Life Spine Announces First Clinical Use of TiBOW™ MIS TLIF Expandable Spacer System

August 08, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders announced today the first clinical uses of TiBOW MIS TLIF Expandable Spacer System featuring Osseo-Loc™ Surface Technology with Dr. James Lynch of Reno, Nevada, and Dr. John Anson of Las Vegas, Nevada.

TiBOW joins Life Spine’s extensive portfolio of micro invasive and expandable products cleared by the FDA. The system allows for in-situ expansion for increased endplate coverage and stability, for minimally invasive TLIF and oblique approaches. With multiple Lordotic options, TiBOW provides the surgeon the ability to restore normal sagittal alignment while building upon Life Spine’s commitment of offering ground-breaking procedural solutions.

TiBOW MIS TLIF Expandable Spacer System features the innovative surface technology, Osseo-Loc, which creates a geometric surface architecture that provides an osteophylic environment, documented for the recruitment of bone building cells (osteoblasts) on titanium implants1.

“Life Spine has set out to build an expandable product platform that reflects many of the unmet needs of its surgeon customers, as well as challenges associated with micro invasive TLIF procedures,” John Anson M.D. of the Spine and Brain Institute noted. “The design of this system addresses common challenges associated with narrow TLIF devices by providing an expandable footprint and unimpeded graft aperture. I believe TiBOW is a safe and effective option for my patients, while potentially offering less pain and the ability to return to work faster.”

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

Life Spine is a registered trademark.

1K.Kieswetter, Z. Schwartz, T. W. Hummert, D. L. Cochran, J. Simpson and B. D. Boyan
“Surface roughness modulates the local production of growth factors by osteoblast-like MG-62 cells” The Journal of Biomedical Materials Research (1996): Web.

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

ConforMIS Reports Second Quarter 2017 Financial Results and Updates Fiscal Year 2017 Guidance

BILLERICA, Mass., Aug. 03, 2017 (GLOBE NEWSWIRE) — ConforMIS, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient’s unique anatomy, announced today financial results for the second quarter ended June 30, 2017.

Q2 Summary:

  • Total revenue of $18.5 million, down 4.4% year-over-year on a reported basis and down 3.6% on a constant currency basis
  • Product revenue of $18.0 million, down 5.5% year-over-year on a reported basis and down 4.8% on a constant currency basis
    – U.S. product revenue increased 1.5% year-over-year
    – Rest of World product revenue decreased 31.1% year-over-year on a reported basis and decreased 27.5% year-over-year on a constant currency basis

“As ConforMIS continues into this transition year, we experienced mixed results in the second quarter,” said Mark Augusti, President and Chief Executive Officer of ConforMIS, Inc. “The impact from changes in the field sales organization and in reimbursement adversely affected our overall revenue growth, while on a positive note, we were able to achieve a 300 basis point improvement in gross margin and a $2 million reduction in net loss over the prior year.”

Mr. Augusti continued, “We believe the changes that we are making will have a positive impact on our results moving forward. That said, we have adjusted our 2017 guidance to reflect our revenue expectations for the remainder of the year.”

Second Quarter 2017 Financial Results

Revenue Three months ended June 30, Increase/decrease
($, in thousands) 2017 2016 $
Change
%
Change
%
Change
(as reported) (constant
currency)
United States $ 15,219 $ 15,002 $ 218 1.5 % 1.5 %
Rest of world 2,827 4,102 (1,276 ) -31.1 % -27.5 %
Product revenue 18,046 19,104 (1,058 ) -5.5 % -4.8 %
Royalty revenue 438 229 209 91.1 % 91.1 %
Total revenue $ 18,484 $ 19,333 $ (849 ) -4.4 % -3.6 %

Total revenue decreased $0.8 million to $18.5 million, or 4.4% year-over-year on a reported basis and decreased 3.6% on a constant currency basis. Total revenue in the second quarter of 2017 included royalty revenue related to patent license agreements of $0.4 million, as compared to $0.2 million in the second quarter of 2016.

Product revenue decreased $1.1 million to $18.0 million, or 5.5% year-over-year on a reported basis and decreased 4.8% on a constant currency basis. U.S. product revenue increased $0.2 million to $15.2 million, or 1.5% year-over-year, and Rest of World product revenue decreased $1.3 million to $2.8 million, or 31% year-over-year on a reported basis and decreased 27.5% on a constant currency basis. Product revenue from sales of iTotal CR, iDuo and iUni was $13.3 million for the three months ended June 30, 2017 compared to $15.7 million for the three months ended June 30, 2016, a decrease of $2.4 million, or 15.3% year-over-year, on a reported basis and 14.8% on a constant currency basis.  Product revenue from sales of iTotal PS was $4.8 million for the three months ended June 30, 2017 compared to $3.4 million for the three months ended June 30, 2016, an increase of $1.4 million, or 41.2% year-over-year, on a reported and constant currency basis.

Gross profit increased $0.2 million to $6.2 million, or 34% of revenue, in the second quarter of 2017, compared to $6.0 million, or 31% of revenue, in the second quarter of 2016. The increase in gross margin year-over-year was driven primarily by manufacturing efficiencies and cost reductions as a result of vertical integration and the timing of royalty payments received.

Total operating expenses increased $0.1 million to $20.2 million, or 0.2% year-over-year.

Net loss was $12.1 million, or $0.28 per basic share, in the second quarter of 2017, compared to a net loss of $14.1 million, or $0.34 per basic share, for the same period last year. The decrease in second quarter net loss was driven primarily by higher foreign currency exchange transaction income related to international intercompany receivables and higher royalty revenue.

As of June 30, 2017, the Company’s cash and cash equivalents and investments totaled $71.2 million, compared to $65.5 million as of December 31, 2016.  As previously announced, in January 2017 the Company secured up to $50 million in term debt financing, of which $15 million was borrowed in January and $15 million was borrowed in June.

2017 Financial Guidance

For the full year 2017, the Company expects total revenue in a range of $75 million to $78 million, representing year-over-year decline of 6% to 3% on a reported basis and 6% to 2% on a constant currency basis.  This is updated from previous guidance in a range of $80 million to $84 million, representing year-over-year growth of 0% to 5% on a reported basis and 1% to 6% on a constant currency basis.  The Company’s 2017 revenue guidance assumes the following:

  • Product revenue in a range of $74 million to $77 million, representing year-over-year decline of 6% to 2% on a reported basis and 5% to 2% on a constant currency basis.  This is updated from previous guidance in a range of $79 million to $83 million, representing year-over-year growth of 0% to 5% on a reported basis and 1% to 6% on a constant currency basis.
  • Royalty revenue of approximately $0.8 million related to ongoing patent license royalty payments has not changed.

For the full year 2017, the Company expects gross margin in a range of 34% to 36%, from previous guidance of 36% to 38%.

Note on Non-GAAP Financial Measures

In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain information regarding the Company’s financial results or projected financial results on a non-GAAP “constant currency basis.” This information estimates the impact of changes in foreign currency rates on the translation of the Company’s current or projected future period financial results as compared to the applicable comparable period. This impact is derived by taking the adjusted current or projected local currency results and translating them into U.S. Dollars based upon the foreign currency exchange rates for the applicable comparable period. It does not include any other effect of changes in foreign currency rates on the Company’s results or business. Non-GAAP information is not a substitute for, and is not superior to, information presented on a GAAP basis.

Conference Call

As previously announced, ConforMIS will conduct a conference call and webcast today at 4:30 PM Eastern Time. Management will discuss financial results and strategic matters. To participate in the conference call, please call 877-809-6331 (or 615-247-0224 for international) and use conference ID number 57887575 or listen to the webcast in the investor relations section of the company’s website at ir.conformis.com. The online archive of the webcast will be available on the company’s website for 30 days.

About ConforMIS, Inc.

