Biologics Market to Reach $399 Billion by 2025 – Research and Markets

Posted On April 28, 2017 By OrthoSpineNews In Biologics /

April 28, 2017

DUBLIN–(BUSINESS WIRE)–Research and Markets has announced the addition of the “Biologics Market, 2014-2025” report to their offering.

The global biologics market is anticipated to reach USD 399.5 billion by 2025. Introduction of targeted therapies coupled with rising adoption of patient centric personalized medicine anticipated to fuel demand. Ever-increasing understanding of the cell physiology and stress, as well as the factors involved in protein production and heterologous gene expression have empowered the use of different living factories.

These living factories are the prokaryotic and eukaryotic cells. Enhancement of drug functionality through achieving successful protein folding and post-translational modifications is supportive for projected progress rate.

Moreover, rising adoption of biopharmaceuticals over chemically synthesized molecules is expected to propel revenue generation significantly. In addition to this, presence of several metabolic disorders that can be treated through the use of biologics is attributive to influence demand.

Combination of advanced bioengineering technologies for biopharmaceutical production is expected to boost progress in pharmaceutical industry. With recent advances in automation, the selection process can be done through high throughput screening (HTS) system for selection of viable clones.

Aforementioned method enables robust production of biopharmaceutical products by obtaining high-producing cell line. Advances with respect to upstream and downstream processing would directly translate into the growth in revenue for this market at a larger level.

However, development of biosimilars is expected to restrain the biologics year on year growth to certain extent. Although, the regulatory approval pathway for these products is not framed yet some drug manufacturers are opting to invest in the development of biobetters.

Companies Mentioned

Samsung BioLogics
Amgen
Novo Nordisk A/S
AbbVie Inc.
Sanofi
Johnson & Johnson Services, Inc
Pfizer Inc.
Merck & Co., Inc.
GSK group of companies
Celltrion
Precision Biologics, Inc.
Merck KGaA
Eli Lilly and Company
Novartis AG
Bayer AG
F. Hoffmann-La Roche Ltd
AstraZeneca

Key Topics Covered:

1 Research Methodology

2 Executive Summary

3 Biologics Market Variables, Trends & Scope

4 Biologics Market: Source Estimates & Trend Analysis

5 Biologics Market: Product Estimates & Trend Analysis

6 Biologics Market: Manufacturing Estimates & Trend Analysis

7 Biologics Market: Disease Category Estimates & Trend Analysis

8 Biologics Market: Regional Estimates & Trend Analysis, by Source, Product, Manufacturing, & Disease Category

9 Competitive Landscape

For more information about this report visit http://www.researchandmarkets.com/research/kcqf7v/biologics_market

Contacts

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com
For E.S.T Office Hours Call 1-917-300-0470
For U.S./CAN Toll Free Call 1-800-526-8630
For GMT Office Hours Call +353-1-416-8900
U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716
Related Topics: Biopharmaceuticals

TransEnterix Announces Pricing of $24.9 Million Public Offering of Common Stock and Warrants

Posted On April 28, 2017 By OrthoSpineNews In Financial /

April 28, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE MKT:TRXC) (“TransEnterix”), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, announced the pricing of its public offering of units, each consisting of one share of the Company’s common stock, one Series A warrant to purchase one share of common stock and one Series B warrant to purchase 0.75 shares of common stock at a price of $1.00 per unit. Each Series A warrant may be exercised at any time beginning on the date of issuance, and from time to time thereafter, through and including the first anniversary of the issuance date, unless terminated earlier as provided in the Series A warrant. In the event the FDA provides clearance with respect to the company’s Senhance System 510(k) application, which was submitted to the FDA in April 2017, the holders of Series A warrants will have 10 business days following written notice to exercise, in whole or in part, their Series A warrants. Any Series A warrants that remain unexercised after such 10 business day period will expire. Each Series B warrant may be exercised at any time beginning on the date of issuance and from time to time thereafter through and including the fifth anniversary of the issuance date. TransEnterix expects the gross proceeds of the offering to be $24.9 million, before deducting underwriter’s discounts and expenses payable by TransEnterix. If a registration statement registering the resale of the shares of common stock underlying the Series A warrants under the Securities Act of 1933, as amended, is not available, the holder of such Series A warrants may, in its sole discretion, elect to exercise the warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the warrant. Any holder of Series B warrants may elect to exercise any such Series B warrant through a cashless exercise at any time prior to expiration. All of the securities to be sold in the offering are to be sold by TransEnterix.

Stifel is acting as the sole book-running manager. The offering is expected to close on or about May 3, 2017, subject to customary closing conditions.

A shelf registration statement relating to the securities offered in the public offering described above was filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 7, 2014 and declared effective on December 19, 2014 (File No. 333-199998), and post-effectively amended pursuant to Post-Effective Amendment No. 1 on Form S-3, as filed with the SEC on March 8, 2016 and declared effective on June 22, 2016 and a related registration statement was filed pursuant to Rule 462(b) under the Securities Act of 1933. The offering is being made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement related to the offering has been filed with the SEC and may be obtained for free by visiting EDGAR on the SEC website at www.sec.gov. A final prospectus supplement related to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104 or by telephone: (415) 364-2720.

This press release does not constitute an offer to sell, or a solicitation of an offer to buy, the securities in the described offering, nor will there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale is unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

About TransEnterix, Inc.

TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Company also developed the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States.

Forward Looking Statements

This press release includes statements relating to the proposed offering of TransEnterix’s securities. These statements and other statements regarding our future plans and goals constitute “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including our expectations regarding the proposed offering and use of proceeds. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc.
Investor Contact:
Mark Klausner, +1-443-213-0501
invest@transenterix.com
or
Media Contact:
(For EU) Conrad Harrington, +44 (0)20 3178 8914
or
(For US) Hannah Dunning, +1-415-618-8750
TransEnterix-SVC@sardverb.com

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Lennart Johansson to Join BONESUPPORT™ Board of Directors

Posted On April 28, 2017 By OrthoSpineNews In Biologics, Top Stories /

LUND, Sweden, April 28, 2017 /PRNewswire/ —

BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces the election of Lennart Johansson to its Board of Directors.

Mr Johansson has been a Senior Advisor at Patricia Industries AB since 2015, and was previously Managing Director (Business Development, Operating and Financial Investments) at Investor AB (2006-2015). Before that, he was Partner and Chief Executive Officer of Emerging Technologies ET AB. He is currently Board Member of Swedish Orphan Biovitrum AB and Hi3G Access AB; Deputy Board Member of Mölnlycke Health Care AB; and Chairman of Vectura AB. Mr Johansson holds an MBA from the Stockholm School of Economics (1980).

Håkan Björklund, Chairman of BONESUPPORT, said: “We are pleased to welcome Lennart to the BONESUPPORT Board. This is an exciting period for the Company and we are confident that Lennart’s experience will be a valuable asset assisting us to achieve our goals.”

Mr Johansson added: “I very much look forward to working with the BONESUPPORT management team and Board to help capitalize on the Company’s potential to become a global leader in the management and treatment of bone disease via its unique CERAMENT^[^Ⓡ^]platform.”

About BONESUPPORT™

BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East.

CERAMENT’s distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling.

CERAMENT G and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU.

BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT’s mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com

BONESUPPORT™ and CERAMENT™ are registered trademarks.

