Collegium Pharmaceutical (COLL) risk factors, FY2024 10-K

Risks Related to Our Financial Position and Capital Needs

1. 01Our ability to use our net operating loss carryforwards and certain other tax attributes may be limited
2. 02We have substantial outstanding indebtedness, which may adversely affect our business, financial condition and results of operations
3. 03Adverse developments affecting the financial services industry, including events or concerns involving liquidity, defaults or non-performance by financial institutions or transactional counterparties, could adversely affect our business, financial condition, or results of operations

Risks Related to our Products

1. 04If we cannot continue successfully commercializing our products and any products that we may acquire in the future, our business, financial condition and results of operations may be materially adversely affected and the price of our common stock may decline
2. 05Our business and future success are substantially dependent on our ability to continue successfully commercializing our products, including Jornay, Belbuca, Xtampza, the Nucynta Products, Symproic, and any products that we may acquire in the future
3. 06Despite receiving approval by the FDA, additional data may emerge that could change the FDA’s position on the product labeling of any of our products, including our abuse-deterrent claims with respect to Xtampza ER, and our ability to market our products successfully may be adversely affected
4. 07Our opioid products are subject to mandatory REMS programs, which could increase the cost, burden and liability associated with the commercialization of these products

Risks Related to Intellectual Property

1. 08Unfavorable outcomes in intellectual property litigation could be costly and potentially limit our ability to commercialize our products
2. 09If we are unable to obtain or maintain intellectual property rights for our technologies, products or any products we may acquire, we may lose valuable assets or be unable to compete effectively in our market
3. 10We have been, and may continue to be, forced to litigate to enforce or defend our intellectual property, which could be expensive, time consuming and unsuccessful, and result in the loss of valuable assets
4. 11If we are unable to protect the confidentiality of our trade secrets, our business and competitive position would be harmed
5. 12Obtaining and maintaining our patent protection depends on compliance with various procedural, document submissions, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements

Risks Related to the Commercialization of Our Products

1. 13If we are unable to utilize our own sales and marketing capabilities successfully or enter into strategic alliances with marketing collaborators, we may not continue to be successful in commercializing our products and may be unable to generate sufficient product revenue
2. 14If the medical community, patients, and healthcare payors do not accept and use our products, we will not achieve sufficient product revenues and our business will suffer
3. 15Some of our products contain controlled substances, and the manufacture, use, sale, importation, exportation and distribution of which are subject to regulation by state and federal law enforcement and other regulatory agencies
4. 16Current and future legislation and regulatory changes may increase the difficulty and cost for us to continue to commercialize our products and may reduce the prices we are able to obtain for our products
5. 17Further, changes in the leadership and funding of the FDA, CMS, NIH and other federal agencies under the Trump Administration as well as regulatory reforms that may be proposed or implemented by the Trump Administration may have a material effect on how pharmaceutical products are regulated
6. 18The Affordable Care Act and any changes in healthcare law may increase the difficulty and cost for us to continue to commercialize our products and affect the prices we may obtain
7. 19Law enforcement and regulatory agencies may apply policies and guidelines that seek to limit the availability or use of opioids and stimulants. Such efforts may inhibit our ability to continue to commercialize our products
8. 20If the FDA or other applicable regulatory authorities approve generic products with claims that compete with our products, our sales could decline

Risks Related to Our Dependence on Third Parties

1. 21other vendors to formulate, test, supply, store and distribute our products, and we control only certain aspects of their activities
2. 22Because we currently rely on a sole supplier or limited number of suppliers to manufacture the active pharmaceutical ingredient of our products, any production problems with any of these suppliers could have a material adverse effect on us
3. 23Supply chain disruptions and shortages may limit manufacturing and commercial supply of our products and have a material impact on our business
4. 24Manufacturing issues may arise that could increase product and regulatory approval costs, delay commercialization or limit commercial supply
5. 25We depend on wholesale pharmaceutical distributors for retail distribution of our products; if we lose any of our significant wholesale pharmaceutical distributors or their distribution network is disrupted, our financial condition and results of operations may be adversely affected
6. 26with each such distributor, and as a result, we may be forced to accept terms that adversely impact our results of operations
7. 27Certain of our opioid products are subject to post-marketing requirements or commitments, which may, in some cases, not be capable of timely or satisfactory completion without participation in consortia over which we have limited control

Risks Related to Our Business and Strategy

1. 28Our business may be adversely affected by certain events or circumstances outside our control, including macroeconomic conditions and geopolitical turmoil
2. 29Security breaches and other disruptions to our, or our vendors’, information technology systems may compromise our information and expose us to liability that could adversely impact our financial condition, operations, and reputation
3. 30Litigation or regulatory action regarding opioid medications could negatively affect our business
4. 31We face substantial competition from other biotechnology and pharmaceutical companies, which may result in others discovering, developing or commercializing products more successfully than we do
5. 32Commercial sales of our products and any products we acquire, may expose us to expensive product liability claims, and we may not be able to maintain product liability insurance on reasonable terms or at all
6. 33We or the third parties upon whom we depend may be adversely affected by natural disasters and/or health epidemics, and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
7. 34expenses as a result of the limited nature of our disaster recovery and business continuity plans, which could have a material adverse effect on our business, financial condition and results of operation

Risks Related to Our Common Stock

1. 35The price of our common stock may be volatile and you may lose all or part of your investment
2. 36We are subject to anti-takeover provisions in our second amended and restated articles of incorporation and amended and restated bylaws and under Virginia law that could delay or prevent an acquisition of our company, even if the acquisition would be beneficial to our shareholders
3. 37If we fail to maintain an effective system of internal control over financial reporting, we may not be able to report our financial condition, results of operations or cash flows accurately, which may adversely affect investor confidence in us and, as a result, the value of our common stock
4. 38There can be no assurance that we will repurchase additional shares of our common stock at all or at favorable prices