Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2022 | Apr. 29, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Entity File Number | 001-39112 | |
Entity Registrant Name | OYSTER POINT PHARMA, INC. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 81-1030955 | |
Entity Address, Address Line One | 202 Carnegie Center, Suite 109 | |
Entity Address, City or Town | Princeton | |
Entity Address, State or Province | NJ | |
Entity Address, Postal Zip Code | 08540 | |
City Area Code | 609 | |
Local Phone Number | 382-9032 | |
Title of 12(b) Security | Common stock, par value $0.001 | |
Trading Symbol | OYST | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 26,669,342 | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2022 | |
Entity Central Index Key | 0001720725 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Period Focus | Q1 | |
Document Fiscal Year Focus | 2022 |
Condensed Balance Sheets
Condensed Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Current Assets | ||
Cash and cash equivalents | $ 143,364 | $ 193,372 |
Restricted cash | 61 | 61 |
Accounts receivable, net | 5,736 | 6,656 |
Inventory, net | 4,094 | 6,086 |
Prepaid expenses and other current assets | 14,099 | 9,075 |
Total current assets | 167,354 | 215,250 |
Property and equipment, net | 2,557 | 2,497 |
Investment - related party | 886 | 886 |
Other assets | 3,223 | 1,082 |
Right-of-use assets, net | 2,700 | 2,902 |
Total Assets | 176,720 | 222,617 |
Current Liabilities | ||
Accounts payable | 2,596 | 6,496 |
Accrued expenses and other current liabilities | 19,715 | 21,511 |
Lease liabilities | 715 | 795 |
Total current liabilities | 23,026 | 28,802 |
Lease liabilities, non-current | 2,004 | 2,118 |
Long-term debt, net | 90,636 | 89,815 |
Other liabilities | 5,061 | 2,345 |
Total Liabilities | 120,727 | 123,080 |
Commitments and Contingencies (Note 11) | ||
Stockholders’ Equity | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized; 0 outstanding | 0 | 0 |
Common stock, $0.001 par value per share; 1,000,000,000 shares authorized, 26,662,697 and 26,579,585 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively | 27 | 27 |
Additional paid-in capital | 359,268 | 354,920 |
Accumulated deficit | (303,302) | (255,410) |
Total Stockholders’ Equity | 55,993 | 99,537 |
Total Liabilities and Stockholders’ Equity | $ 176,720 | $ 222,617 |
Condensed Balance Sheets (Paren
Condensed Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2022 | Dec. 31, 2021 |
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) | 26,662,697 | 26,579,585 |
Common stock shares outstanding (in shares) | 26,662,697 | 26,579,585 |
Condensed Statements of Operati
Condensed Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Revenue: | ||
Total revenue | $ 2,704 | $ 0 |
Cost of product revenue | 336 | 0 |
Operating expenses: | ||
Sales and marketing | 26,966 | 4,567 |
General and administrative | 12,932 | 8,525 |
Research and development | 4,681 | 5,828 |
Total operating expenses | 44,579 | 18,920 |
Loss from operations | (42,211) | (18,920) |
Other (expense) income, net | ||
Interest expense | (3,066) | 0 |
Other (expense) income, net | (2,615) | 11 |
Total other (expense) income, net | (5,681) | 11 |
Net loss | $ (47,892) | $ (18,909) |
Net loss per share, basic (in dollars per share) | $ (1.80) | $ (0.73) |
Net loss per share, diluted (in dollars per share) | $ (1.80) | $ (0.73) |
Weighted average shares outstanding, basic (in shares) | 26,631,577 | 25,924,096 |
Weighted average shares outstanding, diluted (in shares) | 26,631,577 | 25,924,096 |
Product revenue, net [Extensible Enumeration] | Product [Member] |
Condensed Statements of Stockho
Condensed Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock | Common StockUnvested restricted stock units | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance, common stock (in shares) at Dec. 31, 2020 | 25,890,490 | ||||
Beginning balance at Dec. 31, 2020 | $ 186,659 | $ 26 | $ 341,384 | $ (154,751) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (18,909) | (18,909) | |||
Issuance of common stock upon exercise of stock options (in shares) | 55,046 | ||||
Issuance of common stock upon exercise of stock options | 218 | 218 | |||
Issuance of common stock upon vesting of restricted stock units (in shares) | 15,252 | ||||
Stock-based compensation expense | 2,680 | 2,680 | |||
Ending balance, common stock (in shares) at Mar. 31, 2021 | 25,960,788 | ||||
Ending balance at Mar. 31, 2021 | $ 170,648 | $ 26 | 344,282 | (173,660) | |
Beginning balance, common stock (in shares) at Dec. 31, 2021 | 26,579,585 | 26,579,585 | |||
Beginning balance at Dec. 31, 2021 | $ 99,537 | $ 27 | 354,920 | (255,410) | |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | $ (47,892) | (47,892) | |||
Issuance of common stock upon exercise of stock options (in shares) | 69,930 | 69,930 | |||
Issuance of common stock upon exercise of stock options | $ 76 | 76 | |||
Issuance of common stock upon vesting of restricted stock units (in shares) | 20,618 | ||||
Shares withheld for taxes (in shares) | (7,436) | ||||
Shares withheld for taxes | (87) | (87) | |||
Stock-based compensation expense | $ 4,359 | 4,359 | |||
Ending balance, common stock (in shares) at Mar. 31, 2022 | 26,662,697 | 26,662,697 | |||
Ending balance at Mar. 31, 2022 | $ 55,993 | $ 27 | $ 359,268 | $ (303,302) |
Condensed Statements of Cash Fl
Condensed Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Cash flows from operating activities | ||
Net loss | $ (47,892) | $ (18,909) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Stock-based compensation expense | 4,359 | 2,680 |
Depreciation | 74 | 23 |
Amortization and accretion of long-term debt related costs | 998 | 0 |
Reduction in the carrying amount of the right-of-use assets | 253 | 110 |
Provision for inventory obsolescence | 175 | 0 |
Change in fair value of net embedded derivative liability | 2,690 | 0 |
Changes in assets and liabilities: | ||
Accounts receivable, net | 920 | 0 |
Inventory | (412) | 0 |
Prepaid expenses and other current assets | (5,024) | (2,949) |
Other assets | (9) | (30) |
Accounts payable | (3,949) | 4,812 |
Lease liabilities | (245) | (109) |
Accrued expenses and other current liabilities | (1,669) | (2,158) |
Other liabilities | 26 | 0 |
Net cash used in operating activities | (49,705) | (16,530) |
Cash flows from investing activities | ||
Purchases of property and equipment | (85) | (340) |
Net cash used in investing activities | (85) | (340) |
Cash flows from financing activities | ||
Payment of deferred offering costs | 0 | (23) |
Repayment of long-term debt | (207) | 0 |
Payment of withholding taxes related to stock-based compensation to employees | (87) | 0 |
Proceeds from the exercise of stock options | 76 | 218 |
Net cash (used in) provided by financing activities | (218) | 195 |
Net decrease in cash, cash equivalents and restricted cash | (50,008) | (16,675) |
Cash, cash equivalents and restricted cash at the beginning of the period | 193,433 | 192,646 |
Cash, cash equivalents and restricted cash at the end of the period | 143,425 | 175,971 |
Reconciliation of cash, cash equivalents and restricted cash | ||
Cash and cash equivalents | 143,364 | 175,910 |
Restricted cash | 61 | 61 |
Cash, cash equivalents and restricted cash | 143,425 | 175,971 |
Supplemental non-cash flow information | ||
Interest | 2,067 | 0 |
Non-cash investing and financing activities: | ||
Accrued property and equipment | 49 | 0 |
Right-of-use assets acquired through leases | $ 50 | $ 344 |
Nature of Business, Basis of Pr
