United Therapeutics Corporation
UNITED THERAPEUTICS Corp (Form: 8-K, Received: 04/03/2017 06:56:26)

 

 

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 3, 2017

 

United Therapeutics Corporation

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

 

000-26301

 

52-1984749

(State or Other

 

(Commission

 

(I.R.S. Employer

Jurisdiction of

 

File Number)

 

Identification Number)

Incorporation)

 

 

 

 

 

1040 Spring Street

 

 

Silver Spring, MD

 

20910

(Address of Principal Executive Offices)

 

(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))

 

 

 



 

Item 7.01.  Regulation FD Disclosure.

 

On April 3, 2017, United Therapeutics Corporation issued the press release attached hereto as Exhibit 99.1 and incorporated herein by reference.

 

The information contained in Item 7.01 to this Current Report on Form 8-K, and Exhibits 99.1 attached hereto, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to liability under that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

 

Item 9.01. Exhibits

 

(d)  Exhibits

 

Exhibit No.

 

Description of Exhibit

 

 

 

99.1

 

Press Release dated April 3, 2017

 

2



 

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: April 3, 2017

By:

/s/ Paul A. Mahon

 

Name:

Paul A. Mahon

 

Title:

General Counsel

 

3


Exhibit 99.1

 

Contact: James Edgemond

Phone: (301) 608-9292

E-mail: jedgemond@unither.com

 

UNITED THERAPEUTICS ANNOUNCES REGULATORY DELAYS

FOR REMOSYNCH IMPLANTABLE PUMP

 

Conference Call Scheduled for 9:00 AM on April 3, 2017

 

Silver Spring, MD and Research Triangle Park, NC, April 3, 2017:  United Therapeutics Corporation (NASDAQ: UTHR) today announced that regulatory delays will result in postponement of the planned U.S. launch of the RemoSynch  Implantable System for Remodulin ®  until 2018.

 

“United Therapeutics’ commitment to bringing better therapies to patients transcends temporary delays or setbacks,” said Martine Rothblatt, Ph.D., United Therapeutics’ Chairman and Chief Executive Officer. “We are sorry to have missed our 2017 launch target, but it is a small miss in the context of our providing more U.S. pulmonary arterial hypertension patients with helpful medicines than any other company.”

 

United Therapeutics has been working with Medtronic, Inc. to develop Medtronic’s proprietary intravascular infusion catheter to be used with Medtronic’s implantable infusion pump and related infusion system components (together referred to as the Implantable System for Remodulin, or RemoSynch) for the delivery of Remodulin to treat patients with pulmonary arterial hypertension. In order to launch RemoSynch in the United States, Medtronic and United Therapeutics have been pursuing parallel regulatory filings relating to the device and the drug, respectively.

 

Conference Call

 

We will host a half-hour teleconference on Monday, April 3, 2017, at 9:00 a.m. Eastern Time to discuss the delayed launch of the RemoSynch Implantable System for Remodulin. The teleconference is accessible by dialing 1-877-351-5881, with international callers dialing 1-970-315-0533. A rebroadcast of the teleconference will be available for one week by dialing 1-855-859-2056, with international callers dialing 1-404-537-3406, and using access code: 2348311.

 

This teleconference is also being webcast and can be accessed via our website at http://ir.unither.com/events.cfm.

 

About United Therapeutics

 

United Therapeutics Corporation is a biotechnology company focused on the development and commercialization of innovative products to address the unmet medical needs of patients with chronic and life-threatening conditions. [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 delayed launch of the RemoSynch Implantable System for Remodulin until 2018. 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. These forward-looking statements 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 3, 2017, 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.

 

Remodulin is a registered trademark, and RemoSynch is a trademark, of United Therapeutics Corporation.