1 unchanged sentence
“Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, 2021, which was filed with the SEC on March 1, 2022.
−Removed: There have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K.
−Removed: Second Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference to Exhibit 3.1 to the Registrant’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2015, filed on August 10, 2015 (File No.
−Removed: 3.2 Certificate of Amendment to the Second Amended and Restated Certificate of Incorporation of the Registrant (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on May 9, 2019 (File No.
−Removed: 3.3 Amended and Restated By-Laws of the Registrant (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed on June 24, 2021 (File No.
−Removed: 3.4 Certificate of Designation of Series A Convertible Preferred Stock of the Registrant (Incorporated by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K filed June 19, 2020 (File No.
−Removed: Modification No.
−Removed: 01 to Base Agreement between Novavax, Inc.
−Removed: and Advanced Technology International, dated as of March 23, 2022
−Removed: Change Order No.
−Removed: 1 to the Collaboration and Exclusive License Agreement between Novavax, Inc.
−Removed: and SK Bioscience Company Limited, dated as of March 31, 2022
−Removed: 31.1* Certification of Chief Executive Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the Securities Exchange Act
−Removed: 31.2* Certification of Chief Financial Officer pursuant to Rule 13a-14(a) or 15d-14(e) of the Securities Exchange Act
−Removed: 32.1* Certification of Chief Executive Officer pursuant to 18 U.S.C.
−Removed: Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
−Removed: 32.2* Certification of Chief Financial Officer pursuant to 18 U.S.C.
−Removed: Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
−Removed: 101 The following financial information from our Quarterly Report on Form 10-Q for the quarter ended March 31, 2022, formatted in Inline Extensible Business Reporting Language (Inline XBRL):
−Removed: (i) the Consolidated Statements of Operations for the three-month periods ended March 31, 2022 and 2021, (ii) the Consolidated Balance Sheets as of March 31, 2022 and December 31, 2021, (iii) the Consolidated Statements of Comprehensive Income (Loss) for the three-month periods ended March 31, 2022 and 2021, (iv) the Consolidated Statements of Changes in Stockholders’ Equity (Deficit) for the three-month periods ended March 31, 2022 and 2021, (v) the Consolidated Statements of Cash Flows for the three-month periods ended March 31, 2022 and 2021, and (vi) the Notes to Consolidated Financial Statements.
−Removed: 104 Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101).
−Removed: ___________________________________
−Removed: * Filed or furnished herewith.
−Removed: ± Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
−Removed: Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
−Removed: NOVAVAX, INC.
−Removed: May 9, 2022 By:
−Removed: /s/ Stanley C.
−Removed: President and Chief Executive Officer
−Removed: (Principal Executive Officer)
−Removed: May 9, 2022 By:
−Removed: Executive Vice President, Chief Financial Officer and Treasurer
−Removed: (Principal Financial and Accounting Officer)
+Added: There have been no material changes from the risk factors previously disclosed in the Annual Report on Form 10-K other than set forth below.
+Added: The emergence and transmissibility of variants of the SARS-CoV-2 virus may affect market acceptance or sales of NVX-CoV2373, and our strategy to develop versions of our COVID-19 vaccine to protect against certain variants may not be successful.
+Added: Our prototype COVID-19 vaccine, NVX-CoV2373, was developed based upon the genetic sequence of the SARS-CoV-2 virus that was first discovered in December 2019.
+Added: As the SARS-CoV-2 virus continues to evolve, new strains of the virus, or those that are already in circulation, may prove more transmissible or cause more severe forms of COVID-19 disease than the predominant strains to date.
+Added: For example, the Omicron and Delta variants have been observed to be more transmissible, or contagious, than previous variants.
+Added: NVX-CoV2373 may not be as effective in protecting against these or other future variant strains, and NVX-CoV2373 may fail to achieve market acceptance or significant sales, despite gaining regulatory approval, provisional registration, conditional marketing authorization or emergency use authorization in a number of jurisdictions, including emergency use authorization the United States, as demand for variant-specific vaccines increases.
+Added: We have several variant-specific vaccine candidates in development, including for Omicron subvariants, and bivalent formulations with NVX-CoV2373, and may develop others in the future.
+Added: However, if these efforts are unsuccessful, we are slower to develop variant-specific vaccines than competitors, or these vaccine candidates prove less effective than competitors’ vaccines, these shortcomings may lead to reputational harm, loss of market share, and adverse financial results.
+Added: Additionally, counterparties to certain of our existing APAs may request variant-specific vaccines in place of NVX-CoV2373 and, depending on when we are able to offer variant-specific vaccines, if at all, such counterparties may seek to delay, reduce or otherwise renegotiate their purchase commitments, which may adversely impact our ability to realize the full financial benefit of such APAs.
+Added: In addition, we may expend significant resources adapting NVX-CoV2373 or conducting clinical trials to protect against variants of the SARS-CoV-2 virus, but a market for this adapted vaccine may not develop and demand may not align with our projections or cost expenditures.
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.