Park City, UT

3 days / 6 sessions
Current Issues in Spine

February 2-4, 2017

l_implanet1.jpg

May 3, 2017 OrthoSpineNews

May 03, 2017

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:IMPL) (Euronext: IMPL, FR0010458729, PEA-PME eligible), a medical technology company specializing in vertebral and knee-surgery implants, today announces its new JAZZ™ Standalone implant has been granted approval by the European authorities and obtained the CE Mark.

JAZZ™ Standalone is an implant that further strengthens the Implanet’s freestanding, rod less fixation line, launched in 2016 with the JAZZ™ Lock implant. It is used in the treatment of adult degenerative bone disorders, the largest spine surgery market segment, representing $246 M1 in Europe.

The JAZZ™ Standalone offers fast and simple freestanding posterior fixation to replace traditional fixation systems. Degenerative spine surgery is experiencing strong growth in Europe and the United States, driven by an aging demographic that demands functional restoration in a less invasive manner.

The JAZZ™ Standalone will be incorporated in the JAZZ product range without new investments in equipment or training for surgical teams.

Régis Le Couedic, Implanet’s Product Development & Manufacturing Director, says: “The result of our work with thought leading surgeons, the JAZZ™ Standalone is a new variant of our JAZZ technology devoted to treating degenerative pathologies. This implant utilizes the JAZZ™ Band platform and enables vertebral segments to be stabilized without the need for pedicle screws and rods. This is a fast, simple and safe surgical procedure that only requires limited surgical accessibility.

Ludovic Lastennet, Implanet CEO, adds: “We are continuing to rigorously pursue our execution plan by regularly marketing new products and line extensions. The marketing approval of a major new component of the JAZZ™ Band platform in Europe is another key breakthrough in terms of expanding the range. Indeed, the JAZZ™ Standalone meets a major and persistent demand from surgeons regarding their need to continually simplify surgical procedures. It should rapidly be adopted by our partners, whether they be pediatric surgeons or surgeons specializing in adult degenerative disorders.”

IMPLANET will participate this week in two major Congresses:

Global Spine Congress (degenerative surgery), Milano, Italy, 3 to 6 May 2017

• E-POSNA Congress (pediatric surgery), Barcelona, Spain, 3 to 6 May 2017

Next financial press release: Q2 2017 revenue, on July 18, 2017

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Compartment C of the Euronext™ regulated market in Paris.

1 Source : Company

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Florent Alba, Tel. : +33 (0)1 44 71 94 94
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net


IMG_7900_office-exterior-960x540.jpg

May 2, 2017 OrthoSpineNews

LEESBURG, Va., May 02, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body BalanceTM, today reported financial results for its first fiscal quarter ended March 31, 2017.

First Quarter 2017 Financial Summary:

  • Total Q1 revenue of $61.9 million, up 9.9% year-over-year. Total Q1 revenue increased 10.7% year-over-year on a constant currency basis.
  • Domestic Q1 revenue of $46.2 million, up 9.5% year-over-year, comprised of:
    – U.S. Complex Spine growth of 7.6% year-over-year
    – U.S. Minimally Invasive Surgery (MIS) growth of 14.4% year-over-year
    – U.S. Degenerative growth of 9.4% year-over-year.
  • International Q1 revenue of $15.7 million, up 11.1% year-over-year, or 14.4% on a constant currency basis.
  • Net loss of $10.9 million for the three months ended March 31, 2017, compared to a net loss of $10.2 million in the comparable period last year.
  • Adjusted EBITDA loss of $0.3 million for the three months ended March 31, 2017, compared to Adjusted EBITDA loss of $1.1 million in the comparable period last year.

Year-to-Date 2017 Highlights:

  • On February 15, 2017, the Company introduced Balance ACSTM (or BACSTM), a comprehensive platform featuring products and services that apply three-dimensional solutions across the full continuum of care with the goal of facilitating quality outcomes for patients undergoing spinal surgery. BACS provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal and sagittal planes, emphasizing Total Body Balance as an important component to surgical success.
  • On April 6, 2017, K2M and LifeHealthcare Group Limited announced a new distribution agreement for K2M’s innovative spinal technologies in Australia and New Zealand (ANZ). The K2M/LifeHealthcare distribution partnership dates back to 2010 and has yielded strong growth and a significant spine market position in ANZ. Looking to build on this success, K2M and LifeHealthcare entered into a new five-year agreement with the shared goal of establishing a number one spine market position in ANZ.
  • On April 21, 2017, K2M received key product registrations in Japan from the PMDA, which are now under its control, including the MESA® and EVEREST® product lines.

