |
Restricted cash | 1,764 | 1,764 |
Operating lease assets | 5,378 | 5,844 |
Total assets | 230,707 | 261,863 |
Current liabilities: | ||
Accounts payable | 3,881 | 2,709 |
Accrued expenses and other current liabilities | 16,182 | 14,307 |
Operating lease liabilities | 1,487 | 1,358 |
Notes payable, net of discount, current | 8,290 | |
Total current liabilities | 21,550 | 26,664 |
Operating lease liabilities, net of current portion | 6,770 | 7,548 |
Derivative liability | 59,901 | 98,313 |
Deferred revenue | 12,000 | 12,000 |
Notes payable, net of discount | 24,891 | 16,936 |
2026 convertible notes, net | 25,348 | 24,307 |
Total liabilities | 150,460 | 185,768 |
Commitments and contingencies (Note 14) | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at June 30, 2021 and December 31, 2020, respectively | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized and 76,454,597 and 75,996,732 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively | 8 | 8 |
Additional paid-in capital | 624,850 | 615,338 |
Accumulated deficit | (544,611) | (539,251) |
Total stockholders' equity | 80,247 | 76,095 |
Total liabilities and stockholders' equity | $ 230,707 | $ 261,863 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Condensed Consolidated Balance Sheets | ||
Preferred stock, par value | $ 0.0001 | $ 0.0001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 200,000,000 | 200,000,000 |
Common stock, shares issued | 76,454,597 | 75,996,732 |
Common stock, shares outstanding | 76,454,597 | 75,996,732 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenue: | ||||
Product revenue, net | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Total revenue, net | $ 11,718 | $ 1,569 | $ 19,061 | $ 4,178 |
Costs and operating expenses: | ||||
Cost, Product and Service [Extensible List] | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember | us-gaap:ProductMember |
Cost of product revenue | $ 1,096 | $ 134 | $ 1,988 | $ 953 |
Research and development | 13,859 | 8,021 | 24,786 | 14,119 |
Selling and marketing | 8,391 | 6,153 | 16,477 | 13,283 |
General and administrative | 8,603 | 5,145 | 16,268 | 10,321 |
Total costs and operating expenses | 31,949 | 19,453 | 59,519 | 38,676 |
Loss from operations | (20,231) | (17,884) | (40,458) | (34,498) |
Other income (expense): | ||||
Interest income | 8 | 17 | 20 | 156 |
Interest expense | (1,655) | (1,694) | (3,335) | (3,327) |
Change in fair value of derivative liability | 13,396 | (17,007) | 38,412 | (20,411) |
Other income (expense), net | 1 | 1 | ||
Total other income (expense), net | 11,750 | (18,684) | 35,098 | (23,582) |
Net loss | $ (8,481) | $ (36,568) | $ (5,360) | $ (58,080) |
Net loss per share - basic | $ (0.11) | $ (0.64) | $ (0.07) | $ (1.06) |
Weighted average common shares outstanding, basic | 76,324,367 | 57,368,292 | 76,198,384 | 54,634,572 |
Net loss per share - diluted | $ (0.25) | $ (0.64) | $ (0.51) | $ (1.06) |
Weighted average common shares outstanding, diluted | 82,093,599 | 57,368,292 | 81,967,616 | 54,634,572 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (5,360) | $ (58,080) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation expense | 7,378 | 3,491 |
Non-cash interest expense | 2,282 | 2,156 |
Change in fair value of derivative liability | (38,412) | 20,411 |
Depreciation and amortization expense | 1,257 | 1,441 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (6,482) | (326) |
Prepaid expenses and other current assets | (167) | 173 |
Inventory | 89 | (113) |
Operating lease assets | 466 | 386 |
Accounts payable | 1,255 | (786) |
Accrued expenses | 928 | (1,866) |
Operating lease liabilities | (649) | (537) |
Net cash used in operating activities | (37,415) | (33,650) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (287) | (374) |
Net cash used in investing activities | (287) | (374) |
Cash flows from financing activities: | ||
Proceeds from issuance of notes payable, net | 3,722 | |
Proceeds from exercise of stock options | 1,735 | 506 |
Proceeds from issuance of common stock pursuant to employee stock purchase plan | 490 | 350 |
Proceeds from the Paycheck Protection Program Loan | 3,201 | |
Repayment of the Paycheck Protection Program Loan | (3,201) | |
Proceeds from issuance of common stock upon public offering, net of issuance costs | (275) | 63,025 |
Repayment of notes payable | (4,167) | |
Net cash provided by financing activities | 1,505 | 63,881 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (36,197) | 29,857 |
Cash, cash equivalents and restricted cash at beginning of period | 229,821 | 56,201 |
Cash, cash equivalents and restricted cash at end of period | 193,624 | 86,058 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Additions to property and equipment included in accounts payable and accrued expenses at balance sheet dates | $ 8 | 63 |
Public offering costs included in accounts payable and accrued expenses at balance sheet dates | $ 318 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2019 | $ 5 | $ 379,980 | $ (383,615) | $ (3,630) |
Balance, shares at Dec. 31, 2019 | 50,333,559 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 128 | 128 | ||
Issuance of common stock upon exercise of stock options, shares | 46,321 | |||
Issuance of common stock upon public offering, net of issuance costs | 12,690 | 12,690 | ||
Issuance of common stock upon public offering, net of issuance costs, shares | 2,657,823 | |||
Stock-based compensation expense | 1,665 | 1,665 | ||
Net income (loss) | (21,512) | (21,512) | ||
Balance at Mar. 31, 2020 | $ 5 | 394,463 | (405,127) | (10,659) |
Balance, shares at Mar. 31, 2020 | 53,037,703 | |||
Balance at Dec. 31, 2019 | $ 5 | 379,980 | (383,615) | (3,630) |
Balance, shares at Dec. 31, 2019 | 50,333,559 | |||
Stockholders' Equity (Deficit) | ||||
Net income (loss) | (58,080) | |||
Balance at Jun. 30, 2020 | $ 6 | 447,033 | (441,695) | 5,344 |
Balance, shares at Jun. 30, 2020 | 62,953,793 | |||
Balance at Mar. 31, 2020 | $ 5 | 394,463 | (405,127) | (10,659) |
Balance, shares at Mar. 31, 2020 | 53,037,703 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 378 | 378 | ||
Issuance of common stock upon exercise of stock options, shares | 75,862 | |||
Issuance of common stock in connection with employee stock purchase plan | 350 | 350 | ||
Issuance of common stock in connection with employee stock purchase plan, shares | 104,579 | |||
Issuance of common stock upon public offering, net of issuance costs | $ 1 | 50,016 | 50,017 | |
Issuance of common stock upon public offering, net of issuance costs, shares | 9,735,649 | |||
Stock-based compensation expense | 1,826 | 1,826 | ||
Net income (loss) | (36,568) | (36,568) | ||
Balance at Jun. 30, 2020 | $ 6 | 447,033 | (441,695) | 5,344 |
Balance, shares at Jun. 30, 2020 | 62,953,793 | |||
Balance at Dec. 31, 2020 | $ 8 | 615,338 | (539,251) | 76,095 |
Balance, shares at Dec. 31, 2020 | 75,996,732 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 1,197 | 1,197 | ||
Issuance of common stock upon exercise of stock options, shares | 228,241 | |||
Issuance of common stock upon cashless exercise of warrant, shares | 11,737 | |||
Issuance costs associated with common stock public offering | (91) | (91) | ||
Stock-based compensation expense | 3,086 | 3,086 | ||
Net income (loss) | 3,121 | 3,121 | ||
Balance at Mar. 31, 2021 | $ 8 | 619,530 | (536,130) | 83,408 |
Balance, shares at Mar. 31, 2021 | 76,236,710 | |||
Balance at Dec. 31, 2020 | $ 8 | 615,338 | (539,251) | 76,095 |
Balance, shares at Dec. 31, 2020 | 75,996,732 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon cashless exercise of warrant, shares | 11,737 | |||
Net income (loss) | (5,360) | |||
Balance at Jun. 30, 2021 | $ 8 | 624,850 | (544,611) | 80,247 |
Balance, shares at Jun. 30, 2021 | 76,454,597 | |||
Balance at Mar. 31, 2021 | $ 8 | 619,530 | (536,130) | 83,408 |
Balance, shares at Mar. 31, 2021 | 76,236,710 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 538 | 538 | ||
Issuance of common stock upon exercise of stock options, shares | 177,256 | |||
Issuance of common stock in connection with employee stock purchase plan | 490 | 490 | ||
Issuance of common stock in connection with employee stock purchase plan, shares | 40,631 | |||
Stock-based compensation expense | 4,292 | 4,292 | ||
Net income (loss) | (8,481) | (8,481) | ||
Balance at Jun. 30, 2021 | $ 8 | $ 624,850 | $ (544,611) | $ 80,247 |
Balance, shares at Jun. 30, 2021 | 76,454,597 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2021 | |
Nature of the Business and Basis of Presentation | |
