UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15 (d) of the
Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): April 8, 2019
United Therapeutics Corporation
(Exact Name of Registrant as Specified in its Charter)
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Delaware |
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000-26301 |
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52-1984749 |
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(State or Other |
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(Commission |
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(I.R.S. Employer |
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Jurisdiction of |
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File Number) |
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Identification Number) |
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Incorporation) |
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1040 Spring Street |
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Silver Spring, MD |
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20910 |
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(Address of Principal Executive Offices) |
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(Zip Code) |
Registrant’s telephone number, including area code: (301) 608-9292
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:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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 o
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. o
Item 8.01. Other Events.
On April 8, 2019, United Therapeutics Corporation issued a press release announcing that its BEAT study of esuberaprost did not meet its primary endpoint. A copy of the press release is attached hereto as Exhibit 99.1 and incorporated herein by reference.
Item 9.01. Exhibits
(d) Exhibits
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Exhibit No. |
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Description of Exhibit |
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99.1 |
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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.
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UNITED THERAPEUTICS CORPORATION | |
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Dated: April 8, 2019 |
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/s/ Paul A. Mahon |
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Name: |
Paul A. Mahon |
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Title: |
General Counsel |
Contact: James Edgemond
Phone: (301) 608-9292
E-mail: jedgemond@unither.com
UNITED THERAPEUTICS ANNOUNCES
BEAT STUDY OF ESUBERAPROST DOES NOT MEET PRIMARY ENDPOINT
Silver Spring, MD and Research Triangle Park, NC, April 8, 2019: United Therapeutics Corporation (Nasdaq: UTHR) today announced that the BEAT clinical study of esuberaprost tablets in patients suffering from pulmonary arterial hypertension did not meet its primary endpoint of delayed time to first clinical worsening event. Accordingly, United Therapeutics has decided to discontinue further esuberaprost development.
About United Therapeutics
United Therapeutics Corporation focuses on the strength of a balanced, value-creating biotechnology model. We are confident in our future thanks to our fundamental attributes, namely our obsession with quality and innovation, the power of our brands, our entrepreneurial culture and our bioinformatics leadership. We also believe that our determination to be responsible citizens — having a positive impact on patients, the environment and society — will sustain our success in the long term.
Through our wholly-owned subsidiary, Lung Biotechnology PBC, we are focused on addressing the acute national shortage of transplantable lungs and other organs with a variety of technologies that either delay the need for such organs or expand the supply. Lung Biotechnology is the first public benefit corporation subsidiary of a public biotechnology or pharmaceutical company. [uthr-g]
Forward-looking Statements
Statements included in this press release 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 ability of our business model to create value, our ability to sustain long-term success, and our organ transplantation research and development programs. These forward-looking statements are subject to certain risks and uncertainties, such as those described in our periodic and other reports filed with the Securities and Exchange Commission that could cause actual results to differ materially from anticipated results. All of these factors could have a material impact on how useful the final results will be to healthcare providers, and how they will be viewed by the FDA and other regulators. In addition, the forward-looking statements in this press release are qualified by the cautionary statements, cautionary language and risk factors set forth in our 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. We claim the protection of the safe harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We are providing this information as of April 8, 2019 and assume no obligation to update or revise the information contained in this press release whether as a result of new information, future events or any other reason.