Special Protein in Zebrafish May Lead to Full Spinal Cord Repair

Nov 04, 2016 – By Rhenn Anthony Taguiam

 

Researchers have discovered that zebrafish — the two-buck wonders in pet stores — may actually hold the key to do full spinal cord repair. It seems the zebrafish is capable of healing a completely severed spinal cord with special proteins.

An injury of this kind in humans can be paralyzing and can even lead to fatal conditions.

Researchers from Duke University have discovered that zebrafish possess a special protein that allows them to heal their severed spine. According to Medical Xpress, the study, published in Science, could lead to developments in tissue repair in humans.

Duke University’s Kenneth Poss claimed this is one of “nature’s most remarkable feats of regeneration.” This is because its potential implications and usage in the world of medicine is astounding. There are currently very limited methods of tissue repair, and animals like zebrafish may hold the key.

A zebrafish’s severed spinal cord forms a literal “bridge” that connects the gap in the injury. Cells form and extend to distances 10 times their own length to heal themselves. By eight weeks, the animals may have already fully reversed their paralysis.

Poss and his team conducted “molecular fishing” to find out which genes are responsible for such activity. It appears the CTGF or the connective tissue growth factor increases while the supporting cells appear to repair the injury.

 

READ THE REST HERE

 

 

Spine Implants Market in the US 2016-2020; New Report Launched

Bangalore, Karnataka — (SBWIRE) — 11/04/2016 — The spine implants help in correcting deformities of the spine and restoring the function of the spine. Some of the conditions that require the use of spine implants are spondylolisthesis, chronic degenerative disc diseases (DDDs), traumatic fracture, and other forms of spinal instability including scoliosis. These implants are mainly composed of titanium, stainless steel, polyether ether ketone (PEEK), carbon fiber, and other bio-absorbable materials.

Report forecast the spine implants market in the US to grow at a CAGR of 5.29% during the period 2016-2020.

The report covers the present scenario and the growth prospects of the spine implants market in the US for 2016-2020. To calculate the market size, the report considers the revenue generated from the sales generated from the sales of spine implants.

Spine Implants Market in the US 2016-2020, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

Key vendors
– Medtronic
– DeBuy Synthes
– Stryker
– NuVasive

Other prominent vendors
– AccelSPINE (CTL Medical Group)
– AESCULAP
– Alliance Spine
– Alphatec Spine
– Amedica Corporation
– Globus Medical
– K2M
– LDR
– Life Spine
– Orthofix International
– Paradigm Spine
– Precision Spine
– RTI Surgical
– Spine Surgical Innovations
– Spineology
– Titan Spine
– TranS1
– Wenzel Spine
– Zimmer Biomet
– Zyga Technology

Market driver
– Increasing prevalence of spinal disorders such as spinal stenosis
– For a full, detailed list, view our report

Market challenge
– Lack of product differentiation
– For a full, detailed list, view our report

Market trend
– Emerging motion preservation technology (non-fusion)
– For a full, detailed list, view our report

Key questions answered in this report
– What will the market size be in 2020 and what will the growth rate be?
– What are the key market trends?
– What is driving this market?
– What are the challenges to market growth?
– Who are the key vendors in this market space?
– What are the market opportunities and threats faced by the key vendors?
– What are the strengths and weaknesses of the key vendors?

Spanning over 80 pages “Spine Implants Market in the US 2016-2020” report covers Executive summary, Scope of the report, Market research methodology, Introduction, Market landscape, Market segmentation by product, Market segmentation by procedure, Market segmentation by end-user, Market drivers, Impact of drivers, Market challenges, Impact of drivers and challenges, Market trends, Vendor landscape, Key vendor analysis, Appendix.

For more information Visit at: http://www.drugpipeline.net/technavio/spine-implants-market-us-2016-2020

About DrugPipeline.net
DrugPipeline.net is a market research reports distribution platform which hosts research reports from all leading global market research firms related to pharma industry. It also assist decision makers locate the right market research solution from a single place.

ConforMIS Reports Third Quarter 2016 Financial Results

BEDFORD, Mass., Nov. 03, 2016 (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 third quarter ended September 30, 2016.

Q3 Summary:

  • Total revenue of $18.6 million, up 34% year-over-year on a reported basis and up 35%  year-over-year on a constant currency basis.
  • Product revenue of $18.4 million, up 36% year-over-year on a reported basis and up 37% year-over-year on a constant currency basis
    • U.S. product revenue increased 43% year-over-year
    • Rest of World product revenue increased 14% year-over-year on a reported basis and 18% year-over-year on a constant currency basis

“We had a solid third quarter of 2016,” said Philipp Lang, MD, MBA, President and Chief Executive Officer of ConforMIS, Inc.  “We saw double digit growth in our base business year-over-year with iTotal CR and our partial knee systems. The revenue growth for our newest product, iTotal PS, has been impressive. This innovative product approximately triples the addressable market for ConforMIS and is rapidly becoming our flagship product for new surgeon acquisition.”

Dr. Lang continued, “We have completed enrollment in our single timepoint study comparing iTotal CR to leading off-the-shelf implants in over 800 patients. The results to-date show that patients that received an iTotal CR implant were significantly faster at completing three functional tests of daily living, including walking, than patients with an off-the-shelf implant. We believe that this and other direct comparative studies will help us increase the utilization of our implants with current and new surgeons.”

Third Quarter 2016 Financial Results

  Three months ended September 30, Increase/decrease
($, in thousands)   2016     2015    $
Change
%
Change
%
Change
         (as reported)  (constant currency)
United States $ 14,954   $ 10,466   $ 4,488     43 %   43 %
Rest of world   3,446     3,024     421     14 %   18 %
Product revenue   18,400     13,490     4,910     36 %   37 %
Royalty revenue   243     404     (161 )   -40 %   -40 %
Total revenue $ 18,643   $ 13,894   $ 4,749     34 %   35 %
           

Total revenue increased $4.7 million to $18.6 million, or 34% year-over-year on a reported basis and 35% year-over-year on a constant currency basis, as compared to the third quarter of 2015, which was affected by our product recall. Total revenue in the third quarter of 2016 included royalty revenue of $0.2 million as compared to $0.4 million in the third quarter of 2015.

