Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2021 | Oct. 29, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-39112 | |
Entity Registrant Name | OYSTER POINT PHARMA, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-1030955 | |
Entity Address, Address Line One | 202 Carnegie Center, Suite 109 | |
Entity Address, City or Town | Princeton | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08540 | |
City Area Code | 609 | |
Local Phone Number | 382-9032 | |
Title of 12(b) Security | Common stock, par value $0.001 | |
Trading Symbol | OYST | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,163,861 | |
Amendment Flag | false | |
Entity Central Index Key | 0001720725 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q3 | |
Document Fiscal Year Focus | 2021 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Current Assets | ||
Cash and cash equivalents | $ 184,166 | $ 192,585 |
Other receivable - related party | 2,500 | 0 |
Prepaid expenses and other current assets | 3,020 | 3,782 |
Total current assets | 189,686 | 196,367 |
Property and equipment, net | 1,976 | 804 |
Restricted cash | 61 | 61 |
Other assets | 2,635 | 0 |
Right-of-use assets, net | 651 | 678 |
Total Assets | 195,009 | 197,910 |
Current Liabilities | ||
Accounts payable | 3,506 | 2,279 |
Accrued expenses and other current liabilities | 11,174 | 8,285 |
Lease liabilities | 481 | 418 |
Total current liabilities | 15,161 | 10,982 |
Lease liabilities, non-current | 179 | 269 |
Long-term debt, net | 41,919 | 0 |
Other long-term liabilities | 238 | 0 |
Liabilities, Noncurrent | 42,336 | 269 |
Total Liabilities | 57,497 | 11,251 |
Commitments and Contingencies | ||
Stockholders’ Equity | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized; none outstanding | 0 | 0 |
Common stock, $0.001 par value per share; 1,000,000,000 shares authorized, 26,094,253 and 25,890,490 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively | 26 | 26 |
Additional paid-in capital | 350,832 | 341,384 |
Accumulated deficit | (213,346) | (154,751) |
Total Stockholders’ Equity | 137,512 | 186,659 |
Total Liabilities and Stockholders’ Equity | $ 195,009 | $ 197,910 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2021 | Dec. 31, 2020 |
Statement of Financial Position [Abstract] | ||
Par value of preferred stock (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock authorized (in shares) | 5,000,000 | 5,000,000 |
Preferred stock outstanding (in shares) | 0 | 0 |
Common stock par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock authorized (in shares) | 1,000,000,000 | 1,000,000,000 |
Common stock shares issued (in shares) | 26,094,253 | 25,890,490 |
Common stock shares outstanding (in shares) | 26,094,253 | 25,890,490 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue: | ||||
Total revenue | $ 17,943 | $ 0 | $ 17,943 | $ 0 |
Operating expenses: | ||||
Research and development | 6,214 | 8,210 | 18,772 | 28,104 |
Selling, general and administrative | 28,497 | 8,112 | 56,885 | 20,641 |
Total operating expenses | 34,711 | 16,322 | 75,657 | 48,745 |
Loss from operations | (16,768) | (16,322) | (57,714) | (48,745) |
Other Nonoperating Income (Expense) [Abstract] | ||||
Other income, net | 222 | 17 | 243 | 457 |
Interest expense | (1,124) | 0 | (1,124) | 0 |
Total other income (expense), net | (902) | 17 | (881) | 457 |
Net loss and comprehensive loss | $ (17,670) | $ (16,305) | $ (58,595) | $ (48,288) |
Net loss per share, diluted (in dollars per share) | $ (0.68) | $ (0.63) | $ (2.25) | $ (2.05) |
Net loss per share, basic (in dollars per share) | $ (0.68) | $ (0.63) | $ (2.25) | $ (2.05) |
Weighted average shares outstanding, basic (in shares) | 26,037,975 | 25,797,282 | 25,984,412 | 23,544,035 |
Weighted average shares outstanding, diluted (in shares) | 26,037,975 | 25,797,282 | 25,984,412 | 23,544,035 |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Common StockUnvested restricted stock units | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance, common stock (in shares) at Dec. 31, 2019 | 21,366,950 | ||||
Beginning balance at Dec. 31, 2019 | $ 137,298 | $ 21 | $ 221,508 | $ (84,231) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (16,519) | (16,519) | |||
Issuance of common stock upon exercise of stock options (in shares) | 3,530 | ||||
Issuance of common stock upon exercise of stock options | 4 | 4 | |||
Stock-based compensation expense | 1,180 | 1,180 | |||
Ending balance, common stock (in shares) at Mar. 31, 2020 | 21,370,480 | ||||
Ending balance at Mar. 31, 2020 | 121,963 | $ 21 | 222,692 | (100,750) | |
Beginning balance, common stock (in shares) at Dec. 31, 2019 | 21,366,950 | ||||
Beginning balance at Dec. 31, 2019 | 137,298 | $ 21 | 221,508 | (84,231) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (48,288) | ||||
Ending balance, common stock (in shares) at Sep. 30, 2020 | 25,844,761 | ||||
Ending balance at Sep. 30, 2020 | 206,673 | $ 26 | 339,166 | (132,519) | |
Beginning balance, common stock (in shares) at Mar. 31, 2020 | 21,370,480 | ||||
Beginning balance at Mar. 31, 2020 | 121,963 | $ 21 | 222,692 | (100,750) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ (15,464) | (15,464) | |||
Issuance of common stock upon exercise of stock options (in shares) | 60,425 | ||||
Issuance of common stock upon exercise of stock options | $ 82 | 82 | |||
Issuance of common stock upon secondary equity offering, net of issuance costs of $8,125 (in shares) | 4,312,500 | ||||
Issuance of common stock upon secondary equity offering, net of issuance costs of 8,125 | 112,625 | $ 5 | 112,620 | ||
Stock-based compensation expense | 1,609 | 1,609 | |||
Ending balance, common stock (in shares) at Jun. 30, 2020 | 25,743,405 | ||||
Ending balance at Jun. 30, 2020 | 220,815 | $ 26 | 337,003 | (116,214) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ (16,305) | (16,305) | |||
Issuance of common stock upon exercise of stock options (in shares) | 87,755 | 13,601 | |||
Issuance of common stock upon exercise of stock options | $ 173 | 173 | |||
Stock-based compensation expense | 1,990 | 1,990 | |||
Ending balance, common stock (in shares) at Sep. 30, 2020 | 25,844,761 | ||||
Ending balance at Sep. 30, 2020 | $ 206,673 | $ 26 | 339,166 | (132,519) | |
Beginning balance, common stock (in shares) at Dec. 31, 2020 | 25,890,490 | 25,890,490 | |||
Beginning balance at Dec. 31, 2020 | $ 186,659 | $ 26 | 341,384 | (154,751) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (18,909) | (18,909) | |||
Issuance of common stock upon exercise of stock options (in shares) | 55,046 | 15,252 | |||
Issuance of common stock upon exercise of stock options | 218 | 218 | |||
Stock-based compensation expense | 2,680 | 2,680 | |||
Ending balance, common stock (in shares) at Mar. 31, 2021 | 25,960,788 | ||||
Ending balance at Mar. 31, 2021 | $ 170,648 | $ 26 | 344,282 | (173,660) | |
Beginning balance, common stock (in shares) at Dec. 31, 2020 | 25,890,490 | 25,890,490 | |||
Beginning balance at Dec. 31, 2020 | $ 186,659 | $ 26 | 341,384 | (154,751) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ (58,595) | ||||
Issuance of common stock upon exercise of stock options (in shares) | 171,610 | ||||
Ending balance, common stock (in shares) at Sep. 30, 2021 | 26,094,253 | 26,094,253 | |||
Ending balance at Sep. 30, 2021 | $ 137,512 | $ 26 | 350,832 | (213,346) | |
Beginning balance, common stock (in shares) at Mar. 31, 2021 | 25,960,788 | ||||
Beginning balance at Mar. 31, 2021 | 170,648 | $ 26 | 344,282 | (173,660) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (22,016) | (22,016) | |||
Issuance of common stock upon exercise of stock options (in shares) | 28,748 | 16,901 | |||
Issuance of common stock upon exercise of stock options | 104 | 104 | |||
Stock-based compensation expense | 3,048 | 3,048 | |||
Ending balance, common stock (in shares) at Jun. 30, 2021 | 26,006,437 | ||||
Ending balance at Jun. 30, 2021 | 151,784 | $ 26 | 347,434 | (195,676) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ (17,670) | (17,670) | |||
Issuance of common stock upon exercise of stock options (in shares) | 87,816 | ||||
Issuance of common stock upon exercise of stock options | $ 283 | 283 | |||
Stock-based compensation expense | $ 3,115 | 3,115 | |||
Ending balance, common stock (in shares) at Sep. 30, 2021 | 26,094,253 | 26,094,253 | |||
Ending balance at Sep. 30, 2021 | $ 137,512 | $ 26 | $ 350,832 | $ (213,346) |
Condensed Statements of Stock_2
Condensed Statements of Stockholders' Equity (Parenthetical) $ in Thousands | 3 Months Ended |
Jun. 30, 2020USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Payment of deferred equity offering costs | $ 8,125 |
Condensed Statement of Cash Flo
Condensed Statement of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (58,595) | $ (48,288) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 8,843 | 4,779 |
Depreciation | 91 | 57 |
Amortization and accretion of long-term debt related costs | 508 | 0 |
Reduction in the carrying amount of the right-of-use assets | 371 | 285 |
Non-cash consideration for license revenue - related party | (443) | 0 |
Embedded Derivative, Gain (Loss) on Embedded Derivative, Net | (212) | 0 |
Changes in assets and liabilities: | ||
Other receivable - related party | (2,500) | 0 |
Prepaid expenses and other current assets | 395 | 2,172 |
Accounts payable | 1,215 | 1,784 |
Lease liabilities | (371) | (283) |
Accrued expenses and other current liabilities | 2,921 | 2,146 |
Other assets | (118) | 0 |
Net cash used in operating activities | (47,895) | (37,348) |
Cash flows from investing activities | ||
Purchases of property and equipment | (1,250) | (342) |
Net cash used in investing activities | (1,250) | (342) |
Cash flows from financing activities | ||
Proceeds from follow-on equity offering, net of issuance costs | 0 | 112,625 |
Payment of debt issuance costs | (30) | 0 |
Net proceeds from long-term debt | 40,151 | 0 |
Proceeds from the exercise of stock options | 605 | 259 |
Net cash provided by financing activities | 40,726 | 112,884 |
Net (decrease) increase in cash, cash equivalents and restricted cash | (8,419) | 75,194 |
Cash, cash equivalents and restricted cash at the beginning of the period | 192,646 | 139,198 |
Cash, cash equivalents and restricted cash at the end of the period | 184,227 | 214,392 |
Reconciliation of cash, cash equivalents and restricted cash | ||
Cash and cash equivalents | 184,166 | 214,331 |
Restricted cash | 61 | 61 |
Cash, cash equivalents and restricted cash | 184,227 | 214,392 |
Supplemental non-cash flow information | ||
Cash paid during the period for interest | 617 | 0 |
Non-cash investing and financing activities: | ||
Right-of-use assets acquired through leases | $ 344 | $ 320 |
Nature of Business, Basis of Pr
Nature of Business, Basis of Presentation and Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Nature of Business, Basis of Presentation and Significant Accounting Policies | Nature of Business, Basis of Presentation and Significant Accounting Policies Description of the Business Oyster Point Pharma, Inc. (the Company) is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. On October 15, 2021, TYRVAYA ™ (varenicline solution) Nasal Spray (TYRVAYA Nasal Spray), formerly referred to as OC-01 (varenicline solution) nasal spray, a highly selective nicotinic acetylcholine receptor (nAChR) agonist, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of the signs and symptoms of dry eye disease. TYRVAYA Nasal Spray’s highly differentiated mechanism of action is designed to increase basal tear production with a goal to re-establish tear film homeostasis . Liquidity On August 5, 2021, the Company entered into a $125 million term loan credit facility (the Credit Agreement) with OrbiMed Royalty & Credit Opportunities III, LP, as administrative agent and initial lender (OrbiMed). The Credit Agreement provides for loans to be funded in three separate tranches: the first $45 million tranche was funded on August 10, 2021, the second $50 million tranche to be funded, at the option of the Company, upon FDA approval of TYRVAYA Nasal Spray for the signs and symptoms of dry eye disease, with an approved label that includes eye dryness score data from clinical trials, among other conditions, and the third $30 million tranche to be funded on or prior to June 30, 2023, at the option of the Company, upon the Company having received at least $40 million in net recurring revenue from the sale and/or licensing of TYRVAYA Nasal Spray in any twelve month period prior to March 31, 2023, among other conditions, including having already drawn on the second tranche . On October 19, 2021, the Company entered into a waiver and amendment (the Amendment) to the Credit Agreement to waive certain labeling requirements required for, and to permit the availability of, the second $50 million tranche of funding under the Credit Agreement (among other customary funding provisions) and make certain other amendments thereto, subject to the terms and conditions contained therein. Because the label approving TYRVAYA Nasal Spray for the signs and symptoms of dry eye disease did not include eye dryness score data from clinical trials, the Amendment was required in order for the Company to draw the second tranche and to be eligible to draw the third