-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, G69n1YZXTwuFIYElxEsQTn+Bdk+a14RqyMnOc0ZvJCJvrfueunErHAn+zu9RZiMX B+YhUmFASicCpNmpmWvHLQ== 0001104659-08-071137.txt : 20081117 0001104659-08-071137.hdr.sgml : 20081117 20081117070315 ACCESSION NUMBER: 0001104659-08-071137 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20081114 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Unregistered Sales of Equity Securities ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081117 DATE AS OF CHANGE: 20081117 FILER: COMPANY DATA: COMPANY CONFORMED NAME: UNITED THERAPEUTICS CORP CENTRAL INDEX KEY: 0001082554 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 521984749 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-26301 FILM NUMBER: 081193999 BUSINESS ADDRESS: STREET 1: 1110 SPRING ST CITY: SILVER SPRING STATE: MD ZIP: 20910 BUSINESS PHONE: 3016089292 MAIL ADDRESS: STREET 1: 1110 SPRING ST CITY: SILVER SPRING STATE: MD ZIP: 20910 8-K 1 a08-28586_28k.htm 8-K

 

 

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): November 14, 2008

 

United Therapeutics Corporation

(Exact Name of Registrant as Specified in the Charter)

 

Delaware

 

000-26301

 

52-1984749

(State or other jurisdiction of
incorporation or
organization)

 

(Commission File Number)

 

(I.R.S. Employer Identification No.)

 

 

 

 

 

1110 Spring Street
Silver Spring, MD

 


20910

(Address of principal executive offices)

 

(Zip Code)

 

(301) 608-9292

(Registrant’s telephone number, including area code)

 

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 1.01                          Entry into a Material Definitive Agreement.

 

On November 14, 2008, United Therapeutics Corporation (the “Company”) entered into several agreements with Eli Lilly and Company and a subsidiary of Eli Lilly and Company (collectively, “Lilly”), which are described separately below.

 

Stock Purchase Agreement

 

On November 14, 2008, the Company entered into a stock purchase agreement with Lilly, pursuant to which the Company agreed to sell, and Lilly agreed to purchase, shares (the “Shares”) of the Company’s common stock, par value $0.01 per share (the “Common Stock”), from the Company for an aggregate purchase price of $150,000,000.  The sale of the Shares will be made at a price per share equal to 0.90 multiplied by the lesser of (i) the average closing price for the Common Stock quoted on the NASDAQ Global Select Market during the five (5) trading day period ending on (and including) November 14, 2008 and (ii) the average closing price for the Common Stock quoted on the NASDAQ Global Select Market during the five (5) trading day period commencing on (and including) November 17, 2008.  The number of Shares will be equal to $150,000,000 divided by the price per share, rounded up to the nearest whole number.

 

The transaction is subject to customary closing conditions, as well as expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. If these conditions are not satisfied, then the sale of the Shares will not occur.  In addition, if the closing under the stock purchase agreement does not occur on or before March 4, 2009, either party may terminate the stock purchase agreement and the sale of the Shares will not occur.

 

License Agreement

 

On November 14, 2008, the Company entered into a license agreement with Lilly, pursuant to which Lilly agreed to grant an exclusive license to the Company for the right to develop, market, promote and commercialize a pharmaceutical product, the bulk active pharmaceutical ingredient of which is tadalafil (the “Product”), for the treatment of pulmonary hypertension in the United States and Puerto Rico.  Tadalafil is also the active pharmaceutical ingredient in Cialis®, developed and marketed by Lilly, and the retail price for the Product will be on parity with Cialis® pricing.  The license agreement will become effective upon completion of the sale of Shares to Lilly pursuant to the stock purchase agreement described above.

 

In exchange for the license, the Company agreed to pay Lilly a one-time fee of $25,000,000, which will be expensed upon the effective date of the agreement.  The Company also agreed to pay Lilly royalties of 5% of the Company’s net sales of the Product in the United States and Puerto Rico as a pass through of Lilly’s third-party royalty obligations, for so long as Lilly is required to make such payments.

 

Lilly retained the exclusive rights to develop, manufacture and commercialize pharmaceutical products containing tadalafil for the treatment of pulmonary hypertension outside of the United States and Puerto Rico and for the treatment of other diseases worldwide.  Lilly will retain authority for all regulatory activities with respect to tadalafil.

 

Lilly will have the right to use the data and intellectual property arising under the license outside of pulmonary hypertension in the United States and Puerto Rico, and for all other uses worldwide.