Product revenue increased $4.9 million to $18.4 million, or 36% year-over-year on a reported basis and 37% year-over-year on a constant currency basis. U.S. product revenue increased $4.5 million to $15.0 million, or 43% year-over-year, and Rest of World product revenue increased $0.4 million to $3.4 million, or 14% year-over-year on a reported basis and 18% on a constant currency basis. Product revenue from sales of iTotal CR, iDuo and iUni increased $1.7 million to $14.4 million, or 13% year-over-year on a reported basis and 14% year-over-year on a constant currency basis. Product revenue from sales of iTotal PS increased $3.2 million to $4.0 million, or 401% year-over-year on a reported basis and 403% year-over-year on a constant currency basis.

Gross profit increased $3.2 million to $6.0 million, or 32% of revenue, which included $1.3 million in unused product, in the third quarter of 2016, compared to $2.8 million, or 20% of revenue, which included $0.8 million in unused product, in the third quarter of 2015. This increase in gross profit was driven primarily by higher product revenue in 2016 compared to 2015.

Total operating expenses decreased $0.1 million to $18.9 million, or 0.4% year-over-year. The decrease in expenses was driven primarily by lower sales and marketing costs and lower general and administrative costs, offset by slightly higher research and development costs compared to the third quarter of 2015.

Net loss was $12.8 million, or $0.31 per basic share, in the third quarter of 2016, compared to a net loss of $17.1 million, or $0.45 per basic share, for the same period last year. This decrease in net loss was driven primarily by higher product revenue in 2016 compared to 2015.

As of September 30, 2016, the Company’s cash and cash equivalents and short and long-term investments totaled $75.8 million, compared to $117.2 million as of December 31, 2015.

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 5481072 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 500 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, operating trends, the potential impact and advantages of using customized implants, 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 sales, expenses, and other results of operations, growth in our customer base, the impact of the CJR program, contracting trends, the impact of our voluntary recall on financial results 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
(in thousands, except share and per share data)
                     
              Three Months Ended September 30, Nine Months Ended September 30,
                2016     2015     2016     2015  
                     
Revenue            
  Product   $ 18,400   $ 13,490   $ 57,486   $ 43,953  
  Royalty       243     404     740     3,863  
Total revenue   18,643     13,894     58,226     47,816  
Cost of revenue   12,645     11,132     39,564     32,371  
  Gross profit   5,998     2,762     18,662     15,445  
                     
Operating expenses        
  Sales and marketing   9,301     9,433     31,063     27,584  
  Research and development   4,099     3,885     12,474     12,218  
  General and administrative   5,503     5,656     17,285     16,790  
                     
    Total operating expenses   18,903     18,974     60,822     56,592  
Loss from operations   (12,905 )   (16,212 )   (42,160 )   (41,147 )
                     
Other income and expenses        
  Interest income   127     24     409     92  
  Interest expense   (4 )   (911 )   (104 )   (1,380 )
  Other income (expense)   34         34     208  
    Total other expenses   157     (887 )   339     (1,080 )
Loss before income taxes   (12,748 )   (17,099 )   (41,821 )   (42,227 )
  Income tax provision   14     8     27     29  
                     
Net loss     $ (12,762 ) $ (17,107 ) $ (41,848 ) $ (42,256 )
                     
Net loss per share – basic and diluted $ (0.31 ) $ (0.45 ) $ (1.01 ) $ (2.69 )
Weighted average common shares outstanding – basic and diluted   41,682,244     37,933,069     41,332,958     15,688,686  
                         

 

CONFORMIS, INC. AND SUBSIDIARIES
Consolidated Balance Sheets
(in thousands, except share and per share data)
                   
              September 30, 2016   December 31, 2015
               
Assets        (unaudited)    
  Current Assets      
    Cash and cash equivalents $ 34,986     $ 117,185  
    Investments   38,337        
    Accounts receivable, net   13,839       14,867  
    Inventories   11,755       11,520  
    Prepaid expenses and other current assets   2,242       2,451  
      Total current assets   101,159       146,023  
  Property and equipment, net   14,985       10,966  
  Other Assets      
    Restricted cash   300       600  
    Investments   2,497        
    Intangible assets, net   808       995  
    Goodwill   753       753  
    Other long-term assets   29       32  
      Total assets $ 120,531     $ 159,369  
                   
Liabilities and stockholder’s equity      
  Current liabilities      
    Accounts payable $ 4,392     $ 4,718  
    Accrued expenses   6,246       7,811  
    Deferred revenue   305       305  
    Current portion of long-term debt   257       295  
      Total current liabilities   11,200       13,129  
    Other long-term liabilities   166       220  
    Deferred revenue   4,396       4,625  
    Long-term debt         183  
      Total liabilities   15,762       18,157  
Stockholders’ equity      
  Preferred stock, $0.00001 par value:      
    Authorized: 5,000,000 and zero shares authorized at September 30, 2016 and    
        December 31, 2015; no shares issued and outstanding as of September 30, 2016 and December 31, 2015          
  Common stock, $0.00001 par value:      
    Authorized: 200,000,000 shares at September 30, 2016 and December 31, 2015;    
        42,758,693 and 41,110,127 shares issued and outstanding at September, 2016 and December 31, 2015, respectively          
  Additional paid-in capital   472,778       467,075  
  Accumulated deficit   (367,190 )     (325,342 )
  Accumulated other comprehensive loss   (819 )     (521 )
    Total stockholders’ equity   104,769       141,212  
    Total liabilities and stockholders’ equity $ 120,531     $ 159,369  
                   

CONTACT: Investor contact

Oksana Bradley

ir@conformis.com

(781) 374-5598

ConforMIS, Inc

DiscGenics Fortifies its Intellectual Property Portfolio with 9 Additional Patents

SALT LAKE CITY, Nov. 3, 2016 /PRNewswire/ — DiscGenics, Inc. (DiscGenics) announces the allowance of 9 additional patents that expand its intellectual property portfolio within both the U.S. and globally to 24 issued patents. The new patents include 2 in the U.S. and 7 in key European markets.

