ITEM 1A. RISK FACTORS
Investing in the Company's common stock involves a high degree of risk. Careful consideration should be given to the following risk factors, in addition to the other information set forth in this Annual Report on Form 10-K and in other documents that were filed and will be filed with the SEC, in evaluating the Company and its business. Additional risks and uncertainties not presently known to or that are currently seen as immaterial may also harm Company's business. If any of these risks occur, business, growth prospects, operating results and financial condition could be materially and adversely affected, the trading price of the Company's common stock could decline, and investors could lose part or all of their investment.
SUMMARY RISK FACTORS
The Company’s business is subject to a number of risks of which investors should be aware before making a decision to invest in its common stock. These risks are more fully described in the “Risk Factors” section of this Annual Report on Form 10-K, but a summary of the risks that could materially and adversely affect the Company’s business, financial condition, operating results and prospects includes the following:
• The Company’s business depends on the successful development and commercialization of TYRVAYA Nasal Spray and the Company’s other product candidates, and the Company has a limited history of commercializing TYRVAYA Nasal Spray, its only approved product. 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 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, which 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. In addition, 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 terms of the Company’s credit facility with OrbiMed place restrictions on the Company’s operating and financial flexibility.
• The Company's business, operations and clinical development timelines and plans could be adversely affected by the effects of health epidemics, including the ongoing SARS-CoV-2 virus pandemic.
• 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.
• The commercial success of TYRVAYA Nasal Spray and the Company’s other product candidates, once approved, depends on the availability and sufficiency of third-party payor coverage and reimbursement.
• The manufacturing 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, including the Company’s reliance on third parties and 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.
• The Company is subject to substantial, ongoing regulatory requirements that may impact TYRVAYA Nasal Spray’s commercial potential.
• 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. In addition, the regulatory approval processes of the FDA and foreign regulatory authorities are highly complex, lengthy, and inherently unpredictable, and the results of the Company's clinical trials may not satisfy the requirements of the FDA or other regulatory authorities. The Company may incur unexpected costs or experience delays in completing, or ultimately be unable to complete, the development and commercialization of product candidates.
• The Company may experience delays or difficulties in the enrollment of subjects in clinical trials, or its current or future product candidates may cause significant adverse events, toxicities or other undesirable side effects, either of which may delay or prevent regulatory or marketing approval.
• 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.
• 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.
• Third party claims or litigation alleging infringement of patents or other proprietary rights or seeking to invalidate the Company's patents or other proprietary rights, may delay or prevent the development and commercialization of TYRVAYA Nasal Spray and any other product candidates. 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.
• The Company may become involved in lawsuits to protect or enforce its patents, the patents of any licensors or its other intellectual property rights, which could be expensive, time consuming, and unsuccessful.
• 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. In addition, the Company may not be able to protect its intellectual property rights throughout the world, which could impair its business.
• If the Company fails to comply with its obligations under any license, collaboration or other agreements, including its license agreement with Pfizer, 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 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 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.
• 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.
• 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.
• The Company’s information technology systems, or those used by the Company’s third-party collaborators, CROs, vendors, contractors or consultants, may fail or suffer other breakdowns, cyber-attacks or information security breaches that could expose the Company to liability, affect its reputation and otherwise harm its business.
• The Company's success is highly dependent on its ability to attract and retain highly skilled executive officers and employees.
• 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 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.
• Changes in U.S. tax law may materially adversely affect the Company's financial condition, results of operations and cash flows, and 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.
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.
TYRVAYA Nasal Spray is the Company’s only drug that has been approved for sale, and it has only been approved for the treatment of the signs and symptoms of dry eye disease in the U.S. since October 2021. The Company is focusing a significant portion of its activities and resources on TYRVAYA Nasal Spray, and the Company believes its prospects are highly dependent on, and a significant portion of the value of the Company relates to, its ability to successfully commercialize TYRVAYA Nasal Spray in the U.S.
Successful commercialization of TYRVAYA Nasal Spray is subject to many risks. The Company has never commercialized a product prior to TYRVAYA Nasal Spray, and there is no guarantee that it will be able to successfully commercialize TYRVAYA Nasal Spray for its approved indication. There are numerous examples of failures to meet expectations of market potential, including by pharmaceutical companies with more experience and resources than the Company has.
Market acceptance of TYRVAYA Nasal Spray and any other product for which the Company receives approval will depend on a number of factors, including:
• the efficacy and safety demonstrated in clinical trials;
• the ability to demonstrate the impact of TYRVAYA Nasal Spray on patients who receive treatment;
• the product label and clinical indications for which the product is approved;
• acceptance by physicians, the medical community, and patients of the product as a safe and effective treatment;
• the potential and perceived advantages or value of the product over alternative treatments, including the ability to distinguish safety and efficacy from less expensive generic or over-the-counter alternative therapies, and the timing of the market introduction of new alternative treatments;
• the convenience of prescribing, administering, and initiating patients on the product;
• the discounts and rebates the Company offers to third-party payors and government authorities to create product availability through health insurance plans
• the prevalence and severity of side effects; and
• the effectiveness of sales and marketing efforts.
The Company may never be successful in achieving its objectives and, even if it does, it may never generate revenue that is significant or large enough to achieve profitability, or comparable to the revenues or profits achieved by competitors or by products that compete with TYRVAYA Nasal Spray. If it does achieve profitability, it may not be able to sustain or increase profitability on a quarterly or annual basis. The Company's failure to become and remain profitable would decrease its value and could impair its ability to maintain or further its research and development efforts, raise necessary additional capital, grow its business, retain key employees and continue its operations.
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 has a limited operating history. Operations to date have been limited to organizing the Company, raising capital, developing TYRVAYA Nasal Spray and the Company’s other product candidates, and obtaining marketing approval of TYRVAYA Nasal Spray. In addition, as a relatively new business, the Company may encounter unforeseen expenses, difficulties, complications, delays and other known and unknown factors. The Company may not be successful manufacturing TYRVAYA Nasal Spray at commercial scale or arranging for a third-party to do so on its behalf or conducting sales and marketing activities necessary for successful product commercialization.
The Company has generated limited revenue from initial sales of TYRVAYA Nasal Spray and has incurred net losses in each reporting period since its formation. The Company has funded its operations primarily from the sale and issuance of its securities, and from borrowing funds from third parties. Additionally, the net losses the Company incurs may fluctuate significantly from quarter to quarter such that a period-to-period comparison of its results of operations may not be a good indicator of the Company's future performance. The size of the Company’s future net losses, and the potential for the Company to achieve profitability, will depend, in part, on the rate of future growth of its expenses and its ability to generate revenue. The Company launched commercial sales of TYRVAYA Nasal Spray in the fourth quarter of 2021, and, in light of 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.
The Company expects to continue incurring significant expenses and operating losses for the foreseeable future. The Company expects that its expenses will increase substantially if and as it:
• continues to expand its sales, marketing, and distribution infrastructure to commercialize TYRVAYA Nasal Spray and any other products for which it may obtain marketing approval;
• provides discounts and rebates in connection with the sale of TYRVAYA Nasal Spray;
• initiates additional preclinical, clinical and other studies for its product candidates or expands or modifies existing studies or currently planned studies;
• changes or adds additional manufacturers or suppliers, some of which may require additional permits or other governmental approvals;
• creates additional infrastructure to support its operations as a public company and its product development and planned future commercialization efforts;
• seeks to identify and develop additional product candidates, and seeks marketing approvals and reimbursement for them;
• acquires or in-licenses other product candidates and technologies;
• makes milestone or other payments in connection with the development or approval of its product candidates;
• maintains, protects, and expands its intellectual property portfolio; and
• experiences any delays or encounters issues with any of the above.
The Company's prior losses and expected future losses have had and will continue to have an adverse effect on working capital and ability to achieve and maintain profitability.
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.
Developing and marketing pharmaceutical products, including conducting preclinical studies and clinical trials, is a very expensive and uncertain process. The Company's operations have consumed significant amounts of cash since inception, and it expects its expenses to increase in connection with ongoing activities, including the commercialization of TYRVAYA Nasal
Spray and the development of other product candidates and indications through clinical trials and potential marketing approvals. The Company's expenses could increase beyond expectations if the Company is required by the FDA or other regulatory agencies to perform clinical trials or preclinical studies in addition to those that it currently anticipates. Other unanticipated costs may also arise, including with respect to the commercialization of TYRVAYA Nasal Spray. Because the design and outcome of its planned and anticipated clinical trials are highly uncertain, it cannot reasonably estimate the actual amounts necessary to successfully complete the development and commercialization of any product candidate it develops.
As of December 31, 2021, the Company had $193.4 million in cash and cash equivalents. Although the Company believes that its available cash and cash equivalents will be sufficient to fund its planned operations for at least 12 months following the date of this Annual Report on Form 10-K, this belief is based on assumptions that may prove to be wrong, and the Company could use its available capital resources sooner than it currently expects. Changing circumstances, some of which may be beyond its control, could cause the Company to consume capital significantly faster than it currently anticipates, and it may need to seek additional funds sooner than planned.
Advancing the commercialization of TYRVAYA Nasal Spray and the development of other product candidates will require a significant amount of capital. The Company's existing cash and cash equivalents may not be sufficient to fund all of the activities that are necessary for the successful commercialization of TYRVAYA Nasal Spray or for the completion of the development of other product candidates. The Company will continue to require additional capital to develop its product candidates and fund operations for the foreseeable future. The Company may seek to raise capital through private or public equity or debt financings, collaborative or other arrangements with corporate sources, or through other sources of financing, which may dilute stockholders or restrict operating activities. The amount of additional capital the Company will need to raise 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 its 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 its product candidates;
• the scope and costs of development and manufacturing activities;
• the cost and timing associated with commercializing TYRVAYA Nasal Spray or any other 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;
• the Company's efforts to enhance operational systems and its ability to attract, hire and retain qualified personnel, including personnel to support the sale of TYRVAYA Nasal Spray and the development of other product candidates;
• the Company’s implementation of operational, financial and management systems;
• the current or potential future 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.
Except for the Company's $125 million term loan credit facility, the Company does not have any committed external source of funds. Adequate additional financing may not be available on acceptable terms, or at all. The Company's failure to raise capital as and when needed or on acceptable terms would have a negative impact on the Company's business, growth prospects, operating results and financial condition and its ability to pursue its business strategy, and the Company may have to delay, reduce the scope of, suspend or eliminate one or more of its research-stage programs, clinical trials or future commercialization efforts.
The terms of the Company’s credit facility place restrictions on the Company’s operating and financial flexibility.
On August 5, 2021, the Company entered into a $125 million term loan credit facility (the “Credit Agreement”) with OrbiMed Royalty & Credit Opportunities III, LP, as administrative agent and initial lender. To date, the Company has drawn on the first two of three tranches available under the Credit Agreement, in an aggregate amount totaling $95 million. The Company’s ability to draw on the third $30 million tranche under the Credit Agreement is subject to conditions, and the Company may not meet such conditions to draw on the third tranche or may not be able to meet the conditions in a manner timely enough to meet its future capital needs.
In addition, borrowings under the Credit Agreement are secured by all or substantially all of the Company’s assets, subject to customary exceptions. The Credit Agreement also contains operating restrictions and covenants that restrict, and any future financing agreements that the Company may enter into may further restrict, the Company’s ability to finance its operations, engage in business activities or expand or fully pursue its business strategies. For example, the Credit Agreement limits the Company’s ability to, among other things:
• incur additional debt;
• incur liens;
• make investments, acquisitions, loans or advances;
• sell assets;
• make restricted payments, including dividends and distributions on, and redemptions, repurchases or retirement of, the Company’s capital stock;
• enter into fundamental changes, including mergers and consolidations;
• enter into transactions with affiliates;
• change the nature of the Company’s business;
• make prepayments of certain debt;
• modify or terminate material agreements; and
• enter into certain outbound licenses of material intellectual property.
These restrictions are subject to certain exceptions. In addition, the Credit Agreement requires that the Company meet certain reporting and operating covenants, including a minimum liquidity covenant. The Company’s ability to comply with these covenants may be affected by events beyond its control, and the Company may not be able to meet those covenants.
The Credit Agreement includes customary events of default, including failure to pay principal, interest or certain other amounts when due; material inaccuracy of representations and warranties; breach of covenants; specified cross-default to other material indebtedness; certain bankruptcy and insolvency events; certain ERISA events; certain undischarged judgments; material impairment of security interests; material adverse change and material regulatory events, in certain cases subject to certain thresholds and grace periods. A breach of any of these covenants could result in an event of default under the Credit Agreement. If the Company defaults under the terms of the Credit Agreement, including failure to satisfy the operating covenants, the lender may accelerate all of the Company’s repayment obligations and take control of the secured assets. Any declaration by the lender of an event of default could significantly harm the Company’s business and prospects and could cause the price of the Company’s common stock to decline.
The Company's business, operations and clinical development timelines and plans could be adversely affected by the effects of health epidemics, including the ongoing SARS-CoV-2 virus pandemic.
The Company’s business, operations and clinical development timelines and plans could be adversely affected by health epidemics, including the ongoing SARS-CoV-2 virus pandemic, in regions where it has concentrations of clinical trial sites or other business operations, and could cause significant disruption in the operations of third-party contractors upon which it relies. For example, federal, state, and local governments have taken varying preventive and proactive measures to slow the spread of SARS-CoV-2 virus pandemic, and such measures have resulted in business closures, work stoppages, slowdowns and delays, work-from-home policies, travel restrictions and cancellation of events, among other effects that could negatively impact productivity and disrupt the Company's business and operations. In addition, while some healthcare facilities and physician offices, particularly those in major markets, have reopened and rescheduled previously cancelled or postponed non-emergency or elective procedures, SARS-CoV-2 cases have increased, and new viral strains have emerged, which may result in additional delays in procedures or otherwise restricted patient visits, or cause disruptions in the operations of payors, distributors, manufacturers, logistics providers and other third parties, which could limit the volume of TYRVAYA Nasal Spray being prescribed and in turn negatively impact sales of TYRVAYA Nasal Spray.
The Company has implemented a work-from-home policy for many of its employees, and it continues evaluating the situation as more information about the virus becomes available. Moreover, the Company's clinical development timelines and plans could be affected by the SARS-CoV-2 virus pandemic. Site initiation and patient enrollment could be delayed or suspended due to prioritization of healthcare facility resources toward the SARS-CoV-2 virus pandemic. In addition, some patients may not be able to comply with clinical trial protocols, and the ability to conduct follow up visits with treated patients may be limited, if quarantines impede patient movement or interrupt healthcare services. The Company cannot assure that the inability to collect such data would not also have an adverse impact on its future clinical trial results.
Similarly, the continued spread of the SARS-CoV-2 virus pandemic could severely impact the Company's preclinical studies and clinical trials due to, among other things:
• delays in receiving approval from local regulatory authorities to initiate planned clinical trials;
• delays or difficulties in recruiting, enrolling and retaining patients in clinical trials due to pandemic-related lockdowns or stay-at-home advisories or other factors;
• delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators and clinical site staff;
• delays in clinical sites receiving the supplies and materials needed to conduct clinical trials, including interruption in global shipping that may affect the transport of clinical trial materials;
• changes in local regulations as part of a response to the SARS-CoV-2 virus pandemic which may require the Company to change the ways in which clinical trials are conducted, to incur unexpected costs, or to discontinue the clinical trials entirely;
• diversion of healthcare resources away from the conduct of clinical trials, including the diversion of hospitals serving as clinical trial sites and hospital staff supporting the conduct of clinical trials;
• interruption of key clinical trial activities, such as clinical trial site monitoring, due to limitations on travel imposed or recommended by federal or state governments, employers and others, or interruption of clinical trial subject visits and study procedures, the occurrence of which could affect the integrity of clinical trial data;
• clinical trial participants becoming infected with the SARS-CoV-2 virus while the clinical trial is ongoing, which could impact the results of the clinical trial, including by potentially increasing the number of observed adverse events;
• interruptions or delays in preclinical studies due to restricted or limited operations at research and development laboratory facilities;
• delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees;
• limitations in employee resources that would otherwise be focused on the conduct of clinical trials, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people;
• refusal of the FDA to accept data from clinical trials in affected geographies;
• increased cybersecurity risks due to the Company's reliance on internet technology and the number of its employees that are working remotely, which may create additional opportunities for cybercriminals to exploit vulnerabilities; and
• disruption or constraints at manufacturers, which could result in product manufacturing delays.
