UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
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Securities Exchange Act of 1934
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Item 8.01. Other Events.
On December 13, 2019, United Therapeutics Corporation (“UT”) announced a delay in the potential launch of the Implantable System for Remodulin® from 2020 to 2021. As previously announced, the system was developed in collaboration with Medtronic Inc. (“Medtronic”), the manufacturer of the system. Although the U.S. Food and Drug Administration (“FDA”) previously approved Medtronic’s premarket approval application (“PMA”) for the device in December 2017, UT’s ability to launch the product is subject to Medtronic satisfying various conditions to its PMA approval. As a result of recent FDA communications, Medtronic has indicated that these conditions will not be satisfied during 2020. UT has no control over when or whether these conditions will be met.
Forward-looking Statements
Statements included in this Current Report on Form 8-K that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, among others, statements regarding the potential launch of the Implantable System for Remodulin. These forward-looking statements are subject to certain risks and uncertainties, such as those described in UT’s periodic and other reports filed with the Securities and Exchange Commission that could cause actual results to differ materially from anticipated results. Such forward-looking statements are qualified by the cautionary statements, cautionary language and risk factors set forth in UT’s periodic reports and documents filed with the Securities and Exchange Commission, including our most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. UT claims the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. UT is providing this information as of December 13, 2019, and assumes no obligation to update or revise the information contained in this Current Report on Form 8-K whether as a result of new information, future events or any other reason.
REMODULIN is a registered trademark of United Therapeutics Corporation.
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SIGNATURE
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.
| UNITED THERAPEUTICS CORPORATION | ||
| Dated: December 13, 2019 | By: | /s/ Paul A. Mahon |
| Name: | Paul A. Mahon | |
| Title: | General Counsel | |
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