Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2022 | Aug. 05, 2022 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2022 | |
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, $0.0001 par value per share | |
Trading Symbol | OCUL | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 76,966,889 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q2 | |
Entity Central Index Key | 0001393434 | |
Amendment Flag | false |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Current assets: | ||
Cash and cash equivalents | $ 134,539 | $ 164,164 |
Accounts receivable, net | 20,482 | 21,135 |
Inventory | 1,500 | 1,250 |
Prepaid expenses and other current assets | 3,801 | 4,751 |
Total current assets | 160,322 | 191,300 |
Property and equipment, net | 6,680 | 6,956 |
Restricted cash | 1,764 | 1,764 |
Operating lease assets | 4,305 | 4,867 |
Total assets | 173,071 | 204,887 |
Current liabilities: | ||
Accounts payable | 3,703 | 4,592 |
Accrued expenses and other current liabilities | 19,450 | 20,121 |
Deferred revenue | 1,189 | |
Operating lease liabilities | 1,771 | 1,624 |
Total current liabilities | 26,113 | 26,337 |
Other liabilities: | ||
Operating lease liabilities, net of current portion | 4,999 | 5,924 |
Derivative liability | 10,461 | 20,192 |
Deferred revenue, net of current portion | 13,000 | 13,000 |
Notes payable, net of discount | 25,128 | 25,000 |
2026 convertible notes, net | 27,567 | 26,435 |
Total liabilities | 107,268 | 116,888 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at June 30, 2022 and December 31, 2021, respectively | ||
Common stock, $0.0001 par value; 200,000,000 shares authorized and 76,910,026 and 76,731,940 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively | 8 | 8 |
Additional paid-in capital | 642,907 | 633,795 |
Accumulated deficit | (577,112) | (545,804) |
Total stockholders' equity | 65,803 | 87,999 |
Total liabilities and stockholders' equity | $ 173,071 | $ 204,887 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2022 | Dec. 31, 2021 |
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 | 76,910,026 | 76,731,940 |
Common stock, shares outstanding | 76,910,026 | 76,731,940 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Revenue: | ||||
Total revenue, net | $ 12,266 | $ 11,718 | $ 25,453 | $ 19,061 |
Costs and operating expenses: | ||||
Cost, Product and Service [Extensible List] | Product | Product | Product | Product |
Cost of product revenue | $ 1,155 | $ 1,096 | $ 2,454 | $ 1,988 |
Research and development | 13,100 | 13,859 | 26,200 | 24,786 |
Selling and marketing | 10,140 | 8,391 | 19,203 | 16,477 |
General and administrative | 7,787 | 8,603 | 15,344 | 16,268 |
Total costs and operating expenses | 32,182 | 31,949 | 63,201 | 59,519 |
Loss from operations | (19,916) | (20,231) | (37,748) | (40,458) |
Other income: | ||||
Interest income | 73 | 8 | 89 | 20 |
Interest expense | (1,696) | (1,655) | (3,378) | (3,335) |
Change in fair value of derivative liability | 2,773 | 13,396 | 9,731 | 38,412 |
Other income (expense), net | 1 | (2) | 1 | |
Total other income, net | 1,150 | 11,750 | 6,440 | 35,098 |
Net loss | $ (18,766) | $ (8,481) | $ (31,308) | $ (5,360) |
Net loss per share, basic | $ (0.24) | $ (0.11) | $ (0.41) | $ (0.07) |
Weighted average common shares outstanding, basic | 76,764,296 | 76,324,367 | 76,755,028 | 76,198,384 |
Net loss per share, diluted | $ (0.25) | $ (0.25) | $ (0.47) | $ (0.51) |
Weighted average common shares outstanding, diluted | 82,533,528 | 82,093,599 | 82,524,260 | 81,967,616 |
Product | ||||
Revenue: | ||||
Total revenue, net | $ 12,144 | $ 11,718 | $ 24,642 | $ 19,061 |
Collaboration revenue | ||||
Revenue: | ||||
Total revenue, net | $ 122 | $ 811 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (31,308) | $ (5,360) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Stock-based compensation expense | 8,490 | 7,378 |
Non-cash interest expense | 2,391 | 2,282 |
Change in fair value of derivative liability | (9,731) | (38,412) |
Depreciation and amortization expense | 1,109 | 1,257 |
Loss on disposal of property and equipment | 2 | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 653 | (6,482) |
Prepaid expenses and other current assets | 950 | (167) |
Inventory | (250) | 89 |
Operating lease assets | 562 | 466 |
Accounts payable | (809) | 1,255 |
Accrued expenses | (1,946) | 928 |
Deferred revenue | 1,189 | |
Operating lease liabilities | (778) | (649) |
Net cash used in operating activities | (29,476) | (37,415) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (771) | (287) |
Net cash used in investing activities | (771) | (287) |
Cash flows from financing activities: | ||
Proceeds from issuance of notes payable, net | 3,722 | |
Proceeds from exercise of stock options | 140 | 1,735 |
Proceeds from issuance of common stock pursuant to employee stock purchase plan | 482 | 490 |
Issuance costs from the issuance of common stock upon public offering | (275) | |
Repayment of notes payable | (4,167) | |
Net cash provided by financing activities | 622 | 1,505 |
Net decrease in cash, cash equivalents and restricted cash | (29,625) | (36,197) |
Cash, cash equivalents and restricted cash at beginning of period | 165,928 | 229,821 |
Cash, cash equivalents and restricted cash at end of period | 136,303 | 193,624 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 990 | 1,065 |
Supplemental disclosure of non-cash investing and financing activities: | ||
Additions to property and equipment included in accounts payable and accrued expenses | $ 245 | $ 8 |
Condensed Consolidated Statem_3
Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
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 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) | ||||