It is highly uncertain and difficult to predict the full extent of the economic impact brought by and the duration of the SARS-CoV-2 virus pandemic. The pandemic could result in significant disruptions to the global financial markets, reducing the Company's ability to access capital, which could in the future negatively affect its liquidity. In addition, a recession or market correction resulting from the spread of the SARS-CoV-2 virus pandemic could materially affect the Company’s business and the value of the Company's common stock.
The global SARS-CoV-2 virus pandemic continues to rapidly evolve, and the Company will continue to monitor the SARS-CoV-2 virus pandemic situation closely. The ultimate impact of the SARS-CoV-2 virus pandemic or a similar health epidemic is highly uncertain and subject to change. The Company does not yet know the full extent of the potential impacts on its business, clinical trials, healthcare systems or the global economy as a whole.
The Company's success is highly dependent on its ability to attract and retain highly skilled executive officers and employees.
To succeed, the Company must recruit, retain, manage and motivate qualified executives as it builds out its management team, and the Company faces significant competition for experienced personnel. The Company is highly dependent on the principal members of its management and needs to continue to add executives with operational and commercialization experience and to build out a leadership team that can manage its operations as a public company. If the Company does not succeed in attracting and retaining qualified personnel, particularly at the management level, it could adversely affect its ability to execute the Company's business plan and harm its operating results. In particular, the loss of one or more of its executive officers could be detrimental if no suitable replacement is recruited in a timely manner. The competition for qualified personnel in the biotechnology field is intense, and as a result, the Company may be unable to continue to attract and retain qualified personnel necessary for the future success of its business, or may be required to expend significant financial resources in its employee recruitment and retention efforts.
Many of the other biotechnology companies that the Company competes against for qualified personnel have greater financial and other resources, different risk profiles and a longer history in the industry. They also may provide more diverse opportunities and better prospects for career advancement. Some of these characteristics may be more appealing to high-quality candidates than what the Company has to offer.
If the Company is unable to continue to attract and retain high-quality personnel, the rate and success at which it can discover, develop and commercialize its product candidates will be limited and the potential for successfully growing its business
will be harmed. In addition, the intense competition for such personnel may significantly increase the Company’s costs of doing business.
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.
The Company may engage in various acquisitions and strategic partnerships in the future, including licensing or acquiring products, intellectual property rights, technologies or businesses. Any acquisition or strategic partnership may entail numerous risks, including:
• increased operating expenses and cash requirements;
• the assumption of indebtedness or contingent liabilities;
• the issuance of equity securities which would result in dilution to the Company's stockholders;
• assimilation of operations, intellectual property, products and product candidates of an acquired company, including difficulties associated with integrating new personnel;
• the diversion of management’s attention from the Company's existing products, product candidates and initiatives in pursuing such an acquisition or strategic partnership;
• retention of key employees, the loss of key personnel, and uncertainties in its ability to maintain key business relationships;
• risks and uncertainties associated with the other party to such a transaction, including the prospects of that party and their existing products or product candidates and regulatory approvals; and
• the potential inability to generate revenue from acquired intellectual property, technology or products sufficient to meet its objectives or even to offset the associated transaction and maintenance costs.
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.
In the ordinary course of the Company’s business, the Company may collect, store, use, transmit, disclose, or otherwise process proprietary, confidential, and sensitive data, including personal data (such as health-related data), intellectual property, and trade secrets. The Company may rely upon third parties (such as service providers) for the Company’s data processing-related activities. The Company may share or receive sensitive data with or from third parties.
The Company faces a variety of evolving threats to its information technology systems and data which could cause security incidents. Cyberattacks, malicious internet-based activity, and online and offline fraud are prevalent and continue to increase. These threats are becoming increasingly difficult to detect. These threats come from a variety of sources. Traditional computer “hackers,” threat actors, company personnel (such as through theft or misuse), sophisticated nation-states, and nation-state-supported actors may engage in attacks. The evolving threats include but are not limited to social-engineering attacks (including through phishing attacks), malicious code (such as viruses and worms), malware (including as a result of advanced persistent threat intrusions), denial-of-service attacks (such as credential stuffing), personnel misconduct or error, ransomware attacks, supply-chain attacks, software bugs, server malfunctions, software or hardware failures, loss of data or other information technology assets, adware, telecommunications failures, earthquakes, fires, floods, and other similar threats. Ransomware attacks, including those perpetrated by organized criminal threat actors, nation-states, and nation-state-supported actors, are becoming increasingly prevalent and severe. Ransomware attacks can lead to significant interruptions in the Company’s operations, loss of data and income, reputational harm, and diversion of funds. Extortion payments may alleviate the negative impact of a ransomware attack, but the Company may be unwilling or unable to make such payments due to, for example, applicable laws or regulations prohibiting such payments. Similarly, supply-chain attacks have increased in frequency and severity, and the Company cannot guarantee that third parties and infrastructure in the Company’s supply chain have not been compromised or that they do not contain exploitable defects or bugs that could result in a breach of or disruption to the Company’s information technology systems (including the Company’s products/services) or the third-party information technology systems that support the Company and the Company’s services. The SARS-CoV-2 pandemic and the Company’s remote workforce poses increased risks to the Company’s information technology systems and data, as more of the Company’s personnel work from home, utilizing network connections outside the Company’s premises. Future business transactions (such as acquisitions or integrations) could expose the Company to additional cybersecurity risks and vulnerabilities, as the Company’s systems could be negatively affected by vulnerabilities present in acquired or integrated entities’ systems and technologies. Any of the previously identified or similar threats could cause a security incident. A security incident could result in unauthorized, unlawful, or accidental acquisition, modification, destruction, loss, alteration, encryption, disclosure of, or access to data. A security incident could disrupt the Company’s ability (and that of third parties upon whom the Company relies) to provide the Company’s products and services.
The Company may spend significant resources to endeavor to protect against, detect, and/or mitigate vulnerabilities. The Company may have to modify its business activities (including the Company’s commercial launch and clinical trial activities) in an effort to protect against security incidents. Certain data privacy and security obligations may also require the Company to implement and maintain specific security measures, industry-standard or reasonable security measures to protect the Company’s information technology systems and data.
While the Company has implemented security measures designed to protect against security incidents, there can be no assurance that these measures will be effective. The Company may be unable in the future to detect vulnerabilities in the Company’s information technology systems because such threats and techniques change frequently, are often sophisticated in nature, and may not be detected until after a security incident has occurred. Despite the Company’s efforts to identify and remediate vulnerabilities, if any, in the Company’s information technology systems, the Company’s efforts may not be successful. Further, the Company may experience delays in developing and deploying remedial measures designed to address any such identified vulnerabilities.
The Company’s contracts may not contain limitations of liability, and even where they do, there can be no assurance that limitations of liability in the Company’s contracts are sufficient to protect the Company from claims related to the Company’s data privacy and security obligations. The costs related to significant security breaches, disruptions or data breaches could be material and exceed the limits of any insurance coverage the Company may have. In addition, the Company cannot be sure that its existing insurance coverage will continue to be available on acceptable terms or that its insurers will not deny coverage as to any future claim. To the extent any disruption, data breach or security breach were to result in a loss of, or damage to, the Company’s data or systems, or inappropriate disclosure of confidential or proprietary information, including personal data, the Company could incur liability and the further development and commercialization of its products and product candidates could be delayed and its business and operations could be adversely affected and/or could result in the loss or disclosure of critical or sensitive data, which could result in financial, legal, business or reputational harm to the Company.
If the Company and/or third parties upon whom the Company relies experience or are perceived to have experienced (in the past or future) a security incident, the Company may experience adverse consequences. Applicable data privacy and security obligations may require the Company to notify relevant stakeholders of security incidents. Such disclosures are costly, and the disclosures or the failure to comply with such requirements could lead to adverse consequences. These consequences may include: government enforcement actions (for example, investigations, fines, penalties, audits, and inspections); additional reporting requirements and/or oversight; restrictions on processing data (including personal data); litigation (including class claims); indemnification obligations; negative publicity; reputational harm; monetary fund expenditures; interruptions in the Company’s operations (including availability of data); financial loss; and other similar harms. Security incidents and attendant consequences may cause customers to stop using the Company’s products, deter new customers from using the Company’s products, deter third parties from doing business with or otherwise engaging with the Company, deter clinical trial participants from participating in the Company’s clinical trials and negatively impact the Company’s reputation and ability to grow and operate the Company’s business.
The Company is subject to stringent and evolving obligations related to data privacy and security. The Company’s actual or perceived failure to comply with such obligations could lead to regulatory investigations or actions; litigation; fines and penalties; a disruption of the Company’s business operations; reputational harm; and other adverse business consequences .
The Company processes personal data and other sensitive information (including patient health data, and proprietary and confidential business data) including in connection with the Company’s clinical trials. The Company’s data processing activities subject it to numerous data privacy and security obligations, such as various laws, regulations, guidance, industry standards, external and internal privacy and security policies, contracts, and other obligations that govern the processing of personal data by the Company and by others on its behalf. Data protection has become a significant issue in the U.S., China, countries in the European Economic Area (EEA), and in many other countries in which the Company may operate.
In the U.S., federal, state and local governments have enacted numerous data privacy and security laws, including data breach notification laws, personal data privacy laws, and consumer protection laws. These privacy laws include, without limitation, the following laws and regulations: Section 5 of the Federal Trade Commission Act, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) (which imposes specific requirements relating to the privacy, security and transmission of individually identifiable health information) and the California Consumer Privacy Act of 2018 (CCPA) (which imposes specific requirements on covered businesses relating to personal data practices). If the Company is or were to become subject to these laws and/or new or amended data privacy laws, the risk of enforcement actions against the Company could increase because we may be subject to obligations under applicable regulatory frameworks and the number of individuals or entities that could initiate actions against the Company may increase (including individuals via a private right of action). These regulatory
frameworks may impact the Company’s ability to utilize individuals’ personal data, may impose significant penalties for the misuse of personal data and reflect the Company’s vulnerability to the evolving regulatory environment related to such data.
Internationally, any Company’s operations that we may engage in may become subject to increased scrutiny or attention from foreign data protection authorities. For example, any Company clinical trial programs and research collaborations that the Company may conduct outside the U.S. may implicate foreign data protection laws, including in China and Europe. Many jurisdictions have established, or are in the process of establishing, privacy and data security regulatory frameworks that may require compliance by the Company or third parties upon whom the Company relies. For example, European data protection laws, including, without limitation, the European Union’s General Data Protection Regulation (EU GDPR) and the United Kingdom’s equivalent (UK GDPR) impose stringent data protection requirements for processing personal data of individuals located, respectively in the EEA and United Kingdom (“UK”). Under the EU GDPR, government regulators may impose monetary fines for noncompliance of up to €20 million or four percent of a company’s worldwide annual revenues, whichever is greater, and authorizes government regulators to impose penalties for non-compliance (such as bans on personal data processing). Further, individuals may initiate litigation related to the Company’s processing of their personal data.
In addition, many jurisdictions, including China, have enacted data localization and cross-border personal data transfer laws. These laws may make it more difficult for the Company to transfer personal data across jurisdictions, which could impede the Company’s business. For example, European data protection laws, including the EU GDPR, generally restrict the transfer of personal data from Europe to the U.S. and most other countries unless the parties to the transfer have implemented specific safeguards designed to protect the relevant personal data. Uncertainties exist with respect to the legality under European law of such safeguards. As a result, there is a risk that any personal data transfers by the Company or parties upon the Company relies from Europe may not comply with European data protection laws. Any such noncompliance may increase the Company’s exposure to the EU GDPR’s heightened sanctions, restrict the Company’s ability to conduct clinical trials in Europe, require the Company to increase the Company’s personal data processing capabilities in Europe and limit the Company’s ability to collaborate with parties that are subject to European data protection laws. Further, the United Kingdom’s decision to leave the EU, often referred to as Brexit, created uncertainty regarding data protection regulation in the United Kingdom, leading to further uncertainty and risk of liability.
The Company’s obligations related to data privacy and security are evolving and may result in increasing regulatory and public scrutiny and escalating levels of enforcement and sanctions, including potentially substantial monetary penalties and personal data processing penalties that could require the Company to change its business practices. Interpretation of these frameworks is likely to remain uncertain and potentially inconsistent for the foreseeable future. This evolution may create uncertainty in the Company’s business and that of parties upon whom the Company relies. Furthermore, this evolution may impact the Company’s ability to operate in certain jurisdictions and its ability to collect, store, transfer, use, share or otherwise process personal data; necessitate the Company’s accepting more onerous obligations in its contracts; as well as result in liability or impose additional costs (including financial and time-related resources) on the Company. These obligations may necessitate changes to the Company’s information technology systems and practices and to those of any third parties that process personal data on the Company’s behalf. Despite the Company's efforts to bring its practices into compliance with these obligations, it may not be successful in its efforts to achieve compliance (for example, due to lack of clarity in the obligations or to internal or external factors such as resource allocation limitations or a lack of cooperation from third parties upon which the Company relies). Alleged noncompliance could result in proceedings (e.g., investigations, fines, penalties, audits, inspections and similar); litigation (including class-related claims); additional reporting and/or oversight; bans on personal data processing; and orders not to use personal data. Any of these events could have a material adverse effect on the Company’s reputation, business and financial condition, including but not limited to: loss of customers; interruptions or stoppages in the Company’s business operations (including the Company’s commercial launch and clinical trials); inability to process personal data or to operate in certain jurisdictions; limitations in the Company’s ability to develop or commercialize the Company’s products; expenditure of time and resources to defend any claim or inquiry; adverse publicity; and revision or restructuring of the Company’s operations.
Changes in U.S. tax law may materially adversely affect the Company's financial condition, results of operations and cash flows.
The tax regimes the Company is subject to or operates under, including income and non-income taxes, are unsettled and may be subject to significant change. Changes in tax laws, regulations, or rulings, or changes in interpretations of existing laws and regulations, could materially affect the Company’s financial position and results of operations. For example, the 2017 Tax Cuts and Jobs Act (Tax Act), together with the CARES Act that was enacted March 27, 2020, made broad and complex changes to the U.S. tax code, including changes to U.S. federal tax rates, additional limitations on the deductibility of interest, both positive and negative changes to the utilization of future net operating loss (NOL) carryforwards, allowing for the expensing of certain capital expenditures, and putting into effect the migration from a “worldwide” system of taxation to a territorial system.
Recently, in the U.S., Congress and the Biden administration proposed legislation (which has not yet been enacted) to make various tax law changes, including to increase U.S. taxation of international business operations and impose a global minimum tax. These proposals, recommendations and enactments include changes to the existing framework in respect of income taxes that could apply to the Company’s business.
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’s net operating loss carryforwards (NOLs) and certain other tax attributes could expire unused and be unavailable to offset future income tax liabilities because of their limited duration or because of restrictions under U.S. tax law. The Company’s NOLs generated in tax years ending on or prior to December 31, 2017, are only permitted to be carried forward for 20 taxable years under applicable U.S. federal tax law. As of December 31, 2021, the Company had a U.S. federal NOL balance of $202.9 million, $4.5 million of which will expire beginning in the year 2035 if unutilized, and $198.4 million of which will carry forward indefinitely. As of December 31, 2021, the Company had a state NOL balance of $209.9 million, which will expire beginning in the year 2035 if unutilized.
The deductibility of federal NOLs, particularly for tax years beginning after December 31, 2020, may be limited. It is uncertain if and to what extent various states will conform to the Tax Act or the CARES Act.
In addition, the Company’s NOLs and tax credit carryforwards are subject to review and possible adjustment by the IRS and state tax authorities. Under the Sections 382 and 383 of the Code, if a corporation undergoes an “ownership change” (generally defined as a cumulative change in the Company’s ownership by “5-percent stockholders” that exceeds 50 percentage points over a rolling three-year period), the corporation’s ability to use its pre-change NOLs and certain other pre-change tax attributes to offset its post-change income and taxes may be limited. Similar rules may apply under state tax laws. The Company determined that no significant limitation would be placed on the utilization of its net operating loss and tax credit carryforwards due to prior ownership changes. The Company may, however, experience ownership changes in the future as a result of equity offerings or subsequent shifts in its stock ownership, some of which are outside its control. If the Company’s ability to utilize those NOLs and tax credit carryforwards becomes limited by an “ownership change” as described above, it may not be able to utilize a significant portion of its NOLs and certain other tax attributes, which could have a material adverse effect on its cash flows and results of operations.
Risks Related to Commercialization of the Company’s Product Candidates
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.
