The following discussion analyzes the Company's historical financial condition and results of operations. As you read this discussion and analysis, refer to the Company's financial statements and the notes thereto included elsewhere in this Quarterly Report on Form 10-Q, which represents the results of operations for the three and six months endedJune 30, 2021 and 2020. Also refer to the Company's Annual Report on Form 10-K for the year endedDecember 31, 2020 , which includes detailed discussions of various items impacting the Company's business, results of operations and financial condition. The discussion and analysis below has been organized as follows: •Executive summary, including a description of the business and recent events that are important to understanding the results of operations and financial condition; •Results of operations, including an explanation of significant differences between the periods in the specific line items of the condensed statements of operations; •Financial condition addressing the Company's sources of liquidity, future funding requirements, cash flow, sources and uses of cash, updates to contractual obligations and commitments, and off-balance sheet arrangements; and •Critical accounting policies, significant judgements and estimates, which are most important to both the portrayal of the Company's results of operations and financial condition. Some of the information contained in the following discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q, including information with respect to the Company's plans and strategy for its business, includes forward-looking statements within the meaning of Section 27A of the Act and Section 21E of the Exchange Act that involve risks and uncertainties. As a result of many factors, including those factors set forth in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year endedDecember 31, 2020 and in this Quarterly Report on Form 10-Q, the Company's actual results could differ materially from the results described in or implied by these forward-looking statements. Please also see the section of this Quarterly Report on Form 10-Q titled "Special Note Regarding Forward-Looking Statements." 14 --------------------------------------------------------------------------------
Executive Summary Introduction and OverviewOyster Point Pharma, Inc. is a clinical stage biopharmaceutical company focused on the discovery, development and commercialization of first-in-class pharmaceutical therapies to treat ophthalmic diseases. The Company's lead product candidate OC-01 (varenicline) nasal spray, a highly selective nicotinic acetylcholine receptor (nAChR) agonist, is being developed as a nasal spray to treat the signs and symptoms of dry eye disease. Based on OC-01 (varenicline) nasal spray's clinical trial results and its novel mechanism of action, the Company believes OC-01 (varenicline) nasal spray, if approved by the FDA, has the potential to become the new standard of care and redefine how dry eye disease is treated for millions of patients. The Company has no products approved for sale and has not generated revenue since its inception in 2015. The Company expects to finance its operations through private and public equity or debt financing, collaborative or other arrangements with corporate sources or through other sources of financing. The Company's net losses were$40.9 million and$32.0 million for the six months endedJune 30, 2021 and 2020, respectively. As ofJune 30, 2021 , the Company had an accumulated deficit of$195.7 million . The Company expects that its selling, general and administrative expenses will continue to increase as the Company prepares for the commercialization of its lead product candidate, OC-01 (varenicline) nasal spray, if approved by the FDA. Additionally, operating expenses will increase as the Company advances its other product candidates through preclinical and clinical development, seeks regulatory approval, and prepares for and, if approved, proceeds to commercialization; acquires, discovers, validates and develops additional product candidates; obtains, maintains, protects and enforces its intellectual property portfolio; and hires additional personnel. The Company has incurred and will continue to incur additional costs associated with operating as a public company. The Company plans to continue to use third-party service providers, including clinical research organizations (CROs) and contract manufacturing organization (CMOs), to carry out its preclinical and clinical development and to manufacture and supply the materials to be used during the development and commercialization of its product candidates. During the second quarter of 2021, the Company commenced its hiring of a specialty sales force of approximately 150 to 200 field representatives. Recent Events Credit Facility