MCRA Assists SANUWAVE with Successful De Novo Decision: 3rd Wound Care De Novo Since 2010

Posted On January 10, 2018 By OrthoSpineNews In Regulatory /

WASHINGTON, Jan. 10, 2018 /PRNewswire-USNewswire/ — Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) has announced its role in the successful de novo clearance by the U.S. Food and Drug Administration (FDA) on December 28, 2017 enabling SANUWAVE Health, Inc. to initiate commercialization of the dermaPACE System for the treatment of Diabetic Foot Ulcers (DFU) in the U.S.

SANUWAVE retained MCRA in January of 2015 to lead interactions and correspondence with the FDA for the dermaPACE. SANUWAVE withdrew a PMA submitted previously using data from the first DFU clinical study and recognized the need to enlist MCRA’s expertise. SANUWAVE’s Chairman of the Board and CEO, Kevin A. Richardson IIsaid, “We chose MCRA for their extensive regulatory experience and interaction with FDA over the past decade. They took clinical data from, essentially, a Not-Approvable PMA, and worked wonders in obtaining a de novo decision with basically the same clinical data. Their depth of knowledge and experience in regulatory and clinical science made them an excellent partner for working hand-in-hand with our team and the FDA.”

This significant achievement marks the third clearance of a de novo application for a wound care technology since 2010. Samuel Pollard, a Senior Regulatory Associate at MCRA, added “MCRA was excited to assist SANUWAVE on the strategy and execution of a viable US market solution to a unique regulatory challenge. MCRA’s US Regulatory and Clinical Research Organization (CRO) experience helped drive this device to a successful FDA decision. These successes demonstrate MCRA’s commitment to a surgeon-centric approach, which provides medical solutions that enable patients to regain a healthy lifestyle.”

About Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is the leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA’s value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance, and quality assurance. MCRA’s integrated approach of these key value creating initiatives, as well as orthopedic specialization, provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT, and New York, NY, and serves nearly 450 clients globally. MCRA has a demonstrated history of driving successful de novo and other regulatory submissions in all areas of the medical device industry including spine, orthopedics, cardio-vascular, diagnostic imaging, endoscopy, ophthalmics, general/plastic surgery, drug delivery, wound care, diabetes, dental, general healthcare, nephrology, neurology, cardiology, and in vitro diagnostic (IVD) devices.

Contact

David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com

SOURCE Musculoskeletal Clinical Regulatory Advisers, LLC

New Kleiner Spine Graft Delivery Tool Improves Outcomes for Patients, Surgeons, Hospitals and Payers

Posted On January 10, 2018 By OrthoSpineNews In Spine, Top Stories /

DENVER, Jan. 10, 2018 /PRNewswire/ — Kleiner Device Labs today announced full commercial availability of a new spinal bone graft delivery tool, the KG® 1, featuring a patented design that facilitates less-invasive procedures and has been proven in clinical testing to reduce spinal fusion failure rates by 68%¹.

“In my own surgical practice, I was frustrated by unacceptable failure rates in spinal fusions and bad outcomes for my patients that were driven by existing graft delivery tools that jam, don’t distribute graft material to the right locations or quantity, or required excessive manipulation that creates soft tissue inflammation or damage. The round, end dispensing tools left me frustrated and with ‘am I done yet?’ questions,” said Jeff Kleiner, M.D., founder and CEO of Kleiner Device Labs.

“In testing, we found that the KG 1’s design solves all these problems, and use of the new tool, alone, improved my spinal arthrodesis rate from 75% to 92%¹,” added Kleiner.

The benefits for patients include higher success rates and far fewer remedial second surgeries, less post-operative pain and infection risk, and less use of bone morphogenetic protein (BMP).

For surgeons, the KG 1 facilitates less-invasive procedures, faster surgeries, and reduces frustrations and guesswork in the OR.

Michael J. Rauzzino, M.D., of Front Range Spine and Neurosurgery in Denver, added, “I have found that I have been able to get a great deal more graft material into the disc space in a much more quantifiable and rapid fashion. The delivery device has been very simple and easy to use and I have used it for both minimally invasive as well as in open applications. It has been particularly helpful for me in the minimally invasive fusions we do, greatly increasing the amount of bone graft material that I have been able to get into the interspace. I have also found it extremely helpful for our minimally invasive lateral approaches to the spine where due to the depth of the wound and the anatomy, it was difficult to get a good deal of bone graft into the interspace.”

Srdjan Mirkovic, M.D. of NorthShore Orthopaedic Institute in Chicago added, “Over the last five months in my T-lif and L-Lif operations, I have been able to expedite bone graft insertion for these procedures and avoid the problems that I encountered with round, end-dispensing bone funnels including cannula tip visualization, jamming, injury to the bony end plates of the disk space and failure to distribute bone graft in the disk space. I found that I was able to introduce more scaffold and cells and still have room for my fusion cage. It has decreased my operating time, eliminated the frustration and challenge of interbody grafting and improved my early fusion results without using BMP. It has worked well with all of the flowable graft extender and ground autograft that I have used.”

For hospitals and payers, facilitating surgeons’ use of the KG 1 can reduce the costs of spinal fusion surgery through reducing the number of remedial procedures, higher OR throughput and reduced use of BMP.