The development and commercialization of pharmaceutical products is highly competitive. The Company faces competition with respect to TYRVAYA Nasal Spray for the treatment of dry eye disease and will face competition with respect to TYRVAYA Nasal Spray for other indications and with respect to any other product candidates that it may seek to develop or commercialize in the future, from major pharmaceutical companies, specialty pharmaceutical companies and biotechnology companies worldwide. Potential competitors also include academic institutions, government agencies and other public and private organizations that conduct research and development activities, seek patent protection and establish collaborative arrangements for the research, development, manufacturing and commercialization of pharmaceutical products.
The dry eye disease market is already served by a variety of competing products. Many of these existing products have achieved widespread acceptance among healthcare providers, patients and payors. If the Company’s competitors’ products are or are perceived as being more effective, safer or less expensive than TYRVAYA Nasal Spray or other product candidates the Company develops, then the Company’s commercial opportunities will be negatively impacted. If the Company is unable to demonstrate the value of TYRVAYA Nasal Spray based on its clinical data, patient experience, and real-world evidence, the successful commercialization of TYRVAYA Nasal Spray could be adversely affected.
The Company's commercial opportunity for TYRVAYA Nasal Spray or any other product candidates could also be reduced or eliminated if its competitors develop and commercialize new products that are safer, more effective, have fewer or less severe side effects, are more convenient or are less expensive than the Company's products. The competitors also may obtain FDA or other regulatory approval for their products more rapidly than the Company may obtain approval for its candidates, which
could result in competitors establishing a strong market position before the Company is able to enter the market for a new product candidate or a new indication for TYRVAYA Nasal Spray.
In addition, the Company's ability to compete may be affected in many cases by insurers or other third-party payors, particularly Medicare, seeking to encourage the use of generic products. For example, a generic version of Restasis ® to treat dry eye disease recently received FDA approval in February 2022. Generic products are generally offered at lower prices than branded products, and consequently, after the introduction of a generic competitor, a significant percentage of the sales of any branded product may be lost to the generic product. Accordingly, competition from generic products could have a material adverse impact on the Company’s ability to successfully commercialize TYRVAYA Nasal Spray or any other product candidate, if approved, or negatively impact sales or pricing of TYRVAYA Nasal Spray or the Company’s ability to gain market acceptance or market share. In addition, over the counter products are currently available for the treatment of dry eye disease which may impact sales of the Company's products.
Many of the companies against which the Company is competing or against which it may compete in the future have significantly greater financial resources and expertise in research and development, manufacturing, preclinical testing, conducting clinical trials, obtaining regulatory approvals and marketing approved products than the Company does. Mergers and acquisitions in the pharmaceutical and biotechnology industries may result in even more resources being concentrated among a smaller number of the Company's competitors. Smaller and other early-stage companies may also prove to be significant competitors, including through collaborative arrangements with large and established companies. These third parties compete with the Company in recruiting and retaining qualified scientific and management personnel, establishing clinical trial sites and patient registration for clinical trials, as well as in acquiring technologies complementary to, or necessary for, the Company's programs.
TYRVAYA Nasal Spray is subject to substantial, ongoing regulatory requirements that may impact its commercial potential.
The manufacturing processes, labeling, packaging, distribution, adverse event reporting, storage, advertising, promotion and recordkeeping of TYRVAYA Nasal Spray are subject to extensive and ongoing regulatory requirements. These requirements include restrictions on the promotion of the product, submissions of safety and other post-marketing information and reports, compliance with current Good Manufacturing Practices (cGMP), as well as Good Clinical Practice (GCP) for any clinical trials that the Company conducts post-approval, all of which may result in significant expense and limit the Company’s ability to successfully commercialize TYRVAYA Nasal Spray.
Discovery of any issues post-approval, including any safety concerns, such as unexpected side effects or drug-drug interaction problems, adverse events of unanticipated severity or frequency, or concerns over misuse or abuse of the product, problems with the facilities where the product is manufactured, packaged or distributed, or failure to comply with regulatory requirements, may result in, among other things, restrictions on TYRVAYA Nasal Spray or on the Company, including:
• withdrawal of approval, addition of warnings or narrowing of the approved indication in the product label;
• restrictions on the marketing or manufacturing of the product, withdrawal of the product from the market, or voluntary or mandatory product recalls;
• fines, warning letters or holds on clinical trials;
• refusal by the FDA to approve pending applications or supplements to approved applications filed by the Company, or suspension or revocation of product license approvals;
• product seizure or detention, or refusal to permit the import or export of products; and
• restrictions on operations, including restrictions on the marketing or manufacturing of the product or the imposition of costly new manufacturing requirements; or
• injunctions or the imposition of civil or criminal penalties.
If any of these actions were to occur, the Company may have to discontinue the commercialization of TYRVAYA Nasal Spray, limit its sales and marketing efforts, conduct post-approval studies, or discontinue or change any other ongoing or planned clinical studies, which in turn could result in significant expense and delay or limit the Company’s ability to generate sales revenues. In addition, regulatory requirements may also change from time to time, potentially harming or making costlier its commercialization efforts. The Company cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or other countries. If the Company is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if the Company is not able to maintain regulatory compliance, then it may lose the marketing approval that it has obtained and it may not achieve or sustain sales or profitability, which would adversely affect its business.
TYRVAYA Nasal Spray is based on an API that is already on the market, which exposes the Company to additional risks.
The API in TYRVAYA Nasal Spray has been previously approved by the FDA and the EMA as an oral tablet under the trade name Chantix ® , indicated as an aid to smoking cessation treatment, and is available in more than 80 countries throughout the world. From 2009 to 2016, the FDA required Chantix ® to carry a boxed warning advising consumers of potential serious mental health side effects from Chantix. Although the FDA removed this box warning from Chantix in 2016, regulatory authorities may add back the warning if future events warrant it. Regulatory authorities have in the past and may in the future also identify impurities in varenicline, the active ingredient in TYRVAYA Nasal Spray and Chantix, or identify other adverse side effects related to varenicline. Additionally, manufacturers have begun selling Chantix in generic form, which could lead to increased use of varenicline by patients and increase the possibility that patients experience adverse side effects related to varenicline. Any adverse side effects that arise from the use of any form of varenicline, whether Chantix, generic varenicline or TYRVAYA Nasal Spray, could prevent or inhibit the successful commercialization of TYRVAYA Nasal Spray and seriously harm the Company's business. Furthermore, if manufacturer demand for the varenicline active ingredient increases in the future, particularly as a result of the marketing of generic forms of varenicline, the Company may not be able to continue to obtain the active ingredient on commercially reasonable terms, which could harm Company's business.
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 Company’s strategy is to commercialize TYRVAYA Nasal Spray in the U.S. with a targeted sales and marketing organization. While the Company has established its commercial team and sales force, it does not have prior experience commercializing pharmaceutical products as an organization. In order to successfully market TYRVAYA Nasal Spray, the Company must continue to build and maintain its sales, marketing, managerial, compliance, and related capabilities or make arrangements with third parties to perform these services. These efforts will continue to be expensive and time-consuming, and the Company competes with other pharmaceutical and biotechnology companies to recruit, hire, train, and retain marketing and sales personnel. If the Company is unable to establish and maintain adequate sales, marketing, and distribution capabilities, whether independently or with third parties, it may not generate significant revenue from TYRVAYA Nasal Spray.
In particular, the Company is required to expend significant time and resources to train its sales force to be credible, persuasive, and compliant with applicable laws in marketing TYRVAYA Nasal Spray for its approved indication, and to equip them with compliant and effective materials, including medical and sales literature to help them appropriately inform and educate customers regarding the potential benefits and safety of TYRVAYA Nasal Spray and its proper administration. In addition, the ongoing pandemic caused by SARS-COV-2 may negatively impact the effectiveness of the Company’s sales and marketing efforts, which may not be as effective should access to providers be limited. If the Company is unable to maintain an effectively trained sales force, or if lockdowns or other current or future restrictions prevent the sales force from adequately doing their job, then the Company’s efforts to successfully commercialize TYRVAYA Nasal Spray could be jeopardized, which would negatively impact its ability to generate product revenues and profits.
Additionally, the Company’s strategy in the U.S. includes the use of a network of third parties to distribute and support patient’s use of TYRVAYA Nasal Spray. Further, for the year ended December 31, 2021, a significant percentage of the Company's sales of TYRVAYA Nasal Spray were to four large wholesale drug distributors, and the Company may continue to rely on a limited number of wholesale drug distributors for the distribution of TYRVAYA Nasal Spray. While the Company has and may in the future enter into agreements with such third parties to engage in such activities, the counterparties may not perform as agreed or may terminate their agreements with the Company. Loss of any such third-party through contract termination or its failure to perform its duties effectively would adversely affect product distribution and uptake by patients. While the Company has and expects to continue to enter into these agreements on commercially reasonable terms, there is no guarantee that it will be able to continue to do so, if at all, particularly given the commercial buying power of such third parties. If the Company is unable to maintain its business relationships with these third parties, including such wholesale drug distributors, on commercially acceptable terms, it could have a material adverse effect on the Company’s sales and may prevent it from achieving profitability.
The Company competes with many other companies that currently have extensive and well-funded marketing and sales operations. If the Company, alone or with commercialization partners, is unable to compete successfully against these established companies, the commercial success of TYRVAYA Nasal Spray and of any future products will be limited. In addition, if the Company is unable to effectively develop and maintain its commercial team, including its U.S. sales force, or to maintain and expand its customer base, the Company’s ability to effectively commercialize TYRVAYA Nasal Spray and any other products and generate product revenues and profits would be limited.
Customer buying patterns and other factors may cause the Company’s quarterly results to fluctuate, which may adversely affect the Company’s short-term results.
The Company’s product revenues and results of operations may vary from period to period due to a variety of factors, including the buying patterns of the Company’s direct purchasers, which patterns may vary from quarter to quarter and may be impacted by seasonality. If the Company’s customers limit their product purchases, the Company’s sales could be adversely affected. Further, any changes in purchasing patterns or inventory levels, product returns, delays in purchasing products, or delays in payment for products by the Company’s customers could also have a negative impact on its revenue and results of operations. In addition, the Company is unable to predict the long-term impact of the SARS-COV-2 virus and the pace of recovery and how this may impact purchases of TYRVAYA Nasal Spray by healthcare providers in the future, as individual providers and their patients may have different responses as the pandemic evolves.
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.
The manufacture of pharmaceutical products relies on technically complex processes and, in some cases, highly specialized raw materials, and is highly regulated. Deviations, difficulties or delays in production, or failure to obtain specialized raw materials, could result in shut-downs, work stoppages, approval delays, voluntary market withdrawals, product recalls, penalties, supply disruptions or shortages, increased costs, product liability or reputational harm. In addition, all manufacturing processes must comply with current Good Manufacturing Practices (cGMP) and other applicable regulations. Failure to comply with cGMP requirements could result in possible legal or regulatory actions, such as warning letters, suspension of manufacturing, seizure of products, injunctions, voluntary recall of products, failure to secure product approvals, or debarment. Any of these events could have a material adverse effect on our business, financial condition and results of operations.
In addition, the Company relies, and expects to continue to rely, on third-party manufacturers for the commercial supply of TYRVAYA Nasal Spray, and for the supply of its product candidates for use in clinical trials. As a result, the Company does not have complete control over all aspects of the manufacturing process. This reliance on third-party manufacturers entails additional risks, including:
• the potential failure of the third-party to manufacture TYRVAYA Nasal Spray or other product candidates according to the Company’s schedule, or at all, including the potential that the third-party contractors might give greater priority to the supply of other products over the Company’s products, or otherwise might not satisfactorily perform according to the terms of the agreements between the Company and the third-party;
• the Company’s potential inability to establish or maintain necessary agreements with the third-party manufacturers or to do so on acceptable terms.
• the potential termination or nonrenewal of arrangements or agreements by the Company's third-party contractors at a time that is costly or inconvenient for the Company;
• the potential breach by the third-party manufacturers of the Company's agreements with them;
• the potential failure of the third-party manufacturers to comply with applicable regulatory requirements, including cGMPs;
• the potential failure of the third-party to manufacture TYRVAYA Nasal Spray or other product candidates according to the Company’s specifications;
• the potential mislabeling of TYRVAYA Nasal Spray or clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified;
• the potential failure of the third-party manufacturer to distribute TYRVAYA Nasal Spray to commercial vendors in a timely manner, resulting in lost sales;
• the potential failure of the third-party manufacturer to deliver clinical supplies to clinical sites on time, leading to clinical trial interruptions; and
• the potential misappropriation of the Company's proprietary information, including its trade secrets and know-how.
In addition, if the third-party manufacturers cannot successfully conform with the strict regulatory requirements of the FDA and other regulatory authorities, then they will not be able to secure or maintain marketing approval for their manufacturing facilities. If the regulatory authorities do not approve these facilities for the manufacture of pharmaceutical products or if they withdraw any such approval in the future, then the Company may need to find alternative manufacturing facilities, which would significantly impact its ability to market TYRVAYA Nasal Spray and to develop, obtain marketing approval for and market other product candidates, if approved. The Company's failure, or the failure of its third-party manufacturers, to comply with applicable regulations could also result in sanctions being imposed on the Company, including fines, injunctions, civil penalties, delays,
suspension or withdrawal of approvals, license revocation, seizures or recalls of TYRVAYA Nasal Spray or other product candidates, operating restrictions and criminal prosecutions, any of which could significantly and adversely affect supplies of TYRVAYA Nasal Spray or other product candidates and harm the Company’s business and results of operations.
The Company currently relies on single source manufacturers and suppliers for TYRVAYA Nasal Spray. This adds to the manufacturing risks faced by the Company, which is left without backup facilities in the event of any failure by a supplier. In addition, if the Company decides to move to different or add additional manufacturers and suppliers in the future, any such transition or addition would require significant efforts in testing and validating the manufacturing and formulation process and could result in delays or other issues, which could have an adverse effect on the supply of TYRVAYA Nasal Spray or other product candidates.
The Company's current and anticipated future dependence upon others for the manufacture of its product candidates may adversely affect its future profit margins and its ability to commercialize TYRVAYA Nasal Spray or any product candidates that receive marketing approval on a timely and competitive basis.
In addition, to date, the Company's third-party manufacturer has a limited history of manufacturing TYRVAYA Nasal Spray on a commercial scale, and has until recently only manufactured TYRVAYA Nasal Spray in limited quantities in batch sizes appropriate for the Company's clinical trials and registration batches to support the NDA submission for TYRVAYA Nasal Spray. There are risks associated with scaling up manufacturing to commercial volumes including, among others, cost overruns, technical or other problems with process scale-up, process reproducibility, stability issues, lot consistency and timely availability of raw materials. There is no assurance that the Company's manufacturer will be successful in maintaining a larger-scale commercial manufacturing process for TYRVAYA Nasal Spray that achieves its objectives for manufacturing capacity and cost of goods, in a timely manner or at all. In addition, there is no assurance that the Company’s manufacturers will be able to manufacture TYRVAYA Nasal Spray to specifications acceptable to the FDA or other regulatory authorities, to produce it in sufficient quantities to meet potential future demand. If the manufacturers are unable to produce sufficient quantities of TYRVAYA Nasal Spray, either on a timely basis or at all, and in a cost-effective manner, the Company's commercialization efforts would be impaired, which could materially affect the Company's business, financial condition, results of operations and growth prospects.
The commercial success of TYRVAYA Nasal Spray and the Company’s other product candidates, once approved, depends on the availability and sufficiency of third-party payor coverage and reimbursement.
Patients in the U.S. and elsewhere generally rely on third-party payors to reimburse part or all of the costs associated with their prescription drugs. Accordingly, market acceptance of TYRVAYA Nasal Spray and the Company’s other product candidates, once approved, is dependent on the extent to which third-party coverage and reimbursement is available from third-party payors, including government health administration authorities (including in connection with government healthcare programs, such as Medicare and Medicaid), private healthcare insurers and other healthcare funding organizations.
The Company is currently in discussions with such third-party payors with respect to coverage and reimbursement for TYRVAYA Nasal Spray. As of the date of this Annual Report on Form 10-K, significant uncertainty exists as to the overall coverage and reimbursement status of TYRVAYA Nasal Spray. Coverage decisions may not favor new products when more established or lower cost therapeutic alternatives are already available. Even if the Company obtains coverage for a given product such as TYRVAYA Nasal Spray, the associated reimbursement rate may not be adequate to cover the Company’s costs, including research, development, intellectual property, manufacture, sale and distribution expenses, or may require copayments that patients find unacceptably high. Patients are unlikely to use the Company's products unless reimbursement is adequate to cover all or a significant portion of the cost of its products.
