Coherus Oncology (CHRS) FY2025 10-K Risk Factors: 11 New, 22 Dropped

What the changes say

Coherus faces heightened competition and commercialization dependencies after divesting UDENYCA to focus on immuno-oncology pipelines like LOQTORZI.

What changed since the prior 10-K

New

NewRisks Related to Competitive Activity
Our product LOQTORZI and product candidates tagmokitug and casdozokitug, if approved, will face significant competition from other immuno-oncology biologics. If we fail to compete effectively, we may not achieve significant market penetration and expansion
Our product LOQTORZI and product candidates tagmokitug and casdozokitug face intense competition from large multinational pharmaceutical companies with greater resources.
NewRisks Related to Reliance on Third Parties
We are dependent on Junshi Biosciences for the commercialization of our product and the failure to commercialize could have a material adverse effect on our business and operating results
We depend entirely on Junshi Biosciences to commercialize our product, and their failure to do so would harm our operating results.
NewRisks Related to Our Future Operations Following the UDENYCA Sale
There are risks and uncertainties associated with the UDENYCA TSA, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows or stock price
Providing transition support services to Intas under the UDENYCA TSA will consume management time and expose us to unanticipated costs and Intas financial status.
NewRisks Related to Manufacturing and Supply Chain
or such benefits may be delayed or not occur at all. If we do not realize some or all of the benefits expected to result from the onshoring initiative, or if such benefits are delayed, our business and expected future financial and operating results could be adversely affected
Adverse developments or delays in our manufacturing onshoring initiative could cause shipment delays, inventory shortages, or write-downs affecting operating results.
NewRisks Related to Manufacturing and Supply Chain
complete a pre-approval plant inspection, regulatory approval of the products may not be granted or may be substantially delayed until any violations are corrected to the satisfaction of the regulatory authority, if ever
Regulatory authorities may inspect our manufacturing facilities or our partners' facilities, and any violations could result in costly remedial measures or suspended sales.
NewRisks Related to Adverse Events
our primary business, initiation of investigations by regulators, substantial monetary awards to patients or other claimants, the inability to commercialize our product candidates and decreased demand for our product candidates, if approved for commercial sale
Undesirable side effects from our product or product candidates could lead to withdrawn approvals, label warnings, REMS plans, or liability lawsuits.
NewRisks Related to the Discovery and Development of Our Product Candidates
The regulatory approval processes of the FDA, EMA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. If we and our collaboration partners are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmed
The regulatory approval processes of the FDA, EMA and foreign authorities are lengthy and unpredictable, threatening our ability to commercialize product candidates.
NewRisks Related to the Discovery and Development of Our Product Candidates
We are marketing LOQTORZI in the United States and may seek to partner commercially our pipeline products outside the United States
We must obtain separate regulatory approvals to market LOQTORZI and pipeline products outside the United States, which may be delayed or denied.
NewRisks Related to the Discovery and Development of Our Product Candidates
We may fail to obtain orphan drug designations from the FDA for our product candidates, and even if we obtain such designations, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivity
We may fail to obtain or maintain orphan drug designations and their associated financial incentives and market exclusivity from the FDA.
NewRisks Related to Ownership of Our Common Stock
protect our intellectual property, provide exclusivity for our product candidates or prevent others from designing around our claims. Any of these outcomes could impair our ability to prevent competitors from using the technologies claimed in any patents issued to us, which may have an adverse impact on our business
Changes to U.S. patent laws and third-party challenges to our patent validity could impair our intellectual property protection and competitive advantage.
NewRisks Related to Ownership of Our Common Stock
board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable terms
Deficiencies in our internal controls over financial reporting under Sarbanes-Oxley Section 404 could misstate financial statements and cause our stock price to fall.