“We have made significant progress during the first four months of 2017, driving toward our fiscal year growth objectives and achieving multiple operational milestones, which together will enhance our ability to increase our share of the global spine market over time. We reported constant currency revenue growth of 10.7% year-over-year in the first quarter, driven by 10% growth in the U.S. and 14.4% constant currency growth in our international markets,” said President and Chief Executive Officer, Eric Major. “We delivered strong revenue growth in the U.S. in the first quarter, which represents solid performance in light of the 20% U.S. growth we reported in the same period last year, and we continue to believe in our ability to grow U.S. revenue in the mid-teens in 2017. Outside the U.S., we continue to see progress in both Australia and Japan that is in line with our goal of creating a solid foundation for future growth in each of these markets. In April, we announced a new supply agreement with our Australian partner, LifeHealthcare. Later in April, we received product registrations in Japan, that we now control, for key products including our MESA and EVEREST systems. With these registrations, K2M will have an opportunity to implement a new distribution strategy in the entire spine surgery market in Japan.”

First Quarter 2017 Financial Results

  Three Months Ended March 31, Increase/Decrease
($, thousands) 2017 2016 $ Change % Change
% Change
  (as reported)
(constant currency)
United States $46,207 $42,193 $4,014 9.5 % 9.5 %
International 15,678 14,113 1,565 11.1 % 14.4 %
Total Revenue $61,885 $56,306 $5,579 9.9 % 10.7 %

Total revenue for the first quarter 2017 increased $5.6 million, or 9.9%, to $61.9 million, compared to $56.3 million for the first quarter of 2016. Total revenue increased 10.7% year-over-year on a constant currency basis. The increase in revenue was primarily driven by greater sales volume from primarily domestic new surgeon users and newer product offerings, offset partially by lower sales in certain international distributor markets as compared to last year.

Revenue in the United States increased $4.0 million, or 9.5% year-over-year, to $46.2 million, and international revenue increased $1.6 million, or 11.1% year-over-year, to $15.7 million. First quarter 2017 international revenue increased 14.4% year-over-year on a constant currency basis. Foreign currency exchange impacted first quarter international revenue by approximately $0.4 million, representing approximately 329 basis points of international growth year-over-year.

The following table represents domestic revenue by procedure category.

  Three Months Ended March 31, Increase/Decrease
($, thousands) 2017 2016 $ Change % Change
Complex Spine $17,136 $15,930 $1,206 7.6 %
Minimally Invasive 7,872 6,881 991 14.4 %
Degenerative 21,199 19,382 1,817 9.4 %
U.S. Revenue $46,207 $42,193 $4,014 9.5 %

By procedure category, U.S. revenue in the Company’s complex spine, MIS and degenerative categories represented 37.1%, 17.0% and 45.9% of U.S. revenue, respectively, for the three months ended March 31, 2017.

Gross profit for the first quarter of 2017 increased 10.1% to $40.4 million, compared to $36.7 million for the first quarter 2016.  Gross margin was 65.3% for the first quarter of 2017, compared to 65.2% last year. Gross profit includes amortization expense on investments in surgical instruments of $3.5 million, or 5.6% of sales, for the three months ended March 31, 2017, compared to $3.3 million, or 5.8% of sales, for the comparable period last year.

Operating expenses for the first quarter 2017 increased $2.9 million, or 6.1%, to $49.5 million, compared to $46.6 million for the first quarter 2016. The increase in operating expenses was driven primarily by a $2.7 million increase in sales and marketing expenses compared to the comparable period last year.

Loss from operations for the first quarter of 2017 improved  $0.8 million, to $9.1 million, compared to a loss from operations of $9.9 million for the comparable period last year. Loss from operations included intangible amortization of $2.4 million and $2.6 million for each of the first quarters of 2017 and 2016, respectively.

Total other expenses for the first quarter of 2017 increased $1.6 million to $1.8 million, compared to $0.2 million last year. The increase in other expense, net, was primarily attributable to interest expense incurred on the capital lease obligation related to our headquarters and operations facilities as well as the Convertible Senior Notes issued in August 2016, and, to a lesser extent, an increase of $0.4 million year-over-year in unrealized losses from foreign currency re-measurement on intercompany payable balances.  Foreign currency losses impacted operating results compared to last year due to changes in the average exchange rates of the U.S. Dollar, Pound Sterling and Euro applied to intercompany balances in both periods.

Net loss for the first quarter of 2017 was $10.9 million, or $(0.26) per diluted share, compared to a loss of $10.2 million, or $(0.25) per diluted share, for the first quarter of 2016.

As of March 31, 2017, we had cash and cash equivalents of $38.6 million as compared to $45.5 million as of December 31, 2016. We had working capital of $110.4 million as of March 31, 2017 as compared to $115.9 million as of December 31, 2016.

At March 31, 2017, outstanding long-term indebtedness included the carrying value of the Convertible Senior Notes of $37.4 million and the capital lease obligation of $34.7 million. The Company had no borrowings outstanding on the revolving credit facility as of March 31, 2017.