The patent portfolio provides coverage on its proprietary culture process and novel Discogenic Cell technology that is the therapeutic agent within its first product, Injectable Discogenic Cell Therapy (IDCT). The company is currently in the process of completing its preclinical development and looks forward to initiating initial human clinical trial during 2017 pending regulatory approvals.

About DiscGenics, Inc.

DiscGenics is a privately funded biotechnology company developing advanced spinal stem cell therapeutics to treat patients with diseases of the intervertebral disc. News and other information are available at: http://www.DiscGenics.com.

Media Contact: Bob Wynalek
Chief Operating and Commercialization Officer
801-410-0705
Bob@DiscGenics.com

 

SOURCE DiscGenics, Inc.

Related Links

http://www.discgenics.com

Integra LifeSciences Announces Plans for a Two-For-One Stock Split and Increase in Authorized Shares

PLAINSBORO, N.J., Oct. 27, 2016 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART) today announced that its Board of Directors has recommended an increase in the number of authorized shares and a two-for-one stock split.

“The recommendation from the board of directors acknowledges the inflection point the Company has gone through and demonstrates their confidence in our long-term outlook,” said Peter Arduini, President and Chief Executive Officer, Integra Lifesciences. “This is the first increase in authorized shares in our 20-year history as a public company,” continued Mr. Arduini. “This authorization enhances our capital flexibility and better positions the Company for long-term growth.”

Stockholder approval is required for the proposal to amend the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of common stock from 60,000,000 to 240,000,000 shares for the purpose of, among other things, effecting a two-for-one stock split (the “Amendment”). A special meeting of stockholders is expected to be held on Wednesday, December 21, 2016 at the Company’s Corporate Headquarters, 315 Enterprise Drive, Plainsboro, New Jersey.

If approved, the Company currently anticipates filing the Amendment with the Delaware Secretary of State on December 21, 2016. Holders of shares of the Company’s common stock at the time of the filing of the Amendment with the Delaware Secretary of State will be entitled to receive new shares, which are expected to be distributed on or about January 3, 2017.

Integra LifeSciences does not expect the stock split or increase in authorized shares to have any impact on 2016 financial performance.

About Integra

Integra LifeSciences, a world leader in medical technology, is dedicated to limiting uncertainty for caregivers, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading regenerative technologies, in specialty surgical solutions, orthopedics and tissue technologies.  For more information, please visit www.integralife.com.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties and reflect Integra LifeSciences’ judgment as of the date of this release. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ from predicted results. These risks and uncertainties include market conditions and other factors beyond Integra LifeSciences’ control and the economic, competitive, governmental, technological and other factors identified under the heading “Risk Factors” included in item 1A of Integra LifeSciences’ Annual Report on Form 10-K for the year ended December 31, 2015, and information contained in subsequent filings with the Securities and Exchange Commission could affect actual results. These forward-looking statements are made only as the date thereof, and Integra LifeSciences undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

Contacts:

Integra LifeSciences Holdings Corporation

Investor Relations: 
Angela Steinway
(609) 936-2268
angela.steinway@integralife.com 

Michael Beaulieu
(609) 750-2827
michael.beaulieu@integralife.com

Scientists develop new implant coating derived from mussels

November 2, 2016

A team of Japanese researchers has pioneered a new method for improving the biocompatibility of implant surfaces based on the chemical properties of mussels. The study contributes to a field of research that is exploring the use of proteins to ‘immobilise’, or fix, organic cells to metal surfaces.

The authors, based at the RIKEN research institute, Saitama, Japan, identified the natural adhesive properties of mussels as a potential method for improving attachment to metal surfaces. These molluscs use protein secretions to tightly bond their cells with surfaces, including metallic or ceramic ones, and can retain this grip even when submerged under water. The team identified that advances in controlling gene expression may enable them to activate the binding property of specific proteins, which could then be applied to implant surfaces.

The key chemical in the reaction is dopamine (3,4-dihydroxyphenethylamine) which had not previously been integrated into protein-based growth factors for use on implant surfaces. However, the scientists were concerned that the direct incorporation of such a chemical may compromise the protein’s underlying structure, negating the effect.

An innovative two-stage engineering method was devised by the team to express dopamine in a growth factor. The non-intrusive chemical tyrosine was incorporated into the protein, which was subsequently mixed with the enzyme tyrosinase. Tyrosinase has been used in other research to convert tyrosine into dopamine. In this case, the reaction took place without unsettling the tertiary structure of the protein, and dopamine was safely generated within it – closely matching that of the underwater adhesive secreted by mussels.

The authors tested the chemical by applying it to titanium-coated discs. Titanium is commonly used for many medical devices including dental implants. After applying the modified growth factor, significantly enhanced cell growth was observed on the surface of the discs as well as improved cell binding properties.

This outcome could have an impact on implant procedures, as cells may bond with implant surfaces more easily if they are coated with the treated growth factor. As well as having applications in implant dentistry, the new method for expressing dopamine in growth-factor proteins could be harnessed in regenerative medicine and cell culture systems. The study was published in Angewandte Chemie.