Dropped

DroppedRisks Related to Launch and Commercialization of our Products and our Product Candidates
Medicare, 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
DroppedRisks Related to Competitive Activity
If 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
DroppedRisks Related to Reliance on Third Parties
Our 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)
DroppedRisks Related to the UDENYCA Sale and our future operations following the UDENYCA Sale
The announcement and pendency of the UDENYCA Sale, whether or not consummated, may adversely affect our business
Foreign price controls may reduce expected revenue and pricing for products.
DroppedRisks Related to the UDENYCA Sale and our future operations following the UDENYCA Sale
The 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
DroppedRisks Related to the UDENYCA Sale and our future operations following the UDENYCA Sale
The UDENYCA Purchase Agreement limits our ability to pursue alternatives to the UDENYCA Sale
DroppedRisks Related to the UDENYCA Sale and our future operations following the UDENYCA Sale
Our stockholders should not assume that they will receive any of the proceeds of the UDENYCA Sale
DroppedRisks Related to the UDENYCA Sale and our future operations following the UDENYCA Sale
We have incurred and will continue to incur significant expenses in connection with the UDENYCA Sale, regardless of whether the UDENYCA Sale is completed
DroppedRisks Related to the UDENYCA Sale and our future operations following the UDENYCA Sale
Immediately 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
DroppedRisks Related to the UDENYCA Sale and our future operations following the UDENYCA Sale
We have discretion in the use of the proceeds from the UDENYCA Sale and our choices about the use of proceeds may not be effective
Competitor improvements to reference products like Neulasta may reduce biosimilar sales.
DroppedRisks Related to the UDENYCA Sale and our future operations following the UDENYCA Sale
proceeds 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
DroppedRisks Related to Intellectual Property
technology 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
DroppedRisks Related to the Discovery and Development of Our Product Candidates
received 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
DroppedRisks Related to the Discovery and Development of Our Product Candidates
The development, manufacture and commercialization of biosimilar products under various global regulatory pathways pose unique risks
DroppedRisks Related to the Discovery and Development of Our Product Candidates
If other biosimilars of pegfilgrastim (Neulasta) are determined to be interchangeable and our biosimilar product is not, our business could suffer
Exclusive licensee Orox/Gador is responsible for certain product commercialization in Latin America.
DroppedRisks Related to the Discovery and Development of Our Product Candidates
Failure 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
The announcement and pendency of the UDENYCA Sale may adversely affect business.
DroppedRisks Related to Our Compliance with Applicable Laws
Since 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
Closing conditions for the UDENYCA Sale, including FDA authorization, are beyond our control.
DroppedRisks Related to Our Compliance with Applicable Laws
state law requirements, we may become subject to penalties or other enforcement mechanisms, which could have a material adverse effect on our business
The UDENYCA Purchase Agreement limits our ability to pursue alternative acquisition proposals.
DroppedRisks Related to Ownership of Our Common Stock
remediation is in progress and will require validation and testing of operating effectiveness of internal controls over multiple financial reporting cycles
DroppedRisks Related to Ownership of Our Common Stock
Our 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
Stockholders should not assume they will receive proceeds from the UDENYCA Sale.
DroppedRisks Related to Ownership of Our Common Stock
Sales of a substantial number of shares of our common stock in the public market could cause our stock price to fall
We incurred significant expenses in connection with the UDENYCA Sale regardless of completion.
DroppedRisks Related to Ownership of Our Common Stock
adequate remedies for any breach. Our confidential information and trade secrets thus may become known by our competitors in ways we cannot prove or remedy
Post-sale, we will operate strictly as an immuno-oncology and LOQTORZI commercial company.