 

Early in the third quarter of 2008, Lilly filed a new drug application for the Product for the treatment of pulmonary arterial hypertension with the United States Food and Drug Administration (the “FDA”).  The Company may conduct additional trials for the Product related to the treatment of pulmonary hypertension in the United States and Puerto Rico with the prior consent of Lilly.

 

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Upon approval of the Product by the FDA, Lilly will be responsible for the manufacture of the Product, pursuant to a separate manufacturing and supply agreement, discussed below.

 

Should Lilly seek to grant rights to a third party to develop or commercialize the Product for the treatment of pulmonary hypertension in any other country (excluding Japan) in the future, the license agreement provides that the Company will have a right of first negotiation to acquire those rights.

 

The license agreement will continue until the later of: (i) expiration, lapse, cancellation, abandonment or invalidation of the last to expire claim within a Lilly patent covering the commercialization of the Product for the treatment of pulmonary hypertension in the United States and Puerto Rico; or (ii) expiration of any government-conferred exclusivity rights to use of the Product for the treatment of pulmonary hypertension in the United States and Puerto Rico.

 

The Company has the right to terminate the license agreement upon six months written notice to Lilly. Lilly has the right to terminate the license agreement if a separate brand name for the Product is not approved by the FDA for the treatment of pulmonary arterial hypertension (in which event it will refund the $25,000,000 license fee to the Company) or upon a change of control of the Company.  Either party may terminate the license agreement upon a material breach by the other party of the license agreement or the manufacturing and supply agreement, described below.

 

Manufacturing and Supply Agreement

 

On November 14, 2008, the Company entered into a manufacturing and supply agreement with Lilly. Under the terms of the manufacturing and supply agreement, Lilly agreed to manufacture the Product and distribute it via Lilly’s wholesaler network, in the same manner that it distributes its own pharmaceutical products.  The manufacturing and supply agreement will become effective upon completion of the sale of Shares to Lilly pursuant to the stock purchase agreement described above.

 

As consideration for Lilly’s agreement to manufacture and supply the Product, the Company agreed to make a one-time payment to Lilly of $125,000,000, which will be expensed upon the effective date of the agreement. Lilly will refund this payment in the event that the FDA does not approve a separate brand name for the Product for the treatment of pulmonary arterial hypertension.  The Company also agreed to purchase the Product at a fixed cost, which may be adjusted by Lilly from time to time.

 

The manufacturing and supply agreement will continue in effect until expiration or termination of the license agreement.

 

The foregoing summaries of the stock purchase agreement, the license agreement and the manufacturing and supply agreement are qualified by reference to the copies of the agreements that will be filed as exhibits to the Company’s annual report on Form 10-K for the fiscal year ending December 31, 2008.

 

A copy of the press release issued by the Company on November 17, 2008, announcing that the Company had entered into the stock purchase agreement, the license agreement and the manufacturing and supply agreement, is attached hereto as Exhibit 99.1.

 

Item 3.02.                       Unregistered Sales of Equity Securities.

 

The disclosure required by this item is included in Item 1.01 and is incorporated herein by reference.

 

The Company will sell the Shares to Lilly in a private placement exempt from the registration requirements of the Securities Act of 1933 (the “Securities Act”) pursuant to Section 4(2) of the Securities Act and/or Rule 506 under Regulation D promulgated under the Securities Act. Lilly has represented to the Company in the stock purchase

 

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agreement that it is an “accredited investor” as defined in Regulation D and that the Shares are being acquired for investment. The Company has not engaged in general solicitation or advertising with regard to the issuance and sale of the Shares and has not offered securities to the public in connection with this issuance and sale.

 

The Company intends to use the funds for payment of an aggregate of $150,000,000 in fees due to Lilly under the license agreement and the manufacturing and supply agreement.

 

Item 9.01                          Exhibits.

 

(d)  Exhibits

 

Exhibit No.

 

Description of Exhibit

99.1

 

Press Release, dated November 17, 2008

 

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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.

 

 

UNITED THERAPEUTICS CORPORATION

 

(Registrant)

 

 

Dated: November 17, 2008

By:

/s/ PAUL A. MAHON

 

Name:

Paul A. Mahon

 

Title:

General Counsel

 

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Exhibit Index

 

Exhibit No.