Intellijoint Surgical® Raises $11M to Expand the US Launch of intellijoint HIP®

November 1, 2016 (Waterloo, Ontario) – Intellijoint Surgical®, Inc., an innovative medical technology company that develops and commercializes 3D mini-optical navigation solutions for surgery, is excited to announce the completion of its Series A with $11MM in financing. The Series A was led by private investors from the Waterloo-Toronto corridor and closed in multiple tranches. Intellijoint is committed to improving patient outcomes through innovative technology made accessible for every patient, every surgeon and every healthcare facility.

“The US launch of the next generation intellijoint HIP® earlier this year is being extremely well received in the marketplace and is seeing significant growth,” commented Intellijoint Surgical® CEO and Co-Founder, Armen Bakirtzian. “This Series A capital will allow Intellijoint to enhance its product offering with the Direct Anterior Approach Application and allow for expansion into new US markets while enabling deeper penetration of Intellijoint’s presence in New York and Illinois.”

Intellijoint Surgical’s flagship product, intellijoint HIP®, is a mini-optical navigation solution that assists orthopaedic surgeons in reaching preoperative surgical targets by providing real-time, intraoperative measurements for cup position, leg length, offset and hip center of rotation during a Total Hip Arthroplasty (THA). intellijoint HIP® has been used in over 500 procedures in Canada and US, and is both Health Canada licensed and FDA approved.

“Intellijoint has addressed the shortcoming of traditional navigation. The miniature optical camera provides accurate measurements while compensating for patient movement, which is routine during a total hip replacement. It provides me with valuable information and I choose to use it in every case,” added Dr. Wayne Paprosky, Midwest Orthopaedics at Rush and member of Intellijoint’s scientific medical advisory board.

About Intellijoint Surgical, Inc.

Intellijoint Surgical® develops and commercializes surgical navigation solutions. Intellijoint’s flagship product, intellijoint HIP® provides surgeons with real-time, intraoperative measurements to ensure proper positioning of orthopaedic implants during Total Hip Arthroplasty. Intellijoint is committed to driving clinical results through the development of solutions that are accessible, fast, and easy-to-use. Guided by a scientific advisory board comprised of Dr. Allan Gross, an orthopaedic surgeon at Mount Sinai Hospital, and members, Dr. Javad Parvizi at Thomas Jefferson University Hospital, Dr. Michael Cross at Hospital for Special Surgery, Dr. Wayne Paprosky at Rush University Medical Center, and Dr. Ran Schwarzkopf at NYU School of Medicine, Intellijoint is setting the new standard in miniature 3D surgical navigation.

Intellijoint Surgical has plans to use its core technology to expand into other orthopaedic procedures.

Intellijoint Surgical is the recipient of the 2015 North American Frost & Sullivan Enabling Technology Leadership Award and the Futurpreneur Shopify True Grit Award 2016.

For more information, please visit: www.intellijointsurgical.com

Orthopaedics giant Smith & Nephew to open £8m R&D centre in Hull

3 NOVEMBER 2016 –  By Julia Bradshaw

 

Smith & Nephew, the global medical devices company, will open a state-of-the-art research and development centre in Hull, creating 100 jobs.

Despite the outcome of the EU referendum, the company has decided to invest $10m (£8m) in a brand new European ‘medtech’ centre, to be located in the UK.

The facility will conduct research across all of Smith & Nephew’s divisions, with a focus on wound dressings in particular.

It will employing 100 scientists and other staff, including toxicologists, chemists and engineers. Some will be new roles, while others will be transferred from existing sites in York and the US.

The facility will open in the second quarter of 2017 and chief executive Olivier Bohuon said there would be room to grow the headcount.

He said the orthopaedics giant could have opened the lab anywhere in Europe, but chose the UK.

 

READ THE REST HERE

 

Medovex Corporation Announces Successful Largest Living Tissue Population Test to Date

ATLANTA, GA–(Marketwired – Nov 2, 2016) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that the company conducted a successful live tissue test of the DenerveX™ System under the most stringent standards required by FDA and other regulatory agencies.

Patrick Kullmann, Medovex President and COO, stated, “This latest testing of the DenerveX System is the largest living tissue population test to date. The results confirm that the DenerveX System delivers its intended treatment and that it supports the type of reimbursement that the company has already secured in its first targeted country, Germany.”

The GLP (Good Laboratory Practice) protocol testing consisted of a 12 porcine subject clinical evaluation of the DenerveX System at 0, 30 and 60 day time period post procedure. The total subject pool consisted of 144 treatments, of which 48 treatment sites were randomly selected and initially evaluated per the GLP.

Of the 48 evaluated treatments, 92% of the DenerveX System treatments reached their targeted facet joint treatment sites. Dorsal nerve roots and dorsal ganglia did not have evidence of neurodegeneration at the sites examined. No routinely examined organs had changes interpreted to be related to the study. All subjects survived the study to term absent complication.

Martin Deeg MD of Stuttgart, Germany an advisory board member with experience with the DenerveX System, reviewed the data and stated, “The DenerveX System delivered treatments that would be expected and desired as needed to provide longer term pain relief, and that would set up the DenerveX System and procedure as a new and unique therapy for Facet Joint Syndrome.”

Vik Kapoor MD of Manchester, England, also an advisory board member and equally experienced with the DenerveX System, added, “The DenerveX System proved out in the data that it will fundamentally change the way Facet Joint Syndrome will be treated in the future.”

Jarrett Gorlin, Medovex CEO, commented, “The DenerveX System represents a very new and creative approach in treating pain associated with the Facet Joint Syndrome. Our future customers have commented their clear appreciation for our different approach in performing a new procedure by way of a posterior calsulectomy of the facet joint, compared to the less effective standard radio frequency ablation (Rhizotomy). This gives us cause for continued cautious optimism going forward.”

The DenerveX System consists of the DenerveX device, a single use medical device and the DenerveX Pro-40 Power Generator, both designed to be less invasive with faster recovery time than current surgical treatment options. It consists of two procedures combined into one device and is expected to provide for a longer lasting treatment solution while offering potential savings to the health care system. DenerveX is not yet commercially available.

