ADDED
We may not achieve sustained profitability, and we may need to raise additional capital in the future.
If we are unable to raise capital or obtain financing if and when needed, we may need to adjust our operations.
If the benefits of the Merger do not meet the expectations of investors or securities analysts, the market price of our common stock may decline.
In addition, combining Astria with our business may be more difficult, costly or time consuming than expected and the combined company may fail to realize the anticipated benefits, cost savings and synergies of the Merger.
The commercial viability of any approved product could be compromised if the product is less effective than expected, causes undesirable side effects that either were not previously identified or were worse than expected, or fails to achieve market acceptance by physicians, patients, third-party payors, health authorities, and others.
For example, our actual or perceived failure to comply with non-U.S.
governmental laws and regulations and other obligations related to privacy, data protection, and information security could harm our business.
Our ability to maintain global brand uniformity for ORLADEYO may be impacted by the sale of our European ORLADEYO business.
Future acquisitions, strategic investments, partnerships, alliances, or divestitures could fail to meet our expectations and/or adversely affect our operating results and financial condition.
BUSINESS Our Business We are a global biotechnology company focused on developing and commercializing medicines for hereditary angioedema ( HAE ) and other rare diseases, driven by our deep commitment to improving the lives of people living with these conditions.
REMOVED
Government exercising any options under our current procurement contract, and our ability to execute any such order; additional regulatory approvals, or milestones, royalties or profit from sales of our products by us or our partners; the implementation of our business model, strategic plans for our business, products, product candidates and technology; our ability to establish and maintain collaborations or out-license rights to our products and product candidates; plans, programs, progress and potential success of our collaborations, including with Torii Pharmaceutical Co., Ltd.
We have incurred losses since our inception and may never achieve sustained profitability.
If we are unable to raise capital if and when needed, we may need to adjust our operations.
If we fail to obtain additional financing or acceptable partnership arrangements if and when needed, we may be unable to complete the development and commercialization of our products and product candidates or continue operations.
There can be no assurance that our or our partners commercialization efforts, methods, and strategies for our products or technologies will succeed, and our future revenue generation is uncertain.
We have expanded, and may continue expanding, our development and regulatory capabilities and are implementing sales, marketing, and distribution capabilities, and as a result, we may encounter difficulties managing our growth, which could disrupt our operations.
We may be required to make a prepayment or repay our outstanding indebtedness under the Pharmakon Loan Agreement earlier than we expect if a prepayment event or an event of default occurs, including, but not limited to, a material adverse change with respect to us, which could have a material adverse effect on our business.
For example, our actual or perceived failure to comply with European governmental laws and regulations and other obligations related to privacy, data protection, and information security could harm our business.
In addition, the United Kingdom s withdrawal from the European Union could result in increased regulatory and legal complexity, which may make it more difficult for us to do business in Europe and impose additional challenges in securing regulatory approval of our product candidates in Europe.
If we fail to maintain effective internal control over financial reporting, we may not be able to produce accurate and timely financial statements, which may adversely affect investor confidence in us and our financial reporting, adversely affect our business and operating results and may negatively impact the trading price of our common stock.