8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): January 9, 2012

Orthofix International N.V.

(Exact name of Registrant as specified in its charter)

Curacao	0-19961	N/A
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

7 Abraham de Veerstraat Curacao	N/A
(Address of principal executive offices)	(Zip Code)

Registrant’s telephone number, including area code: 011-59-99-465-8525

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):

oWritten communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

oSoliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

oPre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

oPre-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.

Amendment No. 2 to Matrix Commercialization Collaboration Agreement with Musculoskeletal Transplant Foundation

Orthofix International N.V. (the “Company”) is party, through its wholly owned subsidiary, Orthofix Holdings, Inc. (“Orthofix”), to a Matrix Commercialization Collaboration Agreement, dated as of July 24, 2008, between Orthofix and Musculoskeletal Transplant Foundation (“MTF”), as amended by Amendment No. 1 thereto dated December 15, 2010 (as amended, the “Existing Agreement”).

Under the terms of the Existing Agreement, Orthofix and MTF agreed to commercialize Trinity® Evolution™, a stem cell-based bone growth biologic matrix.  Orthofix maintains exclusive marketing rights to Trinity® Evolution™, and MTF supplies the product, in an allograft tissue form, to customers in accordance with orders received directly from Orthofix.  MTF sources, processes and packages the tissue form and is the sole supplier of Trinity® Evolution™ to Orthofix’s customers.

On January 9, 2012, Orthofix and MTF entered into Amendment No. 2 to Matrix Commercialization Collaboration Agreement (the “Amendment”).  The Amendment amends the term of the Existing Agreement until the later of (i) 15 years after the date that that certain development milestones were achieved under the Existing Agreement (which occurred during 2010) or (ii) the date that certain licensing arrangements between the Company and NuVasive, Inc. expire.

Under the Amendment, Orthofix and MTF have agreed to collaborate to develop and commercialize a next generation of the stem cell-based bone growth biologic matrix currently sold and marketed as Trinity® Evolution™ (the “Matrix II”).  The Amendment provides that MTF will develop and improve the Matrix II, and that Orthofix will provide funding support to MTF in connection with this development.  In addition, Orthofix will develop application tools and instruments in connection with the Matrix II.  The Amendment also provides that the parties will share responsibility for contributing scientific or medical personnel, technical expertise and other resources to the development and improvement of the Matrix II, communicating findings and discoveries to one another with respect to the Matrix II and exchanging information related to such collaboration.

The Amendment provides that, upon commercialization of the Matrix II, Orthofix will be provided with exclusive marketing rights to the Matrix II, and MTF will supply the Matrix II to Orthofix’s customers in accordance with orders received directly from Orthofix, as is currently the case with the current generation of the Trinity® Evolution™ product.

Item 2.02.              Results of Operations and Financial Condition.

On January 10, 2012, the Company issued a press release announcing, among other things, its preliminary unaudited net sales for the fiscal quarter and year ended December 31, 2011. A copy of the press release is furnished herewith as Exhibit 99.1 and attached hereto.

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Item 9.01.              Financial Statements and Exhibits.

(d)Exhibits

99.1Press release, dated January 10, 2012.

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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.

Orthofix International N.V.
By:	/s/ Brian McCollum
	Brian McCollum
	Chief Financial Officer and Senior Vice President of Finance

Date: January 10, 2012

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EXHIBIT INDEX

Exhibit No.	Description
99.1	Press release, dated January 10, 2012.

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EX-99.1

Exhibit 99.1

Orthofix International Announces Preliminary Fourth Quarter Sales and New Development Agreement with MTF

LEWISVILLE, Texas - January 10, 2012 (BUSINESS WIRE) — Orthofix International N.V., (NASDAQ:OFIX) (the Company) announced today preliminary unaudited fourth quarter net sales are expected to be a record of approximately $151.3 million, increasing 5% over $143.8 million in the fourth quarter of the prior year. For the full year 2011, net sales are anticipated to be approximately $578.7 million.  President and Chief Executive Officer Robert Vaters said, “I am very pleased with our preliminary net sales results, which represent the second consecutive quarter of record sales. I remain confident in our ability to grow faster than the overall markets where we participate.” The Company will be reporting final 2011 financial results along with 2012 guidance next month.