Net 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 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 | |||
Balance at Dec. 31, 2021 | $ 8 | 633,795 | (545,804) | 87,999 |
Balance, shares at Dec. 31, 2021 | 76,731,940 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 129 | 129 | ||
Issuance of common stock upon exercise of stock options, shares | 27,674 | |||
Stock-based compensation expense | 4,209 | 4,209 | ||
Net loss | (12,542) | (12,542) | ||
Balance at Mar. 31, 2022 | $ 8 | 638,133 | (558,346) | 79,795 |
Balance, shares at Mar. 31, 2022 | 76,759,614 | |||
Balance at Dec. 31, 2021 | $ 8 | 633,795 | (545,804) | 87,999 |
Balance, shares at Dec. 31, 2021 | 76,731,940 | |||
Stockholders' Equity (Deficit) | ||||
Net loss | (31,308) | |||
Balance at Jun. 30, 2022 | $ 8 | 642,907 | (577,112) | 65,803 |
Balance, shares at Jun. 30, 2022 | 76,910,026 | |||
Balance at Mar. 31, 2022 | $ 8 | 638,133 | (558,346) | 79,795 |
Balance, shares at Mar. 31, 2022 | 76,759,614 | |||
Stockholders' Equity (Deficit) | ||||
Issuance of common stock upon exercise of stock options | 11 | 11 | ||
Issuance of common stock upon exercise of stock options, shares | 9,469 | |||
Issuance of common stock in connection with employee stock purchase plan | 482 | 482 | ||
Issuance of common stock in connection with employee stock purchase plan, shares | 140,943 | |||
Stock-based compensation expense | 4,281 | 4,281 | ||
Net loss | (18,766) | (18,766) | ||
Balance at Jun. 30, 2022 | $ 8 | $ 642,907 | $ (577,112) | $ 65,803 |
Balance, shares at Jun. 30, 2022 | 76,910,026 |
Nature of the Business and Basi
Nature of the Business and Basis of Presentation | 6 Months Ended |
Jun. 30, 2022 | |
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 candidates are designed to 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 product candidates, undertaking preclinical studies and clinical trials, manufacturing its products and product candidates, building its sales and marketing infrastructure for the commercialization of the Company’s approved products and product candidates, and commercializing its approved products. 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. Newly-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, 2022, the Company had two U.S. Food and Drug Administration (“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, is not currently being manufactured by the Company, and has not in the past generated, nor is it anticipated to in the future to generate, material revenues. The Company’s most advanced product candidates are in either Phase 1 or Phase 2 of 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 incurred losses and negative cash flows from operations since its inception, and the Company expects to continue to generate operating losses and negative cash flows from operations in the foreseeable future. As of June 30, 2022, the Company had an accumulated deficit of 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”). The significant accounting policies used in preparation of these financial statements are consistent with those described in Note 2 - Summary of Significant Accounting Policies in our 2021 Annual Report on Form 10-K. Unaudited Interim Financial Information The balance sheet at December 31, 2021 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited financial statements as of June 30, 2022 and for the three and six months ended June 30, 2022 and 2021 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, 2021 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 28, 2022. 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, 2022 and results of operations and cash flows for the three and six months ended June 30, 2022 and 2021 have been made. The results of operations for the three and six months ended June 30, 2022 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2022 . Effects of COVID-19 The pandemic caused by an outbreak of a new strain of coronavirus, ( the “COVID-19 pandemic”) that is affecting the U.S. and global economy and financial markets and the related responses of government, businesses and individuals are impacting our employees, patients, customers, communities and business operations. The implementation of travel bans and restrictions, quarantines, shelter-in-place/stay-at-home and social distancing orders and shutdowns, for example, affected our business in 2020 and 2021. During the first half of 2022, the COVID-19 pandemic and related employee recruitment and retention challenges for ambulatory surgical centers (“ASCs”), and hospital out-patient departments (“HOPDs”) slowed the overall pace of cataract procedures performed in the United States, thereby reducing the number of opportunities for ophthalmologists to use DEXTENZA as a treatment for post-surgical ocular inflammation and pain. In addition, recruitment and retention challenges with regards to the Company’s own sales force have adversely affected its ability to market DEXTENZA to ophthalmologists and in the office setting. The full extent to which the COVID-19 pandemic will continue to directly or indirectly impact the Company’s business, results of operations and financial condition and those of the Company’s customers, vendors, suppliers, and collaboration partners will depend on future developments that are highly uncertain and cannot be accurately predicted, 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 markets. Management continues to actively monitor this situation and the possible effects on the Company’s financial condition, liquidity, operations, suppliers, industry, and workforce. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2022 | |