Coverage and reimbursement policies for products can differ significantly from payor to payor, as there is no uniform policy of coverage and reimbursement for products among third-party payors in the U.S. There also may be significant delays in obtaining coverage and reimbursement, as the process of determining coverage and reimbursement is often time consuming and costly and can require the Company to provide scientific and clinical support for the use of its products to each payor separately, with no assurance that coverage or adequate reimbursement will be obtained.
In addition, the Company expects that the market power of third-party payors, and the increased emphasis by such third-party payors and government authorities in the U.S. on managed care and cost containment measures will continue and will place pressure on pharmaceutical pricing and coverage. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for TYRVAYA Nasal Spray or other products for which the
Company receives regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.
If the Company is unable to obtain and maintain sufficient third-party coverage and adequate reimbursement for TYRVAYA Nasal Spray and its products that receive regulatory approval, the commercial success of TYRVAYA Nasal Spray or other products may be greatly hindered and the Company's financial condition and results of operations may be materially and adversely affected.
If product liability lawsuits are brought against the Company, it may incur substantial liabilities and may be required to limit commercialization of its products.
The Company's business exposes it to significant product liability risks inherent in the development, testing, manufacturing and marketing of therapeutic treatments. Regardless of their merits or eventual outcome, such liability claims may also result in injury to the Company's reputation, withdrawal of clinical trial participants, costs to defend the related litigation, a diversion of management’s time and its resources, initiation of investigations by regulators, substantial monetary awards to patients or other claimants, the inability to commercialize TYRVAYA Nasal Spray or any other product candidates and decreased demand for TYRVAYA Nasal Spray or any other product candidates, if approved for commercial sale. Product liability claims could also delay or prevent completion of the Company's development programs.
In addition, for pharmaceutical products such as TYRVAYA Nasal Spray that are approved for marketing, such claims could also result in an FDA, EMA or other regulatory authority investigation of the safety and effectiveness of such products, the Company's manufacturing processes and facilities or its marketing programs. These investigations could potentially lead to a recall of the product or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals.
The Company currently has product liability insurance that it believes is appropriate for its product portfolio. However, such insurance may not provide sufficient coverage against potential liabilities and, if judgments exceed the Company's insurance coverage, could adversely affect its results of operations and business and cause the stock price to decline. Furthermore, clinical trial and product liability insurance is becoming increasingly expensive. As a result, the Company may in the future be unable to maintain or obtain insurance coverage at a reasonable cost or in sufficient amounts to protect it against losses, including those caused by product liability claims.
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 Company plans to seek regulatory approval of TYRVAYA Nasal Spray or any other product candidates outside of the U.S. and, accordingly, it expects that it will be subject to additional risks related to operating in foreign countries if it obtains the necessary approvals, including:
• differing regulatory requirements regimes in foreign countries;
• unexpected changes in tariffs, trade barriers, price and exchange controls and other regulatory requirements;
• economic weakness, including inflation, or political instability in particular foreign economies and markets;
• compliance with tax, employment, immigration and labor laws for employees living or traveling abroad;
• foreign taxes;
• foreign currency fluctuations, which could result in increased operating expenses and reduced revenue, and other obligations incident to doing business in another country;
• difficulties staffing and managing foreign operations;
• differing payor reimbursement regimes, governmental payors or patient self-pay systems and price controls;
• workforce uncertainty in countries where labor unrest is more common than in the U.S.;
• potential liability under the U.S. Foreign Corrupt Practices Act (FCPA) or comparable foreign regulations;
• challenges enforcing the Company's contractual and intellectual property rights, especially in those foreign countries that do not respect and protect intellectual property rights to the same extent as the U.S.;
• production shortages resulting from any events affecting finished product or raw material supply, or manufacturing capabilities abroad; and
• business interruptions resulting from geo-political actions, including war and terrorism.
These and other risks associated with international operations may materially adversely affect the Company's ability to attain or maintain profitable operations.
Pursuant to the formal withdrawal arrangements agreed between the United Kingdom and the European Union, the United Kingdom withdrew from the European Union, commonly referred to as “Brexit”, effective December 31, 2020. On December 24, 2020, the United Kingdom and European Union entered into a Trade and Cooperation Agreement. The agreement sets out certain procedures for approval and recognition of medical products in each jurisdiction. Any delay in obtaining, or an inability to obtain, any marketing approvals, as a result of the Trade and Cooperation Agreement or otherwise, could prevent the Company from commercializing any product candidates in the United Kingdom and/or the European Union and restrict the Company’s ability to generate revenue and achieve and sustain profitability. If any of these outcomes occur, the Company may be forced to restrict or delay efforts to seek regulatory approval in the United Kingdom and/or European Union for any product candidates, which could significantly and materially harm its 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.
On August 5, 2021, the Company entered into a license and collaboration agreement (the License Agreement) with Ji Xing Pharmaceuticals Limited, a biotechnology company headquartered in Shanghai, China (Ji Xing). Pursuant to the License Agreement, the Company has granted Ji Xing an exclusive license to develop and commercialize OC-01 (varenicline solution) and OC-02 (simpinicline), for all prophylactic uses for, and treatment of, ophthalmology diseases or disorders in the greater China region, including mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan. The pharmaceutical industry in China is subject to comprehensive government regulation and supervision, encompassing the approval, registration, manufacturing, packaging, licensing and marketing of new medicines. In recent years, the regulatory framework in China for pharmaceutical companies has undergone significant changes, which the Company expects will continue. Any such change may cause delays in or prevent the successful research, development, manufacturing or commercialization of OC-01 and OC-02 in the greater China region and may reduce the current benefits the Company believes are available to it from licensing such products to be developed, manufactured and sold in the greater China region. In addition, any failure by the Company or its partners to maintain compliance with applicable laws and regulations or obtain and maintain required licenses and permits may result in the suspension or termination of its business activities in China or create other legal risks.
Risks Related to Development of the Company’s Product Candidates
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.
In 2021, the Company successfully obtained FDA approval of TYRVAYA Nasal Spray for treatment of the signs and symptoms of dry eye disease. The Company is also conducting clinical trials of TYRVAYA Nasal Spray for the potential treatment of Neurotrophic Keratopathy (NK), and the Company has other product candidates in preclinical development. The research and development of biopharmaceutical products is inherently risky. The Company cannot give any assurance that any of its product candidates will receive marketing approval, which is necessary before they can be commercialized. Before obtaining regulatory approvals for the commercial sale of any of the Company's product candidates, the Company must demonstrate through lengthy, complex and expensive preclinical studies and clinical trials that its product candidates are both safe and effective for use in each target indication. Product candidates in later stages of clinical trials may fail to be proven safe and effective despite having successfully progressed through preclinical studies and initial clinical trials.
Clinical testing is expensive and can take many years to complete, and its outcome is inherently uncertain. Failure can occur at any time during the clinical trial process. The results of preclinical studies of the Company's product candidates may not be predictive of the results of early-stage clinical trials, and the results of early-stage clinical trials may not be predictive of the results of later-stage clinical trials. The results of clinical trials in one set of subjects may not be predictive of those obtained in another. In some instances, there can be significant variability in safety or efficacy results between different clinical trials of the same product candidate due to numerous factors, including changes in trial procedures set forth in protocols, differences in the size and type of the patient populations, changes in and adherence to the dosing regimen or other clinical trial protocol requirements and the rate of dropout among clinical trial participants.
The Company may also experience issues in implementing its clinical trials that could delay or prevent it from satisfying the applicable requirements of the FDA and other regulatory authorities, including:
• the number of participants required for clinical trials of its product candidates may be larger than it anticipates, enrollment in these clinical trials may be slower than the Company anticipates or participants may drop out of these clinical trials at a higher rate than the Company anticipates;
• the Company's third-party contractors may fail to comply with regulatory requirements or to meet their obligations to the Company in a timely manner, or at all;
• regulators or institutional review boards may not authorize the Company to commence a clinical trial or may require a clinical trial to be ended before it is completed; and
• the Company may experience delays in reaching, or may fail to reach, agreement on acceptable clinical trial contracts or clinical trial protocols with prospective trial sites.
The Company may be unable to design and execute clinical trials that support marketing approval. It cannot be certain that any of its future clinical trials will be successful. For example, use of OC-01 (varenicline) nasal spray requires the patient to follow a prescribed technique to administer the nasal spray. Failure to properly administer the nasal spray by the patient or inappropriate technique demonstration by the investigators, may adversely affect the outcome of OC-01 (varenicline) nasal spray in demonstrating efficacy in future clinical trials, such as the OLYMPIA trial in NK. Additionally, any safety concerns observed with OC-01 could limit the prospects for regulatory approval of the product in NK and potentially other indications, which could materially affect the Company's business, financial condition, results of operations and growth prospects.
In addition, even if such clinical trials are successfully completed, the Company cannot guarantee that the FDA or foreign regulatory authorities will interpret the results as the Company does, and more trials could be required before it submits its product candidates for approval. To the extent that the results of the trials are not satisfactory to the FDA or foreign regulatory authorities for support of a marketing application, the Company may be required to expend significant resources, which may not be available to it, to conduct additional trials in support of potential approval of its product candidates. Even if regulatory approval is secured for any of the Company's product candidates, the terms of such approval may limit the scope and use of its product candidate, which may also limit its commercial potential.
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 may not be able to initiate or continue clinical trials for its product candidates if it is unable to locate and enroll a sufficient number of subjects to participate in these trials to such trial’s conclusion as required by the FDA or foreign regulatory authorities. Patient enrollment is a significant factor in the timing of clinical trials. Any difficulties the Company experiences relating to the initiation or completion of patient visits in clinical trials, including as a result of the SARS-CoV-2 virus , could delay regulatory approval for its product candidates. Patient enrollment for any of the Company’s future clinical trials may be affected by other factors, including:
• size and nature of the patient population;
• severity of the disease under investigation;
• availability and efficacy of approved drugs for the disease under investigation;
• participant eligibility criteria for the trial in question as defined in the protocol;
• investigators’ and participants' perceived risks and benefits of the product candidate in relation to other available therapies;
• availability of clinical trials for other product candidates targeting the same patients;
• efforts to facilitate timely enrollment in clinical trials;
• participant referral practices of investigators;
• the ability to monitor participants adequately during and after treatment;
• proximity and availability of clinical trial sites for prospective trial subjects;
• the risk that subjects enrolled in clinical trials will drop out of the trials before completion; and
• disruptions or difficulties, or other restrictions, in initiating, enrolling, conducting or completing trials due to the SARS-CoV-2 virus outbreak .
The Company’s inability to enroll a sufficient number of subjects for its clinical trials could result in significant delays or may require it to abandon one or more clinical trials altogether. Enrollment delays in the Company’s clinical trials may result in increased development costs for its product candidates and could jeopardize its ability to obtain marketing approval for the sale of its product candidates. Furthermore, even if the Company is able to enroll a sufficient number of subjects for its clinical trials, the Company may have difficulty maintaining enrollment of such subjects in its clinical trials.
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.
Adverse events or other undesirable side effects caused by or associated with treatment by the Company's product candidates could cause it or regulatory authorities to interrupt, delay or halt clinical trials and could result in a more restrictive label or the delay or denial of regulatory approval by the FDA or foreign regulatory authorities.
During the conduct of clinical trials, subjects report changes in their health, including illnesses, injuries, and discomforts, to their study doctor. Often, it is not possible to determine whether or not the product candidate being studied caused these conditions. It is possible that as the Company tests its product candidates in larger, longer and more extensive clinical trials, or as use of these product candidates becomes more widespread if they receive regulatory approval, illnesses, injuries, discomforts and other adverse events that were not observed in earlier trials, as well as conditions that did not occur or went undetected in previous trials, will be reported by subjects. Many times, side effects are only detectable after investigational products are tested in large-scale, Phase 3 clinical trials or, in some cases, after they are made available to subjects on a commercial scale after approval.
With respect to TYRVAYA Nasal Spray, if, in the course of the clinical trials for NK or any other potential indications, the Company or others identify undesirable side effects or adverse events caused by TYRVAYA Nasal Spray that were not previously detected, a number of potentially significant negative consequences could result, including but not limited to:
• regulatory authorities may withdraw approvals of TYRVAYA Nasal Spray or require additional warnings on the label;
• the Company may be required to change the way the product is administered or to conduct additional clinical trials or post-approval studies;
• the Company may be required to create a Risk Evaluation and Mitigation Strategy (REMS) plan, which could include a medication guide outlining the risks of such side effects for distribution to patients, a communication plan for healthcare providers, and/or other elements to assure safe use;
• the Company could be sued and held liable for harm caused to patients; and
• the Company’s reputation may suffer.
Any of these events could prevent the Company from achieving or maintaining market acceptance of TYRVAYA Nasal Spray or any product candidate, if approved, and could materially affect its business, financial condition, results of operations, and growth prospects.
Interim, topline and preliminary data from the Company's clinical trials may change as more patient data become available and are subject to audit and verification procedures that could result in material changes in the final data.
From time to time, the Company may publicly disclose preliminary, interim or topline data from its clinical trials. These interim updates are based on a preliminary analysis of then-available data, and the results and related findings and conclusions may be subject to change following a more comprehensive review of the data. The Company also may use assumptions and estimates as part of its preliminary analyses of the data, and it may not have received or had the opportunity to fully and carefully evaluate all data. Topline data also remain subject to audit and verification procedures before they can be finalized. In addition, the information the Company chooses to publicly disclose regarding a particular study or clinical trial is typically selected from a more extensive amount of available information. For example, the Company may report interim analyses of only certain of the endpoints of the clinical trial, rather than all of the endpoints. Additional disclosure of interim data by the Company or by its competitors in the future could result in volatility in the price of the Company’s common stock. Further, investors may not agree with what the Company determines is the material or otherwise appropriate information to include in its public disclosures, and any information the Company determines not to disclose may ultimately be deemed significant by the Company or, if subsequently disclosed, by investors, with respect to future decisions, conclusions, views, activities or otherwise regarding a particular product candidate or the Company's business. Further, others, including regulatory agencies and investors may not accept the Company’s conclusions regarding such preliminary or interim analyses, which could impact the value of a particular program or the approvability or commercialization of the particular product candidate, or result in volatility in the price of the Company's common stock.
In sum, the topline results that the Company reports may differ significantly from the final results of the same studies, or different conclusions or considerations may qualify such results, once additional data have been received and fully evaluated. As a result, topline and interim data from clinical trials are subject to the risk that one or more of the reported clinical outcomes may materially change, and should be viewed with caution until the final data are available. If the preliminary or topline data that the Company reports differ from the final results, or if others, including regulatory authorities, disagree with the Company’s conclusions, then the Company’s ability to obtain approval for, and to successfully commercialize the Company product candidates may be harmed, which could materially affect its business, financial condition, results of operations and growth prospects.
Risks Related to Intellectual Property
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.
The Company relies upon a combination of patents, trademarks, trade secret protection, and confidentiality agreements to protect the intellectual property related to its development programs and product candidates. The Company's success depends in part on its ability to obtain and maintain patent protection in the U.S. and other countries with respect to TYRVAYA Nasal Spray and other product candidates. The Company seeks to protect its proprietary position by filing patent applications in the U.S. and abroad related to its development programs and product candidates. The patent prosecution process is expensive and time-consuming, and the Company may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner.
The patents and patent applications that the Company owns may fail to result in issued patents with claims that protect TYRVAYA Nasal Spray or other product candidates in the U.S. or in other foreign countries. There is no assurance that all of the potentially relevant prior art relating to the Company's patents and patent applications has been found, which can prevent a patent from issuing from a pending patent application, or be used to invalidate a patent. Even if patents do successfully issue and even if such patents cover TYRVAYA Nasal Spray or other product candidates, third parties may challenge their validity, enforceability or scope, which may result in such patents being narrowed, invalidated or held unenforceable. Any successful opposition to these patents or any other patents owned by or licensed to the Company could deprive it of rights necessary for the successful commercialization of any product candidates that it may develop. Further, if the Company encounters delays in regulatory approvals, the period of time during which it could market a product candidate under patent protection could be reduced.
The patent application process is subject to numerous risks and uncertainties, and there can be no assurance that the Company or any of its potential future collaborators will be successful in protecting its product candidates by obtaining and defending patents. These risks and uncertainties include the following:
• the U.S. Patent and Trademark office, or USPTO and various foreign governmental patent agencies require compliance with a number of procedural, documentary, fee payment and other provisions during the patent process, the noncompliance with which can result in abandonment or lapse of a patent or patent application, and partial or complete loss of patent rights in the relevant jurisdiction;
• patent applications may not result in any patents being issued;
• patents may be challenged, invalidated, modified, revoked, circumvented, found to be unenforceable or otherwise may not provide any competitive advantage;
• the Company's competitors, many of whom have substantially greater resources than the Company does and many of whom have made significant investments in competing technologies, may seek or may have already obtained patents that will limit, interfere with or block the Company's ability to make, use and sell its products and product candidates;
• there may be significant pressure on the U.S. government and international governmental bodies to limit the scope of patent protection both inside and outside the U.S. for disease treatments that prove successful, as a matter of public policy regarding worldwide health concerns; and
• countries other than the U.S. may have patent laws less favorable to patentees than those upheld by U.S. courts, allowing foreign competitors a better opportunity to create, develop and market competing products.