DenerveX System is not yet CE marked or FDA cleared and is not yet commercially available. A full evaluation of the test results continues. The results of the test have not yet been submitted to, or evaluated by, the notified body or FDA for consideration and comment. There can be no assurance that the notified body or FDA will not have further questions or require additional information when it reviews the test results.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

  • CONTACT INFORMATION

    Medovex Corp.
    Jason Assad
    470-505-9905
    Email Contact

Wright Medical Group N.V. Reports 2016 Third Quarter Financial Results and Updates 2016 Guidance

AMSTERDAM, The Netherlands, Nov. 02, 2016 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today reported financial results for its third quarter ended September 25, 2016 and provided updated 2016 guidance.  As a result of the previously announced sale of the large joints (hip/knee) business to Corin Orthopaedics Holdings Limited (Corin), this business which was previously reported as a separate reporting segment is now reported as discontinued operations.

As a result of the merger between Wright Medical Group, Inc. and Tornier N.V. on October 1, 2015, legacy Wright’s historical results of operations replaced legacy Tornier’s historical results of operations for all periods prior to the merger and the results of the two legacy businesses have been consolidated only from that date forward in accordance with United States generally accepted accounting principles (GAAP).  This release and Wright’s website at ir.wright.com contain certain unaudited non-GAAP combined pro forma financial results for Wright Medical Group N.V. which give effect to the merger as if it had occurred on the first day of fiscal 2015, as well as reconciliations to the most comparable GAAP measures.

Net sales from continuing operations totaled $157.3 million during the third quarter ended September 25, 2016.  Combined pro forma net sales from continuing operations totaled $144.8 million during the third quarter of 2015.  Global extremities and biologics net sales grew 96% as reported, and on a non-GAAP pro forma constant currency basis, grew 9%.  Gross margins from continuing operations were 70.7% during the quarter ended September 25, 2016 and were 78.2% on a non-GAAP adjusted basis.  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, “As anticipated, our third quarter results were impacted by revenue dis-synergies; however, the underlying drivers of growth in our business remain strong as we continued to see excellent growth from new products, in particular our SIMPLICITI and AEQUALIS ASCEND FLEX shoulder systems, our INFINITY total ankle replacement system and the ongoing commercial activities for AUGMENT Bone Graft and the SALVATION limb salvage system.  Global extremities and biologics pro forma constant currency net sales growth of 9%, adjusted EBITDA from continuing operations of $5.7 million and adjusted gross margins from continuing operations of 78.2% reflect the strength of our markets and our unique position in them.”

Net loss from continuing operations for the third quarter of 2016 totaled $53 million, or $(0.51) per diluted share.

The company’s net loss from continuing operations for the third quarter of 2016 included the after-tax effects of $10.3 million of inventory step-up amortization, $6.5 million of transaction and transition costs, a gain of $3.2 million related to mark-to-market adjustments on derivatives, $10.5 million of non-cash interest expense related to its convertible notes, a $2.2 million unrealized loss related to mark-to-market adjustments on contingent value rights (CVRs) issued in connection with the BioMimetic acquisition, and $1.6 million of non-cash inventory provisions associated with a product rationalization initiative.

The company’s third quarter 2016 non-GAAP net loss from continuing operations, as adjusted for the above items, was $27 million.  The company’s third quarter 2016 non-GAAP adjusted EBITDA from continuing operations, as defined in the non-GAAP to GAAP reconciliation provided later in this release, was $5.7 million. The attached financial tables include reconciliations of all historical non-GAAP measures to the most comparable GAAP measures.

Cash and cash equivalents totaled $314.3 million as of the end of the third quarter of 2016.

Company Reaches Settlement Agreement in Metal-On-Metal Hip Litigation and Enters into Settlement Agreement with Three of its Insurance Carriers

In a separate press release issued today, the company announced that it had reached a Master Settlement Agreement (MSA) in its metal-on-metal hip litigation and entered into a Settlement Agreement with three of its insurance carriers (Three Settling Insurers).  Under the terms of the MSA, the parties agreed to settle 1,292 specifically identified CONSERVE, DYNASTY or LINEAGE revision claims which meet the eligibility requirements of the MSA and are either pending in the multi-district litigation (MDL) and the consolidated proceeding pending in state court in California (JCCP), or are subject to tolling agreements approved in the MDL or JCCP, for a total settlement amount of $240 million, of which approximately $180 million will be funded from cash on hand and $60 million will be funded from insurance recoveries.  For additional information, please refer to Wright’s separate press release issued today and the disclosures in its third quarter 2016 quarterly report on Form 10-Q when filed.

Palmisano commented, “We are very pleased to have reached this settlement agreement, in particular the population of claims that the settlement covers as well as the required 95% opt-in rate for those claims.  With this clarity, we will continue to focus on accelerating growth opportunities in the extremities and biologics markets.  This settlement addresses approximately 85% of the known U.S. revision claims that do not have potential statute of limitations issues and removes a great deal of the uncertainty that has been associated with this litigation.”

Palmisano concluded, “One year post the close of the merger of Wright and Tornier, we are a stronger and more focused business.  With the closing of the sale of our large joints business, we are now completely focused on the extremities and biologics markets.  We have completed the integration of our sales forces globally with less revenue dis-synergies this year than we originally anticipated.  We are ahead of schedule on our integration activities and associated benefits.  We have improved our balance sheet and reached a Settlement Agreement for our metal-on-metal hip litigation.  Also, the guidance we are providing today is for sales and adjusted EBITDA well ahead of the expectations we provided at the beginning of the year.  While I am very pleased with what we have accomplished in our first year as a combined company, we are nowhere close to meeting our full potential, and we continue to have great opportunities for improvement.  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% three to four years post the close of the merger.”