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. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results may differ from these estimates. 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 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, 2022, four specialty distributor customers accounted for 41%, 26%, 17%, and 10%, and three specialty distributor customers accounted for 41%, 25% and 20% , respectively, of the Company’s total product revenue, and no other customer accounted for more than 10% of the Company’s total product revenue. At June 30, 2022, For the three and six months ended June 30, 2021, three specialty distributor customers accounted for 45%, 28% , and , respectively, of the Company’s total product revenue, and no other customer accounted for more than 10% of the Company’s total product revenue. At December 31, 2021, three specialty distributor customers accounted for 42%, 26% and 21% of the Company’s total accounts receivable. No other customer accounted for more than 10% of total accounts receivable for the year ended December 31, 2021. Recently Adopted Accounting Pronouncements Effective January 1, 2022, the Company adopted 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), which 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 adoption of this standard did not have any impact on the Company’s condensed consolidated financial statements. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 and December 31, 2021 and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of June 30, 2022 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 32,424 $ — $ — $ 32,424 Liability: Derivative liability (Note 7) $ — $ — $ 10,461 $ 10,461 Fair Value Measurements as of December 31, 2021 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 62,392 $ — $ — $ 62,392 Liability: Derivative liability (Note 7) $ — $ — $ 20,192 $ 20,192 |
Restricted Cash
Restricted Cash | 6 Months Ended |
Jun. 30, 2022 | |
Restricted Cash | |
Restricted Cash | 4. Restricted Cash The Company held restricted cash of $1,764 at June 30, 2022 and December 31, 2021, on its condensed consolidated balance sheet. The Company held restricted cash as security deposits for the lease of its research and development space, 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, 2022 2021 Cash and cash equivalents $ 134,539 $ 191,860 Restricted cash 1,764 1,764 Total cash, cash equivalents and restricted cash $ 136,303 $ 193,624 |
Inventory
Inventory | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 Raw materials $ 325 $ 388 Work-in-process 662 605 Finished goods 513 257 $ 1,500 $ 1,250 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 and December 31, 2021 consisted of the following: June 30, December 31, 2022 2021 Accrued payroll and related expenses $ 4,747 $ 6,597 Accrued rebates and programs 3,260 3,615 Accrued professional fees 1,081 1,227 Accrued research and development expenses 1,683 1,102 Accrued interest payable on 2026 convertible notes 7,606 6,475 Accrued other 1,073 1,105 $ 19,450 $ 20,121 |
Derivative Liability
Derivative Liability | 6 Months Ended |
Jun. 30, 2022 | |
Derivative Liability | |
Derivative Liability | 7. Derivative Liability The unsecured senior subordinated convertible notes (the “2026 Convertible Notes”) (Note 8) contains an embedded conversion option that meets 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 $41,092 at June 30, 2022. 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 inputs when determining the fair value for disclosure purposes are the common stock price and bond yield which are 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, 2022 2021 Company's stock price $ 4.02 $ 6.97 Expected annual volatility 80.7 % 82.6 % Bond yield 16.4 % 12.6 % A roll-forward of the derivative liability is as follows: As of June 30, 2022 Balance at December 31, 2021 $ 20,192 Change in fair value (9,731) Balance at June 30, 2022 $ 10,461 |
Convertible Notes
Convertible Notes | 6 Months Ended |
Jun. 30, 2022 | |
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 accrued 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 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. The terms and conditions of the 2026 Convertible Notes are described in the Company’s periodic reports including its Annual Report on Form 10-K for the year ended December 31, 2021 filed with the SEC on February 28, 2022. A summary of the 2026 Convertible Notes at June 30, 2022 and December 31, 2021 is as follows: June 30, December 31, 2022 2021 2026 Convertible Notes $ 37,500 $ 37,500 Less: unamortized discount (9,933) (11,065) Total $ 27,567 $ 26,435 Accrued interest related to the 2026 Convertible Notes amounted to $7,606 and $6,475 at June 30, 2022 and December 31, 2021, respectively. |
Income Taxes
Income Taxes | 6 Months Ended |
Jun. 30, 2022 | |
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 income (loss) for the three and six month periods ended June 30, 2022 or 2021. The Company has provided a valuation allowance for the full amount of its net deferred tax assets because, at June 30, 2022 and December 31, 2021, 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. |
Collaboration Agreements
Collaboration Agreements | 6 Months Ended |
Jun. 30, 2022 | |
Collaboration Agreements | |