The patent prosecution process is also expensive and time consuming, and the Company may not be able to file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner or in all jurisdictions where protection may be commercially advantageous. It is also possible that the Company will fail to identify patentable aspects of its research and development output before it is too late to obtain patent protection. Moreover, if the Company chooses to license certain patent rights in the future from third parties, it may not have the right to control the preparation, filing and prosecution of such patent applications, or to maintain the patents, directed to technology that it licenses from those third parties. The Company may also require the cooperation of its future licensor, if any, in order to enforce the licensed patent rights, and such cooperation may not be provided. Therefore, any licensed patents and applications may not be prosecuted and enforced in a manner consistent with the best interests of the Company's business. The Company cannot be certain that patent prosecution and maintenance activities by any of its future licensors have been or will be conducted in compliance with applicable laws and regulations, which may affect the validity and enforceability of such patents or any patents that may issue from such applications. If they fail to do so, this could cause the Company to lose rights in any applicable intellectual property that it in-licenses, and as a result its ability to develop and commercialize products or product candidates may be adversely affected and it may be unable to prevent competitors from making, using and selling competing products.
If the patent applications the Company holds or may in-license in the future with respect to its development programs and product candidates fail to issue, if their breadth or strength of protection is threatened, or if they fail to provide meaningful exclusivity for TYRVAYA Nasal Spray or other product candidates, it could dissuade other companies from collaborating with the Company to develop product candidates, and threaten its ability to commercialize TYRVAYA Nasal Spray or other product candidates, if approved. Any such outcome could have a materially adverse effect on the Company's business.
The patent position of biotechnology and pharmaceutical companies generally is highly uncertain, involves complex legal and factual questions, and has been and will continue to be the subject of litigation and new legislation. In addition, the laws of foreign countries may not protect the Company's rights to the same extent as the laws of the U.S. For example, many countries restrict the patentability of methods of treatment of the human body. Publications in scientific literature often lag behind the actual discoveries, and patent applications in the U.S. and other jurisdictions are typically not published until 18 months after filing, or in some cases not at all. Therefore, there is a risk that the Company cannot know with certainty whether it was the first to make the inventions claimed in its own patents or pending patent applications, or that it was the first to file for patent protection of such inventions. As a result of these and other factors, the issuance, scope, validity, enforceability, and commercial value of the Company patent rights are highly uncertain. The Company's pending and future patent applications may not result in patents being issued which protect its technology or products, in whole or in part, or which effectively prevent others from commercializing competitive technologies and products. Changes in either the patent laws or interpretation of the patent laws in the U.S. and other countries may diminish the value of the Company patents or narrow the scope of its patent protection.
Moreover, the Company may be subject to a third-party pre-issuance submission of prior art to the USPTO or become involved in opposition, derivation, reexamination, inter partes review, post-grant review or interference proceedings challenging its patent rights or the patent rights of others. In particular, the costs of defending patents or enforcing its proprietary rights in post-issuance administrative proceedings and litigation can be substantial and the outcome can be uncertain. An adverse determination in any such submission, proceeding or litigation could reduce the scope of, or invalidate, the Company's patent rights, allow third parties to commercialize its technology or products and compete directly with the Company, without payment to it, or result in its inability to manufacture or commercialize products without infringing third-party patent rights. In addition, if the breadth or strength of protection provided by the Company's patents and patent applications is threatened, it could dissuade companies from collaborating to license, develop or commercialize current or future product candidates.
The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and patents in which the Company has an interest may be challenged in the courts or patent offices in the U.S. and abroad. Such challenges may result in loss of exclusivity or in patent claims being narrowed, invalidated or held unenforceable, in whole or in part, which could limit the Company ability to stop others from using or commercializing similar or identical technology and products, or limit the duration of the patent protection of its technology and products. Generally, issued patents are granted a term of 20 years from the earliest claimed non-provisional filing date. In certain instances, patent terms can be adjusted to recapture a portion of delay incurred by the USPTO in examining the patent application (patent term adjustment). The scope of patent protection may also be limited.
In particular, the Company’s European patent related to OC-01 (varenicline) has been opposed. There is a risk that the European patent will be invalidated, or will have its claims amended, through the opposition process. Invalidation or amendment of this patent could have a material impact on the Company’s ability to commercialize OC-01 in Europe and could permit the sale of competing products by third parties in Europe. There is a risk that the Company may face additional oppositions in Europe as additional patents grant.
Further, the Company or its current or future licensors, if any, may fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection on them. Therefore, it may miss potential opportunities to strengthen its patent position. It is possible that defects of form in the preparation or filing of the Company's patents or patent applications may exist, or may arise in the future, for example with respect to proper priority claims, inventorship, claim scope, or requests for patent term adjustments. If the Company or its current or future licensors fail to establish, maintain or protect such patents and other intellectual property rights, such rights may be reduced or eliminated. If there are material defects in the form, preparation, prosecution, or enforcement of the Company's patents or patent applications, such patents may be invalid and/or unenforceable, and such applications may never result in valid, enforceable patents. Any of these outcomes could impair the Company's ability to prevent competition from third parties, which may have an adverse impact on its business.
Without patent protection for the Company's current or future product candidates, it may be open to competition from generic versions of such products. Given the amount of time required for the development, testing, and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after such candidates are commercialized.
As a result, the Company's patent portfolio may not provide it with sufficient rights to exclude others from commercializing products similar or identical to its own.
Depending upon the timing, duration and specifics of FDA marketing approval of future product candidates, one or more of the Company's U.S. patents may be eligible for limited patent term restoration under the Drug Price Competition and Patent Term Restoration Act of 1984, referred to as the Hatch-Waxman Amendments. The Hatch-Waxman Amendments permit a patent restoration term of up to five years beyond the normal expiration of the patent as compensation for patent term lost during drug development and the FDA regulatory review process, which is limited to the approved indication (or any additional indications approved during the period of extension). This extension is based on the first approved use of a product and is limited to only one patent that covers the approved product, the approved use of the product, or a method of manufacturing the product. However, the applicable authorities, including the FDA and the USPTO in the U.S., and any equivalent regulatory authority in other countries, may not agree with the Company assessment of whether such extensions are available, and may refuse to grant extensions to its patents, or may grant more limited extensions than the Company requests. The Company may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to expiration of relevant patents or otherwise failing to satisfy applicable requirements. Moreover, the applicable time-period or the scope of patent protection afforded could be less than the Company requests. If it is unable to extend the expiration date of its existing patents or obtain new patents with longer expiry dates, the Company's competitors may be able to take advantage of its investment in development and clinical trials by referencing its clinical and preclinical data to obtain approval of competing products following its patent expiration and launch their product earlier than might otherwise be the case.
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.
Periodic maintenance fees on any issued patent are due to be paid to the USPTO and other foreign patent agencies in several stages over the lifetime of the patent. The USPTO and various foreign national or international patent agencies require compliance with a number of procedural, documentary, fee payment, and other similar provisions during the patent application process. While an inadvertent lapse can in many cases be cured by payment of a late fee or by other means in accordance with the applicable rules, there are situations in which noncompliance can result in abandonment or lapse of the patent or patent application, resulting in partial or complete loss of patent rights in the relevant jurisdiction. Noncompliance events that could result in abandonment or lapse of patent rights include, but are not limited to, failure to timely file national and regional stage patent applications based on the Company's international patent application, failure to respond to official actions within prescribed time limits, non-payment of fees, and failure to properly legalize and submit formal documents. If the Company or any of its licensors fail to maintain the patents and patent applications covering TYRVAYA Nasal Spray, or other product candidates, the Company's competitors may be able to enter the market, which would have an adverse effect on its business.
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.
The Company cannot guarantee that any of its patent searches or analyses, including the identification of relevant patents, the scope of patent claims or the expiration of relevant patents, are complete or thorough, nor can it be certain that it has identified each and every third-party patent and pending application in the U.S. and abroad that is relevant to or necessary for the commercialization of TYRVAYA Nasal Spray or other current and future product candidates in any jurisdiction. The scope of a patent claim is determined by an interpretation of the law, the written disclosure in a patent and the patent’s prosecution history. The Company's interpretation of the relevance or the scope of a patent or a pending application may be incorrect, which may negatively impact its ability to market TYRVAYA Nasal Spray or other product candidates, if approved. The Company may incorrectly determine that its products are not covered by a third-party patent or may incorrectly predict whether a third-party’s pending application will issue with claims of relevant scope. The Company's determination of the expiration date of any patent in the U.S. or abroad that it considers relevant may be incorrect, and its failure to identify and correctly interpret relevant patents may negatively impact its ability to develop and market its products.
Third party claims or litigation alleging infringement of patents or other proprietary rights, or seeking to invalidate the Company's patents or other proprietary rights, may delay or prevent the development and commercialization of OC-01 (varenicline) nasal spray and any other product candidates.
The commercial success depends in part on the Company avoiding infringement and other violations of the patents and proprietary rights of third parties. There is a substantial amount of litigation, both within and outside the U.S., involving patent and other intellectual property rights in the biotechnology and pharmaceutical industries, including patent infringement lawsuits,
interferences, derivation, and administrative law proceedings, inter partes review, and post-grant review before the USPTO, as well as oppositions and similar processes in foreign jurisdictions. Numerous U.S. and foreign issued patents and pending patent applications, which are owned by third parties, exist in the fields in which the Company and its collaborators are developing product candidates. As the biotechnology and pharmaceutical industries expand and more patents are issued, and as the Company gains greater visibility and market exposure as a public company, the risk increases that the Company product candidates or other business activities may be subject to claims of infringement of the patent and other proprietary rights of third parties. Third parties may assert that the Company is infringing their patents or employing their proprietary technology without authorization.
Also, there may be third-party patents or patent applications with claims to materials, formulations, methods of manufacture or methods for treatment related to the use or manufacture of the Company's current and future product candidates. Because patent applications can take many years to issue, there may be currently pending patent applications which may later result in issued patents that current or future product candidates may infringe.
The Company is aware of two issued U.S. patents owned by Pfizer (U.S. Pat. No.: 7,265,119 (the ‘119) and 6,890,927 (the ‘927) that Pfizer has listed in the Orange Book as covering its varenicline tartrate product, which is marketed as Chantix as an aid to smoking cessation treatment. Certain claims of these three patents are directed toward the compound varenicline tartrate and related salts thereof, and therefore may be relevant to TYRVAYA Nasal Spray. Of the two issued patents, both were in force at the time the Company received FDA approval of TYRVAYA Nasal Spray and on October 18, 2019, the Company entered into a non-exclusive patent license for these patents. However, even with the aforementioned license, the Company cannot provide assurances that third parties won’t allege infringement, which could delay or prevent the development and commercialization of TYRVAYA Nasal Spray or other product candidates.
In addition, third parties may obtain patent rights in the future and claim that use of the Company technologies infringes upon their rights. If any third-party patents were held by a court of competent jurisdiction to cover the manufacturing process of any of the Company's product candidates, any molecules formed during the manufacturing process, methods of treating certain diseases or conditions that it is pursuing with its product candidates, its formulations including combination therapies, or any final product itself, the holders of any such patents may be able to block its ability to commercialize such product candidate unless the Company obtained a license under the applicable patents, or until such patents expire. Such a license may not be available on commercially reasonable terms or at all. In addition, the Company may be subject to claims that it is infringing other intellectual property rights, such as trademarks or copyrights, or misappropriating the trade secrets of others, and to the extent that the Company's employees, consultants or contractors use intellectual property or proprietary information owned by others in their work for the Company, disputes may arise as to the rights in related or resulting know-how and inventions.
Parties making claims against the Company may obtain injunctive or other equitable relief, which could effectively block its ability to further develop and commercialize one or more of its current and future product candidates. Defense of these claims, regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from the Company's business. In the event of a successful infringement or other intellectual property claim against the Company, it may have to pay substantial damages, including treble damages and attorneys’ fees for willful infringement, obtain one or more licenses from third parties, pay royalties or redesign its affected products, which may be impossible or require substantial time and monetary expenditure. the Company cannot predict whether any such license would be available at all or whether it would be available on commercially reasonable terms. Furthermore, even in the absence of litigation, the Company may need to obtain licenses from third parties to advance its research or allow commercialization of its product candidates, and it has done so from time to time. It may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In that event, the Company would be unable to further develop and commercialize one or more of its product candidates, which could harm its business significantly. It cannot provide any assurances that third-party patents do not exist which might be enforced against its product candidates, resulting in either an injunction prohibiting its sales, or, with respect to its sales, an obligation on its part to pay royalties or other forms of compensation to third parties.
During the course of any intellectual property litigation, there could be public announcements of the initiation of the litigation as well as results of hearings, rulings on motions, and other interim proceedings in the litigation. If securities analysts or investors regard these announcements as negative, the perceived value of the Company's existing products, programs or intellectual property could be diminished. Accordingly, the market price of shares of the Company's common stock may decline. Such announcements could also harm its reputation or the market for future products, which could have a material adverse effect on the Company's business.
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.
Competitors may infringe or otherwise violate its patents, the patents of its licensors or its other intellectual property rights. To counter infringement or unauthorized use or misappropriations, the Company may be required to file legal claims, which can be expensive and time-consuming. In addition, in an infringement proceeding, a court may decide that one or more patent of the Company or any of its current or future licensors is not valid or is unenforceable, or may refuse to stop the other party from using the technology at issue on the grounds that the Company's patents do not cover the technology in question. An adverse result in any litigation or defense proceedings could put one or more of the Company's patents at risk of being invalidated or interpreted narrowly and could put its patent applications at risk of not issuing. The initiation of a claim against a third-party may also cause the third-party to bring counter claims against the Company such as claims asserting that its patents are invalid or unenforceable. In patent litigation in the U.S., defendant counterclaims alleging invalidity or unenforceability are commonplace. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness, non-enablement or lack of statutory subject matter. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant material information from the USPTO, or made a materially misleading statement, during prosecution. Third parties may also raise similar validity claims before the USPTO in post-grant proceedings such as ex parte reexaminations, inter partes review, or post-grant review, or oppositions or similar proceedings outside the U.S., in parallel with litigation or even outside the context of litigation. The outcome following legal assertions of invalidity and unenforceability is unpredictable. The Company cannot be certain that there is no invalidating prior art, of which it and the patent examiner were unaware during prosecution. For any patents and patent applications that it licenses from third parties, the Company may have limited or no right to participate in the defense of such licensed patents against challenge by a third-party. If a defendant were to prevail on a legal assertion of invalidity or unenforceability, it would lose at least part, and perhaps all, of the patent protection on its current or future product candidates. Such a loss of patent protection could harm its business.
The Company may not be able to prevent, alone or with its licensors, misappropriation of its intellectual property rights, particularly in countries where the laws may not protect those rights as fully as in the U.S. The Company's business could be harmed if in litigation the prevailing party does not offer it a license on commercially reasonable terms. Any litigation or other proceedings to enforce its intellectual property rights may fail, and even if successful, may result in substantial costs and distract the management and other employees.
Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of the Company's confidential information could be compromised by disclosure during this type of litigation. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have an adverse effect on the price of the Company's common shares.
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.
Because of the expense and uncertainty of litigation, it may conclude that even if a third-party is infringing its in-licensed patents, any patents that may be issued as a result of its future patent applications, or other intellectual property rights, the risk-adjusted cost of bringing and enforcing such a claim or action may be too high or not in the best interest of the Company or its stockholders. In such cases, the Company may decide that the more prudent course of action is to simply monitor the situation or initiate or seek some other non-litigious action or solution.
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 U.S. has enacted and implemented wide-ranging patent reform legislation. The U.S. Supreme Court has ruled on several patent cases in recent years, either narrowing the scope of patent protection available in certain circumstances or weakening the rights of patent owners in certain situations. In addition to increasing uncertainty with regard to the Company ability to obtain patents in the future, this combination of events has created uncertainty with respect to the value of patents, once obtained. Depending on actions by Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken the Company's ability to obtain new patents or to enforce patents that the Company has licensed or that it might obtain in the future. Similarly, changes in patent law and regulations in other countries or jurisdictions or changes in the governmental bodies that enforce them or changes in how the relevant governmental authority enforces patent laws or regulations may weaken the Company's ability to obtain new patents or to enforce patents that the Company has licensed or that it may obtain in the future.