Outlook

The company is maintaining the existing midpoint of its net sales from continuing operations for full-year 2016 guidance but narrowing the range to approximately $677 million to $683 million from its previously provided guidance range of $675 million to $685.  The company previously stated it expected dis-synergies to be less than the original guidance of $25 million to $30 million for full-year 2016 and today is formally updating its expectation for dis-synergies to be approximately $15 million for full-year 2016, which is consistent with the assumptions the company used to update its second quarter of 2016 guidance.

The company is also increasing its full-year 2016 non-GAAP adjusted EBITDA from continuing operations, as described in the non-GAAP reconciliation provided later in this release, to be in the range of $43 million to $48 million from its previous range of $40 million to $45 million.  This guidance assumes cost synergies of approximately $25 million for full-year 2016.

The company anticipates 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 2016 of $(0.52) to $(0.47) per diluted share.

The company estimates approximately 103.0 million diluted weighted-average ordinary shares outstanding for fiscal year 2016.

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; due diligence, transaction and transition costs associated with acquisitions and divestitures; amortization of inventory step-up; and charges associated with product rationalization initiatives.  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 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%. Additionally, this adjusted earnings per share from continuing operations target excludes possible future acquisitions; other material future business developments; non-cash interest expense associated with the 2017, 2020 and 2021 convertible notes; due diligence, transaction and transition costs associated with acquisitions and divestitures; amortization of inventory step-up; charges associated with product rationalization initiatives; mark-to-market adjustments to CVRs; non-cash mark-to-market derivative adjustments; and non-cash write-offs of unamortized debt discount and deferred financing charges associated with the partial settlement of the 2017 convertible notes and 2020 convertible notes. Further, this adjusted earnings per share from continuing operations target excludes any expenses, earnings or losses related to the 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 2016 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. 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 third quarter of 2016 supplemental financial information, visit ir.wright.com.  For updated information on Wright Medical Group N.V. segment reporting changes and non-GAAP combined pro forma historical financial information, including third quarter of 2016, 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 November 2, 2016 through November 9, 2016.  To hear this replay, dial 855-859-2056 (U.S.) / 404-537-3406 (Outside U.S.) and enter passcode 69669971.  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 quality of life for patients worldwide and 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 combined pro forma net sales; combined pro forma 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. While pro forma data gives effect to the merger with Tornier as if it had occurred on the first day of fiscal 2015 and enhances comparability of financial information between periods, pro forma data is not indicative of the results that actually would have been obtained if the merger had occurred as of the beginning of 2015. 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 2016 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 2016, including net sales from continuing operations, adjusted EBITDA from continuing operations and adjusted earnings per share from continuing operations; anticipated sales and cost synergies and dis-synergies and the timing thereof; the company’s expectations regarding the benefits of its merger with Tornier and integration efforts and progress; the effects of the MSA and settlement agreement with the Three Settling Insurers and the amount and funding of the settlement amounts; 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 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 MSA and settlement agreement with the Three Settling Insurers; risks associated  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 27, 2015 filed by Wright with the SEC on February 23, 2016 and Wright’s Quarterly Report on Form 10- Q for the quarter ended September 25, 2016 anticipated to be filed by Wright with the SEC on November 2, 2016.  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   Nine months ended
  September 25, 2016   September 30, 2015   September 25, 2016   September 30, 2015
Net sales $ 157,332     $ 80,139     $ 497,339     $ 238,493  
Cost of sales 46,149     23,052     141,824     63,812  
Gross profit 111,183     57,087     355,515     174,681  
Operating expenses:              
Selling, general and administrative 129,840     85,997     401,069     250,801  
Research and development 12,481     9,570     36,705     24,644  
Amortization of intangible assets 7,466     2,562     21,407     7,741  
Total operating expenses 149,787     98,129     459,181     283,186  
Operating loss (38,604 )   (41,042 )   (103,666 )   (108,505 )
Interest expense, net 16,795     11,185     41,673     29,793  
Other (income) expense, net (365 )   10,236     (3,494 )   7,395  
Loss from continuing operations before income taxes (55,034 )   (62,463 )   (141,845 )   (145,693 )
(Benefit) provision for income taxes (2,325 )   187     (6,913 )   511  
Net loss from continuing operations $ (52,709 )   $ (62,650 )   $ (134,932 )   $ (146,204 )
Loss from discontinued operations, net of tax (57,436 )   $ (36,211 )   $ (252,571 )   $ (46,720 )
Net loss $ (110,145 )   $ (98,861 )   $ (387,503 )   $ (192,924 )
               
Net loss from continuing operations per share, basic (1) $ (0.51 )   $ (1.19 )   $ (1.31 )   $ (2.78 )
Net loss from continuing operations per share, diluted (1) $ (0.51 )   $ (1.19 )   $ (1.31 )   $ (2.78 )
               
Net loss per share, basic (1) $ (1.07 )   $ (1.87 )   $ (3.77 )   $ (3.67 )
Net loss per share, diluted (1) $ (1.07 )   $ (1.87 )   $ (3.77 )   $ (3.67 )
               
Weighted-average number of shares outstanding-basic (1) 103,072     52,750     102,854     52,607  
Weighted-average number of shares outstanding-diluted (1) 103,072     52,750     102,854     52,607  
                       

_______________________________

(1) The prior year balances were converted to meet post-merger valuations.