Reworded

100% rewrittenRisks Related to Reliance on Third Parties
We have an exclusive license from Junshi Biosciences to develop and commercialize LOQTORZI in the United States and Canada. Junshi Biosciences is responsible for supplying us with drug substance and final drug products
Expanded to detail specific collaboration risks including partner failures in supply, regulatory inspections, financial difficulties, or termination.
Was: We 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
90% rewrittenRisks Related to Our Compliance with Applicable Laws
Healthcare reform measures, including the IRA and the OBBBA, may increase the difficulty and cost for us to obtain marketing approval for and commercialize our product, affect the prices we may set, and have a material adverse effect on our business and results of operations
Updated healthcare reform references to include the OBBBA alongside the IRA and ACA.
Was: Healthcare 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
75% rewrittenRisks Related to Manufacturing and Supply Chain
We 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
Minor text edits updated references from plural products to singular product and product candidates.
73% rewrittenRisks Related to Competitive Activity
Casdozokitug is in development and, although it is the only antagonist antibody in development known to us that is targeting the immune regulatory cytokine IL-27, if approved it faces competition from other immuno-oncology products that are currently approved and that may be approved in the future
Updated pipeline targets, replacing CHS-114 with tagmokitug and updating competitor lists for CCR8 programs.
Was: Casdozokitug is in development and is the only antagonist antibody in development known to us that is targeting the immune regulatory cytokine IL-27
72% rewrittenRisks Related to Ownership of Our Common Stock
Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our product and product candidates
Updated phrasing from our products to our product and product candidates regarding patent protection.
Was: Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our products
67% rewrittenRisks Related to Competitive Activity
These 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
Removed specific biosimilar litigation bullet points and generalized competitor resource advantages and M&A impacts.
61% rewrittenRisks Related to Ownership of Our Common Stock
The market price of our common stock may be highly volatile, and purchasers of our common stock could incur substantial losses
Advanced stock price date range to December 31, 2025, and updated earnout and regulatory filing risk factors.
60% rewrittenRisks Related to Manufacturing and Supply Chain
We currently engage single suppliers for manufacture, clinical trial services, formulation development and product testing of our product and product candidates. The loss of any of these suppliers or vendors could materially and adversely affect our business
Updated singular and plural references regarding single suppliers and vendors for manufacturing and development.
Was: We 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
58% rewrittenRisks Related to Intellectual Property
We 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
54% rewrittenRisks Related to the Discovery and Development of Our Product Candidates
We 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
54% rewrittenRisks Related to Ownership of Our Common Stock
The continuation of the war in Ukraine and conflicts in the Middle East may exacerbate certain risks we face
52% rewrittenRisks Related to Launch and Commercialization of our Product and our Product Candidates
The third-party coverage and reimbursement status of our product is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for any new products or our current product could limit our ability to market those products and decrease our ability to generate revenue
Was: The 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
51% rewrittenRisks Related to Ownership of Our Common Stock
If we are unable to maintain effective (non-patent) proprietary rights for our product and product candidates, we may not be able to compete effectively in our markets
Was: If 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
48% rewrittenRisks Related to Ownership of Our Common Stock
Future 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
42% rewrittenRisks Related to Our Future Operations Following the UDENYCA Sale
There is no guarantee that we will receive either of the Earnout Payments under the UDENYCA Purchase Agreement
40% rewrittenRisks Related to Launch and Commercialization of our Product and our Product Candidates
We 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
34% rewrittenRisks Related to Our Financial Condition and Capital Requirements
We have a limited history of profitability, which we have not maintained and may not achieve again, and only one product that has been approved and marketed and with multiple product candidates that are not approved and still in development
Was: We 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
33% rewrittenRisks Related to Adverse Events
Adverse events involving another anti-PD-1 or PD-L1 antibody product may negatively affect our business
Was: Adverse 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
30% rewrittenRisks Related to Ownership of Our Common Stock
We 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
29% rewrittenRisks Related to Launch and Commercialization of our Product and our Product Candidates
We have a limited operating history in an emerging regulatory environment on which to assess our business
29% rewrittenRisks Related to Our Ability to Hire and Retain Highly Qualified Personnel
We 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
27% rewrittenRisks Related to Competitive Activity
If other competitors to toripalimab (in indications besides those approved for LOQTORZI), casdozokitug and tagmokitug are approved and successfully commercialized before toripalimab (in indications besides those approved for LOQTORZI), casdozokitug and tagmokitug, our business would suffer
Was: If 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
25% rewrittenRisks Related to Adverse Events
Our product 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
Was: Our 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
24% rewrittenRisks Related to Adverse Events
Any of these events could prevent us from achieving or maintaining market acceptance of the particular product or product candidate, if approved, and could significantly harm our business, results of operations and prospects
Was: Any 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
22% rewrittenRisks Related to Intellectual Property
If 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
22% rewrittenRisks Related to Launch and Commercialization of our Product and our Product Candidates
Our product and our product candidates, even if approved, will remain subject to regulatory scrutiny
Was: Our products and our product candidates, even if approved, will remain subject to regulatory scrutiny

