Cover
Cover - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2021 | Feb. 16, 2022 | Jun. 30, 2021 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 2021 | ||
Current Fiscal Year End Date | --12-31 | ||
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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | 26,633,077 | ||
Documents Incorporated by Reference | Portions of the registrant’s definitive Proxy Statement relating to the 2021 Annual Meeting of Stockholders are incorporated herein by reference in Part III of this Annual Report on Form 10-K to the extent stated herein. The proxy statement will be filed with the Securities and Exchange Commission within 120 days of the registrant’s fiscal year ended December 31, 2021. | ||
Entity Public Float | $ 214.6 | ||
Entity Central Index Key | 0001720725 | ||
Document Fiscal Year Focus | 2021 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Audit Information
Audit Information | 12 Months Ended |
Dec. 31, 2021 | |
Auditor [Line Items] | |
Auditor Firm ID | 238 |
Auditor Name | PricewaterhouseCoopers LLP |
Auditor Location | Florham Park, New Jersey |
BALANCE SHEETS
BALANCE SHEETS - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Current Assets | ||
Cash and cash equivalents | $ 193,372 | $ 192,585 |
Restricted cash | 61 | 0 |
Accounts receivable, net | 6,656 | 0 |
Inventory, net | 6,086 | 0 |
Prepaid expenses and other current assets | 9,075 | 3,782 |
Total current assets | 215,250 | 196,367 |
Property and equipment, net | 2,497 | 804 |
Restricted cash | 0 | 61 |
Investment - related party | 886 | 0 |
Other assets | 1,082 | 0 |
Right-of-use assets, net | 2,902 | 678 |
Total Assets | 222,617 | 197,910 |
Current Liabilities | ||
Accounts payable | 6,496 | 2,279 |
Accrued expenses and other current liabilities | 21,511 | 8,285 |
Total lease liabilities | 795 | 418 |
Total current liabilities | 28,802 | 10,982 |
Lease liabilities, non-current | 2,118 | 269 |
Long-term debt | 89,815 | 0 |
Other long-term liabilities | 2,345 | 0 |
Total Liabilities | 123,080 | 11,251 |
Commitments and Contingencies (Note 14) | ||
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, 26,579,585 and 25,890,490 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively | 27 | 26 |
Additional paid-in capital | 354,920 | 341,384 |
Accumulated deficit | (255,410) | (154,751) |
Total Stockholders’ Equity | 99,537 | 186,659 |
Total Liabilities and Stockholders’ Equity | $ 222,617 | $ 197,910 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Dec. 31, 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) | 26,579,585 | 25,890,490 |
Common stock shares outstanding (in shares) | 26,579,585 | 25,890,490 |
STATEMENTS OF OPERATIONS AND CO
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Total revenue | $ 24,539 | $ 0 |
Cost of product revenue | 1,525 | 0 |
Operating expenses: | ||
Sales and marketing | 54,622 | 9,873 |
General and administrative | 40,813 | 21,305 |
Research and development | 24,234 | 39,811 |
Total operating expenses | 119,669 | 70,989 |
Loss from operations | (96,655) | (70,989) |
Interest expense | (3,734) | 0 |
Other income, net | (270) | 469 |
Total other income (expense), net | (4,004) | 469 |
Net loss and comprehensive loss | $ (100,659) | $ (70,520) |
Net loss per share, basic (in dollars per share) | $ (3.87) | $ (2.92) |
Net loss per share, diluted (in dollars per share) | $ (3.87) | $ (2.92) |
Weighted-average shares outstanding, basic (in shares) | 26,036,536 | 24,128,603 |
Weighted-average shares outstanding, diluted (in shares) | 26,036,536 | 24,128,603 |
Product revenue, net | ||
Total revenue | $ 1,153 | $ 0 |
Milestone revenue - related party | ||
Total revenue | 5,000 | 0 |
License revenue - related party | ||
Total revenue | $ 18,386 | $ 0 |
STATEMENTS OF STOCKHOLDERS' EQU
STATEMENTS OF STOCKHOLDERS' EQUITY - USD ($) $ in Thousands | Total | Shares committed under the ESPP | Common Stock | Common StockUnvested restricted stock units | Common StockShares committed under the ESPP | Additional Paid-In Capital | Additional Paid-In CapitalShares committed under the ESPP | 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 | (70,520) | (70,520) | ||||||
Issuance of common stock upon follow-on equity offering, net of issuance costs of $8,125 (in shares) | 4,312,500 | |||||||
Issuance of common stock upon follow-on equity offering, net of issuance costs of $8,125 | 112,625 | $ 5 | 112,620 | |||||
Issuance of stock (in shares) | 175,030 | |||||||
Issuance of common stock upon exercise of stock options | 283 | 283 | ||||||
Issuance of common stock upon vesting of restricted stock units (RSUs) (in shares) | 36,010 | |||||||
Stock-based compensation expense | $ 6,973 | 6,973 | ||||||
Ending balance, common stock (in shares) at Dec. 31, 2020 | 25,890,490 | 25,890,490 | ||||||
Ending balance at Dec. 31, 2020 | $ 186,659 | $ 26 | 341,384 | (154,751) | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Net loss | $ (100,659) | (100,659) | ||||||
Issuance of stock (in shares) | 599,582 | 599,582 | ||||||
Issuance of common stock upon exercise of stock options | $ 1,146 | $ 1 | 1,145 | |||||
Issuance of common stock upon vesting of restricted stock units (RSUs) (in shares) | 44,960 | |||||||
issuance of common stock under the Employee Stock Purchase Plan (ESPP) | 44,553 | |||||||
Issuance of common stock under the employee stock purchase plan (ESPP) | $ 443 | $ 443 | ||||||
Stock-based compensation expense | $ 11,948 | 11,948 | ||||||
Ending balance, common stock (in shares) at Dec. 31, 2021 | 26,579,585 | 26,579,585 | ||||||
Ending balance at Dec. 31, 2021 | $ 99,537 | $ 27 | $ 354,920 | $ (255,410) |
STATEMENTS OF STOCKHOLDERS' E_2
STATEMENTS OF STOCKHOLDERS' EQUITY (Parenthetical) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Payments of Stock Issuance Costs | $ 361 |
Payments of Stock Issuance Costs | 361 |
Follow-on offering | |
Statement of Stockholders' Equity [Abstract] | |
Payments of Stock Issuance Costs | 8,125 |
Payments of Stock Issuance Costs | $ 8,125 |
STATEMENT OF CASH FLOWS
STATEMENT OF CASH FLOWS - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Cash flows from operating activities | ||
Net loss | $ (100,659) | $ (70,520) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 11,948 | 6,973 |
Depreciation | 141 | 77 |
Amortization and accretion of long-term debt related costs | 1,384 | 0 |
Reduction in the carrying amount of the right-of-use assets | 541 | 384 |
Provision for inventory obsolescence | 879 | 0 |
Non-cash consideration for license revenue - related party | (886) | 0 |
Change in fair value of net embedded derivative liabilities | 314 | 0 |
Changes in assets and liabilities: | ||
Accounts receivable, net | (6,656) | 0 |
Inventory | (6,965) | 0 |
Prepaid expenses and other assets | (5,660) | (381) |
Other assets | (132) | 0 |
Accounts payable | 3,868 | 1,773 |
Lease liabilities | (539) | (382) |
Accrued expenses and other current liabilities | 13,052 | 3,677 |
Net cash used in operating activities | (89,370) | (58,399) |
Cash flows from investing activities | ||
Purchases of property and equipment | (1,485) | (700) |
Net cash used in investing activities | (1,485) | (700) |
Cash flows from financing activities | ||
Payments of deferred offering costs | (30) | (361) |
Proceeds from follow-on offering, net of issuance costs | 0 | 112,625 |
Proceeds from long-term debt | 95,000 | 0 |
Payment of debt issuance costs | (4,917) | 0 |
Proceeds from the exercise of stock options and sale of common stock under the ESPP | 1,589 | 283 |
Net cash provided by financing activities | 91,642 | 112,547 |
Net increase in cash, cash equivalents and restricted cash | 787 | 53,448 |
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 | 193,433 | 192,646 |
Supplemental Cash Flow Information | ||
Interest | 2,352 | 0 |
Non-cash investing and financing activities: | ||
Accrued property and equipment | 349 | 0 |
Right-of-use assets acquired through leases | $ 2,765 | $ 320 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2021 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business 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 Since inception, the Company has incurred recurring losses and negative cash flows from operations. The Company generated net losses of $100.7 million and $70.5 million for the years ended December 31, 2021 and 2020, respectively, and had an accumulated deficit of $255.4 million as of December 31, 2021. The Company historically financed its operations primarily through the sale and issuance of its securities, however in the second half of 2021, the Company secured debt capital in the form of a long-term credit facility to finance its operations, as further described in Note 10, Long-term Debt . The Company began selling TYRVAYA Nasal Spray in November 2021 and generated net product revenues of $1.2 million for the year ended December 31, 2021. The Company is subject to risks and uncertainties common to companies in the biopharmaceutical industry, including, but not limited to, the ability to secure sufficient capital to fund operations, competition from other companies’ products, the availability and sufficiency of third-party payor coverage and reimbursement, compliance with law and government regulations, the ability to develop and bring to market new products, protection of proprietary technology, and dependence on third parties and key personnel. Successfully commercializing TYRVAYA Nasal Spray requires significant sales and marketing efforts, and the Company’s pipeline programs may require significant additional research and development efforts, including extensive preclinical and clinical testing. These activities will in turn require significant amounts of capital, qualified personnel and adequate infrastructure. There can be no assurance when, if ever, the Company will realize significant revenue from the sales of TYRVAYA Nasal Spray or if the development efforts supporting the Company’s pipeline, including future clinical trials, will be successful. The future viability of the Company is dependent on its ability to fund its operations through the sales and licensing of TYRVAYA Nasal Spray, its ability to draw on the $30 million third tranche of the long-term credit facility, as further described in Note 10, Long-term Debt, and raise additional capital through equity offerings or other collaborative or strategic arrangements. The Company’s ability to draw on the third tranche is contingent upon achieving at least $40 million in TYRVAYA Nasal Spray net recurring revenue, as defined in the Credit Agreement, in any twelve-month period on or before March 31, 2023, and upon no improper promotional event having occurred, among other conditions. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, or reduce the scope of its marketing and commercialization efforts, which could materially and adversely affect the Company's business, financial condition and operations. Additionally, i f the Company decides to enter into additional license agreements or other collaborative or strategic arrangements to supplement its funds, it may have to give up certain rights, thereby limiting its ability to develop and commercialize TYRVAYA Nasal Spray, as well as other product candidates in the pipeline or may have other terms that are not favorable to the Company, which could materially affect its business, results of operation and financial condition. The Company had cash and cash equivalents of $193.4 million as of December 31, 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 issuance date of its Annual Report on Form 10-K. Risks and Uncertainties The Company operates in a dynamic and highly competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company related to intellectual property, product, regulatory, or other matters; and the Company’s ability to attract and retain employees necessary to support its growth. Product candidates developed by the Company require approval from the U.S. Food and Drug Administration (FDA) and or other international regulatory agencies prior to commercial sales. There can be no assurance that the product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approval, it could have a material adverse impact on the Company. The Company relies on single source manufacturers and suppliers for the supply of its product candidates. This adds to the manufacturing risks faced by the Company, which could be left without backup facilities in the event of any failure by a supplier. In addition, if the Company decides to move to a different or add additional manufacturers and suppliers in the future, any such transition or addition could result in delays or other issues, which could have an adverse effect on the supply of TYRVAYA Nasal Spray or other product candidates. Any disruption from these manufacturers or suppliers could have a negative impact on the Company’s business, financial position and results of operations. In addition, the Company is dependent upon the services of its employees, consultants and other third parties. For the year ended December 31, 2021, a significant percentage of the Company's sales of TYRVAYA Nasal Spray were to four large wholesale drug distributors, and the Company may continue to rely on a limited number of wholesale drug distributors for the distribution of TYRVAYA Nasal Spray. If the Company is unable to maintain its business relationships with wholesale drug distributors on commercially acceptable terms, it could have a material adverse impact on the Company’s business, financial condition and results of operations. The Company does not believe its financial results were significantly affected by the SARS-CoV-2 virus pandemic during the year ended December 31, 2021. However, the extent to which the SARS-CoV-2 virus pandemic may affect the Company’s future financial results and operations will depend on future developments which are highly uncertain and cannot be predicted, including new information which may emerge concerning the pandemic, the availability and effectiveness of vaccines and treatment options, and current or future domestic and international actions to contain it and treat it. The Company continues to evaluate the potential impact of the SARS-CoV-2 virus pandemic on its business, including the potential impact of the pandemic on the commercial launch of TYRVAYA Nasal Spray and its acceptance by patients and prescribers, and any potential supply-chain challenges, as well as the potential impact of the pandemic on its pipeline and the conduct of clinical trials and preclinical studies In addition, the Company has taken a variety of measures in an effort to ensure the availability and functioning of the Company's critical infrastructure and to promote the safety and security of its employees, including remote working arrangements for employees and investing in personal protective equipment for the future return to the office. With the surge of the Delta and Omicron variants of the virus across the U.S. during the second half of 2021 and early 2022, the Company postponed its plans for a voluntary return to the office for its employees until March 2022. The Company’s sales force is primarily working i n-person and has been instructed to follow all locally required SARS-CoV-2 related precautions. The Company will continue monitoring SARS-CoV-2 infection rates and make practical decisions ab out voluntary reopening in compliance with Centers for Disease Control and Prevention, federal, state and local guidelines. The Company continues to evaluate and develop pipeline candidates for the potential treatment of various medical indications. The ongoing SARS-CoV-2 virus pandemic may impact access to supplies necessary to conduct preclinical studies, cause delay to the timelines to initiate or complete in vitro or in vivo animal studies, or may indirectly impact the operations of third parties that are necessary for the Company to advance preclinical projects. If the SARS-CoV-2 virus pandemic continues and persists for an extended period of time, the Company could experience significant disruptions to its clinical development timelines, which could adversely affect its business, financial condition and results of operations. |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | Basis of Presentation and Summary of Significant Accounting Policies Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP). 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 revenue and expenses in the financial statements and accompanying notes as of the date of the financial statements. On an ongoing basis, management evaluates its estimates, including those related to the valuation of stock-based awards, revenue and gross-to-net deductions, inventory, income taxes, net embedded derivative liability bifurcated from the Company's long-term credit agreement and certain research and development accruals. Management bases its estimates on historical experience and on various other assumptions that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results could differ from these estimates, and such differences could be material to the Company’s financial position and results of operations. Segment Reporting The Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions, which is the development and commercialization of pharmaceutical therapies to treat ophthalmic diseases. Concentration Risk Financial instruments that potentially subject the Company to concentrations of credit risk are money market funds, which are included in cash and cash equivalents on the Company's balance sheets. The Company attempts to minimize the risks related to cash and cash equivalents by using highly-rated financial institutions that invest in a broad and diverse range of financial instruments. The Company's investment portfolio is maintained in accordance with its investment policy that defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. The Company currently relies on a third-party contract manufacturing organization (CMO) to manufacture TYRVAYA Nasal Spray. The commercialization of TYRVAYA Nasal Spray and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company does not intend to establish its own manufacturing facilities. If the Company is unable to continue its relationships with these third-party manufacturers, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company relies and expects to continue to rely for the foreseeable future on CMOs to manufacture and supply its commercial product. For the year ended December 31, 2021, a significant percentage of the Company's sales of TYRVAYA Nasal Spray were to four large wholesale drug distributors. Sales to Western Wellness Solutions LLC, McKesson Corporation, Cardinal Health, Inc., and AmerisourceBergen accounted for 42.1%, 21.2%, 18.3% and 17.0% of total gross sales, respectively, for the year ended December 31, 2021. License and milestone revenue are derived from a related party customer located in China. For the year ended December 31, 2021, the Company’s sole geographic market for product sales is the U.S. Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of three months or less at the time of purchase to be cash equivalents. As of December 31, 2021 and 2020, cash and cash equivalents consisted of cash on deposit with banks denominated in U.S. dollars and investment in money market funds. Restricted cash represents cash held to support a letter of credit agreement related to certain office leases, which expire in 2022. The following table provides a reconciliation of cash, cash equivalents and restricted cash within the balance sheets that sum to the total of the same such amounts shown in the statements of cash flows (in thousands): Year ended December 31, 2021 2020 2019 Cash and cash equivalents $ 193,372 $ 192,585 $ 139,147 Restricted cash 61 61 51 Cash, cash equivalents and restricted cash $ 193,433 $ 192,646 $ 139,198 Accounts Receivable, Net Accounts receivable are recorded net of customer allowances for distribution fees, trade discounts, prompt pay discounts, chargebacks and expected credit losses. Allowances for distribution fees, prompt payment discounts and chargebacks are based on contractual terms. The Company evaluates the collectability of accounts receivable on a regular basis, by reviewing the financial condition and payment history of customers, an overall review of collections experience on other accounts, and economic factors or events expected to affect future collections experience. The Company determines the allowance for doubtful accounts by estimating the expected credit losses, measured over the life of the customer receivable that considers forecasts of future economic conditions in addition to information about past events and current economic conditions. There was no allowance for doubtful accounts recorded as of December 31, 2021. The Company recorded an allowance of $0.9 million for expected prompt pay discounts, distributor service agreement fees and chargebacks to wholesalers as of December 31, 2021. Inventory, Net Inventory is stated at the lower of cost or net realizable value, using the first-in, first-out method. Inventory consists of raw materials, work-in-process and finished goods. Costs to be capitalized as inventory primarily include third-party components, manufacturing costs and overheard costs. Cost is determined using the standard cost method, which approximates actual costs. The Company began capitalizing inventory post FDA approval of TYRVAYA Nasal Spray on October 15, 2021, as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to the FDA approval of TYRVAYA Nasal Spray were recorded as research and development expense in the statements of operations and comprehensive loss during the year ended December 31, 2020 and during the current year prior to October 15, 2021. Inventory manufactured that will be used in a promotional sample program is expensed to sales and marketing expense when it is produced as a sample. Inventory produced that will be used in pre-clinical and clinical studies of the Company's product candidates is expensed to research and development expense in the statements of operations and comprehensive loss. If information becomes available that suggests inventory may not be realizable, the Company may be required to write off portion or all of the previously capitalized inventory. Once inventory has been written-off or written-down, it creates a new cost basis for the inventory that is not subsequently written-up. The Company recorded a reserve for inventory obsolescence of $0.9 million as of December 31, 2021. Property and Equipment Property and equipment is recorded at cost and depreciated using the straight-line method over the estimated useful lives of the related assets. Construction-in-progress reflects amounts incurred for property and equipment for use in manufacturing process and or improvements that have not yet been placed in service and are not depreciated or amortized. Repairs and maintenance are expensed when incurred. Upon retirement or sale, the cost of the assets disposed of and the related accumulated depreciation are removed from the accounts, and any resulting gain or loss is included in loss from operations in the statements of operations and comprehensive loss. Estimated useful lives by major asset category are as follows: Marketing equipment 3 years Office equipment 5 years Furniture and fixtures 7 years Laboratory equipment 7 years Leasehold improvements Shorter of lease term or estimated useful life Long-lived assets are tested for recoverability whenever events or circumstances indicate that the carrying amount may not be recoverable. When such events occur, the Company compares the carrying amounts of the assets to their undiscounted expected future cash flows. If the undiscounted cash flows are insufficient to recover the carrying value, the assets are recorded at the lesser of the carrying value or fair value. For the years ended December 31, 2021, and 2020 no impairment charges were recorded. Fair Value of Financial Instruments The carrying amounts for financial instruments consisting of cash equivalents, restricted cash, accounts receivable, and accounts payable approximate their fair value due to their short-term maturities. 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 statement of operations and comprehensive loss . Loan Commitment Fees, Debt Issuance and Discount Costs 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 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. When the Company draws down on the term loan credit facility, it reclassifies the remaining unamortized capitalized loan commitment fees on a pro-rata basis to debt issuance and discount costs that reduce the carrying amount of the debt liability. Investment - Related Party The Company accounts for the senior common shares received under a collaboration and license agreement (License Agreement) with Ji Xing Pharmaceuticals Limited (Ji Xing), as further described in Note 12, License and Collaboration Agreements . as a non-marketable equity investment (the Investment). The Investment was recorded at its initial fair value and is subject to impairment analysis on a periodic basis. The Company has elected to subsequently account for its non-marketable equity investment at cost minus impairment, if any. If the Company identifies observable price changes in orderly transactions for the identical or a similar investment of the same issuer, it measures the equity security at fair value as of the date that the observable transaction occurred . 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-related party is considered impaired, the Company will recognize an impairment loss through other income (expense), net in the statements of operations and comprehensive loss and establish a new carrying value for the Investment. There was no impairment expense recorded for the Investment during the year ended December 31, 2021. Leases The Company determines if an arrangement is or contains a lease and the classification of that lease at inception of a contract. The Company’s operating and finance lease assets are included in right-of-use assets, net lease liabilities lease liabilities, non-current Right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the lease commencement date. Right-of-use assets are based on the corresponding lease liability adjusted for (i) payments made at or before the commencement date, (ii) initial direct costs incurred, and (iii) tenant incentives under the lease. The Company does not account for renewals or early terminations unless it is reasonably certain to exercise these options at commencement. Operating lease expense is recognized on a straight-line basis over the lease term. For finance leases, right of use assets are amortized on a straight-line basis over the shorter of the lease term or the estimated useful life of the leased assets. The Company accounts for lease and non-lease components as a single lease component for operating leases. The discount rate used to calculate the present value of the Company's lease liabilities is based on either an explicit rate stipulated in the contract (for finance leases) or the incremental borrowing rate based on the information available at the lease commencement date in determining the present value of future payments. The Company’s incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, in an economic environment where the leased asset is located. The Company determines the incremental borrowing rate by considering various factors, such as its credit rating, interest rates of similar debt instruments of entities with comparable credit ratings, the lease term and the currency in which the lease was denominated. The Company does not record leases with terms of 12 months or less on the balance sheet. Revenue The Company recognizes revenue based on the transfer of control of promised goods or services to a customer in an amount that reflects the consideration to which the Company expects to receive in exchange for those goods and services. Customer contracts that contain multiple performance obligations requires an allocation of the transaction price to each distinct good and service based upon the stand-alone selling prices of the goods and 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 Product Revenue and Gross to Net Deductions — Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon delivery, based on an amount that reflects the consideration to which the Company expects to be entitled, which is then adjusted for any gross-to-net (GTN) deductions. The GTN deductions are reflected as either a reduction to the accounts receivable account (and settled through the issuance of credits), or, are reflected as a current liability and settled through cash payments. The Company offers rights of return to its customers for products that are six months prior to and up to twelve months after expiration and, accordingly, product returns are included within the GTN deductions. Judgment is required in estimating GTN deductions, which takes into account legal interpretations of applicable laws and regulations, current experience and contract prices under applicable programs, unbilled claims, and processing time lags. The Company analyzes its accruals for GTN deductions on a monthly basis and makes any adjustments if needed. Accruals for GTN deductions are based off estimates of the amounts earned or to be claimed on the related sales. These estimates take into consideration current contractual terms, actual utilization data, forecasted payor mix, total prescriptions and industry data. The following are typical GTN deductions the Company applies to the sales price at the time of the sale of its product: Prompt Pay Discount — The Company offers cash discounts to its distributors, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount . Chargebacks — The Company participates in programs with government entities, the most significant of which are the U.S. Department of Veterans Affairs, whereby pricing on products is extended below wholesaler list price to participating entities. These entities purchase products through wholesalers at the lower program price and the wholesalers then charge the Company the difference between their acquisition cost and the lower program price. The Company records chargebacks as reduction to the accounts receivable account on the Company's balance sheet. Product Returns — Estimated returns for products are determined after considering information provided by external sources, and other factors such as estimated levels of inventory in the distribution channel and projected demand, introductions of generic products, and introductions of competitive new products. The estimated amount for product returns is included in accrued expenses and other current liabilities on the Company's balance sheet. Distribution Service Fees — The Company records service fees paid to its wholesaler customers for distribution and inventory management services as a reduction to revenue. The Company accrues estimated service fees based on contracted terms. Accrued service fees are recorded as a reduction to the accounts receivable account on the Company's balance sheet. Bridge Offer and Co-Pay Offer — The Company established patient support programs to help offset patients’ out of pocket costs. The Bridge Offer program is for patients who are commercially insured and waiting on coverage; The Co-Pay Offer program is for patients who are commercially insured with coverage. The Company’s patient support programs are administered by a third-party copay vendor, which generates GTN deductions in the form of pharmacy redemptions. The estimated cost of pharmacy redemptions is included in accrued expenses and other current liabilities on the Company's balance sheet. Any prepayments by the Company to the vendor are included in prepaid expenses on the Company's balance sheet. Managed Care and Medicare Part D Rebates — These rebates represent programs to lower the overall cost of prescription drugs of covered patients and are based on contracted discount rates and administration fees. The rebates are amounts owed after the final dispensing of the product by a pharmacy to a benefit plan participant. The rebates are paid by the Company on a monthly or quarterly basis to managed care organizations and pharmacy benefit managers. The estimated accrual is included in accrued expenses and other current liabilities on the Company’s balance sheet. Various Government Rebates — The Company participates in certain federal and state government rebate programs such as Medicaid and Tricare. These programs require the Company to enter into, and have in effect, a national rebate agreement with the U.S. Secretary of the Department of Health and Human Services in exchange for coverage of the Company’s product. These rebates are paid by the Company on a quarterly basis based on actual claims. The Company also pays 70% of the cost of the product, when the Medicare Part D beneficiaries are in the coverage gap. The estimated amount of unpaid or unbilled Medicaid, Tricare and Coverage Gap rebates are included in accrued expenses and other current liabilities on the Company's balance sheet. The Company’s customers consist of national and regional pharmaceutical wholesale distributors. The Company also uses a specialty wholesale distributor that acts as an alternative to traditional access, affordability and distribution options for patients. The Company’s customer base for the sales of products is currently located in the U.S. with no customers from foreign countries. The Company accounts for shipping and handling activities of its customer contracts as a fulfillment cost. The Company's payment terms vary by type and location of customers and the products or services offered. Payment terms differ by customer and are generally required in a term ranging from 35 to 95 days from the invoice date. The vast majority of products are shipped under free on board destination shipping terms. As a practical expedient, sales commissions, which represent costs to obtain a contract, are expensed when incurred because the amortization period would have been one year or less. These costs are recorded in sales and marketing expense in the statements of operations and comprehensive loss. The Company entered into a third-party logistics distribution agreement (the 3PL Agreement) to engage a logistics distribution agent (the 3PL Agent) to distribute the Company’s products to its customers. The 3PL Agent provides services to the Company that include storage, distribution, processing product returns, customer service support, logistics support, electronic data interface and system access support. Revenue is recognized upon transfer of control of the product to the customer. During the second half of 2021, the Company applied for mandatory distribution licenses that some states require in order for the Company to sell its product throughout the U.S. In order for the Company to execute sales in the U.S. prior to obtaining such licenses, the Company and an affiliate of the 3PL Agent (the Title Company) entered into a Title Model Addendum (the Addendum) to the 3PL Agreement so that the Title Company may purchase and take title to the product and sell the product to the wholesale distributors who have contracted to purchase the product from the Company. Although under the Addendum the Title Company takes title to the product, the economic substance of the transaction provides that the Title Company does not possess the risk of loss or participate in the significant risks and rewards of ownership of the product or have the ability to control, direct the use of, and obtain substantially all of the remaining benefits from the product. Accordingly, the Company does not recognize revenue on the transfer of the goods until the goods are sold from the Title Company to the wholesalers. In November 2021, the Company obtained all of the necessary state distribution licenses to sell its products throughout the U.S. and, after a customary period of notice to the Title Company, intends to cease using the Addendum process in the first quarter of 2022. 