Rotation Medical Announces Key Events at Arthroscopy Association of North America Annual Meeting

May 09, 2017

PLYMOUTH, Minn.–(BUSINESS WIRE)–Rotation Medical Inc., a medical device company focused on developing new technologies to treat rotator cuff disease, today announced key events for the upcoming Arthroscopy Association of North America Annual Meeting May 18-20 in Denver. These events include first-ever presentation of results of the REBUILD study of the company’s Bioinductive Implant for rotator cuff repair, as well as multiple podium presentations.

Rotation Medical’s REBUILD (Rotation MEdical BioindUctive ImpLant Database) is a prospective, non-randomized, real-world registry study designed to collect patient-reported outcomes, including shoulder function, pain and quality of life, after receiving the Bioinductive Implant. Dr. Louis McIntyre of Northwell Health Physician Partners Orthopaedic Institute at Sleepy Hollow (New York) will share results of the first 200 patients enrolled in the study, as well as provide case examples and an overview of published clinical data on Thursday, May 18, 11:40 a.m. to 12:30 p.m.

Attendees will also have the opportunity to learn more about the Rotation Medical Bioinductive Implant at the following events:

  • Clinical Case Panel #1: Rotator Cuff. Dr. Jeffrey Abrams of Princeton Orthopaedic Associates (New Jersey) will highlight his use of the Bioinductive Implant. Thursday, May 18, 10:20-10:50 a.m.
  • Symposium 1: The Failed Cuff, What Now? Dr. Michael O’Brien of Tulane Institute of Sports Medicine (Louisiana) will discuss patch options and results. Thursday, May 18, 10:50-11:30 a.m.
  • The Holy Grail: Can We Successfully Treat the Overhead Athlete? Expert Advice and Experience. Dr. Michael T. Freehill of Michigan Medicine Orthopaedic Sports Medicine will highlight his use of the Bioinductive Implant. Thursday, May 18, 4:45-6:15 p.m.
  • State of the Art Grafts and Patches in Rotator Cuff Surgery: Augmentation, Interpositions, Superior Capsular Reconstruction and Bioinductive Implant. Dr. Richard Ryu of the Ryu Hurvitz Orthopedic Clinic (California) and Dr. Matthew T. Provencher of The Steadman Clinic and Steadman Philippon Research Institute (Colorado) will present the biology and mechanics of rotator cuff patches and grafts, including the surgical technique for the Bioinductive Implant. Friday, May 19, 7:45-9:15 a.m.
  • Feature Lecture #8: Patch Options and Results. Dr. Ryu will also provide an overview of the Bioinductive Implant for full thickness and partial tears. Friday, May 19, 3:15-3:30 p.m.

“Given the high failure rate and difficult recovery required for traditional approaches to rotator cuff repair, we believe the results of our REBUILD real-world study will speak to the potential of our Bioinductive Implant to transform the treatment of rotator cuff disease,” said Martha Shadan, president and CEO of Rotation Medical. “Attendees at this year’s AANA Annual Meeting will also have many opportunities to hear from their peers how our Bioinductive Implant can improve outcomes for people with rotator cuff tears.”

About Rotator Cuff Tears

Rotator cuff damage is the most common source of shoulder pain, affecting more than 4 million people annually in the U.S. Traditional approaches to treating degenerate or torn rotator cuffs often do not address the poor quality of the underlying tendon tissue, and a significant number of these tendons, after standard treatment, either degenerate further and/or re-tear.

About the Rotation Medical BioInductive Implant

Cleared by the U.S. Food and Drug Administration in March 2014, the Rotation Medical Bioinductive Implant is designed to address both the biomechanics and biology required to heal a rotator cuff tendon tear by inducing new tissue growth at the site of implantation, resulting in increased tendon thickness and healing of tendon defects with new tissue growth. The collagen-based implant is about the size of a postage stamp and it is part of the Rotation Medical rotator cuff system, which also includes disposable instruments that allow the arthroscopic procedure to be performed easily and quickly. For important safety information, visit http://rotationmedical.com/our-solution/risks/.

About Rotation Medical

Rotation Medical Inc. was founded in 2009 and is committed to improving the treatment of rotator cuff disease with the Rotation Medical rotator cuff system, a breakthrough technology that has the potential to prevent rotator cuff disease progression and reduce re-tears by inducing the growth of new tendinous tissue. The company is privately held and funded by New Enterprise Associates (NEA), Life Sciences Partners (LSP) and Pappas Ventures. For more information, visit http://www.rotationmedical.com/.