tranche under the Credit Agreement. The Amendment also increased the amount of principal that is required to be repaid if the Company does not meet certain minimum recurring revenue thresholds from the sale and/or licensing of TYRVAYA Nasal Spray on a quarterly basis for the most recently ended four fiscal quarter period, from $5 million to $10 million if (i) the Company does not meet such minimum recurring revenue thresholds from the sale and/or licensing of TYRVAYA Nasal Spray in the last four quarters and (ii) an improper promotional event has occurred. The Company would also be barred from drawing the second tranche in the event an improper promotional event occurs prior to the funding of the second tranche. The Company delivered notice to OrbiMed on October 19, 2021 that it intended to borrow the second tranche and the Company received the second tranche funding on November 4, 2021. Additional information on the terms of the Amendment and the Credit Agreement are further described in Note 7, Long-term Debt and Note 10, Subsequent Events. On August 5, 2021, the Company entered into a license and collaboration agreement (the License Agreement) with Ji Xing Pharmaceuticals Limited (Ji Xing), which is an entity affiliated with RTW Investments, LP. RTW Investments, LP is one of the Company's beneficial owners, which owns more than 5% of the Company's outstanding shares as of September 30, 2021, and, as a result, the License Agreement is considered to be a related party transaction. Pursuant to the License Agreement, the Company was entitled to receive upfront payments of $17.5 million from the licensee, as well as up to 795,123 of the licensee's senior common shares. As described in Note 8, License and Collaboration Agreements, during the third quarter, the Company received $15.0 million in cash consideration, 397,562 of the senior common shares of Ji Xing as partial consideration upon signing of the License Agreement, and included $2.5 million in other receivable-related party on the condensed balance sheet as of September 30, 2021. Following FDA approval of TYRVAYA Nasal Spray on October 15, 2021, the Company received an additional $5 million development milestone payment and an additional 397,561 of the senior common shares of Ji Xing. The Company is also eligible to receive up to $204.8 million in aggregate development and sales-based milestone payments and royalty payments that are tiered on future net sales of OC-01 and OC-02 and are based on royalty rates between 10% and 20%. The Company incurred net losses of $58.6 million and $48.3 million for the nine months ended September 30, 2021 and 2020, respectively, and had an accumulated deficit of $213.3 million as of September 30, 2021. The Company has been incurring higher expenses due to the Company's preparation for the commercialization of TYRVAYA Nasal Spray, including to establish commercial scale manufacturing arrangements and to provide for the marketing, commercial operations and distribution of the product. The Company expended and will continue to expend funds to complete the research, development and clinical testing of its product candidates. The Company will require additional funds as it commercializes TYRVAYA Nasal Spray and to commercialize any future products. The Company is unable to entirely fund these efforts with its current financial resources and there can be no assurance that it will be able to secure such additional financing on a timely basis, if at all, that will be sufficient to meet these needs. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce and or eliminate certain commercial related expenses, included in selling, general and administrative expenses, as well as delay, reduce or eliminate the scope of one or more of its research or development programs, which would materially and adversely affect its business, financial condition and operations. The Company had cash and cash equivalents of $184.2 million as of September 30, 2021. Management believes that the Company’s current cash and cash equivalents will be sufficient to fund its planned operations for at least 12 months from the date of issuance of these financial statements. SARS-CoV-2 Update The Company continues to be subject to risks and uncertainties as a result of the SARS-CoV-2 virus pandemic. The pandemic and related public health developments, have adversely affected workforces, economies, and financial markets globally, potentially leading to an economic downturn. With the surge of the Delta variant of the virus across the United States (U.S.) during the second half of 2021, the Company delayed its plans for a voluntary return to the office for its employees until at least December 2021. However, the Company will continue monitoring SARS-CoV-2 infection rates and make practical decisions about voluntary reopening in compliance with Centers for Disease Control and Prevention (CDC), federal, state and local guidelines. As of September 30, 2021, the Company has not been materially affected by the adverse results of the pandemic, however, it is not possible to predict the duration or magnitude of the adverse results of the pandemic or the full extent of its effects on the Company's financial condition, liquidity or results of operations. The extent to which the global pandemic will impact the Company’s business beyond September 2021 will depend on future developments that are highly uncertain and cannot be predicted. Basis of Presentation The unaudited interim condensed financial statements and accompanying notes have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments, which are of a normal recurring nature, necessary to state fairly the Company’s financial position as of September 30, 2021 and as of December 31, 2020, the results of operations for the three and nine months ended September 30, 2021 and 2020, and cash flows for the nine months ended September 30, 2021 and 2020. While management believes that the disclosures presented are adequate to mitigate the risk of the information being misleading, these unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or for the full year. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of expenses in the condensed financial statements and accompanying notes. Significant items subject to such estimates and assumptions include stock-based compensation, net embedded derivative liability bifurcated from the Credit Agreement and certain research and development accruals. Actual results could differ from these estimates, and such differences could be material to the Company’s financial position and results of operations. Significant Accounting Policies Update The Company’s significant accounting policies are disclosed in Note 1, Nature of Business, Basis of Presentation and Significant Accounting Policies in the Annual Report on Form 10-K for the year ended December 31, 2020. The Company adopted new accounting policies, as described below, as a result of the events and transactions that took place during the nine months ended September 30 2021. Stock-Based Compensation Effective April 1, 2021, the Company established its first offering period under the Company's 2019 Employee Stock Purchase Plan (the ESPP), as described in Note 4, Stockholders' Equity . Stock-based compensation expense related to purchase rights issued under the ESPP, is based on the Black-Scholes option-pricing model fair value of the estimated number of awards as of the beginning of the offering period. Stock-based compensation expense is recognized using the straight-line method over the offering period. The determination of the grant date fair value of shares purchased under the ESPP is affected by the estimated fair value of the Company's common stock as well as other assumptions and judgments, which are estimated as follows: • Expected term. The expected term for the ESPP is the beginning of the offering period to the end of each purchase period. • Expected volatility. As the Company has a limited trading history of its common stock, the expected volatility is estimated based on the third quartile of the range of the observed volatilities for comparable publicly traded biotechnology and pharmaceutical related companies over a period equal to length of the offering period. The comparable companies are chosen based on industry, stage of development, size and financial leverage of potential comparable companies. • Risk-free interest rate. The risk-free interest rate is based on the implied yield currently available on U.S. Treasury zero-coupon issues with a remaining term equivalent to the expected term of the offering period. • Expected dividend rate. The Company has not paid and does not anticipate paying any dividends in the near future. Accordingly, the Company has estimated the dividend yield to be zero. Revenue The Company entered into the License Agreement with Ji Xing during the three months ended September 30, 2021, as further described in Note 8, License and Collaboration Agreements . The License Agreement provides for Ji Xing to develop and commercialize certain Company products in exchange for payments by the licensee that include a non-refundable, up-front license fee, development and sales-based milestone payments, as well as royalties on net sales of licensed products . In connection with the License Agreement, the Company adopted revenue policies under the guidance of ASC 606, Revenue from Contracts with Customers , to recognize revenue based on the transfer of control of promised goods or services in an amount that reflects the consideration to which the Company expects to receive in exchange for those goods and services. Revenue is recognized when the Company transfers control of a good or service to the customer in an amount that reflects the transaction price allocated to the distinct goods or services. U.S. GAAP provides a five-step model for recognizing revenue from contracts with customers: 1. Identify the contract with the customer 2. Identify the performance obligations within the contract 3. Determine the transaction price 4. Allocate the transaction price to the performance obligations 5. Recognize revenue when (or as) the performance obligations are satisfied License Revenue — The Company recognizes license revenue when the licensee has the ability to direct the use of and benefit from the licensed intellectual property. Royalty Revenue — The Company recognizes royalty revenue from licensees based on third-party sales of licensed products and is recorded when the related third-party product sale occurs. Development and Sales Milestone Revenue — The Company recognizes development and sales-based milestone revenue when the development and sales milestones occur. Loan Commitment Fees, Debt Issuance and Discount Costs As described in Note 7, Long-term Debt, the Company entered into a term loan credit facility with OrbiMed during the three months ended September 30, 2021. The Company capitalizes initial loan commitment fees that are directly associated with obtaining access to capital under its term loan credit facility. Loan commitment fees related to undrawn tranches are recorded in other assets on the Company's condensed balance sheet and are amortized using a straight-line method over the term of the loan commitment. Debt issuance and discount costs that are attributable to the specific tranches drawn on the term loan credit facility are recorded as a reduction of the carrying amount of the debt liability incurred and are amortized to interest expense using the effective interest method over the repayment term. If the Company draws down on the term loan credit facility, it will reclassify the capitalized loan commitment fees on a pro-rata basis to debt issuance and discount costs that reduce the carrying amount of the debt liability. Non-Marketable Equity Investment In connection with the License Agreement described in Note 8, License and Collaboration Agreements, the Company received 397,562 senior common shares from Ji Xing valued at $0.4 million as of September 30, 2021 (the Investment). The Investment was recorded at fair value and will be subject to impairment analysis on a periodic basis. The impairment analysis would involve an assessment of both qualitative and quantitative factors, which may include regulatory approval of the investee's product or technology, as well as the investee’s financial metrics, such as subsequent rounds of financing that may indicate the Investment is impaired. If the Investment is considered impaired, the Company will recognize an impairment through other income (expense), net in the statements of operations and establish a new carrying value for the Investment. Net Embedded Derivative Asset or Liability Certain contracts may contain explicit terms that affect some or all of the cash flows or the value of other exchanges required by the contract. When these embedded features in a contract act in a manner similar to a derivative financial instrument and are not clearly and closely related to the economic characteristics of the host contract, the Company bifurcates the embedded feature and accounts for it as an embedded derivative asset or liability in accordance with guidance under ASC 815-40, Derivatives and Hedging . Embedded derivatives are measured at fair value with changes in fair value reported in other income, net in the condensed statement of operations . Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the FASB) under its accounting standards codifications (ASC) or other standard setting bodies and are adopted by the Company as of the specified effective date, unless otherwise discussed below. ASU 2020-10 — In October 2020, the FASB issued ASU 2020-10, Codification Improvements, which updated various codification topics by clarifying or improving disclosure requirements to align with the Securities and Exchange Commission’s (SEC’s) regulations. The amendments in ASU 2020-10 are effective for annual periods beginning after December 15, 2020, for public business entities. The Company adopted ASU 2020-10 on January 1, 2021 and its adoption did not have a material effect on the Company’s financial statements and related disclosures. ASU 2016-13 — In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The standard introduced the expected credit loss methodology for the measurement of credit losses on financial assets measured at amortized cost basis, replacing the previous incurred loss methodology. The amendment in ASU 2016-13 also modified the accounting for available-for-sale debt securities, which must be individually assessed for credit losses when fair value is less than the amortized costs basis. The guidance is effective for annual periods beginning after December 15, 2019, including interim periods within those years, for public business entities. The Company adopted ASU 2016-13 on January 1, 2021 and its adoption did not have a material effect on the Company's financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value MeasurementsThe Company assesses the fair value of financial instruments as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or model derived valuations whose inputs are observable or whose significant value drivers are observable. Level 3 Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable. Assets and Liabilities Measured at Fair Value on a Recurring Basis As further discussed in Note 7, Long-term Debt, the Company is required to make quarterly payments to OrbiMed in the form of a revenue sharing fee, which was evaluated under ASC 815-40, Derivatives and Hedging, and determined to be an embedded derivative liability. In addition, the Company has the right to optionally prepay, in whole or in part, the outstanding principal amount of the term loan in an amount equal to the outstanding principal, accrued and unpaid interest, together with other fees and payments required under the term loan. This prepayment option has been determined to qualify as an embedded derivative asset under ASC 815-40, Derivatives and Hedging . The embedded derivative asset and liability have been netted to result in a net embedded derivative liability and is classified as a Level 3 financial liability in the fair value hierarchy as of September 30, 2021. The valuation method for both embedded derivatives includes certain unobservable Level 3 inputs including revenue projections, probability and timing of future cash flows, probability of regulatory approval, discounts rates and risk-free rates of interest. The change in fair value due to the remeasurement of the net embedded derivative liability is recorded as other income, net in the Company’s condensed statement of operations and comprehensive loss. The following table reconciles the beginning and ending balances for the Company’s net embedded derivative liability that is carried at fair value as long-term liabilities on the Company's condensed balance sheet using significant unobservable inputs (Level 3) (in thousands): Three months ended September 30, Nine months ended September 30, 2021 2021 Beginning balance: $ — $ — Net embedded derivative liability 450 450 Change in fair value of the net embedded derivative liability (212) (212) Ending balance $ 238 $ 238 As of September 30, 2021, financial assets and liabilities measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at September 30, 2021 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Money market funds 183,166 — — 183,166 Total assets $ 183,166 $ — $ — $ 183,166 Liabilities: Net embedded derivative liability — — 238 238 Total liabilities $ — $ — $ 238 $ 238 As of December 31, 2020, financial assets and liabilities measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at December 31, 2020 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Money market funds 191,585 — — 191,585 Total assets $ 191,585 $ — $ — $ 191,585 Liabilities: Net embedded derivative liability — — — — Total liabilities $ — $ — $ — $ — Money market funds are included in cash and cash equivalents on the Company's condensed balance sheets and are classified within Level 1 of the fair value hierarchy as they are valued using quoted market prices. The carrying amounts reflected in the Company's condensed balance sheets for cash equivalents, other receivable-related party, restricted cash, and accounts payable approximate their fair values, due to their short-term nature. Assets and Liabilities Measured at Fair Value on a Non-Recurring Basis Investment in Ji Xing Senior Common Shares - Related Party In connection with entering into the License Agreement with Ji Xing, as described in Note 8, License and Collaboration Agreements, the Company received 397,562 senior common shares of Ji Xing on August 5, 2021 (Investment), which were accounted for as a non-marketable equity investment and valued as of August 5, 2021. The Investment is classified within Level 3 in the fair value hierarchy because the fair value was determined based on a market approach in which one or more significant inputs to the valuation model are unobservable. The Investment is subject to non-recurring fair value measurements for the evaluation of potential impairment losses and observable price changes in orderly transactions for an identical or similar investment of Ji Xing. The following table represents significant unobservable inputs used in determining the estimated fair value of the Investment as of August 5, 2021 (in thousands): Valuation Technique Unobservable Inputs Value Asset Investment Market Approach - Backsolve method Equity values of recent rounds of financing by the issuer $ 443 Concentration of Credit Risk |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current LiabilitiesAccrued expenses and other current liabilities consisted of the following (in thousands): September 30, 2021 December 31, 2020 Accrued compensation 7,000 3,500 Accrued professional services 3,161 1,244 Accrued research and development expense 1,013 3,541 Total accrued expenses and other current liabilities $ 11,174 $ 8,285 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Stockholders' Equity | Stockholders' Equity Common Stock The Company is authorized to issue 1,000,000,000 shares of common stock, at a par value of $0.001 per share. Each share of common stock is entitled to one vote. The Company reserved common stock for future issuance as follows: September 30, 2021 December 31, 2020 Outstanding options under the 2016 Equity Incentive Plan 2,370,256 2,567,566 Outstanding options under the 2019 Equity Incentive Plan 2,031,932 918,145 Outstanding options under the 2021 Inducement Plan 270,600 — Equity awards available for grant under the 2019 Equity Incentive Plan (1) 1,588,105 1,790,106 Equity awards available for grant under the 2021 Inducement Plan 379,400 — Unvested restricted stock units (RSUs) 178,595 61,215 Shares reserved for purchase under the Employee Stock Purchase Plan (the ESPP) 270,000 270,000 Total 7,088,888 5,607,032 (1) — Effective January 1, 2021, in connection with the evergreen provision under the 2019 Equity Incentive Plan (the 2019 Plan) 1,035,619 shares were added to the 2019 Plan. 2021 Inducement Plan In July 2021, the Company's Board of Directors approved the adoption of the Company's 2021 Inducement Plan (the Inducement Plan), which is used exclusively for grants of awards to individuals who were not previously employees or directors of the Company (or following a bona fide period of non-employment) as a material inducement to such individuals’ entry into employment with the Company. The Company reserved 650,000 shares of its common stock that may be issued under the Inducement Plan. The terms and conditions of the Inducement Plan are substantially similar to those of the 2019 Plan. Stock Options The following table summarizes stock option activity under the 2016 Equity Incentive Plan, the 2019 Plan and the 2021 Inducement Plan during the nine months ended September 30, 2021 (in thousands, except shares, contractual term and per share data): Outstanding Options Number of Shares Underlying Outstanding Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Balance, January 1, 2021 3,485,711 $ 10.74 8.2 $ 36,506 Options granted 1,479,153 16.59 Options exercised (171,610) 3.53 2,272 Options forfeited (120,466) 19.42 342 Balance, September 30, 2021 4,672,788 12.64 8.1 17,535 Shares vested and exercisable as of September 30, 2021 2,058,694 7.15 7.0 14,885 Vested and expected to vest as of September 30, 2021 4,672,788 $ 12.64 8.1 $ 17,535 The weighted average fair value of options granted during the nine months ended September 30, 2021 was $10.88 per share. As of September 30, 2021, the total unrecognized stock-based compensation expense for stock options was $28.8 million, which is expected to be recognized over a weighted average period of 2.9 years. Restricted Stock Units Restricted stock units (the RSUs) are granted to the Company's directors and certain employees. The value of an RSU award is based on the Company's stock price on the date of the grant. The shares underlying the RSUs are not issued until the RSUs vest. Upon vesting, each RSU converts into one share of the Company's common stock. Activity with respect to the Company's restricted stock units during the nine months ended September 30, 2021 was as follows (in thousands, except share, contractual term, and per share data): Outstanding RSUs Number of Shares Underlying Outstanding Awards Weighted Average Grant Date Fair Value per Share Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2021 61,215 $ 23.83 1.4 $ 1,152 Restricted stock units granted 154,431 18.26 2,820 Restricted stock units vested (32,153) 27.15 648 Restricted units forfeited (4,898) 18.77 87 Balance, September 30, 2021 178,595 18.56 2.5 2,116 Unvested and expected to vest as of September 30, 2021 178,595 $ 18.56 2.5 $ 2,116 As of September 30, 2021, the total unrecognized stock-based compensation expense for RSUs was $2.6 million, which is expected to be recognized over a weighted average period of 2.6 years. 2019 Employee Stock Purchase Plan In October 2019, the Company adopted the ESPP, which became effective on October 29, 2019. Effective April 1, 2021, the Company established its first offering period under the ESPP, which began on April 16, 2021 and ends on November 15, 2021. After the first offering period, the ESPP provides for automatic six Stock-Based Compensation Expense Total stock-based compensation expense related to the Company's equity incentive plans was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Research and development $ 485 $ 246 $ 1,311 $ 702 Selling, general and administrative 2,630 1,744 7,532 4,077 Total stock-based compensation expense $ 3,115 $ 1,990 $ 8,843 $ 4,779 |
Net Loss Per Share
Net Loss Per Share | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator: Net loss $ (17,670) $ (16,305) $ (58,595) $ (48,288) Denominator: Weighted average shares outstanding, basic and diluted 26,037,975 25,797,282 25,984,412 23,544,035 Net loss per share, basic and diluted $ (0.68) $ (0.63) $ (2.25) $ (2.05) The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive: As of September 30, 2021 2020 Options to purchase common stock 4,672,788 3,205,831 Unvested restricted stock units 178,595 63,929 Shares committed under the ESPP 30,170 — Total 4,881,553 3,269,760 |
Leases
Leases | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Leases | Leases The Company is party to several operating and finance lease agreements related to office and laboratory space and office equipment. In February 2021, the Company entered into a lease agreement for laboratory and office space in New Jersey for a three-year term beginning on March 1, 2021 and ending on February 29, 2024. Total future minimum lease payments under the Company's operating lease agreements are $0.7 million as of September 30, 2021. Total lease payments required over the life of the Company's operating leases are $1.6 million. Rent expense was $0.4 million and $0.3 million for the nine months ended September 30, 2021 and September 30, 2020, respectively. The remaining lease terms were between 0.8 and 2.4 years as of September 30, 2021. Supplemental balance sheet information for the Company's leases is as follows (in thousands): September 30, 2021 December 31, 2020 Operating lease right-of-use assets $ 629 $ 644 Finance lease right-of-use assets 22 34 Total right-of-use assets $ 651 $ 678 Operating lease liabilities $ 464 $ 400 Finance lease liabilities 17 18 Total lease liabilities $ 481 $ 418 Operating lease liabilities, non-current $ 172 $ 250 Finance lease liabilities, non-current 7 19 Total lease liabilities, non-current $ 179 $ 269 The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of September 30, 2021 Finance Leases Operating Leases Total 2021 (remainder) $ 5 $ 138 $ 143 2022 16 376 392 2023 4 126 130 2024 — 21 21 Total undiscounted cash flows 25 661 686 Less: imputed interest (1) (25) (26) Total lease liabilities 24 636 660 Less: current portion (17) (464) (481) Lease liabilities $ 7 $ 172 $ 179 In August 2021, the Company entered into a lease agreement for office space in Boston, Massachusetts for a five Leases |