Nature of Business, Basis of Presentation and Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Nature of Business, Basis of Presentation and Significant Accounting Policies | Nature of Business, Basis of Presentation and Significant Accounting Policies Description of the Business Oyster Point Pharma, Inc. (the Company) is a commercial-stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. On October 15, 2021, TYRVAYA ® (varenicline solution) Nasal Spray (TYRVAYA Nasal Spray), formerly referred to as OC-01 (varenicline solution) nasal spray, a highly selective nicotinic acetylcholine receptor (nAChR) agonist, was approved by the U.S. Food and Drug Administration (FDA) for the treatment of the signs and symptoms of dry eye disease. TYRVAYA Nasal Spray’s highly differentiated mechanism of action is designed to increase basal tear production with a goal to re-establish tear film homeostasis . Liquidity Since inception, the Company has incurred recurring losses and negative cash flows from operations. The Company generated net losses of $47.9 million for the three months ended March 31, 2022, and had an accumulated deficit of $303.3 million as of March 31, 2022. The Company had cash and cash equivalents of $143.4 million as of March 31, 2022. The Company has historically financed its operations primarily through the sale and issuance of its securities. In the second half of 2021, the Company secured debt capital in the form of a $125.0 million long-term credit facility (the Credit Agreement), to finance its operations, as further described in Note 8, Long-term Debt. The Company is also a party to a license agreement with Ji Xing Pharmaceuticals Limited (Ji Xing), according to which it is eligible to receive additional development and sales-based milestone payments and royalties in future periods. In addition, the Company began selling TYRVAYA Nasal Spray in November 2021 and generated net product revenues of $2.7 million for the three months ended March 31, 2022. Based on the Company’s current business plan, management believes that the Company’s available cash and cash equivalents may not be sufficient to fund its operations for the next twelve months from the date these condensed financial statements are issued, and that the future viability of the Company is dependent on its ability to fund its operations through the sales and licensing of TYRVAYA Nasal Spray and raising additional capital. Management believes that it may be able to raise such additional capital, including by drawing up to $30.0 million on the third tranche of the Credit Agreement, raising up to $100.0 million of equity capital through its at-the-market sales agreement with Cowen and Company, LLC, and potentially receiving upfront and milestone payments through collaborative or strategic arrangements to license its OC-01 intellectual property in additional non-U.S. regions and/or intellectual property related to its pipeline assets worldwide. The Company’s ability to draw on the third tranche of the Credit Agreement is contingent upon achieving at least $40.0 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 without an improper promotional event having occurred, among other conditions. The Credit Agreement also requires the Company to maintain a minimum level of cash and permitted cash equivalent investments of at least $5.0 million at all times in a deposit account subject to control by the lender. If the Company is in violation of this covenant and an event of default resulting from such violation is continuing, the lender could exercise remedies, including but not limited to, the acceleration of all outstanding debt under the Credit Agreement. In addition, the Company has generated limited revenue from initial sales of TYRVAYA Nasal Spray, and given its limited commercial history, cannot guarantee that its commercialization efforts will result in product revenues that meet its sales expectations or those of analysts and investors. Finally, although the Company believes that it will continue to raise capital to fund its operations as it has in the past, the Company’s ability to raise equity capital may depend on the stability of U.S. capital markets and demand from investors, among other factors. There can be no assurance that the Company will be successful in commercializing TYRVAYA Nasal Spray or raising this additional capital or that such capital, if available, will be on terms that are acceptable to the Company. If the Company is unable to successfully commercialize TYRVAYA Nasal Spray and raise sufficient additional capital, the Company may be compelled to reduce the scope of its operations and planned capital expenditures. 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 or make other changes to its operating plan, which could materially and adversely affect the Company's business, financial condition and operations. 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 of product candidates, including future clinical trials, will be successful. Additionally, if 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 and adversely affect its business, results of operation and financial condition. The accompanying unaudited condensed financial statements have been prepared assuming that the Company will continue as a going concern, which contemplates continuity of operations, realization of assets, and satisfaction of liabilities in the ordinary course of business. No adjustments have been made relating to the recoverability and classification of recorded asset amounts and classification of liabilities that might be necessary should the Company not continue as a going concern. The propriety of assuming that the Company will continue as a going concern is dependent upon, among other things, the ability to generate sufficient cash from operations, and potential other funding sources, including cash on hand, to meet the Company’s obligations as they become due. The factors described above raise substantial doubt about the Company’s ability to continue as a going concern within the next twelve months from the date these condensed financial statements are issued. Risks and Uncertainties 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 laws 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. The current global macro-economic environment is volatile, which may result in supply chain constraints and elevated rates of inflation. In addition, 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 FDA and/or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company's 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 three months ended March 31, 2022, a majority 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 materially affected by the SARS-CoV-2 virus pandemic during the three months ended March 31, 2022. 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 return to the office. The Company commenced a voluntary return to the office for its employees in 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 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 The unaudited interim condensed financial statements and accompanying notes have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information and the applicable rules and regulations of the Securities and Exchange Commission (SEC). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments, which are of a normal recurring nature, necessary to state fairly the Company’s financial position as of March 31, 2022 and December 31, 2021, the results of operations for the three months ended March 31, 2022 and 2021, and cash flows for the three months ended March 31, 2022 and 2021. While management believes that the disclosures presented are adequate to mitigate the risk of the information being misleading, these unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or for the full year. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of 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. Significant Accounting Policies Update The Company’s significant accounting policies are disclosed in Note 1, Nature of Business, in the Annual Report on Form 10-K for the year ended December 31, 2021. The Company updated its stock-based compensation accounting policy, as described below, in connection with the Performance Stock Units (PSUs) granted during the three months ended March 31, 2022. Stock-Based Compensation - Performance Stock Units In January 2022, the Company granted PSUs to certain executive officers, as further described in Note 6 , Stockholders' Equity and Equity Incentive Plans . The PSUs are subject to vesting based on the Company’s attainment of pre-established performance milestones and service conditions. The performance milestones are comprised of two non-market milestones and one market milestone. The fair value of the non-market milestones is based on the market price of the Company’s stock as of the date of grant. The fair value of the market performance milestone is estimated using a Monte Carlo simulation. The probability of the number of actual shares expected to be earned is considered in the grant date valuation, and therefore, stock-based compensation expense is not adjusted at the vesting date to reflect the actual number of shares earned. The Company records stock-based compensation expense over the estimated service period for each performance-based milestone subject to the achievement of the milestones being considered probable. At each reporting date, the Company assesses whether achievement of the milestones are considered probable and, if so, records stock-based compensation expense based on the portion of the service period elapsed to date with respect to the milestones, with a cumulative catch-up. Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board under its accounting standards codifications (ASC) or other standard setting bodies and are adopted by the Company as of the specified effective date. For the three months ended March 31, 2022, there were no newly adopted accounting pronouncements that had a material impact to the Company's condensed financial statements. As of March 31, 2022, there are no recently issued but not yet adopted accounting pronouncements that are expected to materially impact the Company's condensed financial statements. 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 condensed statement of operations and comprehensive loss for the three months ended March 31, 2021 has been conformed to separately present sales and marketing expenses. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory Inventory, net consisted of the following (in thousands): March 31, 2022 December 31, 2021 Raw materials $ 1,128 $ 2,524 Work in process 2,256 3,053 Finished goods 710 509 Inventory, net $ 4,094 $ 6,086 Raw materials in the amount of $2.2 million are not expected to be incorporated into products that will be sold within the next 12 months and are included in other assets on the condensed balance sheet as of March 31, 2022. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company assesses the fair value of financial instruments as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, a three-tier fair value hierarchy has been established, which prioritizes the inputs used in measuring fair value as follows: Level 1 Quoted prices in active markets for identical assets or liabilities. Level 2 Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities in markets that are not active; or model derived valuations whose inputs are observable or whose significant value drivers are observable. 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 8, Long-term Debt, in connection with entering into a Credit Agreement in 2021, the Company is required to make quarterly payments to OrbiMed Royalty & Credit Opportunities III, LP (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 . Lastly, the term loan contains a lender-held put option that requires the Company to repay $5 million of the outstanding principal amount of the term loan if the Company fails to achieve certain pre-defined levels of OC-01 net recurring revenues for the trailing four quarters, which commences with the quarter ending December 31, 2022 and continues through the maturity of the term loan. These three 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 March 31, 2022. The net embedded derivative liability is recorded in other liabilities on the Company's condensed balance sheets. The valuation method for the embedded derivatives includes certain unobservable Level 3 inputs including revenue projections, probability and timing of future cash flows, 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 (expense) income, net in the Company’s condensed statements of operations and comprehensive loss. The following table reconciles the beginning and ending balances for the Company’s net embedded derivative liability that is carried at fair value as a long-term liability on the Company's condensed balance sheets using significant unobservable inputs (Level 3) (in thousands): Three Months Ended March 31, 2022 Beginning balance as of January 1 $ 2,345 Change in fair value of the net embedded derivative liability 2,690 Ending balance as of March 31 $ 5,035 As of March 31, 2022, financial assets and liabilities measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements as of March 31, 2022 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 119,378 — — 119,378 Total assets $ 119,378 $ — $ — $ 119,378 Liabilities: Net embedded derivative liability — — 5,035 5,035 Total liabilities $ — $ — $ 5,035 $ 5,035 As of December 31, 2021, financial assets and liabilities measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements as of 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 liability — — 2,345 2,345 Total liabilities $ — $ — $ 2,345 $ 2,345 Money market funds are included in cash and cash equivalents on the Company's condensed balance sheets and are classified within Level 1 of the fair value hierarchy as they are valued using quoted market prices. The carrying amounts reflected in the Company's condensed balance sheets for cash equivalents, restricted cash, accounts receivable, 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 - Related Party The Company accounts for the senior common shares received under a collaboration and license agreement with Ji Xing Pharmaceuticals Limited (Ji Xing), as a non-marketable equity investment (the Investment). Ji Xing is an entity affiliated with RTW Investments, LP. RTW Investments, LP, is one of the Company's beneficial owners and, as a result, the Investment is considered to be a related party transaction. 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. There was no impairment expense recorded for the Investment during the three months ended March 31, 2022 . Concentration of Credit Risk |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment, Net | Property and Equipment, net Property and equipment, net consisted of the following (in thousands): March 31, 2022 December 31, 2021 Laboratory equipment $ 798 $ 585 Furniture and fixtures 73 73 Leasehold improvements 263 226 Marketing equipment 258 258 Office equipment 68 68 Construction-in-progress 1,408 1,524 Total property and equipment $ 2,868 $ 2,734 Accumulated depreciation (311) (237) Property and equipment, net $ 2,557 $ 2,497 |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | Accrued Expenses and Other Current LiabilitiesAccrued expenses and other current liabilities consisted of the following (in thousands): March 31, 2022 December 31, 2021 Accrued gross-to-net deductions $ 4,163 $ 4,837 Accrued compensation 8,014 9,153 Accrued professional services 6,109 5,451 Accrued research and development expense 1,145 1,243 Accrued other expense 284 827 Total accrued expenses and other current liabilities $ 19,715 $ 21,511 |
Stockholders' Equity and Equity
Stockholders' Equity and Equity Incentive Plans | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Stockholders' Equity and Equity Incentive Plans | Stockholders' Equity and Equity Incentive Plans 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's outstanding equity awards as well as reserved common stock for future issuance is as follows: March 31, 2022 December 31, 2021 Outstanding options under the 2016 Equity Incentive Plan (the 2016 Plan) 1,863,246 1,935,240 Outstanding options under the 2019 Equity Incentive Plan (the 2019 Plan) 3,148,375 2,078,232 Outstanding options under the 2021 Equity Inducement Plan (the 2021 Plan) 456,900 270,600 Outstanding performance stock units (PSUs) under the 2019 Plan 444,500 — Unvested restricted stock units (RSUs) under the 2019 Plan 397,304 179,149 Equity awards available for grant under the 2019 Plan (1) 854,755 1,535,488 Equity awards available for grant under the 2021 Plan 193,100 379,400 Shares reserved for purchase under the Employee Stock Purchase Plan (the ESPP) (2) 491,242 225,447 Total 7,849,422 6,603,556 (1) Effective January 1, 2022, in connection with the evergreen provision contained in the 2019 Plan, an additional 1,070,967 shares of common stock were reserved for issuance under the 2019 Plan, including 7,784 shares of common stock that have become available for issuance under the 2019 Plan as a result of the forfeiture, termination, tender to or withholding for payment of an exercise price or for tax withholding obligations, expiration or repurchase of stock options, restricted stock units or other stock awards that had been granted under the 2016 Plan, pursuant to the terms of the 2019 Plan. (2) Effective January 1, 2022, in connection with an evergreen provision contained in the ESPP, an additional 265,795 shares of common stock were reserved for issuance under the ESPP. Performance Stock Units In January 2022, the Company granted PSUs to certain executive officers. The PSUs are subject to vesting based on the Company’s attainment of pre-established performance milestones and service conditions. The performance milestones are comprised of two non-market milestones and one market milestone. The non-market performance milestones are subject to attaining certain forecasted net product revenues and future prescriptions of TYRVAYA Nasal Spray, and the market performance milestone is subject