Seagen (SGEN)

Risks

• Our success depends on our ability to effectively commercialize our products. If we and our collaborators are unable to effectively commercialize our products and to expand their utilization, our ability to generate significant revenue and our prospects for profitability will be adversely affected.
• Our success also depends on our ability to obtain regulatory approvals for our product candidates and for our current products in additional territories, as well as our ability to expand the labeled indications of use for our current products. Our inability to do so could have a material adverse effect on our business, results of operations, financial condition and growth prospects.
• Even if regulatory approval is achieved, the launch of a new product or of an existing product in a new indication or territory is subject to a number of risks and uncertainties and may not be successful.
• Reports of adverse events or safety concerns involving our products or product candidates could delay or prevent us from obtaining or maintaining regulatory approvals or could negatively impact sales of our products or the prospects for our product candidates.
• Clinical trials and product development are expensive, time consuming and uncertain, may take longer than we expect and may not be successful. Our failure to effectively advance our development programs in a timely manner or at all could have a material adverse effect on our business, results of operations, financial condition and growth prospects.
• The successful commercialization of our products will depend, in part, on the extent to which governmental authorities and health insurers establish adequate coverage and reimbursement levels and pricing policies.
• The successful commercialization of our products will also depend in part on the acceptance of our products by the medical community, patients and third-party payors.
• Any failures or setbacks in our ADC development program or our other platform technologies could negatively affect our business and financial position.
• We face intense competition and rapid technological change, which may result in others discovering, developing or commercializing competing products before or more successfully than we do.
• Our products and any future approved products remain subject to extensive ongoing regulatory obligations and oversight, including post-approval requirements, that could result in penalties and significant additional expense and could negatively impact our and our collaborators’ ability to commercialize our current and any future approved products.
• Healthcare law and policy changes may negatively impact our business, including by decreasing the prices that we and our collaborators receive for our products.
• We are subject to various state, federal and international laws and regulations, including healthcare laws and regulations, that may impact our business and could subject us to significant fines and penalties or other negative consequences.
• Product liability and product recalls could harm our business, and we may not be able to obtain adequate insurance to protect us against product liability losses.
• Our operations involve hazardous materials and are subject to environmental, health and safety laws and regulations.
• Our collaborators and licensees may not perform as expected, which may negatively affect our ability to develop and commercialize our products and product candidates and/or generate revenues through technology licensing, and may otherwise negatively affect our business.
• We currently rely on third-party manufacturers and other third parties for production of our drug products, and our dependence on these third parties may impair the continued development and commercialization of our products and product candidates.
• We are dependent upon a small number of distributors for a significant portion of our net sales, and the loss of, or significant reduction or cancellation in sales to, any one of these distributors could adversely affect our revenues and increase our costs.
• We are dependent on third parties such as contract research organizations, medical institutions and clinical investigators to assist with the design, review, management and conduct of our clinical trials and other activities.
• If we are unable to enforce our intellectual property rights or if we fail to sustain and further procure additional intellectual property rights, we may not be able to successfully commercialize our products or any future products and competitors may be able to develop competing therapies.
• We may incur substantial costs and lose important rights or may not be able to continue to commercialize our products or to commercialize any of our product candidates that may be approved for commercial sale as a result of litigation or other proceedings relating to patent and other intellectual property rights, and we may be required to obtain patent and other intellectual property rights from others.
• We and our collaborators rely on license agreements for certain aspects of our products and product candidates and technologies such as our ADC technology. Failure to maintain these license agreements or to secure any required new licenses could prevent us from continuing to develop and commercialize our products and product candidates.
• We have been and may in the future be subject to litigation, which could result in substantial expenses and damages and may divert management’s time and attention from our business.
• The evolving effects of the COVID-19 pandemic and associated global economic instability could have further adverse effects on our business, including our commercialization efforts, supply chain, regulatory activities, clinical development activities and other business operations.
• If we are unable to manage our growth, our business, results of operations, financial condition and growth prospects may be adversely affected.
• Risks associated with our expanding operations in countries outside the U.S. could materially adversely affect our business.
• We have engaged in, and may in the future engage in, strategic transactions that increase our capital requirements, dilute our stockholders, cause us to incur debt or assume contingent liabilities and subject us to other risks.
• If we lose our key personnel or are unable to attract and retain additional qualified personnel, our future growth and ability to compete would suffer.
• If our information technology systems or data are or were compromised, we could experience interruptions to our operations, legal claims, liability, harm to our reputation, a loss of sales and other adverse impacts.
• Our operating results are difficult to predict and may fluctuate. If our operating results are below the expectations of securities analysts or investors, the trading price of our stock could decline.
• We have a history of net losses. We expect to continue to incur net losses and may not achieve future sustained profitability for some time, if at all.
• We may need to raise additional capital that may not be available to us.
• The potential future impairment of intangible assets and goodwill may negatively affect our results of operations and financial position.
• Our stock price is volatile and our shares may suffer a decline in value.
• Substantial future sales or issuances of shares of our common stock or equity-related securities could cause the market price of our common stock to decline.
• Our existing stockholders have significant control of our management and affairs.
• Anti-takeover provisions could make it more difficult for a third party to acquire us.
• Our disclosures related to environmental, social and governance, or ESG, matters expose us to various risks, including risks to our reputation and stock price.
• Changes in tax laws or regulations may have a material adverse effect on our business, results of operations, financial condition or growth prospects.
• If our facilities are damaged or our research and development, manufacturing or other business processes are interrupted, our business could be seriously harmed.
• Legislative actions and new accounting pronouncements are likely to impact our future financial position or results of operations.