Nature of the Business and Basis of Presentation | 1. Nature of the Business and Basis of Presentation Ocular Therapeutix, Inc. (the “Company”) was incorporated on September 12, 2006 under the laws of the State of Delaware. The Company is a biopharmaceutical company focused on the formulation, development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary, bioresorbable hydrogel platform technology. The Company’s product pipeline candidates provide differentiated drug delivery solutions that reduce the complexity and burden of the current standard of care by creating local programmed-release alternatives. Since inception, the Company’s operations have been primarily focused on organizing and staffing the Company, acquiring rights to intellectual property, business planning, raising capital, developing its technology, identifying potential product candidates, undertaking preclinical studies and clinical trials, manufacturing initial quantities of its products and product candidates and building the initial sales and marketing infrastructure for the commercialization of the Company’s approved products and product candidates and launching its initial product. The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations, regulatory approval and compliance, reimbursement, uncertainty of market acceptance of products and the need to obtain additional financing. Recently approved products will require significant sales, marketing and distribution support up to and including upon their launch. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization. As of June 30, 2021, the Company had two FDA-approved products in commercialization in the United States: DEXTENZA ® ® Sealant, an ophthalmic device designed to prevent wound leaks in corneal incisions following cataract surgery. While ReSure Sealant is commercially available in the United States, it does not receive sales support and has not in the past generated, nor is it anticipated to in the future to generate, material revenues. The Company’s other product candidates are in clinical stage development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval and adequate reimbursement or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapidly changing technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. The Company may not be able to generate significant revenue from sales of any product for several years, if at all. Accordingly, the Company will need to obtain additional capital to finance its operations. The Company has a history of losses and negative cash flows from operations, and the Company expects to continue to generate operating losses and negative cash flows from operations in the foreseeable future. As of June 30, 2021, the Company had an accumulated deficit of $544,611. The Company believes that its existing cash and cash equivalents of $191,860, as of June 30, 2021, along with its current operating plan, which includes revenues from the sale of DEXTENZA, will enable it to fund its planned operating expenses, debt service obligations and capital expenditure requirements through at least the next 12 months. The future viability of the Company beyond that point is dependent on its ability to generate cash flows from the sale of DEXTENZA and raise additional capital to finance its operations. The Company will need to finance its operations through public or private securities offerings, debt financings or other sources, which may include licensing, collaborations or other strategic transactions or arrangements. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs for product candidates, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations. The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Unaudited Interim Financial Information The balance sheet at December 31, 2020 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited financial statements as of June 30, 2021 and for the three and six months ended June 30, 2021 and 2020 have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 11, 2021. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of June 30, 2021 and results of operations and cash flows for the three and six months ended June 30, 2021 and 2020 have been made. The results of operations for the three and six months ended June 30, 2021 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2021. Risks and Uncertainties The Company is monitoring the potential impact of the COVID-19 pandemic, if any, on the carrying value of certain assets. To date, the Company has not experienced material business disruption, nor has it incurred impairment of any assets as a result of the COVID-19 pandemic. The extent to which these events may impact the Company’s business will depend on future developments, which are highly uncertain and cannot be predicted at this time. The duration and intensity of the COVID-19 pandemic and any resulting disruption to the Company’s operations is uncertain, and the Company will continue to assess the impact of the COVID-19 pandemic on its financial position. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, revenue recognition, clinical trial accruals and the fair value of derivatives. Actual results may differ from these estimates. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, and those of its customers, vendors, suppliers, and collaboration partners, will depend on future developments that are highly uncertain, subject to change and difficult to predict, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international customers and markets. Concentration of Credit Risk and of Significant Suppliers and Customers The Company is dependent on a small number of third-party manufacturers to supply products for research and development activities in its preclinical and clinical programs and for sales of its products. The Company’s development programs as well as revenue from future sales of its product sales could be adversely affected by a significant interruption in the supply of any of the components of these products. For the three and six months ended June 30, 2021, three specialty distributor customers accounted for 45%, 28%, and 15%, and 45%, 25% and 14% , respectively, of the Company’s total revenue, and no other customer accounted for more than 10% of the Company’s total revenue. At June 30, 2021, For the three and six months ended June 30, 2020, three specialty distributor customers accounted for 48%, 16% and 14% and 41%, 19% and 14% , respectively, of the Company’s total revenue and no other customer accounted for more than 10% of total revenue. At December 31, 2020, Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). This standard amends the guidance on convertible instruments and the derivatives scope exception for contracts in an entity’s own equity and improves and amends the related earnings per share guidance for both Subtopics. The amendments in the ASU are effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The FASB also specified that an entity should adopt the guidance as of the beginning of its fiscal year and is not permitted to adopt the guidance in an interim period. The Company is assessing the potential impact of ASU 2020-06 on its condensed consolidated financial statements. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value of Financial Assets and Liabilities | |
Fair Value of Financial Assets and Liabilities | 3. Fair Value of Financial Assets and Liabilities The following tables present information about the Company’s financial assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2021 and December 31, 2020 and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of June 30, 2021 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 187,384 $ — $ — $ 187,384 Liability: Derivative liability (Note 7) $ — $ — $ 59,901 $ 59,901 Fair Value Measurements as of December 31, 2020 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 213,372 $ — $ — $ 213,372 Liability: Derivative liability (Note 7) $ — $ — $ 98,313 $ 98,313 |
Restricted Cash
Restricted Cash | 6 Months Ended |
Jun. 30, 2021 | |
Restricted Cash | |
Restricted Cash | 4. Restricted Cash The Company held restricted cash of $1,764 at June 30, 2021 and December 31, 2020, on its condensed consolidated balance sheet. The Company held restricted cash as security deposits for the lease of its manufacturing space and corporate headquarters. The Company’s condensed consolidated statements of cash flows include restricted cash with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on such statements. A reconciliation of the cash, cash equivalents, and restricted cash reported within the balance sheet that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows is as follows: June 30, June 30, 2021 2020 Cash and cash equivalents $ 191,860 $ 84,294 Restricted cash 1,764 1,764 Total cash, cash equivalents and restricted cash $ 193,624 $ 86,058 |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2021 | |
Inventory | |
Inventory | 5. Inventory The Company values its inventories at the lower of cost or estimated net realizable value. Inventory consisted of the following: June 30, December 31, 2021 2020 Raw materials $ 347 $ 384 Work-in-process 437 232 Finished goods 328 585 $ 1,112 $ 1,201 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 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 as of June 30, 2021 and December 31, 2020 consisted of the following: June 30, December 31, 2021 2020 Accrued payroll and related expenses $ 4,873 $ 5,853 Accrued rebates and programs 2,736 1,438 Accrued professional fees 1,077 868 Accrued research and development expenses 1,258 1,013 Accrued interest payable on 2026 convertible notes 5,325 4,194 Accrued other 913 941 $ 16,182 $ 14,307 |
Derivative Liability
Derivative Liability | 6 Months Ended |
Jun. 30, 2021 | |
Derivative Liability | |
Derivative Liability | 7. Derivative Liability The unsecured senior subordinated convertible notes (the “2026 Convertible Notes”) (Note 8) contained an embedded conversion option that met the criteria to be bifurcated and accounted for separately (the “Derivative Liability”) from the 2026 Convertible Notes. The Derivative Liability was recorded at fair value upon the issuance of the 2026 Convertible Notes and is subsequently remeasured to fair value at each reporting period. The Derivative Liability was initially valued and remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the embedded conversion option. The difference between the entire instrument with the embedded conversion option compared to the instrument without the embedded conversion option is the fair value of the derivative, recorded as the Derivative Liability in the Company’s condensed consolidated balance sheet. The estimated fair value of the 2026 Convertible Notes was $92,181 at June 30, 2021. The fair value of the 2026 Convertible Notes was estimated utilizing a binomial lattice model which requires the use of Level 3 unobservable inputs. The main input when determining the fair value for disclosure purposes is the bond yield which is updated each period to reflect the yield of a comparable instrument issued as of the valuation date. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value. The main inputs to valuing the 2026 Convertible Notes with the conversion option are as follows: As of June 30, December 31, 2021 2020 Company's stock price $ 14.18 $ 20.70 Expected annual volatility 97.7 % 105.5 % Bond yield 11.9 % 12.0 % A roll-forward of the derivative liability is as follows: As of Balance at December 31, 2020 $ 98,313 Change in fair value (38,412) Balance at June 30, 2021 $ 59,901 |