2017 Outlook

The Company is reaffirming its fiscal year 2017 guidance expectations. The Company expects:

  • Total revenue on an as reported basis in the range of $263.0 million to $270.0 million, representing growth of 11% to 14% year-over-year, compared to total revenue of $236.6 million in fiscal year 2016.
  • Total revenue on a constant currency basis is expected to increase 12% to 15% year-over-year in 2017.
  • The Company continues to expect mid-teens growth in its U.S. business in 2017.
  • Total net loss of approximately $34.0 million to $31.0 million, compared to a total net loss of $41.7 million in fiscal year 2016.
  • Adjusted EBITDA in a range of $6.0 million to $10.0 million, compared to Adjusted EBITDA of $0.6 million in fiscal year 2016.

Conference Call

Management will host a conference call at 5:00 p.m. Eastern Time on May 2nd to discuss the results of the first quarter, and to host a question and answer session. Those who would like to participate may dial 877-741-4244 (719-325-4870 for international callers) and provide access code 9971371 approximately 10 minutes prior to the start of the call. A live webcast of the call will also be provided on the investor relations section of the Company’s website at http://Investors.K2M.com/.

For those unable to participate, a replay of the call will be available for two weeks at 888-203-1112 (719-457-0820 for international callers); access code 9971371. The webcast will be archived on the investor relations section of the Company’s website.

About K2M Group Holdings, Inc.

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products; pricing pressures and our ability to compete effectively generally; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in our industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions in our main facility or information technology systems;  our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations;  our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; increased costs and additional regulations and requirements as a result of being a public company; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock due to sales of additional shares by our pre-IPO owners or otherwise; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

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

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

K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
 (In Thousands, Except Share and Per Share Data)
March 31, December 31,
2017 2016
ASSETS
Current assets:
Cash and cash equivalents $ 38,580 $ 45,511
Accounts receivable, net 46,155 46,430
Inventory, net 63,667 61,897
Prepaid expenses and other current assets 7,563 6,147
Total current assets 155,965 159,985
Property, plant and equipment, net 51,614 50,714
Goodwill 121,814 121,814
Intangible assets, net 20,412 22,758
Other assets, net 29,239 28,254
Total assets $ 379,044 $ 383,525
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current maturities under capital lease obligation $ 1,009 $ 973
Accounts payable 20,502 15,367
Accrued expenses 14,619 15,673
Accrued payroll liabilities 9,388 12,068
Total current liabilities 45,518 44,081
Convertible senior notes 37,444 36,894
Capital lease obligation, net of current maturities 34,675 34,933
Deferred income taxes, net 5,017 5,017
Other liabilities 1,047 1,032
Total liabilities 123,701 121,957
Stockholders’ equity:
Common stock, $0.001 par value, 750,000,000 shares authorized; 42,565,112 and 42,282,741 shares issued and 42,556,501 and 42,274,130 shares outstanding, respectively 43 42
Additional paid-in capital 478,796 474,512
Accumulated deficit (221,954 ) (211,081 )
Accumulated other comprehensive loss (1,408 ) (1,771 )
Treasury stock, at cost, 8,611 and 8,611 shares, respectively (134 ) (134 )
Total stockholders’ equity 255,343 261,568
Total liabilities and stockholders’ equity $ 379,044 $ 383,525
K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
 (In Thousands, Except Share and Per Share Data)
Three Months Ended March 31,
2017
2016
Revenue $ 61,885 $ 56,306
Cost of revenue 21,479 19,604
Gross profit 40,406 36,702
Operating expenses:
Research and development 5,250 5,028
Sales and marketing 30,474 27,755
General and administrative 13,754 13,848
Total operating expenses 49,478 46,631
Loss from operations (9,072 ) (9,929 )
Other expense, net:
Foreign currency transaction (loss) gain (27 ) 420
Interest expense (1,732 ) (651 )
Total other expense, net (1,759 ) (231 )
Loss before income taxes (10,831 ) (10,160 )
Income tax expense 42 25
Net loss $ (10,873 ) $ (10,185 )
Basic and diluted $ (0.26 ) $ (0.25 )
Weighted average shares outstanding:
Basic and diluted 42,224,734 41,353,123
K2M GROUP HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
 (In Thousands)
Three Months Ended
March 31,
2017 2016
Net loss $ (10,873 ) $ (10,185 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 7,195 6,743
Provision for inventory reserves 1,146 1,013
Provision for allowance for doubtful accounts (57 )
Stock-based compensation expense 1,541 2,106
Accretion of discounts and amortization of issuance costs of convertible senior notes 32
Changes in operating assets and liabilities:
Accounts receivable 438 (2,862 )
Inventory (1,263 ) (2,139 )
Prepaid expenses and other assets (4,032 ) (2,705 )
Accounts payable, accrued expenses, and accrued payroll liabilities 969 (3,351 )
Net cash used in operating activities (4,847 ) (11,437 )
Investing activities
Purchase of surgical instruments (3,157 ) (3,339 )
Purchase of property, plant and equipment (1,553 ) (6,141 )
Changes in cash restricted for leasehold improvements 61 3,333
Purchase of intangible assets (23 ) (1,282 )
Net cash used in investing activities (4,672 ) (7,429 )
Financing activities
Borrowings on bank line of credit 5,000
Principal payments under capital lease (223 )
Issuances and exercise of stock-based compensation benefit plans, net of income tax 2,744 365
Net cash provided by financing activities 2,521 5,365
Effect of exchange rate changes on cash and cash equivalents 67 32
Net increase in cash and cash equivalents (6,931 ) (13,469 )
Cash and cash equivalents at beginning of period 45,511 34,646
Cash and cash equivalents at end of period $ 38,580 $ 21,177
Significant non-cash investing activities
Leasehold improvements under capital lease $ $ 8,562
Additions to property, plant and equipment $ 750 $ 1,234
Significant non-cash financing activities
Accretion of discount on convertible senior notes $ 550 $
Cash paid for:
Income taxes $ 64 $ 109
Interest $ 1,090 $ 623