Contacts

Merryman Communications
Joni Ramirez
323-532-0746
joni@merrymancommunications.com

OrthAlign, Inc. Announces Appointment of Andy Turner as Country Director of Australia and New Zealand

OrthAlign, Inc., a privately held U.S.-based medical device and technology company providing orthopedic surgeons with advanced precision technologies, announced today the appointment of Andy Turner as Country Director of Australia and New Zealand to support continued growth and investment of OrthAlign technologies in that region of the world. He will be based in Sydney.

Andy has over twenty years experience in the orthopaedic industry, in both the sales and marketing functions. His career began in Europe with DePuy, followed by a move to Biomet, where he was responsible for launching the Vanguard knee system across Europe. Andy moved to Australia in 2008 and has held senior management and executive positions for Smith & Nephew and ZimmerBiomet, where he was responsible for marketing, sales, and product management of the orthopedic portfolios. During his career, he has successfully managed some of the largest global orthopedic brands, namely, Legion, CPCS, Polar, NexGen, Oxford, and CPT, respectively. Andy’s strong commercial acumen and sales drive has resulted in meeting corporate objectives and financial targets at every stage of his career. He holds an Honors Degree in Management with a Major in Physiology from Hallam University, Sheffield, UK.

“The addition of Andy as a local leader for OrthAlign in Australia and New Zealand is just one of many major investments that we are making in those very important markets. KneeAlign® has already established itself as one of the leading orthopaedic technologies in ANZ, but OrthAlign technology is just scratching the surface,” said James Young Kim, OrthAlign’s Vice President and General Manager of International. “Andy’s local presence will greatly enhance our continued efforts in customer expansion, growth in our portfolio of products, and focus in providing world class customer service to our surgeons, hospitals, and surgery centers. With 65,000 knee and 45,000 hip arthroplasties completed in Australia and New Zealand in 2016, we are excited about the growth opportunities that are before us.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, developing advanced technologies that deliver healthier and more pain-free lifestyles to joint replacement patients, globally. We provide healthcare professionals with cutting edge, computer-assisted surgical tools that seamlessly and cost-effectively deliver vital data and clinical results to optimize outcomes for our patients. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are registered trademarks of OrthAlign, Inc.”

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

AMSTERDAM, The Netherlands, May 03, 2017 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today reported financial results for its first quarter ended March 26, 2017 and reaffirmed 2017 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.

Net sales from continuing operations totaled $177.2 million during the first quarter ended March 26, 2017, representing 5% as reported growth, and 6% growth on a constant currency basis.  Gross margins from continuing operations were 79.0% during the quarter ended March 26, 2017 and were 79.4% 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, “Our upper extremities business continued to have strong growth as SIMPLICITI drove 13% growth in U.S. shoulder.  Additionally, we launched our PERFORM reversed glenoid in March and anticipate that this will drive accelerating revenue in the second half of the year as we deliver additional instrument sets to the U.S. field.”

Palmisano continued, “In our U.S. lower extremities and biologics business, we saw outstanding growth of 28% in the most technologically advanced portions of our portfolio, which include AUGMENT, SALVATION and Total Ankle Replacement.  Growth in the core lower extremities and biologics portfolio was significantly lower, partially due to the revenue dis-synergies in the quarter, which we anticipated.  The key to improving our growth rates in this core lower extremities and biologics portfolio is our sales force expansion, which we have completed ahead of schedule.  This accelerated implementation of our sales force expansion plan resulted in some short-term distraction in the first quarter that we expect will be offset in the second half of the year.”

Palmisano further commented, “We had outstanding gross margin performance of 79.0% as reported and 79.4% on a non-GAAP adjusted basis, in the first quarter and adjusted EBITDA margin expansion of 260 basis points, right on track with our plan for the year.  We will continue to focus on improving our balance sheet and our cash flow throughout 2017 and expect to make significant progress on our specific Vital Few initiatives in this area.”

Net loss from continuing operations for the first quarter of 2017 totaled $36.7 million, or $(0.35) per diluted share.

The company’s net loss from continuing operations for the first quarter of 2017 included the after-tax effects of $3.0 million of transition costs, an unrealized loss of $0.4 million related to mark-to-market adjustments on derivatives, $11.0 million of non-cash interest expense related to its convertible notes, and a $6.2 million unrealized loss related to mark-to-market adjustments on contingent value rights (CVRs) issued in connection with the BioMimetic acquisition.

The company’s first quarter 2017 non-GAAP net loss from continuing operations, as adjusted for the above items, was $16.2 million.  The company’s first quarter 2017 non-GAAP adjusted EBITDA from continuing operations, as defined in the non-GAAP to GAAP reconciliation provided later in this release, was $18.2 million. The attached financial tables include reconciliations of all historical non-GAAP measures to the most comparable GAAP measures.