with OrbiMed OnAugust 5, 2021 , the Company entered into a$125 million Credit Agreement with OrbiMed, to be funded in three separate tranches, the first$45 million tranche to be funded no later thanAugust 13, 2021 , the second$50 million tranche to be funded, at the option of the Company, upon FDA approval of OC-01 (varenicline) nasal spray and the third$30 million tranche to be funded, at the option of the Company, upon the Company receiving$40 million in net recurring revenue from the sale and/or licensing of OC-01. The Company's obligations under the Credit Agreement are secured by all or substantially all of its assets and property, subject to customary exceptions. The Credit Agreement matures onAugust 5, 2027 . The term loans bear interest at a rate per annum equal to the sum of (x) the daily secured overnight financing rate as administered by theFederal Reserve Bank of New York , subject to a 0.40% floor, plus (y) a margin of 8.10%. Commencing on the first full fiscal quarter after the closing date, the Company is required to make quarterly revenue interest payments to OrbiMed in an amount equal to 3% of all net revenue from annual sales and licenses of OC-01 up to$300 million and 1% of all revenue from annual sales and licenses of OC-01 between$300 million and$500 million , subject to caps on such quarterly payments. These caps increase both on an annual basis and upon funding of the second and third term loan tranches. If the Company does not obtain OC-01 approval byJune 30, 2022 , the Credit Agreement requires monthly repayments of principal starting onAugust 5, 2024 . Additionally, commencing with the fourth full fiscal quarter after OC-01 approval, if the Company does not meet certain minimum recurring revenue thresholds from the sale and/or licensing of OC-01 on a quarterly basis for the most recently ended four fiscal quarter period, the Credit Agreement requires a$5 million repayment of principal on the interest payment date following such fiscal quarter. The Company is permitted to prepay, in whole or in part, the term loans, subject to the payment of a prepayment fee, an exit fee and a buyout amount (calculated as the revenue interest cap set forth above less the amount of royalty payments made to OrbiMed). The term loans are also required to be mandatorily prepaid with the proceeds of certain asset sales and casualty events (subject to payment of the prepayment fee and exit fee) and the issuance of convertible debt. 15 -------------------------------------------------------------------------------- For further discussion of the Credit Agreement, including information pertaining to affirmative and negative covenants of the Company, and events of default, see Item 1 - Note 8, Subsequent Events.
Ji Xing License and Collaboration Agreement
OnAugust 5, 2021 , the Company entered into a license and collaboration agreement (License Agreement) withJi Xing Pharmaceuticals Limited (Ji Xing), a biotechnology company headquartered inShanghai and backed byRTW Investments, LP (RTW). Pursuant to the License Agreement, the Company will grant Ji Xing an exclusive license to develop and commercialize OC-01 (varenicline) and OC-02 (simpinicline) nasal sprays, for all prophylactic uses for, and treatment of, ophthalmology diseases or disorders in the greaterChina region. Ji Xing will be responsible for the development, regulatory, manufacturing and commercialization activities costs in the greaterChina region. The Company will be responsible for supplying the drug substance and finished products of OC-01 (varenicline) and OC-02 (simpinicline) for Ji Xing's clinical development at quantities to be agreed by the parties, subject to one or more separate supply agreements as contemplated by the License Agreement. The Company will receive an upfront cash payment consisting of$17.5 million and up to 0.75% equity interest in Ji Xing, half of which will be subject to a pre-specified vesting condition. In addition, the Company is eligible to receive up to$204.8 million in aggregate development and sales-based milestone payments and tiered low teens to low twenties royalties based on future net sales of OC-01 and OC-02 in the greaterChina region. For further discussion of the License Agreement, see Item 1 - Note 8, Subsequent Events.
Hiring of
The Company continues to make meaningful progress toward its plannedU.S. launch of OC-01 (varenicline) nasal spray in the fourth quarter of 2021, if approved by the FDA, by initiating the hiring of sales representatives during the month of July, with a planned target of hiring 150-200 sales representatives. Sales representatives are currently in the field communicating our dry eye disease-state awareness campaign.
Preclinical Data Highlighting Potent Activity of OC-01 (varenicline) and OC-02 (simpinicline) against SARS-CoV-2 Virus and Variants.