Convertible Notes
Convertible Notes | 6 Months Ended |
Jun. 30, 2021 | |
Convertible Notes | |
Convertible Notes | 8. Convertible Notes On March 1, 2019, the Company issued $37,500 of 2026 Convertible Notes. Each 2026 Convertible Note accrues interest at an annual rate of 6% of its outstanding principal amount, which is payable, along with the principal amount at maturity, on March 1, 2026, unless earlier converted, repurchased or redeemed. The Company presents deferred interest in accrued current liabilities because the 2026 Convertible Notes are currently convertible and the interest is payable in cash. The effective annual interest rate for the 2026 Convertible Notes was The holders of the 2026 Convertible Notes may convert all or part of the outstanding principal amount of their 2026 Convertible Notes into shares of the Company’s common stock, par value $0.0001 per share, prior to maturity and provided that no conversion results in a holder beneficially owning more than 19.99% of the issued and outstanding common stock of the Company. The conversion rate is initially 153.8462 shares of the Company’s common stock per $1,000 principal amount of the 2026 Convertible Notes, which is equivalent to an initial conversion price of $6.50 per share. The conversion rate is subject to adjustment in customary circumstances such as stock splits or similar changes to the Company’s capitalization. At its election, the Company may choose to make such conversion payment in cash, in shares of common stock, or a combination thereof. Upon any conversion of any 2026 Convertible Note, the Company is obligated to make a cash payment to the holder of such 2026 Convertible Note for any interest accrued but unpaid on the principal amount converted. Upon the occurrence of a Corporate Transaction (as defined below), each holder has the option to require the Company to repurchase all or part of the outstanding principal amount of such note at a repurchase price equal to 100% of the outstanding principal amount of the 2026 Convertible Note to be repurchased, plus accrued and unpaid interest to, but excluding the repurchase date. In addition, each holder is entitled to receive an additional make-whole cash payment in accordance with a table set forth in each 2026 Convertible Note. Upon conversion by the holder, the Company has the right to select the settlement of the conversion in shares of common stock, cash, or in a combination thereof. In addition, the Company is obligated to make a cash payment to the holder of such 2026 Convertible Note for any interest accrued but unpaid on the principal amount converted. ● If the Company elects to satisfy such conversion by shares of common stock, the Company shall deliver to the converting holder in respect of each $1,000 principal amount of 2026 Convertible Notes being converted a number of common shares equal to the conversion rate in effect on the conversion date; ● If the Company elects to satisfy such conversion by cash settlement, the Company shall pay to the converting holder in respect of each $1,000 principal amount of 2026 Convertible Notes being converted cash in an amount equal to the sum of the Daily Conversion Values (as defined below) for each of the twenty ( 20 ) consecutive trading days during a specified period. The “Daily Conversion Values” is defined as each of the 20 consecutive trading days during the specified period, 5.0% of the product of (a) the conversion rate on such trading day and (b) the Daily VWAP on such trading day. The Daily VWAP is defined as each of the 20 consecutive trading days during the applicable observation period, the per share volume-weighted average price as displayed under the heading “Bloomberg VWAP” on the Bloomberg page for the Company. ● If the Company elects to satisfy such conversion by combination, the Company shall pay or deliver, as the case may be, in respect of each $1,000 principal amount of 2026 Convertible Notes being converted, a settlement amount equal to the sum of the Daily Settlement Amounts (as defined below) for each of the twenty ( 20 ) consecutive trading days during the specified period. The “Daily Settlement Amount” is defined as, for each of the 20 consecutive trading days during the specified period: (a) cash in an amount equal to the lesser of (i) the Daily Measurement Value (as defined below) and (ii) the Daily Conversion Value on such Trading Day; and (b) if the Daily Conversion Value on such trading day exceeds the Daily Measurement Value, a number of shares equal to (i) the difference between the Daily Conversion Value and the Daily Measurement Value, divided by (ii) the Daily VWAP for such Trading Day. The “Daily Measurement Value” is defined as the Specified Dollar Amount (as defined below) , if any, divided by 20. The “Specified Dollar Amount” is defined as the maximum cash amount per $1,000 principal amount of Notes to be received upon conversion as specified in the notice specifying the Company’s chosen settlement method. In the event of a Corporate Transaction, the noteholder shall have the right to either (a) convert all of the unpaid principal at the conversion rate and receive a cash payment equal to (i) the outstanding accrued but unpaid interest under the 2026 Convertible Note to, but excluding, the corporate transaction conversion date (to the extent such date occurs prior to March 1, 2026, the maturity date of the 2026 Convertible Notes) plus (ii) an additional amount of consideration based on a sliding scale depending on the date of such as Corporate transaction or (b) require the Company to repurchase all or part of the outstanding principal amount of such 2026 Convertible Note at a repurchase price equal to 100% of the outstanding principal amount of the 2026 Convertible Note to be repurchased, plus accrued and unpaid interest to, but excluding, the repurchase date. A corporate transaction includes (i) a merger or consolidation executed through a tender offer or change of control (other than one in which stockholders of the Company own a majority by voting power of the outstanding shares of the surviving or acquiring corporation); (ii) a sale, lease, transfer, of all or substantially all of the assets of the Company; or (iii) if the Company’s common stock ceases to be listed or quoted on any of the New York Stock Exchange, the Nasdaq Global Select Market, the Nasdaq Global Market or the Nasdaq Capital Market (the “Corporate Transaction”). On or after March 1, 2022, if the last reported sale price of the common stock has been at least 130% of the conversion rate then in effect for 20 of the preceding 30 trading days (including the last trading day of such period), the Company is entitled, at its option, to redeem all or part of the outstanding principal amount of the 2026 Convertible Notes, on a pro rata basis, at an optional redemption price equal to 100% of the outstanding principal amount of the 2026 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the optional redemption date. The 2026 Convertible Notes are subject to acceleration upon the occurrence of specified events of default, including a default or breach of certain contracts material to the Company and the delisting and deregistration of the Company’s common stock. As discussed in Note 7, the Company determined that the embedded conversion option is required to be separated from the 2026 Convertible Notes and accounted for as a freestanding derivative instrument subject to derivative accounting. The allocation of proceeds to the conversion option results in a discount on the 2026 Convertible Notes. The Company is amortizing the discount to interest expense over the term of the 2026 Convertible Notes using the effective interest method. A summary of the 2026 Convertible Notes at June 30, 2021 and December 31, 2020 is as follows: June 30, December 31, 2021 2020 2026 Convertible Notes $ 37,500 $ 37,500 Less: unamortized discount (12,152) (13,193) Total $ 25,348 $ 24,307 Accrued interest related to the 2026 Convertible Notes amounted to $5,325 and $4,194 at June 30, 2021 and December 31, 2020, respectively. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income Taxes | |
Income Taxes | 9. Income Taxes The Company did not provide for any income taxes in its condensed consolidated statement of operations and comprehensive loss for the three and six month periods ended June 30, 2021 or 2020. The Company has provided a valuation allowance for the full amount of its net deferred tax assets because, at June 30, 2021 and December 31, 2020, it was more likely than not that any future benefit from deductible temporary differences and net operating loss and tax credit carryforwards would not be realized. The Company has not recorded any amounts for unrecognized tax benefits as of June 30, 2021 or December 31, 2020. As of June 30, 2021 and December 31, 2020, the Company had accrued interest or tax penalties recorded related to income taxes. The Company’s income tax return reporting periods since December 31, 2017 are open to income tax audit examination by the federal and state tax authorities. In addition, because the Company has net operating loss carryforwards, the Internal Revenue Service is permitted to audit earlier years and propose adjustments up to the amount of net operating losses generated in those years. |
