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Sun Oct 25 · markets closed1 signal on Oct 2494 insider buys this week · $48.3MCIRO short report next: Oct 30The week ahead

CHRS

Coherus Oncology, Inc.
NASDAQ · HEALTH CARE · BIOLOGICAL PRODUCTS, (NO DIAGNOSTIC SUBSTANCES)
1.01
−0.04 −3.81%
USD · close Oct 23
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nobody we score has called it yet
MKT CAP $156MP/E —DIV YIELD —FCF YIELD —REV TTM —NET INCOME −$132.1M −173.5%NET CASH $9.3M52W 0.96 – 2.51SEC XBRL · TTM TO Invalid Date

How CHRS rewrote its risk factors

10-K ITEM 1A · FY2024 → FY2025
Text kept
48%
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252
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Length
−7,182
words, now 32,047

New in FY2025

  • Risk Factors Investing in the common stock of a commercial-stage innovative oncology company, including one with a significant international partnership and multiple product candidates in development, is a highly speculative undertaking and involves a substantial degree of risk.
  • Risks 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.
  • We have generated significant operating losses in all the years since our inception except for certain periods that had gains from divestitures and 2020 and 2019.
  • It is uncertain that we will be profitable in future periods, particularly now that the UDENYCA Sale was consummated, as research and development is expensive and risky.
  • The amount of our future net losses or any future net income will depend, in part, on the amount of our future expenditures offset by the amount of future product sales, including sales of our current product or any other products that may receive regulatory approval.
  • Innovative oncology product development is a highly speculative undertaking and involves a substantial degree of risk.
  • For example, as of December 31, 2025, we had an accumulated deficit of $1.4 billion.
  • The losses and accumulated deficit were primarily due to the substantial investments we made to commercialize our product and identify, develop or acquire our product candidates, including conducting, among other things, analytical characterization, process development and manufacturing, formulation and clinical studies and providing general and administrative support for these operations.
  • We have incurred and anticipate we will continue to incur certain development and commercial expenses for LOQTORZI, the anti-PD-1 antibody we licensed from Junshi Biosciences in 2021, and have agreed to pay up to $90.0 million for the achievement of certain regulatory approvals and up to $290.0 million for the attainment of certain sales thresholds.
  • The launch of this product and future work to advance our other product candidates through clinical development in combination with toripalimab will be expensive and could result in us continuing to experience future net losses.
  • For LOQTORZI, our only commercial product, and if we obtain regulatory approval to market any other product candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive approval and our ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payers, and adequate market share for our product candidates which include all product candidates for which we obtained commercial rights, in those markets.
  • However, even if additional product candidates in addition to our current product gain regulatory approval and are commercialized, we may not become profitable.
  • Our expenses will increase substantially if and as we: ● establish a sales, marketing and distribution infrastructure to commercialize any of our product candidates for which we may obtain marketing approval; ● make upfront, milestone, royalty or other payments under any license agreements; ● continue our nonclinical and clinical development of our product candidates; ● initiate additional nonclinical, clinical or other studies for our product candidates; ● expand the scope of our current clinical studies for our product candidates; ● advance our programs into more expensive clinical studies; ● change or add contract manufacturers, clinical research service providers, testing laboratories, device suppliers, legal service providers or other vendors or suppliers; ● seek regulatory approvals for our product candidates that successfully complete clinical studies; ● seek to identify, assess, acquire and/or develop other product candidates or products that may be complementary to our product; ● seek to create, maintain, protect and expand our intellectual property portfolio; ● engage legal counsel and technical experts to help us evaluate and avoid infringing any valid and enforceable intellectual property rights of third parties; ● engage in litigation, including patent litigation; ● seek to attract and retain skilled personnel; ● create additional infrastructure to support our operations as a public company and our product development and planned future commercialization efforts; and ● experience any delays or encounter issues with any of the above, including but not limited to failed studies, conflicting results, safety issues, manufacturing delays, litigation or regulatory challenges that may require longer follow-up of existing studies, additional major studies or additional supportive studies or analyses in order to pursue marketing approval.
  • In addition, the UDENYCA Sale closed on the UDENYCA Closing Date, which may make it more difficult or make it take more time for us to become profitable at any point in the future.
  • UDENYCA was our largest product that contributed significantly more revenue to our business than LOQTORZI currently.
