We have included in Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2021, a description of certain risks and uncertainties that could affect our business, future performance or financial condition (the “Risk Factors").
−Removed: Other than in respect of the additional risk factor included below, during the three months ended September 30, 2021, there were no material changes from the disclosure provided in the Form 10-K for the year ended December 31, 2020 with respect to the Risk Factors.
−Removed: Investors should consider the Risk Factors, as well as the risk factor included below, prior to making an investment decision with respect to our stock.
−Removed: A significant portion of our revenue growth in 2021 is as a result of purchase orders from Pfizer for use in the manufacture of its clinical-stage COVID antiviral therapeutic candidate, PF-07321332.
−Removed: If Pfizer discontinues the development of PF-07321332, our revenue will be materially and adversely affected .
−Removed: In June and August 2021, we announced that we had received purchase orders of $13.9 million and approximately $15.0 million, respectively, from an undisclosed global pharmaceutical company for the sale and purchase of a proprietary Codexis enzyme product that is intended for use in the manufacture of a critical intermediate for its undisclosed active pharmaceutical ingredient in a therapeutic drug.
−Removed: In October 2021, we announced that these purchase orders, which aggregate to approximately $29 million, were received by us from Pfizer, Inc.
−Removed: and that the proprietary Codexis enzyme product is intended for use in the manufacture of PF-07321332, Pfizer’s clinical-stage COVID antiviral therapeutic candidate.
−Removed: In the event that Pfizer discontinues the development of PF-07321332 and, as a result, no longer requires the use of our enzyme to manufacture PF-07321332, our revenue will be materially and adversely affected.
−Removed: We have no control over the development of PF-07321332 and no additional insight into the development of PF-07321332 other than that publicly reported by Pfizer, including the results of any preclinical studies or clinical trials or the timing of announcements related to such studies or trials.
−Removed: If Pfizer decides to discontinue the development of PF-07321332 for the prevention of COVID-19 infection or if Pfizer otherwise determines that the clinical or commercial profile of PF-07321332 doesn’t sufficiently warrant continued development, our future revenues may be materially and adversely impacted.
+Added: Other than in respect of the additional risk factor included below, during the three months ended March 31, 2022, there were no material changes from the disclosure provided in the Form 10-K for the year ended December 31, 2021 with respect to the Risk Factors.
+Added: Investors should consider the Risk Factors prior to making an investment decision with respect to our stock.
+Added: We have identified a material weakness in our internal control over accounting related to our product revenue recognition process and such weakness led to a conclusion that our internal control over financial reporting and disclosure controls and procedures were not effective as of March 31, 2022.
+Added: Our inability to remediate the material weakness, our discovery of any additional weaknesses, and/or our inability to achieve and maintain effective disclosure controls and procedures and internal control over financial reporting could adversely affect our results of operations and our stock price.
+Added: Section 404 of the Sarbanes-Oxley Act of 2002 requires that companies evaluate and report on the effectiveness of their internal control over financial reporting.
+Added: In addition, we regularly engage our independent registered public accounting firm to report on its evaluation of those controls.
+Added: As disclosed in more detail under Part I, Item 4, “Controls and Procedures” above, we have identified a material weakness in our internal control as of March 31, 2022 related to management's controls over the revenue recognition process.
+Added: Specifically, our controls addressing the completeness and accuracy of reports used to calculate product revenue from arrangements subject to overtime revenue recognition did not operate at the proper level of precision to identify the errors.
+Added: Due to the material weakness in our internal control over financial reporting, we have concluded that our disclosure controls and procedures were not effective as of March 31, 2022.
+Added: Failure to have effective internal control over financial reporting and disclosure controls and procedures could impair our ability to produce accurate financial statements on a timely basis and could lead to a restatement of our financial statements.
+Added: If, as a result of the ineffectiveness of our internal control over financial reporting and disclosure controls and procedures, we cannot provide reliable financial statements, our business decision processes may be adversely affected, our business and results of operations could be harmed and investors could lose confidence in our reported financial information.
+Added: In addition, in some circumstances, failure to maintain effective internal control over financial reporting could result in investigations or sanctions by regulatory authorities.
+Added: Our management is taking steps to remediate the material weakness, including enhancing management's review controls over revenue and the level of detail and precision applied when reviewing the completeness and accuracy of reports used to determine product revenue for arrangements subject to overtime revenue recognition.
+Added: We intend to remediate this material weakness as soon as possible, but we cannot be certain as to when such remediation will be completed, if ever.
+Added: Additional details regarding the remediation efforts are disclosed under Part I, Item 4, “Controls and Procedures” above.
+Added: In addition, we may in the future identify additional internal control deficiencies that could rise to the level of a material weakness or uncover other errors in financial reporting.
+Added: During the course of our evaluation of this material weakness, we may identify areas requiring improvement and may be required to design additional enhanced processes and controls to address issues identified through this review.
+Added: In addition, there can be no assurance that such remediation efforts will be successful, that our internal control over financial reporting will be effective as a result of these efforts or that any such future deficiencies identified may not be material weaknesses that would be required to be reported in future periods.
+Added: In addition, we cannot assure you that our independent registered public accounting firm will be able to attest that such internal controls are effective when they are required to do so.
+Added: If we fail to remediate the material weakness and maintain effective internal control over financial reporting or disclosure controls and procedures, we may not be able to rely on the integrity of our financial results, which could result in inaccurate or late reporting of our financial results, as well as delays or the inability to meet our reporting obligations or to comply with SEC rules and regulations.
+Added: Any of these could result in delisting actions by the Nasdaq Stock Market, investigation and sanctions by regulatory authorities, stockholder investigations and lawsuits, and could adversely affect our business and the trading price of our common stock.
UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
3 unchanged sentences
Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.