K2M GROUP HOLDINGS, INC.
Reconciliation of GAAP to Non-GAAP Measures
(Unaudited)
 (In Thousands)

Use of Non-GAAP Financial Measures

This press release includes the non-GAAP financial measures of revenue in constant currency, Adjusted Gross Profit, and Adjusted EBITDA.

The Company presents these non-GAAP measures because it believes these measures are useful indicators of the Company’s operating performance.  Management uses these non-GAAP measures principally as a measure of the Company’s operating performance and believes that these measures are useful to investors because they are frequently used by analysts, investors and other interested parties to evaluate companies in the Company’s industry.  The Company also believes that these measures are useful to its management and investors as a measure of comparative operating performance from period to period.

Constant currency information compares results between periods as if exchange rates had remained constant period-to-period.  We calculate constant currency by converting the prior-year results using current-year foreign currency exchange rates.

Adjusted Gross Profit represents Gross Profit less amortization expense of surgical instruments.  The Company presented Adjusted Gross Profit because it believes it is a useful measure of the Company’s gross profit and operating performance because the measure is not burdened by the timing impact of instrument purchases and related amortization.

Adjusted EBITDA represents net loss plus interest expense, income tax expense, depreciation and amortization, stock-based compensation expense and foreign currency transaction loss (gain).

The Company presents Adjusted EBITDA because it believes it is a useful indicator of the Company’s operating performance.  Management uses Adjusted EBITDA principally as a measure of the Company’s operating performance and for planning purposes, including the preparation of the Company’s annual operating budget and financial projections.

Adjusted EBITDA is a non-GAAP financial measure and should not be considered as an alternative to net loss as a measure of financial performance or cash flows from operations as a measure of liquidity, or any other performance measure derived in accordance with GAAP and it should not be construed as an inference that the Company’s future results will be unaffected by unusual or non-recurring items.  In addition, Adjusted EBITDA is not intended to be a measure of free cash flow for management’s discretionary use, as it does not reflect certain cash requirements such as tax payments, debt service requirements, capital expenditures and certain other cash costs that may recur in the future.  Adjusted EBITDA contains certain other limitations, including the failure to reflect the Company’s cash expenditures, cash requirements for working capital needs and cash costs to replace assets being depreciated and amortized.  In evaluating Adjusted EBITDA, you should be aware that in the future the Company may incur expenses that are the same as or similar to some of the adjustments in this presentation.  The Company’s presentation of Adjusted EBITDA should not be construed to imply that the Company’s future results will be unaffected by any such adjustments.  Management compensates for these limitations by primarily relying on its GAAP results in addition to using Adjusted EBITDA supplementally.  The Company’s definition of Adjusted EBITDA is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation.

The following table presents reconciliations of gross profit to adjusted gross profit and net loss to Adjusted EBITDA for the periods presented.

Three Months Ended March 31,
2017 2016
Reconciliation from Gross Profit to Adjusted Gross Profit
Gross profit $ 40,406 $ 36,702
Surgical instrument amortization 3,464 3,272
Adjusted gross profit (a Non-GAAP Measure) $ 43,870 $ 39,974
Three Months Ended March 31,
2017 2016
Reconciliations from Net Loss to Adjusted EBITDA
Net loss $ (10,873 ) $ (10,185 )
Interest expense 1,732 651
Income tax expense 42 25
Depreciation and amortization 7,195 6,743
Stock-based compensation expense 1,541 2,106
Foreign currency transaction loss (gain) 27 (420 )
Adjusted EBITDA (a Non-GAAP measure) $ (336 ) $ (1,080 )

The following table presents a reconciliation of net loss to Adjusted EBITDA for our 2017 guidance:

Year Ended
December 31,
2017
Net loss $ (32,450 )
Interest expense 6,700
Income tax expense 100
Depreciation and amortization 27,500
Stock-based compensation expense 6,150
Foreign currency transaction loss
Adjusted EBITDA $ 8,000

The reconciliation assumes the mid-point of the Adjusted EBITDA range and the midpoint of each component of the reconciliation, corresponding to guidance of $6.0 million to $10.0 million for 2017.

