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 12, 2021

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 2.02. Results of Operations and Financial Condition.

On January 12, 2021, Orthofix Medical Inc. (the “Company”) issued a press release announcing, among other things, its preliminary unaudited net sales for the fiscal quarter and year ended December 31, 2020. A copy of the press release is furnished herewith as Exhibit 99.1 and attached hereto.

The information furnished in this Item 2.02, including the exhibit furnished herewith as Exhibit 99.1, will not be treated as “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.  This information will not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended (the “Securities Act”), or into another filing under the Exchange Act, unless that filing expressly incorporates by reference this Item 2.02 of this report.

Item 7.01 Regulation FD Disclosure.

The press release furnished in Exhibit 99.1 also provides an update on the Company’s business outlook, that is intended to be within the safe harbor provided by the Private Securities Litigation Reform Act of 1995 (the “Act”) as comprising forward looking statements within the meaning of the Act.

The information furnished in this Item 7.01, including the exhibit furnished herewith as Exhibit 99.1, will not be treated as “filed” for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section. This information will not be deemed incorporated by reference into any filing under the Securities Act, or into another filing under the Exchange Act, unless that filing expressly incorporates by reference this Item 7.01 of this report.

Item 9.01. Financial Statements and Exhibits.

(d)Exhibits

99.1	Press release, dated January 12, 2021.
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 Development Officer

Date: January 12, 2021

EX-99.1

Exhibit 99.1

Orthofix Announces Preliminary 2020 Fourth Quarter and Full Year Net Sales Results

• Fourth quarter net sales of approximately $118 million, an increase of 6% sequentially and a decrease of 3% versus the prior year

• U.S. Spinal Implants fourth quarter net sales increased 11% over the prior year

• Motion Preservation fourth quarter net sales in the U.S. were approximately $7 million, an increase of 27% sequentially and 129% over prior year

LEWISVILLE, Texas —January 12, 2021— Orthofix Medical Inc. (NASDAQ:OFIX) today announced preliminary unaudited fourth quarter 2020 net sales of approximately $118 million, a decrease of 3% on a reported basis and 4% on a constant currency basis. For the full year 2020, preliminary unaudited net sales were approximately $407 million, a decrease of 12% on both a reported and constant currency basis. On a sequential basis, compared to the third quarter of 2020, net sales increased 6%.

“First I would like to thank all of our team members for their remarkableefforts throughout this unprecedented and volatile year. This pandemic presented patients, surgeons and hospital teams with extraordinary challenges, which continues to require an extraordinary response by the Orthofix team. I am grateful to work alongside people so motivated and committed to improving patients’ lives,” said Orthofix President and Chief Executive Officer Jon Serbousek.

“We are pleased by our continued positive revenue momentum in the fourth quarter driven primarily by our Spinal Implants business, despite the continued headwinds and uncertainty caused by COVID-19 across the globe. When normalizing for certain large stocking orders that did not recur in 2020, our Q4 2020 consolidated net sales were approximately flat to last year. Our solid finish to 2020 directly reflects on the tenacity and resolve of our teams around the world, and our ability to execute on our strategic initiatives throughout the year. As we move into 2021, we will use this momentum and believe we are better positioned to deliver growth.”

	Three Months Ended December 31,
(Unaudited, U.S. Dollars, in millions)	2020		2019		Change			Constant Currency Change
Bone Growth Therapies	$	51	$	51		(1	%)		(1	%)
Spinal Implants		28		25		9	%		9	%
Biologics		15		17		(9	%)		(9	%)
Global Spine		94		93		0	%		0	%
Global Extremities		24		28		(15	%)		(18	%)
Net sales	$	118	$	121		(3	%)		(4	%)

	Year Ended December 31,
(Unaudited, U.S. Dollars, in millions)	2020		2019		Change			Constant Currency Change
Bone Growth Therapies	$	171	$	197		(13	%)		(13	%)
Spinal Implants		95		95		0	%		0	%
Biologics		55		65		(15	%)		(15	%)
Global Spine		322		357		(10	%)		(10	%)
Global Extremities		85		103		(17	%)		(18	%)
Net sales	$	407	$	460		(12	%)		(12	%)

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Fourth Quarter Revenue Highlights

Global Spine

• Bone Growth Therapies net sales approximated prior year amounts due to adding new surgeon users that offset limited access to physicians’ offices as a result of the COVID-19 pandemic

• Spinal Implants net sales increased largely due to the growth and continued adoption of our M6-C^™ artificial cervical disc in the U.S.

• Biologics net sales decreased primarily due to the effects of the COVID-19 pandemic, channel transition and continued pricing pressure in the market

Global Extremities

• Global Extremities net sales decreased primarily due to lower procedure volumes attributable to the COVID-19 pandemic, particularly within international markets, and the non-recurrence of certain large stocking orders occurring in fourth quarter of 2019

As of December 31, 2020, cash, cash equivalents, and restricted cash was approximately $96-97 million compared to $70 million as of December 31, 2019.

Upcoming Presentations / Conference Calls

Orthofix will report its full financial results for 2020 and provide its financial outlook for 2021 during its earnings announcement planned for late February.

