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H.S. junior Avg
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New words:
absent, acquire, acquired, acquirer, acquiring, acquisition, atopic, attached, attention, circumstance, consent, consummated, consummation, CVR, DAO, decide, Delaware, diamine, discourage, divert, document, enzyme, Exhibit, foregoing, frame, free, hereto, IND, IRA, merge, modification, organizational, outflow, outpace, oxidase, penalizing, pendency, platform, promptly, purport, pursuit, reaching, respond, software, solicit, stockholder, subsidiary, surviving, thereof, timeframe, upside, vernal, VWAP, wholly
Removed:
activation, cholinergic, demonstrated, domestic, earlier, emerge, ensure, fully, functioning, indirectly, infection, initiate, instructed, lacrimal, learn, manufactured, meaningful, modulate, monitoring, partial, prepaid, produced, promote, rabbit, remote, secretion, statistically, transduction, vitro, vivo
Financial report summary
?Competition
Alcon Inc. - Registered Shares • Glaukos • Aerie Pharmaceuticals • Aldeyra Therapeutics • Ocular Therapeutix • Kala Bio • Abbvie • Aurinia PharmaceuticalsRisks
- Risks Related to the Company's Business
- The Company’s business depends on the successful development and commercialization of TYRVAYA Nasal Spray and the Company’s other product candidates. To the extent TYRVAYA Nasal Spray is not commercially successful, the Company’s business, financial condition, and results of operations may be adversely affected. The Company may never generate significant revenue or be profitable.
- The Company has a limited operating history and has incurred significant losses and negative cash flows from operations since its formation, and it anticipates that it will continue to incur losses for the foreseeable future. The Company also has a limited history of commercializing TYRVAYA Nasal Spray, its only approved product. These factors may make it difficult for investors to evaluate the Company’s current business and predict its future success and viability.
- The Company will need substantial additional funding in the future. If it is unable to raise capital when needed, or on acceptable terms, it may be forced to delay, reduce or eliminate future commercialization efforts or one or more of its research and development programs.
- The terms of the Company’s credit facility place restrictions on the Company’s operating and financial flexibility.
- The Company's success is highly dependent on its ability to attract and retain highly skilled executive officers and employees.
- If the Company engages in acquisitions, in-licensing or strategic partnerships, this may increase its capital requirements, dilute stockholders, cause it to incur debt or assume contingent liabilities, and subject the Company to other risks.
- If the Company’s information technology systems and/or data are or were compromised, the Company could experience adverse consequences resulting from such compromise, including but not limited to interruptions to the Company's operations such as its commercial launch and clinical trials, claims that the Company breached its data privacy and security obligations, harm to the Company's reputation, and a loss of customers or sales.
- Changes in U.S. tax law may materially adversely affect the Company's financial condition, results of operations and cash flows.
- The Company’s ability to use its net operating loss carryforwards and certain other tax attributes to offset future taxable income may be subject to certain limitations.
- The Company faces significant competition, and if its competitors’ products are or are perceived as being more effective, safer or less expensive than TYRVAYA Nasal Spray or other product candidates, or if the Company is unable to differentiate TYRVAYA Nasal Spray from other therapies for the treatment of dry eye disease, then the Company’s ability to successfully commercialize TYRVAYA Nasal Spray would be adversely affected.
- TYRVAYA Nasal Spray is subject to substantial, ongoing regulatory requirements that may impact its commercial potential.
- TYRVAYA Nasal Spray is based on an API that is already on the market, which exposes the Company to additional risks.
- If the Company is unable to maintain sales and marketing capabilities or enter into agreements with third parties to market, distribute, and sell its products, it may be unable to generate adequate revenue.
- The manufacture of TYRVAYA Nasal Spray and the Company’s other product candidates is complex and highly regulated, and there are particular risks associated with manufacturing the products to commercial scale. In addition, the Company’s reliance on third parties increases the risk that the Company will not have sufficient quantities of its products or product candidates or such quantities at an acceptable cost, which could delay, prevent or impair its commercialization or development efforts.
