0001113481-14-000023.txt : 20140423 0001113481-14-000023.hdr.sgml : 20140423 20140423170119 ACCESSION NUMBER: 0001113481-14-000023 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20140421 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140423 DATE AS OF CHANGE: 20140423 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDICINES CO /DE CENTRAL INDEX KEY: 0001113481 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043324394 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31191 FILM NUMBER: 14779330 BUSINESS ADDRESS: STREET 1: 8 SYLVAN WAY CITY: PARSIPPANY STATE: NJ ZIP: 07054 BUSINESS PHONE: 973-290-6000 MAIL ADDRESS: STREET 1: 8 SYLVAN WAY CITY: PARSIPPANY STATE: NJ ZIP: 07054 FORMER COMPANY: FORMER CONFORMED NAME: MEDICINES CO/ MA DATE OF NAME CHANGE: 20000504 8-K 1 form8-ktenaxis.htm 8-K Form 8-K (Project Napa - Tenaxis)


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 21, 2014


THE MEDICINES COMPANY
(Exact Name of Registrant as Specified in Charter)


Delaware
 
000-31191
 
04-3324394
(State or Other Jurisdiction
of Incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
                       

8 Sylvan Way
Parsippany, New Jersey
 
07054
(Address of Principal Executive Offices)
 
(Zip Code)

Registrant's telephone number, including area code: (973) 290-6000

 
(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 (see General Instruction A.2. below):
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 April 21, 2014, The Medicines Company (the “Company”) entered into an Agreement and Plan of Merger (the “Merger Agreement”) with Tenaxis Medical, Inc., a Delaware corporation (“Tenaxis”), Napa Acquisition Corp., a Delaware corporation and wholly owned subsidiary of the Company (the “Merger Sub”), and Fortis Advisors LLC, a Delaware limited liability company, solely in its capacity as the representative and agent of the stockholders and optionholders of Tenaxis (the “Representative”). The acquisition of Tenaxis will be accomplished through a merger of the Merger Sub with and into Tenaxis (the “Merger”). Tenaxis shall survive the Merger as the surviving corporation, and, as such, become a wholly owned subsidiary of the Company.

Under the Merger Agreement, at the closing, the Company will pay to the holders of Tenaxis’s capital stock, the holders of options to purchase shares of Tenaxis’s capital stock (whether or not such capital stock or options were vested or unvested as of immediately prior to the Closing) and the holders of certain warrants and side letters (collectively, the “Tenaxis Equityholders”) an aggregate of $58.0 million in cash, subject to customary adjustments at and after the closing.

Additionally, the Company has agreed to pay to the Tenaxis Equityholders milestone payments subsequent to the Closing, if the Company achieves certain regulatory approval milestones and commercial net sales milestones with respect to Tenaxis’ surgical sealant product. In the event that all of the milestones set forth in the Merger Agreement are achieved, the Company will pay the Tenaxis Equityholders up to an additional $112.0 million in cash in the aggregate.

At the closing, all of the outstanding shares of Tenaxis’s capital stock, options (whether or not vested), warrants and side letters will be cancelled and converted into the right to receive a portion of the cash payments described above.

The Company will fund the amounts to be paid at closing and intends to fund the milestone payments, if any, with cash on hand.
 
The Merger Agreement includes customary representations, warranties, covenants and indemnification obligations. At the closing, the Company will also enter into an eighteen (18) month escrow arrangement in a customary form with the Representative and an escrow agent, and will deposit $5.4 million into an escrow fund for the recovery of indemnification claims. Some indemnification claims can also be recovered from future milestone payments.

The closing of the transactions under the Merger Agreement is subject to customary closing conditions, including execution of non-competition and non-solicitation agreements by certain of Tenaxis’ management stockholders and the acceptance of employment offers by certain employees.
 
The Merger Agreement and this summary are not intended to modify or supplement any factual disclosures about the Company or Tenaxis. The foregoing descriptions of the Merger and the Merger Agreement do not purport to be complete and are qualified in their entirety by reference to the complete text of the Merger Agreement, which the Company intends to file, with confidential terms redacted, with the Securities and Exchange Commission as an exhibit to the Company's Periodic Report on Form 8-K announcing the closing of the Merger.
 
The representations, warranties and covenants contained in the Merger Agreement were made only for the purposes of the Merger Agreement, were made as of specific dates, were made solely for the benefit of the parties to the Merger 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 Merger Agreement. The assertions embodied in those representations and warranties may be subject to important qualifications and limitations agreed to by the Company and Tenaxis 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 Company’s 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 April 23, 2014, the Company issued a press release announcing, among other things, its entry into the Merger Agreement and the completion of its acquisition of Tenaxis. 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, including the Company’s preliminary revenue results, are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company’s 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 decisions of regulatory authorities regarding clinical trials related to, marketing approval for or material limitations on the marketing of Tenaxis’s surgical sealant product; the extent of the commercial success of Tenaxis’s surgical sealant product; the ability of the Company to successfully integrate Tenaxis’s business with the Company’s other businesses; and such other factors as are set forth in the risk factors detailed from time to time in the Company’s periodic reports and registration statements filed with the Securities and Exchange Commission. 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 April 23, 2014






SIGNATURES
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.

THE MEDICINES COMPANY
Date:  April 23, 2014        
By:    /s/ Stephen M. Rodin
Stephen M. Rodin
Senior Vice President and General Counsel







Exhibit Index


Exhibit No.
Description
99.1
Press release issued by the Company on April 23, 2014






EX-99.1 2 pressreleasetenaxis.htm EXHIBIT Press Release (Tenaxis)


EXHIBIT 99.1



The Medicines Company Adds Novel, Approved, Surgical Sealant to Its Surgical Hemostasis Portfolio

Acquires Tenaxis Medical, Inc.