 

Description of Exhibit

99.1

 

Press Release, dated November 17, 2008

 

6


EX-99.1 2 a08-28586_2ex99d1.htm EX-99.1

Exhibit 99.1

 

Date: November 17, 2008

 

For Release:

Immediately

Refer to:

Mark E. Taylor (317) 276-5795 (Lilly)

 

Andrew Fisher (202) 483-7000 (United Therapeutics)

 

Lilly Licenses U.S. Rights for Tadalafil PAH Indication to United Therapeutics

Lilly Takes $150 Million Equity Stake in United Therapeutics

Companies Also Sign Manufacturing and Supply Agreement

 

United Therapeutics Conference Call to be Held at

9:00 a.m. Eastern Time on November 17, 2008

 

INDIANAPOLIS, IN and SILVER SPRING, MD – Eli Lilly and Company (NYSE:LLY) and United Therapeutics Corporation (NASDAQ:UTHR) today announced that the two companies have entered into a license and a supply agreement related to the U.S. commercialization rights for the pulmonary arterial hypertension (PAH) indication of Lilly’s molecule, tadalafil. The PAH indication is currently under regulatory review in the United States, Canada, Mexico, Japan and the European Union.

 

Under the terms of the agreements, United Therapeutics will make an upfront payment of $150 million to Lilly for the exclusive rights to commercialize tadalafil for PAH in the United States, as well as for a product manufacturing and supply arrangement. Lilly will manufacture and supply tadalafil to United Therapeutics and will retain authority globally for all regulatory, development, intellectual property and manufacturing aspects of the tadalafil molecule for all potential indications. Lilly will also retain commercialization rights to tadalafil for PAH outside of the U.S. In addition, Lilly will purchase $150 million of common stock from United Therapeutics. The transaction is subject to clearance of the stock purchase under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

 

“United Therapeutics brings substantial expertise and passion to the treatment of patients with PAH and will be an excellent partner for this product,” commented Dr. Gwen G. Krivi, Ph.D., vice president of Lilly Research Labs and global brand development platform leader for Lilly. “Their experience in this field will greatly enhance the ability to provide tadalafil for PAH, if approved, as a new therapeutic option for this very serious disease.  We are also pleased to make

 



 

a financial investment in a promising and profitable biotechnology company.  The collaboration with United Therapeutics adds to the success of Lilly’s networking strategy.”

 

“The addition of tadalafil for PAH expands our portfolio and strengthens United Therapeutics’ position in the area of cardiovascular disease,” said Martine Rothblatt, Ph.D, chairman and chief executive officer of United Therapeutics. “Building upon the success of Remodulin, we are committed to addressing the unmet medical needs of patients. We also welcome the support and confidence expressed by Lilly through their financial investment in our company.”

 

United Therapeutics Conference Call

 

United Therapeutics will hold a one hour teleconference on Monday, November 17, 2008, at 9:00 a.m. Eastern Time.  The teleconference is accessible by dialing (800) 603-1777, with international callers dialing (706) 679-8129.  A rebroadcast of the teleconference will be available for one week following the teleconference by dialing (800) 642-1687, with international callers dialing (706) 645-9291, and using access code 74119757.  This teleconference is also being web cast and can be accessed via United Therapeutics’ website at http://ir.unither.com/events.cfm.

 

About Pulmonary Arterial Hypertension

 

Pulmonary arterial hypertension (PAH) is a rare blood vessel disorder of the lung in which the pressure in the pulmonary artery (the blood vessel that leads from the heart to the lungs) rises above normal levels.  It is a severe, chronic and life threatening disease.

 

About United Therapeutics

 

United Therapeutics is a biotechnology company focused on the development and commercialization of unique products to address the unmet medical needs of patients with chronic and life-threatening cardiovascular and infectious diseases and cancer.  [uthr-g]

 

About Lilly

 

Lilly, a leading innovation-driven corporation, is developing a growing portfolio of first-in-class and best-in-class pharmaceutical products by applying the latest research from its own worldwide laboratories and from collaborations with eminent scientific organizations. Headquartered in Indianapolis, Ind., Lilly provides answers – through medicines and information

 

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– for some of the world’s most urgent medical needs.  Additional information about Lilly is available at www.lilly.com.  C-LLY

 

This news release contains forward-looking statements.  These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made.  Factors that might cause such a difference include, among others, the completion of clinical trials, the FDA review processes and other governmental regulation, United Therapeutics’ ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, the ability to effectively market products, and other factors described in Lilly’s and United Therapeutics’ most recent filings with the Securities and Exchange Commission. Neither Lilly nor United Therapeutics undertakes any duty to update forward looking statements.

 

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