Contact Information

Björn Westberg
Chief Financial Officer
+46-(0)-46-286-53-24
info@bonesupport.com

SOURCE BONESUPPORT AB

Safe Orthopaedics Reports Its Full-Year Results for 2016

Posted On April 28, 2017 By OrthoSpineNews In Financial /

April 28, 2017

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering an innovative range of sterile implants combined with their single-use instruments for spinal surgery, has today reported its full-year results for 2016.

Audit procedures of the FY 2016 financial statements are being performed, and Safe Orthopaedics’ annual financial report will be available in the Investors > Documentation > Documents and Publications section of the Company’s website (www.SafeOrtho.com) from April 29, 2017.


in thousands of euros financial statements under audit, report non-issued	FY 2016	FY 2015
Revenues	2,365	2,498
Purchases used and change in inventories	(1,559)	(2,023)
External costs	(2,820)	(2,682)
Personnel costs	(3,633)	(3,903)
Taxes	(70)	(59)
Depreciation, amortization and charges to provisions	(162)	(883)
Other operating income/(expense)	(224)	(167)
Operating income/(loss) before non-recurring items	(6,104)	(7,218)
Other income/(expense)	(183)	–
Operating income/(loss)	(6,287)	(7,218)
Net financial income	282	656
Net income	(6,005)	(6,566)

€1.1 million improvement in operating performance before non-recurring items

FY 2016 revenues declined slightly to €2.4 million. Even so, when adjusted for the operations in the United States discontinued effective March 1, 2016, Safe Orthopaedics’ revenues grew 10% to €2.3 million from €2.1 million in FY 2015.

Revenues continued to grow in France, rising 16% to €1.2 million in 2016 despite its limited sales and marketing resources. The refocusing drive launched in the first quarter led to the reassignment of certain sales and marketing resources to the region, with new sales staff hired in the second half of the year. Although they did not contribute to FY 2016 revenues, these new staff should have a positive impact in 2017, especially following the recent listing of Safe Orthopaedics’ products in AP-HP’s 39 hospitals in the Paris region, which account for roughly one-quarter of the French market¹.

In the Rest of the World (excluding the United States), revenue growth was fairly sedate during FY 2016 (+3%). The recent launch of sales and marketing operations in Germany should boost the Company’s growth in 2017.

Following the withdrawal from the United States in 2016, Safe Orthopaedics unlocked various savings, which led to a €1.1 million improvement in operating performance before non-recurring items.

After the decline in net financial income due to a negative foreign exchange impact, the FY 2016 net loss totaled €6.0 million versus a loss of €6.6 million in FY 2015.

Reduced cash consumption and financial position

Following its withdrawal from the United States in March 2016, Safe Orthopaedics set about reducing its cash consumption so that it could invest more in expanding its sales and marketing operations, chiefly in France, Germany and other European and emerging markets.

As a result, it used €5.8 million in cash in FY 2016, down from €6.5 million in 2015. Safe Orthopaedics’ net cash² at December 31, 2016 stood at €2.7 million, compared with €5.9 million at December 31, 2015.

During 2017, based on its projections, the Company will need to attract new financing in order to fulfill its funding requirements.

The company is working on several scenarios:

A round of fundraising take the form of a capital increase, public or private, or the issuance of bonds, convertible or not
The use of drawings on the Yorkville OCABSA program or on the Pacéo (currently suspended).

No decision has been made between these scenarios at this stage. However, the Board of April 20th 2017 has approved the principle of a round of fundraising. Some historical shareholders of the Company, including funds managed by Kurma Partners, have signaled their interest in a participation in this transaction, if it were launched by the Company, at a level of 1M€, in the shape of subscriptions and/or guarantees, the format of which would be adapted to the type of transaction, it being understood that this expression of interest does not equate to a commitment on their part.

The accounts of the Company have therefore been established, in this context, by applying the business continuity principle.

However, even though the Company estimates that based on its track record and discussions carried out to date, it is likely that this refinancing would be completed, there subsists in fact an uncertainty regarding its business continuity.

Acceleration in business development and Outlook

During 2016 and since the beginning of 2017, Safe Orthopaedics has continued its realignment from an R&D-oriented company to one focused in priority on marketing its innovative technologies and delivering sales growth.

By strengthening its sales and marketing teams, which now account for over one-third of its headcount, Safe Orthopaedics intends to maintain this momentum. Following the recent hires of very experienced managers, such as Jochen Esser (Head of Sales Germany, see press release dated March 6, 2017) and Pascale Davis (Global Head of Marketing, see press release dated April 24, 2017), Safe Orthopaedics plans to recruit additional talents in its priority markets during 2017.

“2016 marked a change in Safe Orthopaedics’ strategy. Thanks to our decision to withdraw from the United States to refocus in priority on the European market, we successfully managed to reduce our cash consumption in less than a year, while also delivering growth, as demonstrated by our fourth-quarter 2016 performance,” said Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics since March 2016. “I intend to keep moving firmly in the same direction during 2017. AP-HP’s recent decision to list our products and the commercial launch of our product range in Germany, Europe’s largest market by far, have made me even more confident in our ability to maintain a solid pace of growth and further improve our financial performance in the current year.”

Next financial release: First-quarter 2017 revenues: May 9, 2017 (before the market opens)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally-invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpine^TM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees.

For more information, visit: www.SafeOrtho.com

¹ Source: Company
² Net cash represents cash and cash equivalents less short-term debt

Contacts

Safe Orthopaedics
Thierry Lambert
CFO
Tél.: +33 (0)1 34 21 50 00
investors@safeorthopaedics.com
or
NewCap
Julien Perez / Valentine Brouchot
Investor Relations
Nicolas Merigeau
Media Relations
Tél.: +33 (0)1 44 71 94 94
SafeOrtho@newcap.eu

RTI Surgical® Announces 2017 First Quarter Results

Posted On April 28, 2017 By OrthoSpineNews In Financial /

April 27, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, reported operating results for the first quarter of 2017. In addition, the company outlined progress against the initial stages of its transformation toward long-term profitable growth.

RTI’s first quarter 2017 financial results, as described in greater detail below, reflect that the company’s initial actions are beginning to yield positive results. RTI has delivered double-digit revenue growth across its direct business, including its spine, surgical specialties and cardiothoracic segments. The company reported continued strong performance in its International business, with revenue growth in Europe and Asia-Pacific. The Commercial/other business continues to see signs of stabilization despite a decline in revenues.

Under the leadership of Camille Farhat, who assumed the CEO position on March 15, 2017, RTI’s management is implementing a series of actions to return the company to sustainable profitable growth. These initiatives include improving execution, reducing costs and directing resources to those businesses, products and markets with the greatest growth potential. The initial phase of the company’s restructuring program remains on target to yield annualized savings of approximately $8 million, starting in the second quarter.

“I am pleased that our initial strategic initiatives are taking hold, as evidenced by two consecutive quarters of improving performance. While these results are a positive sign, we still have significant work ahead of us,” said Camille Farhat, chief executive officer, RTI. “We are in the early stages of what will be a long-term transformation of the company. Our current focus is on cost reduction, disciplined execution and targeted innovation to better position RTI’s operating platform for growth and profitability.”

He added, “Longer-term, we are completing a thorough evaluation of RTI, its businesses, markets and products. Although we are in the initial phases of this evaluation, there are three central themes that standout: 1) continue investment in our spine business and build scale, 2) increase investment in our commercial business to drive innovation and create new growth opportunities, and, 3) improve margins of our tissue-based implants. We have a talented team, outstanding products and a fierce dedication to meeting our customers’ needs. I am confident that we are on the right path toward setting up RTI for long-term profitable growth and improved cash flow generation.”

