Coherus Oncology (CHRS) risk factors, FY2024 10-K

Risks Related to Our Financial Condition and Capital Requirements

1. 01We have a limited history of profitability, which we have not maintained and may not achieve again, and only two products that have been approved and marketed, one of which we have agreed to sell, and with multiple products that are not approved and still in development

Risks Related to Launch and Commercialization of our Products and our Product Candidates

1. 02We have a limited operating history in an emerging regulatory environment on which to assess our business
2. 03The third-party coverage and reimbursement status of our products are uncertain. Failure to obtain or maintain adequate coverage and reimbursement for new or current products could limit our ability to market those products and decrease our ability to generate revenue
3. 04Medicare, then the cost of the relevant product may be absorbed by healthcare providers or charged to patients. If this is the case, our expectations of the pricing we expect to achieve for such product and the related potential revenue may be significantly diminished
4. 05Our products and our product candidates, even if approved, will remain subject to regulatory scrutiny
5. 06We also cannot predict the likelihood, nature or extent of government regulation that may arise from future legislation or administrative or executive action, either in the United States, China or other foreign countries

Risks Related to Competitive Activity

1. 07Casdozokitug is in development and is the only antagonist antibody in development known to us that is targeting the immune regulatory cytokine IL-27
2. 08These companies may also have greater brand recognition and more experience in conducting preclinical testing and clinical trials of product candidates, obtaining FDA and other regulatory approvals of products and marketing and commercializing products once approved
3. 09If other competitors to toripalimab (in indications besides those approved for LOQTORZI), casdozokitug, CHS-1000 and CHS-114 are approved and successfully commercialized before toripalimab (in indications besides those approved for LOQTORZI), casdozokitug, CHS-1000 and CHS-114, our business would suffer
4. 10If an improved version of an originator product, such as Neulasta, is developed or if the market for the originator product significantly declines, sales of our biosimilar product may suffer
5. 11Any product candidates for which we intend to seek approval as original biologic products may face competition sooner than anticipated

Risks Related to Our Ability to Hire and Retain Highly Qualified Personnel

1. 12We are highly dependent on the services of our key executives and personnel, including our President and Chief Executive Officer, Dennis M. Lanfear, and if we are not able to retain these members of our management or recruit additional management, product development and scientific personnel, our business will suffer
2. 13We may experience difficulties in managing changes in our number of employees, particularly due to employees departing due to divestitures, reductions in force and turnover, which could disrupt our operations

Risks Related to Reliance on Third Parties

1. 14We have an exclusive license from Junshi Biosciences to develop and commercialize LOQTORZI in the United States and Canada. Our licensors are responsible for supplying us with drug substance and final drug products
2. 15Our exclusive licensee, Orox / Laboratorio Gador S.A., is responsible for commercialization of certain of our products and product candidates, including UDENYCA, in certain Caribbean and Latin American countries (excluding Brazil, and in the case of UDENYCA, also excluding Argentina)

Risks Related to the UDENYCA Sale and our future operations following the UDENYCA Sale

1. 16The announcement and pendency of the UDENYCA Sale, whether or not consummated, may adversely affect our business
2. 17The closing of the UDENYCA Sale is subject to multiple conditions beyond our control. Failure to complete the UDENYCA Sale could materially and adversely affect our future business, results of operations, financial condition and stock price
3. 18The UDENYCA Purchase Agreement limits our ability to pursue alternatives to the UDENYCA Sale
4. 19There is no guarantee that we will receive either of the Earnout Payments under the UDENYCA Purchase Agreement
5. 20Our stockholders should not assume that they will receive any of the proceeds of the UDENYCA Sale
6. 21We have incurred and will continue to incur significant expenses in connection with the UDENYCA Sale, regardless of whether the UDENYCA Sale is completed
7. 22Immediately following the UDENYCA Sale, we will be a commercial-stage biopharmaceutical company focused on the research, development and commercialization of innovative immunotherapies to treat cancer
8. 23We have discretion in the use of the proceeds from the UDENYCA Sale and our choices about the use of proceeds may not be effective
9. 24proceeds other than as described above and has not committed to making any such decision by a particular date. This uncertainty may negatively impact the value and liquidity of our common stock