Leases | Leases The Company is party to several operating and finance lease agreements related to office and laboratory space and office equipment. In February 2021, the Company entered into a lease agreement for laboratory and office space in New Jersey for a three-year term beginning on March 1, 2021 and ending on February 29, 2024. Total future minimum lease payments under the Company's operating lease agreements are $0.7 million as of September 30, 2021. Total lease payments required over the life of the Company's operating leases are $1.6 million. Rent expense was $0.4 million and $0.3 million for the nine months ended September 30, 2021 and September 30, 2020, respectively. The remaining lease terms were between 0.8 and 2.4 years as of September 30, 2021. Supplemental balance sheet information for the Company's leases is as follows (in thousands): September 30, 2021 December 31, 2020 Operating lease right-of-use assets $ 629 $ 644 Finance lease right-of-use assets 22 34 Total right-of-use assets $ 651 $ 678 Operating lease liabilities $ 464 $ 400 Finance lease liabilities 17 18 Total lease liabilities $ 481 $ 418 Operating lease liabilities, non-current $ 172 $ 250 Finance lease liabilities, non-current 7 19 Total lease liabilities, non-current $ 179 $ 269 The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of September 30, 2021 Finance Leases Operating Leases Total 2021 (remainder) $ 5 $ 138 $ 143 2022 16 376 392 2023 4 126 130 2024 — 21 21 Total undiscounted cash flows 25 661 686 Less: imputed interest (1) (25) (26) Total lease liabilities 24 636 660 Less: current portion (17) (464) (481) Lease liabilities $ 7 $ 172 $ 179 In August 2021, the Company entered into a lease agreement for office space in Boston, Massachusetts for a five Leases |
Long-term Debt
Long-term Debt | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Long-term Debt | Long-term Debt Credit Facility with OrbiMed On August 5, 2021, the Company entered into a $125 million term loan credit facility (the Credit Agreement) with OrbiMed Royalty & Credit Opportunities III, LP, as administrative agent and initial lender (OrbiMed). The Credit Agreement provides for loans to be funded in three separate tranches: the first $45 million tranche was funded on August 10, 2021, the second $50 million tranche to be funded, at the option of the Company, upon FDA approval of TYRVAYA Nasal Spray for the signs and symptoms of dry eye disease , with an approved label that includes eye dryness score data from clinical trials, among other conditions, and the third $30 million tranche to be funded on or prior to June 30, 2023, at the option of the Company, upon the Company having received at least $40 million in net recurring revenue from the sale and/or licensing of TYRVAYA Nasal Spray in any twelve month period prior to March 31, 2023, among other conditions, including having already drawn on the second tranche . The term loans underlying the Credit Agreement mature on August 5, 2027 and are structured for full principal repayment at maturity. The term loans bear interest at the secured overnight financing rate (with a floor of 0.40%) plus a spread of 8.10% per annum (Contractual Interest). Upon an event of default, the Contractual Interest rate shall increase by 3%. The Company is required to pay a 6% exit fee (the Exit Fee), or $2.7 million for the first $45 million tranche at the time of the loan maturity; further, in connection with any prepayment event, the Company must also pay a prepayment premium equal to 10% of the principal amount of the loans drawn if the prepayment occurs prior to the first anniversary of the closing date, 8% after the first anniversary and prior to the second anniversary of the closing date, 6% after the second anniversary and prior to the third anniversary, and 4% after the third anniversary and prior to the fourth anniversary of the closing date. An early prepayment fee shall not be payable at any time on or after the earlier to occur of (a) the drawing of the second tranche and (b) the fourth anniversary of the closing date. Additionally, any repayment of the debt will be subject to a buyout amount, which is the revenue interest cap described below, minus the revenue sharing fee (the Revenue Sharing Fee) payments made to date to OrbiMed under the Credit Agreement. Commencing with the fourth full fiscal quarter after the TYRVAYA Nasal Spray approval, if the Company does not meet certain minimum recurring revenue thresholds from the sale and/ or licensing of OC-01 in the last four quarters, the Credit Agreement requires a $5 million repayment of principal on the interest payment date following such fiscal quarter. This test is applied each quarter following commencement of the Credit Agreement. The Company is permitted to prepay at any time, in whole or in part, the term loans, subject to the payment of a prepayment fee, an exit fee, and a buyout amount. The term loans are also required to be mandatorily prepaid with the proceeds of certain asset sales and casualty events and the issuance of convertible debt and would be subject to prepayment upon the occurrence of an event of default, upon if the loans become an Applicable High Yield Discount Obligation, or upon if it becomes illegal for the lender to lend the loans to the Company. The optional prepayment feature, the contingent prepayment features, and the contingent interest features that are unrelated to the Company’s credit worthiness meet the criteria to be accounted for as embedded derivatives because their economic characteristics are not clearly and closely related to that of the debt host and they meet the definition of a derivative. The optional prepayment feature has been bifurcated as an embedded derivative asset; however, because the probability of triggering the contingent repayment and the contingent interest features is remote, the fair values of these features are currently immaterial. Commencing with the fourth quarter of 2021, the Company is required to make quarterly payments to OrbiMed in the form of the Revenue Sharing Fee in an amount equal to 3% of all net revenue from fiscal year net sales and licenses of OC-01 up to $300 million and 1% of all revenue from fiscal year sales and licenses of TYRVAYA Nasal Spray in excess of $300 million and up to $500 million, subject to caps on such fiscal year net sales and license revenues. These caps increase both on an annual fiscal year basis and upon funding of the second and third term loan tranches. The Revenue Sharing Fee for the first tranche is capped at a fixed $9 million. The Company is subject to additional Revenue Sharing Fee cap amounts for any future tranches drawn. The Company is obligated to pay the Revenue Sharing Fee cap amount regardless of the level of net sales and license revenues. If the Company were to make a prepayment of the term loan, in whole or part, or when the Company repays the principal of the loan at maturity, it is obligated to pay a buyout amount, which is composed of the Revenue Sharing Fee cap amount minus and Revenue Sharing Fees paid since the origination of the term loan. The Company has separated the Revenue Sharing Fee feature from the host debt instrument and accounted for it as an embedded derivative liability because its economic characteristics are not clearly and closely related to that of the host contract, and it meets the definition of a derivative. In addition, the Company has the right to optionally prepay, in whole or in part, the outstanding principal amount of the term loan in an amount equal to the outstanding principal, accrued and unpaid interest, together with early prepayment fee, the exit fee and buyout amount (if applicable). This prepayment option has been determined to qualify as an embedded derivative asset. The Revenue Sharing Fee feature does not meet the scope exception in ASC 815, Derivatives and Hedging , for non-exchange-traded contracts for which the settlement is based on a specified volume of sales or service revenues of one of the parties to the contract because it does not affect the variability of payment, only the timing of certain payments under the debt host. The embedded derivative asset and liability have been netted together to result in a net embedded derivative liability, which is recorded in other long-term liabilities on the Company’s condensed balance sheet. This bifurcation of the net embedded derivative liability resulted in an adjustment to increase the debt discount on the loan drawn under the first tranche. The discount created by the bifurcated net embedded derivative liability, together with the exit fee, the buyout amount, and any debt issuance fees attributable to the initial tranche are deferred and amortized using the effective interest method over the life of the term loan, which resulted in an effective interest rate of 14.11% on the loan as of September 30, 2021. The value of the net embedded derivative liability as of August 5, 2021 and September 30, 2021 was $0.4 million and $0.2 million, respectively, with the change in fair value of $0.2 million recorded in other income, net in the condensed statement of operations for the three and nine months ended September 30, 2021. In connection with entering into the Credit Agreement, and as shown in the table below, the Company incurred loan commitment fees , which were capitalized and recorded in other assets on the Company's condensed balance sheet as of September 30, 2021. The Company amortizes loan commitment fees on a straight-line basis over the term of the loan commitment. The balance of the loan commitment fees and accumulated amortization recorded on the Company’s condensed balance sheet were as follows: September 30, 2021 Loan commitment fees $ 1,981 Accumulated amortization of loan commitment fees (271) Loan commitment fees, net $ 1,710 In connection with entering into the Credit Agreement, and as shown in the table below, the Company incurred debt issuance costs, which were capitalized and recorded as a contra-liability on the Company's condensed balance sheet as of September 30, 2021. The debt issuance and discount costs are being accreted over the life of the tranche drawn by the Company using the effective interest method, which currently include the $2.7 million exit fee which will be paid upon maturity of the first tranche, the $9.0 million Revenue Sharing Fee, as well as the net embedded derivative liability recorded in connection with the Revenue Sharing Fee. The balances of the long-term debt, debt issuance and discount costs, net embedded derivative liability, and accumulated accretion recorded on the Company's condensed balance sheet were as follows: September 30, 2021 Long-term debt $ 45,000 Debt issuance and discount costs (2,868) Net embedded derivative liability (450) Accumulated accretion of long-term debt related costs 237 Long-term debt, net $ 41,919 During the three months and nine months ended September 30, 2021, the Company recorded interest expense of $1.1 million in each period, of which $0.5 million related to the amortization of the loan commitment fees and accretion of the Revenue Sharing Fee and the related net embedded derivative liability, as well as debt issuance and discount costs. The following table identifies the Company's obligations under the Credit Agreement as of September 30, 2021 (in thousands): Less than a year 1-3 years 3-5 years More than 5 years Total Debt Principal $ — $ — $ — $ 45,000 $ 45,000 Exit Fee — — — 2,700 2,700 Contractual Interest on debt 3,878 7,767 7,756 3,283 22,684 Revenue Sharing Cap (a) — — — 9,000 9,000 Total obligations $ 3,878 $ 7,767 $ 7,756 $ 59,983 $ 79,384 (a) — The Revenue Sharing Fee is capped at $9 million and timing of payments will vary based on the Company's net sales of OC-01. The Company’s obligations under the Credit Agreement are secured by all or s ubstantially all of its assets and property, subject to customary exceptions. Any material subsidiaries that the Company (other than certain immaterial subsidiaries) forms or acquires after closing are required to provide a guarantee of the Company’s obligations under the Credit Agreement and provide a pledge of their assets. The Credit Agreement contains customary affirmative and negative covenants, including but not limited to the Company’s ability to enter into certain forms of indebtedness, as well as to pay dividends and other restricted payments. The Credit Agreement also includes provisions for customary events of default. The Credit Agreement required compliance with a minimum liquidity covenant of $20 million prior to TYRVAYA Nasal Spray approval and now requires $5 million following the approval of TYRVAYA Nasal Spray approval. The Company was in compliance with the minimum liquidity requirement as of September 30, 2021. On October 19, 2021, the Company entered into a waiver and amendment (Amendment) to the Credit Agreement, to waive certain labeling requirements required for, and to permit the availability of, the second $50 million tranche of funding under the Credit Agreement (among other customary funding provisions) and make certain other amendments thereto, subject to the terms and conditions contained therein. Because the label approving TYRVAYA Nasal Spray for the signs and symptoms of dry eye disease did not include eye dryness score data from clinical trials, the Amendment was required in order for the Company to draw the second tranche and to be eligible to draw the third tranche under the Credit Agreement. The Amendment also increased the amount of principal that is required to be repaid if the Company does not meet certain minimum recurring revenue thresholds from the sale and/or licensing of TYRVAYA Nasal Spray on a quarterly basis for the most recently ended four fiscal quarter period, from $5 million to $10 million if (i) the Company does not meet such minimum recurring revenue thresholds from the sale and/or licensing of TYRVAYA Nasal Spray in the last four quarters and (ii) an improper promotional event has occurred. |