ConforMIS is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. ConforMIS offers a broad line of customized knee implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS’ iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 450 issued patents and pending patent applications that cover customized implants and patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements about our strategy, future operations, future financial position and results, market growth, total revenue and revenue mix by product and geography, gross margin, operating trends, the potential impact and advantages of using customized implants, and potential transition at the Company as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates regarding the potential market opportunity for our current and future products, our expectations regarding our revenue, gross margin, expenses, revenue growth, transition and other results of operations, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Statements of Operations
(unaudited)
(in thousands, except share and per share data)
Three Months Ended
June 30,
Six Months Ended
June 30,
2017 2016 2017 2016
Revenue
Product $ 18,046 $ 19,104 $ 38,425 $ 39,086
Royalty 438 229 514 497
Total revenue 18,484 19,333 38,939 39,583
Cost of revenue 12,236 13,332 26,196 26,919
Gross profit 6,248 6,001 12,743 12,664
Operating expenses
Sales and marketing 9,375 10,648 20,191 21,762
Research and development 4,335 3,977 8,895 8,375
General and administrative 6,444 5,487 14,902 11,782
Total operating expenses 20,154 20,112 43,988 41,919
Loss from operations (13,906 ) (14,111 ) (31,245 ) (29,255 )
Other income and expenses
Interest income 127 143 230 282
Interest expense (372 ) (75 ) (679 ) (100 )
Foreign currency exchange transaction income 2,117 2,507
Total other income (expenses), net 1,872 68 2,058 182
Loss before income taxes (12,034 ) (14,043 ) (29,187 ) (29,073 )
Income tax provision 56 9 63 13
Net loss $ (12,090 ) $ (14,052 ) $ (29,250 ) $ (29,086 )
Net loss per share – basic and diluted $ (0.28 ) $ (0.34 ) $ (0.68 ) $ (0.71 )
Weighted average common shares outstanding – basic and diluted 43,193,065 41,314,942 43,035,672 41,155,421
 CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share and per share data)
June 30,
2017
December 31, 2016
Assets  (unaudited) 
Current Assets
Cash and cash equivalents $ 39,207 $ 37,257
Investments 29,218 28,242
Accounts receivable, net 11,868 14,675
Inventories 11,784 11,720
Prepaid expenses and other current assets 2,592 3,954
Total current assets 94,669 95,848
Property and equipment, net 16,493 15,084
Other Assets
Restricted cash 762 300
Investments 2,750
Intangible assets, net 622 746
Goodwill 753 753
Other long-term assets 35 79
Total assets $ 116,084 $ 112,810
Liabilities and stockholder’s equity
Current liabilities
Accounts payable $ 5,076 $ 5,474
Accrued expenses 8,187 8,492
Deferred revenue 305 305
Total current liabilities 13,568 14,271
Other long-term liabilities 451 164
Deferred revenue 4,167 4,320
Long-term debt,less debt issuance costs 29,612
Total liabilities 47,798 18,755
Commitments and contingencies
Stockholders’ equity
Preferred stock, $0.00001 par value:
Authorized: 5,000,000 shares authorized at June 30, 2017 and December 31, 2016, respectively, no shares outstanding as of June 30,2017 and December 31, 2016.
Common stock, $0.00001 par value:
Authorized: 200,000,000 shares at June 30, 2017 and December 31, 2016; 44,866,228 and 43,399,547 shares issued and outstanding at June 30, 2017 and December 31, 2016, respectively
Additional paid-in capital 482,576 476,486
Accumulated deficit (412,491 ) (382,930 )
Accumulated other comprehensive (loss) income (1,799 ) 499
Total stockholders’ equity 68,286 94,055
Total liabilities and stockholders’ equity $ 116,084 $ 112,810

 

CONTACT:
Investor contact
Oksana Bradley
ir@conformis.com
(781) 374-5598

DePuy Synthes Announces Exclusive Co-Marketing Agreement With Medical Enterprises Distribution, LLC To Further Transform Hip Replacement

WARSAW, Ind.Aug. 7, 2017 /PRNewswire/ — DePuy Synthes* has announced an exclusive agreement with Medical Enterprises Distribution, LLC to co-market the ME1000™ Surgical Impactor for use in Total Hip Arthroplasty (THA). The ME1000 is designed to replace the handheld mallet used in THA. The ME1000 delivers constant, stable energy that is designed to automate bone preparation, implant assembly and positioning. This in turn may lead to more consistent clinical outcomes and favorably impact patient satisfaction.

Because the battery-powered ME1000 automates THA, there is also likely to be less surgeon fatigue and potentially less work-related injuries that can arise from mallet use. A 2016 study published in The Journal of Arthroplasty showed that 66.1% of 183 orthopaedic surgeons who responded to a survey experienced a work-related injury and that 31% of responding surgeons required surgery for their injury.1 The paper cited the use of repetitive movements with operating instruments and tools as a potential cause for upper limb tendinitis and discussed the need for measures to improve the surgical environment and work ergonomics for orthopaedic surgeons.1

“In addition to its potential benefits for both patients and orthopaedic surgeons, the ME1000 can be easily integrated into a surgeon’s operational technique and into the hospital’s processes,” said Aaron Villaruz, Global Hip Platform Leader, DePuy Synthes Joint Reconstruction. “We at DePuy Synthes view this technology as a significant advancement as we strive to help our customers meet their goals of improving clinical outcomes, increasing patient satisfaction and managing costs.”

The ME1000 is compatible only with DePuy Synthes hip systems. Adapters are available for anterior and posterior approaches to THA. One of the early users of the technology is Dr. Joel Matta**, a pioneer in the Anterior Approach to Hip Replacement who is affiliated with the Steadman Clinic in Vail, CO.

“I’ve used the ME1000 on more than 100 primary DePuy Synthes hip implants, and my observation is that, compared to a mallet, the ME1000 reduces peak forces while increasing energy per second,” said Dr. Matta. “I have found that the rotational stability of the implants is more easily and consistently achieved, and the risk of fracture potentially reduced. It is also easier for me to make adjustments, and achieve a precise position of the acetabular cup. I also appreciate that the physical effort and resultant fatigue from performing a hip replacement surgery is markedly reduced which benefits my capabilities during a full surgical schedule.”

DePuy Synthes is expected to begin co-marketing the ME1000 with Medical Enterprises Distribution, LLC within the current quarter.

About DePuy Synthes Companies

DePuy Synthes Companies, part of the Johnson & Johnson Medical Devices Companies***, provides one of the most comprehensive orthopaedics portfolios in the world. DePuy Synthes Companies solutions, in specialties including joint reconstruction, trauma, craniomaxillofacial, spinal surgery and sports medicine, are designed to advance patient care while delivering clinical and economic value to health care systems worldwide. For more information, visit www.depuysynthes.com.

About Medical Enterprises Distribution, LLC

Based in Norcross, GA, Medical Enterprises Distribution, LLC, is a pioneering healthcare technology firm focused on surgical procedure innovation.  For more information, visit http://www.medistribution.com.

ME1000 Photo Courtesy of Medical Enterprises Distribution, LLC

Cautionary Note Regarding Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the effectiveness and value of the ME1000. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of DePuy Synthes and/or Johnson & Johnson.  Risks and uncertainties include, but are not limited to: uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; product efficacy or safety concerns resulting in product recalls or regulatory action; manufacturing difficulties and delays; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns for health care products and services; and trends toward health care cost containment. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors”, its most recently filed Quarterly Report on Form 10-Q, including in the section captioned “Cautionary Note Regarding Forward-Looking Statements”, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.govwww.jnj.com or on request from Johnson & Johnson.  Neither DePuy Synthes nor Johnson & Johnson undertakes to update any forward-looking statement because of new information or future events or developments.

Alqahtani S, Alzahrani M, Tanzer M. Adult Reconstructive Surgery: A High-Risk Profession for Work-Related Injuries. The Journal of Arthroplasty 2016; 31(6): 1194-8.

*DePuy Synthes represents the products and services of DePuy Synthes, Inc. and its affiliates.
**Consultant to DePuy Synthes Joint Reconstruction with an ownership interest in Medical Enterprises Distribution, LLC.
***The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopaedics, and cardiovascular businesses within Johnson & Johnson’s Medical Devices segment.

©DePuy Synthes 2017. All rights reserved.

The third-party trademarks used herein are the trademarks of their respective owners.

SOURCE DePuy Synthes

Related Links

http://www.depuysynthes.com

Wright Medical Group N.V. Reports 2017 Second Quarter Financial Results

AMSTERDAM, The Netherlands, Aug. 02, 2017 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today reported financial results for its second quarter ended June 25, 2017 and reaffirmed 2017 annual guidance.

Net sales from continuing operations totaled $179.7 million during the second quarter ended June 25, 2017, representing 5% as reported growth, and 6% growth on a constant currency basis.  Gross margins from continuing operations were 78.8% during the quarter ended June 25, 2017.  Reconciliations of all historical non-GAAP financial measures used in this release to the most comparable GAAP measures can be found in the attached financial tables.

Robert Palmisano, president and chief executive officer, commented, “All of our most important financial results are right on track with our plan for the year.  We also continued to make significant progress in the second quarter on the initiatives that will enable us to achieve our longer term goals.  Global net sales growth of 5%, including expected dis-synergies, adjusted EBITDA of $19.8 million and gross margins of 78.8% reflect the strength of our markets and our unique position in them.  We believe we are well positioned as we head into the back half of the year to accelerate our business momentum.”

Palmisano continued, “Highlights in the quarter included 16% sales growth in U.S. shoulders, driven by strong contributions from the ongoing rollout of our SIMPLICITI shoulder system, as well as the launch of our PERFORM Reversed glenoid, which is off to a terrific start.  We anticipate that our PERFORM Reversed launch will drive accelerating revenue in the second half of the year as we deliver additional instrument sets to the U.S. field.  In our U.S. lower extremities and biologics business, we saw outstanding growth of 32% in the most technologically advanced portions of our portfolio, which include AUGMENT Bone Graft, SALVATION Limb Salvage and Total Ankle Replacement.  We also launched our INVISION Total Ankle Revision System in July and believe the combination of INVISION, our continuum of care total ankle replacement portfolio and significantly improved reimbursement could create a tipping point in the adoption of total ankle replacement.”