Cash, cash equivalents and restricted cash totaled $386.0 million as of the end of the first quarter of 2017.  This amount includes $150 million classified as restricted cash on the company’s balance sheet that is held in escrow to fund a portion of the metal-on-metal hip litigation Master Settlement Agreement (MSA).

Palmisano concluded, “Today we are the leading Extremities-Biologics company in the world, both in terms of leading edge products and size.  Through the remainder of the year, we intend to build on our lead.  We are right on track with the key revenue growth drivers for 2017, and remain confident in our full-year guidance, which calls for annual constant currency growth of 12 to 14 percent, excluding the impacts of revenue dis-synergies, the Salto divestiture and the impact of the extra selling days.  We continue to expect there will be strong acceleration in the second half of the year as we annualize the impact of the merger revenue dis-synergies and begin to realize the benefits from an expanded U.S. sales force and new product launches.  In addition, I believe we are positioned well for future success and achieving our key financial goals of mid-teens constant currency net sales growth, gross margins in the high 70% range and non-GAAP adjusted EBITDA margins of approximately 20% three to four years post the close of the merger.”

Outlook

The company continues to anticipate net sales for full-year 2017 of approximately $755 million to $765 million, representing an as reported growth rate of 9% to 11%.  This range assumes:

  • a negative impact from foreign currency exchange rates as compared to 2016 of approximately 2%;
  • $10 million of net sales dis-synergies resulting from customers lost over the course of 2016 due to the sales force integrations;
  • approximately $3 million of dis-synergies from the anticipated divestiture of the international Salto ankle business; and
  • a positive impact of approximately 1% due to four extra selling days in the fourth quarter of 2017.

The midpoint of this net sales guidance range assumes constant currency growth of approximately 13%, excluding the negative impacts of revenue dis-synergies and Salto divestiture of 2%, and the approximately 1% positive impact of the extra selling days.  Additionally, the company anticipates the second half of the year to grow faster than the first half of the year as it realizes the benefits from its new product launches and sales force expansion.

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

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

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

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

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

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

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

Supplemental Financial Information

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

Internet Posting of Information

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

Conference Call and Webcast

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

A replay of the call will be available beginning at 5:30 p.m. Central Time on May 3, 2017 through May 10, 2017.  To hear this replay, dial (855) 859-2056 (U.S.) / (404) 537-3406 (Outside U.S.) and enter code 90734703.  A replay of the conference call will also be available via the internet starting today and continuing for at least 12 months.  To access a replay of the conference call via the internet, go to the Investor Relations -Presentations/Calendar section of the company’s corporate website located at www.wright.com.

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

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

About Wright Medical Group N.V.

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

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

Non-GAAP Financial Measures  

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

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “intend,” “could,” “may,” “will,” “believe,” “estimate,” “look forward,” “forecast,” “goal,” “target,” “project,” “continue,” “outlook,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the company’s anticipated financial results for 2017, including net sales from continuing operations, adjusted EBITDA from continuing operations and adjusted earnings per share from continuing operations; anticipated sales acceleration in the second half of the year and benefits from expanded U.S. sales force and new product launches, anticipated sales and cost synergies and dis-synergies and the timing thereof; the company’s expectations regarding the benefits of its merger with Tornier and integration efforts and progress; 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 metal-on-metal master settlement agreement and the settlement agreement with the three settling insurers; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 25, 2016 filed by Wright with the SEC on February 23, 2017 and in other subsequent SEC filings by Wright. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