Wright Medical Group N.V.
Consolidated Net Sales Analysis
(dollars in thousands–unaudited)

  Three months ended   Nine months ended
  September 25, 2016   September 30, 2015   % change   September 25, 2016   September 30, 2015   % change
U.S.                      
Lower extremities 51,586     43,929     17.4 %   158,872     128,277     23.9 %
Upper extremities 46,207     3,654     1,164.6 %   146,117     11,703     1,148.5 %
Biologics 18,247     12,198     49.6 %   53,167     34,612     53.6 %
Sports med & other 2,025     613     230.3 %   6,326     1,558     306.0 %
Total U.S. $ 118,065     $ 60,394     95.5 %   $ 364,482     $ 176,150     106.9 %
                       
International                      
Lower extremities 14,201     10,917     30.1 %   45,984     35,313     30.2 %
Upper extremities 17,326     1,764     882.2 %   62,241     5,723     987.6 %
Biologics 4,739     5,260     (9.9 )%   13,804     15,070     (8.4 )%
Sports med & other 3,001     1,804     66.4 %   10,828     6,237     73.6 %
Total International $ 39,267     $ 19,745     98.9 %   $ 132,857     $ 62,343     113.1 %
                       
Global                      
Lower extremities 65,787     54,846     19.9 %   204,856     163,590     25.2 %
Upper extremities 63,533     5,418     1,072.6 %   208,358     17,426     1,095.7 %
Biologics 22,986     17,458     31.7 %   66,971     49,682     34.8 %
Sports med & other 5,026     2,417     107.9 %   17,154     7,795     120.1 %
Total net sales $ 157,332     $ 80,139     96.3 %   $ 497,339     $ 238,493     108.5 %
                                           

Wright Medical Group N.V.
Reconciliation of Non-GAAP Combined Pro Forma Net Sales to Net Sales
(dollars in thousands–unaudited)

  Three months ended
  September 30, 2015
  Standalone Wright Medical Group, Inc.   Standalone Tornier N.V., recast (1)   Discontinued net sales (2)   Non-GAAP combined pro forma net sales
U.S.              
Lower extremities $ 43,929     $ 8,675     $ (2,905 )   $ 49,699  
Upper extremities 3,654     37,908         41,562  
Biologics 12,198     412         12,610  
Sports med & other 613     1,810         2,423  
Total extremities & biologics 60,394     48,805     (2,905 )   106,294  
Large joint     33     (33 )    
Total U.S. $ 60,394     $ 48,838     $ (2,938 )   $ 106,294  
               
International              
Lower extremities $ 10,917     $ 2,275     $     $ 13,192  
Upper extremities 1,764     14,862         16,626  
Biologics 5,260     114         5,374  
Sports med & other 1,804     1,505         3,309  
Total extremities & biologics 19,745     18,756         38,501  
Large joint     7,350     (7,350 )    
Total International $ 19,745     $ 26,106     $ (7,350 )   $ 38,501  
               
Global              
Lower extremities $ 54,846     $ 10,950     $ (2,905 )   $ 62,891  
Upper extremities 5,418     52,770         58,188  
Biologics 17,458     526         17,984  
Sports med & other 2,417     3,315         5,732  
Total extremities & biologics 80,139     67,561     (2,905 )   144,795  
Large joint     7,383     (7,383 )    
Total net sales $ 80,139     $ 74,944     $ (10,288 )   $ 144,795  
                               

_______________________________

(1) Legacy Tornier product line sales have been recast to reflect the reclassification of cement, instruments and freight from the historical Tornier product line “Large Joints and Other” to the product line associated with those revenues that will be utilized for future revenue reporting.

(2) To reduce from Tornier’s historical sales the U.S. sales associated with Tornier’s Salto Talaris and Salto XT ankle replacement products and silastic toe replacement products and the global sales associated with Tornier’s Large Joint business.

Wright Medical Group N.V.
Reconciliation of Non-GAAP Combined Pro Forma Net Sales to Net Sales
(dollars in thousands–unaudited)

  Nine months ended
  September 30, 2015
  Standalone Wright Medical Group, Inc.   Standalone Tornier N.V., recast (1)   Discontinued net sales (2)   Non-GAAP combined pro forma net sales
U.S.              
Lower extremities 128,277     29,636     (9,732 )   148,181  
Upper extremities 11,703     115,846         127,549  
Biologics 34,612     1,290         35,902  
Sports med & other 1,558     5,021         6,579  
Total extremities & biologics 176,150     151,793     (9,732 )   318,211  
Large joint     119     (119 )    
Total U.S. $ 176,150     $ 151,912     $ (9,851 )   $ 318,211  
               
International              
Lower extremities 35,313     7,402         42,715  
Upper extremities 5,723     51,293         57,016  
Biologics 15,070     357         15,427  
Sports med & other 6,237     5,372         11,609  
Total extremities & biologics 62,343     64,424         126,767  
Large joint     29,921     (29,921 )    
Total International $ 62,343     $ 94,345     $ (29,921 )   $ 126,767  
               
Global              
Lower extremities 163,590     37,038     (9,732 )   190,896  
Upper extremities 17,426     167,139         184,565  
Biologics 49,682     1,647         51,329  
Sports med & other 7,795     10,393         18,188  
Total extremities & biologics 238,493     216,217     (9,732 )   444,978  
Large joint     30,040     (30,040 )    
Total sales $ 238,493     $ 246,257     $ (39,772 )   $ 444,978  
                               

_______________________________

(1) Legacy Tornier product line sales have been recast to reflect the reclassification of cement, instruments and freight from the historical Tornier product line “Large Joints and Other” to the product line associated with those revenues that will be utilized for future revenue reporting.

(2) To reduce from Tornier’s historical sales the U.S. sales associated with Tornier’s Salto Talaris and Salto XT ankle replacement products and silastic toe replacement products and the global sales associated with Tornier’s Large Joint business.