The patented KG 1 graft delivery tool includes a cannula, plunger and detachable funnel, which facilitates easier loading of graft material. The KG 1’s unique shape allows easier entry into the disk interspace, minimizing soft tissue damage or irritation. The bi-portal design ejects graft material to fill both sides of the disk space while leaving a central void for insertion of a fusion cage. The KG 1 is disposable, guaranteeing sterility of the instrument and eliminating the system costs of cleaning and restocking. Made of Lexan®, the KG 1 has been strength tested and proven beyond normal surgical applications.

The KG 1 is available commercially from the company and through authorized distributors, as well as to Veterans Administration and military healthcare facilities on the GSA schedule through Government Marketing & Procurement.

For KG 1 technical specifications, instructions for use, or clinical efficacy information, please go to the company’s web site.

Images of the KG 1 are available on Flikr, here.

About Kleiner Device Labs
Kleiner Device Labs is creating new tools and devices to advance minimally invasive spine surgery and improve outcomes and costs for patients, surgeons, hospitals and payers. Kleiner Device Labs is headquartered in Incline Village, California. More information is available on the company’s web site at http://www.kleinerlabs.com/.

Lexan is a registered trademark of Sabic Global Technologies B.V.
KG is a registered trademark of Kleiner Device Labs/Spinal Surgical Strategies

¹Kleiner, et. al., Med Devices and Tech, 2016

Media and Investor Contact:
Brad Samson
Kleiner Device Labs
brad.samson@kleinerlabs.com
714.955.3951

SOURCE Kleiner Device Labs

Spine Industry Veteran Paul Graveline Joins Spinal Elements

Posted On January 10, 2018 By OrthoSpineNews In Spine, Top Stories /

January 10, 2018

CARLSBAD, Calif.–(BUSINESS WIRE)–Leading spinal solutions provider Spinal Elements today announced that Paul Graveline has joined the company as its Executive Vice President and Chief Commercial Officer. In his new role, Mr. Graveline will have responsibility for all of the commercial efforts of Spinal Elements.

“Paul is very well known in our industry and has a tremendous depth of experience in building and leading organizations,” said Jason Blain, President and CEO of Spinal Elements. “His leadership and experience will be an invaluable addition to our efforts as Spinal Elements continues to grow both in the United States and abroad. We are all very excited to have Paul on the Spinal Elements team.”

Mr. Graveline brings more than 20 years of experience in surgical spine technology. His past positions include Global Vice President of Sales for Zimmer Biomet Spine, Chief Operating Officer for Zimmer Spine, and Vice President of Sales for Stryker Spine.

“This is a talented group of people and the quality of the products is tremendous. With new expandable technologies, an interspinous process device, and a differentiated lateral access platform all launching this year, this is an exciting time to join Spinal Elements,” said Graveline, adding, “The technology we have available today combined with what is in our development pipeline makes this an amazing opportunity to create something special in our industry.”

About Spinal Elements

Spinal Elements is an outcomes-driven spinal surgical solutions company with locations in Carlsbad, CA and Marietta, GA. A leading designer, developer, manufacturer and marketer of innovative medical devices used in spinal surgical procedures, our mission is to combine leading medical device technologies, biologics and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. For more information, please visit www.amendia.com or www.spinalelements.com.

Contacts

for Spinal Elements
Laura Charlton (formerly Johnson)
(760) 450-7749 cell
laurajohnsonpr@yahoo.com

(Photo: Business Wire)

Globus Medical Reports Preliminary Fourth Quarter and Full Year Sales Results

Posted On January 10, 2018 By OrthoSpineNews In Financial /

AUDUBON, Pa., Jan. 09, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced preliminary unaudited sales results for the fourth quarter and full year ending December 31, 2017. The company anticipates fourth quarter 2017 sales of approximately $175.5 million, an increase of 15.8% over the fourth quarter 2016. Full year 2017 estimated sales are expected to be approximately $635.4 million, an increase of 12.7% over the prior year.

“We are very pleased to report record sales of $175.5 million for the fourth quarter, an increase of 15.8% over the fourth quarter of 2016,” said Dave Demski, Globus Medical Chief Executive Officer. “The growth in the quarter was 100% organic, as the anniversary of the Alphatec acquisition occurred in early September. US Spine sales continued the recent trend of mid-single-digit growth and our International business, led by Japan, showed significant improvement with 16.3% year-over-year growth. We are also encouraged by the strong robotic sales that contributed the rest of the growth in the fourth quarter. We are executing well in all aspects of our business and are excited by our prospects for 2018.”

“The recently announced tax legislation will lower our marginal income tax rates, providing additional cash to our business,” said Dan Scavilla, Senior Vice President and Chief Financial Officer, “We have made the decision to reinvest a portion of the anticipated savings by increasing our spending on Emerging Technologies by approximately $14 million in 2018, investing for long-term growth while still providing a meaningful lift in EPS to our shareholders.”

The company established full year 2018 guidance of $690 million in sales and fully diluted non-GAAP earnings per share of $1.50. This EPS guidance assumes a full year benefit of tax reform, renewed suspension of the medical device tax and increased investment in Emerging Technologies.