InJuly 2021 , the Company announced preclinical data in non-human primates and in vitro models evaluating OC-01 (varenicline) nasal spray against SARS-CoV-2 and the alpha and beta variants, the viruses that cause COVID-19 disease.Administration of OC-01 (varenicline) nasal spray to non-human primates was observed to inhibit viral replication in the nose within 24 hours of infectious SARS-CoV-2 challenge with absence of subgenomic RNA at Day 3 and Day 5 post-challenge. The results were published on the preprint server bioRxiv. In addition, varenicline was observed to inhibit cellular entry and replication of SARS-CoV-2 and its alpha and beta variants in multiple human cell types. Lastly, OC-02 (simpinicline) was also observed to inhibit cellular entry and replication of SARS-CoV-2 alpha variant in Calu-3 human cells at very low concentrations. Additional preclinical studies with SARS-CoV-2 variants are currently underway.
2021 Inducement Plan
InJuly 2021 , the Company's Board of Directors approved the adoption of the 2021 Inducement Plan (Inducement Plan), which is to be used exclusively for grants of awards to individuals who were not previously employees or directors of the Company (or following a bona fide period of non-employment) as a material inducement to such individuals' entry into employment with the Company, pursuant to Nasdaq Listing Rule 5635(c)(4). The Company has reserved 650,000 shares of its common stock that may be issued under the Inducement Plan. The terms and conditions of the Inducement Plan are substantially similar to those of the 2019 Plan.
Enrollment of First Subject in the
In
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Pipeline Expansion with Enriched Tear Film (ETF™) Gene Therapy to Target Ophthalmic Diseases
InJune 2021 , the Company announced the expansion of its pipeline with the introduction of its proprietary ETF™ gene therapy and proof-of-concept in vivo study results from it first gene therapy candidate, OC-101. Preclinical study results from a 42-day proof-of-concept in vivo study demonstrated a single, intralacrimal gland injection of an adeno-associated virus (AAV) vector that delivers the human Nerve Growth Factor (NGF) gene. A single injection produced statistically significant increase of NGF in tear film, as compared to control. Preclinical study results also demonstrated that following AAV transduction of the lacrimal gland, cholinergic activation with OC-01 (varenicline) nasal spray produced statistically significant increase of NGF levels in tear film of a rabbit model, as compared to control, and pre-cholinergic activation, potentially indicating OC-01's ability to modulate lacrimal secretion of NGF. No macroscopic or microscopic safety findings were observed associated with either the intralacrimal gland administration of OC-01 or intranasal administration of OC-01.
Research Collaboration with
InMay 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 pay for potential development and regulatory milestones, as well as the potential for sales-related milestones and tiered royalties of net sales, if a licensed phage therapy is approved by the FDA or certain other regulatory authorities. Pursuant to the terms of the agreement, the Company paid a one-time, non-refundable, upfront payment of$0.5 million for the collaboration and option agreement which was included in research and development expense for the three and six months endedJune 30, 2021 . Prescription Drug User Fee Act (PDUFA) target action date ofOctober 17, 2021 The Company submitted a 505(b)(2) New Drug Application (NDA) for OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease inDecember 2020 . The FDA has assigned a PDUFA target action date ofOctober 17, 2021 as the goal to complete its review of the NDA. The Impact of the SARS-CoV-2 Virus Pandemic During the six months endedJune 30, 2021 , the financial results of the Company were not significantly affected by the SARS-CoV-2 virus pandemic. 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 impact of the SARS-CoV-2 virus pandemic on its trials, expected timelines and costs, as well as potential supply-chain challenges as it prepares itself for commercialization of the OC-01 (varenicline) nasal spray candidate and as it continues to learn more about the impact of the SARS-CoV-2 virus pandemic on the industry. 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 previously instituted remote working arrangements for employees through the second quarter of 2021 and investing in personal protective equipment for the future return to the office. During the second quarter of 2021, Company management instituted a voluntary return to the Company's office located inNew Jersey beginningSeptember 7, 2021 , and continues to actively monitor and evaluate such plans as the pandemic continues to evolve. 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 indirectly impact the operation 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. For further discussion of the risks that the Company faces as a result of the SARS-CoV-2 virus pandemic refer to the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year endedDecember 31, 2020 . 17 --------------------------------------------------------------------------------