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. Milestone Revenue — The Company recognizes milestone revenue when the milestone event occurs. Royalties Royalties incurred in connection with the Company’s license agreement with Pfizer Inc. as further described in Note 14, License and Collaboration Agreements, are expensed to cost of product revenue as revenue from product sales is recognized. Research and Development Research and development expenses primarily consist of CMOs and clinical research organizations (the CROs) related costs, costs relating to manufacturing clinical trial materials and pre-approval inventory, testing of preproduction samples, prototypes and models, regulatory compliance costs, employee compensation and benefits, consulting, laboratory supplies, product licenses, sponsored research, as well as facility-related expenses and depreciation. All research and development costs are charged to research and development expenses within the statements of operations and comprehensive loss as incurred. Payments associated with licensing agreements to acquire exclusive licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternate commercial use are also expensed as incurred. The Company’s accruals for research and development activities performed by third parties are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued expenses and other current liabilities on the balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accruals accordingly. Payments made to third parties under these arrangements in advance of the performance of the related services by the third parties are recorded as prepaid expenses until the services are rendered. Stock-Based Compensation For stock options granted to employees and directors, as well as the purchase rights issued under the Employee Stock Purchase Plan (ESPP), the Company recognizes stock-based compensation expense in accordance with ASC 718, Compensation-Stock Compensation . The Company uses the Black-Scholes option pricing model to estimate the fair value of options and purchase rights granted that are expensed on a straight-line basis over the vesting period for stock options and offering period for rights issued under the ESPP. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes option-pricing model, require the input of several assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, and the expected life of the award. Restricted stock units (RSUs) are measured and recognized over the vesting period and are based on the quoted market price of the Company's stock on the grant date. Income Taxes The Company accounts for income taxes in accordance with ASC 740, Income Taxes, using the asset and liability method whereby deferred tax asset and liability amounts are determined based on the differences between the financial reporting and tax bases of assets and liabilities. The differences are measured using the enacted tax rates and laws that are in effect for the year in which they are expected to affect taxable income. Valuation allowances are established where necessary to reduce deferred tax assets to the amounts expected to be realized. The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination that the position meets the more-likely-than-not threshold and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether the factors underlying the more-likely-than-not threshold assertion have changed and the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available. The Company's policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. Net Loss per Common Share Basic and diluted net loss per common share is presented in conformity with ASC 260, Earning Per Share for all periods presented. In accordance with this guidance, basic and diluted net loss per common share is determined by dividing the net loss by the weighted-average number of common shares outstanding during the period. Basic net loss and diluted net loss per share are calculated without consideration of potentially dilutive securities. Once the Company becomes profitable, the diluted net income per share would account for potentially dilutive securities outstanding for the period. Comprehensive Loss Comprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that would result from transactions and economic events other than those with stockholders. There have been no items qualifying as other comprehensive income (loss) and, therefore, for all periods presented, the Company’s comprehensive loss was the same as its reported net loss. Collaborative Arrangements The Company analyzes its collaborative arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (ASC 808) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. ASC 808 describes arrangements within its scope and considerations surrounding presentation and disclosure, with recognition matters subjected to other authoritative guidance, in certain cases by analogy. For arrangements determined to be within the scope of ASC 808 where a collaborative partner is not a customer for certain research and development activities, the Company accounts for payments received for the reimbursement of research and development costs as a contra-expense in the period such expenses are incurred. Similarly, the payments made by the Company in connection with such collaborative arrangement are recorded as research and development expense in the Company's statements of operations and comprehensive loss. If the payments to and from the collaborative partner are not within the scope of other authoritative accounting guidance, the Company bases the statement of operations classification for the payments received on a reasonable, rational analogy to authoritative accounting guidance, applied in a consistent manner. Related Parties The Company applies ASC 850, Related Party Disclosures , for the identification of related parties and disclosure of related party transactions. See Note 12, License and Collaboration Agreements, for additional information on the Company's related parties transactions. Reclassification Beginning in 2021, sales and marketing expenses are reported separately from selling, general and administrative expenses in the Company’s statements of operations and comprehensive loss. The statement of operations and comprehensive loss for the year ended December 31, 2020 has been conformed to separately present sales and marketing expenses. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (the FASB) under its ASCs or other standard setting bodies and adopted by the Company as of the specified effective date, unless otherwise discussed below. Recently adopted accounting pronouncements 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 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, |
Inventory, net
Inventory, net | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Inventory, net | Inventory, net Inventory, net consisted of the following (in thousands): December 31, 2021 Raw materials, net $ 2,524 Work in process 3,053 Finished goods 509 Inventory, net $ 6,086 |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 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 10, Long-term Debt, in connection with entering into a long-term credit facility in 2021, 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 . These two embedded derivatives have been bifurcated and netted to result in a net embedded derivative liability, which is classified as a Level 3 financial liability in the fair value hierarchy as of December 31, 2021. The net embedded derivative liability is recorded in other long-term liabilities on the Company's balance sheet. 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, discount rates and risk-free rates of interest. The change in fair value due to the remeasurement of the net embedded derivative liability is recorded in other income, net in the Company’s statements of operations and comprehensive loss. The following table reconciles the beginning and ending balances for the Company’s net embedded derivative liabilities that are carried at fair value as long-term liabilities on the Company's balance sheet using significant unobservable inputs (Level 3) (in thousands): December 31, 2021 Beginning balance January 1 $ — Recognition of net embedded derivative liabilities 2,031 Change in fair value of the net embedded derivative liabilities 314 Ending balance December 31 $ 2,345 As of December 31, 2021, financial assets measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at December 31, 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 162,376 — — 162,376 Total assets $ 162,376 $ — $ — $ 162,376 Liabilities: Net embedded derivative liabilities — — 2,345 2,345 Total liabilities $ — $ — $ 2,345 $ 2,345 As of December 31, 2020, financial assets measured and recognized at fair value 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 Money market funds are included in cash and cash equivalents on the Company's 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 balance sheets for cash equivalents, accounts receivable, 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 a license agreement with Ji Xing, as described in Note 12, License and Collaboration Agreements, the Company received 397,562 senior common shares of Ji Xing in August 2021 and 397,561 senior common shares in October 2021 (the Investment), which were accounted for as a non-marketable equity investment and valued as of August 5, 2021 and October 15, 2021, respectively. 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 and October 15, 2021 (in thousands): Valuation Technique Unobservable Inputs Value Investment - related party August 5, 2021 Market Approach - Backsolve method Equity values of recent rounds of financing by the issuer $ 443 October 15, 2021 Market Approach - Backsolve method Equity values of recent rounds of financing by the issuer 443 Total $ 886 |
Property and Equipment, net
Property and Equipment, net | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, net Property and equipment, net consisted of the following (in thousands): December 31, 2021 2020 Laboratory equipment $ 585 $ — Furniture and fixtures 73 73 Leasehold improvements 226 158 Marketing equipment 258 — Office equipment 68 68 Construction-in-progress 1,524 601 Total property and equipment $ 2,734 $ 900 Accumulated depreciation (237) (96) Property and equipment, net $ 2,497 $ 804 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued GTN deductions $ 4,837 $ — Accrued compensation 9,153 3,500 Accrued professional services 5,451 1,244 Accrued research and development expense 1,243 3,541 Accrued other expense 827 — Accrued expenses and other current liabilities $ 21,511 $ 8,285 |
Stockholders' Equity
Stockholders' Equity | 12 Months Ended |
Dec. 31, 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: December 31, 2021 2020 Outstanding options under the 2016 Incentive Plan 1,935,240 2,567,566 Outstanding options under the 2019 Incentive Plan 2,078,232 918,145 Outstanding options under the 2021 Inducement Plan 270,600 — Equity awards available for grant under the 2019 Incentive Plan (1) 1,535,488 1,790,106 Equity awards available for grant under the 2021 Incentive Plan 379,400 — Unvested restricted stock units (RSUs) under the 2019 Incentive Plan 179,149 61,215 Shares reserved for purchase under the Employee Stock Purchase Plan (the ESPP) (2) 225,447 270,000 Total 6,603,556 5,607,032 (1) — Effective January 1, 2022, in connection with an evergreen provision contained in the 2019 Equity Incentive Plan (the 2019 Plan) an additional 1,063,183 shares were reserved for issuance under the 2019 Plan. (2) — Effective January 1, 2022, in connection with an evergreen provision contained in the ESPP, an additional 265,795 shares were reserved for issuance under the ESPP. |
Equity Incentive Plans
Equity Incentive Plans | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Equity Incentive Plans | Equity Incentive Plans 2019 Incentive Plan The Company's 2019 Incentive Plan (2019 Plan) provides for the granting of stock options, restricted stock, restricted stock units, stock appreciation rights, performance units, and performance shares to the Company's employees, directors, and others. The exercise price of an incentive stock option (ISO) and non-qualified stock option (NSO) shall not be less than 100% of the estimated fair value of the shares on the date of grant, as determined by the BOD. The exercise price of an ISO granted to a 10% stockholder shall not be less than 110% of the estimated fair value of the shares on the date of grant, as determined by the BOD. The Company accounts for forfeitures as they occur, rather than estimate expected forfeitures. Effective January 1, 2022, in connection with an evergreen provision contained in the 2019 Plan, an additional 1,063,183 shares were reserved for issuance under the 2019 Plan. 2021 Inducement Plan In July 2021, the Company's Board of Directors approved the adoption of the 2021 Inducement Plan (2021 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 2021 Plan. The terms and conditions of the 2021 Plan are substantially similar to those of the 2019 Plan. 2019 Employee Stock Purchase Plan The Company maintains an Employee Stock purchase plan (ESPP) which allows eligible employees to purchase shares of the Company's common stock at 85% of the fair market value of the Company's stock at the beginning or the end of the offering period, whichever is lower through payroll deductions. Employees may contribute up to $25,000 per calendar year and subject to any other plan limitations. The ESPP is qualified under Section 423 of the U.S. Internal Revenue Code. The Company estimates the fair value of each purchase right under the ESPP on the date of grant using the Black-Scholes option valuation model and uses the straight-line approach to record the expense over the offering period. The Company issued 44,553 shares of common stock under the ESPP during the year ended December 31, 2021. Effective January 1, 2022, in connection with an evergreen provision contained in the ESPP, an additional 265,795 shares were reserved for issuance under the ESPP. Stock Options The following table summarizes stock option activity under the 2016 Plan, 2019 Plan and the 2021 Plan during the year ended December 31, 2021 (in thousands, except share, 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 Outstanding at January 1, 2021 3,485,711 $ 10.74 8.2 $ 36,506 Options granted 1,629,550 16.07 — Options exercised (599,582) 1.91 9,288 Options forfeited (231,607) 19.24 409 Outstanding at December 31, 2021 4,284,072 $ 13.54 8.1 $ 28,874 Vested and exercisable as of December 31, 2021 1,862,771 $ 9.36 7.1 $ 20,461 Vested and expected to vest as of December 31, 2021 4,284,072 $ 13.54 8.1 $ 28,874 During the years ended December 31, 2021 and 2020, the Company granted options with a weighted-average grant date fair value of $10.66 and $20.41 per share, respectively. The fair value of options that vested during the years ended December 31, 2021 and 2020 was $10.3 million and $3.2 million, respectively. As of December 31, 2021, the total unrecognized stock-based compensation expense for stock options was $25.9 million, which is expected to be recognized over a weighted average period of 2.7 years. Restricted Stock Units Restricted stock units (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. Activity with respect to the Company's restricted stock units during the year ended December 31, 2021 was as follows (in thousands, except share, contractual term, and per share data): Outstanding RSUs Number of Shares Underlying Outstanding Units Weighted Average Grant Date Fair Value per Unit 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 175,431 17.30 3,035 Restricted stock units vested (44,960) 24.90 795 Restricted stock units forfeited (12,537) 180 Outstanding at December 31, 2021 179,149 $ 17.52 2.4 $ 3,271 Unvested and expected to vest as of December 31, 2021 179,149 $ 17.52 2.4 $ 3,271 During the years ended December 31, 2021 and 2020, the Company granted RSUs with a weighted-average grant date fair value of $17.30 and $27.01 per unit, respectively. The fair value of RSUs vested during the year ended December 31, 2021 and 2020 was $1.1 million and $0.9 million, respectively. As of December 31, 2021, the total unrecognized stock-based compensation expense for RSUs was $2.3 million, which is expected to be recognized over a weighted average period of 2.5 years. Stock-Based Compensation Expense The following table is a summary of stock-based compensation expense by function recognized (in thousands): Year Ended December 31, 2021 2020 Selling and marketing $ 2,912 $ 1,360 General and administrative 7,301 4,647 Research and development 1,735 966 Total stock-based compensation $ 11,948 $ 6,973 Fair Value of Options Granted and Purchase Rights issues under the ESPP In determining fair value of the stock options granted and purchase rights issued under the ESPP, the Company uses the Black-Scholes model, which requires the input of several assumptions. These assumptions include: estimating the length of time employees will retain their vested stock options before exercising them or the length of the offering period for the ESPP (expected term), the estimated volatility of the Company’s common stock price over the expected term (expected volatility), risk-free interest rate and expected dividend rate. Changes in the following assumptions can materially affect the estimate of fair value and ultimately how much stock-based compensation expense is recognized. Expected term. The expected term for options is calculated using the simplified method which is used when there is insufficient historical data about exercise patterns and post-vesting employment termination behavior. The simplified method is based on the mid-point between the vesting date and the end of the contractual term. The Company uses the length of an offering period as the expected term for the purchase rights issued under the ESPP. 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 the expected term of the stock option grants. 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 stock award. 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. The table below discloses weighted average assumptions for the fair value of options granted: Year Ended December 31, 2021 2020 Expected volatility 70.0% - 98.0% 82.0% - 118.00% Risk-free interest rate 0.07% - 1.33% 0.36% - 1.40% Dividend yield —% —% Expected term 6.08 years 6.08 years The table below discloses weighted average assumptions for the fair value of the purchase rights granted to employees under the ESPP for the year ended December 31, 2021: Expected volatility 77.0% - 82.4% Risk-free interest rate 0.04% - 0.07% Dividend yield —% Expected term 0.50 years-0.58 years |
Net Loss per Share
Net Loss per Share | 12 Months Ended |