Palmisano further commented, “Growth in the core U.S. lower extremities and biologics portfolio was significantly lower than our more technologically advanced products, partially due to the revenue dis-synergies in the quarter, which we anticipated.  As previously announced, we completed the hiring and training of approximately 100 sales representatives in our U.S. lower extremities business in the quarter.  We expect to see some benefit from these rep adds beginning in the third quarter and meaningful benefit in the fourth quarter and beyond as the expanded footprint, greater focus on the core product portfolio and greater incentives to drive growth begin to take effect.”

Net loss from continuing operations for the second quarter of 2017 totaled $21.0 million, or $(0.20) per diluted share.

The company’s net loss from continuing operations for the second quarter of 2017 included the after-tax effects of $3.2 million of transition costs, an unrealized gain of $4.3 million related to mark-to-market adjustments on derivatives, $11.2 million of non-cash interest expense related to its convertible notes, and a $3.9 million unrealized gain related to mark-to-market adjustments on contingent value rights (CVRs) issued in connection with the BioMimetic acquisition.

The company’s second quarter 2017 non-GAAP net loss from continuing operations, as adjusted for the above items, was $14.6 million.  The company’s second quarter 2017 non-GAAP adjusted EBITDA from continuing operations, as defined in the non-GAAP to GAAP reconciliation provided later in this release, was $19.8 million. The attached financial tables include reconciliations of all historical non-GAAP measures to the most comparable GAAP measures.

Cash, cash equivalents and restricted cash totaled $378.9 million as of the end of the second quarter of 2017.  This amount includes $150 million classified as restricted cash on the company’s balance sheet that is held in escrow to fund a portion of the metal-on-metal hip litigation Master Settlement Agreement (MSA).

Palmisano concluded, “We are right on track with the key revenue growth drivers for 2017, and remain confident in our full-year revenue guidance of $755 million to $765 million and full-year adjusted EBITDA guidance of $78.5 million to $85.5 million.  We continue to expect there will be strong acceleration in the second half of the year as we annualize the impact of the merger revenue dis-synergies and begin to realize the benefits from an expanded U.S. sales force and new product launches.  In addition, I believe we are positioned well for future success and achieving our key financial goals of mid-teens constant currency net sales growth, gross margins in the high 70% range and non-GAAP adjusted EBITDA margins of approximately 20% in the next one to two years.”

Outlook

The company continues to anticipate net sales for full-year 2017 of approximately $755 million to $765 million, representing an as reported growth rate of 9% to 11% over 2016.  This guidance range assumes an approximate 1% headwind from currency for the full year, which is approximately 1% of cushion as compared to current rates.  In addition, this range implies second half of 2017 constant currency revenue growth of 12% to 15%, excluding the estimated impact of the four extra selling days in Q4 of 2017.

The company continues to anticipate full-year 2017 non-GAAP adjusted EBITDA from continuing operations, as described in the non-GAAP reconciliation provided later in this release, of $78.5 million to $85.5 million.

The company continues to anticipate non-GAAP adjusted earnings per share from continuing operations, including share-based compensation, as described in the non-GAAP to GAAP reconciliation provided later in this release, for full-year 2017 of $(0.33) to $(0.26) per diluted share.

The company estimates approximately 105.1 million diluted weighted average ordinary shares outstanding for fiscal year 2017.

The company’s non-GAAP adjusted EBITDA from continuing operations target is measured by adding back to net loss from continuing operations charges for interest, income taxes, depreciation and amortization expenses, non-cash share-based compensation expense and non-operating income and expense.  Additionally, the company’s adjusted EBITDA from continuing operations target excludes possible future acquisitions; other material future business developments; and due diligence, transaction and transition costs associated with acquisitions and divestitures.  Further, this adjusted EBITDA from continuing operations target excludes any expenses, earnings or losses related to the divested large joints business, legacy Wright’s divested OrthoRecon business and legacy Tornier’s divested ankle replacement and silastic toe products.

The company’s non-GAAP adjusted earnings per share from continuing operations target is measured by adding back to net loss from continuing operations non-cash interest expense associated with the 2017, 2020 and 2021 convertible notes; due diligence, transaction and transition costs associated with acquisitions and divestitures; mark-to-market adjustments to CVRs; non-cash mark-to-market derivative adjustments; and charges for non-cash amortization expenses, net of taxes. Note that as a result of the company’s relatively low effective tax rate due to the valuation allowance impacting a substantial portion of the company’s income/loss, the company is currently estimating the tax effect on amortization expense at 0%. Further, this adjusted earnings per share from continuing operations target excludes possible future acquisitions; other material future business developments; and any expenses, earnings or losses related to the divested large joints business.

All of the historical non-GAAP financial measures used in this release are reconciled to the most directly comparable GAAP measures. With respect to the company’s 2017 financial guidance regarding non-GAAP adjusted EBITDA from continuing operations and non-GAAP adjusted earnings per share from continuing operations, however, the company cannot provide a quantitative reconciliation to the most directly comparable GAAP measures without unreasonable effort due to its inability to make accurate projections and estimates related to certain information needed to calculate some of the adjustments as described above, including the market driven fair value adjustments to CVRs and derivatives. The anticipated differences between these non-GAAP financial measures and the most directly comparable GAAP measure are described above qualitatively.

The company’s anticipated ranges for net sales from continuing operations, non-GAAP adjusted EBITDA from continuing operations, and non-GAAP adjusted earnings per share from continuing operations are forward-looking statements, as are any other statements that anticipate or aspire to future events or performance.  They are subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets.  The anticipated targets are not predictions of the company’s actual performance.  See the cautionary information about forward-looking statements in the “Cautionary Note Regarding Forward-Looking Statements” section of this release.

Supplemental Financial Information

To view the second quarter of 2017 supplemental financial information, visit ir.wright.com.  For historical information on Wright Medical Group N.V. segment reporting changes and non-GAAP combined pro forma financial information, please refer to the presentation posted on Wright’s website at ir.wright.com in the “Financial Information” section.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com.  The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

Conference Call and Webcast

As previously announced, Wright will host a conference call starting at 3:30 p.m. Central Time today.  The live dial-in number for the call is (844) 295-9436 (U.S.) / (574) 990-1040 (Outside U.S.).  The participant passcode for the call is “Wright.”  A simultaneous webcast of the call will be available via Wright’s corporate website at www.wright.com.

A replay of the call will be available beginning at 5:30 p.m. Central Time on August 2, 2017 through August 9, 2017.  To hear this replay, dial (855) 859-2056 (U.S.) / (404) 537-3406 (Outside U.S.) and enter code 13575026.  A replay of the conference call will also be available via the internet starting today and continuing for at least 12 months.  To access a replay of the conference call via the internet, go to the “Investor Relations – Presentations/Calendar” section of the company’s corporate website located at www.wright.com.

The conference call may include a discussion of non-GAAP financial measures.  Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this release, the Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) today, or otherwise available in the “Investor Relations – Supplemental Financial Information” section of the company’s corporate website located at www.wright.com.

The conference call may include forward-looking statements.  See the cautionary information about forward-looking statements in the “Cautionary Note Regarding Forward-Looking Statements” section of this release.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide.  Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.  For more information about Wright, visit www.wright.com.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates,  registered as indicated in the United States, and in other countries.  All other trademarks and trade names referred to in this release are the property of their respective owners.

Non-GAAP Financial Measures

To supplement the company’s consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles, the company uses certain non-GAAP financial measures in this release. Reconciliations of the historical non-GAAP financial measures used in this release to the most comparable GAAP measures for the respective periods can be found in tables later in this release. Wright’s non-GAAP financial measures include net sales, excluding the impact of foreign currency; net income, as adjusted; EBITDA, as adjusted; gross margin, as adjusted; earnings, as adjusted; and earnings, as adjusted, per diluted share, in each case, from continuing operations. The company’s management believes that the presentation of these measures provides useful information to investors.  These measures may assist investors in evaluating the company’s operations, period over period. Wright’s non-GAAP financial measures exclude such items as non-cash interest expense related to the company’s 2017 convertible notes, 2020 convertible notes and 2021 convertible notes, net gains and losses on mark-to-market adjustments on and settlements of derivative assets and liabilities, write-off of unamortized debt discount and deferred financing charges following the partial settlement of 2017 convertible notes and 2020 convertible notes, mark-to-market adjustments on CVRs, and transaction and transition costs, all of which may be highly variable, difficult to predict and of a size that could have substantial impact on the company’s reported results of operations for a period.  It is for this reason that the company cannot provide without unreasonable effort a quantitative reconciliation to the most directly comparable GAAP measures for its 2017 financial guidance regarding non-GAAP adjusted EBITDA from continuing operations and non-GAAP adjusted earnings per share from continuing operations. Management uses the non-GAAP measures in this release internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets.  Investors should consider non-GAAP financial measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the company’s anticipated financial results for 2017, including net sales from continuing operations, adjusted EBITDA from continuing operations and adjusted earnings per share from continuing operations; anticipated sales acceleration in the second half of the year and benefits from expanded U.S. sales force and new product launches, anticipated sales and cost synergies and dis-synergies and the timing thereof; and the company’s ability to achieve its key financial goals. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the failure to integrate the legacy Wright and Tornier businesses and realize net sales synergies and cost savings from the merger with Tornier or delay in realization thereof; operating costs and business disruption as a result of the merger, including adverse effects on employee retention and sales force productivity and on business relationships with third parties; integration costs; actual or contingent liabilities; adverse effects of diverting resources and attention to providing transition services to the purchaser of the large joints business; the adequacy of the company’s capital resources and need for additional financing; the timing of regulatory approvals and introduction of new products; physician acceptance, endorsement, and use of new products; failure to achieve the anticipated benefits from approval of AUGMENT® Bone Graft; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims and product recalls; pending and threatened litigation; risks associated with the metal-on-metal master settlement agreement and the settlement agreement with the three settling insurers; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 25, 2016 filed by Wright with the SEC on February 23, 2017 and in other subsequent SEC filings by Wright. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