Collaboration Agreements | 10. Collaboration Agreements AffaMed License Agreement In October 2020, the Company entered into a license agreement with AffaMed Therapeutics Limited (“AffaMed”) for the development and commercialization of the Company’s DEXTENZA product regarding ocular inflammation and pain following cataract surgery and ocular itching associated with allergic conjunctivitis and for the Company’s OTX-TIC product candidate (collectively with DEXTENZA, the “AffaMed Licensed Products”) regarding open-angle glaucoma or ocular hypertension, in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations. The Company and AffaMed subsequently amended the license agreement in October 2021 (as amended, the “License Agreement”). The Company retains development and commercialization rights for the AffaMed Licensed Products in the rest of the world. The terms and conditions of the License Agreement are described in the Company’s periodic reports including its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 28, 2022. The Company recognized $122 and $811 of collaboration revenue related to the performance obligation to conduct a Phase 2 clinical trial of OTX-TIC under the License Agreement for the three and six months ended June 30, 2022. During the three months ended March 31, 2022, the Company invoiced AffaMed $2,000 for a clinical trial support payment, under the License Agreement, in connection with the initiation of the OTX-TIC Phase 2 clinical trial. The Company concluded this clinical support payment was no longer constrained and has allocated the amount to the performance obligation to conduct a Phase 2 clinical trial of OTX-TIC. As of June 30, 2022, the aggregate amount of the transaction price allocated to performance obligations that are partially unsatisfied was $1,189 . This amount is expected to be recognized as performance obligations are satisfied through June 2023. For the Phase 2 clinical trial of OTX-TIC, performance obligation revenue is recognized under an input method using the ratio of effort incurred to date compared to the total estimated effort required to complete the performance obligation. The calculation of the total estimated effort includes the total amount of forecasted costs associated with the completion of the Phase 2 clinical trial, as well as the assumed timing of this activity. Such cost estimates include forecasted direct labor and material costs, subcontractor costs, and external contract research organization, or CRO, costs. Deferred revenue activity for the six months ended June 30, 2022 was as follows: Deferred Revenue Deferred revenue at December 31, 2021 $ 13,000 Additions 2,000 Amounts recognized into revenue (811) Deferred revenue at June 30, 2022 $ 14,189 As of June 30, 2022, the aggregate amount of the transaction price allocated to DEXTENZA product and OTX-TIC product performance obligations that are partially unsatisfied was $13,000 . This amount is expected to be recognized as performance obligations are satisfied. The Company recognizes revenue related to the amounts allocated to the combined performance obligations for the development and commercialization of the Company’s DEXTENZA product regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis 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 currently expects to recognize the revenue over a period of approximately seven commencing on the date the Company begins delivering product to AffaMed. This estimate of this period considers the timing of development and commercial activities under the License Agreement and may be reduced or increased based on the various activities as directed by the joint committees, decisions made by AffaMed, regulatory feedback or other factors not currently known. |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2022 | |
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”). Under the Credit Facility, the Company has a total borrowing capacity of , which was fully drawn down as of June 30, 2022. The carrying value of the Company’s variable interest rate notes payable are recorded at amortized cost, which approximates fair value due to their short-term nature. The terms and conditions of the Credit Agreement and the Credit Facility are described in the Company’s periodic reports including its Annual Report on Form 10-K for the year ended December 31, 2021, filed with the SEC on February 28, 2022. Borrowings outstanding are as follows : June 30, December 31, 2022 2021 Borrowings outstanding $ 25,000 $ 25,000 Accrued exit fee 222 110 Unamortized discount (94) (110) Long-term notes payable $ 25,128 $ 25,000 As of June 30, 2022, the annual requirement for the repayment of principal for the Credit Facility, inclusive of the final payment of $875 due at expiration, was as follows: Year Ending December 31, Principal Final Payment Total 2022 (July 1 to December 31) — — — 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, 2022 | |
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, 2022 and 2021. Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Numerator: Net loss attributable to common stockholders $ (18,766) $ (8,481) $ (31,308) $ (5,360) Denominator: Weighted average common shares outstanding, basic 76,764,296 76,324,367 76,755,028 76,198,384 Net loss per share - basic $ (0.24) $ (0.11) $ (0.41) $ (0.07) Diluted net loss per share was calculated as follows for the three and six months ended June 30, 2022 and 2021: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Net loss attributable to common stockholders, basic $ (18,766) $ (8,481) $ (31,308) $ (5,360) Interest expense on 2026 Convertible Notes 1,141 1,095 2,264 2,173 Change in fair value of derivative liability (2,773) (13,396) (9,731) (38,412) Net loss attributable to common stockholders, diluted $ (20,398) $ (20,782) $ (38,775) $ (41,599) Weighted average common shares outstanding, basic 76,764,296 76,324,367 76,755,028 76,198,384 Shares issuable upon conversion of 2026 Convertible Notes, as if converted 5,769,232 5,769,232 5,769,232 5,769,232 Weighted average common shares outstanding, diluted 82,533,528 82,093,599 82,524,260 81,967,616 Net loss per share attributable to common stockholders, diluted $ (0.25) $ (0.25) $ (0.47) $ (0.51) The Company excluded the following common stock equivalents and restricted stock units, outstanding as of June 30, 2022 and 2021, from the computation of diluted net loss per share for the six months ended June 30, 2022 and 2021 because they had an anti-dilutive impact. Six Months Ended June 30, 2022 2021 Options to purchase common stock 13,892,884 11,049,287 Restricted stock units 1,017,111 — 14,909,995 11,049,287 |