to (i) at least one of the non-market milestones being met and (ii) attaining total shareholder return based on the change in the price of the Company's common stock. Depending on the terms of the PSUs and the outcome of the performance milestones, a recipient may ultimately earn 0% to 125% (as specified for each PSU grant) of the target number of PSUs granted. The number of PSUs that may vest and be issued are based upon the determination of the Compensation Committee of the Company's Board of Directors that one or more of the three performance milestones are achieved in the period beginning on the vesting commencement date of January 1, 2022 and ending on June 30, 2023, with the PSUs vesting on July 1, 2024, subject to the participant continuing their service through such vesting date. The fair value of the non-market milestones is based on the market price of the Company’s stock as of the date of grant. The fair value of the market performance milestone is estimated using a Monte Carlo simulation. The probability of the number of actual shares expected to be earned is considered in the grant date valuation, and therefore, stock-based compensation expense is not adjusted at the vesting date to reflect the actual number of shares earned. The Monte Carlo simulation assumes that at least one of the non-market milestones are met and includes the following assumptions: • Expected term - 1.48 years. • Expected volatility - Historical volatility of the Company's common stock price over a lookback period that is commensurate to the performance period, which is 61.3%. • Risk-free interest rate - The Interpolated Constant Maturity U.S. Treasury Curve, which is 0.64%. • Expected dividend rate - The Company has estimated the dividend yield to be zero. The Company records stock-based compensation expense over the estimated service period for each performance-based milestone subject to the achievement of the milestones being considered probable. At each reporting date, the Company assesses whether achievements of the milestones are considered probable and, if so, records stock-based compensation expense based on the portion of the service period elapsed to date with respect to the milestones, with a cumulative catch-up. The Company did not record stock-based compensation expense related to the PSUs during the three months ended March 31, 2022. Stock Options The following table summarizes stock option activity under the 2016 Plan, the 2019 Plan and the 2021 Plan during the three months ended March 31, 2022 (in thousands, except shares, contractual term and per share data): Outstanding Options Number of Shares Underlying Outstanding Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2022 4,284,072 $ 13.54 8.1 $ 28,874 Options granted 1,268,995 15.52 — Options exercised (69,930) 1.09 995 Options forfeited (14,616) 16.17 12 Outstanding at March 31, 2022 5,468,521 14.15 8.3 12,193 Shares vested and exercisable as of March 31, 2022 2,111,311 10.84 7.1 10,526 Vested and expected to vest as of March 31, 2022 5,468,521 $ 14.15 8.3 $ 12,193 The weighted average fair value of options granted during the three months ended March 31, 2022 was $11.47 per share. As of March 31, 2022, the total unrecognized stock-based compensation expense for stock options was $36.7 million, which is expected to be recognized over a weighted average period of 3.0 years. Restricted Stock Units The RSUs are granted to the Company's directors and 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 three months ended March 31, 2022 was as follows (in thousands, except share, contractual term, and per share data): Outstanding RSUs Number of Shares Underlying Outstanding Awards Weighted Average Grant Date Fair Value per Share Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2022 179,149 $ 17.52 2.4 $ 3,271 Restricted stock units granted 239,223 15.74 3,765 Restricted stock units vested (20,618) 18.77 241 Restricted units forfeited (450) 16.00 5 Outstanding at March 31, 2022 397,304 16.39 3.1 4,625 Unvested and expected to vest as of March 31, 2022 397,304 $ 16.39 3.1 $ 4,625 As of March 31, 2022, the total unrecognized stock-based compensation expense for RSUs was $5.5 million which is expected to be recognized over a weighted average period of 3.3 years. Stock-Based Compensation Expense The following is a summary of stock-based compensation expense by function recognized (in thousands): Three Months Ended March 31, 2022 2021 Sales and marketing $ 1,252 $ 524 General and administrative 2,475 1,790 Research and development 632 366 Total stock-based compensation expense $ 4,359 $ 2,680 |
Net Loss Per Share
Net Loss Per Share | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data): Three Months Ended March 31, 2022 2021 Numerator: Net loss $ (47,892) $ (18,909) Denominator: Weighted average shares outstanding, basic and diluted 26,631,577 25,924,096 Net loss per share, basic and diluted $ (1.80) $ (0.73) 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: March 31, 2022 2021 Options to purchase common stock 5,468,521 4,033,044 Unvested restricted stock units 397,304 140,595 Shares committed under the ESPP 80,275 — Total 5,946,100 4,173,639 |
Long-term Debt
Long-term Debt | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Long-term Debt | Long-term Debt Credit Facility with OrbiMed On August 5, 2021, the Company entered into the Credit Agreement with OrbiMed as administrative agent and initial lender. 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% per annum) plus a spread of 8.10% per annum. The Company is required to make quarterly payments to OrbiMed in the form of a revenue sharing fee in an amount equal to 3.0% of all net revenue from fiscal year net sales and licenses of OC-01 up to $300.0 million and 1% of all revenue from fiscal year sales and licenses of TYRVAYA Nasal Spray in excess of $300.0 million and up to $500.0 million, subject to caps on such fiscal year net sales and license revenues. As of March 31, 2022, the Company has accrued $0.1 million for the revenue sharing fee which is classified in accrued expenses and other current liabilities on the Company's condensed balance sheet. 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 13.98% on the loan as of March 31, 2022. In connection with entering into the Credit Agreement the Company incurred loan commitment fees , which were capitalized and recorded in other assets on the Company's condensed balance sheet as of March 31, 2022. The Company amortizes loan commitment fees on a straight-line basis over the term of the loan commitment. Undrawn loan commitment fees, net of accumulated amortization, were $0.5 million and $0.6 million as of March 31, 2022 and December 31, 2021, respectively. The balances of the long-term debt, debt issuance and discount costs, net of amortization and accretion recorded on the Company's condensed balance sheet were as follows: March 31, 2022 December 31, 2021 Long-term debt $ 95,000 $ 95,000 Debt issuance and discount costs, net of amortization (4,364) (5,185) Long-term debt, net $ 90,636 $ 89,815 During the three months ended March 31, 2022, the Company recorded interest expense of $3.1 million, of which $1.0 million related to the amortization of the loan commitment fees and accretion of the debt issuance and discount costs. 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 requires compliance with a minimum liquidity covenant of $5.0 million. The Company was in compliance with the minimum liquidity requirement as of March 31, 2022. |
Leases
Leases | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Leases | Leases The Company is party to non-cancelable operating leases for office and laboratory space in New Jersey and Massachusetts. 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 4.2 years. Supplemental balance sheet information for the Company's leases is as follows (in thousands): March 31, 2022 December 31, 2021 Operating lease right-of-use assets $ 2,645 $ 2,884 Finance lease right-of-use assets 55 18 Total right-of-use assets $ 2,700 $ 2,902 Operating lease liabilities $ 684 $ 779 Finance lease liabilities 31 16 Total lease liabilities $ 715 $ 795 Operating lease liabilities, non-current $ 1,974 $ 2,114 Finance lease liabilities, non-current 30 4 Total lease liabilities, non-current $ 2,004 $ 2,118 The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of March 31, 2022 Finance Leases Operating Leases Total 2022 (remainder) $ 25 $ 634 $ 659 2023 22 666 688 2024 16 572 588 2025 — 562 562 2026 — 525 525 Total undiscounted cash flows 63 2,959 3,022 Less: imputed interest (2) (301) (303) Total lease liabilities 61 2,658 2,719 Less: current portion (31) (684) (715) Lease liabilities $ 30 $ 1,974 $ 2,004 Rent expense was $0.3 million and $0.1 million for the three months ended March 31, 2022 and March 31, 2021, respectively. |