In addition, the Company announced that it has reached an agreement with MTF to both co-develop and commercialize a new technology for use in bone grafting applications and to expand MTF’s Trinity Evolution processing capacity.  MTF and Orthofix have also extended the initial term of their existing agreement for an additional five years.

“Our collaboration with Orthofix has been highly successful, and we are excited to expand our partnership through the development of this innovative new tissue form for the benefit of surgeons and patients,” said Bruce Stroever, Chief Executive Officer of MTF.  The new tissue form incorporates all three properties necessary to facilitate bone growth, enables excellent handling characteristics, and is complementary to Trinity Evolution.

Mr. Vaters added, “Together with the expanded capacity for Trinity Evolution, we are adding to our biologic pipeline and are very well positioned to help MTF fulfill its mission and meet the market’s increased demand for novel bone grafting solutions.”  The parties plan to introduce the new tissue form in 2013.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on developing and delivering innovative repair and regenerative technologies to the spine and orthopedic markets. Orthofix’s products are widely distributed around the world to orthopedic surgeons and patients via Orthofix’s sales representatives and its subsidiaries,

including BREG, Inc., and via collaborations with other leading orthopedic product companies.  In addition, Orthofix is collaborating on R&D activities with leading research and clinical organizations such as the Musculoskeletal Transplant Foundation, the Orthopedic Research and Education Foundation, Texas Scottish Rite Hospital for Children, and the Cleveland Clinical Foundation.  For more information about Orthofix, please visithttp://www.orthofix.com/ www.orthofix.com.

About the Musculoskeletal Transplant Foundation

The Musculoskeletal Transplant Foundation is the nation’s largest full service tissue organization dedicated to providing quality tissue through a commitment to excellence in education, research, recovery and care for recipients, donors and their families. A not-for-profit organization, MTF is a consortium of academic medical institutions and organ and tissue recovery organizations across the country. In its first 20 years, MTF and its recovery partners have recovered over 60,000 donors and provided over 3 million tissue grafts to patients in need. For more information, please visit MTF’s website at www.mtf.org.

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995.  These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries and are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.

The forward-looking statements in this release do not constitute guarantees or promises of future performance.  Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the expected sales of our products, including recently launched products, unanticipated expenditures, the resolution of pending litigation matters (including the government investigation and False Claims Act matters relating to our bone growth stimulation and spinal implant businesses, and the possible violations of the FCPA by our former Mexican orthopedic distribution entity, as well as certain product liability claims against our sports medicine global business unit), changing relationships with customers, suppliers, strategic partners and lenders, changes to and the interpretation of governmental regulations, risks relating to the protection of intellectual property, changes to the reimbursement policies of third parties, the impact of competitive products, changes to the competitive environment, the acceptance of new products in the market, conditions of the orthopedic industry, credit markets and the economy, corporate development and market development activities, including acquisitions or divestitures, unexpected costs or operating unit performance related to recent acquisitions, and other factors described in our annual report on Form 10-K and other periodic reports filed by the Company with the Securities and Exchange Commission (SEC).  Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements,

which speak only as of the date hereof.  The Company undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances, or otherwise.

The Company cannot predict the timing or outcome of ongoing litigation matters and governmental investigations of our businesses which could result in civil or criminal liability or findings of violations of law (as further described in the “Legal Proceedings” sections of our annual report on Form 10-K and quarterly reports on Form 10-Q), that could materially impact our financial position and/or liquidity.

Contact:	Mark Quick
	Director of Investor Relations and Business Development
	markquick@orthofix.com
	214-937-2924

Source: Orthofix International N.V.