Stock-Based Awards
Stock-Based Awards | 6 Months Ended |
Jun. 30, 2022 | |
Stock-Based Awards | |
Stock-Based Awards | 13. Stock-Based Awards 2021 Stock Incentive Plan The 2021 Stock Incentive 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. Upon its adoption, the number of shares of common stock authorized for issuance under the 2021 Stock Incentive Plan equaled the total of At the Company’s 2022 Annual Meeting of Stockholders held on June 16, 2022, the Company’s stockholders approved an amendment to the 2021 Stock Incentive Plan (as amended, the “2021 Plan”) to increase the number of shares of common stock authorized for issuance under the 2021 Plan by 3,600,000 shares. As of June 30, 2022, Stock Option Awards for the Three and Six months Ended June 30, 2022 During the three and six months ended June 30, 2022, the Company granted options to purchase 557,050 and 3,419,253 shares of common stock, at a weighted exercise price of $3.69 and $5.02, respectively, per share under the 2021 Plan. Restricted Stock Units (RSU) Awards for the Three and Six months Ended June 30, 2022 During the three and six months ended June 30, 2022, the Company granted 120,404 and 1,054,883 restricted stock units (“RSUs”), respectively, under the 2021 Plan. Each RSU is equivalent to one share of common stock upon vesting. Each RSU award vests on an annual basis over a period. Holders of RSUs are not entitled to vote on any matters and are not entitled to dividends. The Company has determined the fair value of each RSU based on the closing price of the Company’s common stock on the date of grant and recognizes the compensation expense using the straight-line method over the service period, which coincides with the vesting period. Stock-based Compensation Expense The Company recorded stock-based compensation expense related to stock options and RSUs in the following expense categories of its condensed consolidated statements of operations: Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Research and development $ 1,036 $ 1,206 $ 2,098 $ 1,883 Selling and marketing 1,191 1,129 2,329 1,883 General and administrative 2,054 1,957 4,063 3,612 $ 4,281 $ 4,292 $ 8,490 $ 7,378 As of June 30, 2022, the Company had an aggregate of $25,612 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.7 years. |
Related Party Transactions
Related Party Transactions | 6 Months Ended |
Jun. 30, 2022 | |
Related Party Transactions | |
Related Party Transactions | 14. Related Party Transactions In November 2020, the Company 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 , for the three and six months ended June 30, 2021, respectively. On April 26, 2021, the Company and Specialty Pharma terminated their relationship. The Company has engaged Wilmer Cutler Pickering Hale and Dorr LLP (“WilmerHale”) to provide certain legal services to the Company. The Company's Chief Business Officer’s sister is a managing partner at WilmerHale, who has not participated in providing legal services to the Company. The Company incurred fees for legal services rendered by WilmerHale of approximately $211 and $535 for the three and six months ended June 30, 2022, respectively. As of June 30, 2022 and December 31, 2021, there was $153 and $119 recorded in accounts payable for WilmerHale. As of June 30, 2022 and December 31, 2021, there was $58 and $68 recorded in accrued expenses for WilmerHale. |
Common Stock
Common Stock | 6 Months Ended |
Jun. 30, 2022 | |
Common Stock. | |
Common Stock | 15. Common Stock On August 9, 2021, the Company and Jefferies LLC (“Jefferies”) mutually terminated an Open Market Sale Agreement and entered into another Open Market Sale Agreement (the “2021 Sales Agreement”) under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $100,000 from time to time through Jefferies, acting as agent. As of August 5, 2022, the Company has |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2022 | |
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. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results may differ from these estimates. |
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 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, 2022, four specialty distributor customers accounted for 41%, 26%, 17%, and 10%, and three specialty distributor customers accounted for 41%, 25% and 20% , respectively, of the Company’s total product revenue, and no other customer accounted for more than 10% of the Company’s total product revenue. At June 30, 2022, For the three and six months ended June 30, 2021, three specialty distributor customers accounted for 45%, 28% , and , respectively, of the Company’s total product revenue, and no other customer accounted for more than 10% of the Company’s total product revenue. At December 31, 2021, three specialty distributor customers accounted for 42%, 26% and 21% of the Company’s total accounts receivable. No other customer accounted for more than 10% of total accounts receivable for the year ended December 31, 2021. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements Effective January 1, 2022, the Company adopted 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), which 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 adoption of this standard did not have any impact on the Company’s condensed consolidated financial statements. |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 32,424 $ — $ — $ 32,424 Liability: Derivative liability (Note 7) $ — $ — $ 10,461 $ 10,461 Fair Value Measurements as of December 31, 2021 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Money market funds $ 62,392 $ — $ — $ 62,392 Liability: Derivative liability (Note 7) $ — $ — $ 20,192 $ 20,192 |
