This Quarterly Report on Form 10-Q contains forward-looking statementsregarding future events and our future results that are subject to the safe harbors created under the Securities Act of 1933, as amended (the “Securities Act”), and the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statements contained herein that are not statements of historical facts contained in this Quarterly Report on Form 10-Q may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by words such as “aim,” “anticipate,” “assume,” “attempt,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “seek,” “should,” “strive,” “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:
| ● | whether we will be able to continue to maintain or increase sales for our products; |
| ● | our expectations regarding our ability to develop and commercialize our product candidates; |
| ● | 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; |
| ● | our expectations regarding government and third-party payer coverage and reimbursement; |
| ● | our ability to manufacture our products and product candidates in conformity with regulatory requirements and to scale up manufacturing capacity of these products for commercial supply; |
| ● | our reliance on third-party contract manufacturers to supply our products candidates and product for us; |
| ● | 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; |
| ● | our expectations about making required future interest and principal payments as they become due in connection with our debt obligations; |
| ● | our financial performance, including, but not limited to, projected future performance of our gross margins, projected future cash reserves, research and development expenses and selling and general administrative expenses; |
| ● | the implementation of strategic plans for our business, products and product candidates; |
| ● | the initiation, timing, progress and results of future preclinical and clinical studies and our research and development programs; |
| ● | the scope of protection we are able to establish and maintain for intellectual property rights covering our products and product candidates; |
| ● | 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; |
| ● | the cost, timing and outcomes of litigation involving our products and product candidates; |
| ● | our reliance on third-party contract research organizations to conduct clinical trials of our product candidates; |
| ● | the benefits of the use of our products and product candidates; |
| ● | our expectations about potential risks, disruptions and losses from future cyberattacks and security incidents; |
| ● | the rate and degree of market acceptance of our current or any future products and product candidates; |
| ● | our ability to compete with companies currently producing competitor products, including Neulasta and other biosimilar products made by other companies; |
| ● | developments and projections relating to our competitors, our market opportunity and our industry; and |
| ● | the potential impact of COVID-19 and the continuation of the war in Ukraine and conflicts in the Middle East on our business and prospects. |
We have based these forward-looking statements on our current expectations about future events. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Our actual results may differ materially from those suggested by these forward-looking statements for various reasons, including those identified in Part II, Item 1A Risk Factors and discussed elsewhere in this Quarterly Report on Form 10-Q. Given these risks and uncertainties, you are cautioned not to place undue reliance on forward-looking statements. The forward-looking statements included in this report are made only as of the date hereof. Except as required under federal securities laws and the rules and regulations of the Securities and Exchange Commission (“SEC”), we do not undertake, and specifically decline, any obligation to update any of these statements or to publicly announce the results of any revisions to any forward-looking statements after the distribution of this report, whether as a result of new information, future events, changes in assumptions or otherwise. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, or investments we may make or enter into, except for the acquisition of Surface to the extent described herein.
This Quarterly Report on Form 10-Q also contains estimates, projections, market opportunity estimates and other information concerning our industry, our business, and the markets for certain diseases, including data regarding the estimated size of those markets, and the incidence and prevalence of certain medical conditions. Information that is based on estimates, forecasts, projections, market research or similar methodologies is inherently subject to uncertainties and actual events or circumstances may differ materially from events and circumstances reflected in this information. Unless otherwise expressly stated, we obtained this industry, business, market and other data from reports, research surveys, studies and similar data prepared by market research firms and other third parties, industry, medical and general publications, government data, publicly filed reports and similar sources.