These preliminary results are unaudited and are based on management’s initial analysis of operations for the periods ended December 31, 2017, and are therefore subject to change. The company expects to announce its fourth quarter and full year 2017 financial and operating results in late February.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal solutions company based in Audubon, PA. The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures. For example, non-GAAP adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, provision for litigation, and acquisition related costs, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense. Provision for litigation represents costs incurred for litigation settlements or unfavorable verdicts when the loss is known or considered probable and the amount can be reasonably estimated, or in the case of a favorable settlement, when income is realized. Acquisition related costs represents the change in fair value of business-acquisition-related contingent consideration; costs related to integrating recently acquired businesses including but not limited to costs to exit or convert contractual obligations, severance, and information system conversion; and specific costs related to the consummation of the acquisition process such as banker fees, legal fees, and other acquisition-related professional fees. Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.

In addition, for the period ended December 31, 2017 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represent net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs and the tax effects of such adjustments. The tax impact of these non-GAAP adjustments is calculated based on the consolidated effective tax rate on a GAAP basis, applied to the non-GAAP adjustments, unless the underlying item has a materially different tax treatment, in which case the estimated tax rate applicable to the adjustment is used. We believe these non-GAAP measures are also useful indicators of our operating performance, and particularly as additional measures of comparative operating performance from period to period as they remove the effects of litigation, amortization of intangibles, acquisition related costs, and the tax effects of such adjustments, which we believe are not reflective of underlying business trends. Additionally, for the periods ended December 31, 2017 and for other comparative periods, we also present the non-GAAP measure of free cash flow, which represents the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment. We believe that this financial measure provides meaningful information for evaluating our overall liquidity for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions. Finally, we utilize the non-GAAP measure of constant currency sales growth, which is calculated by translating current year sales at the same average exchange rates in effect during the applicable prior year period. We believe constant currency sales growth provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth are not calculated in conformity with U.S. GAAP within the meaning of Item 10(e) of Regulation S-K. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP. These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results. Our definitions of non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth may differ from that of other companies and therefore may not be comparable. Additionally, we have recast prior periods for non-GAAP net income and non-GAAP diluted earnings per share.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus Medical products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

Histogenics Corporation Announces Receipt of $10 Million Up-front Payment for Japanese NeoCart Agreement

Posted On January 10, 2018 By OrthoSpineNews In Biologics, Top Stories /

WALTHAM, Mass., Jan. 09, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function, announced that it has received the $10 million up-front payment from MEDINET Co., Ltd. (MEDINET), under the previously announced agreement for the development and commercialization of NeoCart® for the Japanese market. Per the terms of the agreement, the up-front payment was due within ten days of entering into the agreement. Histogenics and MEDINET announced entering into the agreement in December 2017, which included up to $87 million in total milestones and tiered royalties on sales, and a goal of commercializing NeoCart in Japan in 2021, if approved.

“Our partnership with MEDINET for NeoCart is off to a strong start, and we’re pleased to receive the initial $10 million payment. The clinical and operations teams at both companies have initiated work to prepare for the upcoming confirmatory Phase 3 clinical trial in Japan,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “Histogenics is also rapidly evaluating partnerships in other potential regions for NeoCart as part of our strategy to leverage our robust restorative cell therapy platform globally.”

About Histogenics Corporation

Histogenics (Nasdaq:HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use. Histogenics recently completed enrollment of its NeoCart Phase 3 clinical trial and expects to report top-line, one-year superiority data in the third quarter of 2018. NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.

About MEDINET Co., Ltd.

MEDINET is a pioneering leader in the development and commercialization of cancer immuno-cell therapies. MEDINET is also rigorously preparing to enter into the regenerative medical product market to leverage its long clinical and translational medicine history responding to the expected aging of the population. MEDINET went public in October, 2003 on the MOTHERS, Tokyo Stock Exchange. For more information, visit http://www.medinet-inc.co.jp/english/.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; NeoCart’s regulation as a Regenerative Medical Product; the market size and potential patient population in Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2016 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2017, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC’s website at www.sec.gov. Additional factors may be set forth in those sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017, to be filed with the SEC in the first quarter of 2018. In addition to the risks described above and in Histogenics’ annual report on Form 10-K and quarterly reports on Form 10-Q, current reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein. Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf. The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

K2M Group Holdings, Inc. Reports Preliminary Fourth Quarter and Full Year 2017 Financial Results

Posted On January 9, 2018 By OrthoSpineNews In Financial /

LEESBURG, Va., Jan. 08, 2018 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (NASDAQ:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today announced preliminary financial results for the fourth quarter and full year ended December 31, 2017.

Fiscal Year 2017 Financial Summary:

• Full year 2017 revenue of $257.5 million to $258.1 million, up approximately 9% year-over-year on a reported and constant currency basis
• The Company continues to expect full year 2017 net loss and Adjusted EBITDA will be within the range of its previously provided guidance

Fourth Quarter Revenue Summary:

• Total Q4 revenue of $67.3 million to $67.9 million, up approximately 9% to 10% year-over-year, or 8% to 9% on a constant currency basis

Domestic Q4 revenue of $51.7 million to $52.0 million, up approximately 9% year-over-year, comprised of:
– U.S. Complex Spine growth of approximately 8% year-over-year
– U.S. Minimally Invasive Surgery (MIS) growth of approximately 15% year-over-year
– U.S. Degenerative growth of approximately 8% year-over-year
International Q4 revenue of $15.6 million to $15.9 million, up approximately 11% to 13% year-over-year, or 8% to 10% on a constant currency basis