First Quarter 2017

RTI reported a net loss applicable to common shares of $2.8 million in the first quarter of 2017, or $0.05 per fully diluted common share, primarily due to a previously disclosed pre-tax charge for severance-related expenses totaling $4.4 million. As outlined in the reconciliation tables that follow, excluding these charges, adjusted net income applicable to common shares was $139,000. Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA) were $6.5 million.

Worldwide revenues were $69.9 million for the first quarter of 2017, an increase of 4 percent, domestic revenues were $63.3 million, an increase of 3 percent, and International revenues were $6.6 million, an increase of 8 percent when compared to the first quarter of 2016. The increase in domestic revenues was primarily due to strong performance in the domestic direct business. The increase in International revenues was mainly driven by growth in Asia, primarily in Spine, and in Europe, primarily in Biologics.

Direct revenues were $43.8 million for the first quarter of 2017, an increase of 13 percent compared to the first quarter of 2016, with double-digit growth reported in RTI’s spine, surgical specialties and cardiothoracic direct business segments. Commercial/other revenues were $26.1 million for the first quarter of 2017, a decline of 9 percent compared to the first quarter of 2016, partly due to lower orders in RTI’s OEM trauma business. Commercial/other revenues continue to stabilize on a sequential basis.

Fiscal 2017 Outlook

RTI’s focus for 2017 will remain squarely on disciplined execution, targeted innovation, and ongoing implementation of strategic actions to achieve profitable growth across each of its business lines and geographies. The company has developed its guidance based on its ongoing restructuring and operational improvement program, its current business profile and existing market conditions.

Within this context, based on first quarter results, RTI expects full year revenues for 2017 to be between $274 million and $285 million, in line with prior communication, with direct revenues anticipated to grow mid-to-high single digits on a percentage basis compared to 2016, while commercial/other revenues are expected to be relatively flat to low single-digit decline on a percentage basis.

As detailed in the reconciliation provided later in this release, excluding the $4.4 million pre-tax charge for severance-related expenses in 2017 as noted above, RTI expects adjusted full year net income per fully diluted common share to be between $0.05 and $0.10, in line with prior communication, based on 59.5 million fully diluted shares outstanding.

RTI will continue to evaluate its operating platform throughout the year and will update its top and bottom line guidance as its actions might warrant.

Conference Call

RTI will host a conference call and simultaneous audio webcast to discuss its first quarter 2017 results at 8:30 a.m. ET today. The conference call can be accessed by dialing (877) 383-7419. The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on the RTI website following the call.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward-Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.


RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)


	For the Three Months Ended
	March 31,
		2017			2016
Revenues	$	69,939		$	67,351
Costs of processing and distribution		34,160			31,326
Gross profit		35,779			36,025

Expenses:
Marketing, general and administrative		29,671			27,552
Research and development		3,688			4,161
Severance charges		4,403			–
Contested proxy expenses		–			308
Total operating expenses		37,762			32,021
Operating (loss) income		(1,983	)		4,004
Total other expense – net		(799	)		(314	)
(Loss) income before income tax provision		(2,782	)		3,690
Income tax benefit (provision)		910			(1,289	)
Net (loss) income		(1,872	)		2,401
Convertible preferred dividend		(910	)		(858	)
Net (loss) income applicable to common shares	$	(2,782	)	$	1,543

Net (loss) income per common share – basic	$	(0.05	)	$	0.03
Net (loss) income per common share – diluted	$	(0.05	)	$	0.03
Weighted average shares outstanding – basic		58,495,796			57,914,893
Weighted average shares outstanding – diluted		58,495,796			58,211,644


RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of Net (Loss) Income Applicable to Commons Shares to Adjusted EBITDA
(Unaudited, in thousands)


	For the Three Months
	Ended March 31,
		2017			2016
Net (loss) income	$	(2,782	)	$	1,543
Interest expense, net		819			360
Provision for income taxes		(910	)		1,289
Depreciation		2,672			3,382
Amortization of intangible assets		896			928
EBITDA		695			7,502
Reconciling items for Adjusted EBITDA
Preferred dividend		910			858
Non-cash stock based compensation		834			500
Foreign exchange gain		(20	)		(46	)
Other reconciling items(1)
Severance charges excluding stock based compensation		4,070			–
Contested proxy expenses		–			308
Adjusted EBITDA	$	6,489		$	9,122
Adjusted EBITDA as a percent of revenues		9	%		14	%


(1) See explanations in Use of Non-GAAP Financial Measures section later in this release.


	RTI SURGICAL, INC. AND SUBSIDIARIES
	Reconciliation of Net (Loss) Income Applicable to Common Shares and Net (Loss) Income Per Diluted Share to
	Adjusted Net Income Applicable to Common Shares and Adjusted Net Income Per Diluted Share
	(Unaudited, in thousands, except per share data)

		For the Three Months Ended
		March 31, 2017						March 31, 2016
		Net						Net
		Income			Amount			Income			Amount
		Applicable to			per Diluted			Applicable to			per Diluted
		Common Shares			Share			Common Shares			Share
	As reported	$	(2,782	)	$	(0.05	)	$	1,543		$	0.03
	Severance charges (1)		4,403		$	0.07			–			–
	Contested proxy expenses (2)		–			$			308			0.01
	Tax effect on adjustments		(1,482	)	$	(0.03	)		(125	)		(0.00	)
	Adjusted *	$	139		$	0.00		$	1,726		$	0.03


*	See explanations in Use of Non-GAAP Financial Measures section later in this release.
	Amount Per Diluted Share may not foot due to rounding.

Fiscal 2017 Outlook

Full year net income per fully diluted common share is expected to be in the range of $0.01 to $0.06, based on 59.5 million fully diluted shares outstanding. Excluding severance charges taken in 2017, full year net income per fully diluted common share is expected to be in the range of $0.05 to $0.10.


RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP Guidance Net Income Per Common Share – Diluted to
Adjusted Non-GAAP Guidance Net Income Per Common Share – Diluted
(Unaudited)


					Twelve Months Ended
					December 31, 2017
					$ Amount
					Per Common
					Share – Diluted
GAAP Guidance Net Income Per Common Share – Diluted					$ 0.01 – 0.06
Severance charges, net of tax effect					0.04
Adjusted Non-GAAP Guidance Net Income Per Common Share – Diluted					$ 0.05 – 0.10

Use of Non-GAAP Financial Measures

To supplement the Company’s unaudited condensed consolidated financial statements presented on a GAAP basis, the Company discloses certain non-GAAP financial measures that exclude certain amounts, including Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share – Diluted. The calculation of the tax effect on the adjustments between GAAP net (loss) income applicable to common shares and non-GAAP net income applicable to common shares is based upon our estimated annual GAAP tax rate, adjusted to account for items excluded from GAAP net (loss) income applicable to common shares in calculating Adjusted Net Income Applicable to Common Shares-Diluted. A reconciliation of the non-GAAP financial measures to the corresponding GAAP measures is included in the tables listed above.

The following is an explanation of the adjustments that management excluded as part of adjusted measures for the three month period ended March 31, 2017 and 2016 as well as the reason for excluding the individual items:

(1) Severance charges – This adjustment represents charges relating to the termination of former employees. Management removes the amount of these costs from our operating results to supplement a comparison to our past operating performance.

(2) Contested proxy expenses – This adjustment represent charges relating to contested proxy expenses. Management removes the amount of these costs from our operating results to supplement a comparison to our past operating performance.