Leases | Leases The Company is party to non-cancelable operating leases for office and laboratory space in New Jersey and Massachusetts. 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 4.2 years. Supplemental balance sheet information for the Company's leases is as follows (in thousands): March 31, 2022 December 31, 2021 Operating lease right-of-use assets $ 2,645 $ 2,884 Finance lease right-of-use assets 55 18 Total right-of-use assets $ 2,700 $ 2,902 Operating lease liabilities $ 684 $ 779 Finance lease liabilities 31 16 Total lease liabilities $ 715 $ 795 Operating lease liabilities, non-current $ 1,974 $ 2,114 Finance lease liabilities, non-current 30 4 Total lease liabilities, non-current $ 2,004 $ 2,118 The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of March 31, 2022 Finance Leases Operating Leases Total 2022 (remainder) $ 25 $ 634 $ 659 2023 22 666 688 2024 16 572 588 2025 — 562 562 2026 — 525 525 Total undiscounted cash flows 63 2,959 3,022 Less: imputed interest (2) (301) (303) Total lease liabilities 61 2,658 2,719 Less: current portion (31) (684) (715) Lease liabilities $ 30 $ 1,974 $ 2,004 Rent expense was $0.3 million and $0.1 million for the three months ended March 31, 2022 and March 31, 2021, respectively. |
License and Collaboration Agree
License and Collaboration Agreements | 3 Months Ended |
Mar. 31, 2022 | |
Equity Method Investments and Joint Ventures [Abstract] | |
License and Collaboration Agreements | License and Collaboration Agreements Ji Xing In August 2021, the Company entered into a license and collaboration agreement with Ji Xing. 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. Per the terms of the agreement, the Company is eligible to receive development and sales-based milestone payments and royalty payments that are tiered on future net sales of OC-01 and OC-02. The Company did not recognize any license or milestone revenue during the three months ended March 31, 2022 or March 31, 2021. 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 . The Company has not exercised the option granted under the agreement as of March 31, 2022 . Pfizer Inc. |
Commitment and Contingencies
Commitment and Contingencies | 3 Months Ended |
Mar. 31, 2022 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and ContingenciesContingenciesFrom time to time, the Company may have certain contingent liabilities that arise in the ordinary course of its business activities. The Company accrues a liability for such matters when it is probable that future expenditures will be made and that such expenditures can be reasonably estimated. Significant judgment is required to determine both probability and the estimated amount. There are no matters pending that the Company currently believes are reasonably possible or probable of having a material impact to the Company's business, financial position, results of operations, or statements of cash flows. |
Nature of Business, Basis of _2
Nature of Business, Basis of Presentation and Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2022 | |
Accounting Policies [Abstract] | |
Risks and Uncertainties | Risks and Uncertainties 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 laws 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. The current global macro-economic environment is volatile, which may result in supply chain constraints and elevated rates of inflation. In addition, 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 FDA and/or other international regulatory agencies prior to commercial sales. There can be no assurance that the Company's 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 three months ended March 31, 2022, a majority 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 materially affected by the SARS-CoV-2 virus pandemic during the three months ended March 31, 2022. 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 return to the office. The Company commenced a voluntary return to the office for its employees in 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 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 unaudited interim condensed financial statements and accompanying notes have been prepared in accordance with U.S. generally accepted accounting principles (U.S. GAAP) for interim financial information and the applicable rules and regulations of the Securities and Exchange Commission (SEC). Accordingly, certain information and footnote disclosures normally included in financial statements prepared in accordance with U.S. GAAP have been condensed or omitted pursuant to such rules and regulations. In the opinion of management, the accompanying unaudited condensed financial statements contain all adjustments, which are of a normal recurring nature, necessary to state fairly the Company’s financial position as of March 31, 2022 and December 31, 2021, the results of operations for the three months ended March 31, 2022 and 2021, and cash flows for the three months ended March 31, 2022 and 2021. While management believes that the disclosures presented are adequate to mitigate the risk of the information being misleading, these unaudited condensed financial statements should be read in conjunction with the audited financial statements and the related notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021. The results of the Company’s operations for any interim period are not necessarily indicative of the results of operations for any other interim period or for the full year. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts of assets and liabilities, disclosure of contingent assets and liabilities and the reported amounts of 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. |
Stock-Based Compensation - Performance Stock Units | Stock-Based Compensation - Performance Stock Units In January 2022, the Company granted PSUs to certain executive officers, as further described in Note 6 , Stockholders' Equity and Equity Incentive Plans . The PSUs are subject to vesting based on the Company’s attainment of pre-established performance milestones and service conditions. The performance milestones are comprised of two non-market milestones and one market milestone. The fair value of the non-market milestones is based on the market price of the Company’s stock as of the date of grant. The fair value of the market performance milestone is estimated using a Monte Carlo simulation. The probability of the number of |
Recent Accounting Pronouncements | Recent Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board under its accounting standards codifications (ASC) or other standard setting bodies and are adopted by the Company as of the specified effective date. For the three months ended March 31, 2022, there were no newly adopted accounting pronouncements that had a material impact to the Company's condensed financial statements. As of March 31, 2022, there are no recently issued but not yet adopted accounting pronouncements that are expected to materially impact the Company's condensed financial statements. |
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 condensed statement of operations and comprehensive loss for the three months ended March 31, 2021 has been conformed to separately present sales and marketing expenses. |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Inventory Disclosure [Abstract] | |
Schedule of current inventory | Inventory, net consisted of the following (in thousands): March 31, 2022 December 31, 2021 Raw materials $ 1,128 $ 2,524 Work in process 2,256 3,053 Finished goods 710 509 Inventory, net $ 4,094 $ 6,086 |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Fair Value Disclosures [Abstract] | |
Schedule of changes in other long-term liabilities | The following table reconciles the beginning and ending balances for the Company’s net embedded derivative liability that is carried at fair value as a long-term liability on the Company's condensed balance sheets using significant unobservable inputs (Level 3) (in thousands): Three Months Ended March 31, 2022 Beginning balance as of January 1 $ 2,345 Change in fair value of the net embedded derivative liability 2,690 Ending balance as of March 31 $ 5,035 |