–Tables Follow–

Wright Medical Group N.V.
Condensed Consolidated Statements of Operations
 (dollars in thousands, except per share data–unaudited)
Three months ended Six months ended
June 25,
2017
June 26,
2016
June 25,
2017
June 26,
2016
Net sales $ 179,693 $ 170,716 $ 356,884 $ 340,007
Cost of sales 1 38,122 49,009 75,248 95,675
Gross profit 141,571 121,707 281,636 244,332
Operating expenses:
Selling, general and administrative 130,818 136,483 260,652 271,229
Research and development 12,547 12,108 24,979 24,224
Amortization of intangible assets 6,999 7,484 14,396 13,941
Total operating expenses 150,364 156,075 300,027 309,394
Operating loss (8,793 ) (34,368 ) (18,391 ) (65,062 )
Interest expense, net 18,339 13,024 36,534 24,878
Other (income) expense, net (6,557 ) (2,061 ) 1,418 (3,129 )
Loss from continuing operations before income taxes (20,575 ) (45,331 ) (56,343 ) (86,811 )
Provision (benefit) for income taxes 385 (3,300 ) 1,324 (4,588 )
Net loss from continuing operations $ (20,960 ) $ (42,031 ) $ (57,667 ) $ (82,223 )
Loss from discontinued operations, net of tax (20,202 ) $ (187,329 ) $ (42,194 ) $ (195,135 )
Net loss $ (41,162 ) $ (229,360 ) $ (99,861 ) $ (277,358 )
Net loss from continuing operations per share, basic and diluted $ (0.20 ) $ (0.41 ) $ (0.55 ) $ (0.80 )
Net loss from discontinued operations per share, basic and diluted $ (0.19 ) $ (1.82 ) $ (0.41 ) $ (1.90 )
Net loss per share, basic and diluted $ (0.39 ) $ (2.23 ) $ (0.96 ) $ (2.70 )
Weighted-average number of shares outstanding-basic and diluted 104,377 102,785 104,020 102,745
                                                               
Cost of sales includes amortization of inventory step-up adjustment of $10.4 million and $20.6 million for the three and six months ended June 26, 2016, respectively.

 Wright Medical Group N.V.
Consolidated Net Sales Analysis
(dollars in thousands–unaudited)
Three months ended Six months ended
June 25,
2017
June 26,
2016
%
change
June 25,
2017
June 26,
2016
%
change
U.S.
Lower extremities 54,348 52,008 4.5 % 109,809 107,286 2.4 %
Upper extremities 57,535 49,909 15.3 % 113,493 99,910 13.6 %
Biologics 19,273 17,792 8.3 % 37,907 34,920 8.6 %
Sports med & other 1,780 2,164 (17.7 )% 3,881 4,301 (9.8 )%
Total U.S. $ 132,936 $ 121,873 9.1 % $ 265,090 $ 246,417 7.6 %
International
Lower extremities 14,767 16,241 (9.1 )% 28,409 31,783 (10.6 )%
Upper extremities 22,987 23,940 (4.0 )% 45,409 44,915 1.1 %
Biologics 5,129 4,867 5.4 % 10,300 9,065 13.6 %
Sports med & other 3,874 3,795 2.1 % 7,676 7,827 (1.9 )%
Total International $ 46,757 $ 48,843 (4.3 )% $ 91,794 $ 93,590 (1.9 )%
Global
Lower extremities 69,115 68,249 1.3 % 138,218 139,069 (0.6 )%
Upper extremities 80,522 73,849 9.0 % 158,902 144,825 9.7 %
Biologics 24,402 22,659 7.7 % 48,207 43,985 9.6 %
Sports med & other 5,654 5,959 (5.1 )% 11,557 12,128 (4.7 )%
Total net sales $ 179,693 $ 170,716 5.3 % $ 356,884 $ 340,007 5.0 %
Wright Medical Group N.V.
Supplemental Net Sales Information
(unaudited)
Three months ended June 25, 2017 net sales growth/(decline)
U.S.
as
reported
Int’l
constant
currency
Int’l
as
reported
Global
constant
currency
Global
as
reported
Product line
Lower extremities 4 % (5 %) (9 %) 2 % 1 %
Upper extremities 15 % (1 %) (4 %) 10 % 9 %
Biologics 8 % 8 % 5 % 8 % 8 %
Sports med & other (18 %) 7 % 2 % (2 %) (5 %)
Total net sales 9 % (1 %) (4 %) 6 % 5 %
Six months ended June 25, 2017 net sales growth/(decline)
U.S.
as
reported
Int’l
constant
currency
Int’l
as
reported
Global
constant
currency
Global
as
reported
Product line
Lower extremities 2 % (7 %) (11 %) 0 % (1 %)
Upper extremities 14 % 4 % 1 % 11 % 10 %
Biologics 9 % 15 % 14 % 10 % 10 %
Sports med & other (10 %) 4 % (2 %) (1 %) (5 %)
Total net sales 8 % 2 % (2 %) 6 % 5 %
 Wright Medical Group N.V.
Reconciliation of Adjusted Non-GAAP Earnings Per Share to Net Loss from Continuing Operations Per Share
(dollars in thousands, except per share data–unaudited)
Three months ended Six months ended
June 25,
2017
June 26,
2016
June 25,
2017
June 26,
2016
Net loss from continuing operations, as reported $ (20,960 ) $ (42,031 ) $ (57,667 ) $ (82,223 )
Net loss from continuing operations per share, as reported $ (0.20 ) $ (0.41 ) $ (0.55 ) $ (0.80 )
Reconciling items:
Inventory step-up amortization 10,387 20,616
Non-cash interest expense on convertible notes 1 11,249 8,240 22,248 15,296
Non-cash loss on extinguishment of debt 12,343 12,343
Derivatives mark-to-market adjustments 2 (4,329 ) (16,632 ) (3,964 ) (23,273 )
Transaction and transition costs 3,201 9,014 6,173 19,847
Management changes 1,348 1,348
CVR mark-to-market adjustments 2 (3,924 ) 1,401 2,236 6,725
Contingent consideration fair value adjustment 2 176 306 176 306
Legal settlement 1,800 1,800
Costs associated with 2021 Notes issuance 234 234
IRS settlement 3 (3,073 ) (3,073 )
Tax effect of reconciling items 4 (52 ) (2,132 ) (70 ) (3,321 )
Non-GAAP net loss from continuing operations, as adjusted $ (14,639 ) $ (18,795 ) $ (30,868 ) $ (33,375 )
Add back amortization of intangible assets 6,999 7,484 14,396 13,941
Adjusted non-GAAP earnings $ (7,640 ) $ (11,311 ) $ (16,472 ) $ (19,434 )
Weighted-average basic shares outstanding 104,377 102,785 104,020 102,745
Adjusted non-GAAP earnings per share $ (0.07 ) $ (0.11 ) $ (0.16 ) $ (0.19 )
                                                 
Impacting interest expense, net
Impacting other (income) expense, net
IRS Settlement includes $0.8 million of interest income and $2.3 million tax benefit.
Determined based upon the effective tax rate in the jurisdiction in which the expense was incurred.