Collaboration Agreements
Collaboration Agreements | 6 Months Ended |
Jun. 30, 2021 | |
Collaboration Agreements | |
Collaboration Agreements | 10. Collaboration Agreements AffaMed License Agreement On October 29, 2020, the Company entered into license agreement (“License Agreement”) with AffaMed Therapeutic Limited (“AffaMed”) for the development and commercialization of the Company’s DEXTENZA product regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis (collectively, the “DEXTENZA Field”) and for the Company’s OTX-TIC product candidate (collectively with DEXTENZA, the “AffaMed Licensed Products”) regarding open-angle glaucoma and ocular hypertension (collectively, the “TIC Field” and, with the DEXTENZA Field, each a “Field”), in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations (collectively, the “Territories”). The Company retains development and commercialization rights for the AffaMed Licensed Products in the rest of the world. Under the License Agreement, the Company received a non-refundable upfront payment of $12,000 in December 2020. The Company is also eligible to receive up to an additional $91,000 in aggregate, inclusive of a low-seven-figure clinical support payment, upon the achievement of certain regulatory, development and commercial milestones. The Company is also entitled to receive tiered, escalating royalties on the net sales of the AffaMed Licensed Products ranging from a low-teen to low-twenties percentage. Royalties under the License Agreement are payable on an AffaMed Licensed Product-by-AffaMed Licensed Product and jurisdiction-by-jurisdiction basis and are subject to potential reductions in specified circumstances, subject to a specified floor. The License Agreement expires upon the expiration of the last royalty term for the last AffaMed Licensed Product in any applicable Field in the Territories. Either party may, subject to specified cure periods, terminate the License Agreement in the event of the other party’s uncured breach. Either party may also terminate the License Agreement under specified circumstances relating to the other party’s insolvency. AffaMed has the right to terminate the License Agreement at any time after completion of a Phase 3 clinical trial for OTX-TIC for any or no reason upon providing the Company three months’ notice. During an established period following its change of control or its entry into a global licensing agreement that includes the Territories with a third party, the Company has the option to terminate the License Agreement, subject to a specified notice period and the repayment of any costs and expenses incurred by AffaMed in connection with the License Agreement, including upfront and milestone payments AffaMed has previously paid to the Company, at a prespecified premium. At the inception of the License Agreement, the Company identified the following performance obligations in the agreement: ● the license, regulatory filings and manufacturing of DEXTENZA; ● the license, regulatory filings and manufacturing for the Company’s OTX-TIC product candidate regarding open-angle glaucoma and ocular hypertension in the Territories; ● obligations to participate on various joint research, development and project committees; and ● the conduct of a Phase 2 clinical trial of OTX-TIC The Company has concluded there is a combined performance obligation for a development and commercialization license and manufacturing obligations for DEXTENZA Field and the Company’s OTX-TIC product candidate regarding open-angle glaucoma and ocular hypertension in the Territories. We recognize revenue related to the amounts allocated to the combined performance obligations for DEXTENZA Field and the Company’s OTX-TIC product candidate based on the point in time upon which control of supply is transferred to AffaMed for each delivery of the associated supply. The Company has not recognized any revenue under the License Agreement as of June 30, 2021 as there has not been any delivery of product under the License Agreement. The entire transaction price is recorded as deferred revenue as of June 30, 2021 and December 31, 2020. Regeneron Collaboration Agreement In October 2016, the Company entered into a Collaboration, Option and License Agreement (the “Collaboration Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”) for the development and potential commercialization of products containing the Company’s extended-delivery hydrogel formulation in combination with Regeneron’s large molecule vascular endothelial growth factor (“VEGF”)-targeting compounds for the treatment of retinal diseases. The Collaboration Agreement does not cover the development of any product candidates that deliver small molecule drugs, including tyrosine kinase inhibitors, or TKIs, or deliver large molecule drugs other than those that target VEGF proteins. Under the terms of the Collaboration Agreement, the Company and Regeneron have agreed to conduct a joint research program with the aim of developing an extended-delivery formulation of aflibercept, currently marketed under the tradename EYLEA, that is suitable for advancement into clinical development. The Company has granted Regeneron an option (the “Option”) to enter into an exclusive, worldwide license to develop and commercialize products containing the Company’s hydrogel in combination with Regeneron’s large molecule VEGF-targeting compounds (“Regeneron Licensed Products”). Under the term of the Collaboration Agreement, Regeneron is responsible for funding an initial preclinical tolerability study. If the Option is exercised, Regeneron will be obligated to conduct further preclinical development and an initial clinical trial under a collaboration plan. The Company is obligated to reimburse Regeneron for certain development costs incurred by Regeneron under the collaboration plan during the period through the completion of the initial clinical trial, subject to a cap of under certain circumstances. If Regeneron elects to proceed with further development following the completion of the collaboration plan, it will be solely responsible for conducting and funding further development and commercialization of product candidates. If the Option is exercised, Regeneron is required to use commercially reasonable efforts to research, develop and commercialize at least one Regeneron Licensed Product. Such efforts shall include initiating the dosing phase of a subsequent clinical trial within specified time periods following the completion of the first-in-human clinical trial or the initiation of preclinical toxicology studies, subject to certain extensions. Under the terms of the Collaboration Agreement, Regeneron has agreed to pay the Company $10,000 upon the exercise of the Option. If Regeneron elects to exercise the Option, the Company is also eligible to receive up to $100,000 per Regeneron Licensed Product upon first commercial sale of such Regeneron Licensed Product and up to $50,000 based on the achievement of specified sales milestones for all Regeneron Licensed Products. In addition, the Company is entitled to tiered, escalating royalties, in a range from a high-single digit to a low-to-mid teen percentage of net sales of Regeneron Licensed Products. In December 2017, the Company delivered to Regeneron a proposed final formulation for the initial preclinical tolerability study. Regeneron initiated the preclinical study in early 2018. The Company and Regeneron subsequently reached an understanding that the proposed formulation was not final and ceased development of it. On May 8, 2020, the Company entered into an amendment (the “Amendment”) to the Collaboration Agreement. Pursuant to the Amendment, the Company and Regeneron have adopted a new work plan to transition joint efforts under the Collaboration Agreement to the research and development of an extended-delivery formulation of aflibercept to be delivered to the suprachoroidal space. Regeneron has agreed to pay personnel and material costs of the Company for specified preclinical development activities in connection with the revised work plan, as well as certain other costs. In addition, the Amendment provides for the modification of the terms of the Option previously granted to Regeneron under the Collaboration Agreement. As amended, the Option is exclusive for twenty-four months following May 8, 2020. Through June 30, 2021, the Option has not been exercised, and no payments have been made. For the three and six months ended June 30, 2021, the Company has recorded $418 and $515, respectively, related to work performed for preclinical development activities in connection with the revised work plan which the Company has recorded as a reduction of research and development expense as this research is not an output of the Company’s ordinary business activities. As of June 30, 2021 and December 31, 2020, the Company has included the $934 and $1,256, respectively in prepaid expenses and other current assets. As further described under Note 18, on August 5, 2021, Regeneron notified the Company of its termination of the Collaboration Agreement. The termination became effective immediately. |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2021 | |