Investor Contact:
Westwicke Partners on behalf of K2M Group Holdings, Inc.
Mike Piccinino, CFA
443-213-0500

Expanding_Orthopedics_FLXfit_WEB.jpg

May 2, 2017 OrthoSpineNews

OR AKIVA, Israel, May 2, 2017 /PRNewswire/ —

Expanding Orthopedics Inc. (EOI), a privately held medical device company focused on developing and commercializing innovative expandable devices for spine surgery, today announced a significant increase in new surgeon users in Q1 has led to record revenues in the sales of their FLXfit™ 3D Expanding TLIF Cage, achieving its largest revenue quarter to date.

Dale Binke, Vice President of US Sales, commented, “Our record breaking quarter was highlighted by strong clinical acceptance which accelerated our growth in both MIS and open surgical approaches.” He explained that “As we build the sales organization, we have been able to recruit and retain best in class distributors and sales agents. They recognize that FLXfit™ offers features that no other cage on the market can rival, which provides tremendous value with surgeon satisfaction and surgeon retention.”

Ofer Bokobza, CEO of Expanding Orthopedics, commented, “Our growth and rapid expansion is fueled by surgeons’ pursuit to provide the best care to their patients”.  Ofer explained “FLXfit™ provides clear differentiation over competitive expandable cages. The large footprint design coupled with a unique expansion mechanism helping to restore and retain lordosis leading to sagittal alignment”. He concluded “Additional product releases this year will continue our strong growth for 2017.”

About Expanding Orthopedics Inc.

Expanding Orthopedics Inc. is a medical device company developing and marketing innovative products designed to address unmet clinical needs for spine care and improve long-term patients’ outcome. The Company is spearheaded by a seasoned management team, and is backed by prominent spine surgeons. EOI owns a broad patent portfolio around anatomically fit, expandable devices for enhanced stability through a minimally invasive approach.

Contact info:
David Elkaim, VP Marketing and Sales
E-mail: david@xortho.com
Phone: +1(347)3219683

SOURCE Expanding Orthopedics Inc. (EOI)


Membrane.jpg

May 2, 2017 OrthoSpineNews

Phoenix – May 2, 2017 — Axolotl Biologix, an innovator in regenerative medicine technologies that improve patient outcomes with less pain and lower costs, today announced that it has begun shipping its second amniotic allograft product, AxoBioMembrane™, to meet a wide range of wound care needs.

AxoBioMembrane is a dehydrated human amniotic membrane allograft that helps accelerate and improve soft tissue repair, while helping inhibit bacteria and infection, inflammation, and scar tissue formation. Containing extracellular matrix components and providing a natural biological wound barrier, AxoBioMembrane offers many clinical applications in wound care for surgical, orthopedic, podiatric, ophthalmic, maxillofacial and other applications.

AxoBioMembrane is available for order immediately in three standard sizes 1×2 cm, 2×3 cm, and 4×4 cm, as well as custom sizes which may be ordered.

“Launching our second new amnion-derived product so far this year, we are excited to be rapidly building a portfolio of regenerative treatment products that provide significant improvement in patient outcomes, while delivering high value for clinicians,” noted Bob Maguire, founder and CEO of Axolotl Biologix.

About Axolotl Biologix, Inc.

Axolotl Biologix, Inc., is expanding the human body’s ability to regenerate by developing and manufacturing regenerative human cell and tissue medical technologies that are disrupting traditional, more invasive, painful, and expensive treatment protocols.  The Phoenix-based company is rapidly building a portfolio of unique, patented regenerative treatment products to improve patient outcomes with less pain and lower costs.  For more information, please visit the company’s website at www.axobio.com.

 

Media:

bsamson@axobio.com

714-955-3951


CEO-Jeffrey-Eugene-Rose-And-Pamela-Annette-Rose-Convicted-Of-Conspiracy-Health-Care-Fraud-1.jpg

May 2, 2017 OrthoSpineNews

 – April 27, 2017

A southern California practice management company called Monarch Medical Group used to advertise that it could provide physicians with new revenue streams from transdermal pain creams, oral medication dispensing, and urine drug-screening tests.