Schedule of financial assets measured and recognized at fair value | As of March 31, 2022, financial assets and liabilities measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements as of March 31, 2022 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 119,378 — — 119,378 Total assets $ 119,378 $ — $ — $ 119,378 Liabilities: Net embedded derivative liability — — 5,035 5,035 Total liabilities $ — $ — $ 5,035 $ 5,035 As of December 31, 2021, financial assets and liabilities measured at fair value on a recurring basis were as follows (in thousands): Fair Value Measurements as of 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 liability — — 2,345 2,345 Total liabilities $ — $ — $ 2,345 $ 2,345 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Property, Plant and Equipment [Abstract] | |
Schedule of property, plant and equipment, net | Property and equipment, net consisted of the following (in thousands): March 31, 2022 December 31, 2021 Laboratory equipment $ 798 $ 585 Furniture and fixtures 73 73 Leasehold improvements 263 226 Marketing equipment 258 258 Office equipment 68 68 Construction-in-progress 1,408 1,524 Total property and equipment $ 2,868 $ 2,734 Accumulated depreciation (311) (237) Property and equipment, net $ 2,557 $ 2,497 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Payables and Accruals [Abstract] | |
Schedule of accrued expenses and other current liabilities | Accrued expenses and other current liabilities consisted of the following (in thousands): March 31, 2022 December 31, 2021 Accrued gross-to-net deductions $ 4,163 $ 4,837 Accrued compensation 8,014 9,153 Accrued professional services 6,109 5,451 Accrued research and development expense 1,145 1,243 Accrued other expense 284 827 Total accrued expenses and other current liabilities $ 19,715 $ 21,511 |
Stockholders' Equity and Equi_2
Stockholders' Equity and Equity Incentive Plans (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Equity [Abstract] | |
Schedule of conversions of stock | The Company's outstanding equity awards as well as reserved common stock for future issuance is as follows: March 31, 2022 December 31, 2021 Outstanding options under the 2016 Equity Incentive Plan (the 2016 Plan) 1,863,246 1,935,240 Outstanding options under the 2019 Equity Incentive Plan (the 2019 Plan) 3,148,375 2,078,232 Outstanding options under the 2021 Equity Inducement Plan (the 2021 Plan) 456,900 270,600 Outstanding performance stock units (PSUs) under the 2019 Plan 444,500 — Unvested restricted stock units (RSUs) under the 2019 Plan 397,304 179,149 Equity awards available for grant under the 2019 Plan (1) 854,755 1,535,488 Equity awards available for grant under the 2021 Plan 193,100 379,400 Shares reserved for purchase under the Employee Stock Purchase Plan (the ESPP) (2) 491,242 225,447 Total 7,849,422 6,603,556 (1) Effective January 1, 2022, in connection with the evergreen provision contained in the 2019 Plan, an additional 1,070,967 shares of common stock were reserved for issuance under the 2019 Plan, including 7,784 shares of common stock that have become available for issuance under the 2019 Plan as a result of the forfeiture, termination, tender to or withholding for payment of an exercise price or for tax withholding obligations, expiration or repurchase of stock options, restricted stock units or other stock awards that had been granted under the 2016 Plan, pursuant to the terms of the 2019 Plan. (2) Effective January 1, 2022, in connection with an evergreen provision contained in the ESPP, an additional 265,795 shares of common stock were reserved for issuance under the ESPP. |
Schedule of stock options activity | The following table summarizes stock option activity under the 2016 Plan, the 2019 Plan and the 2021 Plan during the three months ended March 31, 2022 (in thousands, except shares, contractual term and per share data): Outstanding Options Number of Shares Underlying Outstanding Options Weighted Average Exercise Price Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2022 4,284,072 $ 13.54 8.1 $ 28,874 Options granted 1,268,995 15.52 — Options exercised (69,930) 1.09 995 Options forfeited (14,616) 16.17 12 Outstanding at March 31, 2022 5,468,521 14.15 8.3 12,193 Shares vested and exercisable as of March 31, 2022 2,111,311 10.84 7.1 10,526 Vested and expected to vest as of March 31, 2022 5,468,521 $ 14.15 8.3 $ 12,193 |
Schedule of activity for restricted stock units | Activity with respect to the Company's restricted stock units during the three months ended March 31, 2022 was as follows (in thousands, except share, contractual term, and per share data): Outstanding RSUs Number of Shares Underlying Outstanding Awards Weighted Average Grant Date Fair Value per Share Weighted Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding at January 1, 2022 179,149 $ 17.52 2.4 $ 3,271 Restricted stock units granted 239,223 15.74 3,765 Restricted stock units vested (20,618) 18.77 241 Restricted units forfeited (450) 16.00 5 Outstanding at March 31, 2022 397,304 16.39 3.1 4,625 Unvested and expected to vest as of March 31, 2022 397,304 $ 16.39 3.1 $ 4,625 |
Schedule of stock-based compensation expense | The following is a summary of stock-based compensation expense by function recognized (in thousands): Three Months Ended March 31, 2022 2021 Sales and marketing $ 1,252 $ 524 General and administrative 2,475 1,790 Research and development 632 366 Total stock-based compensation expense $ 4,359 $ 2,680 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Earnings Per Share [Abstract] | |
Schedule of earnings per share, basic and diluted | The following table sets forth the computation of basic and diluted net loss per share (in thousands, except share and per share data): Three Months Ended March 31, 2022 2021 Numerator: Net loss $ (47,892) $ (18,909) Denominator: Weighted average shares outstanding, basic and diluted 26,631,577 25,924,096 Net loss per share, basic and diluted $ (1.80) $ (0.73) |
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: March 31, 2022 2021 Options to purchase common stock 5,468,521 4,033,044 Unvested restricted stock units 397,304 140,595 Shares committed under the ESPP 80,275 — Total 5,946,100 4,173,639 |
Long-Term Debt (Tables)
Long-Term Debt (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Debt Disclosure [Abstract] | |
Schedule of long-term debt | The balances of the long-term debt, debt issuance and discount costs, net of amortization and accretion recorded on the Company's condensed balance sheet were as follows: March 31, 2022 December 31, 2021 Long-term debt $ 95,000 $ 95,000 Debt issuance and discount costs, net of amortization (4,364) (5,185) Long-term debt, net $ 90,636 $ 89,815 |
Leases (Tables)
Leases (Tables) | 3 Months Ended |
Mar. 31, 2022 | |
Leases [Abstract] | |
Supplemental balance sheet information for lessee | Supplemental balance sheet information for the Company's leases is as follows (in thousands): March 31, 2022 December 31, 2021 Operating lease right-of-use assets $ 2,645 $ 2,884 Finance lease right-of-use assets 55 18 Total right-of-use assets $ 2,700 $ 2,902 Operating lease liabilities $ 684 $ 779 Finance lease liabilities 31 16 Total lease liabilities $ 715 $ 795 Operating lease liabilities, non-current $ 1,974 $ 2,114 Finance lease liabilities, non-current 30 4 Total lease liabilities, non-current $ 2,004 $ 2,118 |
Schedule of maturities of lease liabilities | The maturities of the lease liabilities under non-cancelable operating and finance leases are as follows (in thousands): As of March 31, 2022 Finance Leases Operating Leases Total 2022 (remainder) $ 25 $ 634 $ 659 2023 22 666 688 2024 16 572 588 2025 — 562 562 2026 — 525 525 Total undiscounted cash flows 63 2,959 3,022 Less: imputed interest (2) (301) (303) Total lease liabilities 61 2,658 2,719 Less: current portion (31) (684) (715) Lease liabilities $ 30 $ 1,974 $ 2,004 |
Nature of Business, Basis of _3
Nature of Business, Basis of Presentation and Significant Accounting Policies (Details) - USD ($) $ in Thousands | Aug. 05, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 | Jun. 30, 2021 |
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Net loss | $ (47,892) | $ (18,909) | |||
Accumulated deficit | (303,302) | $ (255,410) | |||
Cash and cash equivalents | 143,364 | 175,910 | $ 193,372 | ||
Total revenue | 2,704 | $ 0 | |||
Required recurring revenue for funding | $ 40,000 | ||||
Cowen And Company, LLC | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Equity capital raised through at-the-market sales (up to) | $ 100,000 | ||||
Revolving Credit Facility | OrbiMed Credit Facility | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
OrbiMed credit facility | $ 125,000 | ||||
