UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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| ITEM 7.01 | Regulation FD Disclosure |
On October 4, 2023, Teva Pharmaceutical Industries Ltd. (the “Company”) issued a press release announcing its entry into an exclusive collaboration with Sanofi to co-develop and co-commercialize Teva’s TEV-48574 asset, a novel anti-TL1A therapy for the treatment of ulcerative colitis and Crohn’s disease, two types of inflammatory bowel disease. A copy of the press release is furnished as Exhibit 99.1 hereto and is incorporated by reference herein.
The information in this Item 7.01 and Exhibit 99.1 hereto is being furnished to the Securities and Exchange Commission (the “Commission”) and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) nor shall it be deemed incorporated by reference in any filing made by the Company under the Securities Act or the Exchange Act, except as set forth by specific reference in such filing.
Cautionary Note Regarding Forward-Looking Statements
The foregoing description of the collaboration agreement contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management’s current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression. Important factors that could cause or contribute to such differences include risks relating to: our exclusive collaboration with Sanofi, including uncertainties around the effective date of the collaboration and our ability to satisfy the closing conditions related thereto; risks related to the timing of and our ability to achieve expected results for TEV-48574 (anti-TL1A), including our ability to commercialize TEV-48574 (anti-TL1A); the extent to which we will realize the anticipated financial and other benefits of the Sanofi collaboration; our ability to satisfy the conditions to receiving milestone cash payments under the Sanofi collaboration agreement; the risk that we will incur significant costs in connection with the development of TEV-48574 (anti-TL1A), which may exceed any revenue generated by TEV-48574 (anti-TL1A); risks that regulatory approvals and other requirements may delay the development and commercialization of TEV-48574 (anti-TL1A); our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, our ability to successfully launch and execute our new Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines, and the effectiveness of our patents and other measures to protect our intellectual property rights; our business and operations in general, including, the impact of global economic conditions and other macroeconomic developments and the governmental and societal responses thereto, and costs and delays resulting from the extensive pharmaceutical regulation to which we are subject. Investors should read the important risk factors described in the Company’s most recent Annual Report on Form 10-K, Quarterly Report on Form 10-Q and Current Reports on Form 8-K filed with the Commission. Forward-looking statements speak only as of the date on which they are made, and the Company assumes no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. Investors are cautioned not to put undue reliance on these forward-looking statements.
| ITEM 9.01 | Financial Statements and Exhibits |
(d) Exhibits
| Exhibit No. |
Description of Document | |
| 99.1 | Press release of the Company issued on October 4, 2023. | |
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document). | |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| TEVA PHARMACEUTICAL INDUSTRIES LIMITED | ||||||
| Date: October 4, 2023 | By: | /s/ Eli Kalif | ||||
| Name: | Eli Kalif | |||||
| Title: | Executive Vice President, Chief Financial Officer | |||||
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