Dec. 31, 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): Year Ended December 31, 2021 2020 Numerator: Net loss $ (100,659) $ (70,520) Denominator: Weighted-average shares outstanding, basic and diluted 26,036,536 24,128,603 Net loss per share, basic and diluted $ (3.87) $ (2.92) 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: December 31, 2021 2020 Options to purchase common stock 4,284,072 3,485,711 Unvested restricted stock units 179,149 61,215 Shares committed under the ESPP 33,589 — Total 4,496,810 3,546,926 |
Long-term Debt
Long-term Debt | 12 Months Ended |
Dec. 31, 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 was funded on November 4, 2021, upon FDA approval of TYRVAYA Nasal Spray for the signs and symptoms of dry eye disease , and the third $30 million tranche may be funded, at the option of the Company, on or prior to June 30, 2023, upon the Company having received at least $40 million in TYRVAYA Nasal Spray net recurring revenue, as defined in the Credit Agreement, in any twelve-month period prior to March 31, 2023, among other conditions. On October 19, 2021, the Company entered into a waiver and amendment (Amendment) to the Credit Agreement, to waive certain product 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. Additionally, c ommencing with the fourth full fiscal quarter after the regulatory approval of TYRVAYA Nasal Spray , the amount of the principal to be repaid will be increased to $10 million if (i) the Company does not meet certain 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. 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 loan, subject to the payment of a prepayment fee, an exit fee, and a buyout amount. 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 (Revenue Sharing Fee) payments made to date to OrbiMed under the Credit Agreement. The term loan underlying the Credit Agreement matures on August 5, 2027 and is structured for full principal repayment at maturity. The term loan bears interest at the secured overnight financing rate (with a floor of 0.40%) plus a spread of 8.10% per annum (Contractual Interest). The Company is required to pay a 6% exit fee (the Exit Fee), or $2.7 million for the first $45 million tranche and $3.0 million on the second $50 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. The term loan is 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 aggregate Revenue Sharing Fee for drawing down on the first two tranches is capped at $19 million. In the event that the Company draws upon the third tranche, the Revenue Sharing Fee cap amount will be $25 million. 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 any Revenue Sharing Fees paid since the origination of the term loan. As of December 31, 2021, the Company has accrued $0.2 million for the Revenue Sharing Fee which is classified in accrued expenses and other current liabilities on the balance sheet. 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 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 balance sheet. This bifurcation of the net embedded derivative liability resulted in an adjustment to increase the debt discount on the loan amounts drawn under the first two tranches. 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 drawn tranches are deferred and amortized using the effective interest method over the life of the term loan, which resulted in an effective interest rate of 13.96% on the loan as of December 31, 2021. The fair value of the net embedded derivative liabilities as of December 31, 2021 was $2.3 million. Changes in fair value of the embedded derivative liabilities of $0.3 million are recorded in other income, net in the statement of operations and comprehensive loss for the year ended December 31, 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 balance sheet as of December 31, 2021. The Company amortizes loan commitment fees on a straight-line basis over the term of the loan commitment. Net loan commitment fees of $0.9 million were reclassified to debt issuance costs and shown as a direct deduction of the debt liability when the second tranche of the term loan was funded. The balance of the undrawn loan commitment fees which relates to the $30 million third tranche and accumulated amortization recorded on the Company’s balance sheet as of December 31, 2021 were as follows (in thousands): December 31, 2021 Loan commitment fees $ 743 Accumulated amortization of loan commitment fees (159) Loan commitment fees, net $ 584 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 balance sheet as of December 31, 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 include the $5.7 million of exit fees to be paid upon maturity of the first and second tranches, the $19.0 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, and accumulated accretion recorded on the Company's balance sheet as of December 31, 2021, were as follows (in thousands): December 31, 2021 Long-term debt $ 95,000 Debt issuance and discount costs (6,071) Accumulated accretion of long-term debt related costs 886 Long-term debt $ 89,815 During the year ended December 31, 2021, the Company recorded interest expense of $3.6 million in connection with the Credit Agreement, of which $1.3 million related to the amortization of the loan commitment fees, as well as debt issuance and discount costs. The following table identifies the Company's obligations under the Credit Agreement as of December 31, 2021 (in thousands): Less than a year 2-3 years 4-5 years More than 5 years Total Debt Principal $ — $ — $ — $ 95,000 $ 95,000 Exit Fee — — — 5,700 5,700 Contractual Interest on debt 8,187 16,397 16,374 4,867 45,825 Revenue Sharing Fee (a) 207 — — — 207 Total obligations $ 8,394 $ 16,397 $ 16,374 $ 105,567 $ 146,732 (a) — The Revenue Sharing Fee is currently capped at $19 million as of December 31, 2021. The timing of future remaining payments in connection with the Revenue Sharing Fee will vary and will be based on the Company's net sales of OC-01, as defined in the Credit Agreement, through August 2027, the maturity of the Credit Agreement. 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 $5 million following the approval of TYRVAYA Nasal Spray approval. The Company was in compliance with the minimum liquidity requirement as of December 31, 2021. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Leases | Leases Lease Obligations The Company is party to non-cancelable operating leases for office space in Princeton, New Jersey ending on July 31, 2022. In August 2021, the Company entered into a non-cancelable lease agreement for office space in Boston, Massachusetts for a five-year term beginning on December 3, 2021 and ending on November 30, 2026. Total future minimum lease payments under this agreement are $2.7 million as of December 31, 2021 with the first lease payment made on December 1, 2021. The lease terms do not include the option to extend the lease for additional periods. In February 2021, the Company entered into a non-cancelable 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 this agreement are $0.3 million as of December 31, 2021. The lease term includes the option to extend the lease for an additional period of three years at six month notice. The Company's variable lease payments primarily consist of maintenance and other operating expenses from its real estate leases. Variable lease payments are excluded from the right of use assets and lease liabilities and are recognized in the period in which the obligation for those payments is incurred. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company leases certain office equipment under finance leases with remaining lease terms of less than 1.3 years. Interest expense and amortization expense for the finance leases were immaterial for the years ended December 31, 2021 and 2020. Supplemental balance sheet information for the leases is as follows (in thousands): 2021 2020 Operating lease right-of-use assets (a) $ 2,884 $ 644 Finance lease right-of-use assets 18 34 Total right-of-use assets 2,902 678 Operating lease liabilities (a) $ 779 $ 400 Finance lease liabilities 16 18 Total lease liabilities 795 418 Operating lease liabilities, non-current (a) $ 2,114 $ 250 Finance lease liabilities, non-current 4 19 Total lease liabilities, non-current 2,118 269 Operating leases: Rent expense $ 578 $ 427 Weighted average remaining lease term (in years) 4.3 1.6 Weighted average discount rate 5.65 % 7.65 % (a) — Increase in operating lease right-of-use assets and operating lease liabilities is due the Company entering into two leases in February and August in 2021, as described above. The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of December 31, 2021 Finance Leases Operating Leases Total 2022 $ 16 $ 904 $ 920 2023 4 666 670 2024 — 572 572 2025 — 562 562 2026 — 526 526 Total undiscounted cash flows 20 3,230 3,250 Less: imputed interest — (337) (337) Total lease liabilities $ 20 $ 2,893 $ 2,913 Less: current portion (16) (779) (795) Lease liabilities $ 4 $ 2,114 $ 2,118 |
Leases | Leases Lease Obligations The Company is party to non-cancelable operating leases for office space in Princeton, New Jersey ending on July 31, 2022. In August 2021, the Company entered into a non-cancelable lease agreement for office space in Boston, Massachusetts for a five-year term beginning on December 3, 2021 and ending on November 30, 2026. Total future minimum lease payments under this agreement are $2.7 million as of December 31, 2021 with the first lease payment made on December 1, 2021. The lease terms do not include the option to extend the lease for additional periods. In February 2021, the Company entered into a non-cancelable 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 this agreement are $0.3 million as of December 31, 2021. The lease term includes the option to extend the lease for an additional period of three years at six month notice. The Company's variable lease payments primarily consist of maintenance and other operating expenses from its real estate leases. Variable lease payments are excluded from the right of use assets and lease liabilities and are recognized in the period in which the obligation for those payments is incurred. Lease expense for minimum lease payments is recognized on a straight-line basis over the lease term. The Company leases certain office equipment under finance leases with remaining lease terms of less than 1.3 years. Interest expense and amortization expense for the finance leases were immaterial for the years ended December 31, 2021 and 2020. Supplemental balance sheet information for the leases is as follows (in thousands): 2021 2020 Operating lease right-of-use assets (a) $ 2,884 $ 644 Finance lease right-of-use assets 18 34 Total right-of-use assets 2,902 678 Operating lease liabilities (a) $ 779 $ 400 Finance lease liabilities 16 18 Total lease liabilities 795 418 Operating lease liabilities, non-current (a) $ 2,114 $ 250 Finance lease liabilities, non-current 4 19 Total lease liabilities, non-current 2,118 269 Operating leases: Rent expense $ 578 $ 427 Weighted average remaining lease term (in years) 4.3 1.6 Weighted average discount rate 5.65 % 7.65 % (a) — Increase in operating lease right-of-use assets and operating lease liabilities is due the Company entering into two leases in February and August in 2021, as described above. The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of December 31, 2021 Finance Leases Operating Leases Total 2022 $ 16 $ 904 $ 920 2023 4 666 670 2024 — 572 572 2025 — 562 562 2026 — 526 526 Total undiscounted cash flows 20 3,230 3,250 Less: imputed interest — (337) (337) Total lease liabilities $ 20 $ 2,893 $ 2,913 Less: current portion (16) (779) (795) Lease liabilities $ 4 $ 2,114 $ 2,118 |
License and Collaboration Agree
License and Collaboration Agreements | 12 Months Ended |
Dec. 31, 2021 | |
Equity Method Investments and Joint Ventures [Abstract] | |
License and Collaboration Agreements | License and Collaboration Agreements Ji Xing Pharmaceuticals Limited - Related Party In August 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 in the greater China region. When a license represents the right to use the Company’s intellectual property, it is a performance obligation that is satisfied at the point in time when the Company transfers control of the license to the customer. The Company recognizes license revenues when it has a present right to payment for the license and the customer has the significant risks and rewards of ownership of the asset and has the ability to direct the use of and benefit from the license. In 2021, the Company recognized $18.4 million of license revenue in connection with the License Agreement, which was inclusive of senior common shares of Ji Xing with a fair value of $0.9 million. Development and sales-based milestone payments represents a form of variable consideration that are subject to the constraint on recognition of revenue because the ability to earn the milestone revenue is contingent on a future event. Milestone revenues are recognized when the contingent milestone event has been achieved. In October 2021, the Company recognized $5.0 million in development milestone revenue upon the FDA approval of TYRVAYA Nasal Spray, which occurred on October 15, 2021. There were no sales-based milestone revenues recognized during the year ended December 31, 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 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 as well as other reasons as provided for 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 research collaboration agreement which was included in research and development expense during the year ended December 31, 2021. The Company has not exercised the option granted under the agreement as of December 31, 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 U.S.; and (b) the expiration or abandonment of the last valid claims of the licensed patents. The Company started achieving the milestones upon commercial launch of TYRVAYA Nasal Spray and accrued an immaterial amount of royalties as of December 31, 2021. No milestones were achieved or royalties accrued as of December 31, 2020. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company did not record a federal or state income tax provision or benefit for the years ended December 31, 2021 and December 31, 2020 as it has been incurring net losses since inception. In addition, the net deferred tax assets generated from net operating losses are fully offset by a valuation allowance as the Company believes it is not more likely than not that the benefit will be realized. The Company had an effective tax rate of 0% for the years ended December 31, 2021 and 2020. The provision for income taxes differs from the amount expected by applying the federal statutory rate to the loss before taxes as follows: Year Ended December 31, 2021 2020 Federal statutory income tax rate 21.0 % 21.0 % State taxes (tax effected) 6.8 % 7.7 % Equity compensation 1.4 % — % Research tax credit 1.9 % 1.7 % Other permanent differences (0.1) % 0.3 % Change in valuation allowance (31.0) % (30.7) % Provision for income taxes — % — % The components of the Company’s net deferred tax assets and liabilities as of December 31, 2021 and 2020, were as follows (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 52,962 $ 29,786 Credits 5,663 3,836 Tangible and intangible assets 1,717 2,666 Lease liability 766 195 Stock compensation 4,489 1,737 Accruals and Reserves 3,176 840 Inventory 1,645 — Other 409 — Gross deferred tax assets 70,827 39,060 Less: Valuation allowance (69,257) (38,051) Deferred tax assets, net of valuation allowance 1,570 1,009 Deferred tax liabilities: Prepaids (807) (817) Right of use asset (763) (192) Net deferred tax assets $ — $ — Deferred Tax Assets and Valuation Allowance Recognition of deferred tax assets is appropriate when realization of such assets is more likely than not. Based upon the weight of available evidence, which includes the Company’s historical operating performance and the U.S. cumulative net losses in all prior periods, the Company has provided a full valuation allowance against its U.S. deferred tax assets. The Company’s valuation allowance increased by $31.2 million and $21.6 million for the years ended December 31, 2021, and 2020, respectively. The increases to the Company's valuation allowance for both years related to the losses generated during the periods. NOL Carryforwards For the years ended December 31, 2021 and 2020, the Company had $202.9 million and $120.6 million of U.S. federal net operating losses, respectively. Certain U.S. federal net operating loss carryforwards will begin to expire, if not utilized, in 2035. Included in the U.S. federal net operating loss carryforwards are $198.4 million and $116.1 million as of December 31, 2021 and 2020, respectively, of net operating loss carryforwards, which are not subject to expiration. However, the deductibility of such net operating loss carryforwards will be limited in future years. For the years ended December 31, 2021 and 2020, the Company had state net operating loss carryforwards of $209.9 million and $123.9 million, respectively which generally begin to expire in the year 2035. Utilization of the net operating loss carryforwards may be subject to a substantial annual limitation due to the ownership change limitations provided by Section 382 of the Internal Revenue Code of 1986, as amended, and corresponding provisions of state laws. The annual limitation may result in the expiration of net operating losses and credits before utilization. A Section 382 ownership change generally occurs if one or more stockholders or groups of stockholders who own at least 5% of the Company’s stock increase their ownership by more than 50 percentage points over their lowest ownership percentage within a rolling three-year period. Similar rules may apply under state tax laws. The Company has experienced an ownership change in prior periods. However, the change is not expected to cause a material limitation on the Company’s utilization of net operating loss carryforwards. Subsequent ownership changes may affect the limitation in future years. The Company is not in a taxable position and no net operating loss carryforwards have been utilized to date. Research and Experimentation Credit Carryforwards As of December 31, 2021 and 2020, the Company had federal research and experimentation credit carryforwards of $4.5 million and $3.3 million, respectively, and state research and experimentation credit carryforwards of $1.4 million and $0.7 million. The federal research and experimentation credit carryforwards expire beginning in the years 2037, and the state credit carryforwards are subject to varying expiration periods, the earliest beginning in year 2032. Uncertain Tax Positions As of December 31, 2021 and 2020, the Company had the following unrecognized tax benefits (in thousands): Year Ended December 31, 2021 2020 Balance at the beginning of the year $ 5,438 $ 5,388 Increases for tax positions taken during prior period — 50 Increases for tax positions taken during current period — — Balance at the end of the year $ 5,438 $ 5,438 The reversal of the unrecognized tax benefits would not affect the Company’s effective tax rate to the extent that it continues to maintain a full valuation allowance against its deferred tax assets. The Company does not expect any changes to uncertain tax benefits within the next twelve months. The Company files income tax returns in the U.S. and in various state and local jurisdictions. Due to the Company’s net losses, its federal and state income tax returns are subject to examination for federal and state purposes since inception. If and when the Company claims net operating loss carryforwards from any prior year against future taxable income, those losses may be examined by the taxing authorities. As of December 31, 2021, there were no ongoing examinations. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Commitments Purchase Commitments — As of December 31, 2021, the Company has non-cancelable commitments for the purchase of raw materials, packaging, and product manufacturing costs of approximately $9.0 million for the year ending December 31, 2022. No purchase commitments have been made beyond year 2022. Manufacturing and Supply Commitments — In July 2021, the Company entered into a manufacturing and supply agreement with a CMO to manufacture and supply TYRVAYA Nasal Spray for an initial term of three years. Under this agreement, the Company is to pay a minimum capacity reservation fee in the amount of $2.5 million during each of the years ending December 31, 2021, 2022 and 2023. 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 paid the $2.5 million minimum capacity reservation fee during the year ended December 31, 2021. In addition to the commitments described above, the Company is party to other commitments, which are described elsewhere in these financial statements: Lease commitments, as described in Note 11, Leases, royalties and milestone based commitments, as described in Note 12, License and Collaboration Agreements, as well as long-term debt commitments as described in Note 10, Long-term Debt . Contingencies |