–Tables Follow–

Wright Medical Group N.V.
Condensed Consolidated Statements of Operations
(dollars in thousands, except per share data–unaudited)
Three months ended
March 26, 2017 March 27, 2016
Net sales $ 177,191 $ 169,291
Cost of sales 37,126 46,666
Gross profit 140,065 122,625
Operating expenses:
Selling, general and administrative 129,834 134,746
Research and development 12,432 12,116
Amortization of intangible assets 7,397 6,457
Total operating expenses 149,663 153,319
Operating loss (9,598 ) (30,694 )
Interest expense, net 18,195 11,854
Other expense (income), net 7,975 (1,068 )
Loss from continuing operations before income taxes (35,768 ) (41,480 )
Provision (benefit) for income taxes 939 (1,287 )
Net loss from continuing operations $ (36,707 ) $ (40,193 )
Loss from discontinued operations, net of tax $ (21,992 ) $ (7,799 )
Net loss $ (58,699 ) $ (47,992 )
Net loss from continuing operations per share, basic and diluted $ (0.35 ) $ (0.39 )
Net loss per share, basic and diluted $ (0.57 ) $ (0.47 )
Weighted-average number of shares outstanding-basic and diluted 103,663 102,704
Wright Medical Group N.V.
Consolidated Net Sales Analysis
(dollars in thousands–unaudited)
Three months ended
March 26, 2017 March 27, 2016 %
change
U.S.
Lower extremities 55,461 55,278 0.3 %
Upper extremities 55,958 50,001 11.9 %
Biologics 18,634 17,128 8.8 %
Sports med & other 2,101 2,137 (1.7 )%
Total U.S. $ 132,154 $ 124,544 6.1 %
International
Lower extremities 13,642 15,542 (12.2 )%
Upper extremities 22,422 20,975 6.9 %
Biologics 5,171 4,198 23.2 %
Sports med & other 3,802 4,032 (5.7 )%
Total International $ 45,037 $ 44,747 0.6 %
Global
Lower extremities 69,103 70,820 (2.4 )%
Upper extremities 78,380 70,976 10.4 %
Biologics 23,805 21,326 11.6 %
Sports med & other 5,903 6,169 (4.3 )%
Total net sales $ 177,191 $ 169,291 4.7 %
Wright Medical Group N.V.
Supplemental Net Sales Information
(unaudited)
Three months ended March 26, 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 0 % (8 %) (12 %) (2 %) (2 %)
Upper extremities 12 % 10 % 7 % 11 % 10 %
Biologics 9 % 24 % 23 % 12 % 12 %
Sports med & other (2 %) 0 % (6 %) 0 % (4 %)
Total net sales 6 % 4 % 1 % 6 % 5 %
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
March 26, 2017 March 27, 2016
Gross profit from continuing operations, as reported $ 140,065 $ 122,625
Gross margins from continuing operations, as reported 79.0 % 72.4 %
Reconciling items impacting gross profit:
Inventory step-up amortization 10,229
Transaction and transition costs 685 124
Non-GAAP gross profit from continuing operations, as adjusted $ 140,750 $ 132,978
Net sales from continuing operations 177,191 169,291
Non-GAAP adjusted gross margins from continuing operations 79.4 % 78.5 %
Wright Medical Group N.V.
Reconciliation of Adjusted Non-GAAP Earnings Per Share to Net Loss from Continuing Operations Per Share
(dollars in thousands, except per share data–unaudited)
Three months ended
March 26, 2017 March 27, 2016
Net loss from continuing operations, as reported $ (36,707 ) $ (40,193 )
Net loss from continuing operations per share, as reported $ (0.35 ) $ (0.39 )
Reconciling items:
Inventory step-up amortization 10,229
Non-cash interest expense on convertible notes 1 10,999 7,056
Derivatives mark-to-market adjustments 2 365 (6,641 )
Transaction and transition costs 2,972 10,833
CVR mark-to-market adjustments 2 6,160 5,324
Tax effect of reconciling items 3 (18 ) (1,189 )
Non-GAAP net loss from continuing operations, as adjusted $ (16,229 ) $ (14,581 )
Add back amortization of intangible assets 7,397 6,457
Adjusted non-GAAP earnings $ (8,832 ) $ (8,124 )
Weighted-average basic shares outstanding 103,663 102,704
Adjusted non-GAAP earnings per share $ (0.09 ) $ (0.08 )
Impacting interest expense, net
Impacting other expense (income), net
Determined based upon the effective tax rate in the jurisdiction in which the expense was incurred.
Wright Medical Group N.V.
Reconciliation of Non-GAAP Adjusted EBITDA to Net Loss from Continuing Operations
(dollars in thousands–unaudited)
Three months ended
March 26, 2017 March 27, 2016
Net loss from continuing operations $ (36,707 ) $ (40,193 )
Interest expense, net 18,195 11,854
Provision (benefit) from income taxes 939 (1,287 )
Depreciation 13,446 12,850
Amortization 7,397 6,457
Non-GAAP EBITDA $ 3,270 $ (10,319 )
Reconciling items impacting EBITDA:
Non-cash share-based compensation expense 3,954 3,317
Other expense (income), net 7,975 (1,068 )
Inventory step-up amortization 10,229
Transaction and transition costs 2,972 10,833
Non-GAAP adjusted EBITDA $ 18,171 $ 12,992
  Net sales from continuing operations 177,191 169,291
Non-GAAP adjusted EBITDA margin   10.3 %   7.7 %
Wright Medical Group N.V.
Reconciliation of Other Non-GAAP Financial Measures to Other As Reported Results
(dollars in thousands–unaudited)
Three months ended
March 26, 2017 March 27, 2016
Net sales $ 177,191 $ 169,291
Selling, general and administrative expense, as reported $ 129,834 $ 134,746
Selling, general and administrative expense as a percentages of net sales, as reported 73.3 % 79.6 %
Reconciling items impacting selling, general and administrative expense:
Transaction and transition costs – selling, general and administrative 2,287 10,560
Selling, general and administrative expense, as adjusted $ 127,547 $ 124,186
Selling, general and administrative expense as a percentage of net sales, as adjusted 72.0 % 73.4 %
Research & development expense, as reported $ 12,432 $ 12,116
Research & development expense as a percentages of net sales, as reported 7.0 % 7.2 %
Reconciling items impacting research & development expense:
Transaction and transition costs – research & development 149
Research & development expense, as adjusted $ 12,432 $ 11,967
Research & development expense as a percentage of net sales, as adjusted 7.0 % 7.1 %
Wright Medical Group N.V.
Condensed Consolidated Balance Sheets
(dollars in thousands–unaudited)
March 26, 2017 December 25, 2016
Assets
Current assets:
Cash and cash equivalents $ 235,982 $ 262,265
Restricted cash 150,000 150,000
Accounts receivable, net 119,328 130,602
Inventories 153,066 150,849
Prepaid expenses and other current assets 1 327,878 65,909
Total current assets 986,254 759,625
Property, plant and equipment, net 200,098 201,732
Goodwill and intangible assets, net 1,081,954 1,082,839
Other assets 1 159,711 246,390
Total assets $ 2,428,017 $ 2,290,586
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable $ 36,057 $ 32,866
Accrued expenses and other current liabilities 1 697,645 407,704
Current portion of long-term obligations 21,697 33,948
2021 Notes 1 285,448
Total current liabilities 1,040,847 474,518
Long-term obligations 1 507,430 780,407
Other liabilities 1 224,524 348,797
Total liabilities 1,772,801 1,603,722
Shareholders’ equity 655,216 686,864
Total liabilities and shareholders’ equity $ 2,428,017 $ 2,290,586
___________________________
As of March 26, 2017, the closing price of our ordinary shares was greater than 130% of the 2021 Notes conversion price for 20 or more of the 30 consecutive trading days preceding the quarter-end; and, therefore, the holders of the 2021 Notes may convert the notes during the succeeding quarterly period. Due to the ability of the holders of the 2021 Notes to convert the notes during this period, the carrying value of the 2021 Notes and the fair value of the 2021 Notes Conversion Derivative were classified as current liabilities, and the fair value of the 2021 Notes Hedges were classified as current assets as of March 26, 2017. The respective balances were classified as long-term as of December 25, 2016.
Investors & Media:

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

Primary Logo

Wright Medical Group N.V.

Conventus Orthopaedics Raises $20 Million to Fund Revolutionary Cage™ Extremity Fracture Repair Therapy

MINNEAPOLIS, May 9, 2017 /PRNewswire/ — Conventus Orthopaedics, Inc., a medical device company dedicated to revolutionizing extremity fracture treatment, today announced the completion of a $20 million equity financing. Deerfield Management led the financing which was funded entirely by the existing ownership syndicate.

The Conventus CageTM is an intramedullary implant for the repair of extremity fractures, currently FDA cleared for the treatment of shoulder, elbow and wrist fractures.  Early clinical results have been promising as patients have experienced a stable fracture fixation with a quicker recovery period, less pain, improved range of motion, and fewer surgical complications when compared to historical literature for existing fracture repair methods.

Scott Flora, Conventus’ Executive Chairman, said, “The CageTM is the future of fracture repair.  We are pleased that our investor syndicate, led by Deerfield, share that vision and continue to provide financial support with a long-term view to realize the full potential of this technology.”

“The CageTM is a truly innovative technology, poised to disrupt the orthopaedic trauma market.” said Avi Kometz, MD, Partner at Deerfield Management.  “The early clinical results have been outstanding, leading us to continue our long-term investment thesis in the company.”

About Conventus Orthopaedics, Inc.

Conventus Orthopaedics, Inc. is an early-stage company focused on delivering a new standard of care for fracture treatment in the orthopaedic extremities market.  Their proprietary Cage™ technology aims to improve patient outcomes, enhance the surgeon experience, and deliver economic value to stakeholders within this market segment.

 

SOURCE Conventus Orthopaedics, Inc.

Related Links

http://www.conventusortho.com

3D4Medical Launches Complete Ortho – its Latest Clinical App for iPhone and iPad

May 09, 2017

DUBLIN–(BUSINESS WIRE)–3D4Medical, the world’s leading developer of 3D medical technology, today unveiled the first in its new suite of clinical solutions with the Complete Ortho app for iPhone and iPad, available exclusively on the App Store.