Restricted Cash (Tables)
Restricted Cash (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
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, 2022 2021 Cash and cash equivalents $ 134,539 $ 191,860 Restricted cash 1,764 1,764 Total cash, cash equivalents and restricted cash $ 136,303 $ 193,624 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Inventory | |
Components of inventory | June 30, December 31, 2022 2021 Raw materials $ 325 $ 388 Work-in-process 662 605 Finished goods 513 257 $ 1,500 $ 1,250 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Accrued Expenses and Other Current Liabilities | |
Schedule of accrued Expenses and Other Current Liabilities | June 30, December 31, 2022 2021 Accrued payroll and related expenses $ 4,747 $ 6,597 Accrued rebates and programs 3,260 3,615 Accrued professional fees 1,081 1,227 Accrued research and development expenses 1,683 1,102 Accrued interest payable on 2026 convertible notes 7,606 6,475 Accrued other 1,073 1,105 $ 19,450 $ 20,121 |
Derivative Liability (Tables)
Derivative Liability (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Derivative Liability | |
Schedule of main inputs to valuing the 2026 Convertible Notes with the conversion option | As of June 30, December 31, 2022 2021 Company's stock price $ 4.02 $ 6.97 Expected annual volatility 80.7 % 82.6 % Bond yield 16.4 % 12.6 % |
Summary of roll-forward of the derivative liability | As of June 30, 2022 Balance at December 31, 2021 $ 20,192 Change in fair value (9,731) Balance at June 30, 2022 $ 10,461 |
Convertible Notes (Tables)
Convertible Notes (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Convertible Notes | |
Summary of the 2026 Convertible Notes | A summary of the 2026 Convertible Notes at June 30, 2022 and December 31, 2021 is as follows: June 30, December 31, 2022 2021 2026 Convertible Notes $ 37,500 $ 37,500 Less: unamortized discount (9,933) (11,065) Total $ 27,567 $ 26,435 |
Collaboration Agreements (Table
Collaboration Agreements (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Collaboration Agreements | |
Schedule of deferred revenue | Deferred Revenue Deferred revenue at December 31, 2021 $ 13,000 Additions 2,000 Amounts recognized into revenue (811) Deferred revenue at June 30, 2022 $ 14,189 |
Notes Payable (Tables)
Notes Payable (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Notes Payable | |
Schedule of borrowings outstanding | June 30, December 31, 2022 2021 Borrowings outstanding $ 25,000 $ 25,000 Accrued exit fee 222 110 Unamortized discount (94) (110) Long-term notes payable $ 25,128 $ 25,000 |
Schedule of Annual Repayment Requirements for Credit Facility | Year Ending December 31, Principal Final Payment Total 2022 (July 1 to December 31) — — — 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, 2022 | |
Net Loss Per Share | |
Schedule of basic and diluted net (loss) income per share attributable to common stockholders | Basic net loss per share was calculated as follows for the three and six months ended June 30, 2022 and 2021. Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Numerator: Net loss attributable to common stockholders $ (18,766) $ (8,481) $ (31,308) $ (5,360) Denominator: Weighted average common shares outstanding, basic 76,764,296 76,324,367 76,755,028 76,198,384 Net loss per share - basic $ (0.24) $ (0.11) $ (0.41) $ (0.07) Diluted net loss per share was calculated as follows for the three and six months ended June 30, 2022 and 2021: Three Months Ended June 30, Six Months Ended June 30, 2022 2021 2022 2021 Net loss attributable to common stockholders, basic $ (18,766) $ (8,481) $ (31,308) $ (5,360) Interest expense on 2026 Convertible Notes 1,141 1,095 2,264 2,173 Change in fair value of derivative liability (2,773) (13,396) (9,731) (38,412) Net loss attributable to common stockholders, diluted $ (20,398) $ (20,782) $ (38,775) $ (41,599) Weighted average common shares outstanding, basic 76,764,296 76,324,367 76,755,028 76,198,384 Shares issuable upon conversion of 2026 Convertible Notes, as if converted 5,769,232 5,769,232 5,769,232 5,769,232 Weighted average common shares outstanding, diluted 82,533,528 82,093,599 82,524,260 81,967,616 Net loss per share attributable to common stockholders, diluted $ (0.25) $ (0.25) $ (0.47) $ (0.51) |
Schedule of antidilutive securities, excluded from computation of diluted net loss per share | Six Months Ended June 30, 2022 2021 Options to purchase common stock 13,892,884 11,049,287 Restricted stock units 1,017,111 — 14,909,995 11,049,287 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 6 Months Ended |
Jun. 30, 2022 | |
Stock-Based Awards | |
Schedule of stock-based compensation expense related to stock options | Three Months Ended Six Months Ended June 30, June 30, 2022 2021 2022 2021 Research and development $ 1,036 $ 1,206 $ 2,098 $ 1,883 Selling and marketing 1,191 1,129 2,329 1,883 General and administrative 2,054 1,957 4,063 3,612 $ 4,281 $ 4,292 $ 8,490 $ 7,378 |
Nature of the Business and Ba_2
Nature of the Business and Basis of Presentation - Nature of Business (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 |
Nature of the Business and Basis of Presentation | |||
Accumulated deficit | $ 577,112 | $ 545,804 | |
Cash and cash equivalents | $ 134,539 | $ 164,164 | $ 191,860 |
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, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Total revenue | |||||
Concentration risk | |||||
Number of major customers | 4 | 3 | 3 | 3 | |
Total revenue | Customer one | |||||
Concentration risk | |||||
Concentration risk | 41% | 45% | 41% | 45% | |
Total revenue | Customer two | |||||