“Our preliminary financial results for calendar year 2017 reflect total revenue growth of approximately 9% year-over-year, above the high-end of our guidance range,” said Chairman, President, and Chief Executive Officer, Eric Major. “We delivered approximately 9% growth in the U.S. in 2017—well above-market growth rates—driven by solid execution against our strategic goal of increasing market share by introducing new and innovative spinal implant solutions and expanding our distribution footprint. We have supplemented this organic growth activity with exciting product introductions in both the complex spine and degenerative categories. Looking out to 2018, we are excited about the opportunity of our first-of-its-kind MOJAVE™ PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology™ and our YUKON™ OCT Spinal System that can be used with the PALO ALTO^® Cervical Static Corpectomy Cage System, the first and only static corpectomy cage in the world to receive a cervical 510(k) clearance. We also announced an important strategic collaboration with Brainlab, one of the world’s leading imaging and navigation companies, that we believe will represent additional implant sales opportunities in the second half of 2018. Our Brainlab collaboration will complement our recent launches of the BACS® platform and the EVEREST® Minimally Invasive XT Spinal System.”

Mr. Major continued, “We remain confident in our ability to drive above-market growth in the U.S., fueled by our continued focus on leading the spine market by introducing new and innovative spinal implant solutions to help surgeons care for patients around the world who suffer from debilitating spinal pathologies. We expect our revenue to increase 9%–10% in 2018 with improved profitability.”

The financial estimates presented above are preliminary and remain subject to management’s final review as well as audit by the Company’s independent registered public accounting firm. The Company intends to report complete fourth quarter and full-year 2017 financial results in late February. Details regarding the timing of the release of those results, as well as details of a conference call and publicly available webcast, will be announced in a subsequent press release.

About K2M

K2M Group Holdings, Inc. is a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance. Since its inception, K2M has designed, developed, and commercialized innovative complex spine and minimally invasive spine technologies and techniques used by spine surgeons to treat some of the most complicated spinal pathologies. K2M has leveraged these core competencies into Balance ACS^®, a platform of products, services, and research to help surgeons achieve three-dimensional spinal balance across the axial, coronal, and sagittal planes, with the goal of supporting the full continuum of care to facilitate quality patient outcomes. The Balance ACS platform, in combination with the Company’s technologies, techniques and leadership in the 3D-printing of spinal devices, enable K2M to compete favorably in the global spinal surgery market. For more information, visit www.K2M.com and connect with us on Facebook, Twitter, Instagram, LinkedIn and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance. Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects. In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words. Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payers; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible senior notes and our credit facility; continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on November 1, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements. These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

We operate in a very competitive and challenging environment. New risks and uncertainties emerge from time to time, and it is not possible for us to predict all risks and uncertainties that could have an impact on the forward-looking statements contained in this release. We cannot assure you that the results, events and circumstances reflected in the forward-looking statements will be achieved or occur, and actual results, events or circumstances could differ materially from those described in the forward-looking statements.

The forward-looking statements made in this press release relate only to events as of the date on which the statements are made. We undertake no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as required by law. 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. Unless specifically stated otherwise, our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make.

Spine Surgery Products Market to Reach USD $16.7 Billion by 2025, Globally: Transparency Market Research

Posted On January 9, 2018 By OrthoSpineNews In Spine, Top Stories /

ALBANY, New York, January 9, 2018 /PRNewswire/ —

The global Market for Spine Surgery Product was valued at USD 10.2 billion in 2016 and is estimated to reach USD 16.7 billion by 2025 at a CAGR of 5.8% from 2017 to 2025.

Spinal fusion products are used in spinal fusion surgery. The products are involved in removing the damaged disc and replacing it with any fusion products. Non-fusion products are used during spine surgery, which are implanted to treat spine conditions. This also allows the patient to retain its movement and flexibility. The non-fusion products are becoming the treatment of choice, especially for the younger, more active patient. Increase in number of spine surgeries, rise in use of bone grafts and bone morphogenetic proteins in spinal fusion surgery, growing number of spinal surgeries using electrical stimulation devices such as inductive coupling devices, captive coupling devices and other implants drives the market growth rate by 2025.

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The global spine surgery product market is categorized based on product, application, and by end user. Based on product, the markets are further classified into fusion products {cervical fusion, interbody fusion, spinal fixation, minimally invasive surgical (MIS) devices, spine biologics (demineralized bone matrix, synthetic bone graft substitutes)}; non fusion products (motion preservation, spine stimulators, and vertebral compression fracture (VCF) devices). Fusion product was a major product of segment in the spine surgery product market, which is attributed to treatment in cervical and lumbar surgery. Increase in production of regenerative healing products by companies expands its presence in spinal surgery, orthopedic trauma and dental treatments which is likely to boost the segment growth during forecast period. Commercialization of minimal invasive surgery devices in Asia Pacific countries is likely to boost the fusion product segment growth in the near future. Minimally invasive surgery devices is widely used for spine surgeries as the devices are less expensive and factors such as quicker recovery after surgery, less post-operative pain, and smaller incisions makes minimally invasive surgery as an attractive option among patients and is likely to boost the growth rate of the segment by 2025.