Minimum liquidity covenant after FDA approval | 5,000 | ||||
Amount provided contingent upon certain net sales performance | Revolving Credit Facility | OrbiMed Credit Facility | |||||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | |||||
Contingent increase in credit facility | $ 30,000 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 1,128 | $ 2,524 |
Work in process | 2,256 | 3,053 |
Finished goods | 710 | 509 |
Inventory, net | 4,094 | $ 6,086 |
Long-term inventory | $ 2,200 |
Fair Value Measurements - Chang
Fair Value Measurements - Change in Embedded Derivative Liability (Details) $ in Thousands | Aug. 05, 2021USD ($) | Mar. 31, 2022USD ($)derivativeInstrument | Mar. 31, 2021USD ($) |
Changes In Other Long Term Debt [Roll Forward] | |||
Change in fair value of the net embedded derivative liability | $ 2,690 | $ 0 | |
Significant Unobservable Inputs (Level 3) | |||
Changes In Other Long Term Debt [Roll Forward] | |||
Beginning balance as of January 1 | 2,345 | ||
Ending balance as of March 31 | $ 5,035 | ||
Revolving Credit Facility | OrbiMed Credit Facility | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Lender-held put option, principal repayment | $ 5,000 | ||
Net embedded derivative liability | |||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |||
Number of derivative instruments held | derivativeInstrument | 3 | ||
Net embedded derivative liability | Significant Unobservable Inputs (Level 3) | |||
Changes In Other Long Term Debt [Roll Forward] | |||
Change in fair value of the net embedded derivative liability | $ 2,690 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets and Liabilities Measured at Fair Value (Details) - Fair Value, Recurring - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Assets: | ||
Total assets | $ 119,378 | $ 162,376 |
Liabilities: | ||
Net embedded derivative liability | 2,345 | |
Total liabilities | 5,035 | 2,345 |
Net embedded derivative liability | ||
Liabilities: | ||
Net embedded derivative liability | 5,035 | |
Money market funds | ||
Assets: | ||
Money market funds | 119,378 | 162,376 |
Quoted Price in Active Markets for Identical Assets (Level 1) | ||
Assets: | ||
Total assets | 119,378 | 162,376 |
Liabilities: | ||
Net embedded derivative liability | 0 | |
Total liabilities | 0 | 0 |
Quoted Price in Active Markets for Identical Assets (Level 1) | Net embedded derivative liability | ||
Liabilities: | ||
Net embedded derivative liability | 0 | |
Quoted Price in Active Markets for Identical Assets (Level 1) | Money market funds | ||
Assets: | ||
Money market funds | 119,378 | 162,376 |
Significant Other Observable Inputs (Level 2) | ||
Assets: | ||
Total assets | 0 | 0 |
Liabilities: | ||
Net embedded derivative liability | 0 | |
Total liabilities | 0 | 0 |
Significant Other Observable Inputs (Level 2) | Net embedded derivative liability | ||
Liabilities: | ||
Net embedded derivative liability | 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: | ||
Net embedded derivative liability | 2,345 | |
Total liabilities | 5,035 | 2,345 |
Significant Unobservable Inputs (Level 3) | Net embedded derivative liability | ||
Liabilities: | ||
Net embedded derivative liability | 5,035 | |
Significant Unobservable Inputs (Level 3) | Money market funds | ||
Assets: | ||
Money market funds | $ 0 | $ 0 |
Property and Equipment, Net (De
Property and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 2,868 | $ 2,734 |
Accumulated depreciation | (311) | (237) |
Property and equipment, net | 2,557 | 2,497 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 798 | 585 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 73 | 73 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 263 | 226 |
Marketing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 258 | 258 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | 68 | 68 |
Construction-in-progress | ||
Property, Plant and Equipment [Line Items] | ||
Total property and equipment | $ 1,408 | $ 1,524 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Payables and Accruals [Abstract] | ||
Accrued gross-to-net deductions | $ 4,163 | $ 4,837 |
Accrued compensation | 8,014 | 9,153 |
Accrued professional services | 6,109 | 5,451 |
Accrued research and development expense | 1,145 | 1,243 |
Accrued other expense | 284 | 827 |
Total accrued expenses and other current liabilities | $ 19,715 | $ 21,511 |
Stockholders' Equity and Equi_3
Stockholders' Equity and Equity Incentive Plans - Narrative (Details) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | |
Jan. 31, 2022 | Mar. 31, 2022USD ($)vote$ / sharesshares | Dec. 31, 2021$ / 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 | ||
Weighted-average grant-date fair value of options (in dollars per share) | $ / shares | $ 11.47 | ||
Share-based payment arrangement, nonvested award, cost not yet recognized, amount | $ | $ 36,700 | ||
Weighted-average recognition period of unrecognized stock-based compensation expense (in years) | 3 years | ||
Unvested restricted stock units | |||
Class of Stock [Line Items] | |||
Share-based payment arrangement, nonvested award, cost not yet recognized, amount | $ | $ 5,500 | ||
Weighted-average recognition period of unrecognized stock-based compensation expense (in years) | 3 years 3 months 18 days | ||
Performance Shares | |||
Class of Stock [Line Items] | |||
Expected term (in years) | 1 year 5 months 23 days | ||
Expected volatility rate | 61.30% | ||
Risk free interest rate | 0.64% | ||
Dividend rate | 0.00% | ||
Performance Shares | Minimum | |||
Class of Stock [Line Items] | |||
Percent of shares that may vest and be issued | 0.00% | ||
Performance Shares | Maximum | |||
Class of Stock [Line Items] | |||
Percent of shares that may vest and be issued | 125.00% |
Stockholders' Equity and Equi_4
Stockholders' Equity and Equity Incentive Plans - Reserved Common Stock (Details) - shares | Jan. 01, 2022 | Mar. 31, 2022 | Dec. 31, 2021 |
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 5,468,521 | 4,284,072 | |
Unvested RSUs and shares reserved for purchase under the ESPP (in shares) | 397,304 | 179,149 | |
Total (in shares) | 7,849,422 | 6,603,556 | |
2016 Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 1,863,246 | 1,935,240 | |
Increase in shares available for issuance | 7,784 | ||
2019 Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 3,148,375 | 2,078,232 | |
Equity awards available to grant (in shares) | 854,755 | 1,535,488 | |
Additional shares authorized (in shares) | 1,070,967 | ||
2019 Plan | Performance Shares | |||
Class of Stock [Line Items] | |||
Outstanding performance stock units (PSUs) under the 2019 Plan (in shares) | 444,500 | 0 | |
2019 Plan | Unvested restricted stock units | |||
Class of Stock [Line Items] | |||
Unvested RSUs and shares reserved for purchase under the ESPP (in shares) | 397,304 | 179,149 | |
The 2021 Equity Inducement Plan | |||
Class of Stock [Line Items] | |||
Outstanding options (in shares) | 456,900 | 270,600 | |
Equity awards available to grant (in shares) | 193,100 | 379,400 | |
ESPP | |||
Class of Stock [Line Items] | |||
Unvested RSUs and shares reserved for purchase under the ESPP (in shares) | 491,242 | 225,447 | |
Additional shares authorized (in shares) | 265,795 |
Stockholders' Equity and Equi_5
Stockholders' Equity and Equity Incentive Plans - Option Activity During The Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Number of Shares Underlying Outstanding Options | ||
Beginning balance (in shares) | 4,284,072 | |
Options granted (in shares) | 1,268,995 | |
Options exercised (in shares) | (69,930) | |
Options forfeited (in shares) | (14,616) | |
Ending balance (in shares) | 5,468,521 | 4,284,072 |
Shares exercisable at end of period (in shares) | 2,111,311 | |
Shares vested and expected to vest at end of period (in shares) | 5,468,521 | |
Weighted Average Exercise Price | ||
Beginning balance (in dollars per share) | $ 13.54 | |
Options granted (in dollars per share) | 15.52 | |
Options exercise price (in dollars per share) | 1.09 | |
Options forfeited (in dollars per share) | 16.17 | |
Ending balance (in dollars per share) | 14.15 | $ 13.54 |
Shares vested and exercisable at end of period (in dollars per share) | 10,840 | |
Shares vested and expected to vest at end of period (in dollars per share) | $ 14,150 | |
Weighted-Average Remaining Contractual Term (Years) | ||
Weighted average contractual term (in years) | 8 years 3 months 18 days | 8 years 1 month 6 days |
Shares vested and exercisable at end of period, weighted average remaining contractual term (in years) | 7 years 1 month 6 days | |