  • LOQTORZI may not increase its revenue contribution to our business as quickly as we project or at all and our clinical trials for our product candidates may be delayed, may be unsuccessful or may take more time and expense to complete than we currently anticipate.
  • The inherent risk involved in divesting a major business could make it difficult for us to replace the revenue lost by the UDENYCA Sale or by becoming profitable in the future.
  • Further, the net loss or net income we achieve may fluctuate significantly from quarter-to-quarter and year-to-year such that a period-to-period comparison of our results of operations may not be a good indication of our future performance quarter-to-quarter and year-to-year due to factors including the timing of clinical trials, any litigation that we may initiate or that may be initiated against us as well as any settlements or judgments from such litigation, the execution of collaboration, licensing or other agreements and the timing of any payments we make or receive thereunder.
  • As of December 31, 2025, our cash, cash equivalents and marketable securities were $172.1 million.
  • In February 2026, we received approximately $47.0 million in net proceeds from a public offering of our common stock after deducting the underwriters’ discounts and commissions but before estimated offering expenses payable by us.
  • We expect that our existing cash and cash equivalents, investments, cash collected from our product sales and cash proceeds from the UDENYCA Sale will be sufficient to fund our current operations for the foreseeable future.
  • We have financed our operations primarily through the sale of equity securities, convertible notes, credit facilities, divestitures, license agreements and through recent product sales of our product.
  • Our future funding requirements will depend on many factors, including but not limited to: ● our ability to continue to successfully commercialize our product; ● our ability to maintain continuity for the supply of our product and product candidates; ● the scope, rate of progress, results and cost of any clinical studies, nonclinical testing and other related activities; ● the cost of manufacturing clinical drug supplies and establishing commercial supplies of our product and product candidates; ● the number and characteristics of product candidates that we pursue; ● the cost, timing and outcomes of regulatory approvals; ● our ability to receive either of the Earnout Payments (as defined below) in the future; ● the cost and timing of establishing sales, marketing and distribution capabilities; ● the terms and timing of any licensing or other arrangements to acquire intellectual property rights that we may establish, including any milestone and royalty payments thereunder; ● the timing of repayment in cash, whether due or not, of our long-term debt and the payment of interest, principal and royalties related to our financial liabilities; and ● the cost, timing and outcomes of any litigation that we may file against third parties or that may be filed against us by third parties.
  • The sale of additional equity or convertible securities, such as the sales from time to time through our Sales Agreement with TD Cowen (the “Sales Agreement”) pursuant to which we may issue and sell from time to time up to an additional approximately $64.9 million of our common stock, through or to TD Cowen as our sales agent or principal in an ATM offering, may dilute the share ownership of our existing stockholders.
  • The incurrence of indebtedness could result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as those contained in the 2029 Loan Agreement, including limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business such as a financial covenant which requires us to maintain certain levels of cash and cash equivalents.
  • If we are unable to obtain funding on a timely basis or at all, stay profitable or generate any net profits, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any product or product candidates or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our financial condition and results of operations.
  • Risks 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.
  • We are a commercial-stage innovative oncology company with a limited operating history in an emerging regulatory environment of immuno-oncology products.
  • Although we have received upfront payments, milestone and other contingent payments and/or funding for development from some of our collaboration and license agreements, our only approved product is LOQTORZI, which is approved for commercial sale in the United States, and we have no products approved in any other territories.
  • Our ability to generate meaningful revenue and remain profitable depends on our ability, alone or with strategic collaboration partners, to successfully market and sell our product, and to complete the development of, and obtain the regulatory approvals necessary to commercialize, one or more of our product pipeline candidates, which include: ● casdozokitug; ● tagmokitug; and ● toripalimab in non-NPC indications.