Results of Operations
Comparison of the Results of Operations for the Three Months Ended
The following table summarizes the Company's results of operations for the periods indicated (in thousands, except percentages):
Three Months Ended June 30, 2021 2020 $ Change % Change Research and development: Clinical, preclinical$ 2,066 $ 1,881 $ 185 10 % Chemistry, manufacturing and controls (CMC) 3,420 5,723 (2,303) (40) % Other 1,244 950 294 31 % Total research and development 6,730 8,554 (1,824) (21) % Selling, general and administrative 15,296 6,940 8,356 120 % Loss from operations (22,026) (15,494) (6,532) 42 % Other income, net 10 30 (20) (67) % Net loss$ (22,016) $ (15,464) $ (6,552) 42 %
Research and Development Expenses
Research and development expenses decreased by$1.8 million during the three months endedJune 30, 2021 compared to the three months endedJune 30, 2020 . The decrease was primarily driven by lower CMC expenses incurred by the Company in the second quarter of 2021 compared to the second quarter of 2020, which included significant pre-approval inventory costs, as well as expenses related to the preparation of the NDA filing inDecember 2020 .
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by$8.4 million during the three months endedJune 30, 2021 compared to the three months endedJune 30, 2020 . The increase was driven by higher payroll-related expenses, including stock-based compensation of$4.8 million , due to additional headcount, as well as higher commercial planning expenses of$1.8 million in anticipation of aU.S. launch of OC-01 (varenicline) nasal spray, if approved, in the fourth quarter of 2021. In addition, the Company incurred higher other general and administrative expenses of$1.0 million , related to accounting, legal, facilities, information technology, and other office-related costs. The Company also incurred an increase in medical affairs costs in the amount of$0.8 million during the three months endedJune 30, 2021 compared to the three months endedJune 30, 2020 . 18 --------------------------------------------------------------------------------
Comparison of the Six Months Ended
The following table summarizes the Company's results of operations for the periods indicated (in thousands, except percentages):
Six Months Ended June 30, 2021 2020 $ Change % Change Research and development: Clinical, preclinical$ 4,001 $ 7,993 $ (3,992) (50) % Chemistry, manufacturing and controls (CMC) 9,045 9,560 (515) (5) % Other (488) 2,341 (2,829) (121) % Total research and development 12,558 19,894 (7,336) (37) % Selling, general and administrative 28,388 12,529 15,859 127 % Loss from operations (40,946) (32,423) (8,523) 26 % Other income, net 21 440 (419) (95) % Net loss$ (40,925) $ (31,983) $ (8,942) 28 % Research and Development Expenses Research and development expenses decreased by$7.3 million during the six months endedJune 30, 2021 compared to the six months endedJune 30, 2020 . The decrease in clinical, preclinical, and CMC expense of$4.5 million was primarily due to the completion of the ONSET-2 Phase 3 clinical trial inMay 2020 . The decrease in other research and development costs of$2.8 million was primarily driven by the application fee waiver granted to the Company inApril 2021 . InDecember 2020 , the Company paid a fee of$2.9 million to the FDA under the PDUFA in conjunction with the filing of its NDA for OC-01 (varenicline) nasal spray. The Company filed a request with the FDA to grant a waiver and refund the fee under the small business waiver provision of the PDUFA. Due to the uncertainty regarding the collectability of this refund, the Company recorded the filing fee in research and development expense inDecember 2020 . InFebruary 2021 , the FDA granted the Company's request for the waiver. The refund was recorded as a reduction in other research and development expense for the six months endedJune 30, 2021 .