Wright Medical Group N.V.
 Reconciliation of Non-GAAP Adjusted EBITDA to Net Loss from Continuing Operations
(dollars in thousands–unaudited)
Three months ended Six months ended
June 25,
2017
June 26,
2016
June 25,
2017
June 26,
2016
Net loss from continuing operations $ (20,960 ) $ (42,031 ) $ (57,667 ) $ (82,223 )
Interest expense, net 18,339 13,024 36,534 24,878
Provision (benefit) from income taxes 385 (3,300 ) 1,324 (4,588 )
Depreciation 13,678 13,270 27,124 26,120
Amortization 6,999 7,484 14,396 13,941
Non-GAAP EBITDA $ 18,441 $ (11,553 ) $ 21,711 $ (21,872 )
Reconciling items impacting EBITDA:
Non-cash share-based compensation expense 4,732 3,056 8,686 6,373
Other (income) expense, net (6,557 ) (2,061 ) 1,418 (3,129 )
Inventory step-up amortization 10,387 20,616
Transaction and transition costs 3,201 9,014 6,173 19,847
Management changes 1,348 1,348
Legal settlement 1,800 1,800
Costs associated with 2021 Notes issuance 234 234
Non-GAAP adjusted EBITDA $ 19,817 $ 12,225 $ 37,988 $ 25,217
Net sales from continuing operations 179,693 170,716 356,884 340,007
Non-GAAP adjusted EBITDA margin 11.0 % 7.2 % 10.6 % 7.4 %
Wright Medical Group N.V.
Reconciliation of Non-GAAP Adjusted Gross Margins to Gross Margins from Continuing Operations
(dollars in thousands–unaudited)
Three months ended Six months ended
June 25,
2017
June 26,
2016
June 25,
2017
June 26,
2016
Gross profit from continuing operations, as reported $ 141,571 $ 121,707 $ 281,636 $ 244,332
Gross margins from continuing operations, as reported 78.8 % 71.3 % 78.9 % 71.9 %
Reconciling items impacting gross profit:
Inventory step-up amortization 10,387 20,616
Transaction and transition costs 1,954 685 2,078
Non-GAAP gross profit from continuing operations, as adjusted $ 141,571 $ 134,048 $ 282,321 $ 267,026
Net sales from continuing operations 179,693 170,716 356,884 340,007
Non-GAAP adjusted gross margins from continuing operations 78.8 % 78.5 % 79.1 % 78.5 %
Wright Medical Group N.V.
Reconciliation of Other Non-GAAP Financial Measures to Other As Reported Results
 (dollars in thousands–unaudited)
Three months ended Six months ended
June 25,
2017
June 26,
2016
June 25,
2017
June 26,
2016
Net sales $ 179,693 $ 170,716 $ 356,884 $ 340,007
Selling, general and administrative expense, as reported $ 130,818 $ 136,483 $ 260,652 $ 271,229
Selling, general and administrative expense as a percentages of net sales, as reported 72.8 % 79.9 % 73.0 % 79.8 %
Reconciling items impacting selling, general and administrative expense:
Transaction and transition costs – selling, general and administrative 3,101 6,970 5,388 17,530
Management changes 1,348 1,348
Legal settlement 1,800 1,800
Costs associated with 2021 Notes issuance 234 234
Selling, general and administrative expense, as adjusted $ 127,717 $ 126,131 $ 255,264 $ 250,317
Selling, general and administrative expense as a percentage of net sales, as adjusted 71.1 % 73.9 % 71.5 % 73.6 %
Research & development expense, as reported $ 12,547 $ 12,108 $ 24,979 $ 24,224
Research & development expense as a percentages of net sales, as reported 7.0 % 7.1 % 7.0 % 7.1 %
Reconciling items impacting research & development expense:
Transaction and transition costs – research & development 100 90 100 239
Research & development expense, as adjusted $ 12,447 $ 12,018 $ 24,879 $ 23,985
Research & development expense as a percentage of net sales, as adjusted 6.9 % 7.0 % 7.0 % 7.1 %
Wright Medical Group N.V.
Condensed Consolidated Balance Sheets
(dollars in thousands–unaudited)
June 25,
2017
December 25,
2016
Assets
Current assets:
Cash and cash equivalents $ 228,877 $ 262,265
Restricted cash 150,018 150,000
Accounts receivable, net 116,884 130,602
Inventories 161,769 150,849
Prepaid expenses and other current assets 66,565 65,909
Total current assets 724,113 759,625
Property, plant and equipment, net 206,614 201,732
Goodwill and intangible assets, net 1,080,807 1,082,839
Other assets 279,937 246,390
Total assets $ 2,291,471 $ 2,290,586
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable $ 42,762 $ 32,866
Accrued expenses and other current liabilities 432,430 407,704
Current portion of long-term obligations 25,639 33,948
Total current liabilities 500,831 474,518
Long-term obligations 805,770 780,407
Other liabilities 350,245 348,797
Total liabilities 1,656,846 1,603,722
Shareholders’ equity 634,625 686,864
Total liabilities and shareholders’ equity $ 2,291,471 $ 2,290,586

 

Investors & Media:
Julie D. Tracy
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.tracy@wright.com

Orthofix International Reports Second Quarter 2017 Financial Results

August 07, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX) today reported its financial results for the second quarter ended June 30, 2017. Net sales were $108.9 million, diluted earnings per share from continuing operations was $0.26 and adjusted earnings per share from continuing operations was $0.42.

“The key take-away from the second quarter is the strong sales performance of our Biologics and Spine Fixation businesses. Both have averaged mid-single digit year-over-year growth over the last three quarters,” said Brad Mason, President and Chief Executive Officer. “We believe these growth rates are sustainable in both businesses due to the renewed engagement of our sales partners, the addition of new distributors in underserved markets and our flow of new products to the field.

“The BioStim and Extremity Fixation businesses also performed better than we expected in the second quarter with BioStim delivering another solid top line performance and, when excluding planned subsidiary restructuring and the loss of sales due to the discontinuation of a non-core business last year, Extremity Fixation delivered good constant currency growth.

“Our bottom line performance was in line with our expectations for the period. Our primary focus this year is investing in the areas necessary to support a sustainable increase to our top line growth rate, rather than margin expansion. As we move into next year, without sacrificing our top line growth, we expect to return to adjusted EBITDA margin expansion as a result of a number of opportunities we see across the P&L.”

Financial Results Overview

The following table provides net sales by strategic business unit (“SBU”):

Three Months Ended June 30,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 Change

Constant
Currency
Change

BioStim $ 47,174 $ 44,758 5.4 % 5.4 %
Biologics 15,661 14,256 9.9 % 9.9 %
Extremity Fixation 24,747 26,817 (7.7 %) (6.0 %)
Spine Fixation 21,360 18,244 17.1 % 17.1 %
Net sales $ 108,942 $ 104,075 4.7 % 5.1 %

Gross profit increased $4.2 million to $85.8 million. Gross margin improved slightly to 78.7% compared to 78.4% in the prior year period, which was slightly below our expectations due primarily to larger than usual inventory reserve expenses. Non-GAAP net margin, an internal metric that we define as gross profit less sales and marketing expenses, was $35.3 million compared to $35.5 million in the prior year period. The decrease in non-GAAP net margin was primarily due to higher sales and marketing expenses in Biologics and Extremity Fixation.

Net income from continuing operations was $4.7 million, or $0.26 per share, compared to net loss of ($6.3) million, or ($0.35) per share in the prior year period. Adjusted net income from continuing operations was $7.8 million, or $0.42 per share, compared to adjusted net income of $7.5 million, or $0.40 per share in the prior year period.

EBITDA was $14.0 million, compared to $2.6 million in the prior year period. Adjusted EBITDA was $20.5 million, or 18.8% of net sales, for the second quarter, compared to $19.2 million, or 18.5% of net sales, in the prior year period.

Liquidity

As of June 30, 2017, cash and cash equivalents were $44.3 million compared to $39.6 million as of December 31, 2016. As of June 30, 2017, we had no outstanding indebtedness and borrowing capacity of $125 million. Cash flow from operations decreased $11.6 million to $9.7 million and free cash flow decreased $9.9 million to $1.1 million.

2017 Outlook

For the year ending December 31, 2017, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.

Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions, except per share data) Low High Low High
Net sales $ 411.0 $ 415.0 $ 422.0

(1)

$ 425.0

(1)

Net income from continuing operations $ 20.6 $ 23.7 $ 17.7

(2)

$ 21.4

(2)

Adjusted EBITDA $ 76.0 $ 79.0 $ 79.0

(3)

$ 81.0

(3)

EPS from continuing operations $ 1.12 $ 1.29 $ 0.96

(4)

$ 1.16

(4)

Adjusted EPS from continuing operations $ 1.48 $ 1.58 $ 1.54

(5)

$ 1.60

(5)

Represents a year-over-year increase of 3.0% to 3.7% on a reported basis
Represents a year-over-year increase of 406.1% to 512.0%
Represents a year-over-year decrease of 0.4% to an increase of 2.1%
Represents a year-over-year increase of 405.3% to 510.5%
Represents a year-over-year increase of 5.5% to 9.6%

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company’s financial results for the second quarter of 2017. Interested parties may access the conference call by dialing (800) 406-5345 in the U.S. and (719) 325-4807 outside the U.S., and referencing the conference ID 7718902. A replay of the call will be available for two weeks by dialing (888) 203-1112 in the U.S. and (719) 457-0820 outside the U.S., and entering the conference ID 7718902. A webcast of the conference call may be accessed by going to the Company’s website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company’s sales representatives and distributors. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children, and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (“the Exchange Act”), 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. Therefore, 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 further update any such statement, or the risk factors described in Part I, Item 1A under the heading Risk Factors in our Form 10-K for the year ended December 31, 2016, to reflect new information, the occurrence of future events or circumstances or otherwise.