  • We may not be able to continue to generate meaningful revenue from product sales, as this depends heavily on our success in many areas, including but not limited to: ● our ability to continue to successfully commercialize LOQTORZI; ● healthcare providers, payers, and patients adopting our product and product candidates once approved and launched; ● obtaining additional regulatory approvals for product candidates for which we complete clinical studies; ● obtaining adequate third-party coverage and reimbursements for our product; ● obtaining market acceptance of our product and product candidates as viable treatment options; ● completing nonclinical and clinical development of our product candidates; ● developing and testing of our product formulations; ● attracting, hiring and retaining qualified personnel; ● developing a sustainable and scalable manufacturing process for our product and any approved product candidates and establishing and maintaining supply and manufacturing relationships with third parties that can conduct the process and provide adequate (in amount and quality) products to support clinical development and the market demand for our product and product candidates, if approved; ● addressing any competing technological and market developments; ● identifying, assessing and developing (or acquiring/in-licensing on favorable terms) new product candidates; ● negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; ● maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and ● defending against any litigation including patent or trade secret infringement lawsuits, which may be filed against us, or achieving successful outcomes lawsuits that we may in the future file against third parties.
  • In cases where we are successful in obtaining additional regulatory approvals to market one or more of our product candidates, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the number of competitors in such markets, the accepted price for the product, the ability to get reimbursement at any price, the nature and degree of competition from immuno-oncology companies (including competition from large pharmaceutical companies possessing large established positions in the immuno-oncology market that may be able to gain advantages in the sale of immuno-oncology products based on brand recognition or existing relationships with customers and payers) and whether we own (or have partnered with companies owning) the commercial rights for that territory.
  • If the market for our product and product candidates (or our share of that market) is not as significant as we expect, the price of our product is not what we project, the indication approved by regulatory authorities is narrower than we expect or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved.
  • If we are unable to successfully complete development and obtain additional regulatory approval for our product, our business may suffer.
  • The commercial success of our existing product or any future products will depend upon the degree of market acceptance and adoption by prescribing physicians, healthcare providers and the patients to whom our medicines are prescribed.
  • Additionally, obtaining placement on national or local clinical guidelines/pathways, as well as coverage on third-party payor formularies, can impact our short and long-term financial performance .
  • Even with the requisite approvals from the FDA and comparable foreign regulatory authorities, the commercial success of our product or product candidates, if approved, will depend in part on the medical community, patients and third-party payers accepting our product and product candidates as medically useful, cost-effective and safe.
  • The degree of market acceptance of our product LOQTORZI, or any of our product candidates, if approved for commercial sale, will depend on a number of factors, including: ● the safety and efficacy of the product, as demonstrated in clinical studies, and potential advantages over competing treatments; ● the prevalence and severity of any side effects and any limitations or warnings contained in a product’s approved labeling; ● the clinical indications for which approval is granted; ● for our product candidates, our ability to compete in a competitive immuno-oncology market; ● inclusion, in either parity or better position, on commonly accepted clinical guidelines or pathways that influence prescribing patterns and/or affect reimbursement; ● prevalence of the disease or condition for which the product is approved; ● the cost of treatment, particularly in relation to competing treatments; ● the willingness of the target patient population to try new therapies and of physicians to prescribe these therapies; ● the strength of marketing and distribution support and timing of market introduction of competitive products; ● the extent to which the product is approved for inclusion on formularies of hospitals, integrated delivery networks and managed care organizations; ● publicity concerning our product or competing products and treatments; ● the extent to which third-party payers (including government and national/regional commercial plans) provide adequate third-party coverage and reimbursement for our product and product candidates, if approved; ● the price at which we sell our product; ● the potential impact of the IRA on the pharmaceutical industry and the market for our product; ● the actions taken by current and future competitors to delay, restrict or block customer usage of the product; and ● our ability to maintain compliance with regulatory requirements.
  • Market acceptance of any future product candidates, if approved, will not be fully known until after they are launched and may be negatively affected by a potential poor safety experience and the track record of other products and product candidates.
  • Further, continued market acceptance of LOQTORZI, and any future product candidates that may be approved, depend on our efforts to educate the medical community and third-party payers on the benefits of our product and product candidates and will require significant resources from us and we have significantly less resources compared to large, well-funded pharmaceutical companies.