“Complete Consultation” is the new range of clinical solutions from 3D4Medical that will cover areas such as orthopedics, cardiology, internal medicine and trauma. Aiming to transform the relationship between the healthcare professional and patient, the first product in the range, Complete Ortho, allows the healthcare professional to consult with the patient in a whole new way, both educating and empowering them at every step of their orthopedic healthcare journey in magnificent 3D and all across a fully HIPAA-compliant platform.

First introduced in 2013 in one of the largest and most well-known hospital chains in the US, Complete Ortho was particularly well-received. 3D4Medical is now delighted to bring Complete Ortho to individual orthopedic surgeons and clinics around the world and for free to the general public so everyone can directly benefit.

Complete Ortho streamlines and enhances the entire healthcare professional/patient consultation process, allowing the healthcare professional to take their patient through the entire orthopedic concern with the aid of ground-breaking 3D technology and animations: from the anatomy of the troubling region; the possible pathologies related to the structure in question; the potentially beneficial or appropriate procedures; and any additional information that might be relevant. The patient is better engaged and empowered like never before as the step-by-step process allows for a far greater level of understanding than those achieved by traditional methods. If the patient so wishes, the healthcare professional can email a summary of their information, including the 3D animations, to them in the form of a Digital Consultation for their review on any device, in their own time and space, and perhaps with their loved ones for added support, removing the stress of trying to remember everything that the healthcare professional said, and increasing the accuracy of the information that is informing the patient’s decision. This improvement in the level of shared decision-making, education and empowerment will no doubt lead to a decrease in unnecessary physician return visits, an increase in patient-satisfaction and better medical outcomes across the board.

CEO and founder of 3D4Medical, John Moore, said, “We have had Complete Ortho ready for the hospital setting for a long time now so it is great to finally get it into the hands of both healthcare professionals and the general public. We look forward to the positive impact it will make across the world.”

Alan Getgood of the University of Western Ontario and Canada’s Fowler Kennedy Sport Medicine Clinic noted, “Complete Ortho will provide an excellent resource for physicians to provide a more personalized information portfolio for their patients’ diagnosis and treatment plan. For the patient, this will ensure a better understanding of their prognosis and care pathway that should lead to improved levels of satisfaction.”

Maurice Neligan, Director of Orthopaedic Surgery at Ireland’s Beacon Hospital and Associate Clinical Professor at University College Dublin School of Medicine, stated, “Complete Ortho is a significant advancement in engaging patients. It dispenses with the need for plastic models and scribbled diagrams, replacing them with top-quality illustrations, animations, and information that are personalized to the patient’s pathology and treatment. It is well-known that better-engaged patients have better outcomes and the information generated from patient engagement with Complete Ortho allows a more robust consent process for treatment, lowering the risk of malpractice litigation and the process can be seamlessly incorporated into existing practice models with little or no increase in consultation time.”

International expert in hip and knee joint replacement and Director of the Australian Orthopedic Association National Joint Replacement Registry, Steve Graves, added, “3D technology is proven to be the most effective approach to inform patients about their clinical condition. Complete Ortho is a comprehensive high-quality product that will greatly assist surgeons to ensure that their patients are fully-informed about their condition and proposed management.”

3D4Medical is proud to be an Apple Mobility Partner, helping to deliver best-in-class iOS solutions like Complete Ortho to healthcare professionals and patients around the world. Complete Ortho is exclusively available for iPad Mini2, iPad Mini3, iPad Mini4, iPad Air1, iPad Air2, iPad Pro, iPhone SE, iPhone 5S, iPhone 6, 6+, 6S, 6S+ and 7.

About 3D4Medical

3D4Medical is transforming medical learning and practice across the world and is leading the way in the production of ground-breaking 3D medical technology applications. This technology disrupts traditional methods of education by providing revolutionary applications that allow the educator, student, medical professional and patient to explore and experience medical education like never before, putting high-quality accessible 3D medical information at their fingertips. With the receipt of a prestigious Apple Design Award in 2016, over 12 million downloads worldwide and the #1 top-download positions in the App Store in 148 countries, 3D4Medical has enjoyed great success to date as it continues in its pursuit to improve the lives of patients, students, medical professionals and educators around the world. 3D4Medical is headquartered in Dublin and has over 100 employees.