Basis of Presentation and Sig_2
Basis of Presentation and Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Risks and uncertainties | Risks and Uncertainties The Company operates in a dynamic and highly competitive industry and believes that changes in any of the following areas could have a material adverse effect on the Company’s future financial position, results of operations, or cash flows: ability to obtain future financing; advances and trends in new technologies and industry standards; results of clinical trials; regulatory approval and market acceptance of the Company’s products; development of sales channels; certain strategic relationships; litigation or claims against the Company related to intellectual property, product, regulatory, or other matters; and the Company’s ability to attract and retain employees necessary to support its growth. Product candidates developed by the Company require approval from the U.S. Food and Drug Administration (FDA) and or other international regulatory agencies prior to commercial sales. There can be no assurance that the product candidates will receive the necessary approvals. If the Company is denied approval, approval is delayed or the Company is unable to maintain approval, it could have a material adverse impact on the Company. The Company relies on single source manufacturers and suppliers for the supply of its product candidates. This adds to the manufacturing risks faced by the Company, which could be left without backup facilities in the event of any failure by a supplier. In addition, if the Company decides to move to a different or add additional manufacturers and suppliers in the future, any such transition or addition could result in delays or other issues, which could have an adverse effect on the supply of TYRVAYA Nasal Spray or other product candidates. Any disruption from these manufacturers or suppliers could have a negative impact on the Company’s business, financial position and results of operations. In addition, the Company is dependent upon the services of its employees, consultants and other third parties. For the year ended December 31, 2021, a significant percentage of the Company's sales of TYRVAYA Nasal Spray were to four large wholesale drug distributors, and the Company may continue to rely on a limited number of wholesale drug distributors for the distribution of TYRVAYA Nasal Spray. If the Company is unable to maintain its business relationships with wholesale drug distributors on commercially acceptable terms, it could have a material adverse impact on the Company’s business, financial condition and results of operations. The Company does not believe its financial results were significantly affected by the SARS-CoV-2 virus pandemic during the year ended December 31, 2021. However, the extent to which the SARS-CoV-2 virus pandemic may affect the Company’s future financial results and operations will depend on future developments which are highly uncertain and cannot be predicted, including new information which may emerge concerning the pandemic, the availability and effectiveness of vaccines and treatment options, and current or future domestic and international actions to contain it and treat it. The Company continues to evaluate the potential impact of the SARS-CoV-2 virus pandemic on its business, including the potential impact of the pandemic on the commercial launch of TYRVAYA Nasal Spray and its acceptance by patients and prescribers, and any potential supply-chain challenges, as well as the potential impact of the pandemic on its pipeline and the conduct of clinical trials and preclinical studies In addition, the Company has taken a variety of measures in an effort to ensure the availability and functioning of the Company's critical infrastructure and to promote the safety and security of its employees, including remote working arrangements for employees and investing in personal protective equipment for the future return to the office. With the surge of the Delta and Omicron variants of the virus across the U.S. during the second half of 2021 and early 2022, the Company postponed its plans for a voluntary return to the office for its employees until March 2022. The Company’s sales force is primarily working i n-person and has been instructed to follow all locally required SARS-CoV-2 related precautions. The Company will continue monitoring SARS-CoV-2 infection rates and make practical decisions ab out voluntary reopening in compliance with Centers for Disease Control and Prevention, federal, state and local guidelines. The Company continues to evaluate and develop pipeline candidates for the potential treatment of various medical indications. The ongoing SARS-CoV-2 virus pandemic may impact access to supplies necessary to conduct preclinical studies, cause delay to the timelines to initiate or complete in vitro or in vivo animal studies, or may indirectly impact the operations of third parties that are necessary for the Company to advance preclinical projects. If the SARS-CoV-2 virus pandemic continues and persists for an extended period of time, the Company could experience significant disruptions to its clinical development timelines, which could adversely affect its business, financial condition and results of operations. |
Basis of Presentation | Basis of Presentation The accompanying financial statements have been prepared in accordance with accounting principles generally accepted in the U.S. (U.S. GAAP). |
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 |
Segment Reporting | Segment ReportingThe Company manages its operations as a single operating segment for the purposes of assessing performance and making operating decisions, which is the development and commercialization of pharmaceutical therapies to treat ophthalmic diseases. |
Concentration Risk | Concentration Risk Financial instruments that potentially subject the Company to concentrations of credit risk are money market funds, which are included in cash and cash equivalents on the Company's balance sheets. The Company attempts to minimize the risks related to cash and cash equivalents by using highly-rated financial institutions that invest in a broad and diverse range of financial instruments. The Company's investment portfolio is maintained in accordance with its investment policy that defines allowable investments, specifies credit quality standards and limits the credit exposure of any single issuer. The Company currently relies on a third-party contract manufacturing organization (CMO) to manufacture TYRVAYA Nasal Spray. The commercialization of TYRVAYA Nasal Spray and any other drug candidates, if approved, could be stopped, delayed or made less profitable if those third parties fail to provide sufficient quantities of product or fail to do so at acceptable quality levels or prices. The Company does not intend to establish its own manufacturing facilities. If the Company is unable to continue its relationships with these third-party manufacturers, it could experience delays in the development or commercialization efforts as it locates and qualifies new manufacturers. The Company relies and expects to continue to rely for the foreseeable future on CMOs to manufacture and supply its commercial product. For the year ended December 31, 2021, a significant percentage of the Company's sales of TYRVAYA Nasal Spray were to four large wholesale drug distributors. Sales to Western Wellness Solutions LLC, McKesson Corporation, Cardinal Health, Inc., and AmerisourceBergen accounted for 42.1%, 21.2%, 18.3% and 17.0% of total gross sales, respectively, for the year ended December 31, 2021. License and milestone revenue are derived from a related party customer located in China. |
Cash, Cash Equivalents, and Restricted Cash | Cash, Cash Equivalents, and Restricted Cash The Company considers all highly liquid investments purchased with an original maturity of three months or less at the time of purchase to be cash equivalents. As of December 31, 2021 and 2020, cash and cash equivalents consisted of cash on deposit with banks denominated in U.S. dollars and investment in money market funds. Restricted cash represents cash held to support a letter of credit agreement related to certain office leases, which expire in 2022. |
Accounts Receivable, Net | Accounts Receivable, NetAccounts receivable are recorded net of customer allowances for distribution fees, trade discounts, prompt pay discounts, chargebacks and expected credit losses. Allowances for distribution fees, prompt payment discounts and chargebacks are based on contractual terms. The Company evaluates the collectability of accounts receivable on a regular basis, by reviewing the financial condition and payment history of customers, an overall review of collections experience on other accounts, and economic factors or events expected to affect future collections experience. The Company determines the allowance for doubtful accounts by estimating the expected credit losses, measured over the life of the customer receivable that considers forecasts of future economic conditions in addition to information about past events and current economic conditions. |
Inventory, Net | Inventory, Net Inventory is stated at the lower of cost or net realizable value, using the first-in, first-out method. Inventory consists of raw materials, work-in-process and finished goods. Costs to be capitalized as inventory primarily include third-party components, manufacturing costs and overheard costs. Cost is determined using the standard cost method, which approximates actual costs. The Company began capitalizing inventory post FDA approval of TYRVAYA Nasal Spray on October 15, 2021, as the related costs were expected to be recoverable through the commercialization of the product. |
Property and Equipment | Property and Equipment Property and equipment is recorded at cost and depreciated using the straight-line method over the estimated useful lives of the related assets. Construction-in-progress reflects amounts incurred for property and equipment for use in manufacturing process and or improvements that have not yet been placed in service and are not depreciated or amortized. Repairs and maintenance are expensed when incurred. Upon retirement or sale, the cost of the assets disposed of and the related accumulated depreciation are removed from the accounts, and any resulting gain or loss is included in loss from operations in the statements of operations and comprehensive loss. Estimated useful lives by major asset category are as follows: Marketing equipment 3 years Office equipment 5 years Furniture and fixtures 7 years Laboratory equipment 7 years Leasehold improvements Shorter of lease term or estimated useful life |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts for financial instruments consisting of cash equivalents, restricted cash, accounts receivable, and accounts payable approximate their fair value due to their short-term maturities. |
Net Embedded Derivative Asset or Liability | 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 statement of operations and comprehensive loss . |
Loan Commitment Fees, Debt Issuance and Discount Costs | Loan Commitment Fees, Debt Issuance and Discount Costs 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 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. When the Company draws down on the term loan credit facility, it reclassifies the remaining unamortized capitalized loan commitment fees on a pro-rata basis to debt issuance and discount costs that reduce the carrying amount of the debt liability. |
Investment - Related Party | Investment - Related Party The Company accounts for the senior common shares received under a collaboration and license agreement (License Agreement) with Ji Xing Pharmaceuticals Limited (Ji Xing), as further described in Note 12, License and Collaboration Agreements . as a non-marketable equity investment (the Investment). The Investment was recorded at its initial fair value and is subject to impairment analysis on a periodic basis. The Company has elected to subsequently account for its non-marketable equity investment at cost minus impairment, if any. If the Company identifies observable price changes in orderly transactions for the identical or a similar investment of the same issuer, it measures the equity security at fair value as of the date that the observable transaction occurred . |
Leases | Leases The Company determines if an arrangement is or contains a lease and the classification of that lease at inception of a contract. The Company’s operating and finance lease assets are included in right-of-use assets, net lease liabilities lease liabilities, non-current |
Revenue | Revenue The Company recognizes revenue based on the transfer of control of promised goods or services to a customer in an amount that reflects the consideration to which the Company expects to receive in exchange for those goods and services. Customer contracts that contain multiple performance obligations requires an allocation of the transaction price to each distinct good and service based upon the stand-alone selling prices of the goods and 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 Product Revenue and Gross to Net Deductions — Revenue from product sales is recognized upon transfer of control of a product to a customer, generally upon delivery, based on an amount that reflects the consideration to which the Company expects to be entitled, which is then adjusted for any gross-to-net (GTN) deductions. The GTN deductions are reflected as either a reduction to the accounts receivable account (and settled through the issuance of credits), or, are reflected as a current liability and settled through cash payments. The Company offers rights of return to its customers for products that are six months prior to and up to twelve months after expiration and, accordingly, product returns are included within the GTN deductions. Judgment is required in estimating GTN deductions, which takes into account legal interpretations of applicable laws and regulations, current experience and contract prices under applicable programs, unbilled claims, and processing time lags. The Company analyzes its accruals for GTN deductions on a monthly basis and makes any adjustments if needed. Accruals for GTN deductions are based off estimates of the amounts earned or to be claimed on the related sales. These estimates take into consideration current contractual terms, actual utilization data, forecasted payor mix, total prescriptions and industry data. The following are typical GTN deductions the Company applies to the sales price at the time of the sale of its product: Prompt Pay Discount — The Company offers cash discounts to its distributors, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount . Chargebacks — The Company participates in programs with government entities, the most significant of which are the U.S. Department of Veterans Affairs, whereby pricing on products is extended below wholesaler list price to participating entities. These entities purchase products through wholesalers at the lower program price and the wholesalers then charge the Company the difference between their acquisition cost and the lower program price. The Company records chargebacks as reduction to the accounts receivable account on the Company's balance sheet. Product Returns — Estimated returns for products are determined after considering information provided by external sources, and other factors such as estimated levels of inventory in the distribution channel and projected demand, introductions of generic products, and introductions of competitive new products. The estimated amount for product returns is included in accrued expenses and other current liabilities on the Company's balance sheet. Distribution Service Fees — The Company records service