Notes Payable | |
Notes payable | 11. Notes Payable The Company entered into a credit and security agreement in 2014 (as amended to date, the “Credit Agreement”) establishing the Company’s credit facility (the “Credit Facility”). The Company has a total borrowing capacity of In December 2018, the Company amended the terms of the Credit Agreement to increase total indebtedness under the Credit Facility to $25,000 , which was used primarily to pay-off outstanding balances as of the closing date. The Company was required to make interest-only payments under the Credit Facility until December 2020. Commencing in January 2021, the Company was required to make . The exit fee equal to In June 2021, the Company entered into a Fourth Amended and Restated Credit and Security Agreement (the “Fourth Amendment”) to amend the terms of its debt with existing lenders for total indebtedness of Amounts borrowed under the 2021 Amended Credit Facility are at LIBOR base rate, subject to 1.00% floor, plus 6.75%. The interest rate on the date of the amendment was 8.8%. In addition, a final payment (exit fee) equal to 3.5% of amounts drawn under the Amended Credit Facility, or $875 based on borrowings of $25,000, is due upon the maturity date of November 30, 2025. The Company is accruing the exit fee through November 30, 2025. The Company accounted for the Fourth Amendment as a modification in accordance with the guidance in ASC 470-50, Debt. Amounts paid to the lenders were recorded as debt discount and a new effective interest rate was established. The effective annual interest rate of the outstanding debt under the Fourth Amendment is . There are no financial covenants associated with the Fourth Amendment. However, the Fourth Amendment does contain negative covenants restricting the Company’s activities, including limitations on dispositions, mergers or acquisitions; encumbering its intellectual property; incurring indebtedness or liens; paying dividends; making certain investments; and engaging in certain other business transactions. As of June 30, 2021, the Company was not in violation of any of its covenants under the Fourth Amendment. The obligations under the Fourth Amendment are subject to acceleration upon the occurrence of specified events of default, including a material adverse change in the Company’s business, operations or financial or other condition. The debt is collateralized by substantially all of the Company’s assets, including its intellectual property. In accordance with the 2021 Amended Credit Facility, among other provisions, a negative covenant restricting the Company from paying the holders of the 2026 Convertible Notes ahead in priority to the existing lenders, for so long as indebtedness remains outstanding under the Credit Facility, and a cross-default provision to establish that an event of default under the purchase agreement for the 2026 Convertible Notes also constitutes an event of default under the Fourth Amendment. Borrowings outstanding are as follows : June 30, December 31, 2021 2020 Borrowings outstanding $ 25,000 $ 25,000 Accrued exit fee 15 355 Unamortized discount (124) (129) 24,891 25,226 Less: current portion — (8,290) Long-term notes payable $ 24,891 $ 16,936 As of June 30, 2021, the annual repayment requirements for the Credit Facility, inclusive of the final payment of $875 due at expiration, were as follows: Year Ending December 31, Principal Final Payment Total 2021 (July 1 through December 31) — — — 2022 — — — 2023 — — — 2024 8,333 — 8,333 2025 16,667 875 17,542 $ 25,000 $ 875 $ 25,875 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2021 | |
Net Loss Per Share | |
Net Loss Per Share | 12. Net Loss Per Share Basic net loss per share was calculated as follows for the three and six months ended June 30, 2021 and 2020. Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Numerator: Net loss attributable to common stockholders $ (8,481) $ (36,568) $ (5,360) $ (58,080) Denominator: Weighted average common shares outstanding 76,324,367 57,368,292 76,198,384 54,634,572 Net loss per share - basic $ (0.11) $ (0.64) $ (0.07) $ (1.06) For the three and six months ended June 30, 2020, there is no dilutive impact. Therefore, diluted net loss per share is the same as basic net loss per share. Three Months Ended June 30, Six Months Ended June 30, 2021 2021 Net income attributable to common stockholders, basic $ (8,481) $ (5,360) — Interest expense on 2026 Convertible Notes 1,095 2,173 Change in fair value of derivative liability (13,396) (38,412) Net loss attributable to common stockholders, diluted $ (20,782) $ (41,599) Weighted average common shares outstanding, basic 76,324,367 76,198,384 Shares issuable upon conversion of 2026 Convertible Notes, as if converted 5,769,232 5,769,232 Weighted average common shares outstanding, diluted 82,093,599 81,967,616 Net loss per share attributable to common stockholders, diluted $ (0.25) $ (0.51) The Company excluded the following common stock equivalents, outstanding as of June 30, 2021 and 2020, from the computation of diluted net loss per share for the three and six months ended June 30, 2021 and 2020 because they had an anti-dilutive impact. Six Months ended June 30, 2021 2020 Options to purchase common stock 11,049,287 9,270,173 Warrants for the purchase of common stock — 18,939 11,049,287 9,289,112 The Company also excluded the shares issuable upon conversion of the 2026 Convertible notes from the computation of diluted net loss per share for the three and six months ended June 30, 2020 because they had an anti-dilutive impact. |
Stock-Based Awards
Stock-Based Awards | 6 Months Ended |
Jun. 30, 2021 | |
Stock-Based Awards | |
Stock-Based Awards | 13. Stock-Based Awards 2014 Stock Incentive Plan The 2014 Stock Incentive Plan (the “2014 Plan”) provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock-based awards. The number of shares of common stock that may be issued under the 2014 Plan is subject to increase on the first day of each fiscal year, beginning on January 1, 2015 and ending on December 31, 2024 in an amount equal to the lesser of a pre-determined formula or an amount determined by the Company’s board of directors. On January 1, 2021, the number of shares available for issuance under the 2014 Plan was increased by . During the three and six months ended June 30, 2021, the Company granted options to purchase 229,650 and 2,709,019 shares of common stock, at a weighted exercise price of $16.54 and $18.19 per share, respectively. On June 18, 2021, the Company’s stockholders approved the adoption of the 2021 Stock Incentive Plan (the “2021 Plan”) previously approved by the board of directors. Effective as of the adoption of the 2021 Plan by the Company’s stockholders, no new awards will be granted under the 2014 Plan. However, as of June 30, 2021, all then-outstanding awards under the 2014 Plan remained in effect and continued to be governed by the terms of the 2014 Plan. 2021 Stock Incentive Plan The 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock-based awards. The number of shares of common stock that may be issued under the 2021 Plan is 2014 Employee Stock Purchase Plan The Company has a 2014 Employee Stock Purchase Plan (the “ESPP”). The number of shares of common stock that may be issued under the ESPP will automatically increase on the first day of each fiscal year, commencing on January 1, 2015 and ending on December 31, 2024 in an amount equal to the lesser of a pre-determined formula or as determined by the Company’s board of directors. On January 1, 2021, the number of shares available for issuance under the 2014 Plan was increased by . During the three months ended June 30, 2021, shares of common stock were issued under the ESPP. As of June 30, 2021, shares remained available for issuance under the ESPP. Inducement Stock Option Awards On October 29, 2019, the 2019 Inducement Stock Incentive Plan (the “Inducement Plan”) was approved by the Board of Directors of the Company. Initially, the maximum number of shares of common stock issuable under the Inducement Plan was 500,000 . On December 10, 2020, the Board of Directors of the Company amended the 2019 Inducement Plan to increase the aggregate number of shares issuable from 500,000 to 1,054,000 Stock-based Compensation The Company recorded stock-based compensation expense related to stock options in the following expense categories of its condensed consolidated statements of operations: Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Research and development $ 1,206 $ 362 $ 1,883 $ 737 Selling and marketing 1,129 433 1,883 804 General and administrative 1,957 1,031 3,612 1,950 $ 4,292 $ 1,826 $ 7,378 $ 3,491 As of June 30, 2021, the Company had an aggregate of $26,106 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 3.2 years. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and Contingencies. | |