Those revenue streams could lead to prison for 21 physicians charged in a California state court last week with fraudulently billing workers’ compensation insurers for these ancillary services and accepting kickbacks for patient referrals. It was all part of a scheme allegedly masterminded by Tanya King and her husband, Christopher King, owners of Monarch Medical Group and related companies, according to state prosecutors and the California Department of Insurance (CDI).

The Kings also were charged in the case, as were two pharmacists who owned a pharmacy and a physician assistant.

“The Kings and their co-conspirators played with patients’ lives, buying and selling them for profit without regard to patient safety,” said CDI Commissioner Dave Jones in a news release.

From 2011 to 2015, the operation fraudulently billed insurers for $40 million and collected more than $23 million for services rendered to some 13,000 patients. The 21 physicians netted almost $2.2 million in kickbacks, which were labelled as marketing expenses to make them look legitimate, prosecutors said. The average age of the physicians was 57.

Buy for $40, Bill for $700

The scams alleged by prosecutors were based on the three ancillary services that Monarch Medical Group advertised on its website.

 

READ THE REST HERE


Hadassah-Surgeons-Perform-Worlds-First-Ever-Dual-Robotic-Surgery-in-Jerusalem-768x432.jpg

May 2, 2017 OrthoSpineNews

NEW YORK, April 28, 2017 /PRNewswire-USNewswire/ — The world’s first-of-its-kind dual robotic surgery was performed on April 23 at Hadassah Hospital Ein Kerem in Jerusalem, announced  National President Ellen Hershkin of Hadassah, the Women’s Zionist Organization of America, Inc. (HWZOA).

The revolutionary dual robotic surgery assisted in the repair of a severe spinal fracture suffered by Aharon Schwartz, 42, a factory worker in Jerusalem who was injured when a steel object pinned him to the ground, fracturing his leg in two places and breaking six of his spinal vertebrae.  The 3-hour surgery took place in the state-of-the-art $30M underground hybrid operating theater at Hadassah’s Sarah Wetsman Davidson Hospital Tower.

Dr. Meir Liebergall, Chairman of the Hadassah Medical Organization’s (HMO) Orthopedic Department and head of HMO’s Musculo-Skeletal Medicine Division, explained the pioneering surgery.  “Two robots, Siemens’ Artis Zeego and the Mazor Robotics’ Renaissance® Guidance System, were involved in the surgery.  Artis Zeego, overseen by Dr. Amal Khouri, Director of HMO’s Orthopedic Hospitalization Center, provided real-time 3-dimensional imaging during the surgical procedure, which eliminated the need for pre-surgery CT scans and post-surgery X-rays. Renaissance® Guidance System, a screw placement system which allows spinal implant placement with maximum safety and accuracy, was controlled by HMO Sr. Orthopedic Surgeon Dr. Josh Schroeder. Renaissance communicated with Artis Zeego during the minimally-invasive surgery while Dr. Schroeder led the Hadassah orthopedic team in the insertion of eleven pedicle screws into the patient’s spine with clinical exactitude.”

Dr. Liebergall predicted that patient Schwartz will completely recover from the surgery and will be walking again very shortly.

Hershkin states, “Once again, HMO achieves another world-first – a dual robot-assisted spinal surgery, solidifying its reputation for world class medical innovation and treatment.  Our congratulations go to Dr. Liebergall and his brilliant surgical team for continuing Hadassah’s mission of bringing ground-breaking medical care to the people of Israel.”

The Mazor Robotics Renaissance® Guidance System transforms spine surgery from freehand procedures to highly-accurate, state-of-the-art procedures that may reduce fluoroscopy—even for minimally-invasive surgery (MIS), scoliosis, and other complex spinal deformity cases.

The Siemens Artis Zeego® Robotic Technology enables smoother, swifter and trouble-free patient positioning and execution procedures.

Hadassah, the Women’s Zionist Organization of America, Inc. (HWZOA) is the largest Jewish women’s organization in the United States. With 330,000 members, associates and supporters Hadassah brings Jewish women together to effect change and advocate on critical issues such as medical care and research and women’s empowerment. Through the Hadassah Medical Organization’s two hospitals, the world-renowned trauma center and the leading research facility in Jerusalem, Hadassah supports the delivery of exemplary patient care to over a million people every year. HMO serves without regard to race, religion or nationality and earned a Nobel Peace Prize Nomination in 2005 for building “bridges to peace” through equality in medical treatment. For more information, visit www.hadassah.org.

SOURCE Hadassah, The Women’s Zionist Organization of America, Inc. (HWZOA)

Related Links

http://www.hadassah.org


Cleveland-Clinic-Heart-Center_Feb-2006.jpg

May 2, 2017 OrthoSpineNews

By Maria Castellucci  | May 1, 2017

Dr. Toby Cosgrove, the longtime CEO of the Cleveland Clinic, announced on Monday he will be stepping down by the end of this year.