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

Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share – Diluted should not be considered in isolation, or as a replacement for GAAP measures.

Usefulness of Non-GAAP Financial Measures to Investors

The Company believes that presenting Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share – Diluted in addition to the related GAAP measures provide investors greater transparency to the information used by management in its financial decision-making. The Company further believes that providing this information better enables the Company’s investors to understand the Company’s overall core performance and to evaluate the methodology used by management to assess and measure such performance.


RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Revenues
(Unaudited, in thousands)


	For the Three Months Ended
	March 31,
	2017		2016

Revenues:
Spine	$	20,338	$	17,094
Sports medicine and orthopedics		12,896		12,520
Surgical specialties		1,780		1,015
Cardiothoracic		3,151		2,534
International		5,657		5,517
Subtotal direct		43,822		38,680
Global commercial		23,581		25,330
Other revenues		2,536		3,341
Total revenues	$	69,939	$	67,351
Domestic revenues		63,307		61,184
International revenues		6,632		6,167
Total revenues	$	69,939	$	67,351


RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)

	March 31,			December 31,
		2017			2016
Assets
Cash and cash equivalents	$	17,598		$	13,849
Accounts receivable – net		36,294			41,488
Inventories – net		117,392			119,743
Prepaid and other current assets		5,888			5,213
Total current assets		177,172			180,293

Property, plant and equipment – net		85,118			83,298
Goodwill		54,887			54,887
Other assets – net		51,472			49,553
Total assets	$	368,649		$	368,031

Liabilities and Stockholders’ Equity
Accounts payable	$	28,360		$	26,112
Accrued expenses and other current liabilities		27,345			26,772
Current portion of long-term obligations		5,301			6,080
Total current liabilities		61,006			58,964

Deferred revenue		7,394			6,612
Long-term liabilities		76,068			77,523
Total liabilities		144,468			143,099

Preferred stock, including accrued dividends		60,972			60,016

Stockholders’ equity:
Common stock and additional paid-in capital		416,415			416,570
Accumulated other comprehensive loss		(7,996	)		(8,316	)
Accumulated deficit		(245,210	)		(243,338	)
Total stockholders’ equity		163,209			164,916
Total liabilities and stockholders’ equity	$	368,649		$	368,031


RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited, in thousands)

	For the Three Months
	Ended March 31,
		2017			2016
Cash flows from operating activities:
Net (loss) income	$	(1,872	)	$	2,401
Adjustments to reconcile net (loss) income to net cash provided by operating activities:
Depreciation and amortization expense		3,568			4,310
Stock-based compensation		834			500
Amortization of deferred revenue		(1,274	)		(1,217	)
Other items to reconcile to net cash provided by operating activities		8,321			429
Net cash provided by operating activities		9,577			6,423
Cash flows from investing activities:
Purchases of property, plant and equipment		(3,283	)		(4,637	)
Patent and acquired intangible asset costs		(319	)		(1,196	)
Net cash used in investing activities		(3,602	)		(5,833	)
Cash flows from financing activities:
Proceeds from long-term obligations		2,000			3,000
Net payments from short-term obligations		–			(249	)
Payments on long-term obligations		(4,250	)		(4,133	)
Other financing activities		(34	)		(108	)
Net cash used in financing activities		(2,284	)		(1,490	)
Effect of exchange rate changes on cash and cash equivalents		58			14
Net increase (decrease) in cash and cash equivalents		3,749			(886	)
Cash and cash equivalents, beginning of period		13,849			12,614
Cash and cash equivalents, end of period	$	17,598		$	11,728

Contacts

RTI Surgical Inc.
Robert Jordheim
Chief Financial Officer
rjordheim@rtix.com
or
Roxane Wergin
Director, Corporate Communications
rwergin@rtix.com
386-418-8888

Amplitude Surgical: Record Activity in Q3: Sales of €27 Million – 9-Month Sales of €69 Million, +16% Organic Growth

Posted On April 28, 2017 By OrthoSpineNews In Financial /

April 26, 2017

VALENCE, France–(BUSINESS WIRE)–Regulatory News:

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, announces its sales for the third quarter of its 2016-17 financial year.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “Amplitude Surgical is continuing to record a high level of growth, driven by all its markets. This performance results from the successful implementation of the Group’s development strategy, supported by all members of staff, and, beyond that, our strengthened positioning on the largest markets with an innovative offering to meet the many challenges facing surgeons and their patients represents the bedrock of our future growth.”

Q3 2016-17 sales	31/03/2017	31/03/2016	Δ actual	Δ constant currency
€ thousands – IFRS	31/03/2017	31/03/2016	Δ actual	Δ constant currency
France	18,338	16,930	8.3%	8.3%
International	8,947	7,339	21.9%	14.4%
of which: Subsidiaries	6,510	5,136	26.7%	16.0%
of which: Distributors	2,437	2,202	10.7%	10.6%
Total	27,285	24,269	12.4%	10.2%

9M 2016-17 sales	31/03/2017	31/03/2016	Δ actual	Δ constant currency
€ thousands – IFRS	31/03/2017	31/03/2016	Δ actual	Δ constant currency
France	44,261	39,378	12.4%	12.4%
International	24,907	19,308	29.0%	22.8%
of which: Subsidiaries	17,980	14,392	24.9%	16.6%
of which: Distributors	6,927	4,916	40.9%	40.9%
Total	69,168	58,686	17.9%	15.8%

Over the first 9 months (to end-March 2017) of the Group’s 2016-17 financial year, Amplitude Surgical recorded sales of €69.2 million, up +17.9% in actual terms and +15.8% in organic terms. The buoyant growth at the start of the year has continued at a solid pace, with organic growth of +10.2% in Q3 2016-17, nevertheless affected by a particularly demanding basis of comparison (organic growth of +18.6% in Q3 2015-16).

In France, Amplitude Surgical is continuing to make market share gains, notably by winning over numerous new clients. Sales thus totaled €18.4 million in the 3^rd quarter, up +8.3%, and €44.3 million over the first 9 months of 2017, up +12.4%.

The Group is continuing to record buoyant International growth, both via its subsidiaries and through its distributors. In the 3^rd quarter, sales totaled almost €9 million, up 21.9% in actual terms and 14.4% at constant currency. Over the first 9 months of 2017, sales totaled €24.9 million, up +29.0% in actual terms and +22.8% at constant currency, with 24.9% growth for its subsidiaries, which accounted for 72% of activity, and 40.9% growth for distributors. The sales performance was particularly satisfactory on most markets, and notably the Group’s European markets, while the first contribution of its new subsidiaries in South Africa and Japan came to almost €1 million.

Marketed since mid-2014, the Novastep range for lower-limb (foot and ankle) surgery continued to record very strong growth. Over the first 9 months to the end of March, its sales totaled €4.5 million, up almost 70%, and accounted for almost 7% of Group activity. Sales were doubled in the United States, which now accounts for over 40% of this activity, while in France they increased by almost 50%.

Recent highlights:
In the last quarter, Amplitude Surgical completed the setting up of an Iso 7 and Iso 5 clean room in Valence for the cleaning and packaging of surgical implants. As soon as the equipment was received, manufacturing was launched with a view to passing validation tests over a 6-month period. In accordance with the initial schedule, this equipment should thus be certified in time to become operational during the fall of 2017.

Next financial press release: 2016-17 annual sales, on Wednesday July 26, 2017, after market.

About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. At June 30, 2016, Amplitude Surgical had a workforce of almost 300 employees and recorded sales of over 80 million euros.