License and Collaboration Agree
License and Collaboration Agreements | 9 Months Ended |
Sep. 30, 2021 | |
Equity Method Investments and Joint Ventures [Abstract] | |
License and Collaboration Agreements | License and Collaboration Agreements Ji Xing Pharmaceuticals Limited - Related Party On August 5, 2021, the Company entered into a license and collaboration agreement (the License Agreement) with Ji Xing Pharmaceuticals Limited (Ji Xing), which is an entity affiliated with RTW Investments, LP. RTW Investments, LP is one of the Company's beneficial owners and, as a result, the License Agreement is considered to be a related party transaction. Pursuant to the License Agreement, the Company granted Ji Xing an exclusive license to develop and commercialize OC-01 (varenicline solution) nasal spray and OC-02 (simpinicline) nasal spray pharmaceutical products , for all prophylactic uses for, and treatment of, ophthalmology diseases or disorders (the Field) in the greater China region, including mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan (the Territory). Ji Xing will be responsible for development, regulatory, manufacturing and commercialization activities in the Territory, and the Company will be responsible for supplying the drug substance and finished products of OC-01 (varenicline solution) and OC-02 (simpinicline) for Ji Xing’s clinical development at quantities to be agreed by the parties, subject to one or more separate supply agreements as contemplated by the License Agreement. Ji Xing is prohibited from engaging in certain competitive activities during the term of the License Agreement. Subject to certain limitations, the Company may not commercialize any nAChR agonist in the Field in the Territory, without first offering Ji Xing a right of first negotiation for such product in the Territory. The Company has also granted Ji Xing a right of first negotiation to expand indications or uses of OC-01 (varenicline solution) or OC-02 (simpinicline) in the Territory. In August 2021, the Company recognized $17.9 million of revenue in connection with the License Agreement, which is inclusive of 397,562 senior common shares of Ji Xing valued at $0.4 million. The Company received $15.0 million in cash consideration during the three months ended September 30, 2021 and included $2.5 million in other receivable-related party on the condensed balance sheet as of September 30, 2021. As provided for in the License Agreement, the Company is entitled to receive an additional 397,561 senior common shares of Ji Xing, which occurred on October 28, 2021, and $5.0 million in development milestone payments upon the FDA approval of TYRVAYA Nasal Spray, which occurred on October 15, 2021. Per the License Agreement the Company is eligible to receive up to $204.8 million in aggregate development and sales-based milestone payments and royalty payments that are tiered on future net sales of OC-01 and OC-02 and are based on royalty rates between 10% and 20%. The License Agreement will remain in effect, unless terminated earlier, until the expiration of all royalty terms for all licensed products in the Territory under the License Agreement. Ji Xing may terminate the License Agreement for convenience by providing at least 180 days written notice. Each party has the right to terminate the License Agreement for the other party’s uncured material breach or insolvency. The Company may also terminate the License Agreement if Ji Xing, its affiliates or sublicensees challenges the enforceability, validity or scope of certain patents owned by the Company, subject to customary exceptions set forth in the License Agreement. Upon termination, any license granted by the Company to Ji Xing will terminate, and all sublicenses granted by Ji Xing shall also terminate. Adaptive Phage Therapeutics In May 2021, the Company entered into a research collaboration agreement with Adaptive Phage Therapeutics (APT) for the development of potential biological treatments for multiple ophthalmic diseases. Under the terms of the collaboration agreement, the Company has the option and certain rights to obtain an exclusive license to develop and commercialize APT’s technology for ophthalmic diseases and disorders. Under the license terms, if such option is exercised, the Company would make potential development and regulatory milestones payments, as well as the potential to make sales-related milestones and tiered royalty payments of net sales, if a licensed phage therapy is approved by the FDA or certain other regulatory authorities. Pursuant to the terms of the agreement, the Company paid a one-time, non-refundable, upfront payment of $0.5 million for the collaboration and option agreement which was included in research and development expense for the nine months ended September 30, 2021. The Company has not exercised the option granted under the agreement as of September 30, 2021. Pfizer Inc. The Company is party to a non-exclusive patent license agreement with Pfizer Inc. (Pfizer), which granted the Company non-exclusive rights under Pfizer’s patent rights covering varenicline tartrate to develop, manufacture, and commercialize the OC-01 (varenicline solution) nasal spray product. Pursuant to the license agreement, the Company is required to pay a one-time sales-based milestone payment of $10 million if annual U.S. net sales of TYRVAYA Nasal Spray exceed $250 million prior to December 31, 2026. The Company is also required to pay royalties based on annual U.S. tiered net sales of TYRVAYA Nasal Spray at percentages ranging from 7.5% to 15% until the expiration of the royalty term. The royalty obligation to Pfizer commences upon the first commercial sale of TYRVAYA Nasal Spray and expires upon the later of (a) the expiration of all regulatory or data exclusivity granted to Pfizer in connection with varenicline in the United States; and (b) the expiration or abandonment of the last valid claims of the licensed patents. No milestone was achieved or royalties accrued as of September 30, 2021 and December 31, 2020. |
Commitment and Contingencies
Commitment and Contingencies | 9 Months Ended |
Sep. 30, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Commitments In addition to disclosures in these condensed financial statements, the following are the Company's commitments as of September 30, 2021: Purchase Commitment In July 2021, the Company entered into a manufacturing and supply agreement with a contract manufacturing organization (CMO) to manufacture and supply TYRVAYA Nasal Spray for an initial term of three years. Under this agreement, the Company will pay a minimum capacity reservation fee in the amount of $2.5 million for each of the next three years ending December 31, 2021, 2022, and 2023, respectively. The minimum capacity reservation fee is subject to potential future credit allowances based upon the prior year's manufacturing production, as provided for in the agreement. The Company made no minimum capacity reservation fee payments as of September 30, 2021. Contingencies |
Subsequent events
Subsequent events | 9 Months Ended |
Sep. 30, 2021 | |
Subsequent Events [Abstract] | |
Subsequent events | Subsequent events On October 15, 2021, TYRVAYA Nasal Spray was approved by the FDA for the treatment of the signs and symptoms of dry eye disease. On October 19, 2021, the Company entered into the Amendment to the Credit Agreement, to waive certain labeling requirements required for, and to permit the availability of, the second $50 million tranche of funding under the Credit Agreement (among other customary funding provisions) and make certain other amendments thereto, subject to the terms and conditions contained therein. Because the label approving TYRVAYA Nasal Spray for the signs and symptoms of dry eye disease did not include eye dryness score data from clinical trials, the Amendment was required in order for the Company to draw the second tranche and to be eligible to draw the third tranche under the Credit Agreement. The Company delivered notice to OrbiMed on October 19, 2021 that it intended to borrow the second tranche and the Company received the second tranche funding on November 4, 2021. The Amendment also increased the amount of principal that is required to be repaid if the Company does not meet certain minimum recurring revenue thresholds from the sale and/or licensing of TYRVAYA Nasal Spray on a quarterly basis for the most recently ended four fiscal quarter period, from $5 million to $10 million if (i) the Company does not meet such minimum recurring revenue thresholds from the sale and/or licensing of TYRVAYA Nasal Spray in the last four quarters and (ii) an improper promotional event has occurred. In October 2021, the Company received an additional 397,561 of the senior common shares of Ji Xing and $5.0 million in development milestone payments which were contingent upon the FDA approval of TYRVAYA Nasal Spray which occurred on October 15, 2021. |
Nature of Business, Basis of _2
Nature of Business, Basis of Presentation and Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The unaudited interim condensed financial statements and accompanying notes have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments, which are of a normal recurring nature, necessary to state fairly the Company’s financial position as of September 30, 2021 and as of December 31, 2020, the results of operations for the three and nine months ended September 30, 2021 and 2020, and cash flows for the nine months ended September 30, 2021 and 2020. While management believes that the disclosures presented are adequate to mitigate the risk of the information being misleading, these unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020. The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or for the full year. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of expenses in the condensed financial statements and accompanying notes. Significant items subject to such estimates and assumptions include stock-based compensation, net embedded derivative liability bifurcated from the Credit Agreement and certain research and development accruals. Actual results could differ from these estimates, and such differences could be material to the Company’s financial position and results of operations. |
Revenue | Revenue The Company entered into the License Agreement with Ji Xing during the three months ended September 30, 2021, as further described in Note 8, License and Collaboration Agreements . The License Agreement provides for Ji Xing to develop and commercialize certain Company products in exchange for payments by the licensee that include a non-refundable, up-front license fee, development and sales-based milestone payments, as well as royalties on net sales of licensed products . In connection with the License Agreement, the Company adopted revenue policies under the guidance of ASC 606, Revenue from Contracts with Customers , to recognize revenue based on the transfer of control of promised goods or services in an amount that reflects the consideration to which the Company expects to receive in exchange for those goods and services. Revenue is recognized when the Company transfers control of a good or service to the customer in an amount that reflects the transaction price allocated to the distinct goods or services. U.S. GAAP provides a five-step model for recognizing revenue from contracts with customers: 1. Identify the contract with the customer 2. Identify the performance obligations within the contract 3. Determine the transaction price 4. Allocate the transaction price to the performance obligations 5. Recognize revenue when (or as) the performance obligations are satisfied License Revenue — The Company recognizes license revenue when the licensee has the ability to direct the use of and benefit from the licensed intellectual property. Royalty Revenue — The Company recognizes royalty revenue from licensees based on third-party sales of licensed products and is recorded when the related third-party product sale occurs. |