and 212 more.

Gone since FY2024

  • Risk Factors Risk Factor Summary Below is a summary of the principal factors that make an investment in our common stock speculative or risky.
  • This summary does not address all of the risks that we face.
  • Additional discussion of the risks summarized in this risk factor summary, and other risks that we face, can be found below under the heading “Risk Factors” and should be carefully considered, together with other information in this Annual Report on Form 10-K, including our financial statements and related notes thereto, before making investment decisions regarding our common stock. ● 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. ● The commercial success of our existing products or any future products will depend upon the degree of market acceptance and adoption by prescribing physicians, healthcare providers and the patients to whom our medicines are prescribed.
  • Additionally, obtaining placement on national and/or local clinical guidelines/pathways, as well as coverage on third-party payor formularies, can impact our short and long-term financial performance. ● As we have in-licensed development and/or commercial rights to LOQTORZI, we rely on prior and ongoing preclinical, clinical, regulatory and manufacturing expertise of our collaborators in order to advance this product candidate through regulatory approvals in the United States and other licensed territories. ● Our products and our product candidates, even if approved, will remain subject to regulatory scrutiny. ● Disruptions at the FDA and other government agencies caused by funding shortages, government shut-downs or global health concerns could hinder their ability to hire, retain or deploy key leadership and other personnel, and conduct inspections of manufacturing facilities, or otherwise prevent new or modified products from being developed, or approved or commercialized in a timely manner or at all, which could negatively impact our business. ● Our biosimilar product faces significant competition from the reference product and from other biosimilar products or pharmaceuticals approved for the same indication as the originator products.
  • LOQTORZI faces significant competition from other immuno-oncology biologics.
  • If we fail to compete effectively, we may not achieve significant market penetration and expansion. ● We face intense competition and rapid technological change and the possibility that our competitors may develop therapies that are similar, more advanced or more effective than ours, which may adversely affect our financial condition and our ability to successfully commercialize our product candidates. ● 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. ● 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. ● We 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, clinical and scientific personnel, our business will suffer. ● We rely on third parties to conduct our nonclinical and clinical studies and perform other tasks for us.
  • If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our product candidates and our business could be substantially harmed. ● We are subject to a multitude of manufacturing risks and the risks of inaccurately forecasting sales of our products.
  • We also need to make a determination of excess or obsolete inventory that requires judgment and may result in write-downs of inventory, charges related to firm purchase commitments, or both.
  • Any adverse developments affecting the manufacturing operations of our products and product candidates could substantially increase our costs and limit supply for our products and product candidates. ● The continuation of the war between Russia and Ukraine and conflicts in the Middle East may exacerbate certain risks we face. ● 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. ● 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. ● 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. ​ Risk Factors Investing in the common stock of a biopharmaceutical company, including one with significant international partnerships and multiple products in development, is a highly speculative undertaking and involves a substantial degree of risk.
  • Risks 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 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.
  • With the exception of generating net income of $28.5 million, $132.2 million and $89.8 million in 2024, 2020 and 2019, respectively, we incurred net losses in each year from our inception in September 2010 through December 31, 2024, including net losses of $237.9 million and $291.8 million in 2023 and 2022, respectively.
  • It is uncertain that we will be profitable in future periods, particularly if the UDENYCA Sale is consummated, as research and development is expensive and risky.
  • The amount of our future net losses or any future net income will depend, in part, on the amount of our future expenditures offset by the amount of future product sales, including sales of our current products or any other products that may receive regulatory approval.
  • Biopharmaceutical product development is a highly speculative undertaking and involves a substantial degree of risk.
  • For example, as of December 31, 2024, we had an accumulated deficit of $1.6 billion.
  • The losses and accumulated deficit were primarily due to the substantial investments we made to identify, develop or license our product candidates, including conducting, among other things, analytical characterization, process development and manufacturing, formulation and clinical studies and providing general and administrative support for these operations. ​ We have incurred and anticipate we will continue to incur certain development and commercial expenses for LOQTORZI, the anti-PD-1 antibody we licensed from Junshi Biosciences in 2021, and have agreed to pay up to $90.0 million for the achievement of certain regulatory approvals and up to $290.0 million for the attainment of certain sales thresholds.
  • The recent launch of this product and future work to advance our other product candidates through clinical development in combination with toripalimab will be expensive and could result in us continuing to experience future net losses.