A succession process for his replacement has now begun and Cosgrove will stay on at the clinic in an advisory role, according to a news release. The clinic also said his successor will be a practicing physician, keeping up with the system’s long history as a physician-led institution.

“It is an honor and a privilege to be a part of an extraordinary and forward-thinking organization that puts patients at the center of everything we do,” Cosgrove said in statement.

During his nearly 13 years at the helm, Cosgrove led the prestigious institution through widespread expansion. But his tenure has also been marred with controversy, especially recently due to his ties with the Trump administration.

Under his leadership, revenue at the clinic grew from $3.7 billion in 2004 to $8.5 billion in 2016. He oversaw growth by establishing multiple new locations nationwide and internationally, including setting up services in Canada and Abu Dhabi.

The number of physician-scientists nearly doubled under his leadership from 1,800 to 3,400. And total visits to the clinic increased from 2.8 million to 7.1 million.

 

READ THE REST HERE


prolift.jpg

May 2, 2017 OrthoSpineNews

May 02, 2017

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders, announced today continued growth of their micro invasive expandable interbody, ProLift. “With the introduction of ProLift to the market in Q2 of 2016, we have since consistently doubled our sales growth quarter over quarter,” said Mariusz Knap, Vice President of Marketing for Life Spine. “We are excited about the adoption of ProLift, and will continue to focus on technological advancements that strive to improve surgical efficiencies and outcomes through procedural based and micro invasive expandable solutions. Products such as ProLift are the core competencies which we will continue to drive for our procedural based product portfolios.”

ProLift, a titanium expandable posterior interbody solution allows for in-situ expansion for restoration of normal anatomic disc height and decompression of neural elements. ProLift, used in conjunction with CALYPSORetractor and CENTERLINE® Cortical Bone Screws, provides the surgeon minimal tissue disruption while achieving surgical goals.

Zeshan Hyder, D.O., of Bone and Joint Specialists of Northwest Indiana notes,“The continued evolution of MIS surgery to reduce tissue morbidity and restore anatomical alignment, especially in severe degenerative and collapsed disc, is being achieved in my practice with the expandable technologies such as ProLift, and the lateral system LONGBOW®. Both of these systems reduce the requirements for multiple instrument passes by important neural structures while maintaining my surgical goals and positive patient outcomes.”

ProLift continues Life Spine’s commitment of offering innovative micro invasive procedural solutions to better improve patients’ lives. In addition, Life Spine launched its new website highlighting their complete core and micro invasive procedural solutions. The website is a staple to the new look of Life Spine, and helps surgeons access information about advancements in surgical innovations.

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.

Contacts

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


pete-petit-chairman-ceo-mimedx-group.jpg

May 1, 2017 OrthoSpineNews

MARIETTA, Ga., May 1, 2017 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative biologics utilizing human placental tissue allografts and patent-protected processes for multiple sectors of healthcare, announced today it has received the Innovative Technology Supplier of the Year Award from Vizient, Inc., the nation’s largest member-driven health care improvement company in the country.  The award recognizes MiMedx for its positive impact on patient care provided through Vizient members in 2016. The award was presented earlier this month at the 2017 Vizient Supplier Summit.

The award honors MiMedx for the high level of member adoption of the EpiFix® dehydrated Human Amnion/Chorion Membrane (dHACM) allograft, which received an Innovative Technology contract in May 2015. The contract was based on recommendations from experts at Vizient member hospitals that the MiMedx allograft offers unique and incremental benefit over other products available on the market today.

Chris Cashman, MiMedx Executive Vice President and Chief Commercialization Officer, said, To be chosen as one of three finalists and then be selected as the top supplier in this category is something for which we are very proud.  MiMedx received this recognition for a number of reasons. There has been a very wide adoption of our technology by Vizient members, and utilization within our contract with Vizient has grown by over 500% since its inception in 2015. We have seen the utilization of our allografts produce many extremely positive outcomes and improvements in patient care.”

Vizient’s diverse membership base includes academic medical centers, pediatric facilities, community hospitals, integrated health delivery networks and non-acute health care providers, and represents more than $100 billion in annual aggregate purchasing volume.

“We are pleased to recognize MiMedx Group, Inc. with the Innovative Technology award for 2016. This achievement reflects their commitment to bringing innovative products to the market and to our members that offer improvements to patient care,” said Pete Allen, Executive Vice President, Sourcing Operations for Vizient. “MiMedx has backed their innovative products with clinical support and service excellence that has helped them to be widely adopted as a part of delivering exceptional care for patients by organizations within our membership.”

Bill Taylor, MiMedx President and COO, noted, “We have built a strong relationship with Vizient since contract inception as demonstrated by the significant utilization growth. We are pleased to work with Vizient, and share a common goal with them to improve patient outcomes while controlling costs. Vizient brings clinical and cost effective resources to hospitals, health systems, physician practices and other entities they serve. Our allografts have been recognized for improving patient outcomes, reducing costs and eliminating waste. We believe our mutual focus to this cause has contributed to our rapid growth and success with Vizient.”