Risks Related to Manufacturing and Supply Chain

1. 25We currently engage single suppliers for manufacture, clinical trial services, formulation development and product testing of our products and product candidates. The loss of any of these suppliers or vendors could materially and adversely affect our business
2. 26We and our collaboration partners and contract manufacturers are subject to significant regulation with respect to manufacturing our product candidates. The manufacturing facilities on which we rely may not continue to meet regulatory requirements or may not be able to meet supply demands

Risks Related to Adverse Events

1. 27Our products or our product candidates may cause undesirable side effects or have other properties that could, as applicable, delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if granted
2. 28Any of these events could prevent us from achieving or maintaining market acceptance of the particular product candidate, if approved, and could significantly harm our business, results of operations and prospects
3. 29Adverse events involving an originator product, other biosimilars of such originator product or other anti-PD-1 or PD-L1 antibody product may negatively affect our business

Risks Related to Intellectual Property

1. 30If we infringe or are alleged to infringe intellectual property rights of third parties, our business could be harmed. Third-party claims of intellectual property infringement may prevent or delay our development and commercialization efforts
2. 31technology for commercialization of our product candidates. Third parties may have blocking patents that could prevent us from commercializing our own products, even if our products use or embody our own, patented inventions
3. 32We may be involved in lawsuits or IPR proceedings to protect or enforce our patents, which could be expensive, time consuming and unsuccessful
4. 33We may be subject to claims that our employees, consultants, or independent contractors have wrongfully used or disclosed confidential information of third parties or that our employees have wrongfully used or disclosed alleged trade secrets of their former employers
5. 34If we fail to comply with our obligations in the agreements under which we license intellectual property and other rights from third parties or otherwise experience disruptions to our business relationships with our licensors, we could lose license rights that are important to our business
6. 35We may not be successful in obtaining or maintaining necessary rights to our products and product candidates through acquisitions and in-licenses

Risks Related to the Discovery and Development of Our Product Candidates

1. 36We are heavily dependent on the development, clinical success, regulatory approval and commercial success of our product candidates. We cannot give any assurance that any of our product candidates will receive regulatory approval, which is necessary before they can be commercialized
2. 37received approval from the FDA and EMA, and LOQTORZI, which has received approval from the FDA and is also approved for use in China, and it is possible that none of our other current or future product candidates will ever obtain additional regulatory approvals
3. 38Before obtaining marketing approval from regulatory authorities for the sale of our product candidates, we or our collaboration partners, or both, as the case may be, must conduct clinical studies to demonstrate the safety and efficacy of the product candidates in humans
4. 39If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
5. 40the risk that patients enrolled in clinical trials will drop out of such trials before completion
6. 41The development, manufacture and commercialization of biosimilar products under various global regulatory pathways pose unique risks
7. 42If other biosimilars of pegfilgrastim (Neulasta) are determined to be interchangeable and our biosimilar product is not, our business could suffer
8. 43Failure to obtain regulatory approval in any targeted regulatory jurisdiction would prevent us from marketing our products to a larger patient population and reduce our commercial opportunities
9. 44We may not be successful in our efforts to identify, develop or commercialize additional product candidates

