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): June 4, 2013
The Medicines Company
(Exact Name of Registrant as Specified in Charter)
Delaware |
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000-31191 |
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04-3324394 |
(State or Other Jurisdiction |
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(Commission |
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(IRS Employer |
8 Sylvan Way Parsippany, New Jersey |
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07054 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrants telephone number, including area code: (973) 290-6000
Not Applicable.
(Former Name or Former Address, if Changed Since Last Report)
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 June 4, 2013, The Medicines Company (the Company) entered into a share purchase agreement (the Agreement) with ProFibrix B.V., a company registered in The Netherlands (ProFibrix), and its equityholders to acquire all of the equity of ProFibrix, subject to the Companys satisfactory review of the pending Phase 3 clinical trial results of ProFibrixs lead biologic, Fibrocaps. If we proceed to closing, ProFibrix would become a wholly owned subsidiary of the Company.
ProFibrix does not have any marketed products and has been engaged since its inception in developing fibrinogen based products for the hemostasis and regenerative medicine markets. Fibrocaps, the proposed name of ProFibrixs lead biologic, is a dry powder topical formulation of fibrinogen and thrombin being developed to help stop bleeding during surgery. It is being studied in a Phase 3 trial, FINISH-3, that enrolled 719 surgical patients with mild to moderate surgical bleeding. If the results are favorable, FINISH-3 is expected to be sufficient to support a biologics license application filing in the United States and a Marketing Authorization Application filing with the European regulatory authorities. ProFibrix completed patient enrollment in April 2013 and expects results in the third quarter of 2013.
At signing, the Company paid ProFibrix a $10,000,000 option payment. If the Company proceeds to closing, it would be obligated to make a $90,000,000 cash payment to the ProFibrix equityholders at closing, subject to customary closing adjustments. The Company also would be obligated to pay up to an aggregate of $140,000,000 in cash to the equityholders upon the achievement of contingent U.S. and European regulatory approval and sales milestones.
The Company is not obligated to proceed to closing unless it is satisfied, in its sole discretion, with the results of the FINISH-3 clinical trial of Fibrocaps. If the Company is satisfied with the results of the FINISH-3 clinical trial, it expects to close the transaction before the end of the third quarter of 2013. Otherwise, the Company may terminate the transaction with no further obligations to the ProFibrix equityholders. The completion of the transaction is also subject to the satisfaction or waiver of customary closing conditions.
The Agreement includes customary representations, warranties and covenants of ProFibrix and the Company. ProFibrix has agreed to operate its business in the ordinary course until the earlier of the termination of the Agreement and the closing of the transaction.
The Agreement and this summary are not intended to modify or supplement any factual disclosures about the Company or ProFibrix. The foregoing descriptions of the transaction and the Agreement do not purport to be complete and are qualified in their entirety by reference to the complete text of the agreement, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as exhibits to the Companys Quarterly Report on Form 10-Q for the quarter ended June 30, 2013.
The representations, warranties and covenants contained in the Agreement were made only for the purposes of the Agreement, were made as of specific dates, were made solely for the benefit of the parties to the Agreement and may not have been intended to be statements of fact but, rather, as a method of allocating risk and governing the contractual rights and relationships among the parties to the Agreement. The assertions embodied in those representations and warranties may be subject to important qualifications and limitations agreed to by the Company and ProFibrix in connection with negotiating their respective terms. Moreover, the representations and warranties may be subject to a contractual standard of materiality that may be different from what may be viewed as material to stockholders. For the foregoing reasons, none of the Companys stockholders or any other person should rely on such representations and warranties, or any characterizations thereof, as statements of factual information at the time they were made or otherwise.
Item 8.01. Other Events
On June 4, 2013, the Company issued a press release announcing its entry into the Agreement. The full text of the press release issued in connection with the announcement is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
Safe Harbor
Statements contained in this Current Report on Form 8-K about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words believes, anticipates and expects and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Companys actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include the parties ability to consummate the transaction; the conditions to the completion of the transaction, including the results and the timing of results from the Phase 3 trial of Fibrocaps; the ability to gain regulatory approval of Fibrocaps and, if approved, the commercial success of Fibrocaps; the ability of the Company to successfully integrate ProFibrixs business with the Companys other businesses; and such other factors as are set forth in the risk factors detailed from time to time in the Companys periodic reports and registration statements filed with the Securities and Exchange Commission, including, without limitation, the risk factors detailed in the Companys Quarterly Report on Form 10-Q filed on May 10, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.
Item 9.01. Financial Statements and Exhibits
(d) Exhibits
99.1 Press release issued by the Company on June 4, 2013
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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THE MEDICINES COMPANY | |
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Date: June 4, 2013 |
By: |
/s/ Paul M. Antinori |
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Name: |
Paul M. Antinori |
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Title: |
Senior Vice President and General Counsel |
Exhibit 99.1
Contact:
The Medicines Company
Michael Mitchell
+1-973-290-6097
michael.mitchell@themedco.com
FOR IMMEDIATE RELEASE:
THE MEDICINES COMPANY SIGNS AGREEMENT TO ACQUIRE PROFIBRIX
Affirms The Medicines Companys presence in surgical hemostasis
ProFibrix lead product Fibrocaps expected to deliver Phase 3 data third quarter 2013
Highlights The Medicines Companys long term commitment to recombinant proteins
Parsippany, NJ, Leiden, the Netherlands and Seattle, WA, June 4, 2013 The Medicines Company (NASDAQ: MDCO) and ProFibrix B.V. today announced an agreement for The Medicines Company to purchase all of the outstanding capital stock of ProFibrix B.V. subject to The Medicines Companys satisfactory review of the pending Phase 3 clinical trial results of ProFibrixs lead biologic, Fibrocaps.