ORTHOFIX INTERNATIONAL N.V.
Condensed Consolidated Statements of Operations
Three Months Ended Six Months Ended
June 30, June 30,
(Unaudited, U.S. Dollars, in thousands, except share and per share data) 2017 2016 2017 2016
Net sales $ 108,942 $ 104,075 $ 211,680 $ 202,754
Cost of sales 23,177 22,516 45,758 44,653
Gross profit 85,765 81,559 165,922 158,101
Sales and marketing 50,471 46,043 99,003 90,865
General and administrative 20,409 18,545 38,691 35,550
Research and development 6,887 6,796 14,311 14,436
Charges related to U.S. Government resolutions 12,870 12,870
Operating income (loss) 7,998 (2,695 ) 13,917 4,380
Interest income (expense), net 76 (113 ) 121 (151 )
Other income (expense), net 585 147 (3,763 ) 1,980
Income (loss) before income taxes 8,659 (2,661 ) 10,275 6,209
Income tax expense (3,924 ) (3,685 ) (7,848 ) (7,979 )
Net income (loss) from continuing operations 4,735 (6,346 ) 2,427 (1,770 )
Discontinued operations
Loss from discontinued operations (1,300 ) (1,572 ) (1,827 ) (2,562 )
Income tax benefit 418 474 599 728
Net loss from discontinued operations (882 ) (1,098 ) (1,228 ) (1,834 )
Net income (loss) $ 3,853 $ (7,444 ) $ 1,199 $ (3,604 )
Net income (loss) per common share—basic
Net income (loss) from continuing operations $ 0.26 $ (0.35 ) $ 0.13 $ (0.10 )
Net loss from discontinued operations (0.05 ) (0.06 ) (0.06 ) (0.10 )
Net income (loss) per common share—basic $ 0.21 $ (0.41 ) $ 0.07 $ (0.20 )
Net income (loss) per common share—diluted
Net income (loss) from continuing operations $ 0.26 $ (0.35 ) $ 0.13 $ (0.10 )
Net loss from discontinued operations (0.05 ) (0.06 ) (0.06 ) (0.10 )
Net income (loss) per common share—diluted $ 0.21 $ (0.41 ) $ 0.07 $ (0.20 )
Weighted average number of common shares:
Basic 18,050,551 18,147,681 18,015,308 18,312,781
Diluted 18,343,038 18,147,681 18,288,050 18,312,781
ORTHOFIX INTERNATIONAL N.V.
Condensed Consolidated Balance Sheets
(U.S. Dollars, in thousands except share data) June 30,

2017

December 31,

2016

(unaudited)
Assets
Current assets
Cash and cash equivalents $ 44,330 $ 39,572
Restricted cash 14,369
Accounts receivable, net of allowances of $8,480 and $8,396, respectively 61,213 57,848
Inventories 75,869 63,346
Prepaid expenses and other current assets 17,192 19,238
Total current assets 198,604 194,373
Property, plant and equipment, net 46,651 48,916
Patents and other intangible assets, net 9,508 7,461
Goodwill 53,565 53,565
Deferred income taxes 42,685 47,325
Other long-term assets 16,664 20,463
Total assets $ 367,677 $ 372,103
Liabilities and shareholders’ equity
Current liabilities
Accounts payable $ 14,245 $ 14,353
Other current liabilities 50,858 69,088
Total current liabilities 65,103 83,441
Other long-term liabilities 25,627 25,185
Total liabilities 90,730 108,626
Contingencies
Shareholders’ equity
Common shares $0.10 par value; 50,000,000 shares authorized; 18,119,430 and

17,828,155 issued and outstanding as of June 30, 2017 and December 31,

2016, respectively

1,812 1,783
Additional paid-in capital 211,990 204,095
Retained earnings 65,378 64,179
Accumulated other comprehensive loss (2,233 ) (6,580 )
Total shareholders’ equity 276,947 263,477
Total liabilities and shareholders’ equity $ 367,677 $ 372,103

ORTHOFIX INTERNATIONAL N.V.
Non-GAAP Financial Measures

The following tables present reconciliations of net income (loss) from continuing operations, earnings per share (“EPS”) from continuing operations, gross profit, and net cash from operating activities, in each case calculated in accordance with U.S. generally accepted accounting principles (“GAAP”), to, as applicable, non-GAAP financial measures, referred to as “EBITDA,” “Adjusted EBITDA,” “Adjusted net income from continuing operations,” “Adjusted earnings per share from continuing operations,” “Non-GAAP net margin” and “Free cash flow” that exclude items specified in the tables. A more detailed explanation of the items excluded from these non-GAAP financial measures, as well as why management believes the non-GAAP financial measures are useful to them, is included following the reconciliations.

EBITDA and Adjusted EBITDA

Three Months Ended

June 30,

Six Months Ended

June 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Net income (loss) from continuing operations $ 4,735 $ (6,346 ) $ 2,427 $ (1,770 )
Interest expense (income), net (76 ) 113 (121 ) 151
Income tax expense 3,924 3,685 7,848 7,979
Depreciation and amortization 5,372 5,130 10,447 10,003
EBITDA $ 13,955 $ 2,582 $ 20,601 $ 16,363
Share-based compensation 2,676 1,913 5,492 4,012
Foreign exchange impact (618 ) (185 ) (1,631 ) (2,000 )
Strategic investments 2,226 206 9,326 404
SEC / FCPA matters and related costs 560 545 701 790
Infrastructure investments 1,284 2,246
Legal judgments/settlements 1,392 1,619
International restructuring 321 82
Charges related to U.S. Government resolutions 12,870 12,870
Adjusted EBITDA $ 20,512 $ 19,215 $ 36,190 $ 34,685
As a % of net sales 18.8 % 18.5 % 17.1 % 17.1 %

Adjusted Net Income from Continuing Operations

Three Months Ended

June 30,

Six Months Ended

June 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Net income (loss) from continuing operations $ 4,735 $ (6,346 ) $ 2,427 $ (1,770 )
Foreign exchange impact (618 ) (185 ) (1,631 ) (2,000 )
Strategic investments 2,226 206 9,326 404
SEC / FCPA matters and related costs 560 545 701 790
Infrastructure investments 1,284 2,246
Legal judgments/settlements 1,392 1,619
International restructuring 321 82
Charges related to U.S. Government resolutions 12,870 12,870
Long-term income tax rate adjustment (841 ) (897 ) 107 182
Adjusted net income from continuing operations $ 7,775 $ 7,477 $ 12,631 $ 12,722

Adjusted Earnings per Share from Continuing Operations

Three Months Ended

June 30,

Six Months Ended

June 30,

(Unaudited, per diluted share) 2017 2016 2017 2016
EPS from continuing operations $ 0.26 $ (0.35 ) $ 0.13 $ (0.10 )
Foreign exchange impact (0.03 ) (0.01 ) (0.09 ) (0.11 )
Strategic investments 0.12 0.01 0.51 0.02
SEC / FCPA matters and related costs 0.03 0.03 0.04 0.04
Infrastructure investments 0.07 0.12
Legal judgments/settlements 0.08 0.09
International restructuring 0.02
Charges related to U.S. Government resolutions 0.70 0.69
Long-term income tax rate adjustment (0.06 ) (0.05 ) 0.01 0.02
Adjusted EPS from continuing operations $ 0.42 $ 0.40 $ 0.69 $ 0.68
Weighted average number of diluted common shares 18,343,038 18,511,978 18,288,050 18,645,280

Non-GAAP Net Margin

Three Months Ended

June 30,

Six Months Ended

June 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Gross profit $ 85,765 $ 81,559 $ 165,922 $ 158,101
Sales and marketing (50,471 ) (46,043 ) (99,003 ) (90,865 )
Non-GAAP net margin $ 35,294 $ 35,516 $ 66,919 $ 67,236
BioStim $ 19,469 $ 18,575 $ 36,602 $ 34,983
Biologics 6,470 6,718 12,641 12,822
Extremity Fixation 6,766 8,161 13,178 15,336
Spine Fixation 2,696 2,201 4,703 4,536
Corporate (107 ) (139 ) (205 ) (441 )
Non-GAAP net margin $ 35,294 $ 35,516 $ 66,919 $ 67,236

Free Cash Flow

Six Months Ended

June 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net cash from operating activities $ 9,727 $ 21,373
Capital expenditures (8,593 ) (10,356 )
Free cash flow $ 1,134 $ 11,017

2017 Outlook

Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions) Low High Low High
Net income from continuing operations $ 20.6 $ 23.7 $ 17.7 $ 21.4
Interest expense, net 0.1 0.2 0.2 0.1
Income tax expense 13.6 14.3 15.7 15.5
Depreciation and amortization 20.0 20.0 20.0 20.0
EBITDA $ 54.3 $ 58.2 $ 53.6 $ 57.0
Share-based compensation 11.8 11.8 13.0 13.0
Foreign exchange impact (1.0 ) (1.0 ) (1.6 ) (1.6 )
Strategic investments 8.6 8.1 10.3 9.3
SEC / FCPA matters and related costs 1.3 1.0 1.2 1.0
International restructuring 0.8 0.7 0.9 0.7
Legal judgments/settlements 0.2 0.2 1.6 1.6
Adjusted EBITDA $ 76.0 $ 79.0 $ 79.0 $ 81.0
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, per diluted share) Low High Low High
EPS from continuing operations $ 1.12 $ 1.29 $ 0.96 $ 1.16
Foreign exchange impact (0.05 ) (0.05 ) (0.09 ) (0.09 )
Strategic investments 0.46 0.44 0.56 0.51
SEC / FCPA matters and related costs 0.07 0.05 0.07 0.05
International restructuring 0.04 0.04 0.05 0.04
Legal judgments/settlements 0.01 0.01 0.09 0.09
Long-term income tax rate adjustment (0.17 ) (0.20 ) (0.10 ) (0.16 )
Adjusted EPS from continuing operations $ 1.48 $ 1.58 $ 1.54 $ 1.60
Weighted average number of diluted common shares 18,400,000 18,400,000 18,400,000 18,400,000

Non-GAAP Measures:

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.