Contacts

Amplitude Surgical
Philippe Garcia, +33 (0)4 75 41 87 41
CFO
finances@amplitude-surgical.com
or
NewCap
Investor Relations
Marc Willaume, +33 (0)1 44 71 00 13
amplitude@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 98 55
amplitude@newcap.eu

SANUWAVE Announces Cooperation With Ortho-Medico in Europe and Exhibition at EWMA

Posted On April 28, 2017 By OrthoSpineNews In Biologics, Top Stories /

SUWANEE, GA–(Marketwired – Apr 27, 2017) – SANUWAVE Health, Inc. ( OTCQB : SNWV ) is pleased to announce that the company will exhibit, in conjunction with Ortho-Medico, at EWMA (European Wound Management Association) in Amsterdam, The Netherlands on 3-5 May 2017. With renewed energy and focus, SANUWAVE is intent on continuing to strengthen our association with doctors, hospitals and wound care centers and re-establishing the Company’s products into the EU market.

The Company is using this occasion to promote our lead wound care product dermaPACE®. This Extracorporeal Shockwave Technology (ESWT) device, based upon electrohydraulic principles, is CE Marked and has enjoyed success in certain markets within the European Union treating a wide variety of skin conditions such as pressure ulcers, burns, post-operative wounds, and scar reduction. dermaPACE has been proven, in two US based clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers. Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects. dermaPACE exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment. The use of dermaPACE allows the clinician to more easily, and more cost-effectively, manage wounds. More importantly, the patient’s quality of life improves significantly.

For more information on SANUWAVE’s technology, please read our blog, “Shock This”, on our website at www. sanuwave.com.

SANUWAVE and Ortho-Medico cordially invite you to our booth Number 3 E14 to discuss how dermaPACE can work for you. Our booth is located on the side of the floorplan which can be accessed at: https://www.ewmaexhibition2017.org/ehome/index.php?eventid=155542&.

The conference will be held at: Amsterdam RAI, Europaplein 22, NL 1078 GZ Amsterdam, The Netherlands, www.rai.nl.

Mr. Pete Stegagno and Mr. André Mouton from SANUWAVE and Mr. Jo Schops from Ortho-Medico will be on hand to talk about some new opportunities for 2017 which will be very important for your business or practice and we welcome your visit to our booth. If you are attending EWMA, we thank you for informing us about the timing of your potential visit to our booth to ensure we organize our meeting with you.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. ( OTCQB : SNWV ) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA’s Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food and industrial markets.

About Ortho-Medico

Ortho-Medico has been a known player in the Benelux since 1987 with its full range of orthopedic aids and specific treatments as Shockwave. Ortho-Medico’s final aim, its mission, is to keep the patient as dynamic and active as possible, therefor our innovative expansion in the field of wound care and neurology. Ortho-Medico’s success is founded on a very high-quality, complete product portfolio, very close collaboration with specialists and orthopedic technicians, very quick terms of delivery, reliable advice and an attitude which is aimed at finding solutions.

Forward-Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

AAEAAQAAAAAAAAoPAAAAJGRjMDc0ZGQzLTZlZmMtNDNlMS1hNjdiLWU4YjExOTI3NWY4Yw.png

Providence Medical Technology Announces Issuance of Four Additional U.S. Patents

Posted On April 28, 2017 By OrthoSpineNews In Regulatory, Spine, Top Stories /

WALNUT CREEK, Calif., April 27, 2017 /PRNewswire/ — Providence Medical Technology, Inc., an innovator in tissue-sparing cervical spine technology, today announced the U.S. Patent Office’s issuance of four additional patents, Nos. 9,622,873; 9,622,791; 9,622,874; and 9,629,665, covering various aspects of its proprietary DTRAX® and CAVUX® posterior cervical spinal fixation technologies.

These patents cover, among other things, posterior placement of an implant in a facet joint using a chisel and guide tube; placement of an implant in a facet joint using a forked guide tube; placement of implants of various configurations in a cervical facet joint; and distraction of a facet joint after posterior placement of an implant in the facet joint.

These four recent issuances bring the number of issued patents in Providence’s growing patent portfolio to 35 total. Providence has already filed approximately 40 other applications in various stages of prosecution in the U.S. and overseas covering various aspects of its proprietary technologies.

“We have invested tremendous resources over the years in filing both broad and detailed disclosures covering the important aspects of our technology for tissue-sparing posterior cervical and spinal intervention,” commented Jeff Smith, Chief Executive Officer. “We are extremely pleased with the continued and accelerating growth of our patent portfolio as it provides the means to protect our innovations and rapidly expanding business.”

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary, tissue-sparing approach to posterior cervical fusion. Providence has developed surgical instrumentation and implants that offer unique benefits in the $2 billion worldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, and the ALLY™ line of bone and facet screws. All products are shipped-sterile and single-use to maximize efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com.

SOURCE Providence Medical Technology, Inc.

Advanced Orthopedics & Sports Medicine Specialists Performs First Meniscus Replacements in Colorado

Posted On April 28, 2017 By OrthoSpineNews In Sports Medicine /

April 27, 2017

DENVER–(BUSINESS WIRE)–Advanced Orthopedics & Sports Medicine Specialists, a regional leader in comprehensive orthopedic services, and Active Implants, a company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedures in Colorado have been successfully performed by Dr. Wayne Gersoff. Advanced Orthopedics & Sports Medicine Specialists is the only center in Denver – and one of just 10 sites nationwide – enrolling patients with persistent knee pain caused by injured or deteriorating meniscus cartilage in the SUN trial, which is designed to assess the safety and effectiveness of the NUsurface® Meniscus Implant (pronounced “new surface”) in restoring function similar to that of a natural, healthy meniscus.

The recipient of the implant was 58-year-old Golden resident Kathleen Cohan, who tore her meniscus on both knees during a head-on collision over 35 years ago. Although she underwent two partial meniscectomies to treat the tears, she continued to experience knee pain. The pain became so severe that over the last six years, Cohan has dealt with constant burning and stiffness in her knees. As an avid backcountry skier, she was forced to cut down her skiing from 60 days to only two days a year. She was unable to go hiking, rock climbing or even walk for more than three miles. Cohan’s pain had persisted to the point where she had to take painkillers on an almost daily basis.

The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery.

“There are limited options for patients who experience persistent knee pain following meniscus surgery,” Dr. Gersoff said. “Our hope with the NUsurface implant is that it will alleviate pain in these patients, helping them to delay or avoid knee replacement surgery, and allowing them to return to the activities they enjoy.”

Cohan received the NUsurface Meniscus Implant on May 21, 2016, through a small incision in her right knee and completed a six-week rehabilitation program. It has been almost one year since her surgery and the constant burning pain in her right knee has fully subsided. In addition to her daily leisure activities, she has even returned to backcountry skiing and hiking on a regular basis. Most recently, Cohan went on an adventure trip in Costa Rica with a stable knee, which included rough and steep walking surfaces, class IV river rafting, zip lines and hanging bridges.

“Receiving the NUsurface Meniscus Implant has really helped me return to my active sports lifestyle,” Cohan said. “Avoiding joint replacement is very important to me, and I am hopeful that this implant will help me delay knee replacement for another 10 years.”

The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011.

About the Clinical Trial

The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U.S. All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. Treatment with NUsurface in the SUN trial is eligible for coverage by Medicare and some private insurance companies. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the SUN study, please visit http://sun-trial.com or call (844) 680-8951.

About the NUsurface® Meniscus Implant

The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.