fees paid to its wholesaler customers for distribution and inventory management services as a reduction to revenue. The Company accrues estimated service fees based on contracted terms. Accrued service fees are recorded as a reduction to the accounts receivable account on the Company's balance sheet. Bridge Offer and Co-Pay Offer — The Company established patient support programs to help offset patients’ out of pocket costs. The Bridge Offer program is for patients who are commercially insured and waiting on coverage; The Co-Pay Offer program is for patients who are commercially insured with coverage. The Company’s patient support programs are administered by a third-party copay vendor, which generates GTN deductions in the form of pharmacy redemptions. The estimated cost of pharmacy redemptions is included in accrued expenses and other current liabilities on the Company's balance sheet. Any prepayments by the Company to the vendor are included in prepaid expenses on the Company's balance sheet. Managed Care and Medicare Part D Rebates — These rebates represent programs to lower the overall cost of prescription drugs of covered patients and are based on contracted discount rates and administration fees. The rebates are amounts owed after the final dispensing of the product by a pharmacy to a benefit plan participant. The rebates are paid by the Company on a monthly or quarterly basis to managed care organizations and pharmacy benefit managers. The estimated accrual is included in accrued expenses and other current liabilities on the Company’s balance sheet. Various Government Rebates — The Company participates in certain federal and state government rebate programs such as Medicaid and Tricare. These programs require the Company to enter into, and have in effect, a national rebate agreement with the U.S. Secretary of the Department of Health and Human Services in exchange for coverage of the Company’s product. These rebates are paid by the Company on a quarterly basis based on actual claims. The Company also pays 70% of the cost of the product, when the Medicare Part D beneficiaries are in the coverage gap. The estimated amount of unpaid or unbilled Medicaid, Tricare and Coverage Gap rebates are included in accrued expenses and other current liabilities on the Company's balance sheet. The Company’s customers consist of national and regional pharmaceutical wholesale distributors. The Company also uses a specialty wholesale distributor that acts as an alternative to traditional access, affordability and distribution options for patients. The Company’s customer base for the sales of products is currently located in the U.S. with no customers from foreign countries. The Company accounts for shipping and handling activities of its customer contracts as a fulfillment cost. The Company's payment terms vary by type and location of customers and the products or services offered. Payment terms differ by customer and are generally required in a term ranging from 35 to 95 days from the invoice date. The vast majority of products are shipped under free on board destination shipping terms. As a practical expedient, sales commissions, which represent costs to obtain a contract, are expensed when incurred because the amortization period would have been one year or less. These costs are recorded in sales and marketing expense in the statements of operations and comprehensive loss. The Company entered into a third-party logistics distribution agreement (the 3PL Agreement) to engage a logistics distribution agent (the 3PL Agent) to distribute the Company’s products to its customers. The 3PL Agent provides services to the Company that include storage, distribution, processing product returns, customer service support, logistics support, electronic data interface and system access support. Revenue is recognized upon transfer of control of the product to the customer. During the second half of 2021, the Company applied for mandatory distribution licenses that some states require in order for the Company to sell its product throughout the U.S. In order for the Company to execute sales in the U.S. prior to obtaining such licenses, the Company and an affiliate of the 3PL Agent (the Title Company) entered into a Title Model Addendum (the Addendum) to the 3PL Agreement so that the Title Company may purchase and take title to the product and sell the product to the wholesale distributors who have contracted to purchase the product from the Company. Although under the Addendum the Title Company takes title to the product, the economic substance of the transaction provides that the Title Company does not possess the risk of loss or participate in the significant risks and rewards of ownership of the product or have the ability to control, direct the use of, and obtain substantially all of the remaining benefits from the product. Accordingly, the Company does not recognize revenue on the transfer of the goods until the goods are sold from the Title Company to the wholesalers. In November 2021, the Company obtained all of the necessary state distribution licenses to sell its products throughout the U.S. and, after a customary period of notice to the Title Company, intends to cease using the Addendum process in the first quarter of 2022. 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. Milestone Revenue — The Company recognizes milestone revenue when the milestone event occurs. Royalties Royalties incurred in connection with the Company’s license agreement with Pfizer Inc. as further described in Note 14, License and Collaboration Agreements, |
Research and Development | Research and Development Research and development expenses primarily consist of CMOs and clinical research organizations (the CROs) related costs, costs relating to manufacturing clinical trial materials and pre-approval inventory, testing of preproduction samples, prototypes and models, regulatory compliance costs, employee compensation and benefits, consulting, laboratory supplies, product licenses, sponsored research, as well as facility-related expenses and depreciation. All research and development costs are charged to research and development expenses within the statements of operations and comprehensive loss as incurred. Payments associated with licensing agreements to acquire exclusive licenses to develop, use, manufacture and commercialize products that have not reached technological feasibility and do not have alternate commercial use are also expensed as incurred. The Company’s accruals for research and development activities performed by third parties are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued expenses and other current liabilities on the balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, the Company will adjust the accruals accordingly. Payments made to third parties under these arrangements in advance of the performance of the related services by the third parties are recorded as prepaid expenses until the services are rendered. |
Stock-Based Compensation | Stock-Based Compensation For stock options granted to employees and directors, as well as the purchase rights issued under the Employee Stock Purchase Plan (ESPP), the Company recognizes stock-based compensation expense in accordance with ASC 718, Compensation-Stock Compensation . The Company uses the Black-Scholes option pricing model to estimate the fair value of options and purchase rights granted that are expensed on a straight-line basis over the vesting period for stock options and offering period for rights issued under the ESPP. The Company accounts for forfeitures as they occur. Option valuation models, including the Black-Scholes option-pricing model, require the input of several assumptions, and changes in the assumptions used can materially affect the grant-date fair value of an award. These assumptions include the risk-free rate of interest, expected dividend yield, expected volatility, and the expected life of the award. Restricted stock units (RSUs) are measured and recognized over the vesting period and are based on the quoted market price of the Company's stock on the grant date. |
Income Taxes | Income Taxes The Company accounts for income taxes in accordance with ASC 740, Income Taxes, using the asset and liability method whereby deferred tax asset and liability amounts are determined based on the differences between the financial reporting and tax bases of assets and liabilities. The differences are measured using the enacted tax rates and laws that are in effect for the year in which they are expected to affect taxable income. Valuation allowances are established where necessary to reduce deferred tax assets to the amounts expected to be realized. The Company assesses all material positions taken in any income tax return, including all significant uncertain positions, in all tax years that are still subject to assessment or challenge by relevant taxing authorities. Assessing an uncertain tax position begins with the initial determination that the position meets the more-likely-than-not threshold and is measured at the largest amount of benefit that is greater than fifty percent likely of being realized upon ultimate settlement. As of each balance sheet date, unresolved uncertain tax positions must be reassessed, and the Company will determine whether the factors underlying the more-likely-than-not threshold assertion have changed and the amount of the recognized tax benefit is still appropriate. The recognition and measurement of tax benefits requires significant judgment. Judgments concerning the recognition and measurement of a tax benefit might change as new information becomes available. The Company's policy is to recognize interest and penalties related to the underpayment of income taxes as a component of income tax expense or benefit. To date, there have been no interest or penalties charged in relation to the unrecognized tax benefits. |
Net Loss per Common Share | Net Loss per Common Share Basic and diluted net loss per common share is presented in conformity with ASC 260, Earning Per Share |
Comprehensive Loss | Comprehensive LossComprehensive loss includes net loss as well as other changes in stockholders’ equity (deficit) that would result from transactions and economic events other than those with stockholders. There have been no items qualifying as other comprehensive income (loss) and, therefore, for all periods presented, the Company’s comprehensive loss was the same as its reported net loss |
Collaborative Arrangements | Collaborative Arrangements The Company analyzes its collaborative arrangements to assess whether they are within the scope of ASC 808, Collaborative Arrangements (ASC 808) to determine whether such arrangements involve joint operating activities performed by parties that are both active participants in the activities and exposed to significant risks and rewards dependent on the commercial success of such activities. This assessment is performed throughout the life of the arrangement based on changes in the responsibilities of all parties in the arrangement. ASC 808 describes arrangements within its scope and considerations surrounding presentation and disclosure, with recognition matters subjected to other authoritative guidance, in certain cases by analogy. For arrangements determined to be within the scope of ASC 808 where a collaborative partner is not a customer for certain research and development activities, the Company accounts for payments received for the reimbursement of research and development costs as a contra-expense in the period such expenses are incurred. Similarly, the payments made by the Company in connection with such collaborative arrangement are recorded as research and development expense in the Company's statements of operations and comprehensive loss. If the payments to and from the collaborative partner are not within the scope of other authoritative |
Related Parties | Related Parties The Company applies ASC 850, Related Party Disclosures |
Reclassification | Reclassification Beginning in 2021, sales and marketing expenses are reported separately from selling, general and administrative expenses in the Company’s statements of operations and comprehensive loss. The statement of operations and comprehensive loss for the year ended December 31, 2020 has been conformed to separately present sales and marketing expenses. |
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 ASCs or other standard setting bodies and adopted by the Company as of the specified effective date, unless otherwise discussed below. Recently adopted accounting pronouncements 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 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. |
Basis of Presentation and Sig_3
Basis of Presentation and Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Accounting Policies [Abstract] | |
Reconciliation of Cash, Cash Equivalents, and Restricted Cash | The following table provides a reconciliation of cash, cash equivalents and restricted cash within the balance sheets that sum to the total of the same such amounts shown in the statements of cash flows (in thousands): Year ended December 31, 2021 2020 2019 Cash and cash equivalents $ 193,372 $ 192,585 $ 139,147 Restricted cash 61 61 51 Cash, cash equivalents and restricted cash $ 193,433 $ 192,646 $ 139,198 |
Property and Equipment | Estimated useful lives by major asset category are as follows: Marketing equipment 3 years Office equipment 5 years Furniture and fixtures 7 years Laboratory equipment 7 years Leasehold improvements Shorter of lease term or estimated useful life Property and equipment, net consisted of the following (in thousands): December 31, 2021 2020 Laboratory equipment $ 585 $ — Furniture and fixtures 73 73 Leasehold improvements 226 158 Marketing equipment 258 — Office equipment 68 68 Construction-in-progress 1,524 601 Total property and equipment $ 2,734 $ 900 Accumulated depreciation (237) (96) Property and equipment, net $ 2,497 $ 804 |
Inventory, net (Tables)
Inventory, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Inventory Disclosure [Abstract] | |
Schedule of inventory, net | Inventory, net consisted of the following (in thousands): December 31, 2021 Raw materials, net $ 2,524 Work in process 3,053 Finished goods 509 Inventory, net $ 6,086 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Fair Value Disclosures [Abstract] | |
Schedule of changes in embedded derivatives | The following table reconciles the beginning and ending balances for the Company’s net embedded derivative liabilities that are carried at fair value as long-term liabilities on the Company's balance sheet using significant unobservable inputs (Level 3) (in thousands): December 31, 2021 Beginning balance January 1 $ — Recognition of net embedded derivative liabilities 2,031 Change in fair value of the net embedded derivative liabilities 314 Ending balance December 31 $ 2,345 |
Financial assets measured and recognized at fair value | As of December 31, 2021, financial assets measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements at December 31, 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 162,376 — — 162,376 Total assets $ 162,376 $ — $ — $ 162,376 Liabilities: Net embedded derivative liabilities — — 2,345 2,345 Total liabilities $ — $ — $ 2,345 $ 2,345 As of December 31, 2020, financial assets measured and recognized at fair value 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 |
Fair Value, Investments, Entities that Calculate Net Asset Value Per Share | The following table represents significant unobservable inputs used in determining the estimated fair value of the Investment as of August 5, 2021 and October 15, 2021 (in thousands): Valuation Technique Unobservable Inputs Value Investment - related party August 5, 2021 Market Approach - Backsolve method Equity values of recent rounds of financing by the issuer $ 443 October 15, 2021 Market Approach - Backsolve method Equity values of recent rounds of financing by the issuer 443 Total $ 886 |
Property and Equipment, net (Ta
Property and Equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | Estimated useful lives by major asset category are as follows: Marketing equipment 3 years Office equipment 5 years Furniture and fixtures 7 years Laboratory equipment 7 years Leasehold improvements Shorter of lease term or estimated useful life Property and equipment, net consisted of the following (in thousands): December 31, 2021 2020 Laboratory equipment $ 585 $ — Furniture and fixtures 73 73 Leasehold improvements 226 158 Marketing equipment 258 — Office equipment 68 68 Construction-in-progress 1,524 601 Total property and equipment $ 2,734 $ 900 Accumulated depreciation (237) (96) Property and equipment, net $ 2,497 $ 804 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Payables and Accruals [Abstract] | |
Schedule of accrued liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): December 31, 2021 2020 Accrued GTN deductions $ 4,837 $ — Accrued compensation 9,153 3,500 Accrued professional services 5,451 1,244 Accrued research and development expense 1,243 3,541 Accrued other expense 827 — Accrued expenses and other current liabilities $ 21,511 $ 8,285 |
Stockholders' Equity (Tables)
Stockholders' Equity (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Equity [Abstract] | |
Common stock reserved for future issuance | The Company reserved common stock for future issuance as follows: December 31, 2021 2020 Outstanding options under the 2016 Incentive Plan 1,935,240 2,567,566 Outstanding options under the 2019 Incentive Plan 2,078,232 918,145 Outstanding options under the 2021 Inducement Plan 270,600 — Equity awards available for grant under the 2019 Incentive Plan (1) 1,535,488 1,790,106 Equity awards available for grant under the 2021 Incentive Plan 379,400 — Unvested restricted stock units (RSUs) under the 2019 Incentive Plan 179,149 61,215 Shares reserved for purchase under the Employee Stock Purchase Plan (the ESPP) (2) 225,447 270,000 Total 6,603,556 5,607,032 (1) — Effective January 1, 2022, in connection with an evergreen provision contained in the 2019 Equity Incentive Plan (the 2019 Plan) an additional 1,063,183 shares were reserved for issuance under the 2019 Plan. (2) — Effective January 1, 2022, in connection with an evergreen provision contained in the ESPP, an additional 265,795 shares were reserved for issuance under the ESPP. |