- If product liability lawsuits are brought against the Company, it may incur substantial liabilities and may be required to limit commercialization of its products.
- A variety of risks associated with marketing TYRVAYA Nasal Spray or any other product candidates internationally could materially adversely affect the Company’s business.
- The pharmaceutical industry in China is highly regulated, and such regulations are subject to change, which may negatively affect the commercialization of the Company’s medicines and drug candidates in that country.
- Drug development is a lengthy, highly uncertain undertaking and involves a substantial degree of risk. The outcome of preclinical testing and earlier clinical trials may not be predictive of the success of later clinical trials. The results of the Company's clinical trials may not satisfy the requirements of the FDA or other regulatory authorities, and the Company may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of product candidates.
- If the Company experiences delays or difficulties in the enrollment of subjects in clinical trials, its receipt of necessary regulatory approvals could be delayed or prevented.
- The Company's current or future product candidates may cause significant adverse events, toxicities or other undesirable side effects which may delay or prevent marketing approval.
- If the Company is unable to obtain and maintain patent protection for its technology and products, or if the scope of the patent protection obtained is not sufficiently broad, the Company may not be able to compete effectively in its markets.
- Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment, and other requirements imposed by governmental patent agencies, and the Company's patent protection could be reduced or eliminated for noncompliance with these requirements.
- The Company may not identify relevant third-party patents or may incorrectly interpret the relevance, scope or expiration of a third-party patent, which might adversely affect its ability to develop and market its products.
- Lawsuits or other proceedings to protect or enforce the Company's patents, the patents of any licensors or its other intellectual property rights could be expensive, time consuming, and unsuccessful.
- Because of the expense and uncertainty of litigation, the Company may not be in a position to enforce its intellectual property rights against third parties.
- Changes in U.S. patent law or the patent law of other countries or jurisdictions could diminish the value of patents in general, thereby impairing the Company's ability to protect its products.
- The Company may not be able to protect its intellectual property rights throughout the world, which could impair its business.
- The Company's reliance on third parties may require the Company to share its trade secrets, which increases the possibility that a competitor will discover them or that the Company's trade secrets will be misappropriated or disclosed.
- The Company may be subject to claims that its employees, consultants or independent contractors have wrongfully used or disclosed confidential information of their former employers or other third parties.
- Intellectual property rights do not necessarily address all potential threats to the Company’s competitive advantage.
- If the Company's future trademarks and trade names are not adequately protected, then it may not be able to build name recognition in markets of interest and its business may be adversely affected.
- If the Company fails to comply with its obligations under any license, collaboration or other agreements, including its license agreement with Pfizer Inc., such agreements may be terminated, the Company may be required to pay damages and it could lose intellectual property rights that are necessary for the development and protection of its product candidates.
- The regulatory approval processes of the FDA and foreign regulatory authorities are highly complex, lengthy, and inherently unpredictable. If the Company is unable to obtain regulatory approval for its product candidates, or to do so in a timely manner, it will be unable to generate product revenue and its business will be substantially harmed.
- The Company may face difficulties in commercializing and achieving reimbursement of its products from changes to current regulations and future legislation.
- The US Government actively enforces laws and regulations regarding the promotion of pharmaceutical products.
- The Company's employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers and vendors may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements.
- Obtaining and maintaining regulatory approval of the Company's product candidates in one jurisdiction does not mean that it will be successful in obtaining regulatory approval of its product candidates in other jurisdictions. The FDA and foreign regulatory authorities may not accept data from trials conducted in locations outside of their jurisdiction.
- The Company's business operations and current and future relationships with healthcare professionals, clinical investigators, consultants, patient organizations, customers, CROs and third-party payors in connection with its current and future business activities may be subject to federal and state healthcare fraud and abuse laws, false claims laws, transparency laws, government price reporting, and health information privacy and security laws, which could expose the Company to, among other things, criminal sanctions, civil penalties, contractual damages, exclusion from governmental healthcare programs, reputational harm, administrative burdens and diminished profits and future earnings.