Contacts

3D4Medical
Laura O’Connor
Head of Communications & Regulatory Affairs
media@3d4medical.com

Life Spine Announces 510(k) Clearance of the CRANIAL FUSION System with SOLSTICE® Screws for Cervical Spine Indications

May 09, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, is pleased to announce the FDA 510(k) clearance of the CRANIAL FUSION System. This clearance expands the indications for utilizing SOLSTICE Polyaxial Screws into the cervical spine.

“With the clearance of the Cranial Fusion System, this is an exciting opportunity for use of our Solstice system screws for posterior cervical fusions,” said Mariusz Knap, Vice President of Marketing for Life Spine. “We continue to focus on advancements that strive to improve surgical efficiencies, ease of use and reliability of posterior occipito-cervico-thoracic fixation of the spine, thus providing the highest value of care to our customers and patients.”

The CRANIAL FUSION System is a multiple component system comprised of titanium alloy, with a variety of occipital plates, occipital bone screws, polyaxial screws, hooks, connectors, rods, and locking caps.

SOLSTICE polyaxial screws used with the CRANIAL FUSION System come in 3.5, 4.0 and 4.5mm diameters. The conical polyaxial head angulation facilitates easy rod placement with minimal contouring, and the “friction head” feature maintains screw head position within the surgical wound.

In order to achieve additional levels of fixation, The CRANIAL FUSION System may be connected to the NAUTILUS® Thoracolumbar Pedicle Screw System using the 3.5mm/5.5mm titanium parallel connectors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

About Life Spine

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

Life Spine is a registered trademark.

Contacts

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

CartiHeal Raises $18.3 Million

KFAR SABA, Israel, May 8, 2017 /PRNewswire/ —

Funds will support IDE clinical study for company’s Agili-C™ implant

CartiHeal (2009) Ltd., developer of a cell-free, off-the-shelf implant for use in cartilage and osteochondral defects, announced today the culmination of an $18.3M financing round. The funds will finance the company’s recently-approved IDE clinical trial toward a PMA application.

The two-year pivotal study will involve US and OUS centers, with the aim of demonstrating the Agili-C™ implant’s superiority over the surgical standard of care.

The investment was led by aMoon, together with CartiHeal’s existing investors: Johnson & Johnson Innovation (JJDC Inc.), Peregrine Ventures and Elron, who has been consistently supporting and investing in CartiHeal over the years.

“CartiHeal delivers hope to those who suffer daily from degenerative and non-degenerative joint conditions, regenerating both bone and cartilage with its Agili-C single-step implantation procedure,” says Dr. Yair Schindel, Managing Partner at aMoon. “We are excited to take part in this promising endeavor, already showing remarkable results, and join the highly capable management team and strong investors, in bringing this technology to a growing population of patients globally.”

“This latest investment round is yet another testament to our investors’ confidence in our technology,” says Nir Altschuler, CartiHeal’s founder and CEO. “We believe the implant can greatly benefit patients suffering from a variety of cartilage lesions, who wish to return to a painless and active lifestyle, and who currently don’t have good alternatives.”

About Agili-C™

CartiHeal’s cell-free, off-the-shelf implant for use in cartilage and osteochondral defects was implanted in a series of clinical trials conducted in leading centers in Europe and Israel, in over 250 patients with cartilage lesions in the knee, ankle, and great toe. In these trials, the implant was used to treat a broad spectrum of cartilage lesions, as per its CE Mark, from single focal lesions to multiple and large defects in patients suffering from osteoarthritis.

Results of these prior investigations demonstrated the potential for cartilage regeneration and the remodeling of underlying subchondral bone, along with pain and symptom relief.

About CartiHeal

CartiHeal, a privately-held medical device company headquartered in Israel, develops proprietary implants for the treatment of cartilage and osteochondral defects in traumatic and osteoarthritic joints.

The company’s flagship product, Agili-C™, is CE marked and has been recently approved by the FDA for an Investigational Device Exemption (IDE) clinical trial toward a PMA application.

(Logo: http://mma.prnewswire.com/media/451231/CartiHeal_Logo.jpg )

For more information, please contact:
Caty Pearl
Catyp@pearlcom.co.il
+972-9-8810400

SOURCE CartiHeal (2009) Ltd.

Medovex Corporation to Attend The NSpine Main Conference June 12-15, 2017

ATLANTA, GA–(Marketwired – May 8, 2017) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that it will attend The NSpine Main Conference June 12-15, 2017 in London.

The NSpine Main Conference takes place every two years to provide the latest knowledge for spine healthcare professionals. Growing in strength with each meeting, NSpine provides ascendant medical professionals with the supplementary material they need to forge best practice in their careers.