About Advanced Orthopedic and Sports Medicine Specialists

Advanced Orthopedic and Sports Medicine Specialists is widely recognized as the regional leader in comprehensive orthopedic services. The physicians of Advanced Orthopedic and Sports Medicine Specialists have received specialized training in orthopedic surgery and in subspecialty areas within the field of orthopedic medicine. Advanced Orthopedic and Sports Medicine Specialists specializes in providing comprehensive sports medicine services including the diagnosis and treatment of athletic injuries. We now have 9 Orthopedic Surgeons, 2 Podiatric Surgeons and 1 Board Certified Interventional Physiatrist. Our practice is comprised of surgeons who specialize in sports injuries, upper extremity, spine disorders, total joint replacements, carticel implantation, podiatry abnormalities, musculoskeletal disorders, and surgical and non operative treatment of the neck and spine. Advanced Orthopedic and Sports Medicine Specialists has two locations which offer state of the art digital imaging: our Lowry Office in Central Denver and our Lincoln office located in South Denver. For more information, visit http://www.advancedortho.org/ or call our main office at (303) 344-9090.

About Active Implants

Active Implants, LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

For Active Implants, LLC
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

Zimmer Biomet Reports First Quarter 2017 Financial Results

Posted On April 27, 2017 By OrthoSpineNews In Financial /

WARSAW, Ind., April 27, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results for the quarter ended March 31, 2017. The Company reported first quarter net sales of $1.98 billion, an increase of 3.8% over the prior year period, and an increase of 4.5% on a constant currency basis. Excluding approximately 220 basis points of contribution from the LDR Holding Corporation acquisition, revenue increased by 2.3% over the first quarter of 2016. Diluted earnings per share for the quarter were $1.47 reported, an increase of 172.2% over the prior year period. Adjusted diluted earnings per share for the quarter were $2.13, an increase of 6.0% over the prior year period.

“Zimmer Biomet delivered first quarter revenue and adjusted earnings growth consistent with our expectations, as we positioned the Company for sales acceleration in the second half of the year,” said David Dvorak, President and CEO of Zimmer Biomet. “During the quarter, we made progress towards improving our global supply chain throughput, in concert with ongoing, focused investments to harmonize and optimize our global manufacturing and quality systems. We will continue driving these priorities as we progress through the balance of 2017, while leveraging our specialized sales channels and advancing the commercialization of differentiated clinical offerings.”

Net earnings for the first quarter were $299.4 million, an increase of 175.2% over the prior year period, and $433.4 million on an adjusted basis, an increase of 6.4% over the prior year period. Operating cash flow for the first quarter was $275.4 million.

In the quarter, the Company paid $48.1 million in dividends and declared a first quarter dividend of $0.24 per share.

Guidance

The Company updated its full-year 2017 constant currency revenue and adjusted earnings per share guidance. The Company now estimates full-year, constant currency revenue to increase between 3.2% and 4.2% compared to the prior year, inclusive of approximately 120 basis points of contribution from the LDR transaction. Previously, the Company had expected full-year, constant currency revenue to increase between 3.7% and 4.7%, inclusive of the LDR contribution. The Company now expects foreign currency translation to decrease revenue for the full year by approximately 1.2%. Previously, the Company had estimated foreign currency translation to decrease revenue by 1.5%. Therefore, the Company now expects full-year 2017 revenue to increase between 2.0% and 3.0% when compared to full-year 2016, or to be in a range of $7.835 billion to $7.915 billion. Previously, the Company had estimated revenue growth to be in a range of 2.2% to 3.2% when compared to full-year 2016, or to be in a range of $7.855 billion to $7.930 billion. Revenue growth, excluding the contribution from LDR on a constant currency basis, is also expected to be in a range of 2.0% to 3.0% for the full-year 2017. Previously, the Company had estimated full-year revenue growth to be in a range of 2.5% to 3.5% on a similar basis.

Additionally, the Company now expects its full-year 2017 diluted earnings per share to be in a range of $4.68 to $4.88, and in a range of $8.50 to $8.60 on an adjusted basis. Previously, the Company had expected diluted earnings per share to be in a range of $4.37 to $4.67 on a reported basis, and in a range of $8.50 to $8.68 on an adjusted basis.

Conference Call

The Company will conduct its first quarter 2017 investor conference call today, April 27, 2017, at 8:00 a.m. Eastern Time. The live audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com. It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985. For a complete listing of international toll-free and local numbers, please visit http://investor.zimmerbiomet.com. A digital recording will be available 24 hours after the completion of the conference call, from April 28, 2017 to May 28, 2017. To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985.

Sales Table

The following first quarter sales table provides results by geography and product category, as well as the percentage change compared to the prior year quarter on a reported basis and a constant currency basis.

						Constant
			Net			Currency
			Sales	% Change		% Change
Geographic Results
	Americas		$ 1,235	4.9	%	4.7	%
	EMEA		453	(0.7)		3.1
	Asia Pacific		289	6.9		5.9
		Total	$ 1,977	3.8	%	4.5	%


Product Categories
	Knees
	Americas		$ 429	(0.1)	%	(0.2)	%
	EMEA		168	(3.4)		0.9
	Asia Pacific		105	5.0		3.1
		Total	702	(0.2)		0.6

	Hips
	Americas		246	0.2		–
	EMEA		136	(0.5)		2.7
	Asia Pacific		93	9.5		8.9
		Total	475	1.7		2.4

	S.E.T ⁽¹⁾		425	6.0		6.5

	Dental		108	(0.7)		0.1

	Spine & CMF		186	32.0		32.1

	Other		81	(1.8)		(1.2)

		Total	$ 1,977	3.8	%	4.5	%


⁽¹⁾Surgical, Sports Medicine, Foot and Ankle, Extremities and Trauma

About the Company

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Website Information

We routinely post important information for investors on our website, www.zimmerbiomet.com, in the “Investor Relations” section. We use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD. Accordingly, investors should monitor the Investor Relations section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts. The information contained on, or that may be accessed through, our website is not incorporated by reference into, and is not a part of, this document.

Note on Non-GAAP Financial Measures

This press release includes non-GAAP financial measures that differ from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). These non-GAAP financial measures may not be comparable to similar measures reported by other companies and should be considered in addition to, and not as a substitute for, or superior to, other measures prepared in accordance with GAAP.

Sales growth information for the three-month period ended March 31, 2017 is presented on a GAAP (reported) basis and on a constant currency basis, as well as on a basis that excludes the contribution from the Company’s acquisition of LDR Holding Corporation in July 2016. Projected revenue growth information for the year ended December 31, 2017 is presented on a GAAP basis and on a constant currency basis, as well as on a basis that excludes the contribution from the LDR transaction. Constant currency growth rates exclude the effects of foreign currency exchange rates. They are calculated by translating current and prior-period sales at the same predetermined exchange rate. The translated results are then used to determine year-over-year percentage increases or decreases.

Net earnings, diluted earnings per share and projected diluted earnings per share are presented on a GAAP (reported) basis and on an adjusted basis. Adjusted earnings and earnings per share measures exclude the effects of inventory step-up; certain inventory and manufacturing-related charges connected to discontinuing certain product lines, quality enhancement and remediation efforts; special items; intangible asset amortization; any related effects on our income tax provision associated with these items; and other certain tax adjustments. Special items include expenses resulting directly from our business combinations and/or global restructuring, quality and operational excellence initiatives, including employee termination benefits, certain contract terminations, consulting and professional fees, dedicated project personnel, asset impairment or loss on disposal charges and other items. Other certain tax adjustments include internal restructuring transactions that lower the tax rate on deferred tax liabilities recorded on intangible assets recognized as part of acquisition-related accounting or provide the Company access to offshore funds in a tax efficient manner.