Shares vested and expected to vest at end of period, weighted average remaining contractual term (in years) | 8 years 3 months 18 days | |
Aggregate Intrinsic Value | ||
Aggregate intrinsic value, outstanding ending balance | $ 28,874 | |
Aggregate intrinsic value, options, granted | 0 | |
Aggregate intrinsic value, options exercised | 995 | |
Aggregate intrinsic value, options forfeited | 12 | |
Aggregate intrinsic value, outstanding ending balance | 12,193 | $ 28,874 |
Shares vested and exercisable at end of period, aggregate intrinsic value | 10,526 | |
Shares vested and expected to vest at end of period, aggregate intrinsic value | $ 12,193 |
Stockholders' Equity and Equi_6
Stockholders' Equity and Equity Incentive Plans - RSU Activity During The Period (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2022 | Dec. 31, 2021 | |
Number of Shares Underlying Outstanding Awards | ||
Outstanding at beginning of period (in shares) | 179,149 | |
Restricted stock units granted (in shares) | 239,223 | |
Shares vested in period (in shares) | (20,618) | |
Restricted units forfeited (in shares) | (450) | |
Outstanding at end of period (in shares) | 397,304 | 179,149 |
Unvested and expected to vest (in shares) | 397,304 | |
Weighted Average Grant Date Fair Value per Share | ||
Beginning outstanding balance (in dollars per share) | $ 17.52 | |
Restricted stock units granted, weighted average grant date fair value (in dollars per share) | 15.74 | |
Restricted stock units vested, weighted average grant date fair value (in dollars per share) | 18.77 | |
Restricted units forfeited, weighted average grant date fair value (in dollars per share) | 16 | |
Ending outstanding balance (in dollars per share) | 16.39 | $ 17.52 |
Unvested and expected to vest (in dollars per share) | $ 16.39 | |
Weighted Average Remaining Contractual Term (Years) | ||
Weighted average remaining contractual term, restricted stock units (in years) | 3 years 1 month 6 days | 2 years 4 months 24 days |
Vested and expected to vest, weighted average remaining contractual term (in years) | 3 years 1 month 6 days | |
Aggregate Intrinsic Value | ||
Restricted stock units outstanding, aggregate intrinsic value, beginning of period | $ 3,271 | |
Restricted stock units granted, aggregate intrinsic value | 3,765 | |
Restricted stock units vested, aggregate intrinsic value | 241 | |
Restricted stock units outstanding, aggregate intrinsic value, end of period | 5 | |
Restricted stock units outstanding, aggregate intrinsic value, end of period | 4,625 | $ 3,271 |
Vested and expected to vest, aggregate intrinsic value | $ 4,625 |
Stockholders' Equity and Equi_7
Stockholders' Equity and Equity Incentive Plans - Stock Based Compensation Expense (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 4,359 | $ 2,680 |
Sales and marketing | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 1,252 | 524 |
General and administrative | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | 2,475 | 1,790 |
Research and development | ||
Share-based Payment Arrangement, Expensed and Capitalized, Amount [Line Items] | ||
Total stock-based compensation expense | $ 632 | $ 366 |
Net Loss Per Share - Computatio
Net Loss Per Share - Computation of Basic and Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Numerator: | ||
Net loss | $ (47,892) | $ (18,909) |
Denominator: | ||
Weighted average shares outstanding, diluted (in shares) | 26,631,577 | 25,924,096 |
Weighted average shares outstanding, basic (in shares) | 26,631,577 | 25,924,096 |
Net loss per share, basic (in dollars per share) | $ (1.80) | $ (0.73) |
Net loss per share, diluted (in dollars per share) | $ (1.80) | $ (0.73) |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities (Details) - shares | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 5,946,100 | 4,173,639 |
Options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 5,468,521 | 4,033,044 |
Unvested restricted stock units | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 397,304 | 140,595 |
Shares committed under the ESPP | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Potentially dilutive securities excluded from the computation of diluted net loss per share (in shares) | 80,275 | 0 |
Long-term Debt - Narrative (Det
Long-term Debt - Narrative (Details) - USD ($) $ in Thousands | Aug. 05, 2021 | Mar. 31, 2022 | Mar. 31, 2021 | Dec. 31, 2021 |
Debt Instrument [Line Items] | ||||
Quarterly revenue interest payments, percentage of net recurring revenue over specified amount to aggregate cap | 1.00% | |||
Interest expense | $ (3,066) | $ 0 | ||
Line of Credit | ||||
Debt Instrument [Line Items] | ||||
Amortization of debt issuance costs | 1,000 | |||
Revolving Credit Facility | OrbiMed Credit Facility | ||||
Debt Instrument [Line Items] | ||||
Interest rate floor | 0.40% | |||
Quarterly revenue interest payments, percentage of net recurring revenue up to specified amount | 3.00% | |||
Accrued revenue sharing fee | 100 | |||
Undrawn loan commitment fees | $ 500 | $ 600 | ||
Minimum liquidity covenant after FDA approval | $ 5,000 | |||
Revolving Credit Facility | OrbiMed Credit Facility | Maximum | ||||
Debt Instrument [Line Items] | ||||
Quarterly payments (up to) | 300,000 | |||
Net recurring revenue from annual sales and licenses over specified amount to aggregate cap | 500,000 | |||
Revolving Credit Facility | OrbiMed Credit Facility | Minimum | ||||
Debt Instrument [Line Items] | ||||
Net recurring revenue from annual sales and licenses over specified amount to aggregate cap | $ 300,000 | |||
Effective interest rate on credit facility | 13.98% | |||
Revolving Credit Facility | OrbiMed Credit Facility | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | ||||
Debt Instrument [Line Items] | ||||
Interest rate (as a percentage) | 8.10% |
Long-term Debt - Debt issuance
Long-term Debt - Debt issuance and discount (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Debt Disclosure [Abstract] | ||
Long-term debt | $ 95,000 | $ 95,000 |
Debt issuance and discount costs, net of amortization | (4,364) | (5,185) |
Long-term debt, net | $ 90,636 | $ 89,815 |
Leases - Narrative (Details)
Leases - Narrative (Details) - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Mar. 31, 2021 | |
Leases [Abstract] | ||
Lessee, finance lease, remaining lease term | 4 years 2 months 12 days | |
Lease expense | $ 0.3 | $ 0.1 |
Leases - Supplemental Balance S
Leases - Supplemental Balance Sheet Information (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Operating lease right-of-use assets | $ 2,645 | $ 2,884 |
Finance lease right-of-use assets | 55 | 18 |
Total right-of-use assets | 2,700 | 2,902 |
Operating lease liabilities | 684 | 779 |
Finance lease liabilities | 31 | 16 |
Total lease liabilities | 715 | 795 |
Operating lease liabilities, non-current | 1,974 | 2,114 |
Finance lease liabilities, non-current | 30 | 4 |
Total lease liabilities, non-current | $ 2,004 | $ 2,118 |
Leases - Lease Maturity Schedul
Leases - Lease Maturity Schedules (Details) - USD ($) $ in Thousands | Mar. 31, 2022 | Dec. 31, 2021 |
Finance Leases | ||
2022 (remainder) | $ 25 | |
2023 | 22 | |
2024 | 16 | |
2025 | 0 | |
2026 | 0 | |
Total undiscounted cash flows | 63 | |
Less: imputed interest | (2) | |
Total lease liabilities | 61 | |
Less: current portion | (31) | $ (16) |
Lease liabilities | 30 | 4 |
Operating Leases | ||
2022 (remainder) | 634 | |
2023 | 666 | |
2024 | 572 | |
2025 | 562 | |
2026 | 525 | |
Total undiscounted cash flows | 2,959 | |
Less: imputed interest | (301) | |
Total lease liabilities | 2,658 | |
Less: current portion | (684) | (779) |
Lease liabilities | 1,974 | 2,114 |
Lease, Liability, Payment, Due [Abstract] | ||
2022 (remainder) | 659 | |
2023 | 688 | |
2024 | 588 | |
2025 | 562 | |
2026 | 525 | |
Total undiscounted cash flows | 3,022 | |
Less: imputed interest | (303) | |
Total lease liabilities | 2,719 | |
Less: current portion | (715) | (795) |
Total lease liabilities, non-current | $ 2,004 | $ 2,118 |
License and Collaboration Agr_2
License and Collaboration Agreements (Details) - Pfizer - License - USD ($) $ in Millions | 3 Months Ended | |
Mar. 31, 2022 | Dec. 31, 2021 | |
Collaborative Arrangement, Transaction with Party to Collaborative Arrangement | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
One-time, sales based milestone payment | $ 10 | |
Milestone payment, sales threshold | 250 | |
Accrued royalties | $ 0.2 | $ 0 |
Minimum | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Royalty rates | 7.50% | |
Maximum | ||
Collaborative Arrangement and Arrangement Other than Collaborative [Line Items] | ||
Royalty rates | 15.00% |