CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus and the documents incorporated by reference herein contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning our business, operations and financial performance and condition, as well as our plans, objectives and expectations for our business operations and financial performance and condition. Any statements contained or incorporated by reference herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would” and other similar expressions that are predictions of or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
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whether we will be able to continue to maintain or increase sales for our products;
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our expectations regarding our ability to develop and commercialize toripalimab, CHS-006 and our other product candidates in the United States and Canada, including whether the trial results, data package or biologics license application for toripalimab will be sufficient to support regulatory approval;
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our ability to address comments raised in the complete response letter for the original BLA for toripalimab and timing of the review for the original BLA resubmission for toripalimab;
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our ability to receive marketing authorization for the on-body injector presentation of UDENYCA, including the timing of receiving such marketing authorization, if approved;
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our ability to maintain regulatory approval for our products and our ability to obtain and maintain regulatory approval of our product candidates, if and when approved;
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our expectations regarding government and third-party payer coverage and reimbursement;
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our ability to realize the anticipated benefits from the acquisition of Surface;
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our ability to manufacture our product candidates in conformity with regulatory requirements and to scale up manufacturing capacity of these products for commercial supply;
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our reliance on third-party contract manufacturers to supply our products and product candidates for us;
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our expectations regarding the potential market size and the size of the patient populations for our products and product candidates, if approved for commercial use;
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our expectations about making required future interest and principal payments as they become due in connection with our debt obligations;
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our financial performance, including, but not limited to, projected future performance of our gross margins, research and development expenses and selling and general administrative expenses;
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the implementation of strategic plans for our business, products and product candidates;
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the initiation, timing, progress and results of future preclinical and clinical studies and our research and development programs;
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the scope of protection we are able to establish and maintain for intellectual property rights covering our products and product candidates;
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our ability to finalize the definitive agreements contemplated by the binding term sheet between us and Klinge Biopharma GmbH for the exclusive commercialization rights to FYB203, a biosimilar candidate to Eylea® (aflibercept), in the United States or close on the transactions contemplated by them;
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our expectations regarding the scope or enforceability of third-party intellectual property rights, or the applicability of such rights to our products and product candidates;
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the cost, timing and outcomes of litigation involving our products and product candidates;
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our reliance on third-party contract research organizations to conduct clinical trials of our product candidates;
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the benefits of the use of our products and product candidates;