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Based on application, the market is segmented into vertebral fracture repair, spinal fusion, and others. Vertebral fracture repair segment is accounted to hold the largest market share in 2016, due to increase in number of spine surgeries, number of incidence of vertebral fractures, spondylitis, motor vehicle collisions, etc. is expected to drive the segment growth. Demand for spinal fusion in emerging markets such as Asia Pacific and Latin America is projected to propel the segment growth rate between 2017 and 2025. The spinal fusion segment is likely to account for second highest share by 2025 due to rise in spinal surgeries for tumors, disc degenerative problems, scoliosis, fractures, etc. According to Journal of Spine, 2017, about 75% of cases of spinal stenosis occur in the low back (lumbar spine). This causes pressure on the spinal cord and nerves; however, increasing adoption of spine biologics products, fixation devices and other use of MIS devices are likely to expand the segment growth rate and market attractiveness from 2017 to 2025. By end user, the market are further segmented into hospitals, ambulatory surgical centers, and others. The hospitals segment dominated the spine surgery product market in 2016, and is expected to continue to dominate the market by 2025.

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Increasing investments of manufacturers on the development of new spine products for spine surgery and demands for physicians for robotic system, are the drivers responsible for the remarkable market growth of the segment. Furthermore, product availability, storage capability, reimbursement of treatment cost, and increase in the number of hospitals are expected to propel the segment during the forecast period.

The major players in the spine surgery product are – Stryker, Medtronic, Zimmer Biomet, Globus Medical, K2M, NuVasive, Aesculap Implant Systems, LLC (B. Braun Company), RTI Surgical, Inc., Alphatec Holdings, Inc., Orthofix International N.V., DePuy Synthes, and others

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Orthofix Announces Preliminary 2017 Fourth Quarter and Full Year Net Sales Results

Posted On January 9, 2018 By OrthoSpineNews In Financial /

January 09, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and value-added services, today announced preliminary unaudited fourth quarter 2017 net sales of approximately $117 million. These preliminary results represent reported sales growth of 7.7% and constant currency sales growth of 6.1% over the fourth quarter 2016. For the full year 2017, preliminary unaudited net sales were approximately $434 million, an increase of 5.9% on a reported basis and 5.5% on a constant currency basis over the full year 2016.


	Three Months Ended December 31,
(Unaudited, U.S. Dollars, in millions)	2017		2016		Reported Change			Constant Currency Change
BioStim	$	49.8	$	47.8		4.1	%		4.1	%
Extremity Fixation		29.1		26.8		8.4	%		2.2	%
Spine Fixation		21.2		18.7		13.5	%		13.2	%
Biologics		16.8		15.2		10.7	%		10.7	%
Total net sales	$	116.9	$	108.5		7.7	%		6.1	%


	Year Ended December 31,
(Unaudited, U.S. Dollars, in millions)	2017		2016		Reported Change			Constant Currency Change
BioStim	$	185.9	$	176.6		5.3	%		5.3	%
Extremity Fixation		103.2		102.7		0.5	%		(0.9)	%
Spine Fixation		82.0		72.6		12.8	%		12.7	%
Biologics		62.7		57.9		8.3	%		8.3	%
Total net sales	$	433.8	$	409.8		5.9	%		5.5	%

As of December 31, 2017, cash and cash equivalents were approximately $81 million compared to $40 million as of December 31, 2016.

“In 2017 our strategy was to accelerate our organic topline growth rate while maintaining Adjusted EBITDA margins. This strategy proved very effective and resulted in us far exceeding our growth expectations for the year. Now as we look forward to 2018 and beyond, we are focused on continuing our organic growth momentum, expanding margins and actively pursuing value-accretive inorganic opportunities to further accelerate growth,” said Brad Mason, President and Chief Executive Officer.

“The keys to maintaining our organic sales momentum are, first and foremost, continuing our initiatives to further engage our legacy sales force and add new representation in under-served markets. The second key is to remain committed to investing in R&D and our rapid pace of new product introductions and value-added processes and services, such as our STIM onTrack^™mobile app and JuniOrtho™ pediatric care support tools. Lastly, we must educate physicians and payers through published, peer-reviewed research papers that demonstrate the safety, efficacy and cost-effectiveness of our products.

“While 2017 was a year to invest in accelerating our top-line growth rate, we can now return our focus to Adjusted EBITDA margin expansion. Our biggest opportunity is in gross margins, particularly around improving inventory and instrument set management in our Spine and Extremity Fixation businesses. We also expect to begin to realize the cost benefits of our restructuring initiatives as well as benefit from leveraging our fixed costs in SG&A.

“Lastly, Orthofix is very well positioned to grow through the acquisition of products, technologies and companies. In addition to our strong balance sheet and free cash flow, we have an experienced and proven management team, a global footprint and a reconstructed infrastructure on which to build. We have been and will remain very active in pursuing opportunities of all sizes that will drive shareholder value. However, we will remain disciplined in our investment decisions, focusing on strategic fit, near-term cash EPS accretion and ROIC.

“We are pleased with our positioning going into 2018 and optimistic about our ability to drive shareholder value for the foreseeable future.”

