ofix-8k_20200203.htm
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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): February 3, 2020

 

 

ORTHOFIX MEDICAL INC.

(Exact name of Registrant as specified in its charter)

 

 

Delaware

 

0-19961

 

98-1340767

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(IRS Employer

Identification No.)

 

 

 

 

 

3451 Plano Parkway

Lewisville, Texas

 

75056

(Address of principal executive offices)

 

(Zip Code)

Registrant’s telephone number, including area code: (214) 937-2000

 

 

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):

 

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

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

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

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. 

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

 

Trading

Symbol(s)

 

Name of each exchange on which registered

Common stock, $0.10 par value per share

 

OFIX

 

Nasdaq Global Select Market

 

 

 


 

Item 7.01.

Regulation FD Disclosure.

On February 4, 2020, Orthofix Medical Inc. (the “Company”) issued a press release regarding an agreement to acquire certain assets of Wittenstein SE (“Wittenstein”), a privately-held German-based company. That press release is furnished herewith as Exhibit 99.1.

The information included in this Current Report on Form 8-K under this Item 7.01 (including Exhibit 99.1) shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

 

Item 8.01.

Other Events.

On February 3, 2020, the Company, through a wholly owned subsidiary, entered into an Asset Purchase Agreement (the “Purchase Agreement”) with Wittenstein to acquire assets associated with the FITBONE® intramedullary lengthening system for limb lengthening of the femur and tibia bones. Under the terms of the Purchase Agreement, as consideration for the acquired assets, the Company will pay $18 million in cash consideration and will enter into manufacturing supply contract with Wittenstein.

The acquisition is anticipated to close by the end of the first quarter of 2020, subject to customary closing conditions.

 

Item 9.01.

Financial Statements and Exhibits.

(d)

Exhibits

99.1

Press release, dated February 4, 2020.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).


 


 

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 Medical Inc.

 

 

By:

 

 

/s/ Kimberley A. Elting

 

 

 

Kimberley A. Elting

Chief Legal and Administrative Officer

 

 

 

Date: February 4, 2020

 

 

 

 

ofix-ex991_6.htm

 

Exhibit 99.1

 

 

 

 

Orthofix Announces Agreement to Acquire FITBONE Limb Lengthening System

 

Transaction expands limb reconstruction portfolio

 

LEWISVILLE, TX. – February 4, 2020 – Orthofix Medical Inc. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products today announced an asset purchase agreement with Wittenstein SE, a privately-held German-based company, to acquire assets associated with the FITBONE® intramedullary lengthening system for limb lengthening of the femur and tibia bones. Additionally, the transaction brings other potential applications of the technology, which are in preliminary development, including the FITSPINE® system for early onset scoliosis. Terms of the agreement include $18 million in cash closing consideration and a manufacturing supply contract with Wittenstein SE.

“Founded 40 years ago as an extremity fixation company, Orthofix has a long history of cutting-edge solutions to treat patients born with limb discrepancies,” said Orthofix President and Chief Executive Officer Jon Serbousek. “The addition of the FITBONE intramedullary lengthening system further rounds out our limb reconstruction offerings and is well aligned with our strategy of investing in innovative products to drive growth within our core businesses.”

The FITBONE system consists of an intramedullary lengthening nail that is surgically implanted in the bone through a minimally invasive procedure, an external control set that manages the distraction process, and the FITBONE app that supports the patient throughout the limb lengthening treatment. Over 3,500 cases in more than 15 countries have been performed with the FITBONE system.

With the addition of the FITBONE system, Orthofix becomes the only orthopedic company that offers a comprehensive portfolio of both internal and external fixation solutions for limb reconstruction. The FITBONE system will augment Orthofix’s current deformity and limb reconstruction offerings that include the TL-HEX computer-assisted ring fixation system for external limb lengthening and the eight-Plate Guided Growth System for correcting angular growth deformities in pediatric patients. To learn more about Orthofix’s dedication to helping surgeons and limb deformity correction patients, please visit JuniOrtho.club.

 

“We are proud that we could bring a product such as the FITBONE intramedullary lengthening system to the market to help people in need of limb lengthening,” said Dr. Bertram Hoffmann, Chief Executive Officer of Wittenstein SE. “It has long been our goal to increase global availability. We are pleased that through Orthofix, more surgeons and their patients will have access to this innovative technology that can make a huge difference in an individual’s quality of life.”

The FITBONE intramedullary lengthening system is available in the U.S. under a U.S. Food and Drug Administration 510(k) clearance and in European Countries under a CE Mark approval. The acquisition is anticipated to close by the end of the first quarter of 2020, subject to customary closing conditions. Orthofix does not expect the transaction to be material to 2020 net sales. More information regarding this announcement will be made available during the Company’s fourth quarter and fiscal year 2019 financial results call.  

About Orthofix

Orthofix Medical Inc. is a global medical device company focused on musculoskeletal products and therapies. The Company’s mission is to improve patients' lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic extremities products are distributed in more than 70 countries via the Company's sales representatives and distributors. For more information, please visit www.orthofix.com.

 

About Wittenstein SE

With around 3000 employees worldwide and sales of €436.4 million in 2018/19, Wittenstein SE enjoys a reputation for innovation, precision and excellence in the field of mechatronic drive technology – not just in Germany but internationally. The group comprises six pacesetting Business Units with separate subsidiaries for servo gearboxes, servo actuator systems, medical technology, miniature servo units, innovative gearing technology, rotary and linear actuator systems, nanotechnology and electronic and software components for drive technologies. Through its 60 or so subsidiaries and

 


 

agents in approximately 40 countries, Wittenstein SE (www.wittenstein.de) is additionally represented in all the world's major technology and sales markets.

 

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 estimates, projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, Wittenstein SE and their respective companies’ product portfolios, are based on Orthofix 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, including the possibility that the deal might not close, difficulties commercializing  products and integrating the product into Orthofix’s business, inaccuracies in Orthofix’s estimates and projections of future product sales, including the current and future size of the worldwide and U.S. limb reconstruction market, FDA and regulatory approval risks, and other risks described in the "Risk Factors" section of our 2018 Annual Report on Form 10-K, as well as in other reports that we file in the future. 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.

 

CONTACT:

 

 

 

 

   Mark Quick

Denise Landry

 

 

 

   Investor Relations

Media Relations

 

 

 

   Tel    214 937 2924

Tel   214 937 2529

 

 

 

   markquick@orthofix.com

deniselandry@orthofix.com