BIOCRYST PHARMACEUTICALS INC: FD Settlement Disclosure, Other Events, Financial Statements and Exhibits (Form 8-K)

Item 7.01. FD Regulation Disclosure.

On August 25, 2022, the Company has issued a press release announcing the events described in Section 8.01 of this Current Report on Form 8-K. A copy of the press release is provided as Exhibit 99.1 hereto and is incorporated herein by reference.

Information in this Section 7.01 shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the requirements of this Section. , nor be deemed incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly provided by specific reference in such filing.

Item 8.01. Other events.

On August 25, 2022, BioCryst Pharmaceuticals, Inc. (the “Company”) announced that it had entered into an amendment (the “Amendment”) to its contract dated
September 1, 2018 with the Department of Health and Social Services (“HHS”) for the purchase of the Company’s approved influenza antiviral treatment, RAPIVAB® (peramivir injection). Pursuant to the amendment, HHS exercised Option Period 4 under the contract to purchase an additional 10,000 doses of RAPIVAB during the September 1, 2022 through August 31, 2023 for a total price of approx. $6.9 million. The order is the last of five purchase options under the Company’s supply contract for RAPIVAB. This description of the Change is qualified in its entirety by reference to the full text of the Change provided as Exhibit 10.1 to this Current Report on Form 8-K.

The Company previously announced that it is entering the closing of its
September 2013 galidesivir contract with the National Institute of Allergy and Infectious Diseases within the HHS. In addition, the Company’s other government funding for galidesivir is expected to expire later in 2022. The Company does not intend to continue the galidesivir program without government funding.

Forward-looking statements

This current report on Form 8-K contains forward-looking statements, including statements regarding sales of RAPIVAB and expectations regarding the company’s galidesivir program. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results to differ materially from those expressed or implied by the forward-looking statements. These statements reflect our current views regarding future events and are based on assumptions and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include: the Company relies on third-party manufacturers to manufacture RAPIVAB in a timely manner and in accordance with applicable government regulations, and any failure of such third-party manufacturers to perform their obligations could the Company’s ability to supply RAPIVAB within the framework of its public contract; the availability of government funding; government contracts contain certain terms and conditions that subject the Company to additional risks; and the ongoing COVID-19 pandemic, which could create challenges in all aspects of the Company’s business, including, without limitation, delays, stoppages, difficulties and increased expenses relating to supply chains of the Company and its partners, adversely impact the Company’s ability to access capital or credit markets to finance its operations, or have the effect of increasing the other risks described herein or in documents that the Company periodically files with the
Security and Exchange Commission. Please refer to the documents that the Company periodically files with the Security and Exchange Commissionin particular, the company’s most recent annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, which identify important factors that could cause actual results to differ materially from those contained in the company’s forecasts. – look at the statements.

Item 9.01. Financial statements and supporting documents.

(d) Exhibits

Exhibit No.     Description

                  Amendment, dated August 10, 2022, to the Contract dated
  10.1          September 1, 2018 between BioCryst Pharmaceuticals, Inc. and
                the Department of Health and Human Services
                  Press release dated August 25, 2022 entitled "U.S. Government
  99.1          Exercises Option to Purchase Additional RAPIVAB® (peramivir
                injection) from BioCryst for Pandemic Influenza Preparedness"
104             Cover Page Interactive Data File (embedded within the Inline
                XBRL document)

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