Fibrocaps is a dry powder topical formulation of fibrinogen and thrombin being developed to stop bleeding during surgery. The Phase 3 trial, FINISH-3, has completed enrollment of 719 surgical patients with mild to moderate surgical bleeding. Results of FINISH-3 are expected in the third quarter of 2013. If the results are favorable, FINISH-3 is expected to be sufficient to support a BLA filing in the United States and an MAA filing with the European regulatory authorities.
Under the terms of the agreement, The Medicines Company will pay ProFibrix a $10 million upfront option payment. If the Medicines Company is satisfied with the trial results of FINISH-3 and determines to proceed, it will purchase all of the outstanding capital stock of ProFibrix at closing. Otherwise, The Medicines Company may terminate the transaction with no further obligation to the ProFibrix shareholders. ProFibrix shareholders could receive additional payments related to achieving US and European regulatory approvals and sales milestones. The transaction is subject to the satisfaction of customary closing conditions.
Clive Meanwell, Chairman and Chief Executive Officer of The Medicines Company said, If approved by the regulatory authorities, we believe Fibrocaps will become a leading hemostatic product complementary to Recothrom® Thrombin, topical (Recombinant). This would allow us to leverage our frontline activities in surgery centers at leading US hospitals and potentially accelerate our entry into the European market. In addition, the ProFibrix team, expert in
The Medicines Company |
8 Sylvan Way Parsippany, New Jersey 07054 |
Tel: (973)290-6000 Fax: (973)656-9898 |
fibrinogen biology and development, is pursuing a recombinant fibrinogen project which, if successful, is anticipated to position The Medicines Company as the first provider of recombinant thrombin and recombinant fibrinogen both of which may be used as individual or combination products. Establishing a robust perioperative portfolio serves our purpose to save lives, alleviate suffering and improve the economic efficiency of the approximately 2,500 leading hospitals in the world.
Glenn Sblendorio, President and Chief Financial Officer of The Medicines Company added, We believe the deal structure creates value and aligns the interests of both The Medicines Company and ProFibrix. We anticipate the near term revenue potential for Fibrocaps in both US and European markets to fit well with our strategy for aggressive and sustainable growth in acute and intensive care medicine globally.
Jan Öhrström, MD, Chief Executive Officer of ProFibrix and former Senior Vice President of Development and Chief Medical Officer of ZymoGenetics said, Having led the development of Recothrom, it is clear to me that the ProFibrix team, our technology platform and our lead product are a strategic fit with The Medicines Companys perioperative and hemostasis programs.
BofA Merrill Lynch served as financial advisor and WilmerHale served as legal advisor for the transaction for The Medicines Company.
Barclays served as financial advisor and Dechert served as legal advisor for the transaction for ProFibrix.
About The Medicines Company
The Medicines Company (NASDAQ: MDCO) provides medical solutions to improve health outcomes for patients in acute and intensive care hospitals worldwide. These solutions comprise medicines and knowledge that directly impact the survival and well-being of critically ill patients. The Medicines Companys website is www.themedicinescompany.com.
About ProFibrix
ProFibrix (www.profibrix.com) was founded in 2004 and is headquartered in Leiden, The Netherlands, with a subsidiary in Seattle, WA, USA. The company leverages its expertise in fibrinogen technology to develop and bring to market innovative products for the hemostasis and regenerative medicine markets. Human fibrinogen plays a pivotal role in blood clotting and tissue healing. ProFibrix is led by a team with extensive commercial, clinical and scientific experience in the hemostasis field.
About Fibrocaps
Fibrocaps is a mixture of two essential blood clotting proteins, fibrinogen and thrombin, formulated as a unique dry powder topical product, which is being developed to stop bleeding during or after surgery. Fibrocaps is differentiated from existing liquid fibrin sealants and
hemostats: it is ready for immediate use, is stable at room temperature and does not require frozen storage or thawing.
About the FINISH-3 trial
FINISH-3 is a prospective, randomized, Phase 3 trial of Fibrocaps in patients undergoing spinal, liver, vascular and soft tissue surgery. Patients were enrolled in the U.S. and Europe. Results of FINISH-3 are expected in the third quarter of 2013.
The Medicines Company Forward-Looking Statements
Statements contained in this press release about The Medicines Company that are not purely historical, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words believes, anticipates and expects and similar expressions are intended to identify forward-looking statements, including the Companys expectations regarding regulatory approval and commercialization of Fibrocaps. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Companys actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include the extent of the commercial success of Fibrocaps, whether the results of the Phase 3 clinical trial of Fibrocaps are satisfactory, the ability of the Company to obtain regulatory approvals of Fibrocaps the ability of the Company to successfully integrate the ProFibrix business with its other businesses, the Companys ability to develop its global operations and penetrate foreign markets, whether the Companys products will advance in the clinical trials process on a timely basis or at all, whether the Company will make regulatory submissions for product candidates on a timely basis, whether its regulatory submissions will receive approvals from regulatory agencies on a timely basis or at all, whether physicians, patients and other key decision makers will accept clinical trial results, risks associated with the establishment of international operations, and such other factors as are set forth in the risk factors detailed from time to time in the Companys periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Companys Quarterly Report on Form 10-Q filed on May 10, 2013, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.