Selling, General and Administrative Expenses
Selling, general and administrative expenses increased by$15.9 million during the six months endedJune 30, 2021 compared to the six months endedJune 30, 2020 . The increase was driven by higher payroll-related expenses of$9.4 million , inclusive of stock-based compensation in the amount of$2.6 million , due to additional headcount, as well as higher commercial planning expenses of$3.5 million in anticipation of aU.S. launch of OC-01(varenicline) nasal spray, if approved, in the fourth quarter of 2021. In addition, the Company incurred higher other general and administrative expenses of$1.7 million , related to accounting, legal, facilities, information technology, and other office-related costs. The Company also incurred an increase in medical affairs costs in the amount of$1.3 million during the six months endedJune 30, 2021 compared to the six months endedJune 30, 2020 .
Other Income, Net
Other income, net decreased by$0.4 million for the six months endedJune 30, 2021 compared to the six months endedJune 30, 2020 , due to lower rate of return on the money market funds earned during the period, as well as lower cash balances during the first six months of 2021 compared to the first six months of 2020. 19 --------------------------------------------------------------------------------
Liquidity and Capital Resources
Sources of Liquidity
As of
Future Funding Requirements
Based on the current business plan, management believes that its available cash and cash equivalents will be sufficient to fund the Company's planned operations for at least 12 months from the filing date of this Quarterly Report on Form 10-Q. OnDecember 17, 2020 , the Company submitted a 505(b)(2) NDA to the FDA for its first lead product candidate, OC-01 (varenicline) nasal spray for the treatment of signs and symptoms of dry eye disease. The Company expects to continue to incur an increase in expense related to the Company's preparation for the commercialization of OC-01 (varenicline) nasal spray, if approved, including expenses for the establishment of commercial scale manufacturing arrangements, and to prepare for market access, marketing, distribution and commercial operations. In addition, the Company will continue to expend funds to initiate, continue and or complete the research, development and clinical testing of its current and future product candidates. Since inception, the Company has incurred recurring losses and negative cash flows from operations. The Company generated net losses of$40.9 million and$32.0 million for the six months endedJune 30, 2021 and 2020, respectively, and had an accumulated deficit of$195.7 million as ofJune 30, 2021 . The Company historically financed its operations primarily through the sale and issuance of its securities. The Company does not expect to generate any meaningful revenue unless and until it obtains regulatory approval of and commercializes any of its product candidates or decides to enter into collaborative agreements with third parties. The Company is subject to all of the risks typically related to the development of new product candidates, and it may encounter unforeseen expenses, difficulties, complications, delays and other unknown factors that may adversely affect its business. The Company will require additional funds to commercialize its products and fund operations for the foreseeable future. The Company is unable to entirely fund these efforts with its current financial resources and there can be no assurance that it will be able to secure such additional financing on a timely basis, if at all, that will be sufficient to meet these needs. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce or eliminate certain commercial related expenses, included in selling, general and administrative expenses, as well as delay, reduce or eliminate the scope of or eliminate one or more of its research or development programs, which would materially and adversely affect its business, financial condition and operations. The Company may seek to raise capital through private or public equity or debt financings, collaborative or other arrangement with corporate sources, or through other sources of financing.
