Financial Performance - The company incurred net losses of $106.3 million and $76.7 million for the years ended December 31, 2022, and 2021, respectively, with an accumulated deficit of $321.1 million as of December 31, 2022[159]. - As of December 31, 2022, the company had $60.7 million in cash and cash equivalents, which is insufficient to fund operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern[164]. - The company anticipates continuing to incur substantial operating losses for the foreseeable future and may never achieve or sustain profitability[157]. - The company expects to incur significant legal, accounting, and compliance costs as a public entity, which were not present as a private company[286]. - The company has incurred substantial losses and does not expect to achieve profitability in the near future, which may limit the utilization of net operating loss carryforwards[298]. Market and Product Development - The commercialization of Trudhesa and the development of future product candidates depend on obtaining significant market acceptance among healthcare payors, physicians, and patients[170]. - Market acceptance of Trudhesa may be lower than expected due to competition from other approved migraine treatments[171]. - The market opportunity for Trudhesa may be smaller than expected, potentially leading to lower product revenues and stock price decline[172]. - The company intends to market Trudhesa and future product candidates internationally, requiring separate regulatory approvals in each jurisdiction, which may be costly and time-consuming[233]. - The company may face significant negative consequences if undesirable side effects are identified, potentially preventing market acceptance and increasing commercialization costs[229]. Regulatory and Compliance Risks - The FDA has imposed labeling restrictions for Trudhesa, which may also apply to future product candidates, affecting their marketability[174]. - Regulatory approval processes are expensive and uncertain, with a small percentage of drugs successfully completing the FDA approval process[202]. - The company may need to conduct additional clinical trials if it cannot establish a bridge between future product candidates and listed drugs, which could delay approval[207]. - Changes in FDA policies or additional regulations could delay or prevent regulatory approval for future product candidates, adversely affecting the company's business[236]. - The company is subject to various federal and state laws that regulate healthcare practices, including the Physician Payments Sunshine Act, which requires reporting of payments to healthcare providers[245]. Manufacturing and Supply Chain Challenges - The company relies entirely on third parties for the manufacturing of Trudhesa and any future candidates, which could impair commercialization efforts if difficulties arise[156]. - Manufacturing complexities could lead to delays, increased costs, or shortages of Trudhesa and future product candidates[177]. - The company does not own manufacturing facilities and lacks the expertise for large-scale production, which could affect its ability to meet market demand[188]. - Supply chain disruptions due to the pandemic may hinder the manufacturing of future product candidates[305]. - The company relies on third-party manufacturers for the production of its POD device and active pharmaceutical ingredients, which poses risks of delays and increased costs if issues arise with these suppliers[192]. Intellectual Property Risks - The company holds 8 U.S. issued patents and 34 patents issued in ex-U.S. jurisdictions, with 13 U.S. pending applications and 80 patent applications pending in ex-U.S. jurisdictions[253]. - The company may not be able to obtain or enforce patent protection effectively, which could adversely affect the development and commercialization of its technologies[253]. - The evolving landscape of upper nasal space therapeutics makes it difficult to assess the company's freedom to operate without infringing on third-party rights[268]. - The company may face claims regarding inventorship disputes related to patents and trade secrets, which could lead to costly litigation and loss of valuable intellectual property rights[256]. - Patent terms may not provide adequate protection against competition from generics or biosimilars once the patents expire[275]. Clinical Trial and Development Risks - The company may face delays in clinical trials or regulatory approvals, which could increase costs and hinder commercialization efforts[160]. - Delays in clinical trial commencement or completion could result in increased costs and hinder the ability to obtain regulatory approval[209]. - The company may face delays in clinical trials due to patient recruitment challenges, including those related to COVID-19[211]. - The cost of planned clinical trials may exceed initial estimates, impacting financial projections[219]. - The company plans to conduct future clinical trials using an "open-label" design, similar to the STOP 301 trial for Trudhesa, which may introduce biases affecting the perceived therapeutic effects[227]. Competition and Market Dynamics - Competition in the pharmaceutical market is substantial, with many companies targeting the same markets as Trudhesa[182]. - The company faces significant competition in establishing strategic partnerships, which are crucial for the development and commercialization of product candidates[199]. - The company may face substantial damages if found to infringe third-party patents, which could force it to abandon technology or seek licenses[268]. - Legislative initiatives at the state level are increasingly aimed at controlling pharmaceutical pricing, which may affect the company's revenue[251]. - The company may face enforcement actions or lawsuits if found to have engaged in improper promotion of its products, leading to significant liability and reputational harm[237]. Operational and Environmental Risks - The company is located in Seattle, Washington, an earthquake-prone area, which poses a risk of operational disruption due to natural disasters[319]. - The company and its Contract Manufacturing Organizations (CMOs) must comply with numerous environmental, health, and safety laws, with potential significant costs or liabilities for non-compliance[321]. - Increasingly stringent environmental, health, and safety regulations may lead to substantial compliance costs that could impair research, development, or production efforts[322]. - Cybersecurity risks are heightened due to remote work arrangements, and breaches could lead to significant costs and operational disruptions[293]. - The company maintains insurance for cybersecurity incidents, but coverage may be insufficient for all liabilities incurred[294]. Impact of COVID-19 - The ongoing COVID-19 pandemic has significantly impacted the company's business operations, including clinical trials and commercialization efforts for Trudhesa[301]. - Delays in clinical trials may occur due to changes in hospital policies and resource prioritization towards pandemic efforts, potentially affecting cash reserves and capital raising plans[302]. - Commercialization efforts for Trudhesa could be adversely affected by government-imposed restrictions, limiting the ability to hire and train sales personnel[304]. - The overall impact of the pandemic on the company's financial condition and operations remains highly uncertain and could be material[306]. - The company may need to implement new clinical trial policies based on evolving FDA guidance, which could delay the development of future product candidates[303].
Impel Pharmaceuticals (IMPL) - 2022 Q4 - Annual Report