Commitments and Contingencies | 14. Commitments and Contingencies Collaboration Agreement On October 10, 2016, the Company entered into the Collaboration Agreement with Regeneron, which the parties amended in May 2020 (Note 10). If the Option to enter into an exclusive worldwide license is exercised, Regeneron will be obligated to conduct further preclinical development and an initial clinical trial under a collaboration plan. The Company is obligated to reimburse Regeneron for certain development costs incurred by Regeneron under the collaboration plan during the period through the completion of the initial clinical trial, subject to a cap of under certain circumstances; the timing of such payments are not known. If Regeneron elects to proceed with further development following the completion of the collaboration plan, it will be solely responsible for conducting and funding further development and commercialization of product candidates. If the Option is exercised, Regeneron is required to use commercially reasonable efforts to research, develop and commercialize at least one Regeneron Licensed Product. Such efforts shall include initiating the dosing phase of a subsequent clinical trial within specified time periods following the completion of the first-in-human clinical trial or the initiation of preclinical toxicology studies, subject to certain extensions. As further described under Note 18, on August 5, 2021, Regeneron notified the Company of its termination of the Collaboration Agreement. The termination became effective immediately. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2021 | |
Related Party Transactions | |
Related Party Transactions | 15. Related Party Transactions Since October 2017, the Company has engaged McCarter English LLP (“McCarter”) to provide legal services to the Company, including with respect to intellectual property matters. Jonathan M. Sparks, Ph.D., a partner at McCarter & English, also served as the Company’s in-house counsel from October 2017 through August 31, 2020. The Company incurred fees for legal services rendered by McCarter of $221 and $512 for the three and six months ended June 30, 2020, respectively. As of December 31, 2020, there was Since November 2020, the Company has engaged Specialty Pharma Consulting, LLC (“Specialty Pharma”), an entity affiliated with Kevin Coughenour, to provide services for quality engineering and validation activities in the ordinary course of business. Mr. Coughenour is married to the Company’s former Chief Operating Officer Patricia Kitchen. The Company incurred fees for quality engineering and validation activities rendered by Specialty Pharma of $29 and $155 , for the three and six months ended June 30, 2021, respectively. As of December 31, 2020, there was recorded in accrued expenses for Specialty Pharma. On April 26, 2021, the Company and Specialty Pharma terminated their relationship. |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2021 | |
Warrants | |
Warrants | 16. Warrants On January 29, 2021, holders of warrants to purchase 18,939 shares of common stock at an exercise price of $7.92 exercised their right to purchase their warrants. The exercise price of the warrants was paid through a net share settlement mechanism and as a result the Company issued shares of common stock to satisfy the exercise of all the warrants. There are |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2021 | |
Common Stock | |
Common Stock | 17. Common Stock In June 2021, the Company adopted an amended and restated certificate of incorporation increasing the number of its authorized shares of its common stock to 200,000,000 shares. |
Subsequent Event
Subsequent Event | 6 Months Ended |
Jun. 30, 2021 | |
Subsequent Event | |
Subsequent Event | 18. Subsequent Event On August 5, 2021, Regeneron notified the Company of its termination of the Collaboration Agreement for convenience, in accordance with the terms of the Collaboration Agreement. The termination became effective immediately, subject to specified surviving rights and obligations thereunder. In connection with the termination of the Collaboration Agreement, all licenses, options and other rights granted to either party under the Collaboration Agreement automatically terminated, other than the surviving joint intellectual property rights described below. The Company and Regeneron also became obligated to undertake certain transition activities upon the termination, including the return of specified property of the other party. Each party retains an equal, undivided ownership interest, which may be transferred, licensed and otherwise exploited without a duty to account to the other party, in certain intellectual property rights jointly developed under the collaboration. As a result of the termination, the Company is no longer eligible to receive (i) reimbursement from Regeneron for ongoing research and development activities, (ii) a fee upon exercise of the Option, (iii) payments upon the achievement of specified development and regulatory milestones of the Regeneron Licensed Products, or (iv) tiered, escalating royalties in a range from a high-single digit to a low-to-mid teen percentage of net sales of Regeneron Licensed Products, in each case pursuant to the Collaboration Agreement. The Company is also no longer obligated to reimburse Regeneron for certain development costs, up to an aggregate amount of $30,000 in certain circumstances, were Regeneron to have exercised the Option. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Summary of Significant Accounting Policies | |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, revenue recognition, clinical trial accruals and the fair value of derivatives. Actual results may differ from these estimates. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, and those of its customers, vendors, suppliers, and collaboration partners, will depend on future developments that are highly uncertain, subject to change and difficult to predict, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international customers and markets. |
Concentration of Credit Risk and of Significant Suppliers and Customers | Concentration of Credit Risk and of Significant Suppliers and Customers The Company is dependent on a small number of third-party manufacturers to supply products for research and development activities in its preclinical and clinical programs and for sales of its products. The Company’s development programs as well as revenue from future sales of its product sales could be adversely affected by a significant interruption in the supply of any of the components of these products. For the three and six months ended June 30, 2021, three specialty distributor customers accounted for 45%, 28%, and 15%, and 45%, 25% and 14% , respectively, of the Company’s total revenue, and no other customer accounted for more than 10% of the Company’s total revenue. At June 30, 2021, For the three and six months ended June 30, 2020, three specialty distributor customers accounted for 48%, 16% and 14% and 41%, 19% and 14% , respectively, of the Company’s total revenue and no other customer accounted for more than 10% of total revenue. At December 31, 2020, |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). This standard amends the guidance on convertible instruments and the derivatives scope exception for contracts in an entity’s own equity and improves and amends the related earnings per share guidance for both Subtopics. The amendments in the ASU are effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The FASB also specified that an entity should adopt the guidance as of the beginning of its fiscal year and is not permitted to adopt the guidance in an interim period. The Company is assessing the potential impact of ASU 2020-06 on its condensed consolidated financial statements. |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair Value of Financial Assets and Liabilities | |
Schedule of assets and liabilities measured at fair Value on recurring basis | Fair Value Measurements as of June 30, 2021 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 187,384 $ — $ — $ 187,384 Liability: Derivative liability (Note 7) $ — $ — $ 59,901 $ 59,901 Fair Value Measurements as of December 31, 2020 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 213,372 $ — $ — $ 213,372 Liability: Derivative liability (Note 7) $ — $ — $ 98,313 $ 98,313 |
Restricted Cash (Tables)
Restricted Cash (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Restricted Cash | |
Reconciliation of cash, cash equivalents, and restricted cash reported within the balance sheet to the total amounts shown in the statement of cash flows | June 30, June 30, 2021 2020 Cash and cash equivalents $ 191,860 $ 84,294 Restricted cash 1,764 1,764 Total cash, cash equivalents and restricted cash $ 193,624 $ 86,058 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Inventory | |
Components of inventory | June 30, December 31, 2021 2020 Raw materials $ 347 $ 384 Work-in-process 437 232 Finished goods 328 585 $ 1,112 $ 1,201 |
Accrued Expenses and other cu_2
Accrued Expenses and other current liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued expenses and other current liabilities | June 30, December 31, 2021 2020 Accrued payroll and related expenses $ 4,873 $ 5,853 Accrued rebates and programs 2,736 1,438 Accrued professional fees 1,077 868 Accrued research and development expenses 1,258 1,013 Accrued interest payable on 2026 convertible notes 5,325 4,194 Accrued other 913 941 $ 16,182 $ 14,307 |
Derivative Liability (Tables)
Derivative Liability (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Derivative Liability | |
Schedule of main inputs to valuing the 2026 Convertible Notes with the conversion option | As of June 30, December 31, 2021 2020 Company's stock price $ 14.18 $ 20.70 Expected annual volatility 97.7 % 105.5 % Bond yield 11.9 % 12.0 % |
Summary of roll-forward of the derivative liability | As of Balance at December 31, 2020 $ 98,313 Change in fair value (38,412) Balance at June 30, 2021 $ 59,901 |
Convertible Notes (Tables)
Convertible Notes (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Convertible Notes | |