About MiMedx

MiMedx® is an integrated developer, processor and marketer of patent protected and proprietary regenerative and therapeutic biopharmaceutical products processed from donated placental tissues. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization.  MiMedx is the leading supplier of placental tissue, having supplied over 800,000 allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes statements that look forward in time or that express management’s beliefs, expectations or hopes.  Such statements are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These statements include, but are not limited to, the the positive outcomes and improvements in patient care produced by MiMedx products, the Company’s belief that the focus on clinical and cost effectiveness by both the Company and Vizient has contributed to the Company’s rapid growth and success with Vizient.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the results achieved utilizing MiMedx products may vary, the focus on clinical and cost effectiveness by MiMedx may not have contributed to the Company’s rapid growth and success with Vizient or may not continue to result in growth and success with Vizient, MiMedx allografts may not continue to be cost effective, and the risk factors detailed from time to time in the Company’s periodic Securities and Exchange Commission filings, including, without limitation, its 10-K filing for the fiscal year ended December 31, 2016.  By making these forward-looking statements, the Company does not undertake to update them in any manner except as may be required by the Company’s disclosure obligations in filings it makes with the Securities and Exchange Commission under the federal securities laws.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com


ofx-Billboard-Intro-Layer2.jpg

May 1, 2017 OrthoSpineNews

May 01, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a diversified, global medical device company, today announced the launch of JuniOrtho, a new pediatric brand focused on solutions for children and young adults with orthopedic and congenital deformities. The Company will unveil “JuniOrtho, paediatrics powered by Orthofix at the EPOSNA annual meeting in Barcelona on May 3, 2017.

Designed to be the link between surgeons, parents and children, Orthofix is bringing products and resources together under the JuniOrtho brand to give medical professionals and families alike the best in pediatric orthopedic solutions.

“With a long history of developing innovative and cutting edge extremity fixation technologies, Orthofix has now brought all of our pediatric expertise and products together under the JuniOrtho banner,” said Davide Bianchi, President of the Extremity Fixation strategic business unit. “This launch represents much more than our products; it’s also a commitment to be a resource for surgeons and the parents and caregivers of pediatric patients before, during and after surgery.”

As part of the JuniOrtho brand launch, the company has developed new resources to help educate families and enable them to make informed decisions regarding their child’s surgery. These include:

  • JuniOrtho website – www.juniortho.club featuring tools and resources for families and medical professionals
  • www.limbhealing.com – educational website dedicated to providing information about deformity correction featuring patient stories and useful resources
  • Age appropriate apps, games, coloring sheets, comic books and literature to help young patients understand and be comfortable with their orthopedic procedures

“For parents, the decision to have surgery for a child is a big one. Typically, they come to the surgery consultation after doing some online research regarding their child’s condition and of course they have a lot of questions,” said Christopher Iobst, Director, Center for Limb Lengthening and Reconstruction, Nationwide Children’s Hospital and Clinical Associate Professor of Orthopedic Surgery at The Ohio State University College of Medicine. “Having patient resources such as websites, activity sheets and games is a great way to provide children and their parents with additional insight.”

The JuniOrtho team at Orthofix boasts an unrivalled level of in-house expertise in the field of pediatric orthopedics that began in the late 1970s in Verona, Italy with orthopedic researcher Giovanni De Bastiani. He established the concept of “dynamization,” based on the natural ability of the bone to repair itself. De Bastiani developed a modular system of external axial frame devices that could be fitted to a bone, allowing micromovement at the fracture site to stimulate bone healing. Along with a few colleagues, De Bastiani founded Orthofix in 1980 in order to continue the development of these devices.

The first product commercialized by the Company was the Limb Lengthener, a pediatric extremity fixation product to correct bone deformities (lengthening). Since launching the first pediatric products in the early ’80s, Orthofix has brought to market more than 35 devices to help adults and children suffering from deformities and trauma to bones of the extremities.

Today, Orthofix’s JuniOrtho solutions consist of a wide-range of products designed for children and young adults. Flagship products in this family include the TL HEX TrueLok Hexapod system and the Guided Growth plating systems that are available in more than 70 countries around the world.

Orthofix invites those attending the EPOSNA Annual Meeting to visit Booth #17 to learn more about JuniOrtho products and resources.

About Orthofix

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

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements. The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks described in the “Risk Factors” section of our Annual Report on Form 10-K for the fiscal year ended December 31, 2016, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix, Inc.
Investor Relations:
Mark Quick, 214-937-2924
markquick@orthofix.com
or
Media Relations:
Denise Landry, 214-937-2529
deniselandry@orthofix.com