All areas of the meeting are covered comprehensively with parallel sessions being held to allow delegates to tailor their learning experience to their specific needs. Boasting cadaver sessions, workshops, seminars, lunch symposiums and an exhaustive list of lectures and exhibitions by leading practitioners and innovative companies, NSpine endeavours to cater to its delegates’ academic pursuit.

NSpine 2017 will take place in London, UK on June 12-15 and was developed in collaboration with the European Spine Journal, BioSpine, NASS and EANS.

Manfred Sablowski, Senior Vice President Global Sales & Marketing of Medovex, stated, “The NSpine show will be an excellent meeting venue to meet with key surgeons while we continue to prepare for our launch of the DenerveX System. Sablowski went on to say: “The UK market is very important to us since it will be a leading country for our initial entry into Europe once we receive the CE Mark. The Company will conduct both a cadaver lab and a workshop session with advisory board member and leading spine surgeon Dr. Vik Kapoor.”

The Company’s patented DenerveX™ System is not yet commercially available in the EU and the U.S. The DenerveX System is designed to provide longer lasting relief of pain associated with the facet joint. Lower back pain is the second most common cause of disability in the U.S. for adults. Studies indicate that 10% of the U.S. adult population suffers from lower back pain and that 31% of lower back pain is attributed to facet joint pain.

The DenerveX System consists of the DenerveX Device Kit, containing a single use device, and the DenerveX Pro-40 Power Generator. The DenerveX system is designed to provide a minimally invasive treatment option which combines two actions into one device.

DenerveX is not yet CE marked or FDA cleared.

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

CurveBeam Announces FDA 510(k) Clearance for InReach Cone Beam CT Imaging System for the Upper Extremities

WARRINGTON, Pa., May 8, 2017 /PRNewswire/ — CurveBeam announced it has received FDA 510(k) clearance for the InReach, a Cone Beam CT imaging system primarily designed for the hand, wrist & elbow; & lower extremities in non-weight bearing position.

The InReach is an ultra-compact CT scanner that provides high-contrast 3D datasets of bony anatomy, which could potentially replace radiographs as a first line of diagnosis.

Inspired Spine Presents on Groundbreaking OLLIF Procedure at International Spine Surgery Meeting

Inspired Spine recently presented on the Oblique Lateral Lumbar Interbody Fusion (OLLIF) procedure at the International Society for the Advancement of Spine Surgery (ISASS). Dr. Hamid Abbasi, who developed the OLLIF, discussed the revolutionary procedure that has been a dramatic improvement on existing spinal fusion techniques.

At the ISASS meeting April 12-14, 2017, Dr. Abbasi discussed the key findings of Inspired Spine’s study titled “Oblique Lateral Lumbar Interbody Fusion (OLLIF): Technical Notes and Early Results of a Single Surgeon Comparative Study”. The study compared the OLLIF procedure to an open transforaminal lumbar interbody fusion (TLIF) procedure.

Amazingly, the study of 124 patients showed surgery time for the OLLIF was approximately twice as fast as the open TLIF (mean: 135 min) and blood loss was reduced by over 80% compared to TLIF. The OLLIF surgeries were performed with biplanar fluoroscopy with an incision amounting to only one centimeter.

Inspired Spine has continued the data acquisition since the initial 124 patients, with over 500 OLLIF procedures now being performed nationwide. According to Dr. Abbasi “With the OLLIF procedure, we use a tiny incision and don’t cut through the patient’s muscle tissue like traditional procedures. The procedures are faster, have less blood loss and patients experience a dramatically faster recovery with less pain!”

Along with presenting at the meeting, Inspired Spine had two poster presentations as well. One on the Economic Performance of OLLIF and the other on the Minimally Invasive Direct Thoracic Interbody Fusion (MIS-DTIF). The OLLIF procedure saved the hospitals involved over $9500 per case compared to the open TLIF procedure due to the faster OR times and reduced length of stay.

The OLLIF procedure is available to patients nationwide with certified surgeons by calling (877) 378-2828. The full text of the studies is available by visiting http://inspiredspine.com.

About Inspired Spine

Inspired Spine, a Minnesota-based advanced minimally invasive spinal surgery technology developer, has introduced and performed over 500 procedures using revolutionary new technologies and procedures in advanced minimally invasive systems. These new procedures are transforming how spinal surgeries are approached and can replace more traditional “open” spinal fusion surgeries. Inspired Spine is focused on the development of advanced minimally invasive surgical techniques, procedures and other health care technology to minimize or eliminate the physical and economic risks and discomfort that are created by the daily struggles of enduring back pain and its physical limitations.

CONTACTS

For Inspired Spine
David Greene, MBA
(888) 378-2828
dgreene(at)theusleadnetwork(dot)com