All 65 risk factors

Headings as the filing states them, in filing order.

Risks Related to Our Financial Condition and Capital Requirements

01We have a limited history of profitability, which we have not maintained and may not achieve again, and only one product that has been approved and marketed and with multiple product candidates that are not approved and still in development34% rewritten

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

02We have a limited operating history in an emerging regulatory environment on which to assess our business29% rewritten
03The third-party coverage and reimbursement status of our product is uncertain. Failure to obtain or maintain adequate coverage and reimbursement for any new products or our current product could limit our ability to market those products and decrease our ability to generate revenue52% rewritten
04Our product and our product candidates, even if approved, will remain subject to regulatory scrutiny22% rewritten
05We 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 countries40% rewritten

Risks Related to Competitive Activity

06Our product LOQTORZI and product candidates tagmokitug and casdozokitug, if approved, will face significant competition from other immuno-oncology biologics. If we fail to compete effectively, we may not achieve significant market penetration and expansionNew
07Casdozokitug is in development and, although it is the only antagonist antibody in development known to us that is targeting the immune regulatory cytokine IL-27, if approved it faces competition from other immuno-oncology products that are currently approved and that may be approved in the future73% rewritten
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 approved67% rewritten
09If other competitors to toripalimab (in indications besides those approved for LOQTORZI), casdozokitug and tagmokitug are approved and successfully commercialized before toripalimab (in indications besides those approved for LOQTORZI), casdozokitug and tagmokitug, our business would suffer27% rewritten
10Any 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

11We 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
12We 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 operations29% rewritten

Risks Related to Reliance on Third Parties

13We are dependent on Junshi Biosciences for the commercialization of our product and the failure to commercialize could have a material adverse effect on our business and operating resultsNew
14We have an exclusive license from Junshi Biosciences to develop and commercialize LOQTORZI in the United States and Canada. Junshi Biosciences is responsible for supplying us with drug substance and final drug products100% rewritten

Risks Related to Our Future Operations Following the UDENYCA Sale

15There is no guarantee that we will receive either of the Earnout Payments under the UDENYCA Purchase Agreement42% rewritten
16There are risks and uncertainties associated with the UDENYCA TSA, one or more of which could have a material adverse effect on our business, financial condition, results of operations, cash flows or stock priceNew

Risks Related to Manufacturing and Supply Chain

17or such benefits may be delayed or not occur at all. If we do not realize some or all of the benefits expected to result from the onshoring initiative, or if such benefits are delayed, our business and expected future financial and operating results could be adversely affectedNew
18We currently engage single suppliers for manufacture, clinical trial services, formulation development and product testing of our product and product candidates. The loss of any of these suppliers or vendors could materially and adversely affect our business60% rewritten
19We 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 demands75% rewritten
20complete a pre-approval plant inspection, regulatory approval of the products may not be granted or may be substantially delayed until any violations are corrected to the satisfaction of the regulatory authority, if everNew