- The Company's business activities are subject to the FCPA and similar anti-bribery and anti-corruption laws of other countries in which it operates, as well as U.S. and certain foreign export controls, trade sanctions, and import laws and regulations. Compliance with these legal requirements could limit the Company's ability to compete in foreign markets and subject it to liability if it violates them.
- Disruptions at the FDA, the SEC and other government agencies caused by funding shortages or global health concerns could hinder their ability to hire and retain key leadership and other personnel, prevent new products and services from being developed or commercialized in a timely manner, or otherwise prevent those agencies from performing normal business functions on which the operation of the Company's business may rely, which could negatively impact its business.
- If the Company fails to comply with environmental, health and safety laws and regulations, it could become subject to fines or penalties or incur costs that could have a material adverse effect on its business.
- Any collaboration or partnership arrangements that the Company has or may in the future enter into may not be successful, which could adversely affect the Company’s ability to develop and commercialize its products.
- The Company may pursue collaborations with third parties for the development or commercialization of its product candidates. If it decides to pursue collaborations, but is not able to establish those collaborations on commercially reasonable terms, it may have to alter its development and commercialization plans. If it does enter into collaborations that are not successful, it may not be able to capitalize on the market potential of these product candidates.
- The Company relies on third parties to conduct its clinical trials and those third parties may not perform satisfactorily, including the potential that they may fail to comply with trial protocols or regulatory requirements, and may fail to meet deadlines for the completion of such trials.
- An active trading market for the Company's common stock may not be sustained.
- The price of the Company's stock may be volatile, and investors could lose all or part of their investment.
- Sales of a substantial number of shares of the Company's common stock in the public market could cause its stock price to fall.
- Raising additional capital may cause dilution to the Company's existing stockholders, restrict its operations or require the Company to relinquish rights to its product candidates on unfavorable terms to the Company.
- The Company's principal stockholders and management own a significant percentage of Company's stock and will be able to exert significant control over matters subject to stockholder approval.
- The Company is an “emerging growth company,” and it cannot be certain if the reduced reporting requirements applicable to emerging growth companies will make the Company's common stock less attractive to investors.
- The Company has been incurring increased costs as a result of operating as a public company, and its management is required to devote substantial time to compliance initiatives and corporate governance practices. Additionally, if the Company fails to maintain proper and effective internal control over financial reporting, its ability to produce accurate financial statements on a timely basis could be impaired.
- The Company does not intend to pay dividends on its common stock so any returns will be limited to the value of the stock.
- Provisions in the Company's restated certificate of incorporation and restated bylaws and Delaware law might discourage, delay or prevent a change in control of the Company or changes in its management and, therefore, depress the market price of its common stock.
- The Company's amended and restated bylaws provide that the Court of Chancery of the State of Delaware will be the exclusive forum for substantially all disputes between the Company and its stockholders, which could limit stockholders’ ability to obtain a favorable judicial forum for disputes with the Company or its directors, officers or employees.
- Business disruptions could seriously harm the Company's future revenue and financial condition and increase its costs and expenses.
- If securities or industry analysts do not continue to publish research or reports, or if they publish adverse or misleading research or reports regarding the Company, its business or its market, the stock price and trading volume could decline.
- The Company may be subject to securities litigation, which is expensive and could divert management attention.
- The Company's disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
Management Discussion
- Product revenue, net was $5.6 million for the three months ended September 30, 2022, and was related to sales of TYRVAYA Nasal Spray, which was launched in the U.S. in November 2021. Approximately 34,000 TYRVAYA Nasal Spray prescriptions, written by approximately 6,100 unique eye care professionals, were filled during the three months ended September 30, 2022. The Company did not generate any revenues from product sales during the three months ended September 30, 2021.
- The Company did not recognize any license revenue during the three months ended September 30, 2022. The Company recognized $17.9 million in license revenue during the three months ended September 30, 2021 in connection with the License Agreement entered into with Ji Xing. The license revenue was recognized upon the transfer of control of the licenses to Ji Xing
- and was comprised of $17.5 million cash consideration, and non-cash consideration of 397,562 senior common shares of Ji Xing valued at $0.4 million.