FALSE000115903600011590362023-09-062023-09-06

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

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Securities registered pursuant to Section 12(b) of the Act:

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 ( §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 ( §240.12b-2 of this chapter).         

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

On September 6, 2023, Halozyme Therapeutics, Inc. (the “Company”) was informed by its collaboration and license partner, F. Hoffmann-La Roche, Ltd. (“Roche”), that there will be a delay in the projected launch timing for Tecentriq SC, with ENHANZE® in the U.S. This delay is a result of the need to update Tecentriq SC CMC processes. These updates are expected to be completed in 2023 and are expected to support a potential launch of Tecentriq SC in the U.S. in 2024. There is no expected impact on ex-U.S. filings for Tecentriq SC.

This Current Report on Form 8-K contains forward-looking statements that involve risks and uncertainties. Any statements in this Form 8-K about the Company’s future expectations constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this Form 8-K, the Company’s forward-looking statements include statements about the development, regulatory and commercial efforts of its collaboration partner and the expected regulatory and commercial impact of recent regulatory developments concerning a collaboration product. The inclusion of forward-looking statements should not be regarded as a representation by the Company that any of these results will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties associated with pharmaceutical development and the regulatory approval process for the Company’s collaboration products, as well as risks and uncertainties inherent in the Company’s business, including those described in the Company’s other filings with the Securities Exchange Commission. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s financial and operating results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements, including the factors discussed in the “Risk Factors” section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the Company’s views only as of the date of this Form 8-K. The Company anticipates that subsequent events and developments may cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.