2018 Outlook

For the full year 2018, the Company expects to report net sales of $450 million to $455 million based on current foreign exchange rates, which reflects reported growth of approximately 4% to 5%. This guidance includes a positive currency impact of approximately $4.0 million, offset by an estimated $4.0 million decrease in the 2018 marketing services fee the Company receives from MTF Biologics. This decrease is due to the final contractual step-down in the fee that Orthofix receives from MTF Biologics for our sales of Trinity ELITE^® and Trinity Evolution^®from 65% to 60%. This change, effective March 2018 in accordance with the terms of our amended 2008 agreement with MTF Biologics, coincides with the expiration of a corresponding royalty payment on our net sales of Trinity ELITE and Trinity Evolution that Orthofix currently pays to a third party. The expiration of the royalty payment substantially offsets the impact of the fee reduction to Operating Income and Adjusted EBITDA.

This 2018 net sales guidance reflects the new required revenue recognition standard that is required as of January 1, 2018. One of the primary impacts of this new standard is the timing of revenue recognition for our sales to stocking distributors that were historically accounted for using the sell-through method. This revenue will now be recorded on invoiced sales instead of deferring recognition until cash is received. While we expect that the new revenue recognition standard will provide a materially consistent revenue result on an annual basis as compared to our current revenue recognition policies, there may be some variability on a quarterly basis.

U.S. Tax Changes – Estimated Impact

The recent lowering of the U.S. corporate tax rate from 35% to 21% requires a revaluation of our U.S. deferred tax assets and liabilities. The Company expects to recognize a one-time, non-cash tax charge of $8 million – $12 million in the fourth quarter of 2017 related to this change. The new U.S. tax legislation is subject to a number of complex provisions, which we are currently reviewing. We will provide an update when we announce our fourth quarter and full year 2017 financials.

Upcoming Presentations / Conference Calls

As previously announced, the Company’s President and Chief Executive Officer, Brad Mason, will provide an investor presentation at 8:30 a.m. Pacific Time on Thursday, January 11, 2018, at the J.P. Morgan Healthcare Conference in San Francisco. A live audio webcast will be available on the Company’s website at www.orthofix.com by clicking on the Investors tab and then clicking the link on the Events and Presentations page.

The Company also expects to host a conference call in late February to discuss final fourth quarter and full year 2017 financial results and further discuss our outlook for 2018.

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.

Adjusted EBITDA

Adjusted EBITDA (earnings before interest income (expense), net; income tax expense; and depreciation and amortization) is a non-GAAP financial measure, which is calculated by adjusting EBITDA by certain items such as share-based compensation, foreign exchange impact, strategic investments, SEC/FCPA matters and related costs, infrastructure investments, legal judgments/settlements, charges related to U.S. Government resolutions, restructuring, succession charges and long-term income tax rate.

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.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.

The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to: the expected sales of our products, including recently launched products; the geographic concentration of certain of our sales and accounts receivable in countries or territories that are facing severe fiscal challenges; unanticipated expenditures; changing relationships with customers, suppliers, strategic partners and lenders; changes to and the interpretation of governmental regulations; risks relating to the protection of intellectual property; changes to the reimbursement policies of third parties; the impact of competitive products; changes to the competitive environment; the acceptance of new products in the market; conditions of the orthopedic and spine industry; credit markets and the global economy; corporate development and market development activities, including acquisitions or divestitures; unexpected costs or operating unit performance related to recent or future acquisitions; and other risks described in the “Risk Factors” section of our 2016 Annual Report on Form 10-K, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

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

Wright Medical Group N.V. Announces Preliminary Fourth Quarter and Full-Year 2017 Net Sales

Posted On January 9, 2018 By OrthoSpineNews In Financial /

AMSTERDAM, The Netherlands, Jan. 08, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced preliminary, unaudited fourth quarter and full-year 2017 net sales results. Unless otherwise noted, all net sales growth rates in this release are stated on a constant currency basis, which includes the benefit of the extra four business selling days in the fourth quarter of fiscal year 2017.

The company expects net sales for the fourth quarter of 2017 to be approximately $217.6 million, representing growth of 12.7% as reported and 11.2% on a constant currency basis, including the benefit from the extra four business selling days, which the company estimates to be approximately 4.5%. For the full-year 2017, the company expects net sales to be approximately $745.0 million, representing growth of approximately 8% as reported and on a constant currency basis, including the extra four business selling days. These preliminary, unaudited financial results for the quarter and year ended December 31, 2017 are based on current expectations and are subject to quarter-end closing adjustments; actual results may differ.

Robert Palmisano, president and chief executive officer, commented, “Our preliminary fourth quarter results represent an outstanding performance in our U.S. upper extremities business. This performance was driven by the launch of our PERFORM Reversed glenoid and continued contribution from our SIMPLICITI shoulder system. We anticipate that our ongoing PERFORM Reversed launch and accelerating adoption of the recently acquired BLUEPRINT enabling technology will continue to drive strong shoulder sales growth in 2018.”

Palmisano further commented, “As anticipated, we did not see any benefit in the fourth quarter in our U.S. lower extremities business from the sales force expansion. Additionally, we had some supply constraints primarily related to a third-party coating vendor in the fourth quarter, which we believe have been addressed. However, this affected our total ankle business during the fourth quarter. As previously discussed, we will continue to focus on improving our execution and building our physician relationships to restore growth in our core U.S. lower extremities business and expect to see improvement in 2018 as our larger sales footprint, new products, new reps and expanding relationships begin to take effect.”