We use these non-GAAP financial measures internally to evaluate the performance of the business and believe they are useful measures that provide meaningful supplemental information to investors to consider when evaluating the performance of the Company. We believe these measures offer the ability to make period-to-period comparisons that are not impacted by certain items that can cause dramatic changes in reported operating results, to perform trend analysis, to better identify operating trends that may otherwise be masked or distorted by these types of items and to provide additional transparency of certain items. In addition, certain of these non-GAAP financial measures are used as performance metrics in our incentive compensation programs.

Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures are included in this press release.

Cautionary Statement Regarding Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of forward-looking terms such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “assumes,” “guides,” “targets,” “forecasts,” “sees” and “seeks” or the negative of such terms or other variations on such terms or comparable terminology. All statements other than statements of historical or current fact are, or may be deemed to be, forward-looking statements. Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially. These risks and uncertainties include, but are not limited to: the possibility that the anticipated synergies and other benefits from mergers and acquisitions will not be realized, or will not be realized within the expected time periods; the risks and uncertainties related to our ability to successfully integrate the operations, products, employees and distributors of acquired companies; the effect of the potential disruption of management’s attention from ongoing business operations due to integration matters related to mergers and acquisitions; the effect of mergers and acquisitions on our relationships with customers, vendors and lenders and on our operating results and businesses generally; compliance with the Deferred Prosecution Agreement entered into in January 2017; the success of our quality and operational excellence initiatives; challenges relating to changes in and compliance with governmental laws and regulations, including regulations of the U.S. Food and Drug Administration (the “FDA”) and foreign government regulators, such as more stringent requirements for regulatory clearance of products; the ability to remediate matters identified in any inspectional observations or warning letters issued by the FDA, while continuing to satisfy the demand for our products; the outcome of government investigations; price and product competition; changes in customer demand for our products and services caused by demographic changes or other factors; the impact of healthcare reform measures; reductions in reimbursement levels by third-party payors and cost containment efforts of healthcare purchasing organizations; dependence on new product development, technological advances and innovation; shifts in the product category or regional sales mix of our products and services; supply and prices of raw materials and products; control of costs and expenses; the ability to obtain and maintain adequate intellectual property protection; the ability to form and implement alliances; changes in tax obligations arising from tax reform measures or examinations by tax authorities; product liability and intellectual property litigation losses; the ability to retain the independent agents and distributors who market our products; dependence on a limited number of suppliers for key raw materials and outsourced activities; changes in general industry and market conditions, including domestic and international growth rates and general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; and the impact of the ongoing economic uncertainty affecting countries in the Euro zone on the ability to collect accounts receivable in affected countries. For a further list and description of such risks and uncertainties, see our reports filed with the U.S. Securities and Exchange Commission. Copies of these filings, as well as subsequent filings, are available online at www.sec.gov, www.zimmerbiomet.com or on request from us. We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports. Readers of this communication are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate. This cautionary statement is applicable to all forward-looking statements contained in this communication.

ZIMMER BIOMET HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF EARNINGS
FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016
(in millions, except per share amounts, unaudited)

	2017	2016
Net Sales	$ 1,977.3	$ 1,904.0

Cost of products sold, excluding intangible asset amortization	512.9	640.6
Intangible asset amortization	152.0	126.6
Research and development	91.1	85.7
Selling, general and administrative	760.8	716.9
Special items	110.1	88.7
Operating expenses	1,626.9	1,658.5

Operating Profit	350.4	245.5

Other expense, net	(2.8)	(3.8)
Interest income	0.5	1.3
Interest expense	(82.9)	(88.2)

Earnings before income taxes	265.2	154.8

(Benefit) provision for income taxes	(34.1)	46.1

Net Earnings	299.3	108.7

Less: Net Loss attributable to noncontrolling interest	(0.1)	(0.1)

Net Earnings of Zimmer Biomet Holdings, Inc.	$ 299.4	$ 108.8

Earnings Per Common Share
Basic	$ 1.49	$ 0.54
Diluted	$ 1.47	$ 0.54

Weighted Average Common Shares Outstanding
Basic	201.1	200.1
Diluted	203.1	202.2

Cash Dividends Declared Per Common Share	$ 0.24	$ 0.24

ZIMMER BIOMET HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in millions, unaudited)

	March 31,	December 31,
	2017	2016
Assets
Current Assets:
Cash and cash equivalents	$ 1,039.5	$ 634.1
Receivables, net	1,600.1	1,604.4
Inventories	1,977.0	1,959.4
Other current assets	463.3	465.7
Total current assets	5,079.9	4,663.6

Property, plant and equipment, net	2,053.2	2,037.9
Goodwill	10,685.1	10,643.9
Intangible assets, net	8,650.6	8,785.4
Other assets	519.0	553.6
Total Assets	$ 26,987.8	$ 26,684.4

Liabilities and Stockholders’ Equity

Current liabilities	$ 1,681.1	$ 1,805.9
Current portion of long-term debt	975.0	575.6
Other long-term liabilities	3,859.7	3,967.2
Long-term debt	10,537.8	10,665.8
Stockholders’ equity	9,934.2	9,669.9
Total Liabilities and Stockholders’ Equity	$ 26,987.8	$ 26,684.4

ZIMMER BIOMET HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016
(in millions, unaudited)

		2017	2016

Cash flows provided by (used in) operating activities
	Net earnings	$ 299.3	$ 108.7
	Depreciation and amortization	267.6	246.9
	Share-based compensation	14.0	12.7
	Inventory step-up	14.6	153.7
	Changes in operating assets and liabilities, net of acquired assets and liabilities
	Income taxes	(86.9)	(33.7)
	Receivables	26.8	(83.4)
	Inventories	(11.5)	38.3
	Accounts payable and accrued expenses	(137.0)	(116.3)
	Other assets and liabilities	(111.5)	(54.1)
	Net cash provided by operating activities	275.4	272.8

Cash flows provided by (used in) investing activities
	Additions to instruments	(86.4)	(85.1)
	Additions to other property, plant and equipment	(43.1)	(27.6)
	Purchases of investments	–	(0.3)
	Sales of investments	–	223.5
	Other investing activities	(3.6)	(14.7)
	Net cash (used in) provided by investing activities	(133.1)	95.8

Cash flows provided by (used in) financing activities
	Proceeds from multicurrency revolving facility	400.0	–
	Payments on term loan	(150.0)	(400.0)
	Net (payments) proceeds on other debt	(0.7)	0.3
	Dividends paid to stockholders	(48.1)	(44.6)
	Proceeds from employee stock compensation plans	66.1	31.3
	Business combination contingent consideration payments	(6.0)	–
	Restricted stock witholdings	(5.2)	(4.4)
	Repurchase of common stock	–	(415.5)
	Net cash provided by (used in) financing activities	256.1	(832.9)

Effect of exchange rates on cash and cash equivalents		7.0	1.8
			–
	Increase (decrease) in cash and cash equivalents	405.4	(462.5)
Cash and cash equivalents, beginning of period		634.1	1,459.3
Cash and cash equivalents, end of period		$ 1,039.5	$ 996.8

ZIMMER BIOMET HOLDINGS, INC.
NET SALES BY GEOGRAPHY
FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016
(in millions, unaudited)

	Three Months Ended March 31,
	2017	2016	% Inc / (Dec)