EBITDA

EBITDA is a non-GAAP financial measure, which is calculated by adding interest income (expense), net; income tax expense; and depreciation and amortization to net income (loss) from continuing operations. EBITDA provides management with additional insight to its results of operations.

Adjusted EBITDA, Adjusted Net Income from Continuing Operations and Adjusted Earnings per Share from Continuing Operations

These non-GAAP financial measures provide management with additional insight to its results of operations and are calculated using the following adjustments:

  • Share-based compensation – costs related to our share-based compensation plans, which include stock options, restricted stock awards, performance-based restricted stock awards, market-based restricted stock awards and our stock purchase plan
  • Foreign exchange impact – gains and losses related to foreign currency transactions; guidance presented does not include the impact of any future foreign exchange fluctuations
  • Strategic investments – costs related to our strategic investments, including our investment in eNeura, Inc.
  • SEC / FCPA matters and related costs – legal and other professional fees associated with the SEC Investigation, Securities Class Action Complaint and Brazil subsidiary compliance review
  • Infrastructure investments – costs associated with our multi-year process and systems improvement effort, “Bluecore,” which was completed in 2016
  • Legal judgments/settlements – adverse or favorable legal judgments or negotiated legal settlements
  • International restructuring – costs related to a planned restructuring, primarily consisting of severance charges and the write-down of certain assets
  • Charges related to U.S. Government resolutions – charges related to the settlement with the SEC as further discussed in our Form 10-K for the year ended December 31, 2016
  • Long-term income tax rate adjustment – reflects management’s expectation of a long-term normalized effective tax rate of 38%, which is based on current tax law and current expected income; actual tax expense will ultimately be based on GAAP performance and may differ from the 38% effective tax rate due to a variety of factors, including the jurisdictions in which profits are determined to be earned and taxed, the resolutions of issues arising from tax audits with various tax authorities, and the ability to realize deferred tax assets

Non-GAAP Net Margin

Non-GAAP net margin is an internal non-GAAP metric, which we define as gross profit less sales and marketing expense. Non-GAAP net margin is the primary metric used by our Chief Operating Decision Maker in managing our business.

Free Cash Flow

Free cash flow is a non-GAAP financial measure, which is calculated by subtracting capital expenditures from cash flow from operating activities. Free cash flow is an important indicator of how much cash is generated or used by our normal business operations, including capital expenditures. Management uses free cash flow as a measure of progress on its capital efficiency and cash flow initiatives.

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. Management uses these non-GAAP measures as the basis for assessing the ability of the underlying operations to generate cash. 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. Some of the limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost and can have a material effect on cash flows. Similarly, certain non-cash expenses, such as share-based compensation, do not directly impact cash flows, but are part of total compensation costs accounted for under GAAP.

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. We provide a detailed reconciliation of the non-GAAP financial measures to our most directly comparable GAAP measures, and encourage investors to review this reconciliation.

Usefulness of Non-GAAP Financial Measures to Investors

We believe that providing non-GAAP financial measures that exclude certain items provides investors with greater transparency to the information used by senior management in its financial and operational decision-making. 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.

Contacts

Orthofix International N.V.
Mark Quick, 214-937-2924
markquick@orthofix.com

Zimmer Biomet Announces Quarterly Dividend for Third Quarter of 2017

WARSAW, Ind.Aug. 7, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), a global leader in musculoskeletal healthcare, today announced that its Board of Directors has approved the payment of a quarterly cash dividend to stockholders for the third quarter of 2017.

The cash dividend of $0.24 per share will be paid on or about October 27, 2017 to stockholders of record as of the close of business on September 22, 2017.  Future declarations of dividends are subject to approval of the Board of Directors and may be adjusted as business needs or market conditions change.

About Zimmer Biomet

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.

ZBH-Fin

SOURCE Zimmer Biomet Holdings, Inc.

Related Links

http://www.zimmerbiomet.com

Bioventus Names Greg Anglum Senior V.P and CFO, Tony D’Adamio Senior V.P and General Counsel

August 07, 2017

DURHAM, N.C.–(BUSINESS WIRE)–Bioventus®, a leader in orthobiologic solutions, today announced two changes to its executive leadership team. Greg Anglum has been promoted to Senior Vice President and Chief Financial Officer. Anglum, who joined Bioventus in 2016 as its Chief Accounting Officer, brings more than 20 years of experience driving financial and growth strategies for both private and public companies in various industries. He will also be responsible for the business intelligence and IT teams at Bioventus.

In addition, Bioventus is pleased to announce Anthony (Tony) D’Adamio has joined the company as its Senior Vice President and General Counsel. D’Adamio has nearly 30 years of senior legal executive experience with diagnostic, health care data and clinical service companies. He will be responsible for all general and corporate legal matters as well as the ethics and compliance functions at Bioventus. Both Anglum and D’Adamio will also join the company’s executive leadership team and report to its CEO, Tony Bihl.

“Greg has done an exceptional job serving as Interim CFO for the past three months, seamlessly integrating into our executive team in this important role. He has provided the financial reporting, guidance, analysis, and leadership that gives us great confidence in his ability to perform and grow moving forward,” said Bihl. “One of Tony’s strengths is his ability to provide exceptional legal advice while always seeking to achieve the best overall business solution. His global experience in complex regulated healthcare industries, along with his engaging and collaborative approach make him a great addition to our leadership team.”

Prior to joining Bioventus, Anglum held CFO positions at Overture, a Raleigh-based technology company and StrikeIron, a Software-as-a-Service (SaaS) company. He also spent several years in public accounting roles with Arthur Andersen and Grant Thornton. Anglum earned a Bachelor of Arts degree in economics from Vanderbilt University and an MBA from the Owen Graduate School of Management at Vanderbilt.

D’Adamio most recently served as General Counsel & Secretary of Siemens Medical Solutions and earlier was Deputy General Counsel & Secretary of Siemens Healthcare Diagnostics. He also spent five years as Senior Counsel within the Diagnostics Division of Bayer Healthcare, prior to the acquisition of this business by Siemens. D’Adamio began his legal career at the law firm of Bond, Schoeneck & King before taking corporate legal positions with companies including Group Health Incorporated, Quest Diagnostics and Covance. He received his Juris Doctor cum laude from Howard University School of Law and a Bachelor of Arts from the State University of New York at Binghamton.

About Bioventus

Bioventus is an orthobiologics company that delivers clinically proven, cost-effective products that help people heal quickly and safely. Its mission is to make a difference by helping patients resume and enjoy active lives. The company has two product portfolios for orthobiologics, Bioventus Active Healing Therapies and Bioventus Surgical that make it a global leader in active orthopaedic healing. Its EXOGEN® Ultrasound Bone Healing System uses safe, effective low intensity pulsed ultrasound (LIPUS) to stimulate the body’s natural healing process. EXOGEN has been used to treat more than 1 million patients worldwide and numerous regulatory agencies including the FDA, Health Canada, BSi, TGA, Medsafe, UAE Ministry of Health and SFDA have granted their approval of the product. Today it is the leading bone healing system in the market with complaints for lack of efficacy averaging less than 1%.

Built on a commitment to high quality standards, evidence-based medicine and strong ethical behavior, Bioventus is a trusted partner for physicians worldwide. For more information, visit www.BioventusGlobal.com and follow the company on Twitter @Bioventusglobal.

Bioventus, the Bioventus logo and EXOGEN are registered trademarks of Bioventus LLC.

Contacts

Bioventus
Thomas Hill, 919-474-6715
thomas.hill@bioventusglobal.com

Anika Announces Publication of Data Demonstrating the Efficacy and Safety of HYALOFAST® in Combination with Stem Cells for the Treatment of Cartilage Lesions on the Knee

August 07, 2017

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedics medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today announced the publication of data demonstrating that HYALOFAST®, a biodegradable HA-based scaffold, used in combination with autologous adult mesenchymal stem cells (MSCs), regardless of a patients’ age, is a viable and effective option for the treatment of cartilage lesions of the knee joint. The data, published in the Knee Surgery Sports Traumatology Arthroscopy – Volume 25 – Number 8 edition of August 2017, demonstrated that treatment outcomes were equally effective among patients under the age of 45 as they were with patients over the age of 45, who are difficult to treat with traditional approaches such as microfracture.

