LEWISVILLE, Texas--(BUSINESS WIRE)--
Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical
device company, today announced it has reached final resolutions of
previously disclosed Securities and Exchange Commission (SEC)
investigations of certain historic accounting matters and of
anti-bribery matters in Brazil. The resolutions are on the same material
terms as previously disclosed by the Company, and all monetary payments
being made to the SEC were accrued in the second and third quarters of
2016 and funded into escrow in the fourth quarter of 2016.
"We are very pleased to bring closure to these collective matters, which
relate to activities that occurred largely between 2011 and 2013," said
Brad Mason, President and Chief Executive Officer. "We have instituted
broad remedial measures designed to detect and prevent the issues that
led to the matters being resolved, and these resolutions allow us to
continue moving forward with the Company's critical mission of serving
patients, our physician customers, and shareholders."
The first resolution relates to accounting errors that were addressed in
the restated financial statements filed in March 2014 and March 2015.
The Company voluntarily self-reported this matter to the SEC, conducted
a comprehensive independent review, and cooperated fully with the SEC
during its review. The Company instituted extensive remediation
following a comprehensive review and analysis of its internal controls
over financial reporting. The Company adopted large-scale structural
initiatives such as systems implementations as well as numerous more
granular and directly responsive internal controls and process changes.
Orthofix also implemented a more efficient centralized operational and
financial reporting structure that better reflects the current scope and
complexity of its business.
The second resolution relates to an anti-bribery matter involving the
Company's Brazilian subsidiary. Orthofix self-reported the matter to the
Department of Justice (DOJ) and SEC, conducted a diligent and thorough
internal review with the assistance of outside counsel, and fully
cooperated with the SEC and the DOJ. The Company instituted extensive
remediation measures with respect to this matter, including terminating
employees, as well as relationships with third-party representatives and
distributors; conducting a global review of its anti-corruption and
anti-bribery program; implementing regular audits of its third-party
distributors and sales agents; developing and implementing new global
accounting policies to provide further structure and guidance to foreign
subsidiaries; establishing an internal audit function; expanding
Orthofix's Compliance department in both number and quality of
personnel; and implementing enhanced anti-corruption compliance training
for employees and certain third parties. As part of this SEC resolution,
the Company agreed to retain an independent compliance consultant for
one year to ensure the remediated compliance and ethics programs and
internal controls and processes continue to function properly. Finally,
after careful review by the DOJ, the Company was informed that the DOJ
has decided to take no further action with respect to this matter.
Orthofix International N.V. is a diversified, global medical device
company focused on improving patients' lives by providing superior
reconstructive and regenerative orthopedic and spine solutions to
physicians worldwide. Headquartered in Lewisville, TX, the company has
four strategic business units that include BioStim, Biologics, Extremity
Fixation and Spine Fixation. Orthofix products are widely distributed
via the Company's sales representatives, distributors and subsidiaries.
In addition, Orthofix is collaborating on research and development
activities with leading clinical organizations such as Brown University,
Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite
Hospital for Children and the Musculoskeletal Transplant Foundation. For
more information, please visit www.orthofix.com.
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, 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 described in the "Risk Factors" section of our Annual Report on
Form 10-K for the fiscal year ended December 31, 2015, 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170118005964/en/
Orthofix International N.V.
Denise Landry, 214-937-2529
Source: Orthofix International N.V.
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