The Company may not be able to protect its intellectual property rights throughout the world, which could impair its business.
Filing, prosecuting, and defending patents covering TYRVAYA Nasal Spray, OC-02 and any future product candidate throughout the world would be prohibitively expensive. Competitors may use the Company's technologies in jurisdictions where it has not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where it may have or obtain patent protection, but where patent enforcement is not as strong as that in the U.S. These unauthorized products may compete with the Company's products in such jurisdictions and take away the Company's market share where it does not have any issued or licensed patents and any future patent claims or other intellectual property rights may not be effective or sufficient to prevent them from so competing.
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.
Because the Company relies on third parties for a wide variety of services, including the manufacture of TYRVAYA Nasal Spray and the continuing development of TYRVAYA Nasal Spray and other product candidates, it must, at times, share trade secrets with them. The Company seeks to protect its proprietary technology in part by entering into agreements containing confidentiality and use restrictions and obligations, prior to disclosing proprietary information. These agreements typically limit the rights of the third parties to use or disclose the Company's confidential information, including its trade secrets. Despite the contractual provisions employed when working with third parties, the need to share trade secrets and other confidential information increases the risk that such trade secrets become known by the Company's competitors, are inadvertently incorporated into the technology of others, or are disclosed or used in violation of these agreements. Given that the Company's proprietary position is based, in part, on its know-how and trade secrets, a competitor’s discovery of the Company's trade secrets or other unauthorized use or disclosure could impair its competitive position and may have an adverse effect on business and results of operations.
Despite the Company's efforts to protect its trade secrets, the Company's competitors may discover its trade secrets, either through breach of agreements with third parties, independent development or publication of information by any of the third-party collaborators. A competitor’s discovery of the Company's trade secrets could impair the Company’s competitive position and have an adverse impact on the Company’s business.
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.
The Company employs individuals who were previously employed at other biotechnology or pharmaceutical companies, or at research institutions. Although the Company seeks to protect its ownership of intellectual property rights by ensuring that its agreements with employees, collaborators, and other third parties with whom it does business include provisions requiring such parties to assign rights in inventions to the Company, it may be subject to claims that it or its employees, consultants or independent contractors have inadvertently or otherwise used or disclosed confidential information of its employees’ former employers or other third parties. It may also be subject to claims that former employers or other third parties have an ownership interest in the Company's patents. Litigation may be necessary to defend against these claims. There is no guarantee of success in defending these claims, and if the Company fails in defending any such claims, in addition to paying monetary damages, it may lose valuable intellectual property rights, such as exclusive ownership of, or right to use, valuable intellectual property. Even if the Company is successful, litigation could result in substantial cost and be a distraction to its management and other employees.
Intellectual property rights do not necessarily address all potential threats to the Company’s competitive advantage.
The degree of future protection afforded by the Company’s intellectual property rights is uncertain because intellectual property rights have limitations, and may not adequately protect its business, or permit the Company to maintain its competitive advantage. The following examples are illustrative:
• others may be able to make products that are similar to the Company's current and future product candidates it intends to commercialize that are not covered by the patents that the Company exclusively licensed and has the right to enforce;
• the Company, any of its future licensors or collaborators might not have been the first to make the inventions covered by the issued patents or pending patent applications that it owns;
• the Company or any of its future licensors might not have been the first to file patent applications covering certain of its inventions;
• others may independently develop similar or alternative technologies or duplicate any of the Company's technologies without infringing its intellectual property rights;
• it is possible that the Company's future patent applications will not lead to issued patents;
• issued patents that the Company owns may not provide it with any competitive advantages, or may be held invalid or unenforceable as a result of legal challenges;
• the Company's competitors might conduct research and development activities in countries that provide a safe harbor from patent infringement claims for certain research and development activities, as well as in countries where the Company does not have patent rights, and then use the information learned from such activities to develop competitive products for sale in the Company's major commercial markets; and
• the Company may not develop additional proprietary technologies that are patentable.
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.
The Company intends to use registered or unregistered trademarks or trade names to brand and market itself and its products. The Company's trademarks or trade names may be challenged, infringed, circumvented or declared generic or determined to be infringing on other marks. The Company may not be able to protect its rights to these trademarks and trade names, which it needs to build name recognition among potential partners or customers in the markets of interest. At times, competitors may adopt trade names or trademarks similar to the Company's, thereby impeding its ability to build brand identity and possibly leading to market confusion. In addition, there could be potential trade name or trademark infringement claims brought by owners of other trademarks or trademarks that incorporate variations of the Company's registered or unregistered trademarks or trade names. Over the long term, if the Company is unable to establish name recognition based on its trademarks and trade names, then it may not be able to compete effectively and its business may be adversely affected. The Company may license its trademarks and trade names to third parties, such as distributors. Though these license agreements may provide guidelines for how trademarks and trade names may be used, a breach of these agreements or misuse of such trademarks and tradenames by the Company's licensees may jeopardize its rights in or diminish the goodwill associated with its trademarks and trade names. The Company’s efforts to enforce or protect its proprietary rights related to trademarks, trade names, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely affect its business, growth prospects, operating results and financial condition.
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 Company currently and may in the future license from third parties certain intellectual property relating to current and future product candidates. If the Company breaches any material obligations, or uses the intellectual property licensed to it in an unauthorized manner, it may be required to pay damages and the licensor may have the right to terminate the license, which could result in the Company being unable to develop, manufacture, and sell products that are covered by the licensed technology or enable a competitor to gain access to the licensed technology. Specifically, the Company's license agreement with Pfizer can be terminated by Pfizer upon 60 days’ written notice for the Company's uncured material breach or 30 days following non-payment or immediately upon the Company's insolvency.
Disputes may arise between the Company and its licensors regarding intellectual property subject to a license agreement, including:
• the scope of rights granted under the license agreement and other interpretation-related issues;
• whether and the extent to which the Company's technology and processes infringe on intellectual property of the licensor that is not subject to the licensing agreement;
• the Company's right to transfer or assign the license, or to sublicense patents and other rights to third parties;
• the Company's diligence obligations with respect to the use of the licensed technology in relation to its development and commercialization of its product candidates, and what activities satisfy those diligence obligations; and
• the ownership of inventions and know-how resulting from the joint creation or use of intellectual property by any of the Company's licensors and the Company and its partners.
If the Company's current or future licensors are not fully cooperative or disagree with it as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised. If disputes over intellectual property that the Company licenses prevents or impairs its ability to maintain its licensing arrangements on acceptable terms, it may not be able to successfully develop and commercialize the affected product candidates, which could have a material adverse effect on the Company's business.
In addition, certain of the Company's current or future agreements with third parties may limit or delay its ability to consummate certain transactions, may impact the value of those transactions, or may limit its ability to pursue certain activities.
In addition, even where the Company has the right to control the prosecution of patents and patent applications under a license from third parties, it may still be adversely affected or prejudiced by actions or inactions of its predecessors or licensors and their counsel that took place prior to the Company assuming control over patent prosecution.
The Company's acquired technologies and current or future licensed technology may be subject to retained rights. The Company's predecessors or licensors may retain certain rights under their agreements with the Company, including the right to use the underlying technology for noncommercial academic and research use, to publish general scientific findings from research related to the technology, and to make customary scientific and scholarly disclosures of information relating to the technology. It is difficult to monitor whether the Company's predecessors or future licensors limit their use of the technology to these uses, and the Company could incur substantial expenses to enforce its rights to the Company's licensed technology in the event of misuse.
If the Company is limited in its ability to utilize acquired technologies or current or future licensed technologies, or if it loses its rights to critical acquired or in-licensed technology, it may be unable to successfully develop, out-license, market and sell its products, which could prevent or delay new product introductions. The Company's business strategy depends on the successful development of acquired technologies, and current or future licensed technology, into commercial products. Therefore, any limitations on the Company's ability to utilize these technologies may impair its ability to develop, out-license or market and sell its product candidates.
Risks Related to Government Regulation
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 processes that must be followed to obtain approval by the FDA and foreign regulatory authorities to market a pharmaceutical product is highly complex and unpredictable, and typically takes many years following the commencement of clinical trials. A company’s ability to obtain such an approval, and the time necessary to obtain it, depends upon numerous factors, including the type, complexity and novelty of the product candidates involved. In addition, approval policies, regulations or the type and amount of clinical data necessary to gain approval may change during the course of a product candidate’s clinical development and may vary among jurisdictions, which may cause delays in the approval or the decision not to approve an application. Regulatory authorities have substantial discretion in the approval process and may refuse to accept any application or may decide that the Company’s data is insufficient for approval and require additional preclinical, clinical or other data. Even if the Company eventually completes clinical testing and receives approval of any regulatory filing for its product candidates, the FDA and foreign regulatory authorities may approve its product candidates for a more limited indication or a narrower patient population than it originally requested.
Further, development of a company’s product candidates and/or regulatory approval may be impacted or delayed by events beyond its control. For example, events such as a U.S. federal government shutdown or budget sequestration, such as ones that occurred during 2013, 2018 and 2019, or the FDA’s diversion of resources to handle the SARS-CoV-2 virus pandemic public health emergency and pandemic, may result in significant reductions to the FDA’s budget, employees and operations, and could lead to slower response times and longer review periods, potentially affecting the Company’s ability to progress development of its product candidates or obtain regulatory approval for its product candidates. In addition, the impact of SARS-CoV-2 virus pandemic may cause the FDA to allocate additional resources to product candidates focused on treating related illnesses, which could lead to longer approval processes for the Company’s product candidates. Moreover, the Company’s competitors may file citizens’ petitions with the FDA in an attempt to persuade the FDA that its product candidates, or the clinical trials that support their approval, contain deficiencies. Such actions by its competitors could delay or even prevent the FDA from approving any of the Company’s NDAs.
Applications for the Company’s product candidates could fail to receive regulatory approval for many reasons, including the following:
• the FDA or foreign regulatory authorities may disagree with the design, implementation, or results of the Company's clinical trials;
• the FDA or foreign regulatory authorities may determine that the Company’s product candidates are not safe and effective, are insufficiently effective or have undesirable or unintended side effects, toxicities or other characteristics that preclude the Company’s obtaining marketing approval or prevent or limit commercial use;
• the population studied in the clinical trial may not be sufficiently broad or representative to assure efficacy and safety in the full population for which the Company seeks approval;
• the FDA or foreign regulatory authorities may disagree with the Company’s interpretation of data from preclinical studies or clinical trials;
• the data collected from clinical trials of the Company’s product candidates may not be sufficient to support the submission to obtain regulatory approval;
• the Company may be unable to demonstrate to the FDA or foreign regulatory authorities that a product candidate’s risk-benefit ratio for its proposed indication is acceptable;
• the FDA or foreign regulatory authorities may fail to approve the manufacturing processes, test procedures and specifications or facilities of third-party manufacturers with which the Company contracts for clinical and commercial supplies; and
• the approval policies or regulations of the FDA or foreign regulatory authorities may significantly change in a manner rendering the Company’s clinical data insufficient for approval.
This complex and lengthy approval process, as well as the unpredictability of the results of clinical trials, may result in the Company failing to obtain regulatory approval to market any of its product candidates, or a failure to obtain such approval in a timely manner, which could materially affect its business, financial condition, results of operations and growth prospects.
The Company may face difficulties in commercializing and achieving reimbursement of its products from changes to current regulations and future legislation.
In the U.S., the European Union and other jurisdictions there have been a number of legislative and regulatory changes and proposed changes to the healthcare system that could affect the Company's future results of operations. The Company cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative action, either in the U.S. or abroad. If the Company is slow or unable to adapt to changes in existing requirements or the adoption of new requirements or policies, or if it is unable to maintain regulatory compliance, it may be unable to successfully commercialize its products, and may not achieve or sustain profitability.
For example, the Patient Protection and Affordable Care Act of 2010, as amended by the Health Care and Education Reconciliation Act of 2010 (or collectively, the ACA), substantially affects the way healthcare is financed by both the government and private insurers, and significantly impacts the U.S. pharmaceutical industry. The ACA contains provisions that can reduce the profitability of drug products through increased rebates for drugs reimbursed by Medicaid programs, extension of Medicaid rebates to Medicaid managed care plans, mandatory discounts for certain Medicare Part D beneficiaries and annual fees based on pharmaceutical companies’ share of sales to federal health care programs. There have been extensive judicial, Congressional and executive branch challenges to certain aspects of the ACA, as well as efforts and proposals to revise or repeal the law and its application, to control the prices at which pharmaceutical products are sold, and to implement other healthcare reform measures. Such efforts can be expected to continue in the future, but it is unclear what measures will be enacted or implemented, or how they might affect the Company's business.
In addition, other legislative and administrative changes have been adopted in the U.S. in recent years, and others continue to be proposed. These changes include reductions to payments made under the Medicare program. In addition, during 2021, the Biden administration proposed additional potential legislative and administrative actions to, among other things, reform drug pricing. These recent laws, administrative decisions and proposals, and any new ones that follow, may result in additional reductions in Medicare payments and other healthcare funding, which could have a material adverse effect on customers for the Company's products and product candidates, if approved, and accordingly, on the Company’s results of operations.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.
The Company expects that the ACA, as well as other healthcare reform measures that have been adopted, or may be adopted in the future, could result in more rigorous healthcare insurance coverage criteria and in additional downward pressure on the price that the Company receives for any approved product. Any reduction in reimbursement from Medicare or other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent the Company from being able to generate revenue, attain profitability or commercialize its product candidates.
In the European Union and other countries, similar political, economic and regulatory developments may affect the Company's ability to profitably commercialize its product candidates, if approved. In addition to continuing pressure on prices and cost containment measures, legislative developments at the European Union or member state level may result in significant additional requirements or obstacles that may increase the Company's operating costs. In most EU member states, healthcare
budgetary constraints have resulted in restrictions on the pricing and reimbursement of medicines by relevant health service providers.
Coupled with ever-increasing EU and national regulatory burdens on those wishing to develop and market products, this could prevent or delay marketing approval of the Company's product candidates, restrict or regulate post-approval activities and affect its ability to commercialize its product candidates, if approved.
Legislative and regulatory proposals have been made to expand post-approval requirements and restrict sales and promotional activities for biotechnology products. The Company cannot be sure whether additional legislative changes will be enacted, or whether FDA regulations, guidance or interpretations will be changed, or what the impact of such changes on the marketing approvals of the Company's product candidates, if any, may be. In addition, increased scrutiny by Congress of the FDA approval process may significantly delay or prevent marketing approval, as well as subject the Company to more stringent product labeling and post-marketing testing and other requirements.
The US Government actively enforces laws and regulations regarding the promotion of pharmaceutical products.
The FDA and other US Government agencies strictly regulate the manner in which prescription products, such as TYRVAYA Nasal Spray, may be marketed. In particular, a product may not be promoted for uses that are not approved by the FDA or such other regulatory agencies as reflected in the product’s approved labeling. In addition, sales, marketing and business arrangements in the health care industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Such laws, and the application of those laws, are complex and evolving.
If the Company is found to have improperly promoted the sale of TYRVAYA Nasal Spray, or its other product candidates, if approved, such as through the promotion of the off-label use of those products, or through kickbacks or fraud, or through any other conduct or activity deemed to be unlawful, then the Company may become subject to significant liability. For example, although the Company received marketing approval for TYRVAYA Nasal Spray as a treatment for the signs and symptoms of dry eye disease, physicians may nevertheless choose to prescribe the product for their patients in a manner that is inconsistent with the approved label. If the Company is found to have promoted such off-label uses, it may become subject to significant liability. The U.S. federal government has levied large civil and criminal fines against companies for alleged improper promotion of off-label use and has enjoined several companies from engaging in off-label promotion. The FDA has also requested that companies enter into consent decrees or permanent injunctions under which specified promotional conduct is changed or curtailed. If the Company cannot successfully manage the promotion of TYRVAYA Nasal Spray or other product candidates, if approved, it could become subject to significant liability, which would materially adversely affect business, growth prospects, operating results and financial condition.
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.