  • For UDENYCA and LOQTORZI, which are launched products, and if we obtain regulatory approval to market any other product candidate, our future revenue will depend upon the size of any markets in which our product candidates may receive approval and our ability to achieve sufficient market acceptance, pricing, reimbursement from third-party payers, and adequate market share for our product candidates which include all product candidates for which we obtained commercial rights, in those markets.
  • However, even if additional product candidates in addition to our current products gain regulatory approval and are commercialized, we may not remain profitable.
  • Our expenses will increase substantially if and as we: ● establish a sales, marketing and distribution infrastructure to commercialize any of our product candidates for which we may obtain marketing approval; ● make upfront, milestone, royalty or other payments under any license agreements; ● continue our nonclinical and clinical development of our product candidates; ● initiate additional nonclinical, clinical or other studies for our product candidates; ● expand the scope of our current clinical studies for our product candidates; ● advance our programs into more expensive clinical studies; ● change or add contract manufacturers, clinical research service providers, testing laboratories, device suppliers, legal service providers or other vendors or suppliers; ● seek regulatory approvals for our product candidates that successfully complete clinical studies; ● seek to identify, assess, acquire and/or develop other product candidates or products that may be complementary to our products; ● seek to create, maintain, protect and expand our intellectual property portfolio; ● engage legal counsel and technical experts to help us evaluate and avoid infringing any valid and enforceable intellectual property rights of third parties; ● engage in litigation, including patent litigation, and Inter Partes Review (“IPR”) proceedings with originator companies or others that may hold patents; ● seek to attract and retain skilled personnel; ● create additional infrastructure to support our operations as a public company and our product development and planned future commercialization efforts; and ● experience any delays or encounter issues with any of the above, including but not limited to failed studies, conflicting results, safety issues, manufacturing delays, litigation or regulatory challenges that may require longer follow-up of existing studies, additional major studies or additional supportive studies or analyses in order to pursue marketing approval. ​ In addition, the UDENYCA Sale may make it more difficult or make it take more time for us to become profitable at any point in the future.
  • UDENYCA is our largest product that contributes significantly more revenue to our business than LOQTORZI currently.
  • LOQTORZI may not increase its revenue contribution to our business as quickly as we project or at all and for our clinical trials for our product candidates may be delayed, may be unsuccessful or may take more time and expense to complete than we currently anticipate.
  • The inherent risk involved in divesting a major business could make it difficult for us to replace the revenue lost by selling UDENYCA or by becoming profitable in the future. ​ Further, the net loss or net income we achieve may fluctuate significantly from quarter-to-quarter and year-to-year such that a period-to-period comparison of our results of operations may not be a good indication of our future performance quarter-to-quarter and year-to-year due to factors including the timing of clinical trials, any litigation that we may initiate or that may be initiated against us as well as any settlements or judgments from such litigation, the execution of collaboration, licensing or other agreements and the timing of any payments we make or receive thereunder.
  • As of December 31, 2024, our cash, cash equivalents and marketable securities were $126.0 million.
  • We expect that our existing cash and cash equivalents, investments, cash collected from our product sales and cash proceeds from the UDENYCA Sale (assuming it is consummated) will be sufficient to fund our current operations for the foreseeable future.
  • We have financed our operations primarily through the sale of equity securities, convertible notes, credit facilities, divestitures, license agreements and through recent product sales of our products.
  • Our future funding requirements will depend on many factors, including but not limited to: ● our ability to consummate the UDENYCA Sale; ● our ability to continue to successfully commercialize our products; ● our ability to maintain continuity for the supply of our products; ● the scope, rate of progress, results and cost of any clinical studies, nonclinical testing and other related activities; ● the cost of manufacturing clinical drug supplies and establishing commercial supplies, of our product candidates and any products that we may develop; ● prior to the consummation of the UDENYCA Sale, the timing for us to receive FDA authorization to produce UDENYCA product at our additional packaging and labeling CMO’s facility and the timing for our additional packaging and labeling CMO to make UDENYCA products available in a sufficient quantity to meet the demand from our customers; ● the number and characteristics of product candidates that we pursue; ● the cost, timing and outcomes of regulatory approvals; ● the cost and timing of establishing sales, marketing and distribution capabilities; ● the terms and timing of any licensing or other arrangements to acquire intellectual property rights that we may establish, including any milestone and royalty payments thereunder; ● if not otherwise resolved with proceeds from the UDENYCA Sale, the timing of conversion in common shares or repayment in cash of our convertible debt, or the timing of repayment in cash, whether due or not, of our long-term debt and the payment of interest, principal and royalties related to our financial liabilities; and ● the cost, timing and outcomes of any litigation that we may file against third parties or that may be filed against us by third parties.
  • The sale of additional equity or convertible securities, such as the sales from time to time through our sales agreement dated November 8, 2022 (the “Sales Agreement”) with Cowen and Company, LLC (“TD Cowen”) pursuant to which we may issue and sell from time to time up to $150.0 million of our common stock, including the common stock already sold, through or to TD Cowen as our sales agent or principal in an at-the-market offering (“ATM Offering”), may dilute the share ownership of our existing stockholders.