PARSIPPANY, NJ and MOUNTAIN VIEW, CA, April 23, 2014 --The Medicines Company (NASDAQ: MDCO) and Tenaxis Medical, Inc.(Tenaxis) today announced an agreement for The Medicines Company to acquire Tenaxis. Tenaxis’s sole product, which mechanically seals both human tissue and artificial grafts is approved, but not launched in the US- having received US PMA approval from the FDA in March 2013 as a vascular sealant. The product is also approved with a European CE Mark as a surgical sealant applicable to cardiovascular, general, urological, and thoracic surgery. The addition of the Tenaxis product adds another solution for surgical bleeding to The Medicines Company’s portfolio which also includes the marketed product, RecoThrom (aqueous, recombinant human Thrombin) and the investigational product, Fibrocaps (a dry powder formulation of fibrinogen and thrombin being developed to aid in hemostasis during surgery) which has completed phase III trials and is under FDA and EMA review.

Under the terms of the agreement, The Medicines Company will pay $58 million upfront on closing of the deal. The Medicines Company will also pay milestone payments of up to $112 million contingent upon achieving certain commercial and - in pursuit of even broader indications - regulatory approval milestones. The transaction is subject to the satisfaction of customary closing conditions.

“We continue to execute our strategy for growth, building our presence in surgery and perioperative care,” said Clive Meanwell, Chairman and Chief Executive Officer of The Medicines Company.

Adam Sharkawy, Senior Vice President and Global Innovation Group Leader for Surgery and Perioperative Care added, “A robust portfolio of solutions for intra-operative bleeding is expected to drive growth for us in this sector of hospital medicine. This acquisition will allow us to leverage and build our activities in surgery centers at leading US and European hospitals. In the US, we expect to deploy approximately 100 of our current engagement managers across these surgical product offerings.”
In a pivotal trial in vascular surgery, the Tenaxis sealant was effective when used as prophylactic treatment on native vessels and grafts, reducing the incidence of bleeding within the first minute after removal of vascular clamps. The Tenaxis sealant was compared to Gelfoam Plus, a topical hemostat containing a low concentration of thrombin (125 Units/mL), in the clinical trial used to support licensure (N=217; 1:1 randomization). The Tenaxis surgical sealant was shown to be superior to Gelfoam Plus

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based on a statistically significantly lower incidence of suture hole bleeding at the time of clamp release (60.5% vs. 39.6% of anastomotic sites at Time 0; p = 0.0001); the 20% difference at the time of clamp release persisted at 10 minutes (82% vs. 72%). Superiority was demonstrated in several types of surgical procedures (extremity bypass, hemodialysis access grafting, and other vascular procedures).

“We are excited to be involved in a transaction with The Medicines Company, which will allow more patients to have access to this beneficial technology,” Ronald Dieck, President and CEO of Tenaxis commented.  “We are proud of the surgical sealant technologies that we have developed and their impact on the wellbeing of patients.  The Medicines Company is clearly committed to the area of intraoperative hemostasis and we look forward to working as a team to innovate in this area of medicine.”

The Boards of Directors of both companies have unanimously approved the agreement.

Gibbons P.C. served as legal advisor for the transaction for The Medicines Company. Leerink Swann & Co. served as financial advisor and Wilson Sonsini Goodrich & Rosati, PC served as legal advisor for the transaction for Tenaxis Medical, Inc.

Conference Call Information
There will be a conference call with The Medicines Company management today at 8:30 a.m. Eastern Time to discuss the Tenaxis acquisition, first quarter 2014 financial results, operational developments, and outlook. The conference call will be available via phone and webcast. The webcast can be accessed at www.themedicinescompany.com.
Domestic Dial In: +1 (877) 359-9508
International Dial In: +1 (224) 357-2393
Passcode for both dial in numbers: 27882505
Replay is available from 11:30 a.m. Eastern Time following the conference call through May 7, 2014. To hear a replay of the call dial +1 855 859-2056 (domestic) and +1 404 537-3406 (international). Passcode for both dial in numbers is 27882505.

About The Medicines Company
The Medicines Company's purpose is to save lives, alleviate suffering and contribute to the economics of healthcare by focusing on 3000 leading acute/intensive care hospitals worldwide. Its vision is to be a leading provider of solutions in three areas: acute cardiovascular care, surgery and perioperative care, and serious infection disease care. The company operates in the Americas, Europe and the Middle East, and Asia Pacific regions with global centers today in Parsippany, NJ, USA and Zurich, Switzerland.


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About Tenaxis Medical, Inc.

Located in Mountain View, CA, Tenaxis Medical, Inc. is a privately held company that began operations in 2006.  It develops novel, high performance sealants that are designed to meet unmet needs throughout various medical procedures.  The products are based on a patent foundation that allows for the development of sealants with wide mechanical and chemical properties.

In addition to its Surgical Sealant, the company is developing a second high-performance sealant, Prevent™ GI Sealant, for use throughout the gastrointestinal tract and an anti-surgical adhesion agent that can be delivered laparoscopically to help prevent or reduce pelvic and abdominal adhesions.

Pioneer MPW, LLC is Tenaxis’s largest shareholder. 

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. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's 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 whether physicians, patients and other key decision makers will accept clinical trial results, and such factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Annual Report on Form 10-K filed with the SEC on March 3, 2014, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements.

Contact:
Neera Dahiya Ravindran, MD
Vice President, Investor Relations & Strategic Planning
The Medicines Company
+1 (973) 290-6044
neera.ravindran@themedco.com




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