The Company anticipates that it will need to raise substantial additional capital, the requirements for which will depend on many factors, including:
•the scope, timing, rate of progress and costs of the Company's drug discovery efforts, preclinical development activities, laboratory testing and clinical trials for the Company's product candidates; •the number and scope of clinical programs the Company decides to pursue; •the cost, timing and outcome of preparing for and undergoing regulatory review of the Company's product candidates; •the scope and costs of development and commercial manufacturing activities; •the cost and timing associated with commercializing of the Company's product candidates, if they receive marketing approval; •the extent to which the Company acquires or in-licenses other product candidates and technologies; •the costs of preparing, filing and prosecuting patent applications, maintaining and enforcing the Company's intellectual property rights and defending intellectual property-related claims; •the Company's ability to establish and maintain collaborations on favorable terms, if at all; •its efforts to enhance operational systems and the Company's ability to attract, hire and retain qualified personnel, including personnel to support the development of the Company's product candidates and, ultimately, the sale of the Company's products, following FDA approval; •the Company's implementation of operational, financial and management systems; •any current or future potential effects of the SARS-CoV-2 virus pandemic on the Company's business, operations, preclinical and clinical development and commercialization timelines and plans; and •the costs associated with being a public company. 20 --------------------------------------------------------------------------------
A change in the outcome of any of these or other variables with respect to the development of any of the Company's product candidates could significantly change the costs and timing associated with the development of that product candidate.
Furthermore, the Company's operating plans may change in the future, and it will continue to require additional capital to meet operational needs and capital requirements associated with such operating plans. If additional funds are raised by issuing equity securities, the Company's stockholders may experience dilution. Any future debt financing into which the Company might enter may impose upon it additional covenants that restrict the Company's operations, including limitations on its ability to incur liens or additional debt, pay dividends, repurchase its common stock, make certain investments or engage in certain merger, consolidation or asset sale transactions. Any debt financing or additional equity that it raises may contain terms that are not favorable to the Company or its stockholders. Adequate funding may not be available to the Company on acceptable terms or at all, and any uncertainty and volatility in capital markets caused by the SARS-CoV-2 virus pandemic may negatively impact the availability and cost of capital. The Company's failure to raise capital as and when needed could have a negative impact on its financial condition and ability to pursue its business strategies. If the Company is unable to raise additional funds when needed, it may be required to delay, reduce, or terminate some or all of its development programs and clinical trials or may also be required to sell or license to others rights to its product candidates in certain territories or indications that it would prefer to develop and commercialize itself. If the Company is required to enter into collaborations and other arrangements to supplement its funds, it may have to give up certain rights, thereby limiting its ability to develop and commercialize the product candidates or may have other terms that are not favorable to the Company or its stockholders, which could materially affect its business, results of operation and financial condition. See Item 1A. Risk Factors to the Annual Report on Form 10-K for the year endedDecember 31, 2020 for additional risks associated with the Company's substantial capital requirements. Cash Flow Discussion The following table sets forth the primary sources and uses of cash, cash equivalents and restricted cash for each of the periods presented below (in thousands): Six Months Ended June 30, 2021 2020 $ Change Net cash (used in) provided by: Operating activities$ (37,085) $ (25,098) $ (11,987) Investing activities (994) (342) (652) Financing activities 299 113,051 (112,752)
Net (decrease) increase in cash and cash equivalents
Cash Flows Used in Operating Activities
Net cash used in operating activities increased by$12.0 million for the six months endedJune 30, 2021 compared to the six months endedJune 30, 2020 , due to higher net loss adjusted for non-cash items during the period in the amount of$5.9 million , as well as a decrease in working capital of$6.0 million driven primarily by the timing of payments to the Company's service providers. The Company's higher net loss was driven by the continued development of the Company's product candidates and preparation for the commercial launch of the Company's main product candidate, OC-01 (varenicline) nasal spray, if approved, in the fourth quarter of 2021.
Cash Flows Used in Investing Activities
Net cash used in investing activities increased by
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Cash Flows Provided by Financing Activities
Net cash provided by financing activities decreased by$112.8 million for the six months endedJune 30, 2021 compared to the six months endedJune 30, 2020 , primarily due to the proceeds from the follow on public offering during the second quarter of 2020. The decrease was partially offset by higher proceeds received from the exercise of stock options during the six months endedJune 30, 2021 .