Wright plans to report its full financial results and provide more detail for its fourth quarter and full-year 2017 financial results, as well as issue its 2018 financial guidance, after the market closes on Tuesday, February 27, 2018, to be followed by its quarterly conference call at 3:30 p.m. Central Time that day.

Wright Medical to Present Today at J.P. Morgan Healthcare Conference

Wright’s management will present today, January 8, 2018, at the J.P. Morgan Healthcare Conference at 7:30 a.m. Pacific Time. A live audio webcast of the conference presentation and the Q&A session, along with the accompanying presentation materials, will be available on Wright’s corporate website at www.wright.com, under the “Investors” link. The presentation materials, as well as the reconciliations of its non-GAAP financial measures, will be posted prior to the presentation as soon as practicable after the issuance of this press release. The audio webcast and accompanying presentation materials will be archived on this site under the “Investor Presentations” link following the conference.

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.

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. The company’s management believes that the presentation of these measures provides useful information to investors. 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,” “could,” “may,” “will,” “believe,” “estimate,” “continue,” “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, the preliminary and unaudited net sales results for fourth quarter and full year of 2017 and statements about the company’s anticipated strong shoulder sales growth in 2018 and anticipated improvement in 2018 as its larger sales footprint, new products, new reps and expanding relationships begin to take effect. 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, risks that Wright’s final net sales results will deviate from the preliminary, unaudited net sales results in this release; the failure of the company’s recent U.S. sales force addition; continued supply constraints; focus on core product portfolio and incentives to drive U.S. lower extremities and biologics sales or delay in realization thereof; 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 the subsequent metal-on-metal settlement agreements and ability to obtain the additional new insurance proceeds contingent thereon; 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 subsequent SEC filings by Wright, including its Quarterly Report on Form 10-Q for the quarter ended September 24, 2017 filed by Wright with the SEC on November 2, 2017. 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. Consolidated Sales Analysis (dollars in thousands–unaudited)

	Three months ended						Fiscal year ended
	December 31, 2017		December 25, 2016		% change		December 31, 2017		December 25, 2016		% change
U.S.
Lower extremities	66,816		64,064		4.3	%	228,044		222,936		2.3	%
Upper extremities	71,685		55,462		29.3	%	239,965		201,579		19.0	%
Biologics	21,814		21,436		1.8	%	78,361		74,603		5.0	%
Sports med & other	2,242		2,103		6.6	%	8,141		8,429		(3.4	)%
Total U.S.	$	162,557	$	143,065	13.6	%	$	554,511	$	507,547	9.3	%

International
Lower extremities	16,101		16,717		(3.7	)%	58,473		62,701		(6.7	)%
Upper extremities	28,093		24,261		15.8	%	94,699		86,502		9.5	%
Biologics	6,784		5,079		33.6	%	22,276		18,883		18.0	%
Sports med & other	4,067		3,901		4.3	%	15,030		14,729		2.0	%
Total International	$	55,045	$	49,958	10.2	%	$	190,478	$	182,815	4.2	%

Global
Lower extremities	82,917		80,781		2.6	%	286,517		285,637		0.3	%
Upper extremities	99,778		79,723		25.2	%	334,664		288,081		16.2	%
Biologics	28,598		26,515		7.9	%	100,637		93,486		7.6	%
Sports med & other	6,309		6,004		5.1	%	23,171		23,158		0.1	%
Total sales	$	217,602	$	193,023	12.7	%	$	744,989	$	690,362	7.9	%


Wright Medical Group N.V. Supplemental Net Sales Information (unaudited)

	Three months ended December 31, 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	%	(9	%)	(4	%)	2	%	3	%
Upper extremities	29	%	9	%	16	%	23	%	25	%
Biologics	2	%	30	%	34	%	7	%	8	%
Sports med & other	7	%	(3	%)	4	%	0	%	5	%
Total net sales	14	%	4	%	10	%	11	%	13	%


	Fiscal year ended December 31, 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	%)	(7	%)	0	%	0	%
Upper extremities	19	%	8	%	9	%	16	%	16	%
Biologics	5	%	17	%	18	%	8	%	8	%
Sports med & other	(3	%)	2	%	2	%	0	%	0	%
Total net sales	9	%	4	%	4	%	8	%	8	%

Investors & Media:

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

Wright Medical Group N.V.

MiMedx Releases Preliminary 2017 Revenue of $324.5 Million representing a 32% increase over 2016

Posted On January 9, 2018 By OrthoSpineNews In Financial /

MARIETTA, Ga., Jan. 7, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, today announced preliminary record revenue results for the fourth quarter and full-year 2017 and revenue expectations for the first quarter of 2018.