  • The incurrence of indebtedness could result in increased fixed payment obligations and we may be required to agree to certain restrictive covenants, such as those contained in the loan agreement (the “2029 Loan Agreement”), dated as of May 8, 2024 (the “2029 Term Loan Effective Date”), by and among us, Ankura Trust Company, LLC, as administrative agent (in such capacity, the “Agent”), and the lenders signatory thereto (collectively, the “2029 Lenders”) governing the senior secured term loan facility of up to $38.7 million (the “2029 Term Loan”) we entered into on the 2029 Term Loan Effective Date, including limitations on our ability to incur additional debt, limitations on our ability to acquire, sell or license intellectual property rights and other operating restrictions that could adversely impact our ability to conduct our business such as a financial covenant which requires us to maintain certain levels of cash and cash equivalents.
  • If we are unable to obtain funding on a timely basis or at all, stay profitable or generate any net profits, we may be required to significantly curtail, delay or discontinue one or more of our research or development programs or the commercialization of any products or product candidates or be unable to expand our operations or otherwise capitalize on our business opportunities, as desired, which could materially affect our financial condition and results of operations. ​ Risks Related to Launch and Commercialization of our Products and our Product Candidates We have a limited operating history in an emerging regulatory environment on which to assess our business.
  • We are a biopharmaceutical company with a limited operating history in an emerging regulatory environment of biosimilar and immuno-oncology products.
  • Although we have received upfront payments, milestone and other contingent payments and/or funding for development from some of our collaboration and license agreements, our only approved products are UDENYCA and LOQTORZI which are approved for commercialization in the United States, and we have no products approved in any other territories.
  • Our ability to generate meaningful revenue and remain profitable depends on our ability, alone or with strategic collaboration partners, to successfully market and sell our products, and to complete the development of, and obtain the regulatory approvals necessary to commercialize, one or more of our product pipeline candidates, which include: ● CHS-1000 ● casdozokitug; ● CHS-114; and ● toripalimab in non-NPC indications.
  • We may not be able to continue to generate meaningful revenue from product sales, as this depends heavily on our success in many areas, including but not limited to: ● our ability to continue to successfully commercialize all three UDENYCA product presentations and LOQTORZI; ● competing against numerous current and future pegfilgrastim products with significant market share; ● healthcare providers, payers, and patients adopting our products and product candidates once approved and launched; ● our ability to procure and commercialize our biosimilar product; ● obtaining additional regulatory approvals for product candidates for which we complete clinical studies; ● obtaining adequate third-party coverage and reimbursements for our products; ● obtaining market acceptance of our products and product candidates as viable treatment options; ● completing nonclinical and clinical development of our product candidates; ● developing and testing of our product formulations; ● attracting, hiring and retaining qualified personnel; ● developing a sustainable and scalable manufacturing process for our products and any approved product candidates and establishing and maintaining supply and manufacturing relationships with third parties that can conduct the process and provide adequate (in amount and quality) products to support clinical development and the market demand for our products and product candidates, if approved; ● addressing any competing technological and market developments; ● identifying, assessing and developing (or acquiring/in-licensing on favorable terms) new product candidates; ● negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; ● maintaining, protecting and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; and ● defending against any litigation including patent or trade secret infringement lawsuits, which may be filed against us, or achieving successful outcomes of IPR petitions that we have filed, or may in the future file, against third parties.
  • In cases where we are successful in obtaining additional regulatory approvals to market one or more of our product candidates, our revenue will be dependent, in part, upon the size of the markets in the territories for which we gain regulatory approval, the number of biosimilar or immuno-oncology competitors in such markets, the accepted price for the product, the ability to get reimbursement at any price, the nature and degree of competition from originators and other biosimilar or immuno-oncology companies (including competition from large pharmaceutical companies entering the biosimilar market or possessing large established positions in the immuno-oncology market that may be able to gain advantages in the sale of biosimilar or immuno-oncology products based on brand recognition or existing relationships with customers and payers) and whether we own (or have partnered with companies owning) the commercial rights for that territory.
  • If the market for our products and product candidates (or our share of that market) is not as significant as we expect, the price of our products is not what we project, the indication approved by regulatory authorities is narrower than we expect or the reasonably accepted population for treatment is narrowed by competition, physician choice or treatment guidelines, we may not generate significant revenue from sales of such products, even if approved.
  • If we are unable to successfully complete development and obtain additional regulatory approval for our products, our business may suffer.

and 355 more.

Sentence-level comparison of Item 1A in the two most recent 10-Ks (FY2024 ↗, FY2025 ↗). A reworded sentence counts as one dropped and one added, so heavy edits read as low “kept”. Headings and page furniture are stripped; nothing is summarised by a model.

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