Equity Incentive Plans (Tables)
Equity Incentive Plans (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Share-based Payment Arrangement [Abstract] | |
Activity in stock option plan | Stock Options The following table summarizes stock option activity under the 2016 Plan, 2019 Plan and the 2021 Plan during the year ended December 31, 2021 (in thousands, except share, 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 Outstanding at January 1, 2021 3,485,711 $ 10.74 8.2 $ 36,506 Options granted 1,629,550 16.07 — Options exercised (599,582) 1.91 9,288 Options forfeited (231,607) 19.24 409 Outstanding at December 31, 2021 4,284,072 $ 13.54 8.1 $ 28,874 Vested and exercisable as of December 31, 2021 1,862,771 $ 9.36 7.1 $ 20,461 Vested and expected to vest as of December 31, 2021 4,284,072 $ 13.54 8.1 $ 28,874 |
Activity of restricted stock units | Activity with respect to the Company's restricted stock units during the year ended December 31, 2021 was as follows (in thousands, except share, contractual term, and per share data): Outstanding RSUs Number of Shares Underlying Outstanding Units Weighted Average Grant Date Fair Value per Unit 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 175,431 17.30 3,035 Restricted stock units vested (44,960) 24.90 795 Restricted stock units forfeited (12,537) 180 Outstanding at December 31, 2021 179,149 $ 17.52 2.4 $ 3,271 Unvested and expected to vest as of December 31, 2021 179,149 $ 17.52 2.4 $ 3,271 |
Stock-based compensation expense | The following table is a summary of stock-based compensation expense by function recognized (in thousands): Year Ended December 31, 2021 2020 Selling and marketing $ 2,912 $ 1,360 General and administrative 7,301 4,647 Research and development 1,735 966 Total stock-based compensation $ 11,948 $ 6,973 |
Schedule of valuation assumptions | Year Ended December 31, 2021 2020 Expected volatility 70.0% - 98.0% 82.0% - 118.00% Risk-free interest rate 0.07% - 1.33% 0.36% - 1.40% Dividend yield —% —% Expected term 6.08 years 6.08 years The table below discloses weighted average assumptions for the fair value of the purchase rights granted to employees under the ESPP for the year ended December 31, 2021: Expected volatility 77.0% - 82.4% Risk-free interest rate 0.04% - 0.07% Dividend yield —% Expected term 0.50 years-0.58 years |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 12 Months Ended |
Dec. 31, 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): Year Ended December 31, 2021 2020 Numerator: Net loss $ (100,659) $ (70,520) Denominator: Weighted-average shares outstanding, basic and diluted 26,036,536 24,128,603 Net loss per share, basic and diluted $ (3.87) $ (2.92) |
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: December 31, 2021 2020 Options to purchase common stock 4,284,072 3,485,711 Unvested restricted stock units 179,149 61,215 Shares committed under the ESPP 33,589 — Total 4,496,810 3,546,926 |
Long-term Debt (Tables)
Long-term Debt (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Debt Disclosure [Abstract] | |
Schedule of long-term debt instruments | The balance of the undrawn loan commitment fees which relates to the $30 million third tranche and accumulated amortization recorded on the Company’s balance sheet as of December 31, 2021 were as follows (in thousands): December 31, 2021 Loan commitment fees $ 743 Accumulated amortization of loan commitment fees (159) Loan commitment fees, net $ 584 December 31, 2021 Long-term debt $ 95,000 Debt issuance and discount costs (6,071) Accumulated accretion of long-term debt related costs 886 Long-term debt $ 89,815 |
Long-term debt, exit fees, interest obligation and revenue sharing cap, fiscal year maturity | The following table identifies the Company's obligations under the Credit Agreement as of December 31, 2021 (in thousands): Less than a year 2-3 years 4-5 years More than 5 years Total Debt Principal $ — $ — $ — $ 95,000 $ 95,000 Exit Fee — — — 5,700 5,700 Contractual Interest on debt 8,187 16,397 16,374 4,867 45,825 Revenue Sharing Fee (a) 207 — — — 207 Total obligations $ 8,394 $ 16,397 $ 16,374 $ 105,567 $ 146,732 (a) — The Revenue Sharing Fee is currently capped at $19 million as of December 31, 2021. The timing of future remaining payments in connection with the Revenue Sharing Fee will vary and will be based on the Company's net sales of OC-01, as defined in the Credit Agreement, through August 2027, the maturity of the Credit Agreement. |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Leases [Abstract] | |
Supplemental balance sheet information | Supplemental balance sheet information for the leases is as follows (in thousands): 2021 2020 Operating lease right-of-use assets (a) $ 2,884 $ 644 Finance lease right-of-use assets 18 34 Total right-of-use assets 2,902 678 Operating lease liabilities (a) $ 779 $ 400 Finance lease liabilities 16 18 Total lease liabilities 795 418 Operating lease liabilities, non-current (a) $ 2,114 $ 250 Finance lease liabilities, non-current 4 19 Total lease liabilities, non-current 2,118 269 Operating leases: Rent expense $ 578 $ 427 Weighted average remaining lease term (in years) 4.3 1.6 Weighted average discount rate 5.65 % 7.65 % (a) — Increase in operating lease right-of-use assets and operating lease liabilities is due the Company entering into two leases in February and August in 2021, as described above. |
Maturities of lease liabilities | The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of December 31, 2021 Finance Leases Operating Leases Total 2022 $ 16 $ 904 $ 920 2023 4 666 670 2024 — 572 572 2025 — 562 562 2026 — 526 526 Total undiscounted cash flows 20 3,230 3,250 Less: imputed interest — (337) (337) Total lease liabilities $ 20 $ 2,893 $ 2,913 Less: current portion (16) (779) (795) Lease liabilities $ 4 $ 2,114 $ 2,118 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2021 | |
Income Tax Disclosure [Abstract] | |
Schedule of effective income tax rate reconciliation | The Company had an effective tax rate of 0% for the years ended December 31, 2021 and 2020. The provision for income taxes differs from the amount expected by applying the federal statutory rate to the loss before taxes as follows: Year Ended December 31, 2021 2020 Federal statutory income tax rate 21.0 % 21.0 % State taxes (tax effected) 6.8 % 7.7 % Equity compensation 1.4 % — % Research tax credit 1.9 % 1.7 % Other permanent differences (0.1) % 0.3 % Change in valuation allowance (31.0) % (30.7) % Provision for income taxes — % — % |
Schedule of deferred tax assets and liabilities | The components of the Company’s net deferred tax assets and liabilities as of December 31, 2021 and 2020, were as follows (in thousands): December 31, 2021 2020 Deferred tax assets: Net operating loss carryforwards $ 52,962 $ 29,786 Credits 5,663 3,836 Tangible and intangible assets 1,717 2,666 Lease liability 766 195 Stock compensation 4,489 1,737 Accruals and Reserves 3,176 840 Inventory 1,645 — Other 409 — Gross deferred tax assets 70,827 39,060 Less: Valuation allowance (69,257) (38,051) Deferred tax assets, net of valuation allowance 1,570 1,009 Deferred tax liabilities: Prepaids (807) (817) Right of use asset (763) (192) Net deferred tax assets $ — $ — |
Schedule of unrecognized tax benefits roll forward | As of December 31, 2021 and 2020, the Company had the following unrecognized tax benefits (in thousands): Year Ended December 31, 2021 2020 Balance at the beginning of the year $ 5,438 $ 5,388 Increases for tax positions taken during prior period — 50 Increases for tax positions taken during current period — — Balance at the end of the year $ 5,438 $ 5,438 |
Nature of Business (Details)
Nature of Business (Details) - USD ($) $ in Thousands | Aug. 05, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Line of Credit Facility [Line Items] | ||||
Net loss | $ (100,659) | $ (70,520) | ||
Accumulated deficit | 255,410 | 154,751 | ||
Cash and cash equivalents | 193,372 | 192,585 | $ 139,147 | |
Net product revenue | 24,539 | $ 0 | ||
Required recurring revenue for funding | $ 40,000 | |||
Line Of Credit Facility, Funding Period Three | Revolving Credit Facility | OrbiMed Credit Facility | ||||
Line of Credit Facility [Line Items] | ||||
Contingent increase in borrowing capacity | $ 30,000 | |||
TYRVAYA Nasal Spray | ||||
Line of Credit Facility [Line Items] | ||||
Net product revenue | $ 1,200 |
Basis of Presentation and Sig_4
Basis of Presentation and Significant Accounting Policies - Narrative (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Concentration Risk [Line Items] | ||
Allowance for credit loss | $ 0 | |
Allowance for prompt pay discounts, distributor service agreement fees and chargebacks to wholesalers | 900,000 | |
Inventory obsolescence reserve | $ 900,000 | |
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Right-of-use assets, net | Right-of-use assets, net |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | Total lease liabilities | Total lease liabilities |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease liabilities, non-current | Lease liabilities, non-current |
Finance Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List] | Right-of-use assets, net | Right-of-use assets, net |
Finance Lease, Liability, Current, Statement of Financial Position [Extensible List] | Total lease liabilities | Total lease liabilities |
Finance Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | Lease liabilities, non-current | Lease liabilities, non-current |
Customer Concentration Risk | Revenue Benchmark | Western Wellmness Solutions, LLC | ||
Concentration Risk [Line Items] | ||
Concentration risk | 42.10% | |
Customer Concentration Risk | Revenue Benchmark | McKesson Corporation | ||
Concentration Risk [Line Items] | ||
Concentration risk | 21.20% | |
Customer Concentration Risk | Revenue Benchmark | Cardinal Health, Inc. | ||
Concentration Risk [Line Items] | ||
Concentration risk | 18.30% | |
Customer Concentration Risk | Revenue Benchmark | Amerisourcebergen | ||
Concentration Risk [Line Items] | ||
Concentration risk | 17.00% |
Basis of Presentation and Sig_5
Basis of Presentation and Significant Accounting Policies - Reconciliation of Cash, Cash Equivalents, Restricted Cash and Equivalents (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 | Dec. 31, 2019 |
Accounting Policies [Abstract] | |||
Cash and cash equivalents | $ 193,372 | $ 192,585 | $ 139,147 |
Restricted cash | 0 | 61 | |
Restricted cash | 61 | 0 | 51 |
Cash, cash equivalents and restricted cash | $ 193,433 | $ 192,646 | $ 139,198 |
Basis of Presentation and Sig_6
Basis of Presentation and Significant Accounting Policies - Schedule of Property Plant and Equipment, Estimated Useful Life (Details) | 12 Months Ended |
Dec. 31, 2021 | |
Office equipment | |
Property, Plant and Equipment [Line Items] | |
Useful life of property and equipment | 5 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Useful life of property and equipment | 7 years |
Marketing equipment | |
Property, Plant and Equipment [Line Items] | |
Useful life of property and equipment | 3 years |
Lab Equipment | |
Property, Plant and Equipment [Line Items] | |
Useful life of property and equipment | 7 years |
Inventory, net (Details)
Inventory, net (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Inventory Disclosure [Abstract] | ||
Raw materials, net | $ 2,524 | |
Work in process | 3,053 | |
Finished goods | 509 | |
Inventory, net | $ 6,086 | $ 0 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Changes in Embedded Derivatives (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Change in fair value of net embedded derivative liabilities | $ 314 | $ 0 |
Significant Unobservable Inputs (Level 3) | Embedded Derivative Financial Instruments | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 0 | |
Recognition of net embedded derivative liabilities | 2,031 | |
Change in fair value of net embedded derivative liabilities | 314 | |
Ending balance | $ 2,345 | $ 0 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets and Liabilities Measured and Recognized at Fair Value (Details) - Fair Value, Recurring - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Assets | ||
Total assets | $ 162,376 | $ 191,585 |
Liabilities | ||
Total liabilities | 2,345 | |
Embedded Derivative Financial Instruments | ||
Liabilities | ||
Net embedded derivative liabilities | 2,345 | |
Money Market Funds | ||
Assets | ||
Money market funds | 162,376 | 191,585 |
Quoted Price in Active Markets for Identical Assets (Level 1) | ||
Assets | ||
Total assets | 162,376 | 191,585 |
Liabilities | ||
Total liabilities | 0 | |
Quoted Price in Active Markets for Identical Assets (Level 1) | Embedded Derivative Financial Instruments | ||
Liabilities | ||
Net embedded derivative liabilities | 0 | |
Quoted Price in Active Markets for Identical Assets (Level 1) | Money Market Funds | ||
Assets | ||
Money market funds | 162,376 | 191,585 |
Significant Other Observable Inputs (Level 2) | ||
Assets | ||
Total assets | 0 | 0 |
Liabilities | ||
Total liabilities | 0 | |
Significant Other Observable Inputs (Level 2) | Embedded Derivative Financial Instruments | ||
Liabilities | ||
Net embedded derivative liabilities | 0 | |
Significant Other Observable Inputs (Level 2) | Money Market Funds | ||
Assets | ||
Money market funds | 0 | 0 |
Significant Unobservable Inputs (Level 3) | ||
Assets | ||
Total assets | 0 | 0 |
Liabilities | ||
Total liabilities | 2,345 | |
Significant Unobservable Inputs (Level 3) | Embedded Derivative Financial Instruments | ||
Liabilities | ||
Net embedded derivative liabilities | 2,345 | |
Significant Unobservable Inputs (Level 3) | Money Market Funds | ||
Assets | ||
Money market funds | $ 0 | $ 0 |
Fair Value Measurements - Estim
Fair Value Measurements - Estimated Fair Value of Investment, Unobservable Inputs (Details) - Significant Unobservable Inputs (Level 3) - USD ($) $ in Thousands | Dec. 31, 2021 | Oct. 31, 2021 | Oct. 15, 2021 | Aug. 31, 2021 | Aug. 05, 2021 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Estimated fair value of investment-related party | $ 886 | $ 443 | $ 443 | ||
Fair Value, Nonrecurring | Ji Xing Pharmaceuticals Limited | License revenue - related party | Beneficial Owner | |||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||||
Number of senior common shares received | 397,561 | 397,562 |
Property and Equipment, net (De
Property and Equipment, net (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 2,734 | $ 900 |
Accumulated depreciation | (237) | (96) |
Property and equipment, net | 2,497 | 804 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 585 | 0 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 73 | 73 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 226 | 158 |
Marketing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 258 | 0 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 68 | 68 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 1,524 | $ 601 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Payables and Accruals [Abstract] | ||
Accrued GTN deductions | $ 4,837 | $ 0 |
Accrued compensation | 9,153 | 3,500 |
Accrued professional services | 5,451 | 1,244 |
Accrued research and development expense | 1,243 | 3,541 |
Accrued other expense | 827 | 0 |
Accrued expenses and other current liabilities | $ 21,511 | $ 8,285 |
Stockholders' Equity (Details)
Stockholders' Equity (Details) $ / shares in Units, $ in Millions | May 19, 2020USD ($)$ / sharesshares | Dec. 31, 2021vote$ / sharesshares | Dec. 31, 2020$ / sharesshares |
Class of Stock [Line Items] | |||
Common stock authorized (in shares) | 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 | vote | 1 | ||
Price per share (in usd per share) | $ / shares | $ 28 | ||
Follow-on offering | |||
Class of Stock [Line Items] | |||
Number of common stock sold and issued (in shares) | shares | 4,312,500 | ||
Aggregate gross proceeds from offering | $ | $ 112.6 |
Stockholders' Equity - Reserved
Stockholders' Equity - Reserved Common Stock (Details) - shares | Jan. 01, 2022 | Dec. 31, 2021 | Dec. 31, 2020 |
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 4,284,072 | 3,485,711 | |
Equity awards available to grant (in shares) | 179,149 | 61,215 | |
Shares reserved for future issuance (in shares) | 6,603,556 | 5,607,032 | |
2016 Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 1,935,240 | 2,567,566 | |
2019 Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 2,078,232 | 918,145 | |
Equity awards available for grant (in shares) | 1,535,488 | 1,790,106 | |
2019 Plan | Subsequent Event | |||
Class of Stock [Line Items] | |||
Additional shares authorized (in shares) | 1,063,183 | ||
2019 ESPP | |||
Class of Stock [Line Items] | |||
Equity awards available to grant (in shares) | 225,447 | 270,000 | |
2019 ESPP | Subsequent Event | |||
Class of Stock [Line Items] | |||
Additional shares authorized (in shares) | 265,795 | ||
The 2021 Equity Incentive Plan | |||
Class of Stock [Line Items] | |||
Equity awards available for grant (in shares) | 379,400 | 0 | |
The 2021 Equity Inducement Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 270,600 | 0 | |
Unvested restricted stock units | 2019 Plan | |||
Class of Stock [Line Items] | |||
Equity awards available to grant (in shares) | 179,149 | 61,215 |
Equity Incentive Plans (Details
Equity Incentive Plans (Details) - USD ($) $ / shares in Units, $ in Thousands | Jan. 01, 2022 | Oct. 31, 2019 | Dec. 31, 2021 | Dec. 31, 2020 | Jul. 30, 2021 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares reserved for future issuance (in shares) | 6,603,556 | 5,607,032 | |||
Weighted average grant date fair value (in dollars per share) | $ 16.07 | ||||
Unrecognized stock-based compensation expense | $ 25,900 | ||||
Weighted-average recognition period of unrecognized stock-based compensation expense (in years) | 2 years 8 months 12 days | ||||
Stock-based compensation expense for RSUs | $ 2,300 | ||||
Expected period for recognition of share-based compensation cost (in years) | 2 years 6 months | ||||
Fair value of RSUs vested | $ 1,100 | $ 900 | |||
Fair value of options vested | $ 10,300 | $ 3,200 | |||
Weighted-average grant-date fair value of options (in dollars per share) | $ 10.66 | $ 20.41 | |||
Restricted stock units granted (in dollars per share) | $ 17.30 | ||||
Shares authorized for 2019 Equity Incentive Plan (in shares) | 650,000 | ||||