Fourth Quarter 2017 Revenue Highlights

Q4 2017 revenue of $90.9 Million grew 30% over Q4 2016 revenue and exceeded upper end of guidance by nearly $3 million
Excluding divested subsidiary, Stability Biologics, Q4 2017 revenue grew by 34% over Q4 2016
Q4 2017 Wound Care revenue grew 27% over Q4 2016
Surgical, Sports Medicine and Orthopedics (SSO) revenue for Q4 2017 grew 40% over Q4 2016

Full-Year 2017 Revenue Highlights

Full-year 2017 revenue of $324.5 million increased 32% over full year 2016 and exceeded upper end of guidance
Excluding divested subsidiary, Stability Biologics, full-year 2017 revenue grew by 36% over 2016
Full-year 2017 Wound Care revenue of $238.3 million increased by 30% over 2016
Full-year 2017 SSO revenue of $86.2 million grew 41% over 2016

The Company recorded preliminary record revenue for the year ended December 31, 2017 of $324.5 million, a $79.5 million or 32% increase over 2016 revenue of $245.0 million. The Company recorded record revenue for the 2017 fourth quarter of $90.9 million, a $21.0 million or 30% increase over 2016 fourth quarter revenue of $69.9 million.

Management Commentary
Parker H. “Pete” Petit, Chairman and CEO stated, “The fourth quarter of 2017 makes 28 consecutive quarters of sequential revenue growth and 27 of 28 quarters of meeting or exceeding our revenue guidance. At the end of November, we expected we would exceed our revenue forecast for the quarter, as we indicated in our press release on November 30, 2017. We forecasted December to be a solid growth month, and our sales force more than lived up to our expectations with a robust month to close out the year. We are entering 2018 with strong momentum that should produce an exciting 2018.”

Bill Taylor, President and COO, noted, “Contributing to our accelerating sales momentum is the market growth we have achieved with our refined territory analytics for the larger markets and our effective secondary market strategy. The significant prospects for Venous Leg Ulcer (VLU) reimbursement coverage being added during 2018 as a result of the publication of the compelling results confirming the clinical efficacy of EpiFix® in the treatment of VLUs, will further fuel this momentum. As we stated earlier, with our current breadth of commercial carrier reimbursement coverage primarily for Diabetic Foot Ulcers (DFUs), we expect our 2018 Wound Care growth to be aided by our ability to ultimately achieve over 100 million additional commercial lives having EpiFix coverage for the treatment of VLUs.”

“Both of our sales verticals had strong performances during the fourth quarter. Wound Care performed extremely well in the fourth quarter with 27% growth over the prior year’s fourth quarter, and SSO revenue grew significantly over 2016 with 40% quarter over quarter growth. Fourth quarter revenue from our direct sales force represented approximately 95% of total revenue, and revenue from distributors and Original Equipment Manufacturers (OEMs) accounted for less than 5% of total fourth quarter revenue,” Taylor added.

Speaking to the Company’s cash performance, Petit noted, “The fourth quarter was another quarter of very strong cash flow from operations. We are very pleased with the sustained progress we have made in this important measure of our operating effectiveness.”

“We anticipate 2018 to be another year of highly predictable quarter over quarter revenue growth, continued strengthening of our balance sheet and cash position, and significant gains in profitability. Shareholders should be reminded that the 2017 numbers reported in this press release are preliminary numbers based on management’s best estimates, and we look forward to our planned press release on February 23, 2018 detailing our 2017 financial results. We also plan to host our standard live broadcast of our 2017 financial results on February 23, 2018,” concluded Petit.

First Quarter and Full Year 2018 Guidance Highlights
The Company announced its revenue guidance for the first quarter of 2018 as follows:

First quarter of 2018 revenue forecasted to be in the range of $90.5 to $92.0 million

MiMedx reiterated its full year 2018 guidance that was previously communicated by the Company on December 13, 2017, which included:

Revenue estimated between $383 to $387 million
Gross profit margins expected to be in the range of 89% to 90%
Operating Income expected to be in the range of 15% to 17%
GAAP Diluted EPS projected to be in the range of $0.30 to $0.35
Adjusted Diluted EPS* projected to be in the range of $0.45 to $0.50
*Adjusted Diluted Net Income per share consists of GAAP net income excluding: (i) one time acquisition related costs, (ii) amortization of inventory fair value step-up, (iii) amortization of intangible assets, (iv) share-based compensation (v) gain on divestiture and (vi) the normalization of tax expense.

The guidance above does not reflect the impact of changes in the federal tax code. Those changes, if any, will be released with the release of full year operating results.

Share Repurchase Program
The Company provided an update to its Share Repurchase Program that was initiated in May 2014. MiMedx reported that since inception, the Company’s Board of Directors has authorized $130 million in share repurchases. To date, the amount of shares purchased through the Share Repurchase Program is $124.2 million, and these repurchased shares represent in excess of 10% of the Company’s total diluted shares outstanding.

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself. We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement
This press release includes forward-looking statements, including statements regarding future levels of revenues, gross profit margin, operating income, GAAP diluted EPS and adjusted diluted EPS; our expectations regarding the timing and amount of additional covered insured lives for EpiFix for VLUs and DFUs; our expectation that Wound Care revenues will grow in 2018 and be aided by additional insured lives, and our expectations regarding continued strengthening of our balance sheet, cash position, and profitability. These statements also may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and we caution investors against placing undue reliance on such statements. Actual results may differ from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that we will not achieve forecast revenue, profit margin, operating income, or EPS due to slower growth, higher expenses, or other factors; third-party insurers may choose not to cover, or may be slower to decide to cover, additional insured lives for the use of EpiFix to treat VLUs and DFUs; and that changes to regulation or regulatory interpretations may adversely affect the sale and marketing of our products. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission. Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Month: January 2018

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