Concentration risk | |||||
Concentration risk | 26% | 28% | 25% | 25% | |
Total revenue | Customer three | |||||
Concentration risk | |||||
Concentration risk | 17% | 15% | 20% | 14% | |
Total revenue | Customer four | |||||
Concentration risk | |||||
Concentration risk | 10% | ||||
Accounts receivable | |||||
Concentration risk | |||||
Number of major customers | 4 | 3 | |||
Accounts receivable | Customer one | |||||
Concentration risk | |||||
Concentration risk | 46% | 42% | |||
Accounts receivable | Customer two | |||||
Concentration risk | |||||
Concentration risk | 25% | 26% | |||
Accounts receivable | Customer three | |||||
Concentration risk | |||||
Concentration risk | 16% | 21% | |||
Accounts receivable | Customer four | |||||
Concentration risk | |||||
Concentration risk | 10% |
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, 2022 | Dec. 31, 2021 |
Liability: | ||
Derivative liability | $ 10,461 | $ 20,192 |
Recurring Basis | ||
Liability: | ||
Derivative liability | 10,461 | 20,192 |
Money Market Funds | Recurring Basis | ||
Assets: | ||
Cash equivalents | 32,424 | 62,392 |
Level 1 | Money Market Funds | Recurring Basis | ||
Assets: | ||
Cash equivalents | 32,424 | 62,392 |
Level 3 | Recurring Basis | ||
Liability: | ||
Derivative liability | $ 10,461 | $ 20,192 |
Restricted Cash (Details)
Restricted Cash (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Jun. 30, 2021 | Dec. 31, 2020 |
Restricted Cash | ||||
Cash and cash equivalents | $ 134,539 | $ 164,164 | $ 191,860 | |
Restricted cash | 1,764 | 1,764 | 1,764 | |
Total cash, cash equivalents and restricted cash as shown on the statements of cash flows | $ 136,303 | $ 165,928 | $ 193,624 | $ 229,821 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Inventory | ||
Raw materials | $ 325 | $ 388 |
Work-in-process | 662 | 605 |
Finished goods | 513 | 257 |
Total inventory | $ 1,500 | $ 1,250 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities - Summary (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Accrued Expenses and Other Current Liabilities | ||
Accrued payroll and related expenses | $ 4,747 | $ 6,597 |
Accrued rebates and programs | 3,260 | 3,615 |
Accrued professional fees | 1,081 | 1,227 |
Accrued research and development expenses | 1,683 | 1,102 |
Accrued interest payable on 2026 convertible notes | 7,606 | 6,475 |
Accrued other | 1,073 | 1,105 |
Total | $ 19,450 | $ 20,121 |
Derivative Liability - Main Inp
Derivative Liability - Main Inputs to Valuing Convertible Notes with Conversion Option (Details) - 2026 Convertible Notes $ in Thousands | Jun. 30, 2022 USD ($) | Dec. 31, 2021 |
Derivative Liability | ||
Estimated fair value | $ 41,092 | |
Company's stock price | ||
Derivative Liability | ||
Debt instrument, measurement input | 4.02 | 6.97 |
Expected annual volatility | ||
Derivative Liability | ||
Debt instrument, measurement input | 80.7 | 82.6 |
Bond yield | ||
Derivative Liability | ||
Debt instrument, measurement input | 16.4 | 12.6 |
Derivative Liability - Roll for
Derivative Liability - Roll forward (Details) $ in Thousands | 6 Months Ended |
Jun. 30, 2022 USD ($) | |
Roll forward of the derivative liability | |
Balance at beginning of period | $ 20,192 |
Change in fair value | (9,731) |
Balance at end of period | $ 10,461 |
Convertible Notes - Other (Deta
Convertible Notes - Other (Details) | Mar. 01, 2019 USD ($) D $ / shares | Jun. 30, 2022 USD ($) $ / shares | Dec. 31, 2021 USD ($) $ / 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% | ||
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% | ||
Consecutive trading days | D | 20 | ||
Percentage of product of conversion rate and daily VWAP | 5% | ||
2026 Convertible Notes | On or after March 1, 2022 | |||
Senior Convertible Notes | |||
Debt repurchase price percent | 100% | ||
Consecutive trading days | D | 30 | ||
Minimum percentage of common stock for conversion of debt | 130% | ||
Consecutive proceeding trading days for conversion of purchase price | D | 20 |
Convertible Notes - Summary (De
Convertible Notes - Summary (Details) - 2026 Convertible Notes - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 | Mar. 01, 2019 |
Senior Convertible Notes | |||
Convertible notes | $ 37,500 | $ 37,500 | $ 37,500 |
Less: unamortized discount | (9,933) | (11,065) | |
Total | 27,567 | 26,435 | |
Accrued interest | $ 7,606 | $ 6,475 |
Collaboration Agreements - Addi
Collaboration Agreements - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Collaboration Agreement | |||||
Revenue recognized | $ 12,266 | $ 11,718 | $ 25,453 | $ 19,061 | |
Total deferred revenue: | |||||
Deferred revenue, beginning balance | $ 13,000 | 13,000 | |||
Additions | 2,000 | ||||
Amounts recognized into revenue | (811) | ||||
Deferred revenue, ending balance | 14,189 | 14,189 | |||
License Agreement | AffaMed | |||||
Collaboration Agreement | |||||
Transaction price allocated to performance obligations partially unsatisfied | $ 13,000 | $ 13,000 | |||
License Agreement | AffaMed | Minimum | |||||
Collaboration Agreement | |||||
Remaining performance obligation, expected timing of satisfaction, period | 7 years | 7 years | |||
License Agreement | AffaMed | Maximum | |||||
Collaboration Agreement | |||||
Remaining performance obligation, expected timing of satisfaction, period | 8 years | 8 years | |||
License Agreement | AffaMed | OTX-TIC Product | |||||
Collaboration Agreement | |||||
Revenue recognized | $ 122 | $ 811 | |||
Amount invoiced for initiation of OTX-TIC program | $ 2,000 | ||||
Transaction price allocated to performance obligations partially unsatisfied | $ 1,189 | $ 1,189 |
Notes Payable - Additional Info
Notes Payable - Additional Information (Details) $ in Thousands | Jun. 30, 2022 USD ($) |
Credit Facility. | |
Notes Payable | |