Contractual Obligations and Commitments
InFebruary 2021 , the Company entered into a lease agreement for laboratory and office space inNew Jersey for a three-year term beginning onMarch 1, 2021 and ending onFebruary 29, 2024 . Total future minimum lease payments under this agreement are$0.3 million as ofJune 30, 2021 . As ofJune 30, 2021 , there have been no other material changes in the contractual obligations and commitments from those disclosed in the financial statements and the related notes included in the Company's Annual Report on Form 10-K for the year endedDecember 31, 2020 .
Off-Balance Sheet Arrangements
As of
Critical Accounting Policies, Significant Judgments and Estimates
The Company's financial statements have been prepared in accordance withU.S. GAAP. The preparation of these financial statements requires the Company to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported expenses incurred during the reporting periods. The Company bases its estimates on historical experience and on various other assumptions that it believes are reasonable under the circumstances. The Company evaluates its estimates and assumptions on an ongoing basis. The future effects of the SARS-CoV-2 virus pandemic on the Company's results of operations, cash flows, and financial position are unclear, however the Company believes it has used reasonable estimates and assumptions in preparing the interim condensed financial statements. Actual results may differ from these estimates under different assumptions or conditions. The Company's critical accounting policies and estimates are included in the Company's Annual Report on Form 10-K for the year endedDecember 31, 2020 . The Company periodically reviews its accounting policies, estimates and assumptions and makes adjustments when facts and circumstances dictate. In addition to the accounting policies that are described in the Company's 2020 Annual Report on Form 10-K, the following critical accounting policy was affected by critical accounting estimates in connection with the Company offering its employees an option to purchase the Company's common stock under the ESPP effectiveApril 1, 2021 . Stock-Based Compensation As discussed in Note 4, Stockholders' Equity, effectiveApril 1, 2021 , the Company established its first offering period under the ESPP. Stock-based compensation expense related to purchase rights issued under the ESPP, is based on the Black-Scholes option-pricing model fair value of the estimated number of awards as of the beginning of the offering period. Stock-based compensation expense is recognized using the straight-line method over the offering period. The determination of the grant date fair value of shares purchased under the ESPP is affected by the estimated fair value of our common stock as well as other assumptions and judgments, which are estimated as follows: •Expected term. The expected term for ESPP is the beginning of the offering period to the end of each purchase period. •Expected volatility. As the Company has a limited trading history of its common stock, the expected volatility is estimated based on the third quartile of the range of the observed volatilities for comparable publicly traded biotechnology and pharmaceutical related companies over a period equal to length of the offering period. The comparable companies are chosen based on industry, stage of development, size and financial leverage of potential comparable companies. 22 -------------------------------------------------------------------------------- •Risk-free interest rate. The risk-free interest rate is based on the implied yield currently available onU.S. Treasury zero-coupon issues with a remaining term equivalent to the expected term of the offering period. •Expected dividend rate. The Company has not paid and does not anticipate paying any dividends in the near future. Accordingly, the Company has estimated the dividend yield to be zero.
Recent Accounting Pronouncements
See "Recent Accounting Pronouncements" in Note 1. Nature of Business, Basis of Presentation and Significant Accounting Policies to the Company's unaudited interim condensed financial statements included in this Quarterly Report.
JOBS Act
The Company is an "emerging growth company," as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Section 107(b) of the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, an emerging growth company can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. The Company has irrevocably elected not to avail itself of this extended transition period, and, as a result, it will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies. The Company intends to rely on other exemptions provided by the JOBS Act, including without limitation, not being required to comply with the auditor attestation requirements of Section 404(b) of the Sarbanes-Oxley Act. The Company will remain an emerging growth company until the earliest to occur of: (1) the last day of its first fiscal year in which it has total annual revenues of more than$1.07 billion ; (2) the date it qualifies as a "large accelerated filer," with at least$700.0 million of equity securities held by non-affiliates; (3) the date on which it has issued more than$1.0 billion in non-convertible debt securities during the prior three-year period; and (4) the last day of the fiscal year ending after the fifth anniversary of its initial public offering.
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