Deferred Financing Costs | Loan Commitment Fees, Debt Issuance and Discount Costs As described in Note 7, Long-term Debt, the Company entered into a term loan credit facility with OrbiMed during the three months ended September 30, 2021. The Company capitalizes initial loan commitment fees that are directly associated with obtaining access to capital under its term loan credit facility. Loan commitment fees related to undrawn tranches are recorded in other assets on the Company's condensed balance sheet and are amortized using a straight-line method over the term of the loan commitment. Debt issuance and discount costs that are attributable to the specific tranches drawn on the term loan credit facility are recorded as a reduction of the carrying amount of the debt liability incurred and are amortized to interest expense using the effective interest method over the repayment term. If the Company draws down on the term loan credit facility, it will reclassify the capitalized loan commitment fees on a pro-rata basis to debt issuance and discount costs that reduce the carrying amount of the debt liability. Non-Marketable Equity Investment In connection with the License Agreement described in Note 8, License and Collaboration Agreements, the Company received 397,562 senior common shares from Ji Xing valued at $0.4 million as of September 30, 2021 (the Investment). The Investment was recorded at fair value and will be subject to impairment analysis on a periodic basis. The impairment analysis would involve an assessment of both qualitative and quantitative factors, which may include regulatory approval of the investee's product or technology, as well as the investee’s financial metrics, such as subsequent rounds of financing that may indicate the Investment is impaired. If the Investment is considered impaired, the Company will recognize an impairment through other income (expense), net in the statements of operations and establish a new carrying value for the Investment. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the FASB) under its accounting standards codifications (ASC) or other standard setting bodies and are adopted by the Company as of the specified effective date, unless otherwise discussed below. ASU 2020-10 — In October 2020, the FASB issued ASU 2020-10, Codification Improvements, which updated various codification topics by clarifying or improving disclosure requirements to align with the Securities and Exchange Commission’s (SEC’s) regulations. The amendments in ASU 2020-10 are effective for annual periods beginning after December 15, 2020, for public business entities. The Company adopted ASU 2020-10 on January 1, 2021 and its adoption did not have a material effect on the Company’s financial statements and related disclosures. ASU 2016-13 — In June 2016, the FASB issued ASU 2016-13, Financial Instruments - Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments. The standard introduced the expected credit loss methodology for the measurement of credit losses on financial assets measured at amortized cost basis, replacing the previous incurred loss methodology. The amendment in ASU 2016-13 also modified the accounting for available-for-sale debt securities, which must be individually assessed for credit losses when fair value is less than the amortized costs basis. The guidance is effective for annual periods beginning after December 15, 2019, including interim periods within those years, for public business entities. The Company adopted ASU 2016-13 on January 1, 2021 and its adoption did not have a material effect on the Company's financial statements and related disclosures. |
Fair Value Measurements | The Company assesses the fair value of financial instruments as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or model derived valuations whose inputs are observable or whose significant value drivers are observable. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of financial assets measured and recognized at fair value | As of September 30, 2021, financial assets and liabilities measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at September 30, 2021 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Money market funds 183,166 — — 183,166 Total assets $ 183,166 $ — $ — $ 183,166 Liabilities: Net embedded derivative liability — — 238 238 Total liabilities $ — $ — $ 238 $ 238 As of December 31, 2020, financial assets and liabilities measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at December 31, 2020 Quoted Price in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Assets: Money market funds 191,585 — — 191,585 Total assets $ 191,585 $ — $ — $ 191,585 Liabilities: Net embedded derivative liability — — — — Total liabilities $ — $ — $ — $ — |
Estimated fair value on non-recurring basis | The following table represents significant unobservable inputs used in determining the estimated fair value of the Investment as of August 5, 2021 (in thousands): Valuation Technique Unobservable Inputs Value Asset Investment Market Approach - Backsolve method Equity values of recent rounds of financing by the issuer $ 443 |
Schedule of Changes in Other Long-Term Liabilites | Three months ended September 30, Nine months ended September 30, 2021 2021 Beginning balance: $ — $ — Net embedded derivative liability 450 450 Change in fair value of the net embedded derivative liability (212) (212) Ending balance $ 238 $ 238 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses | Accrued expenses and other current liabilities consisted of the following (in thousands): September 30, 2021 December 31, 2020 Accrued compensation 7,000 3,500 Accrued professional services 3,161 1,244 Accrued research and development expense 1,013 3,541 Total accrued expenses and other current liabilities $ 11,174 $ 8,285 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Equity [Abstract] | |
Schedule of conversions of stock | The Company reserved common stock for future issuance as follows: September 30, 2021 December 31, 2020 Outstanding options under the 2016 Equity Incentive Plan 2,370,256 2,567,566 Outstanding options under the 2019 Equity Incentive Plan 2,031,932 918,145 Outstanding options under the 2021 Inducement Plan 270,600 — Equity awards available for grant under the 2019 Equity Incentive Plan (1) 1,588,105 1,790,106 Equity awards available for grant under the 2021 Inducement Plan 379,400 — Unvested restricted stock units (RSUs) 178,595 61,215 Shares reserved for purchase under the Employee Stock Purchase Plan (the ESPP) 270,000 270,000 Total 7,088,888 5,607,032 (1) — Effective January 1, 2021, in connection with the evergreen provision under the 2019 Equity Incentive Plan (the 2019 Plan) 1,035,619 shares were added to the 2019 Plan. |
Schedule of stock options activity | The following table summarizes stock option activity under the 2016 Equity Incentive Plan, the 2019 Plan and the 2021 Inducement Plan during the nine months ended September 30, 2021 (in thousands, except shares, contractual term and per share data): Outstanding Options Number of Shares Underlying Outstanding Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Balance, January 1, 2021 3,485,711 $ 10.74 8.2 $ 36,506 Options granted 1,479,153 16.59 Options exercised (171,610) 3.53 2,272 Options forfeited (120,466) 19.42 342 Balance, September 30, 2021 4,672,788 12.64 8.1 17,535 Shares vested and exercisable as of September 30, 2021 2,058,694 7.15 7.0 14,885 Vested and expected to vest as of September 30, 2021 4,672,788 $ 12.64 8.1 $ 17,535 |
Schedule of activity for restricted stock units | Activity with respect to the Company's restricted stock units during the nine months ended September 30, 2021 was as follows (in thousands, except share, contractual term, and per share data): Outstanding RSUs Number of Shares Underlying Outstanding Awards Weighted Average Grant Date Fair Value per Share Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2021 61,215 $ 23.83 1.4 $ 1,152 Restricted stock units granted 154,431 18.26 2,820 Restricted stock units vested (32,153) 27.15 648 Restricted units forfeited (4,898) 18.77 87 Balance, September 30, 2021 178,595 18.56 2.5 2,116 Unvested and expected to vest as of September 30, 2021 178,595 $ 18.56 2.5 $ 2,116 |
Schedule of stock-based compensation expense | Total stock-based compensation expense related to the Company's equity incentive plans was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Research and development $ 485 $ 246 $ 1,311 $ 702 Selling, general and administrative 2,630 1,744 7,532 4,077 Total stock-based compensation expense $ 3,115 $ 1,990 $ 8,843 $ 4,779 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Earnings Per Share [Abstract] | |
Schedule of earnings per share, basic and diluted | The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 Numerator: Net loss $ (17,670) $ (16,305) $ (58,595) $ (48,288) Denominator: Weighted average shares outstanding, basic and diluted 26,037,975 25,797,282 25,984,412 23,544,035 Net loss per share, basic and diluted $ (0.68) $ (0.63) $ (2.25) $ (2.05) |
Schedule of antidilutive securities excluded from computation of earnings per share | The following outstanding shares of potentially dilutive securities were excluded from the computation of diluted net loss per share for the periods presented because including them would have been antidilutive: As of September 30, 2021 2020 Options to purchase common stock 4,672,788 3,205,831 Unvested restricted stock units 178,595 63,929 Shares committed under the ESPP 30,170 — Total 4,881,553 3,269,760 |
Leases (Tables)
Leases (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Leases [Abstract] | |
Supplemental balance sheet information for lessee | Supplemental balance sheet information for the Company's leases is as follows (in thousands): September 30, 2021 December 31, 2020 Operating lease right-of-use assets $ 629 $ 644 Finance lease right-of-use assets 22 34 Total right-of-use assets $ 651 $ 678 Operating lease liabilities $ 464 $ 400 Finance lease liabilities 17 18 Total lease liabilities $ 481 $ 418 Operating lease liabilities, non-current $ 172 $ 250 Finance lease liabilities, non-current 7 19 Total lease liabilities, non-current $ 179 $ 269 |
Schedule of maturities of lease liabilities | The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of September 30, 2021 Finance Leases Operating Leases Total 2021 (remainder) $ 5 $ 138 $ 143 2022 16 376 392 2023 4 126 130 2024 — 21 21 Total undiscounted cash flows 25 661 686 Less: imputed interest (1) (25) (26) Total lease liabilities 24 636 660 Less: current portion (17) (464) (481) Lease liabilities $ 7 $ 172 $ 179 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of Long-term Debt Instruments | The balance of the loan commitment fees and accumulated amortization recorded on the Company’s condensed balance sheet were as follows: September 30, 2021 Loan commitment fees $ 1,981 Accumulated amortization of loan commitment fees (271) Loan commitment fees, net $ 1,710 September 30, 2021 Long-term debt $ 45,000 Debt issuance and discount costs (2,868) Net embedded derivative liability (450) Accumulated accretion of long-term debt related costs 237 Long-term debt, net $ 41,919 |
Long-Term Debt, Exit Fees, and Interest Obligation, Fiscal Year Maturity | The following table identifies the Company's obligations under the Credit Agreement as of September 30, 2021 (in thousands): Less than a year 1-3 years 3-5 years More than 5 years Total Debt Principal $ — $ — $ — $ 45,000 $ 45,000 Exit Fee — — — 2,700 2,700 Contractual Interest on debt 3,878 7,767 7,756 3,283 22,684 Revenue Sharing Cap (a) — — — 9,000 9,000 Total obligations $ 3,878 $ 7,767 $ 7,756 $ 59,983 $ 79,384 (a) — The Revenue Sharing Fee is capped at $9 million and timing of payments will vary based on the Company's net sales of OC-01. |
Nature of Business, Basis of _3
Nature of Business, Basis of Presentation and Significant Accounting Policies (Details) - USD ($) $ in Thousands | Aug. 05, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Oct. 19, 2021 | Oct. 15, 2021 | Aug. 31, 2021 | Dec. 31, 2020 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Comprehensive loss | $ (17,670) | $ (16,305) | $ (58,595) | $ (48,288) | |||||
Accumulated deficit | (213,346) | (213,346) | $ (154,751) | ||||||
Cash and cash equivalents | 184,166 | $ 214,331 | 184,166 | $ 214,331 | $ 192,585 | ||||
Ji Xing Pharmaceuticals Limited | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Shares received as consideration | 397,562 | ||||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Payment for license agreement | $ 17,500 | ||||||||
Upfront payment on license agreement | $ 17,900 | ||||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Significant Unobservable Inputs (Level 3) | Fair Value, Nonrecurring | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Number of shares company entitled to receive | 795,123 | ||||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Upfront payment on license agreement | $ 15,000 | ||||||||
Shares received as consideration | 397,562 | ||||||||