Borrowing capacity under the agreement | $ 25,000 |
Notes Payable - Borrowings Outs
Notes Payable - Borrowings Outstanding (Details) - USD ($) $ in Thousands | Jun. 30, 2022 | Dec. 31, 2021 |
Notes Payable | ||
Long-term notes payable | $ 25,128 | $ 25,000 |
Credit Facility. | ||
Notes Payable | ||
Borrowings outstanding | 25,000 | 25,000 |
Accrued exit fee | 222 | 110 |
Unamortized discount | (94) | (110) |
Long-term notes payable | $ 25,128 | $ 25,000 |
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, 2022 USD ($) | |
Annual repayment requirements | |
Credit Facility, Principal | $ 25,000 |
Credit Facility, Final Payment | 875 |
Total | 25,875 |
2024 | |
Annual repayment requirements | |
Credit Facility, Principal | 8,333 |
Total | 8,333 |
2025 | |
Annual repayment requirements | |
Credit Facility, Principal | 16,667 |
Credit Facility, Final Payment | 875 |
Total | $ 17,542 |
Net Loss Per Share - Basic (Det
Net Loss Per Share - Basic (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2022 | Mar. 31, 2022 | Jun. 30, 2021 | Mar. 31, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Basic net loss per share attributable to common stockholders: | ||||||
Net loss attributable to common stockholders | $ (18,766) | $ (12,542) | $ (8,481) | $ 3,121 | $ (31,308) | $ (5,360) |
Weighted average common shares outstanding, basic | 76,764,296 | 76,324,367 | 76,755,028 | 76,198,384 | ||
Net loss per share, basic | $ (0.24) | $ (0.11) | $ (0.41) | $ (0.07) |
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, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Reconciliation of net loss attributable to common stockholders for basic and diluted net loss per share | ||||
Net loss attributable to common stockholders, basic | $ (18,766) | $ (8,481) | $ (31,308) | $ (5,360) |
Interest expense on 2026 Convertible Note | 1,141 | 1,095 | 2,264 | 2,173 |
Change in fair value of derivative liability | (2,773) | (13,396) | (9,731) | (38,412) |
Net loss attributable to common stockholders, diluted | $ (20,398) | $ (20,782) | $ (38,775) | $ (41,599) |
Weighted average common shares outstanding, basic | 76,764,296 | 76,324,367 | 76,755,028 | 76,198,384 |
Shares issuable upon conversion of 2026 Convertible Note, as if converted | 5,769,232 | 5,769,232 | 5,769,232 | 5,769,232 |
Weighted average common shares outstanding, diluted | 82,533,528 | 82,093,599 | 82,524,260 | 81,967,616 |
Net loss per share attributable to common stockholders, diluted | $ (0.25) | $ (0.25) | $ (0.47) | $ (0.51) |
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 | 6 Months Ended | |
Jun. 30, 2022 | Jun. 30, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Total common stock equivalents | 14,909,995 | 11,049,287 |
Options to Purchase Common Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Total common stock equivalents | 13,892,884 | 11,049,287 |
Restricted Stock Units (RSUs) | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share | ||
Total common stock equivalents | 1,017,111 |
Stock-Based Awards - Additional
Stock-Based Awards - Additional Information (Details) - $ / shares | 3 Months Ended | 6 Months Ended | |
Jun. 16, 2022 | Jun. 30, 2022 | Jun. 30, 2022 | |
2014 and 2006 Stock Incentive Plan | |||
Stock-Based Awards | |||
Number of shares of common stock reserved for issuance | 9,766,336 | 9,766,336 | |
2014 Stock Incentive Plan | |||
Stock-Based Awards | |||
Number of shares of common stock reserved for issuance | 456,334 | 456,334 | |
2021 Incentive Plan | |||
Stock-Based Awards | |||
Number of shares of common stock reserved for issuance | 6,000,000 | 6,000,000 | |
Additional number of shares authorized for issuance | 3,600,000 | ||
Number of shares of common stock available for issuance | 5,837,806 | 5,837,806 | |
2021 Incentive Plan | Common Stock | |||
Stock-Based Awards | |||
Shares Issuable Under Options, Granted | 557,050 | 3,419,253 | |
Exercise price (in dollars per share) | $ 3.69 | $ 5.02 |
Stock-Based Awards - Restricted
Stock-Based Awards - Restricted Stock Units (Details) - 2021 Incentive Plan - Restricted Stock Units (RSUs) - shares | 3 Months Ended | 6 Months Ended |
Jun. 30, 2022 | Jun. 30, 2022 | |
Stock-Based Awards | ||
Granted (in shares) | 120,404 | 1,054,883 |
Vesting period | 3 years |
Stock-Based Awards - Stock-Base
Stock-Based Awards - Stock-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | |
Stock-based Compensation | ||||
Stock-based compensation expense | $ 4,281 | $ 4,292 | $ 8,490 | $ 7,378 |
Unrecognized stock-based compensation cost | 25,612 | $ 25,612 | ||
Weighted average period of unrecognized stock-based compensation cost expected to be recognized | 2 years 8 months 12 days | |||
Research and Development Expense | ||||
Stock-based Compensation | ||||
Stock-based compensation expense | 1,036 | 1,206 | $ 2,098 | 1,883 |
Selling and Marketing Expense | ||||
Stock-based Compensation | ||||
Stock-based compensation expense | 1,191 | 1,129 | 2,329 | 1,883 |
General and Administrative Expense | ||||
Stock-based Compensation | ||||
Stock-based compensation expense | $ 2,054 | $ 1,957 | $ 4,063 | $ 3,612 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | |||
Jun. 30, 2022 | Jun. 30, 2021 | Jun. 30, 2022 | Jun. 30, 2021 | Dec. 31, 2021 | |
Specialty Pharma | |||||
Related Party Transactions | |||||
Expenses incurred | $ 29 | $ 155 | |||
WilmerHale | Legal Fees. | Chief Business Officer | |||||
Related Party Transactions | |||||
Expenses incurred | $ 211 | $ 535 | |||
Accounts payable | 153 | 153 | $ 119 | ||
Accrued expenses | $ 58 | $ 58 | $ 68 |
Common Stock (Details)
Common Stock (Details) - Common Stock - 2021 Sales Agreement - USD ($) $ in Thousands | Aug. 09, 2021 | Aug. 05, 2022 |
Common Stock | ||
Maximum aggregate proceeds from offering | $ 100,000 | |
Number of shares issued | 0 |