The Company is exposed to the risk that its employees, independent contractors, consultants, commercial collaborators, principal investigators, CROs, suppliers, vendors and other third parties with which it does business may engage in misconduct or other improper activities. Misconduct by these parties could include failures to comply with federal and state health care fraud and abuse laws and regulations, FDA regulations, requirements to provide accurate information to the FDA, data privacy and security laws and requirements to accurately report financial information or data or to disclose unauthorized activities to us. Misconduct by these parties could also involve the improper use of information obtained in the course of clinical trials, which could result in regulatory sanctions and serious harm to the Company's reputation. Although the Company has adopted a code of business conduct and ethics with respect to its employees, agents and contractors, it is not always possible to identify and deter misconduct by these parties, and the precautions the Company takes to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting it from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. Additionally, the Company is a subject to the risk that a person or government could allege such fraud or other misconduct, even if none occurred. If any such actions are instituted against the Company, and it is not successful in defending itself or asserting its rights, those actions could have a significant impact on business, including the imposition of significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, individual imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of its operations.
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.
Obtaining and maintaining regulatory approval of the Company's product candidates in one jurisdiction does not guarantee that it will be able to obtain or maintain regulatory approval in any other jurisdiction. For example, although the FDA has approved TYRVAYA Nasal Spray for the treatment of signs and symptoms of dry eye disease in the U.S., comparable regulatory authorities in foreign jurisdictions must also approve the manufacturing, marketing and promotion and reimbursement of TYRVAYA Nasal Spray in those countries. In addition, a failure or delay in obtaining regulatory approval in one jurisdiction may have a negative effect on the regulatory approval process in others. Approval procedures vary among jurisdictions and can involve requirements and administrative review periods different from those in the U.S., including additional preclinical studies or clinical trials, since clinical trials conducted in one jurisdiction may not be accepted by regulatory authorities in other jurisdictions. In many jurisdictions outside the U.S., a product candidate must be approved for reimbursement before it can be approved for sale in that jurisdiction. In some cases, the price that the Company intends to charge for its products is also subject to approval.
Obtaining foreign regulatory approvals and establishing and maintaining compliance with foreign regulatory requirements could result in significant difficulties and costs for the Company and could delay or prevent the introduction of TYRVAYA Nasal Spray or other product candidates, if approved, in certain countries. If the Company or any future collaborator fail to comply with the regulatory requirements in international markets or fail to receive applicable marketing approvals, then the Company’s target market will be reduced and its ability to realize the full market potential of TYRVAYA Nasal Spray or other product candidates, if approved, will be harmed.
In addition, the Company may choose to conduct international clinical trials. The acceptance of study data by the FDA or foreign regulatory authorities from clinical trials conducted outside of their respective jurisdictions may be subject to certain conditions. There can be no assurance that the FDA or any applicable foreign regulatory authority will accept data from trials conducted outside of its applicable jurisdiction. If the FDA or any applicable foreign regulatory authority does not accept such data, it would result in the need for additional trials, which would be costly and time-consuming and could delay aspects of the Company's business plan, and result in the Company’s product candidates not receiving approval or clearance for commercialization in the applicable 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.
Healthcare providers and third-party payors play a primary role in the recommendation and prescription of TYRVAYA Nasal Spray and any product candidates for which the Company obtains marketing approval. The Company's current and future arrangements with healthcare professionals, including physicians, clinical investigators, CROs, third-party payors and customers may expose it to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain the business or financial arrangements and relationships through which the Company markets, sells and distributes its products for which it obtains marketing approval. Restrictions under applicable federal and state healthcare laws and regulations include the following:
• the federal Anti-Kickback Statute prohibits, among other things, persons and entities from knowingly and willfully soliciting, offering, receiving or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under a federal healthcare program such as Medicare and Medicaid. Moreover, the ACA provides that the government may assert that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the civil False Claims Act;
• the federal civil and criminal false claims laws, including the civil False Claims Act, which can be enforced by private citizens through civil whistleblower or qui tam actions, and civil monetary penalties laws prohibit individuals or entities from, among other things, knowingly presenting, or causing to be presented, to the federal government, claims for payment that are false or fraudulent, or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;
• the federal Food Drug and Cosmetic Act, which prohibits, among other things, the adulteration or misbranding of drugs, biologics and medical devices;
• analogous state and foreign laws and regulations, such as state anti-kickback and false claims laws which may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party
payors, including private insurers, state laws that require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, state laws that require biotechnology companies to report information on the pricing of certain drug products, state and local laws that require the registration of pharmaceutical sales representatives;
• the federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) prohibits, among other things, executing or attempting to execute a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;
• federal consumer protection and unfair competition laws, which broadly regulate marketplace activities and activities that potentially harm consumers;
• the federal Physician Payments Sunshine Act requires applicable manufacturers of covered drugs, devices, biologics and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to annually report to CMS information regarding payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors) and teaching hospitals as well as information regarding ownership and investment interests held by physicians and their immediate family members. Beginning in 2022, applicable manufacturers also will be required to report such information regarding their payments and other transfers of value to physicians (defined to include doctors, dentists, optometrists, podiatrists and chiropractors), other health care professionals (such as physician assistants and nurse practitioners) and teaching hospitals, as well as information regarding ownership and investment interests held by physicians and their immediate family members; and
• HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act and their implementing regulations, also imposes obligations, including mandatory contractual terms, on “covered entities,” including certain healthcare providers, health plans, healthcare clearinghouses, and their respective “business associates” that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered entity as well as their covered subcontractors, with respect to safeguarding the privacy, security and transmission of individually identifiable health information, as well as analogous state and foreign laws that govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts.
Some state laws require biotechnology companies to comply with the biotechnology industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government and may require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures. Some state laws require biotechnology companies to report information on the pricing of certain drug products. Certain state and local jurisdictions require the registration of pharmaceutical sales representatives. State, federal and foreign laws also govern the privacy and security of health information in some circumstances, many of which differ from each other in significant ways and often are not preempted by HIPAA, thus complicating compliance efforts. For instance, the collection and use of health data in the EU is governed by the General Data Protection Regulation (GDPR), which extends the geographical scope of EU data protection law to non-EU entities under certain conditions, tightens existing EU data protection principles, creates new obligations for companies and new rights for individuals. Failure to comply with the GDPR may result in substantial fines and other administrative penalties. The GDPR may increase the Company's responsibility and liability in relation to personal data that it processes and it may be required to put in place additional mechanisms ensuring compliance with the GDPR. This may be onerous and if the Company's efforts to comply with GDPR or other applicable EU laws and regulations are not successful, it could adversely affect its business in the EU.
Efforts to ensure that the Company's current and future business arrangements with third parties will comply with applicable healthcare laws and regulations will involve on-going substantial costs. It is possible that governmental authorities will conclude that the Company's business practices, including the provision of compensation for consulting services to physicians and other healthcare providers, some of whom may be in a position to recommend, purchase and/or prescribe TYRVAYA Nasal Spray and other product candidates, if approved, may not comply with current or future statutes, regulations or case law involving applicable fraud and abuse or other healthcare laws and regulations. If the Company's operations are found to be in violation of any of these laws or any other governmental regulations that may apply to it, it may be subject to significant penalties, including civil, criminal and administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government funded healthcare programs, such as Medicare and Medicaid or similar programs in other countries or jurisdictions, integrity oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings and the curtailment or restructuring of the Company's operations. Defending against any such actions can be costly, time-consuming and may require significant financial and personnel resources. Therefore, even if the Company is successful in defending against any such actions that may be brought against it, its business may be impaired. Further, if any of the physicians or other healthcare providers or entities with whom the Company expects to do business is found to be not in compliance with applicable laws, they may be subject to criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.
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.
The Company has conducted clinical trials in countries other than the U.S., and may initiate additional such trials in the future. In addition, the Company has entered into the License Agreement with Ji Xing, a biotechnology company headquartered in Shanghai, China. The Company's business activities are subject to the US Foreign Corrupt Practices Act (FCPA) and similar anti-bribery or anti-corruption laws, regulations or rules of other countries in which it operates. The FCPA generally prohibits offering, promising, giving or authorizing others to give anything of value, either directly or indirectly, to a non-U.S. government official in order to influence official action or otherwise obtain or retain business. The FCPA also requires public companies to make and keep books and records that accurately and fairly reflect the transactions of the corporation and to devise and maintain an adequate system of internal accounting controls. The Company's business is heavily regulated and therefore involves significant interaction with public officials, potentially including officials of foreign governments. Additionally, although TYRVAYA Nasal Spray is not yet approved for sale in any country other than the U.S., in many other countries, the healthcare providers who prescribe pharmaceuticals like TYRVAYA Nasal Spray are employed by their government, and the purchasers of pharmaceuticals are government entities. Therefore, any future dealings by the Company with these prescribers and purchasers may be subject to regulation under the FCPA.
The SEC and Department of Justice have increased their FCPA enforcement activities with respect to biotechnology and pharmaceutical companies. There is no certainty that all of the Company's employees, agents or contractors, or those of its affiliates, will comply with all applicable laws and regulations, particularly given the high level of complexity of these laws. Violations of these laws and regulations could result in fines, criminal sanctions against the Company, its officers or its employees, the closing down of its facilities, requirements to obtain export licenses, cessation of business activities in sanctioned countries, implementation of compliance programs and prohibitions on the conduct of the Company's business. Any such violations could include prohibitions on the Company's ability to offer its products in one or more countries and could materially damage its reputation, its brand, international activities, its ability to attract and retain employees and its business, growth prospects, operating results and financial condition.
In addition, the Company's products may be subject to U.S. and foreign export controls, trade sanctions and import laws and regulations. Governmental regulation of the import or export of the Company’s products, or its failure to obtain any required import or export authorization for the Company's products, when applicable, could harm its international sales and adversely affect its revenue. Compliance with applicable regulatory requirements regarding the export of the Company's products may create delays in the introduction of its products in international markets or, in some cases, prevent the export of its products to some countries altogether. Furthermore, U.S. export control laws and economic sanctions prohibit the shipment of certain products and services to countries, governments, and persons targeted by U.S. sanctions. If the Company fails to comply with export and import regulations and such economic sanctions, it may be fined or other penalties could be imposed, including a denial of certain export privileges. Moreover, any new export or import restrictions, new legislation or shifting approaches in the enforcement or scope of existing regulations, or in the countries, persons, or technologies targeted by such regulations, could result in decreased use of its products by, or in its decreased ability to export products to existing or potential customers with international operations. Any decreased use of the Company's products or limitation on its ability to export or sell access to its products could adversely affect the Company's business.
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.
The ability of the FDA to review and approve new products can be affected by a variety of factors, including government budget and funding levels, its ability to hire and retain key personnel and accept the payment of user fees, statutory, regulatory, and policy changes, and other events that may otherwise affect the FDA’s ability to perform routine functions. Average review times at the FDA have fluctuated in recent years as a result. In addition, government funding of the SEC and other government agencies on which the Company's operations may rely, including those that fund research and development activities, is subject to the political process, which is inherently fluid and unpredictable.
Disruptions at the FDA and other agencies may slow the time necessary for new drugs to be reviewed or approved, which could adversely affect the Company's business. For example, in recent years, including in 2013, 2018 and 2019, the U.S.
government shut down several times and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical FDA, SEC and other government employees for a time, and to stop critical activities.
Separately, in response to the SARS-CoV-2 virus pandemic , in March 2020, the FDA announced its intention to postpone most domestic and foreign inspections of manufacturing facilities and products and only restarted domestic inspections on a risk-based basis in July 2020. Regulatory authorities outside the U.S. may adopt similar restrictions or other policy measures in response to the SARS-CoV-2 virus pandemic.
If such disruptions recur, or if a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process the Company's regulatory submissions, which could have a material adverse effect on its business. Further, in the Company's operations as a public company, future government disruptions or shutdowns could impact the Company’s ability to access the public markets and obtain necessary capital in order to properly capitalize and continue its operations.
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.
The Company and any contract manufacturers and suppliers it engages are subject to numerous federal, state, and local environmental, health, and safety laws, regulations, and permitting requirements, including those governing laboratory procedures; the generation, handling, use, storage, treatment, and disposal of hazardous and regulated materials and waste; the emission and discharge of hazardous materials into the ground, air, and water; and employee health and safety. The Company’s operations may involve the use of hazardous and flammable materials, including chemicals and biological and radioactive materials. Its operations also may produce hazardous waste. The Company generally contracts with third parties for the disposal of these materials and wastes. It cannot eliminate the risk of contamination or injury from these materials. In the event of contamination or injury resulting from the Company's use of hazardous materials, it could be held liable for any resulting damages, and any liability could exceed its resources. Under certain environmental laws, it could be held responsible for costs relating to any contamination at the Company's current or past facilities and at third-party facilities. It also could incur significant costs associated with civil or criminal fines and penalties.
Compliance with applicable environmental laws and regulations may be expensive, and current or future environmental laws and regulations may impair the Company's research, product development and manufacturing efforts. In addition, the Company cannot entirely eliminate the risk of accidental injury or contamination from these materials or waste. Although the Company maintains workers’ compensation insurance to cover it for costs and expenses it may incur due to injuries to its employees resulting from the use of hazardous materials, this insurance may not provide adequate coverage against potential liabilities. The Company does not currently maintain insurance for environmental liability or toxic tort claims that may be asserted against the Company in connection with storage or disposal of hazardous and flammable materials, including chemicals and biological materials. Accordingly, in the event of contamination or injury, it could be held liable for damages or be penalized with fines in an amount exceeding its resources, and its clinical trials or regulatory approvals could be suspended, which could have a material adverse effect on business, financial condition, results of operations and growth prospects.
In addition, the Company may incur substantial costs in order to comply with current or future environmental, health and safety laws and regulations. These current or future laws and regulations may impair research, development or commercialization efforts. Failure to comply with these laws and regulations also may result in substantial fines, penalties or other sanctions.
Risks Related to Reliance on Third Parties
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.
Any future collaborations that the Company enters into may not be successful. The success of its collaboration arrangements will depend heavily on the efforts and activities of its collaborators. Collaborations are subject to numerous risks, which may include that:
• collaborators have significant discretion in determining the efforts and resources that they will apply to collaborations;
• collaborators may not pursue development and commercialization of the Company's products or may elect not to continue or renew development or commercialization programs based on trial or test results, changes in their strategic focus due to the acquisition of competitive products, availability of funding or other external factors, such as a business combination that diverts resources or creates competing priorities;
• collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with the Company's current and future product candidates;
• a collaborator with marketing, manufacturing and distribution rights to one or more products may not commit sufficient resources to or otherwise not perform satisfactorily in carrying out these activities;
• the Company could grant exclusive rights to its collaborators that would prevent it from collaborating with others;
• collaborators may not properly maintain or defend their intellectual property rights or may use their intellectual property or proprietary information in a way that gives rise to actual or threatened litigation that could jeopardize or invalidate their intellectual property or proprietary information or expose the Company to potential liability;
• disputes may arise between the Company and a collaborator that causes the delay or termination of the research, development or commercialization of its current or future products or that results in costly litigation or arbitration that diverts management attention and resources;
• collaborations may be terminated, and, if terminated, may result in a need for additional capital to pursue further development or commercialization of the applicable current or future products;
• collaborators may own or co-own intellectual property covering the Company's products that results from the collaboration, and in such cases, the Company might not have the exclusive right to develop or commercialize such intellectual property; and
• a collaborator’s activities may not be in compliance with applicable laws, potentially resulting in civil or criminal proceedings against the collaborator or the Company.
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's development programs and the potential commercialization of its product candidates will require substantial additional cash to fund expenses. The Company may seek to selectively form collaborations to expand its capabilities, potentially accelerate research and development activities and provide for commercialization activities by third parties. Any of these relationships may require the Company to incur non-recurring and other charges, to increase its near and long-term expenditures, to issue securities that dilute its existing stockholders, or to disrupt management and business.
For example, in August 2021, the Company entered into the License Agreement with Ji Xing, a biotechnology company headquartered in Shanghai, China, pursuant to which the Company has granted 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 greater China region. Ji Xing will be responsible for the development, regulatory, manufacturing and commercialization activities and costs in the greater China region, including mainland China, Hong Kong Special Administrative Region, Macau Special Administrative Region, and Taiwan. The success of the collaboration will be partially dependent on factors outside the Company’s control, including Ji Xing’s ability to successfully develop and commercialize the product candidates in the greater China region, as well as economic, industry and market conditions in the greater China region.
The Company would face significant competition in seeking additional appropriate collaborators for other products and regions, and the negotiation process for such agreements can be time-consuming and complex. Whether the Company reaches a definitive agreement for a collaboration will depend, among other things, upon its assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical trials, the likelihood of approval by the FDA or foreign regulatory authorities of the subject product candidate, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing drugs, the existence of uncertainty with respect to the Company's ownership of intellectual property, and industry and market conditions generally. The potential collaborator may also consider alternative product candidates or technologies for similar indications that may be available and whether such collaboration could be more attractive than the one with the Company for its product candidate. Further, the Company may not be successful in its efforts to establish a collaboration or other alternative arrangements for future product candidates because they may be deemed to be at too early of a stage of development for collaborative effort and third parties may not view them as having the requisite potential to demonstrate safety and efficacy.