Risks Related to Our Compliance with Applicable Laws

1. 45Healthcare reform measures, including the IRA, may increase the difficulty and cost for us to obtain marketing approval for and commercialize our products, affect the prices we may set, and have a material adverse effect on our business and results of operations
2. 46Since its enactment, there have been judicial, executive and Congressional challenges to certain aspects of the ACA. On June 17, 2021, the United States Supreme Court dismissed the most recent judicial challenge to the ACA brought by several states without specifically ruling on the constitutionality of the ACA
3. 47We may be subject, directly or indirectly, to federal and state healthcare laws, including fraud and abuse, false claims and physician payment transparency laws. If we are unable to comply or have not fully complied with such laws, we could face substantial penalties
4. 48Because of the breadth of these laws and the narrowness of the statutory exceptions and safe harbors available, it is possible that some of our business activities could be subject to challenge under one or more of such laws. In addition, recent health care reform legislation has strengthened these laws
5. 49state law requirements, we may become subject to penalties or other enforcement mechanisms, which could have a material adverse effect on our business

Risks Related to Ownership of Our Common Stock

1. 50The market price of our common stock may be highly volatile, and purchasers of our common stock could incur substantial losses
2. 51remediation is in progress and will require validation and testing of operating effectiveness of internal controls over multiple financial reporting cycles
3. 52Our principal stockholders and management own a significant percentage of our stock and will be able to exert significant control over matters subject to stockholder approval
4. 53Any of the foregoing factors could have negative consequences on our financial condition and results of operations
5. 54Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall
6. 55Future sales and issuances of our common stock or rights to purchase common stock, including pursuant to our equity incentive plans and convertible notes, could result in additional dilution of the percentage ownership of our stockholders and could cause our stock price to fall
7. 56Adverse developments affecting the financial services industry, such as actual events or concerns involving liquidity, defaults, or non-performance by financial institutions or transactional counterparties, could adversely affect our business operations, financial condition, results of operations and prospects
8. 57We do not intend to pay dividends on our common stock so any returns will be limited to the value of our stock
9. 58Provisions in our amended and restated certificate of incorporation and amended and restated bylaws, as well as provisions of Delaware law, could make it more difficult for a third party to acquire us or increase the cost of acquiring us, even if doing so would benefit our stockholders or remove our current management
10. 59In addition, because we are incorporated in Delaware, we are governed by the provisions of Section 203 of the Delaware General Corporation Law, which limits the ability of stockholders owning in excess of 15% of our outstanding voting stock to merge or combine with us
11. 60We depend on a limited number of wholesalers for a significant amount of our total revenue, and if we lose any of our significant wholesalers, our business could be harmed
12. 61The international aspects of our business expose us to business, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States
13. 62Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks
14. 63Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed
15. 64So called “submarine” patents may be granted to our competitors that may significantly alter our launch timing expectations, reduce our projected market size, cause us to modify our product or process or block us from the market altogether
16. 65We may not identify relevant patents or may incorrectly interpret the relevance, scope or expiration of a patent, which might adversely affect our ability to develop and market our products
17. 66Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products
18. 67Obtaining and maintaining our patent protection depends on compliance with various procedural requirements, document submissions, fee payment and other requirements imposed by governmental patent agencies. Our patent protection could be reduced or eliminated for non-compliance with these requirements
19. 68We may not be able to protect our intellectual property rights throughout the world
20. 69If we are unable to maintain effective (non-patent) proprietary rights for our products and product candidates, we may not be able to compete effectively in our markets
21. 70adequate remedies for any breach. Our confidential information and trade secrets thus may become known by our competitors in ways we cannot prove or remedy
22. 71We may be subject to claims challenging the inventorship of our patent filings and other intellectual property
23. 72We or the third parties upon whom we depend on may be adversely affected by earthquakes, wildfires or other natural disasters and our business continuity and disaster recovery plans may not adequately protect us from a serious disaster
24. 73The continuation of the war in Ukraine and conflicts in the Middle East may exacerbate certain risks we face
25. 74Our information technology systems, or those used by our third-party CROs or other contractors or consultants, may fail or suffer security breaches and geopolitical tensions or conflicts, such as the ongoing war in Ukraine or conflicts in the Middle East, may create a heightened risk of cyberattacks
26. 75We may be negatively impacted by continued inflation
27. 76If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business