Summary of the 2026 Convertible Notes | A summary of the 2026 Convertible Notes at June 30, 2021 and December 31, 2020 is as follows: June 30, December 31, 2021 2020 2026 Convertible Notes $ 37,500 $ 37,500 Less: unamortized discount (12,152) (13,193) Total $ 25,348 $ 24,307 |
Notes Payable (Tables)
Notes Payable (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Notes Payable | |
Schedule of borrowings outstanding | June 30, December 31, 2021 2020 Borrowings outstanding $ 25,000 $ 25,000 Accrued exit fee 15 355 Unamortized discount (124) (129) 24,891 25,226 Less: current portion — (8,290) Long-term notes payable $ 24,891 $ 16,936 |
Schedule of Annual Repayment Requirements for Credit Facility | Year Ending December 31, Principal Final Payment Total 2021 (July 1 through December 31) — — — 2022 — — — 2023 — — — 2024 8,333 — 8,333 2025 16,667 875 17,542 $ 25,000 $ 875 $ 25,875 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Net Loss Per Share | |
Schedule of basic and diluted net loss per share attributable to common stockholders | Basic net loss per share was calculated as follows for the three and six months ended June 30, 2021 and 2020. Three Months Ended June 30, Six Months Ended June 30, 2021 2020 2021 2020 Numerator: Net loss attributable to common stockholders $ (8,481) $ (36,568) $ (5,360) $ (58,080) Denominator: Weighted average common shares outstanding 76,324,367 57,368,292 76,198,384 54,634,572 Net loss per share - basic $ (0.11) $ (0.64) $ (0.07) $ (1.06) For the three and six months ended June 30, 2020, there is no dilutive impact. Therefore, diluted net loss per share is the same as basic net loss per share. Three Months Ended June 30, Six Months Ended June 30, 2021 2021 Net income attributable to common stockholders, basic $ (8,481) $ (5,360) — Interest expense on 2026 Convertible Notes 1,095 2,173 Change in fair value of derivative liability (13,396) (38,412) Net loss attributable to common stockholders, diluted $ (20,782) $ (41,599) Weighted average common shares outstanding, basic 76,324,367 76,198,384 Shares issuable upon conversion of 2026 Convertible Notes, as if converted 5,769,232 5,769,232 Weighted average common shares outstanding, diluted 82,093,599 81,967,616 Net loss per share attributable to common stockholders, diluted $ (0.25) $ (0.51) |
Schedule of antidilutive securities, excluded from computation of diluted net loss per share | Six Months ended June 30, 2021 2020 Options to purchase common stock 11,049,287 9,270,173 Warrants for the purchase of common stock — 18,939 11,049,287 9,289,112 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Stock-Based Awards | |
Schedule of stock-based compensation expense related to stock options | Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Research and development $ 1,206 $ 362 $ 1,883 $ 737 Selling and marketing 1,129 433 1,883 804 General and administrative 1,957 1,031 3,612 1,950 $ 4,292 $ 1,826 $ 7,378 $ 3,491 |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Nature of Business (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 |
Nature of the Business and Basis of Presentation | |||
Accumulated deficit | $ 544,611 | $ 539,251 | |
Cash and cash equivalents | $ 191,860 | $ 228,057 | $ 84,294 |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - Concentration of Credit Risk (Details) - Customer - customer | 3 Months Ended | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Total revenue | |||||
Concentration risk | |||||
Number of major customers | 3 | 3 | 3 | 3 | |
Total revenue | Customer one | |||||
Concentration risk | |||||
Concentration risk | 45.00% | 48.00% | 45.00% | 41.00% | |
Total revenue | Customer two | |||||
Concentration risk | |||||
Concentration risk | 28.00% | 16.00% | 25.00% | 19.00% | |
Total revenue | Customer three | |||||
Concentration risk | |||||
Concentration risk | 15.00% | 14.00% | 14.00% | 14.00% | |
Accounts receivable | |||||
Concentration risk | |||||
Number of major customers | 3 | 3 | |||
Accounts receivable | Customer one | |||||
Concentration risk | |||||
Concentration risk | 51.00% | 45.00% | |||
Accounts receivable | Customer two | |||||
Concentration risk | |||||
Concentration risk | 27.00% | 33.00% | |||
Accounts receivable | Customer three | |||||
Concentration risk | |||||
Concentration risk | 14.00% | 15.00% |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities - Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Liability: | ||
Derivative liability | $ 59,901 | $ 98,313 |
Recurring Basis | ||
Liability: | ||
Derivative liability | 59,901 | 98,313 |
Money Market Funds | Recurring Basis | ||
Assets: | ||
Cash equivalents | 187,384 | 213,372 |
Level 1 | Money Market Funds | Recurring Basis | ||
Assets: | ||
Cash equivalents | 187,384 | 213,372 |
Level 3 | Recurring Basis | ||
Liability: | ||
Derivative liability | $ 59,901 | $ 98,313 |
Restricted Cash (Details)
Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Jun. 30, 2020 | Dec. 31, 2019 |
Restricted Cash | ||||
Cash and cash equivalents | $ 191,860 | $ 228,057 | $ 84,294 | |
Restricted cash | 1,764 | 1,764 | 1,764 | |
Total cash, cash equivalents and restricted cash as shown on the statements of cash flows | $ 193,624 | $ 229,821 | $ 86,058 | $ 56,201 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Inventory | ||
Raw materials | $ 347 | $ 384 |
Work-in-process | 437 | 232 |
Finished goods | 328 | 585 |
Total inventory | $ 1,112 | $ 1,201 |
Accrued Expenses and other cu_3
Accrued Expenses and other current liabilities - Summary (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Accrued Expenses and Other Current Liabilities | ||
Accrued payroll and related expenses | $ 4,873 | $ 5,853 |
Accrued rebates and programs | 2,736 | 1,438 |
Accrued professional fees | 1,077 | 868 |
Accrued research and development expenses | 1,258 | 1,013 |
Accrued interest payable on 2026 convertible notes | 5,325 | 4,194 |
Accrued other | 913 | 941 |
Total | $ 16,182 | $ 14,307 |
Derivative Liability - Main Inp
Derivative Liability - Main Inputs to Valuing Convertible Notes with Conversion Option (Details) - 2026 Convertible Notes $ in Thousands | Jun. 30, 2021USD ($) | Dec. 31, 2020 |
Derivative Liability | ||
Estimated fair value | $ 92,181 | |
Conversion price | ||
Derivative Liability | ||
Debt instrument, measurement input | 14.18 | 20.70 |
Expected annual volatility | ||
Derivative Liability | ||
Debt instrument, measurement input | 97.7 | 105.5 |
Discount yield | ||
Derivative Liability | ||
Debt instrument, measurement input | 11.9 | 12 |
Derivative Liability - Roll for
Derivative Liability - Roll forward (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Roll forward of the derivative liability | |
Balance at beginning of period | $ 98,313 |
Change in fair value | (38,412) |
Balance at end of period | $ 59,901 |
Convertible Notes - Other (Deta
Convertible Notes - Other (Details) | Mar. 01, 2019USD ($)D$ / shares | Jun. 30, 2021USD ($)$ / shares | Dec. 31, 2020USD ($)$ / shares |
Senior Convertible Notes | |||
Common stock, par value | $ / shares | $ 0.0001 | $ 0.0001 | |
2026 Convertible Notes | |||
Senior Convertible Notes | |||
Convertible notes issued | $ | $ 37,500,000 | $ 37,500,000 | $ 37,500,000 |
Interest rate (as a percent) | 6.00% | ||
Effective annual interest rate (as a percent) | 14.80% | ||
Common stock, par value | $ / shares | $ 0.0001 | ||
Maximum beneficial ownership percent | 19.99% | ||
Conversion rate | 153.8462 | ||
Principal amount of debt that is used in conversion calculations | $ | $ 1,000 | ||
Initial conversion price | $ / shares | $ 6.50 | ||
Debt repurchase price percent | 100.00% | ||
Consecutive trading days | D | 20 | ||
Percentage of product of conversion rate and daily VWAP | 5.00% | ||
Percentage of outstanding principal amount | 100.00% | ||
2026 Convertible Notes | On or after March 1, 2022 | |||
Senior Convertible Notes | |||
Debt repurchase price percent | 100.00% | ||
Consecutive trading days | D | 30 | ||
Minimum percentage of common stock for conversion of debt | 130.00% | ||
Consecutive proceeding trading days for conversion of purchase price | $ | 20 |
Convertible Notes - Summary (De
Convertible Notes - Summary (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 | Mar. 01, 2019 |
Senior Convertible Notes | |||
Less: unamortized discount | $ (124) | $ (129) | |
2026 Convertible Notes | |||
Senior Convertible Notes | |||
Convertible notes | 37,500 | 37,500 | $ 37,500 |
Less: unamortized discount | (12,152) | (13,193) | |
Total | 25,348 | 24,307 | |
Accrued interest | $ 5,325 | $ 4,194 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Income Taxes | ||
Unrecognized tax benefits | $ 0 | $ 0 |
Accrued interest or tax penalties related to income taxes | $ 0 | $ 0 |
Collaboration Agreements - Addi
Collaboration Agreements - Additional Information (Details) - USD ($) $ in Thousands | Oct. 28, 2020 | Oct. 10, 2016 | Jun. 30, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
License Agreement | AffaMed | |||||
Collaboration Agreement | |||||
Amount of non-refundable upfront payments received | $ 12,000 | ||||
Additional payments to be received upon the achievement of certain development and commercial milestones | $ 91,000 | ||||
Collaboration Agreement | Regeneron | |||||
Collaboration Agreement | |||||
Payment receivable upon exercise of option | $ 10,000 | ||||
Amount of cost recorded, to date, for work performed for preclinical development activities in connection with the revised work plan | $ 418 | $ 515 | |||
Costs associated with preclinical development activities included in prepaid expenses and other current assets | $ 934 | $ 934 | $ 1,256 | ||
Collaboration Agreement | Regeneron | Maximum | |||||
Collaboration Agreement | |||||