Cartilage lesions are reported in almost 2 out of 3 patients aged 40 to 50 years who are undergoing knee arthroscopy, and current interventions for cartilage repair have limited utility, in part due to the age-related decrease in regenerative potential of articular chondrocytes observed in vitro,” said Charles H. Sherwood, Ph.D., Chief Executive Officer of Anika Therapeutics. “This study shows that we may be able to fill a significant treatment gap in the management of cartilage defects among older patients, and offer a more convenient and cost-effective alternative or adjunct to traditional, invasive approaches such as microfracture with HYALOFAST.

The study evaluated 40 patients with full thickness cartilage lesions of the knee joint, 20 of whom were over the age of 45 and the remaining, who were under the age of 45. All patients were implanted with HYALOFAST soaked in bone marrow aspirate concentrate (BMAC) containing MSCs, and were prospectively evaluated for 4 years. Functional outcomes were assessed using a variety of validated scales1 preoperatively, at 2-years and at the final follow-up at 4 years. At final follow-up, all functional outcomes’ scores significantly improved (P < 0.001) in both groups of patients, and researchers concluded that the outcomes were not impacted by age or concomitant surgical procedures, but by the size and quantity of lesions.

We’re encouraged by the results of this long-term study that shows the potential clinical utility of combining stem cells with the HYALOFAST biodegradable hyaluronic acid-based scaffold to treat cartilage defects in a simple one-step procedure,” said Alberto Gobbi, President of the OASI Bioresearch Foundation Gobbi NPO, visiting professor at the UC San Diego, the next President of the International Cartilage Repair Society (ICRS), and the study’s lead author. “One of the key learnings from our four-year follow-up was that cartilage lesion size and quantity might be a better indicator for surgery than advanced age, which we concluded did not impact outcomes associated with the use of stem cells and HYALOFAST.

HYALOFAST is a non-woven biodegradable hyaluronic acid-based scaffold for hyaline-like cartilage regeneration to treat cartilage injuries and defects. HYALOFAST is commercially available in over 15 countries and has been used in more than 11,000 patients to date. HYALOFAST is pending regulatory submission in the United States and its ‘FastTRACK’ Phase III trial is currently enrolling patients across the U.S. and Europe.

The full manuscript is available here: https://link.springer.com/article/10.1007/s00167-016-3984-6

About Anika Therapeutics, Inc.

Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

1 Visual Analog Scale (VAS) for pain, International Knee Documentation Committee (IKDC), Knee Injury & Osteoarthritis Outcome Score (KOOS), and Tegner.

Contacts

For Investor Inquiries:
Anika Therapeutics, Inc.
Sylvia Cheung, 781-457-9000
Chief Financial Officer
or
For Media Inquiries:
Pure Communications
Sonal Vasudev, 917-523-1418, sonal@purecommunicationsinc.com

Knee surgery: Have we been doing it wrong?

August 7, 2017, MDLinx/University at Buffalo Health and Medicine News

Cleaning up loose cartilage is not always beneficial, according to a new University at Buffalo study that could impact athletes and seniors, reduce health care costs.
A team of University at Buffalo medical doctors has published a study that challenges a surgical practice used for decades during arthroscopic knee surgery.

When treating meniscal tears surgeons also have clipped and smoothed any dislodged cartilage they found in the belief it was helping patients. But the new study finds that practice does not benefit the patient. Patients who did not have dislodged cartilage removed, recovered faster, with less pain, and ended up a year later with identical results.

“Those with less surgery got better faster in comparison with the people we did more surgery on,” said Leslie J. Bisson, MD, professor and chair in the Department of Orthopaedics at the Jacobs School of Medicine and Biomedical Sciences at UB and lead author of the study.

The finding was so surprising that an editor at The Journal of Bone & Joint Surgery, which published the study, also published a commentary that said, “The conclusion that unstable cartilage lesions do not need debridement could have a dramatic impact on practice management, save health–care dollars, and improve early patient outcomes.”

The American Academy of Orthopaedic Surgeons also distributed the study on its weekly collection of papers of note.

 

READ THE REST HERE

SeaSpine Reports Second Quarter 2017 Financial Results

CARLSBAD, Calif., Aug. 03, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the second quarter ended June 30, 2017.

Second Quarter 2017 Financial Highlights and Recent Accomplishments

  • Revenue of $34.2 million, an increase of 3.0% year-over-year
  • U.S. revenue of $30.4 million, an increase of 1.1% year-over-year
    — U.S. orthobiologics revenue of $16.0 million
    — U.S. spinal instrumentation revenue of $14.4 million
  • International revenue of $3.8 million, an increase of 20.5% year-over-year
  • Full commercial launch of the Mariner® Posterior Fixation System, a modular pedicle screw system that provides surgeons with multiple intra-operative options to facilitate posterior lumbar fixation
  • Limited commercial launch of the Skipjack™ Expandable Interbody System, an expandable interbody system that provides in-situ expansion in either height or lordosis for an improved anatomical fit

“We are pleased with our second quarter results, which reflect our ongoing commitment to develop innovative and cost effective solutions to treat spinal disorders and expand our distributor footprint,” said Keith Valentine, President and Chief Executive Officer. “We remain focused on our mission to drive improved procedural solutions that combine efficient spinal instrumentation systems with industry leading orthobiologics to deliver clinical value to surgeons, hospitals, and patients.”

Second Quarter 2017 Financial Results
Revenue for the second quarter of 2017 totaled $34.2 million, a 3.0% increase compared to the same period of the prior year. Total revenue in the U.S. was $30.4 million, a 1.1% increase compared to the same period of the prior year due primarily to the improved performance of orthobiologics distributors during the current year period.

Orthobiologics revenue totaled $17.6 million, a 4.8% increase compared to the second quarter of 2016. The growth in orthobiologics revenue was driven by an increase in U.S. sales. Spinal instrumentation revenue totaled $16.6 million, a 1.1% increase compared to the second quarter of 2016 that was driven by stocking orders from a recently added distributor in Latin America.

Gross margin for the second quarter of 2017 was 59.1%, compared to 58.0% for the same period in 2016.  The increase in gross margin was mainly driven by lower manufacturing costs for orthobiologics products manufactured at the Company’s Irvine, California facility.  This was partially offset by a $0.2 million increase in non-cash amortization of technology intangible assets acquired in September 2016 from N.L.T. Spine Ltd and by lower gross margins associated with international sales, which were slightly higher as a percentage of total revenue in the second quarter of 2017 compared to the same period of the prior year.

Operating expenses for the second quarter of 2017 totaled $28.4 million, compared to $31.5 million for the same period of the prior year.  The $3.1 million decrease in operating expenses was driven by lower selling, general and administrative and intangible amortization expenses.

Net loss for the second quarter of 2017 was $8.0 million, compared to a net loss of $12.0 million for the second quarter of 2016.

Cash and cash equivalents at June 30, 2017 were $12.3 million and the Company had $4.0 million of outstanding borrowings against its $30.0 million credit facility. The Company realized $4.6 million in net proceeds in the second quarter of 2017 through the sale of approximately 477,000 shares of its common stock under its “at the market” equity offering program.

2017 Financial Outlook
SeaSpine expects full-year 2017 revenue to be in the range of $130.0 million to $133.0 million, reflecting growth of 1% to 3% over full-year 2016 revenue.

Webcast and Conference Call Information
The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 49156714. To listen to the webcast, please visit the investor relations section of the SeaSpine website at www.seaspine.com.

About SeaSpine
SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal instrumentation solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal instrumentation portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal instrumentation product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: revenue expectations for full-year 2017.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the Company’s ability to attract and retain new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; unexpected expense, including as a result of developing and supporting the launch of new products; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; the risk of supply shortages, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended June 30, Six Months Ended June 30,
2017 2016 2017 2016
Total revenue, net $ 34,196 $ 33,201 $ 66,090 $ 64,600
Cost of goods sold 13,994 13,930 27,166 28,213
Gross profit 20,202 19,271 38,924 36,387
Operating expenses:
Selling, general and administrative 24,249 26,989 48,219 52,363
Research and development 3,344 3,181 6,394 5,934
Intangible amortization 792 1,281 1,584 2,562
Total operating expenses 28,385 31,451 56,197 60,859
Operating loss (8,183 ) (12,180 ) (17,273 ) (24,472 )
Other income (expense), net 185 (232 ) 172 26
Loss before income taxes (7,998 ) (12,412 ) (17,101 ) (24,446 )
Provision (benefit) for income taxes 45 (429 ) 45 (456 )
Net loss $ (8,043 ) $ (11,983 ) $ (17,146 ) $ (23,990 )
Net loss per share, basic and diluted $ (0.68 ) $ (1.07 ) $ (1.46 ) $ (2.15 )
Weighted average shares used to compute basic and diluted net loss per share 11,888 11,179 11,705 11,173
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In thousands)
June 30, 2017 December 31, 2016
Cash and cash equivalents $ 12,287 $ 14,566
Trade accounts receivable, net of allowances of $522 and $483 21,689 20,982
Inventories 42,515 45,299
Short-term debt 445
  Total current liabilities 25,617 24,418
Long-term borrowings under credit facility 3,994 3,835
Total stockholders’ equity 105,466 110,977

 

Investor Relations Contact
Lynn Pieper Lewis
(415) 937-5402
ir@seaspine.com