In addition, there have been a significant number of recent business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators. Even if the Company is successful in entering into a collaboration, the terms and conditions of that collaboration may restrict it from entering into future agreements on certain terms with potential collaborators.
If and when the Company seeks to enter into future collaborations, it may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If the Company is unable to do so, it may have to curtail the development of a product candidate, reduce or delay its development program or one or more of its other development programs, delay its potential commercialization or reduce the scope of any sales and marketing activities, or increase expenditures and undertake development or commercialization activities at its own expense. If the Company elects to increase its expenditures to fund development or commercialization activities on its own, it may need to obtain additional capital, which may not be available to the Company on acceptable terms or at all. If the Company does not have sufficient funds, it may not be able to further develop its product candidates or bring them to market and generate product revenue.
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.
The Company relies on third parties, such as CROs, clinical data management organizations, medical institutions and clinical investigators, to conduct its current and potential future clinical trials of its product candidates, and the Company expects to continue to do so in the future. These third parties are not the Company's employees, and except for remedies available to the Company under its agreements with such third-party, it has limited ability to control the amount or timing of resources that any such third-party will devote to the Company's clinical trials. Some of these third parties may terminate their engagements with the Company at any time, potentially delaying the Company’s development activities.
The Company's reliance on these third parties for such development activities reduces its control over these activities but does not relieve the Company of its regulatory responsibilities. For example, the Company will remain responsible for ensuring that each of its clinical trials is conducted in accordance with the protocol for the trial, and with applicable regulations, including Good Clinical Practice (GCP) standards, and regulations for conducting, recording and reporting the results of clinical trials to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of trial participants are protected. If the Company or any of its CROs fail to comply with applicable GCP and other requirements, the clinical data generated in the clinical trials may be deemed unreliable and the FDA and foreign regulatory authorities disregard the data or require the Company to perform additional clinical trials, which may delay or prevent the successful completion of the trial. The Company cannot provide assurance that a regulatory authority will determine that any of its clinical trials comply with GCP regulations. The Company also is required to register certain ongoing clinical trials and post the results of certain completed clinical trials on a government-sponsored database, ClinicalTrials.gov, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions.
The third parties the Company relies on for these services may also have relationships with other entities, some of which may be the Company’s competitors. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or conduct the Company's clinical trials in accordance with regulatory requirements and the Company's stated protocols, then the Company will not be able to obtain, or may be delayed in obtaining, marketing approvals for its product candidates and will not be able to, or may be delayed in its efforts to, successfully commercialize its product candidates.
Risks Related to Ownership of Common Stock
An active trading market for the Company's common stock may not be sustained.
Although the Company's common stock is listed on the Nasdaq Global Select Market, the market for the Company's shares has demonstrated varying levels of trading activity. The Company cannot predict the prices at which its common stock will trade or whether an active trading market will be sustained in the future. The lack of an active market may impair investors’ ability to sell their shares at the time they wish to sell them or at a price that they consider reasonable, may reduce the market value of their shares and may impair the Company's ability to raise capital.
The price of the Company's stock may be volatile, and investors could lose all or part of their investment.
The trading price of the Company's common stock may be highly volatile and subject to wide fluctuations in response to various factors, some of which it cannot control. The stock market in general, and pharmaceutical and biotechnology companies in particular, has experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of these companies. Broad market and industry factors, including the state of the U.S. and global economy, and the potential impacts of the SARS-CoV-2 virus pandemic, may negatively affect the market price of the Company's common
stock, regardless of its actual operating performance. In addition to the factors discussed in this “Risk Factors” section and elsewhere in this Annual Report on Form 10-K, these factors include:
• the timing and results of preclinical studies and clinical trials of the Company's product candidates or those of its competitors;
• the success of competitive products or announcements by potential competitors of their product development efforts;
• regulatory actions with respect to the Company's products or its competitors’ products;
• actual or anticipated changes in the Company's growth rate relative to its competitors;
• regulatory or legal developments in the U.S. and other countries;
• developments or disputes concerning patent applications, issued patents or other proprietary rights;
• the recruitment or departure of key personnel;
• announcements by the Company or its competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations or capital commitments;
• actual or anticipated changes in estimates as to financial results, development timelines or recommendations by securities analysts;
• fluctuations in the valuation of companies perceived by investors to be comparable to the Company;
• market conditions in the pharmaceutical and biotechnology sector;
• changes in the structure of healthcare payment systems;
• changes or expected changes to government and such implications for the health care industry;
• share price and volume fluctuations attributable to inconsistent trading volume levels of the Company's shares;
• announcement or expectation of additional financing efforts;
• sales of the Company's common stock by the Company, its insiders or other stockholders;
• expiration of market stand-off or lock-up agreements; and
• general economic, industry and market conditions.
The realization of any of the risks described in this “Risk Factors” section or any of a broad range of other risks, could have a dramatic and adverse impact on the market price of the Company's common stock.
Sales of a substantial number of shares of the Company's common stock in the public market could cause its stock price to fall.
Holders of an aggregate of approximately 10,932,000 shares of the Company's common stock have rights, subject to certain conditions, to require it to file registration statements covering their shares or to include their shares in registration statements that the Company may file for itself or other stockholders. Sales of a substantial number of shares of the Company’s common stock in the public market, or the perception in the market that the holders of a large number of shares intend to sell shares, could reduce the market price of the Company’s common stock. In addition, since January 1, 2021, the Company has filed registration statements on Form S-8 registering an aggregate of 3,153,239 shares of common stock that it may issue under its equity incentive plans and its employee stock purchase plan. As a result, shares registered under the registration statements on Form S-8 can be freely sold in the public market subject to the satisfaction of vesting arrangements and the exercise of such options and volume limitations applicable to affiliates.
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 may seek additional capital through a variety of means, including through public or private equity, debt financings or other sources, including up-front payments and milestone payments from strategic collaborations. To the extent that it raises additional capital through the sale of equity or convertible debt or equity securities, investors' ownership interest will be diluted, and the terms may include liquidation or other preferences that adversely affect their rights as a stockholder. Such financing may result in dilution to stockholders, imposition of debt covenants, increased fixed payment obligations or other restrictions that may affect the Company's business. If the Company raises additional funds through up-front payments or milestone payments pursuant to strategic collaborations with third parties, it may have to relinquish valuable rights to its product candidates or grant licenses on terms that are not favorable to it. In addition, the Company may seek additional capital due to favorable market conditions or strategic considerations even if it believes it has sufficient funds for its current or future operating plans.
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.
As of December 31, 2021, the Company's executive officers, directors, holders of 5% or more of the Company's capital stock and their respective affiliates beneficially owned approximately 69.9% of its voting stock. As a result, this group of stockholders will have the ability to control all matters requiring stockholder approval. For example, these stockholders may be able to control elections of directors, amendments of the Company's organizational documents or approval of any merger, sale of assets or other major corporate transaction. This may prevent or discourage unsolicited acquisition proposals or offers for the Company's common stock that investors may feel are in their best interest as one of the Company's stockholders. The interests of this group of stockholders may not always coincide with other stockholders' interests and they may act in a manner that advances their best interests and not necessarily those of other stockholders, including seeking a premium value for their common stock, and might affect the prevailing market price for the Company's common stock.
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 is an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012 (JOBS Act). For as long as it continues to be an emerging growth company, it intends to take advantage of exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies, including:
• being permitted to provide only two years of audited financial statements, in addition to any required unaudited interim financial statements, with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure in the Company's periodic reports;
• not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act;
• not being required to comply with any requirement that may be adopted by the Public Company Accounting Oversight Board regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements;
• reduced disclosure obligations regarding executive compensation in the Company's periodic reports and proxy statements; and
• exemptions from the requirements of holding nonbinding advisory stockholder votes on executive compensation and stockholder approval of any golden parachute payments not previously approved.
The Company cannot predict if investors will find its common stock less attractive because the Company may rely on these exemptions. If some investors find the Company's common stock less attractive as a result, there may be a less active trading market for the Company’s common stock and the Company's stock price may be more volatile.
The Company will remain an emerging growth company until the earliest to occur of: (1) the last day of the fiscal year in which it has more than $1.07 billion in annual revenue; (2) the date it qualifies as a “large accelerated filer,” with at least $700 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.
Under the JOBS Act, emerging growth companies can also delay adopting new or revised accounting standards until such time as those standards apply to private companies. The Company has irrevocably elected not to avail itself of this exemption from new or revised accounting standards and, therefore, will be subject to the same new or revised accounting standards as other public companies that are not emerging growth companies. As a result, changes in rules of U.S. generally accepted accounting principles or their interpretation, the adoption of new guidance or the application of existing guidance to changes in the Company's business could significantly affect its financial position and results of operations.
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 is subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (Exchange Act), the Sarbanes-Oxley Act, the Dodd-Frank Wall Street Reform and Protection Act, as well as rules adopted, and to be adopted, by the SEC and Nasdaq. Company's management and other personnel have devoted and will continue to devote a substantial amount of time to these compliance initiatives. Moreover, to comply with these rules and regulations, the Company has incurred and will continue to incur legal, accounting and financial compliance costs, and these expenses may increase even more after it is no longer an "emerging growth company".
In addition, the Company has been and will be required to incur costs and obligations in order to comply with SEC rules that implement Section 404 of the Sarbanes-Oxley Act. Under these rules, the Company is required to make a formal assessment of the effectiveness of the Company's internal control over financial reporting, and once it ceases to be an emerging growth company, it will be required to include an attestation report on internal control over financial reporting issued by the Company's independent registered public accounting firm. Efforts to document, evaluate and maintain the Company's internal control over financial reporting, have been and will continue to be both costly and challenging. The Company will need to continue to dedicate internal resources, engage outside consultants and adopt a detailed work plan to assess and document the adequacy of its internal control over financial reporting, continue steps to improve control processes as appropriate, validate through testing that controls are designed and operating effectively, and implement a continuous reporting and improvement process for internal control over financial reporting.
If the Company is not able to comply with the requirements of Section 404 of the Sarbanes-Oxley Act, or if it is unable to maintain proper and effective internal control over financial reporting, it may not be able to produce timely and accurate financial statements. If that were to happen, the market price of the Company's stock could decline and it could be subject to sanctions or investigations by the stock exchange on which the common stock is listed, the SEC or other regulatory authorities.
The Company does not intend to pay dividends on its common stock so any returns will be limited to the value of the stock.
The Company has never declared or paid any cash dividends on its common stock. The Company currently anticipates that it will retain future earnings for the development, operation and expansion of its business and does not anticipate declaring or paying any cash dividends for the foreseeable future. Any return to stockholders will therefore be limited to any appreciation in the value of their 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 restated certificate of incorporation and restated bylaws contain provisions that could depress the market price of its common stock by acting to discourage, delay or prevent a change in control of the Company or changes in its management that the stockholders of the Company may deem advantageous. These provisions, among other things:
• establish a classified board of directors so that not all members of the Company's board are elected at one time;
• permit only the board of directors to establish the number of directors and fill vacancies on the board;
• provide that directors may only be removed “for cause” and only with the approval of two-thirds of the Company's stockholders;
• authorize the issuance of “blank check” preferred stock that the board could use to implement a stockholder rights plan (also known as a poison pill);
• eliminate the ability of the stockholders to call special meetings of stockholders;
• prohibit stockholder action by written consent, which requires all stockholder actions to be taken at a meeting of the stockholders;
• prohibit cumulative voting;
• authorize the board of directors to amend the bylaws;
• establish advance notice requirements for nominations for election to the Company's board or for proposing matters that can be acted upon by stockholders at annual stockholder meetings; and
• require a super-majority vote of stockholders to amend some provisions described above.
In addition, Section 203 of the General Corporation Law of the State of Delaware (DGCL) prohibits a publicly-held Delaware corporation from engaging in a business combination with an interested stockholder, generally a person which together with its affiliates owns, or within the last three years has owned, 15% of Company's voting stock, for a period of three years after the date of the transaction in which the person became an interested stockholder, unless the business combination is approved in a prescribed manner.
Any provision of the Company's amended and restated certificate of incorporation, amended and restated bylaws or Delaware law that has the effect of delaying or preventing a change in control could limit the opportunity for stockholders to receive a premium for their shares of the Company's capital stock and could also affect the price that some investors are willing to pay for Company's 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.
The Company's amended and restated bylaws provide that the Court of Chancery of the State of Delaware is the exclusive forum for:
• any derivative action or proceeding brought on the Company's behalf;
• any action asserting a claim of breach of fiduciary duty;
• any action asserting a claim against the Company arising under the DGCL, its amended and restated certificate of incorporation or its amended and restated bylaws; and
• any action asserting a claim against the Company that is governed by the internal-affairs doctrine.
This exclusive-forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with the Company or its directors, officers or other employees, which may discourage lawsuits against the Company and its directors, officers and other employees. Any person or entity purchasing or otherwise acquiring any interest in any of the Company's securities shall be deemed to have notice of and consented to this provision. If a court were to find this exclusive-forum provision in the Company's amended and restated bylaws to be inapplicable or unenforceable in an action, the Company may incur additional costs associated with resolving the dispute in other jurisdictions, which could seriously harm its business. Nothing in the Company's amended and restated bylaws, including the exclusive-forum provision, precludes stockholders that assert claims under the Securities Act or the Exchange Act from bringing such claims in state or federal court, subject to applicable law.
General Risk Factors
Business disruptions could seriously harm the Company's future revenue and financial condition and increase its costs and expenses.
The Company's operations, and those of its CROs, CMOs, suppliers, and other third-party contractors and consultants upon which the Company relies, could be subject to wildfires, earthquakes, tsunamis, power shortages or outages, floods or monsoons, public health crises, such as pandemics and epidemics, political crises, such as terrorism, war (including trade wars), political instability or other conflicts, and other natural or man-made disasters or other events outside of the Company's control that could disrupt business. The occurrence of any of these business disruptions could seriously harm the Company's operations and financial condition and increase its costs and expenses. For example, the Company relies on third-party manufacturers to produce TYRVAYA Nasal Spray and its other product candidates. The Company's ability to obtain supplies of TYRVAYA Nasal Spray and its other product candidates, or other necessary supplies, could be disrupted if the operations of the Company’s suppliers are affected by a man-made or natural disaster or other business interruption. Damage or extended periods of interruption to the Company’s corporate, development or research facilities due to fire, natural disaster, power loss, communications failure, unauthorized entry or other events could cause the Company to cease or delay the marketing of TYRVAYA Nasal Spray, or the development of some or all of its product candidates. Although the Company maintains property damage and business interruption insurance coverage, the insurance might not cover all losses under such circumstances and the Company's business may be seriously harmed by such delays and interruptions.
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 trading market for the Company's common stock will be influenced by the research and reports that securities or industry analysts publish about it, its business or the Company's market. If no additional securities or industry analysts commence coverage of the Company, the Company's stock price could be negatively impacted. If any of the analysts who cover the Company issue adverse or misleading research or reports regarding it, its business model, intellectual property, stock performance or its market, or if the Company's operating results fail to meet the expectations of analysts, its stock price would likely decline. If one or more of these analysts cease coverage of the Company or fail to publish reports on it regularly, the Company could lose visibility in the financial markets, which in turn could cause its stock price or trading volume to decline.
The Company may be subject to securities litigation, which is expensive and could divert management attention.
The market price of the Company's common stock may be volatile and, in the past, companies that have experienced volatility in the market price of their stock have been subject to securities class action litigation. The Company may be the target
of this type of litigation in the future. Securities litigation against the Company could result in substantial costs and divert management’s attention from other business concerns, which could seriously harm Company's business.
The Company's disclosure controls and procedures may not prevent or detect all errors or acts of fraud.
The Company has designed its disclosure controls and procedures, including new controls and processes that have been implemented upon the Company’s transition from a clinical-stage entity to a commercial-stage company, to reasonably assure that information it must disclose in reports it files or submits under the Exchange Act is accumulated and communicated to management, and recorded, processed, summarized and reported within the time periods specified in the rules and forms of the SEC. The Company believes that any disclosure controls and procedures or internal controls and procedures, no matter how well-conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met.
These inherent limitations include the realities that judgments in decision-making can be faulty, and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people or by an unauthorized override of the controls. Accordingly, because of the inherent limitations in the Company's control system, misstatements due to error or fraud may occur and not be detected.
