Savara (SVRA) risk factors, FY2024 10-K

Risks Related to Development and Commercialization of our Product Candidate

1. 01We are substantially dependent upon the clinical, regulatory, and commercial success of our sole product candidate, MOLBREEVI. If we are unable to successfully complete clinical development of, obtain regulatory approval for, and successfully commercialize MOLBREEVI, our business may be harmed
2. 02Given the developmental nature of our product candidate, we are subject to risks associated with initiating, completing, and achieving positive outcomes from our current and future clinical trials
3. 03reduction in the safety profile of our product candidate following approval
4. 04Pharmaceutical products are subject to stringent regulatory requirements covering quality, safety, and efficacy. Only after successfully completing extensive pharmaceutical development, nonclinical testing, and clinical trials may a product be considered for regulatory approval
5. 05delays due to supply chain disruptions as a result of global health risks, international conflict, or other unexpected event
6. 06Failure at any stage of clinical testing is not uncommon and we may encounter problems that would require additional, unplanned trials or cause us to abandon a clinical development program
7. 07changes in governmental regulations or administrative actions, such as lay-offs and staffing at regulatory agencies such as the FDA
8. 08Our MOLBREEVI product candidate may cause undesirable side effects or adverse events or have other properties that could delay or prevent our clinical development, regulatory approval, or commercialization
9. 09Even if we receive regulatory approval for our product candidate, we may face regulatory difficulties that could materially and adversely affect our business, financial condition, and results of operations
10. 10If our product candidate receives regulatory approval but fails to achieve significant market acceptance among the medical community, patients, or third-party payers, the revenue we generate from its sales will be limited and our business may never achieve profitability
11. 11the resources we devote to marketing our product and restrictions on promotional claims we can make with respect to the product
12. 12Even if we receive regulatory approval to market our product candidate in the U.S., we may never receive approval or commercialize our product outside of the U.S., which would limit our ability to realize the full commercial potential of our product candidate

Risks Related to Our Capital Requirements and Financial Condition

1. 13We have incurred significant losses since inception and expect that we will continue to incur losses for the foreseeable future, which makes it difficult to assess our future viability
2. 14We may require additional financing to obtain regulatory approval for MOLBREEVI and a failure to obtain this necessary capital when needed on acceptable terms, or at all, could force us to delay, limit, reduce, or terminate our product development efforts or other operations
3. 15the continuing negative impacts of global health risks
4. 16Our loan agreement contains covenants which may adversely impact our business; the failure to comply with such covenants could cause our outstanding debt to become immediately payable or accelerate principal payments
5. 17Any future acquisitions that we make could disrupt our business and harm our financial condition
6. 18We have IPR&D and future impairment of IPR&D may have an adverse impact on our future financial condition and results of operations
7. 19Adverse developments affecting financial institutions, companies in the financial services industry, or the financial services industry generally, such as actual events or concerns involving liquidity, defaults, or non-performance, could adversely affect our operations and liquidity

Risks Related to Competition, Retaining Key Employees and Managing Growth

1. 20MOLBREEVI has received Orphan Drug Designation from the FDA and the EMA. If a competitor obtains Orphan Drug exclusivity for a product with the same active ingredient and route of delivery as molgramostim for aPAP, we may be unable to market our product candidate until the exclusivity of the competing product expires
2. 21We expect competition in the marketplace for our MOLBREEVI product candidate should it receive regulatory approval
3. 22If we fail to attract and retain senior management and key scientific personnel and develop and maintain relationships with service providers, consultants and advisers, we may be unable to successfully develop and commercialize our product candidate
4. 23Replacing key employees may be a difficult, costly, and protracted process, and we may not have other personnel with the capacity to assume all the responsibilities of a key employee upon his/her departure. Transition periods can be difficult to manage and may cause disruption to our business
5. 24We currently have limited marketing capabilities and no sales organization. If we are unable to establish sales and marketing capabilities on our own or through third parties, we will be unable to successfully commercialize our product candidate, if approved, or generate product revenue
6. 25To establish a sales and marketing infrastructure and expand our manufacturing capabilities, we will need to increase the size of our organization, and we may experience difficulties in managing this growth

Risks Related to Our Business Operations

1. 26Our operations might be interrupted and financial results could be adversely impacted by the occurrence of a natural disaster, acts of war or terrorism, tariffs, IT system malfunction, telecommunication and electrical failures or other catastrophic event, or public health crises, such as a pandemic
2. 27Our business and operations would suffer in the event of third-party computer system failures, cyber-attacks on third-party systems, or deficiency in our cybersecurity
3. 28The Company’s remote working arrangements could significantly increase the Company’s digital and cybersecurity risks
4. 29If we or our vendors fail to comply with data protection laws and regulations, we could be subject to government enforcement actions (which could include civil or criminal penalties), private litigation, and/or adverse publicity, which could negatively affect our operating results and business
5. 30We must comply with the U.S. Foreign Corrupt Practices Act and similar foreign anti-corruption laws

Risks Related to Our Intellectual Property

1. 31If we are unable to adequately protect our intellectual property rights related to our product candidate, it could have a material adverse effect on our business
2. 32obtain appropriate licenses to patents or proprietary rights held by third parties if infringement would otherwise occur, or if necessary, to secure exclusive rights to them, both in the U.S. and in foreign countries
3. 33there is no assurance that our MOLBREEVI product and its delivery system, if approved, will benefit from this type of market protection
4. 34We may not be able to enforce our intellectual property rights outside of the U.S
5. 35redesigning our product or process so they do not infringe, which may not be possible or may require substantial expense and time

Risks Related to Our Industry

1. 36We are subject to uncertainty relating to healthcare reform measures and reimbursement policies that, if not favorable to our product, could hinder or prevent our product’s commercial success, if our product candidate is approved
2. 37our access to additional capital
3. 38the inability to commercialize our product candidate

Risks Related to our Common Stock

1. 39Our stock price is expected to continue to be volatile
2. 40period-to-period fluctuations in our financial results
3. 41If we fail to satisfy all applicable Nasdaq continued listing requirements, including the $1.00 minimum closing bid price requirement, our common stock may be delisted from Nasdaq, which could have an adverse impact on the liquidity and market price of our common stock
4. 42We do not expect to pay any cash dividends in the foreseeable future
5. 43We may be unable to use certain of our net operating losses and other tax assets