Also, as previously announced, the Company’s President and Chief Executive Officer, Jon Serbousek, and Chief Financial Officer, Doug, Rice, will present at two upcoming virtual investor conferences.

J.P. Morgan Healthcare Conference

The Company will be presenting on Thursday, January 14, 2021 at 2:00pm ET.

ICR Westwicke Conference 2021

The Company will be presenting on Thursday, January 14, 2021 at 4:00pm ET.

Both presentations will be webcast live and will be available on the Company’s website atir.orthofix.com/events-and-presentations/.

About Orthofix

Orthofix Medical Inc. is a global medical device and biologics company with a spine and extremities focus. The Company’s mission is to deliver innovative, quality-driven solutions as we partner with health care professionals to improve patients’ lives. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic extremities products are distributed in over 70 countries via the Company's sales representatives and distributors. For more information, please visitwww.orthofix.com.

Constant Currency

Constant currency is a non-GAAP measure, which is calculated by using foreign currency rates from the comparable, prior-year period, to present net sales at comparable rates. Constant currency can be presented for numerous GAAP measures, but is most commonly used by management to analyze net sales without the impact of changes in foreign currency rates.

Usefulness and Limitations of Non-GAAP Financial Measures

Management uses non-GAAP measures to evaluate performance period-over-period, to analyze the underlying trends in our business, to assess performance relative to competitors and to establish operational goals and forecasts that are used in allocating resources. In addition, management uses these non-GAAP measures to further its understanding of the performance of our business units.

Material Limitations Associated with the Use of Non-GAAP Financial Measures

The non-GAAP measures used in this press release may have limitations as analytical tools, and should not be considered in isolation or as a replacement for GAAP financial measures.

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Compensation for Limitations Associated with Use of Non-GAAP Financial Measures

We compensate for the limitations of our non-GAAP financial measures by relying upon GAAP results to gain a complete picture of our performance. The GAAP results provide the ability to understand our performance based on a defined set of criteria. The non-GAAP measures reflect the underlying operating results of our businesses, which we believe is an important measure of our overall performance.

Usefulness of Non-GAAP Financial Measures to Investors

Management believes it is important to provide investors with the same non-GAAP metrics it uses to supplement information regarding the performance and underlying trends of our business operations in order to facilitate comparisons to its historical operating results and internally evaluate the effectiveness of our operating strategies. Disclosure of these non-GAAP financial measures also facilitates comparisons of our underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict, including the risks described in Part II Item 1A under the heading Risk Factors of our Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, and Part I, Item 1A under the heading Risk Factors in our Annual Report on Form 10-K for the year ended December 31, 2019 (the “2019 Form 10-K”). In addition to the risks described there, factors that could cause or contribute to such differences may include, but are not limited to, risks relating to the effects of the COVID-19 pandemic on our business, including (i) surgeries that use our products being delayed or cancelled as a result of hospitals and surgery centers being closed or limited to life-threatening and/or essential procedures, (ii) portions of our global workforce being unable to work fully and/or effectively due to illness, quarantines, government actions (including "shelter in place" orders or advisories), facility closures or other reasons related to the pandemic, (iii) disruptions to our supply chain, (iv) customers and payors being unable to satisfy contractual obligations to us, including the ability to make timely payment for purchases, (v) general economic weakness in markets in which we operate affecting customer spending, and (vii) other unpredictable aspects of the pandemic. To the extent that the COVID-19 pandemic continues to adversely affect our business and financial results, it may also have the effect of heightening many of the other risks described in Part I, Item 1A under the heading Risk Factors in our 2019 Form 10-K, such as our ability to generate sufficient cash flows to run our business and our ability to protect our information technology networks and infrastructure from unauthorized access, misuse, malware, phishing and other events that could have a security impact as a result of our remote working environment or otherwise. As a result of these various risks, our actual outcomes and results may differ materially from those expressed in these forward-looking statements.

This list of risks, uncertainties and other factors is not complete. We discuss some of these matters more fully, as well as certain risk factors that could affect our business, financial condition, results of operations, and prospects, in reports we file from time-to-time with the Securities and Exchange Commission, which are available to read at www.sec.gov. Any or all forward-looking statements that we make may turn out to be wrong (due to inaccurate assumptions that we make or otherwise), and our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to update, and expressly disclaim any duty to update, our forward-looking statements, whether as a result of circumstances or events that arise after the date hereof, new information, or otherwise.

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Company Contact

Orthofix Medical Inc.

Alexa Huerta

P: 214-937-3190

E: alexahuerta@orthofix.com

Source

Orthofix Medical Inc.

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XML

Document And Entity Information	Jan. 12, 2021
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 12, 2021
Entity Registrant Name	ORTHOFIX MEDICAL INC.
Entity Central Index Key	0000884624
Entity Emerging Growth Company	false
Entity File Number	0-19961
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	98-1340767
Entity Address, Address Line One	3451 Plano Parkway
Entity Address, City or Town	Lewisville
Entity Address, State or Province	TX
Entity Address, Postal Zip Code	75056
City Area Code	214
Local Phone Number	937-2000
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of each class	Common stock, $0.10 par value per share
Trading Symbol	OFIX
Name of each exchange on which registered	NASDAQ