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

  Third Quarter 2016 net sales growth/(decline)
  U.S. combined pro forma Int’l combined pro forma constant currency Int’l combined pro forma Global combined pro forma constant currency Global combined pro forma
Product line          
Lower extremities   4 %   11 %   8 %   5 %   5 %
Upper extremities   11 %   5 %   4 %   9 %   9 %
Biologics   45 %   (10 %)   (12 %)   28 %   28 %
Sports med & other   (16 %)   (5 %)   (9 %)   (10 %)   (12 %)
Total net sales   11 %   4 %   2 %   9 %   9 %
                               

 

  Nine months ended September 25, 2016 net sales growth/(decline)
  U.S. combined pro forma Int’l combined pro forma constant currency Int’l combined pro forma Global combined pro forma constant currency Global combined pro forma
Product line          
Lower extremities   7 %   11 %   8 %   8 %   7 %
Upper extremities   15 %   11 %   9 %   13 %   13 %
Biologics   48 %   (7 %)   (11 %)   31 %   30 %
Sports med & other   (4 %)   (4 %)   (7 %)   (4 %)   (6 %)
Total net sales   15 %   7 %   5 %   12 %   12 %
                               

 

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   Nine months ended
  September 25, 2016   September 25, 2016
Gross profit from continuing operations, as reported $ 111,183     $ 355,515  
Gross margins from continuing operations, as reported 70.7 %   71.5 %
Reconciling items impacting gross profit:      
Inventory step-up amortization 10,306     30,922  
Product rationalization 1,573     3,527  
Transaction and transition costs     124  
Non-GAAP gross profit from continuing operations, as adjusted $ 123,062     $ 390,088  
Net sales from continuing operations 157,332     497,339  
Non-GAAP adjusted gross margins from continuing operations 78.2 %   78.4 %
           

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   Nine months ended
  September 25, 2016   September 25, 2016
Net loss from continuing operations, as reported $ (52,709 )   $ (134,932 )
Net loss from continuing operations per share, as reported $ (0.51 )   $ (1.31 )
Reconciling items:      
Inventory step-up amortization (1) 10,306     30,922  
Product rationalization (1) 1,573     3,527  
Non-cash interest expense on convertible notes 10,516     25,812  
Non-cash loss on extinguishment of debt     12,343  
Derivatives mark-to-market adjustments (3,187 )   (26,460 )
Transaction and transition costs (3) 6,532     24,425  
Management changes (2)     1,348  
CVR mark-to-market adjustments 2,243     8,968  
Contingent consideration fair value adjustment 70     376  
Legal settlement (2)     1,800  
Costs associated with new convertible debt (2)     234  
IRS settlement (4)     (3,073 )
Tax effect of reconciling items (2,313 )   (5,634 )
Non-GAAP net loss from continuing operations, as adjusted $ (26,969 )   $ (60,344 )
Add back amortization of intangible assets 7,466     21,407  
Adjusted non-GAAP earnings $ (19,503 )   $ (38,937 )
Weighted-average basic shares outstanding 103,072     102,854  
Adjusted non-GAAP earnings per share $ (0.19 )   $ (0.38 )
               

_______________________________

(1) Impacting gross profit.
(2) Impacting selling, general, and administrative expense.
(3) Impacting selling, general, and administrative expense and research and development expense for $6.4 million and $0.2 million, respectively, for the three months ended September 25, 2016.  Impacting gross profit; selling, general, and administrative expense; and research and development expense for $0.1 million, $23.9 million, and $0.4 million, respectively, for the nine months ended September 25, 2016.
(4) IRS settlement includes $0.8 million of interest income and $2.3 million tax benefit.

Wright Medical Group N.V.
Reconciliation of Non-GAAP Adjusted EBITDA to Net Loss from Continuing Operations
 (dollars in thousands–unaudited)

  Three months ended   Nine months ended
  September 25, 2016   September 25, 2016
Net loss from continuing operations $ (52,709 )   $ (134,932 )
Interest expense, net 16,795     41,673  
Benefit from income taxes (2,325 )   (6,913 )
Depreciation 14,885     41,005  
Amortization 7,466     21,407  
Non-GAAP EBITDA $ (15,888 )   $ (37,760 )
Reconciling items impacting EBITDA:      
Non-cash share-based compensation expense 3,528     9,901  
Other income, net (365 )   (3,494 )
Inventory step-up amortization 10,306     30,922  
Product rationalization 1,573     3,527  
Transaction and transition costs 6,532     24,425  
Management changes     1,348  
Legal settlement     1,800  
Costs associated with new convertible debt     234  
Non-GAAP adjusted EBITDA $ 5,686     $ 30,903  
               


Wright Medical Group N.V.

Condensed Consolidated Balance Sheets
(dollars in thousands–unaudited)

  September 25, 2016   December 27, 2015
Assets      
Current assets:      
Cash and cash equivalents $ 314,314     $ 139,804  
Accounts receivable, net 121,794     131,050  
Inventories 170,819     210,701  
Prepaid expenses and other current assets 110,702     59,842  
Current assets held for sale 21,805     18,487  
Total current assets 739,434     559,884  
       
Property, plant and equipment, net 211,096     224,256  
Goodwill and intangible assets, net 1,103,571     1,117,917  
Other assets (1) 262,225     139,754  
Non-current assets held for sale     31,683  
Total assets (1) $ 2,316,326     $ 2,073,494  
       
Liabilities and shareholders’ equity      
Current liabilities:      
Accounts payable $ 25,181     $ 30,904  
Accrued expenses and other current liabilities 399,985     171,171  
Current portion of long-term obligations 4,117     2,171  
Current liabilities held for sale 2,049     2,692  
Total current liabilities 431,332     206,938  
Long-term obligations (1) 769,333     561,201  
Other liabilities 370,556     250,329  
Total liabilities (1) 1,571,221     1,018,468  
       
Shareholders’ equity 745,105     1,055,026  
Total liabilities and shareholders’ equity (1) $ 2,316,326     $ 2,073,494  
               

                                               

(1) The prior year debt issuance costs were reclassified to account for adoption of ASU 2015-03 and ASU 2015-15.

Investors & Media:

 

Julie D. Tracy

Sr. Vice President, Chief Communications Officer

Wright Medical Group N.V.

(901) 290-5817

julie.tracy@wright.com