Value of shares received as consideration | 400 | 400 | |||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Accounts Receivable Related parties current | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Upfront payment on license agreement | $ 2,500 | $ 2,500 | |||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Maximum | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty rates | 20.00% | ||||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Maximum | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Aggregate development and net sales-based milestone payments (up to) | $ 204,800 | ||||||||
Royalty rates | 20.00% | ||||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Minimum | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty rates | 10.00% | ||||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Minimum | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Royalty rates | 10.00% | ||||||||
Subsequent Event | Ji Xing Pharmaceuticals Limited | License | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Developmental milestone payment received in equity ( in shares) | 397,561 | ||||||||
Developmental milestone payment | $ 5,000 | ||||||||
Subsequent Event | Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Developmental milestone payment received in equity ( in shares) | 397,561 | ||||||||
Developmental milestone payment | $ 5,000 | ||||||||
Revolving Credit Facility | OrbiMed Credit Facility | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
OrbiMed credit facility | $ 125,000 | ||||||||
Required principal payment if FDA approval not obtained before specified date | 5,000 | ||||||||
Amount provided upon FDA approval | Revolving Credit Facility | OrbiMed Credit Facility | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Contingent increase in credit facility | 50,000 | ||||||||
Amount provided upon FDA approval | Revolving Credit Facility | OrbiMed Credit Facility | Subsequent Event | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Contingent increase in credit facility | $ 50,000 | ||||||||
Amount provided at signing | Revolving Credit Facility | OrbiMed Credit Facility | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Initial borrowing capacity of OrbiMed credit facility | 45,000 | ||||||||
Amount provided contingent upon certain net sales performance | Revolving Credit Facility | OrbiMed Credit Facility | |||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||||||
Contingent increase in credit facility | 30,000 | ||||||||
Required recurring revenue for funding | $ 40,000 |
Fair Value Measurements (Detail
Fair Value Measurements (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Aug. 31, 2021 | Aug. 05, 2021 | Dec. 31, 2020 |
Significant Unobservable Inputs (Level 3) | ||||
Liabilities: | ||||
Investments, Fair Value Disclosure | $ 443 | |||
Fair Value, Recurring | ||||
Assets: | ||||
Money market funds | $ 183,166 | |||
Total assets | $ 191,585 | |||
Liabilities: | ||||
Net embedded derivative liability | 0 | |||
Total liabilities | 238 | 0 | ||
Fair Value, Recurring | Embedded Derivative Financial Instruments | ||||
Liabilities: | ||||
Net embedded derivative liability | 238 | |||
Fair Value, Recurring | Money market funds | ||||
Assets: | ||||
Money market funds | 183,166 | 191,585 | ||
Fair Value, Recurring | Quoted Price in Active Markets for Identical Assets (Level 1) | ||||
Assets: | ||||
Money market funds | 183,166 | |||
Total assets | 191,585 | |||
Liabilities: | ||||
Net embedded derivative liability | 0 | |||
Total liabilities | 0 | 0 | ||
Fair Value, Recurring | Quoted Price in Active Markets for Identical Assets (Level 1) | Embedded Derivative Financial Instruments | ||||
Liabilities: | ||||
Net embedded derivative liability | 0 | |||
Fair Value, Recurring | Quoted Price in Active Markets for Identical Assets (Level 1) | Money market funds | ||||
Assets: | ||||
Money market funds | 183,166 | 191,585 | ||
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | ||||
Assets: | ||||
Money market funds | 0 | |||
Total assets | 0 | |||
Liabilities: | ||||
Net embedded derivative liability | 0 | |||
Total liabilities | 0 | 0 | ||
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | Embedded Derivative Financial Instruments | ||||
Liabilities: | ||||
Net embedded derivative liability | 0 | |||
Fair Value, Recurring | Significant Other Observable Inputs (Level 2) | Money market funds | ||||
Assets: | ||||
Money market funds | 0 | 0 | ||
Fair Value, Recurring | Significant Unobservable Inputs (Level 3) | ||||
Assets: | ||||
Money market funds | 0 | |||
Total assets | 0 | |||
Liabilities: | ||||
Net embedded derivative liability | 0 | |||
Total liabilities | 238 | 0 | ||
Fair Value, Recurring | Significant Unobservable Inputs (Level 3) | Embedded Derivative Financial Instruments | ||||
Liabilities: | ||||
Net embedded derivative liability | 238 | |||
Fair Value, Recurring | Significant Unobservable Inputs (Level 3) | Money market funds | ||||
Assets: | ||||
Money market funds | $ 0 | $ 0 | ||
Fair Value, Nonrecurring | Significant Unobservable Inputs (Level 3) | Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | ||||
Liabilities: | ||||
Number of shares received | 397,562 |
Fair Value Measurements - Embed
Fair Value Measurements - Embedded Derivative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | |
Changes In Other Long Term Debt [Roll Forward] | |||
Change in fair value of the net embedded derivative liability | $ 212 | $ 0 | |
Significant Unobservable Inputs (Level 3) | |||
Changes In Other Long Term Debt [Roll Forward] | |||
Beginning balance: | $ 0 | 0 | |
Change in fair value of the net embedded derivative liability | (212) | (212) | |
Ending balance | $ 238 | 238 | |
Significant Unobservable Inputs (Level 3) | Embedded Derivative Financial Instruments | |||
Changes In Other Long Term Debt [Roll Forward] | |||
Net embedded derivative liability | $ 450 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued compensation | $ 7,000 | $ 3,500 |
Accrued professional services | 3,161 | 1,244 |
Accrued research and development expense | 1,013 | 3,541 |
Total accrued expenses and other current liabilities | $ 11,174 | $ 8,285 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Millions | Apr. 01, 2021 | Sep. 30, 2021USD ($)shares$ / shares | Jul. 30, 2021shares | Dec. 31, 2020$ / sharesshares |
Class of Stock [Line Items] | ||||
Common stock authorized (in shares) | 1,000,000,000 | 1,000,000,000 | ||
Common stock par value (in dollars per share) | $ / shares | $ 0.001 | $ 0.001 | ||
Number of votes per share | 1 | |||
Weighted-average grant-date fair value of options (in dollars per share) | $ / shares | $ 10.88 | |||
Unrecognized stock-based compensation expense | $ | $ 28.8 | |||
Weighted-average recognition period of unrecognized stock-based compensation expense (in years) | 2 years 10 months 24 days | |||
2019 ESPP | ||||
Class of Stock [Line Items] | ||||
ESPP percent discount | 15.00% | |||
ESPP percent of market fair value | 85.00% | |||
ESPP automatic offering period | 6 months | |||
2021 Inducement Plan | ||||
Class of Stock [Line Items] | ||||
Equity awards available to grant (in shares) | 379,400 | 0 | ||
2021 Inducement Plan | Common Stock | ||||
Class of Stock [Line Items] | ||||
Shares authorized for Inducement Stock Incentive Plan (in shares) | 650,000 | |||
Unvested restricted stock units | ||||
Class of Stock [Line Items] | ||||
Unrecognized stock-based compensation expense | $ | $ 2.6 | |||
Weighted-average recognition period of unrecognized stock-based compensation expense (in years) | 2 years 7 months 6 days | |||
Unvested restricted stock units | 2019 Plan | ||||
Class of Stock [Line Items] | ||||
Equity awards available to grant (in shares) | 1,588,105 | 1,790,106 |
Stockholders' Equity - Reserved
Stockholders' Equity - Reserved Common Stock (Details) - shares | Jan. 01, 2021 | Sep. 30, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 4,672,788 | 3,485,711 | |
Unvested RSUs and shares reserved for purchase under the ESPP | 178,595 | 61,215 | |
Total (in shares) | 7,088,888 | 5,607,032 | |
2016 Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 2,370,256 | 2,567,566 | |
2019 Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 2,031,932 | 918,145 | |
Unvested RSUs and shares reserved for purchase under the ESPP | 178,595 | 61,215 | |
Additional shares authorized (in shares) | 1,035,619 | ||
2019 Plan | Unvested restricted stock units | |||
Class of Stock [Line Items] | |||
Equity awards available to grant (in shares) | 1,588,105 | 1,790,106 | |
2021 Inducement Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 270,600 | 0 | |
Equity awards available to grant (in shares) | 379,400 | 0 | |
2019 ESPP | |||
Class of Stock [Line Items] | |||
Unvested RSUs and shares reserved for purchase under the ESPP | 270,000 | 270,000 |
Stockholders' Equity - Option A
Stockholders' Equity - Option Activity During The Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Sep. 30, 2021 | |
Number of Shares Underlying Outstanding Options | |||||
Beginning balance (in shares) | 3,485,711 | 3,485,711 | |||
Options granted (in shares) | 1,479,153 | ||||
Options exercised (in shares) | (87,816) | (87,755) | (60,425) | (171,610) | |
Options forfeited (in shares) | (120,466) | ||||
Ending balance (in shares) | 4,672,788 | 4,672,788 | |||
Shares vested at end of period (in shares) | 2,058,694 | ||||
Shares exercisable at end of period (in shares) | 2,058,694 | 2,058,694 | |||
Shares vested and expected to vest at end of period (in shares) | 4,672,788 | 4,672,788 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | |||||
Beginning balance (in dollars per share) | $ 10.74 | $ 10.74 | |||
Options granted (in dollars per share) | 16.59 | ||||
Options exercise price (in dollars per share) | 3.53 | ||||
Options forfeited (in dollars per share) | 19.42 | ||||
Ending balance (in dollars per share) | $ 12.64 | 12.64 | |||
Shares vested and exercisable at end of period (in dollars per share) | 7,150 | 7,150 | |||
Shares vested and expected to vest at end of period (in dollars per share) | $ 12,640 | $ 12,640 | |||
Weighted-Average Remaining Contractual Term (Years) | |||||
Weighted average contractual term (in years) | 8 years 2 months 12 days | 8 years 1 month 6 days | |||
Shares vested and exercisable at end of period, weighted average remaining contractual term (in years) | 7 years | ||||
Shares vested and expected to vest at end of period, weighted average remaining contractual term (in years) | 8 years 1 month 6 days | ||||
Aggregate Intrinsic Value | |||||
Aggregate intrinsic value, outstanding ending balance | $ 36,506 | $ 36,506 | |||
Aggregate intrinsic value, options exercised | 2,272 | ||||
Aggregate intrinsic value, options forfeited | 342 | ||||
Aggregate intrinsic value, outstanding ending balance | $ 17,535 | 17,535 | |||
Shares vested and exercisable at end of period, aggregate intrinsic value | 14,885 | 14,885 | |||
Shares vested and expected to vest at end of period, aggregate intrinsic value | $ 17,535 | $ 17,535 |
Stockholders' Equity - RSU Acti
Stockholders' Equity - RSU Activity During The Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended |
Mar. 31, 2021 | Sep. 30, 2021 | |
Number of Shares Underlying Outstanding Units | ||
Outstanding at beginning of period (in shares) | 61,215 | 61,215 |
Restricted stock units granted (in shares) | 154,431 | |
Shares vested in period (in shares) | (32,153) | |
Restricted units forfeited (in shares) | (4,898) | |
Outstanding at end of period (in shares) | 178,595 | |
Unvested and expected to vest (in shares) | 178,595 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | ||
Beginning outstanding balance (in dollars per share) | $ 23.83 | $ 23.83 |
Restricted stock units granted, weighted average grant date fair value (in dollars per share) | 18.26 | |
Restricted stock units vested, weighted average grant date fair value (in dollars per share) | 27.15 | |
Restricted units forfeited, weighted average grant date fair value (in dollars per share) | 18.77 | |
Ending outstanding balance (in dollars per share) | 18.56 | |
Unvested and expected to vest (in dollars per share) | $ 18.56 | |
Weighted Average Remaining Contractual Term (Years) | ||
Weighted average remaining contractual term, restricted stock units (in years) | 1 year 4 months 24 days | 2 years 6 months |
Vested and expected to vest, weighted average remaining contractual term (in years) | 2 years 6 months | |
Shave-Based Compensation Arrangement By share-Based Payment Award, Equity Instruments Other Than Options, Aggregate Intrinsic Value [Roll Forward] | ||
Restricted stock units outstanding, aggregate intrinsic value, beginning of period | $ 1,152 | $ 1,152 |
Restricted stock units granted, aggregate intrinsic value | 2,820 | |
Restricted stock units vested, aggregate intrinsic value | 648 | |
Restricted stock units outstanding, aggregate intrinsic value, end of period | 87 | |
Restricted stock units outstanding, aggregate intrinsic value, end of period | 2,116 | |
Vested and expected to vest, aggregate intrinsic value | $ 2,116 |
Stockholders' Equity - Stock Ba
Stockholders' Equity - Stock Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 3,115 | $ 1,990 | $ 8,843 | $ 4,779 |
Research and development | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | 485 | 246 | 1,311 | 702 |