Americas	$ 1,234.8	$ 1,177.3	4.9	%
EMEA	453.2	456.2	(0.7)
Asia Pacific	289.3	270.5	6.9
Total	$ 1,977.3	$ 1,904.0	3.8



ZIMMER BIOMET HOLDINGS, INC.
NET SALES BY PRODUCT CATEGORY
FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016
(in millions, unaudited)

	Three Months Ended March 31,
	2017	2016	% Inc / (Dec)

Knees	$ 701.8	$ 703.2	(0.2)	%
Hips	475.7	467.9	1.7
S.E.T	425.1	401.0	6.0
Dental	107.8	108.6	(0.7)
Spine & CMF	186.3	141.2	32.0
Other	80.6	82.1	(1.8)
Total	$ 1,977.3	$ 1,904.0	3.8

ZIMMER BIOMET HOLDINGS, INC.
RECONCILIATION OF REPORTED NET SALES % CHANGE TO
CONSTANT CURRENCY % CHANGE AND
% CHANGE EXCLUDING LDR HOLDING CORPORATION
(unaudited)


			For the Three Months Ended
			March 31, 2017


					Foreign		Constant
					Exchange		Currency
			% Change		Impact		% Change
Geographic Results
	Americas		4.9	%	0.2	%	4.7	%
	EMEA		(0.7)		(3.8)		3.1
	Asia Pacific		6.9		1.0		5.9
		Total	3.8	%	(0.7)	%	4.5	%


Product Categories
		Knees
		Americas	(0.1)	%	0.1	%	(0.2)	%
		EMEA	(3.4)		(4.3)		0.9
		Asia Pacific	5.0		1.9		3.1
		Total	(0.2)		(0.8)		0.6

		Hips
		Americas	0.2		0.2		–
		EMEA	(0.5)		(3.2)		2.7
		Asia Pacific	9.5		0.6		8.9
		Total	1.7		(0.7)		2.4

		S.E.T	6.0		(0.5)		6.5

		Dental	(0.7)		(0.8)		0.1

		Spine & CMF	32.0		(0.1)		32.1
					–
		Other	(1.8)		(0.6)		(1.2)

		Total	3.8	%	(0.7)	%	4.5	%

	Impact of LDR Holding Corporation		(2.2)		–		(2.2)
		% Change excluding LDR Holding Corporation	1.6	%	(0.7)	%	2.3	%

ZIMMER BIOMET HOLDINGS, INC.
RECONCILIATION OF NET EARNINGS TO ADJUSTED NET EARNINGS
FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016
(in millions, unaudited)

	Three Months
	Ended March 31,
	2017	2016
Net Earnings of Zimmer Biomet Holdings, Inc.	$ 299.4	$ 108.8
Inventory step-up and other inventory
and manufacturing-related charges	23.2	178.3
Intangible asset amortization	152.0	126.6
Special items
Biomet merger-related	37.0	79.1
Other special items	73.1	9.6
Merger-related expense in other expense, net	1.5	–
Taxes on above items ⁽¹⁾	(83.1)	(109.5)
Other certain tax adjustments⁽²⁾	(69.7)	14.3
Adjusted Net Earnings	$ 433.4	$ 407.2

⁽¹⁾The tax effect for the U.S. jurisdiction is calculated based on an effective rate considering federal and state taxes, as well as permanent items. For jurisdictions outside the U.S., the tax effect is calculated based upon the statutory rates where the items were incurred.

⁽²⁾In 2017, other certain tax adjustments relate to a tax restructuring that lowered the tax rate on deferred tax liabilities recorded on intangible assets recognized in acquisition-related accounting. The 2016 adjustment relates to internal restructuring transactions that provide the Company access to cash in a tax efficient manner.

ZIMMER BIOMET HOLDINGS, INC.
RECONCILIATION OF DILUTED EPS TO ADJUSTED DILUTED EPS
FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016
(unaudited)

	Three Months
	Ended March 31,
	2017	2016
Diluted EPS	$ 1.47	$ 0.54
Inventory step-up and other inventory
and manufacturing-related charges	0.11	0.87
Intangible asset amortization	0.75	0.63
Special items
Biomet merger-related	0.18	0.39
Other special items	0.36	0.05
Merger-related expense in other expense, net	0.01	–
Taxes on above items ⁽¹⁾	(0.41)	(0.54)
Other certain tax adjustments⁽²⁾	(0.34)	0.07
Adjusted Diluted EPS	$ 2.13	$ 2.01

⁽¹⁾The tax effect for the U.S. jurisdiction is calculated based on an effective rate considering federal and state taxes, as well as permanent items. For jurisdictions outside the U.S., the tax effect is calculated based upon the statutory rates where the items were incurred.

⁽²⁾In 2017, other certain tax adjustments relate to a tax restructuring that lowered the tax rate on deferred tax liabilities recorded on intangible assets recognized in acquisition-related accounting. The 2016 adjustment relates to internal restructuring transactions that provide the Company access to cash in a tax efficient manner.

ZIMMER BIOMET HOLDINGS, INC. SUMMARY OF EXPENSES INCLUDED IN SPECIAL ITEMS FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016 (in millions, unaudited)


			Three Months
			Ended March 31,
			2017	2016
Biomet merger-related
	Consulting and professional fees		$ 18.7	$ 36.1
	Employee termination benefits		(3.0)	4.1
	Dedicated project personnel		8.7	21.7
	Relocated facilities		2.8	1.7
	Contract terminations		–	10.1
	Information technology integration		2.3	1.4
	Other		7.5	4.0
		Total Biomet merger-related	37.0	79.1

Other
	Consulting and professional fees		50.4	6.9
	Employee termination benefits		1.2	–
	Dedicated project personnel		12.8	1.8
	Relocated facilities		2.4	0.2
	Certain litigation matters		7.0	–
	Information technology integration		0.5	0.1
	Contingent consideration adjustments		(3.6)	–
	Other		2.4	0.6
		Total Other	73.1	9.6
Special items			$ 110.1	$ 88.7

ZIMMER BIOMET HOLDINGS, INC. RECONCILIATION OF 2017 PROJECTED REVENUE % GROWTH TO
2017 PROJECTED CONSTANT CURRENCY % GROWTH
(unaudited)



Projected Year Ended December 31, 2017:	High		Low

Revenue % growth	3.0	%	2.0	%
Foreign exchange impact	1.2		1.2
Constant currency % growth	4.2	%	3.2	%
Impact of LDR Holding Corporation	(1.2)		(1.2)
Constant currency % growth excluding LDR Holding Corporation	3.0	%	2.0	%

ZIMMER BIOMET HOLDINGS, INC.
RECONCILIATION OF 2017 PROJECTED DILUTED EPS
AND PROJECTED ADJUSTED DILUTED EPS
(unaudited)



Projected Year Ended December 31, 2017:	High	Low

Diluted EPS	$ 4.88	$ 4.68
Inventory step-up and other inventory and manufacturing related
charges, intangible asset amortization, special items and other expense	5.80	5.94
Taxes on above items⁽¹⁾and other certain tax adjustments	(2.08)	(2.12)
Adjusted Diluted EPS	$ 8.60	$ 8.50


⁽¹⁾The tax effect for the U.S. jurisdiction is estimated based on an effective rate considering federal and state taxes, as well as permanent items. For jurisdictions outside the U.S., the tax effect is estimated based upon the statutory rates where the items are projected to be incurred.

SOURCE Zimmer Biomet Holdings, Inc.

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