Reimbursable clinical development costs | 25,000 | ||||
Potential increase in reimbursable clinical development costs | 5,000 | ||||
Potential payment receivable per Licensed Product upon the achievement of specified development and regulatory milestones | 145,000 | ||||
Potential payment receivable per Licensed Product upon first commercial sale of such Licensed Product | 100,000 | ||||
Potential payment receivable due for achievement of specified sales milestones for all Licensed Products | $ 50,000 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Details) | 1 Months Ended | ||||
Jun. 30, 2021USD ($) | Jan. 31, 2021USD ($)installment | Dec. 31, 2018USD ($) | May 31, 2021 | Dec. 31, 2020USD ($) | |
Notes Payable | |||||
Borrowing capacity under the agreement | $ 25,000,000 | ||||
Borrowings outstanding | 25,000,000 | $ 25,000,000 | |||
Credit Agreement, 2018 | |||||
Notes Payable | |||||
Outstanding borrowings under credit facility, net of unamortized discount | $ 25,000,000 | ||||
Debt Instrument, Percentage of Exit Fee | 3.50% | ||||
Accrued amount paid | $ 429,000 | ||||
Credit Agreement, 2018 | Period commencing January 2021 | |||||
Notes Payable | |||||
Number of equal monthly installments | installment | 36 | ||||
Required monthly principal payment | $ 694,000 | ||||
Credit Agreement, 2018 | LIBOR | |||||
Notes Payable | |||||
Interest rate (as a percent) | 9.25% | ||||
Interest rate floor (as a percent) | 2.00% | ||||
Basis spread (as a percent) | 7.25% | ||||
2021 Amended Credit Facility | |||||
Notes Payable | |||||
Borrowings outstanding | 25,000,000 | ||||
Indebtedness with existing lenders in which terms of credit facility were amended, amount | 20,833,000 | ||||
Incremental borrowing, amount | 4,167,000 | ||||
Final payment due at maturity | $ 5,208,000 | ||||
Effective annual interest rate (as a percent) | 8.80% | ||||
Exit fee (as a percent) | 3.50% | ||||
Exit fee, amount | $ 875,000 | ||||
Additional final payment | $ 875,000 | ||||
2021 Amended Credit Facility | Period commencing May 2024 | |||||
Notes Payable | |||||
Number of equal monthly installments | 19 | ||||
Required monthly principal payment | $ 1,042,000 | ||||
2021 Amended Credit Facility | Achievement of certain milestones | |||||
Notes Payable | |||||
Number of equal monthly installments | 5 | ||||
Required monthly principal payment | $ 1,042,000 | ||||
2021 Amended Credit Facility | LIBOR | |||||
Notes Payable | |||||
Interest rate floor (as a percent) | 1.00% | ||||
Basis spread (as a percent) | 6.75% |
Notes Payable - Borrowings Outs
Notes Payable - Borrowings Outstanding (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Notes Payable | ||
Borrowings outstanding | $ 25,000 | $ 25,000 |
Accrued exit fee | 15 | 355 |
Less: unamortized discount | 124 | 129 |
Borrowings | 24,891 | 25,226 |
Less: current portion | (8,290) | |
Long-term notes payable | $ 24,891 | $ 16,936 |
Notes Payable - Schedule of Ann
Notes Payable - Schedule of Annual Repayment Requirements for Credit Facility (Details) - 2021 Amended Credit Facility $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Annual repayment requirements | |
Credit Facility, Principal | $ 25,000 |
Credit Facility, Final Payment | 875 |
Credit Facility, Total | 25,875 |
2024 | |
Annual repayment requirements | |
Credit Facility, Principal | 8,333 |
Credit Facility, Total | 8,333 |
2025 | |
Annual repayment requirements | |
Credit Facility, Principal | 16,667 |
Credit Facility, Final Payment | 875 |
Credit Facility, Total | $ 17,542 |
Net Loss Per Share - Basic Net
Net Loss Per Share - Basic Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Basic net loss per share attributable to common stockholders: | ||||||
Net loss attributable to common stockholders | $ (8,481) | $ 3,121 | $ (36,568) | $ (21,512) | $ (5,360) | $ (58,080) |
Weighted average common shares outstanding, basic | 76,324,367 | 57,368,292 | 76,198,384 | 54,634,572 | ||
Net loss per share - basic | $ (0.11) | $ (0.64) | $ (0.07) | $ (1.06) |
Net Loss Per Share - Diluted Ne
Net Loss Per Share - Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Reconciliation of net loss attributable to common stockholders for basic and diluted net loss per share | ||||
Net loss attributable to common stockholders, basic | $ (8,481) | $ (5,360) | ||
Interest expense on 2026 Convertible Note | 1,095 | 2,173 | ||
Change in fair value of derivative liability | (13,396) | (38,412) | ||
Net loss attributable to common stockholders, diluted | $ (20,782) | $ (41,599) | ||
Weighted average common shares outstanding, basic | 76,324,367 | 57,368,292 | 76,198,384 | 54,634,572 |
Shares issuable upon conversion of 2026 Convertible Note, as if converted | 5,769,232 | 5,769,232 | ||
Weighted average common shares outstanding, diluted | 82,093,599 | 57,368,292 | 81,967,616 | 54,634,572 |
Net loss per share attributable to common stockholders diluted | $ (0.25) | $ (0.64) | $ (0.51) | $ (1.06) |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Antidilutive Securities, Excluded from Computation of Diluted Net Loss per Share (Details) - shares | Jun. 30, 2021 | Jun. 30, 2020 |
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Total common stock equivalents | 11,049,287 | 9,289,112 |
Options to Purchase Common Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Total common stock equivalents | 11,049,287 | 9,270,173 |
Warrant | Common Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Total common stock equivalents | 18,939 |
Stock-Based Awards - Additional
Stock-Based Awards - Additional Information (Details) - $ / shares | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Mar. 31, 2020 | Jun. 30, 2021 | Jan. 01, 2021 | |
Common Stock | |||||
Stock-Based Awards | |||||
Issuance of common stock in connection with employee stock purchase plan | 40,631 | 104,579 | |||
Issuance of common stock upon public offering, net of issuance costs, shares | 9,735,649 | 2,657,823 | |||
2014 Stock Incentive Plan | Common Stock | |||||
Stock-Based Awards | |||||
Increased number of shares of common stock reserved for issuance | 1,659,218 | ||||
Shares Issuable Under Options, Granted | 229,650 | 2,709,019 | |||
Exercise price (in dollars per share) | $ 16.54 | $ 18.19 | |||
2014 Employee Stock Purchase Plan | Common Stock | |||||
Stock-Based Awards | |||||
Increased number of shares of common stock reserved for issuance | 207,402 | ||||
Issuance of common stock in connection with employee stock purchase plan | 40,631 | ||||
Number of shares of common stock available for issuance | 690,965 | 690,965 | |||
2021 Incentive Plan | |||||
Stock-Based Awards | |||||
Number of shares of common stock authorized for issuance | 6,000,000 | 6,000,000 | |||
Shares Issuable Under Options, Granted | 9,766,336 | ||||
Number of shares of common stock available for issuance | 456,334 | 456,334 |
Stock-Based Awards - Inducement
Stock-Based Awards - Inducement Stock Option Awards (Detail) - 2019 Inducement Plan - shares | Jun. 30, 2021 | Dec. 10, 2020 | Oct. 29, 2019 |
Stock-Based Awards | |||
Number of shares of common stock authorized for issuance | 1,054,000 | 500,000 | |
Number of shares of common stock available for issuance | 504,251 |
Stock-Based Awards - Stock-Base
Stock-Based Awards - Stock-Based Compensation (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 |
Stock-based Compensation | |||||
Stock-based compensation expense | $ 4,292 | $ 1,826 | $ 7,378 | $ 3,491 | |
Unrecognized stock-based compensation cost | $ 26,106 | 26,106 | 26,106 | ||
Weighted average period of unrecognized stock-based compensation cost expected to be recognized | 3 years 2 months 12 days | ||||
Research and Development Expense | |||||
Stock-based Compensation | |||||
Stock-based compensation expense | 1,206 | 362 | 1,883 | 737 | |
Selling and Marketing Expense | |||||
Stock-based Compensation | |||||
Stock-based compensation expense | 1,129 | 433 | 1,883 | 804 | |
General and Administrative Expense | |||||
Stock-based Compensation | |||||
Stock-based compensation expense | $ 1,957 | $ 1,031 | $ 3,612 | $ 1,950 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Details) - Regeneron - Collaboration Agreement - Maximum $ in Thousands | Oct. 10, 2016USD ($) |
Commitments and Contingencies | |
Reimbursable clinical development costs | $ 25,000 |
Potential increase in reimbursable clinical development costs | $ 5,000 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Specialty Pharma | |||||
Related Party Transactions | |||||
Expenses incurred | $ 29 | $ 155 | |||
Accounts payable | $ 47 | ||||
Accrued expenses | 0 | ||||
McCarter | Legal Fees | |||||
Related Party Transactions | |||||
Expenses incurred | $ 221 | $ 512 | |||
Accounts payable | 47 | ||||
Accrued expenses | $ 0 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - $ / shares | 3 Months Ended | 6 Months Ended | |
Mar. 31, 2021 | Jun. 30, 2021 | Jan. 29, 2021 | |
Common Stock | |||
Warrants | |||
Common stock issued upon exercise of warrants | 11,737 | 11,737 | |
Common Stock Warrants | |||
Warrants | |||
Number of shares callable by warrants | 18,939 | ||
Weighted average exercise price to purchase common stock | $ 7.92 | ||
Warrants outstanding | 0 |
Common Stock (Details)
Common Stock (Details) - shares | Jun. 30, 2021 | Dec. 31, 2020 |
Common Stock | ||
Common Stock, Shares Authorized | 200,000,000 | 200,000,000 |
Subsequent Event (Details)
Subsequent Event (Details) $ in Thousands | Aug. 05, 2021USD ($) |
Subsequent Event | Collaboration Agreement | Regeneron | |
Subsequent Events | |
Maximum amount of reimbursable development costs, no further obligation due to termination of Collaboration Agreement | $ 30,000 |