Risks Related to Adverse Events

21Our product 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 granted25% rewritten
22our primary business, initiation of investigations by regulators, substantial monetary awards to patients or other claimants, the inability to commercialize our product candidates and decreased demand for our product candidates, if approved for commercial saleNew
23Any of these events could prevent us from achieving or maintaining market acceptance of the particular product or product candidate, if approved, and could significantly harm our business, results of operations and prospects24% rewritten
24Adverse events involving another anti-PD-1 or PD-L1 antibody product may negatively affect our business33% rewritten

Risks Related to Intellectual Property

25If 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 efforts22% rewritten
26We may be involved in lawsuits or IPR proceedings to protect or enforce our patents, which could be expensive, time consuming and unsuccessful
27We 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 employers58% rewritten
28If 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
29We may not be successful in obtaining or maintaining necessary rights to our product and product candidates through acquisitions and in-licenses

Risks Related to the Discovery and Development of Our Product Candidates

30We 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 commercialized54% rewritten
31The regulatory approval processes of the FDA, EMA and comparable foreign authorities are lengthy, time consuming and inherently unpredictable. If we and our collaboration partners are ultimately unable to obtain regulatory approval for our product candidates, our business will be substantially harmedNew
32Before 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
33If we encounter difficulties enrolling patients in our clinical trials, our clinical development activities could be delayed or otherwise adversely affected
34the risk that patients enrolled in clinical trials will drop out of such trials before completion
35We are marketing LOQTORZI in the United States and may seek to partner commercially our pipeline products outside the United StatesNew
36We may not be successful in our efforts to identify, develop or commercialize additional product candidates
37We may fail to obtain orphan drug designations from the FDA for our product candidates, and even if we obtain such designations, we may be unable to maintain the benefits associated with orphan drug designation, including the potential for market exclusivityNew

Risks Related to Our Compliance with Applicable Laws

38Healthcare reform measures, including the IRA and the OBBBA, may increase the difficulty and cost for us to obtain marketing approval for and commercialize our product, affect the prices we may set, and have a material adverse effect on our business and results of operations90% rewritten
39We 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
40Because 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

Risks Related to Ownership of Our Common Stock

41The market price of our common stock may be highly volatile, and purchasers of our common stock could incur substantial losses61% rewritten
42Any of the foregoing factors could have negative consequences on our financial condition and results of operations
43Future 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 fall48% rewritten
44Adverse 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
45We do not intend to pay cash dividends on our common stock so any returns would be limited to the value of our stock
46Provisions 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
47In 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
48We 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 harmed30% rewritten
49The 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
50Investors’ expectations of our performance relating to environmental, social and governance factors may impose additional costs and expose us to new risks
51Our 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
52So 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
53We 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 product
54Our failure to identify and correctly interpret relevant patents may negatively impact our ability to develop and market our product and product candidates72% rewritten
55protect our intellectual property, provide exclusivity for our product candidates or prevent others from designing around our claims. Any of these outcomes could impair our ability to prevent competitors from using the technologies claimed in any patents issued to us, which may have an adverse impact on our businessNew
56Obtaining 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
57We may not be able to protect our intellectual property rights throughout the world
58If we are unable to maintain effective (non-patent) proprietary rights for our product and product candidates, we may not be able to compete effectively in our markets51% rewritten
59We may be subject to claims challenging the inventorship of our patent filings and other intellectual property
60We 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
61The continuation of the war in Ukraine and conflicts in the Middle East may exacerbate certain risks we face54% rewritten
62board committees or to serve as executive officers, or to obtain certain types of insurance, including directors’ and officers’ insurance, on acceptable termsNew
63Our 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
64We may be negatively impacted by continued inflation
65If 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

Other Coherus Oncology 10-Ks

FY2024 10-K risk factors
76 risks
Company relies heavily on the pending sale of UDENYCA to Intas to pay off $230 million in convertible notes and $47.7 million in royalties.
Filed Mar 17, 2025

About this page

The headings are the filing's own. The one-line readings and the overview are automated and can be wrong: read Item 1A of the 10-K for the exact wording.