Selling, general and administrative | ||||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||||
Total stock-based compensation expense | $ 2,630 | $ 1,744 | $ 7,532 | $ 4,077 |
Net Loss Per Share (Details)
Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Numerator: | ||||||||
Net loss | $ (17,670) | $ (22,016) | $ (18,909) | $ (16,305) | $ (15,464) | $ (16,519) | $ (58,595) | $ (48,288) |
Denominator: | ||||||||
Weighted average shares outstanding, diluted (in shares) | 26,037,975 | 25,797,282 | 25,984,412 | 23,544,035 | ||||
Weighted average shares outstanding, basic (in shares) | 26,037,975 | 25,797,282 | 25,984,412 | 23,544,035 | ||||
Net loss per share, basic (in dollars per share) | $ (0.68) | $ (0.63) | $ (2.25) | $ (2.05) | ||||
Net loss per share, diluted (in dollars per share) | $ (0.68) | $ (0.63) | $ (2.25) | $ (2.05) |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities (Details) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 4,881,553 | 3,269,760 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 4,672,788 | 3,205,831 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 178,595 | 63,929 |
Shares committed under the ESPP | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 30,170 | 0 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Thousands | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Aug. 31, 2021 | Feb. 28, 2021 | |
Operating Leased Assets [Line Items] | ||||
Term of lease contract | 3 years | |||
Future minimum lease payments | $ 661 | $ 1,600 | ||
Lease expense | $ 400 | $ 300 | ||
Princeton New Jersey Office Space, lease ending in 2022 | Minimum | ||||
Operating Leased Assets [Line Items] | ||||
Remaining term of operating lease | 9 months 18 days | |||
Princeton New Jersey Office Space, lease ending in 2022 | Maximum | ||||
Operating Leased Assets [Line Items] | ||||
Remaining term of operating lease | 2 years 4 months 24 days | |||
Boston, MA Office Space | ||||
Operating Leased Assets [Line Items] | ||||
Term of lease contract | 5 years | |||
Future minimum lease payments | $ 2,700 |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Leases [Abstract] | ||
Operating lease right-of-use assets | $ 629 | $ 644 |
Finance lease right-of-use assets | 22 | 34 |
Total right-of-use assets | 651 | 678 |
Operating lease liabilities | 464 | 400 |
Finance lease liabilities | 17 | 18 |
Total lease liabilities | 481 | 418 |
Operating lease liabilities, non-current | 172 | 250 |
Finance lease liabilities, non-current | 7 | 19 |
Total lease liabilities, non-current | $ 179 | $ 269 |
Leases - Lease Maturity Schedul
Leases - Lease Maturity Schedules (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Feb. 28, 2021 | Dec. 31, 2020 |
Finance Leases | |||
2021 (remainder) | $ 5 | ||
2022 | 16 | ||
2023 | 4 | ||
2024 | 0 | ||
Total undiscounted cash flows | 25 | ||
Less: imputed interest | (1) | ||
Total lease liabilities | 24 | ||
Less: current portion | (17) | $ (18) | |
Lease liabilities | 7 | 19 | |
Operating Leases | |||
2021 (remainder) | 138 | ||
2022 | 376 | ||
2023 | 126 | ||
2024 | 21 | ||
Total undiscounted cash flows | 661 | $ 1,600 | |
Less: imputed interest | (25) | ||
Total lease liabilities | 636 | ||
Less: current portion | (464) | (400) | |
Lease liabilities, non-current | 172 | 250 | |
Total | |||
2021 (remainder) | 143 | ||
2022 | 392 | ||
2022 | 130 | ||
2023 | 21 | ||
Total undiscounted cash flows | 686 | ||
Less: imputed interest | (26) | ||
Total lease liabilities | 660 | ||
Less: current portion | (481) | (418) | |
Total lease liabilities, non-current | $ 179 | $ 269 |
Long-term Debt (Details)
Long-term Debt (Details) $ in Thousands | Oct. 19, 2021USD ($) | Aug. 05, 2021USD ($)shares | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2021USD ($) | Sep. 30, 2020USD ($) |
Debt Instrument [Line Items] | ||||||
Number of tranches | shares | 3 | |||||
Interest expense | $ (1,124) | $ 0 | $ (1,124) | $ 0 | ||
Amortization of loan commitment fees, debt issuance and discount costs | $ 500 | $ 500 | ||||
Debt Instrument, Prepayment Premium Percentage, Period Two | 8.00% | 8.00% | ||||
Debt Instrument, Prepayment Premium Percentage, Period Three | 6.00% | 6.00% | ||||
Debt Instrument, Prepayment Premium Percentage, Period Four | 4.00% | 4.00% | ||||
Revolving Credit Facility | OrbiMed Credit Facility | ||||||
Debt Instrument [Line Items] | ||||||
OrbiMed credit facility | $ 125,000 | |||||
Interest rate floor | 0.40% | |||||
Exit fee on prepayment of principal or at loan maturity, as a percentage | 6.00% | |||||
Exit fee on prepayment of debt or at loan maturity, amount | $ 2,700 | $ 2,700 | ||||
Quarterly revenue interest payments, percentage of net recurring revenue up to specified amount | 3.00% | |||||
Quarterly revenue interest payments, percentage of net recurring revenue over specified amount to aggregate cap | 1.00% | |||||
Effective interest rate on credit facility | 14.11% | 14.11% | ||||
Value of embedded derivative liability | $ 400 | $ 200 | $ 200 | |||
Mark-to-market adjustment on embedded derivative liability | 200 | |||||
Required principal payment if FDA approval not obtained before specified date | 5,000 | |||||
Minimum liquidity covenant prior to FDA approval | 20,000 | |||||
Minimum liquidity covenant after FDA approval | $ 5,000 | |||||
Debt Instrument, Interest Rate Increase On Event Of Default | 3.00% | |||||
Debt Instrument, Prepayment Premium Percentage | 10.00% | |||||
Debt Instrument, Repayment Of Principal In Event Minimum Requirements Are Met | $ 5,000 | |||||
Revenue sharing cap | $ 9,000 | $ 9,000 | ||||
Revolving Credit Facility | OrbiMed Credit Facility | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | ||||||
Debt Instrument [Line Items] | ||||||
Interest rate (as a percentage) | 8.10% | |||||
Revolving Credit Facility | OrbiMed Credit Facility | Maximum | ||||||
Debt Instrument [Line Items] | ||||||
Net recurring revenue from annual sales and licenses up to specified amount | $ 300,000 | |||||
Net recurring revenue from annual sales and licenses over specified amount to aggregate cap | 500,000 | |||||
Revolving Credit Facility | OrbiMed Credit Facility | Minimum | ||||||
Debt Instrument [Line Items] | ||||||
Net recurring revenue from annual sales and licenses over specified amount to aggregate cap | 300,000 | |||||
Revolving Credit Facility | OrbiMed Credit Facility | Amount provided at signing | ||||||
Debt Instrument [Line Items] | ||||||
Initial borrowing capacity of OrbiMed credit facility | 45,000 | |||||
Revolving Credit Facility | OrbiMed Credit Facility | Amount provided upon FDA approval | ||||||
Debt Instrument [Line Items] | ||||||
Contingent increase in credit facility | 50,000 | |||||
Revolving Credit Facility | OrbiMed Credit Facility | Amount provided upon FDA approval | Subsequent Event | ||||||
Debt Instrument [Line Items] | ||||||
Contingent increase in credit facility | $ 50,000 | |||||
Revolving Credit Facility | OrbiMed Credit Facility | Amount provided contingent upon certain net sales performance | ||||||
Debt Instrument [Line Items] | ||||||
Contingent increase in credit facility | 30,000 | |||||
Required recurring revenue for funding | $ 40,000 | |||||
Revolving Credit Facility | Amendment to OrbiMed Credit Facility | Subsequent Event | ||||||
Debt Instrument [Line Items] | ||||||
Required principal payment if FDA approval not obtained before specified date | $ 10,000 |
Long-term Debt - Debt Amortizat
Long-term Debt - Debt Amortization (Details) $ in Thousands | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Debt Instrument [Line Items] | |
Accumulated amortization of loan commitment fees | $ (271) |
Revolving Credit Facility | OrbiMed Credit Facility | |
Debt Instrument [Line Items] | |
Loan commitment fees | 1,981 |
Loan commitment fees, net | $ 1,710 |
Long-term Debt - Debt issuance
Long-term Debt - Debt issuance and discount (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Long-term debt | $ 45,000 | |
Debt issuance and discount costs | (2,868) | |
Derivative Liability, Noncurrent | (450) | |
Amortization and accretion of long-term debt related costs | 237 | |
Long-term debt, net | $ 41,919 | $ 0 |
Long-term Debt - Maturity and F
Long-term Debt - Maturity and Fees (Details) - USD ($) $ in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Total | ||
Long-term debt, net | $ 41,919 | $ 0 |
Revolving Credit Facility | OrbiMed Credit Facility | ||
Less than a year | ||
Debt Principal | 0 | |
Exit Fee | 0 | |
Contractual Interest on debt | 3,878 | |
Revenue Sharing Cap | 0 | |
Total obligations | 3,878 | |
1-3 years | ||
Debt Principal | 0 | |
Exit Fee | 0 | |
Contractual Interest on debt | 7,767 | |
Revenue Sharing Cap | 0 | |
Total obligations | 7,767 | |
3-5 years | ||
Debt Principal | 0 | |
Exit Fee | 0 | |
Contractual Interest on debt | 7,756 | |
Revenue Sharing Cap | 0 | |
Total obligations | 7,756 | |
More than 5 years | ||
Debt Principal | 45,000 | |
Exit Fee | 2,700 | |
Contractual Interest on debt | 3,283 | |
Revenue Sharing Cap | 9,000 | |
Total obligations | 59,983 | |
Total | ||
Total obligations | 45,000 | |
Total obligations | 2,700 | |
Long-Term Debt, Estimated Interest Expense | 22,684 | |
Revenue Sharing Cap | 9,000 | |
Long-term debt, net | $ 79,384 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) $ in Thousands | Aug. 05, 2021 | Aug. 31, 2021 | Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | Oct. 28, 2021 | Oct. 15, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Research and development | $ 6,214 | $ 8,210 | $ 18,772 | $ 28,104 | ||||
Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Research and development | 500 | 500 | ||||||
Ji Xing Pharmaceuticals Limited | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Shares received as consideration | 397,562 | |||||||
Value of shares received in consideration | $ 400 | |||||||
Ji Xing Pharmaceuticals Limited | License | Subsequent Event | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Developmental milestone payment | $ 5,000 | |||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Payment for license agreement | $ 17,500 | |||||||
Upfront payment on license agreement | $ 17,900 | |||||||
Period for written notice of termination | 180 days | |||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Upfront payment on license agreement | $ 15,000 | |||||||
Shares received as consideration | 397,562 | |||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Maximum | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Royalty rates | 20.00% | |||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Maximum | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Aggregate development and net sales-based milestone payments (up to) | $ 204,800 | |||||||
Royalty rates | 20.00% | |||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Minimum | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Royalty rates | 10.00% | |||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Minimum | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Royalty rates | 10.00% | |||||||
Ji Xing Pharmaceuticals Limited | License | Beneficial Owner | Subsequent Event | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Additional shares to be issued in consideration for milestone payment (in shares) | 397,561 | |||||||
Developmental milestone payment | $ 5,000 | |||||||
Pfizer | License | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
One-time, sales based milestone payment | 10,000 | 10,000 | ||||||
Milestone payment, sales threshold | $ 250,000 | $ 250,000 | ||||||
Pfizer | License | Maximum | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Royalty rates | 15.00% | |||||||
Pfizer | License | Minimum | ||||||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||||||||
Royalty rates | 7.50% |
Commitment and Contingencies (D
Commitment and Contingencies (Details) $ in Thousands | 1 Months Ended |
Jul. 31, 2021USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Initial term of manufacturing and supply agreement | 3 years |
Minimum capacity reservation fee | $ 2,500 |
Term of annual payments | 3 years |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) $ in Thousands | Oct. 19, 2021 | Aug. 05, 2021 | Oct. 15, 2021 |
Revolving Credit Facility | OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
Required principal payment if FDA approval not obtained before specified date | $ 5,000 | ||
Amount provided upon FDA approval | Revolving Credit Facility | OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
Contingent increase in credit facility | $ 50,000 | ||
Subsequent Event | Ji Xing Pharmaceuticals Limited | License | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | |||
Subsequent Event [Line Items] | |||
Developmental milestone payment received in equity ( in shares) | 397,561 | ||
Developmental milestone payment | $ 5,000 | ||
Subsequent Event | Revolving Credit Facility | Amendment to OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
Required principal payment if FDA approval not obtained before specified date | $ 10,000 | ||
Subsequent Event | Amount provided upon FDA approval | Revolving Credit Facility | OrbiMed Credit Facility | |||
Subsequent Event [Line Items] | |||
Contingent increase in credit facility | $ 50,000 |