2019 Plan | Subsequent Event | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Additional shares authorized (in shares) | 1,063,183 | ||||
2019 ESPP | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percent of estimated fair value of shares | 85.00% | ||||
ESPP Purchases (in shares) | 44,553 | ||||
2019 ESPP | Subsequent Event | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Additional shares authorized (in shares) | 265,795 | ||||
Stock options | 2019 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percent of estimated fair value of shares | 100.00% | ||||
Incentive Stock Options | 2019 Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Percent of estimated fair value of shares | 110.00% | ||||
Percent of shares owned by individual stockholder | 10.00% | ||||
Unvested restricted stock units | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Restricted stock units granted (in dollars per share) | $ 17.30 | $ 27.01 |
Equity Incentive Plans - Option
Equity Incentive Plans - Option Activity During the Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Shares Underlying Outstanding Options | ||
Outstanding at beginning of period (in shares) | 3,485,711 | |
Options granted (in shares) | 1,629,550 | |
Options exercised (in shares) | (599,582) | |
Options canceled (in shares) | (231,607) | |
Outstanding at end of period (in shares) | 4,284,072 | 3,485,711 |
Vested and exercisable as of December 31, 2021 (in shares) | 1,862,771 | |
Vested and expected to vest as of December 31, 2021 (in shares) | 4,284,072 | |
Weighted- Average Exercise Price | ||
Beginning balance (in dollars per share) | $ 10.74 | |
Options granted (in dollars per share) | 16.07 | |
Options exercise price (in dollars per share) | 1.91 | |
Options canceled (in dollars per share) | 19.24 | |
Ending balance (in dollars per share) | 13.54 | $ 10.74 |
Vested and exercisable as of December 31, 2020 (in dollars per share) | 9.36 | |
Vested and expected to vest as of December 31, 2020 (in dollars per share) | $ 13.54 | |
Weighted-Average Remaining Contractual Term (Years) | ||
Weighted-average remaining contractual term (in years) | 8 years 1 month 6 days | 8 years 2 months 12 days |
Vested and exercisable as of December 31, 2020, Weighted-Average Remaining Contractual Term (in years) | 7 years 1 month 6 days | |
Vested and expected to vest as of December 31, 2020, weighted average exercise price | 8 years 1 month 6 days | |
Aggregate Intrinsic Value | ||
Aggregate intrinsic value, outstanding beginning balance | $ (36,506) | |
Aggregate intrinsic value, options exercised | 9,288 | |
Aggregate intrinsic value, options canceled | 409 | |
Aggregate intrinsic value, outstanding ending balance | 28,874 | $ 36,506 |
Vested and expected to vest as of December 31, 2020, aggregate intrinsic value | 28,874 | |
Vested and exercisable as of December 31, 2020, aggregate intrinsic value | $ 20,461 |
Equity Incentive Plans - RSU Ac
Equity Incentive Plans - RSU Activity During the Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Number of Shares Underlying Outstanding Units | ||
Outstanding at beginning of period (in shares) | 61,215 | |
Restricted stock units granted (in shares) | 175,431 | |
Restricted stock units vested (in shares) | (44,960) | |
Restricted units forfeited (in shares) | (12,537) | |
Outstanding at end of period (in shares) | 179,149 | 61,215 |
Restricted stock units granted (in dollars per share) | $ 17.30 | |
Unvested and expected to vest as of December 31, 2020 (in shares) | 179,149 | |
Weighted Average Grant Date Fair Value per Unit | ||
Outstanding at beginning of period (in dollars per share) | $ 17.52 | $ 23.83 |
Restricted stock units vested (in dollars per share) | 24.90 | |
Vested and expected to vest, weighted average grant date fair value (in dollars per share) | $ 17.52 | |
Weighted Average Remaining Contractual Term (Years) | ||
Weighted Average Remaining Contractual Term (Years) | 2 years 4 months 24 days | 1 year 4 months 24 days |
Vested and expected to vest, weighted average remaining contractual term (in years) | 2 years 4 months 24 days | |
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 | |
Restricted stock units granted, aggregate intrinsic value | 3,035 | |
Restricted stock units vested, aggregate intrinsic value | 795 | |
Restricted stock units canceled, aggregate intrinsic value | 180 | |
Restricted stock units outstanding, aggregate intrinsic value, end of period | 3,271 | $ 1,152 |
Vested and expected to vest, aggregate intrinsic value | $ 3,271 |
Equity Incentive Plans - Stock
Equity Incentive Plans - Stock Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 11,948 | $ 6,973 |
Selling and marketing | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 2,912 | 1,360 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | 7,301 | 4,647 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation | $ 1,735 | $ 966 |
Equity Incentive Plans - Fair V
Equity Incentive Plans - Fair Value Assumptions (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility, minimum | 70.00% | 82.00% |
Expected volatility, maximum | 98.00% | 118.00% |
Risk-free interest rate, minimum | 0.07% | 0.36% |
Risk-free interest rate, maximum | 1.33% | 1.40% |
Dividend yield | 0.00% | 0.00% |
Expected term | 6 years 29 days | 6 years 29 days |
2019 ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected volatility, minimum | 77.00% | |
Expected volatility, maximum | 82.40% | |
Risk-free interest rate, minimum | 0.04% | |
Risk-free interest rate, maximum | 0.07% | |
Minimum | 2019 ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 6 months | |
Maximum | 2019 ESPP | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Expected term | 6 months 29 days |
Net Loss per Share (Details)
Net Loss per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Numerator: | ||
Net loss | $ (100,659) | $ (70,520) |
Denominator: | ||
Weighted-average shares outstanding, basic (in shares) | 26,036,536 | 24,128,603 |
Weighted-average shares outstanding, diluted (in shares) | 26,036,536 | 24,128,603 |
Net loss per share, basic (in dollars per share) | $ (3.87) | $ (2.92) |
Net loss per share, diluted (in dollars per share) | $ (3.87) | $ (2.92) |
Net Loss per Share - Antidiluti
Net Loss per Share - Antidilutive Securities (Details) - shares | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 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 | 4,496,810 | 3,546,926 |
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 | 4,284,072 | 3,485,711 |
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 | 179,149 | 61,215 |
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 | 33,589 | 0 |
Long-term Debt - Narrative (Det
Long-term Debt - Narrative (Details) $ in Thousands | Oct. 19, 2021USD ($) | Aug. 05, 2021USD ($)shares | Dec. 31, 2021USD ($) | Dec. 31, 2020USD ($) | Nov. 04, 2021USD ($) |
Line of Credit Facility [Line Items] | |||||
Number of tranches | shares | 3 | ||||
Required recurring revenue for funding | $ 40,000 | ||||
Quarterly revenue interest payments, percentage of net recurring revenue over specified amount to aggregate cap | 1.00% | ||||
Interest expense | $ 3,734 | $ 0 | |||
Line of Credit | |||||
Line of Credit Facility [Line Items] | |||||
Interest expense | 3,600 | ||||
Amortization of loan fees and discounts | 1,300 | ||||
Revolving Credit Facility | OrbiMed Credit Facility | |||||
Line of Credit Facility [Line Items] | |||||
OrbiMed credit facility | $ 125,000 | ||||
Interest rate floor | 0.40% | ||||
Exit fee on prepayment of debt or at loan maturity, amount | 6.00% | ||||
Exit fee | $ 5,700 | ||||
Prepayment premium percentage, period one | 10.00% | ||||
Prepayment premium percentage, period two | 8.00% | ||||
Prepayment premium percentage, period three | 6.00% | ||||
Prepayment premium percentage, period four | 4.00% | ||||
Quarterly revenue interest payments, percentage of net recurring revenue up to specified amount | 3.00% | ||||
Revenue sharing cap for tier one and two | $ 19,000 | ||||
Aggregate maximum revenue sharing cap | 25,000 | ||||
Accrued revenue sharing fee liability | 200 | ||||
Value of embedded derivative liability | 2,300 | ||||
Changes in fair value of embedded derivative | 300 | ||||
Debt issuance costs | $ 900 | ||||
Minimum liquidity covenant after FDA approval | 5,000 | ||||
Periodic principal payment | $ 10,000 | ||||
Revolving Credit Facility | OrbiMed Credit Facility | Maximum | |||||
Line of Credit Facility [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 | |||||
Line of Credit Facility [Line Items] | |||||
Net recurring revenue from annual sales and licenses over specified amount to aggregate cap | $ 300,000 | ||||
Effective interest rate on credit facility | 13.96% | ||||
Revolving Credit Facility | OrbiMed Credit Facility | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | |||||
Line of Credit Facility [Line Items] | |||||
Interest rate (as a percentage) | 8.10% | ||||
Revolving Credit Facility | OrbiMed Credit Facility | Line Of Credit Facility, Funding, Period One | |||||
Line of Credit Facility [Line Items] | |||||
Borrowing capacity | $ 45,000 | ||||
Exit fee | 2,700 | ||||
Revolving Credit Facility | OrbiMed Credit Facility | Line Of Credit Facility, Funding Period Two | |||||
Line of Credit Facility [Line Items] | |||||
Contingent increase in borrowing capacity | 50,000 | $ 50,000 | |||
Exit fee | 3,000 | ||||
Revolving Credit Facility | OrbiMed Credit Facility | Line Of Credit Facility, Funding Period Three | |||||
Line of Credit Facility [Line Items] | |||||
Contingent increase in borrowing capacity | $ 30,000 |
Long-term Debt - Schedule of Co
Long-term Debt - Schedule of Commitment Fees (Details) - Revolving Credit Facility - OrbiMed Credit Facility $ in Thousands | 12 Months Ended |
Dec. 31, 2021USD ($) | |
Line of Credit Facility [Line Items] | |
Loan commitment fees | $ 743 |
Accumulated amortization of loan commitment fees | (159) |
Loan commitment fees, net | $ 584 |
Long-term Debt - Schedule of Lo
Long-term Debt - Schedule of Long Term Debt (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Debt Disclosure [Abstract] | ||
Long-term debt | $ 95,000 | |
Debt issuance and discount costs | (6,071) | |
Accumulated accretion of long-term debt related costs | 886 | |
Total obligations | $ 89,815 | $ 0 |
Long-term Debt - Schedule of De
Long-term Debt - Schedule of Debt Payments (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Total | ||
Total obligations | $ 89,815 | $ 0 |
Revolving Credit Facility | OrbiMed Credit Facility | ||
Less than a year | ||
Debt Principal | 0 | |
Exit Fee | 0 | |
Contractual Interest on debt | 8,187 | |
Revenue Sharing Fee | 207 | |
Total obligations | 8,394 | |
2-3 years | ||
Debt Principal | 0 | |
Exit Fee | 0 | |
Contractual Interest on debt | 16,397 | |
Revenue Sharing Fee | 0 | |
Total obligations | 16,397 | |
4-5 years | ||
Debt Principal | 0 | |
Exit Fee | 0 | |
Contractual Interest on debt | 16,374 | |
Revenue Sharing Fee | 0 | |
Total obligations | 16,374 | |
More than 5 years | ||
Debt Principal | 95,000 | |
Exit Fee | 5,700 | |
Contractual Interest on debt | 4,867 | |
Revenue Sharing Fee | 0 | |
Total obligations | 105,567 | |
Total | ||
Debt Principal | 95,000 | |
Exit Fee | 5,700 | |
Contractual Interest on debt | 45,825 | |
Revenue Sharing Fee | 207 | |
Total obligations | $ 146,732 |
Leases (Details)
Leases (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Aug. 31, 2021 | Feb. 28, 2021 | Feb. 01, 2021 |
Lessee, Lease, Description [Line Items] | ||||
Lease payments due over the life of the lease | $ 3,230 | $ 2,700 | ||
Lease renewal term | 3 years | |||
Remaining lease terms on finance leases | 1 year 3 months 18 days | |||
Boston, Massachusetts Office Space, Lease Ending In November 2026 | ||||
Lessee, Lease, Description [Line Items] | ||||
Term of operating lease contracts | 5 years | |||
Princeton New Jersey Office Space, Lease Ending in 2029 | ||||
Lessee, Lease, Description [Line Items] | ||||
Term of operating lease contracts | 3 years | |||
Lease payments due over the life of the lease | $ 300 |
Leases - Balance Sheet Informat
Leases - Balance Sheet Information (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Leases [Abstract] | ||
Operating lease, right-of-use asset | $ 2,884 | $ 644 |
Finance lease right-of-use assets | 18 | 34 |
Total right-of-use assets | 2,902 | 678 |
Operating lease liabilities | 779 | 400 |
Finance lease liabilities | 16 | 18 |
Total lease liabilities | 795 | 418 |
Operating lease liabilities, non-current | 2,114 | 250 |
Finance lease liabilities, non-current | 4 | 19 |
Total lease liabilities, non-current | 2,118 | 269 |
Operating leases: | ||
Rent expense | $ 578 | $ 427 |
Weighted average remaining lease term (in years) | 4 years 3 months 18 days | 1 year 7 months 6 days |
Weighted average discount rate | 5.65% | 7.65% |
Leases - Lease Maturity Schedul
Leases - Lease Maturity Schedules (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Aug. 31, 2021 | Dec. 31, 2020 |
Finance Leases | |||
2022 | $ 16 | ||
2023 | 4 | ||
2024 | 0 | ||
2025 | 0 | ||
2026 | 0 | ||
Total undiscounted cash flows | 20 | ||
Less: imputed interest | 0 | ||
Total lease liabilities | 20 | ||
Less: current portion | (16) | $ (18) | |
Lease liabilities | 4 | 19 | |
Operating Leases | |||
2022 | 904 | ||
2023 | 666 | ||
2024 | 572 | ||
2025 | 562 | ||
2026 | 526 | ||
Total undiscounted cash flows | 3,230 | $ 2,700 | |
Less: imputed interest | (337) | ||
Total lease liabilities | 2,893 | ||
Less: current portion | (779) | (400) | |
Lease liabilities | 2,114 | 250 | |
Total | |||
2022 | 920 | ||
2023 | 670 | ||
2024 | 572 | ||
2025 | 562 | ||
2026 | 526 | ||
Total undiscounted cash flows | 3,250 | ||
Less: imputed interest | (337) | ||
Total lease liabilities | 2,913 | ||
Less: current portion | (795) | (418) | |
Total lease liabilities, non-current | $ 2,118 | $ 269 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | ||
Oct. 31, 2021 | Aug. 31, 2021 | Dec. 31, 2021 | Dec. 31, 2020 | |
Schedule of Equity Method Investments [Line Items] | ||||
Required written notice of termination | 180 days | |||
Research and development | $ 24,234 | $ 39,811 | ||
Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Research and development | 500 | |||
Ji Xing Pharmaceuticals Limited | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Shares received in consideration | 900 | |||
Ji Xing Pharmaceuticals Limited | License revenue - related party | Beneficial Owner | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Upfront payment on collaborative agreement | $ 18,400 | |||
Development based milestone payment | $ 5,000 | |||
Ji Xing Pharmaceuticals Limited | License revenue - related party | Beneficial Owner | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Maximum | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Aggregate development and net sales based milestone payments | $ 204,800 | |||
Royalty rates | 20.00% | |||
Ji Xing Pharmaceuticals Limited | License revenue - related party | Beneficial Owner | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | Minimum | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Royalty rates | 10.00% | |||
Pfizer | License revenue - related party | Maximum | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Royalty rates | 15.00% | |||
Pfizer | License revenue - related party | Minimum | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Royalty rates | 7.50% | |||
Pfizer | License revenue - related party | Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||||
Schedule of Equity Method Investments [Line Items] | ||||
Conditional one-time milestone payment | $ 10,000 | |||
Milestone payment threshold | $ 250,000 |
Income Taxes - Income Tax Recon
Income Taxes - Income Tax Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | ||
Federal statutory income tax rate | 21.00% | 21.00% |
State taxes (tax effected) | 6.80% | 7.70% |
Equity compensation | 1.40% | 0.00% |
Research tax credit | 1.90% | 1.70% |
Other permanent differences | (0.10%) | 0.30% |
Change in valuation allowance | (31.00%) | (30.70%) |
Provision for income taxes | 0.00% | 0.00% |
Income Taxes - Deferred Tax Ass
Income Taxes - Deferred Tax Assets and Liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2021 | Dec. 31, 2020 |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 52,962 | $ 29,786 |
Credits | 5,663 | 3,836 |
Tangible and intangible assets | 1,717 | 2,666 |
Lease liability | 766 | 195 |
Stock compensation | 4,489 | 1,737 |
Accruals and Reserves | 3,176 | 840 |
Inventory | 1,645 | 0 |
Other | 409 | 0 |
Gross deferred tax assets | 70,827 | 39,060 |
Less: Valuation allowance | (69,257) | (38,051) |
Deferred tax assets, net of valuation allowance | 1,570 | 1,009 |
Deferred tax liabilities: | ||
Prepaids | (807) | (817) |
Right of use asset | (763) | (192) |
Net deferred tax assets | $ 0 | $ 0 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Tax Credit Carryforward [Line Items] | ||
Income tax provision or benefit | $ 0 | $ 0 |
Provision for income taxes | 0.00% | 0.00% |
Increase in valuation allowance | $ 31,200,000 | $ 21,600,000 |
Net operating loss carryforwards | 202,900,000 | 120,600,000 |
Net operating loss carryforwards subject to expiration | 198,400,000 | 116,100,000 |
State and Local Jurisdiction | ||
Tax Credit Carryforward [Line Items] | ||
Net operating loss carryforwards | 209,900,000 | 123,900,000 |
Research and experimentation credit carryforward | 1,400,000 | 700,000 |
Domestic Tax Authority | ||
Tax Credit Carryforward [Line Items] | ||
Research and experimentation credit carryforward | $ 4,500,000 | $ 3,300,000 |
Income Taxes - Unrecognized Tax
Income Taxes - Unrecognized Tax Benefits (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2021 | Dec. 31, 2020 | |
Reconciliation of Unrecognized Tax Benefits, Excluding Amounts Pertaining to Examined Tax Returns [Roll Forward] | ||
Balance at the beginning of the year | $ 5,438 | $ 5,388 |
Increases for tax positions taken during prior period | 0 | 50 |
Increases for tax positions taken during current period | 0 | 0 |
Balance at the end of the year | $ 5,438 | $ 5,438 |
Commitments and Contingencies (
Commitments and Contingencies (Details) - USD ($) $ in Millions | 1 Months Ended | ||
Oct. 31, 2021 | Jul. 31, 2021 | Dec. 31, 2021 | |
Commitments and Contingencies Disclosure [Abstract] | |||
Non-cancelable purchase commitments | $ 9 | ||
Term of supply commitment | 3 years | ||
Minimum capacity reservation fee | $ 2.5 | ||
Reservation fee paid | $ 2.5 |