28 Apr

MiMedx Announces Record Results For First Quarter Of 2017

MARIETTA, Ga., April 28, 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 its record results for the quarter ended March 31, 2017. First Quarter 2017 Highlights
  • Revenue grew 36% over Q1 2016 revenue
  • Revenue of $72.6 million exceeds upper end of MiMedx guidance range
  • Wound Care revenue of $54.9 million grew 40% over Q1 2016
  • Surgical, Sports Medicine and Orthopedics (SSO) revenue of $17.7 million grew 26% over Q1 2016
  • 24th of last 25 quarters of meeting or exceeding revenue guidance
  • Gross profit margin of 88%
  • Net income of $4.3 million is a 261% increase over Q1 2016
  • Positive Net Cash Flow From Operations of $10.6 million compared to negative $1.0 million in Q1 2016
  • 21st consecutive quarter of positive Adjusted EBITDA*
  • Adjusted Net Income* of $7.4 million is a 51% increase over Q1 2016
  • Adjusted EBITDA* of $12.4 million is a 37% increase over Q1 2016

* See the accompanying tables for definitions of each Non-GAAP metric. Reconciliations of GAAP Net Income to Adjusted EBITDA, GAAP Gross Margin to Adjusted Gross Margin, and GAAP Net Income to Adjusted Net Income and Adjusted Diluted Net Income Per Share appear in the tables below. These non-GAAP measures include, but are not limited to, adjustments for non-cash charges associated with purchase accounting related to the Stability Biologics acquisition, normalization of tax expense, one-time non-recurring cash charges and share based compensation expense.

Results for First Quarter Ended March 31, 2017 The Company recorded record revenue for the 2017 first quarter of $72.6 million, a $19.2 million or 36% increase over 2016 first quarter revenue of $53.4 million. The Company's gross margin for the quarter ended March 31, 2017, was 88%, as compared to the 85% gross margin in the first quarter of 2016. Net Income for the first quarter of 2017, was $4.3 million, or $.04 per diluted common share, a $3.1 million or 261% increase, as compared to Net Income of $1.2 million, or $0.01 per diluted common share in the first quarter of 2016.  Adjusted EBITDA* for the quarter ended March 31, 2017, was $12.4 million, a $3.3 million or 37% improvement, as compared to Adjusted EBITDA* of $9.1 million for the first quarter of 2016. Management Commentary on Results Parker H. "Pete" Petit, Chairman and CEO stated, "We are pleased to have exceeded the top end of our revenue guidance and to have recorded very solid performance on our revenue and profit growth. In light of the impact of the normal seasonality that the market experiences in the first quarter of the year, we are especially satisfied with our growth. With respect to our profit performance, our first quarter GAAP Net Income grew by well over 250% compared to Q1 2016, our Adjusted Net Income grew by 51% over the first quarter of 2016, and our Adjusted EBITDA* grew by 37% over Q1 2016. We expect our profit metrics as a percent of revenue to increase as the year progresses." Bill Taylor, President and COO, said, "Both of our sales verticals had strong growth with Wound Care revenue increasing by 40% over the first quarter of 2016 and SSO growing by 26% compared to the first quarter of last year. We are also extremely pleased with our strong operating cash flow performance compared to last year's first quarter. Our cash flow from operations was $10.6 million, compared to a negative $1.0 million in the first quarter of 2016.  We had another very favorable decline in Days Sales Outstanding (DSO) in our Accounts Receivable during the quarter, which continued the trend experienced in the last half of 2016." "Our three new products introduced during 2016, EpiCord®, our new dehydrated human umbilical cord allograft, AmnioFill®, the first product in the MiMedx placental collagen matrix product family to be commercially launched, and OrthoFlo Lyophilized, an extension of the Company's amniotic fluid product family, are proving to be very impactful in pursuing our market penetration initiatives. We believe the performance of these new products during the first quarter is solid evidence of the contribution they will deliver during 2017 and beyond," added Taylor. Petit commented, "I believe that our shareholders are beginning to realize the very productive asset base that the Company has developed over the last six years.  We have developed the management staff, the technology and the intellectual property to smoothly transition our focus towards becoming predominantly a biopharma company.  In addition, our asset base includes the technology differentiator in that it embodies over 220 proteins, the primary methods of action for which we have scientifically proven.  We have also demonstrated the clinical effectiveness of these proteins through approximately 30 different peer reviewed publications.  That is a significant head start in terms of having the resources necessary to proceed down the Investigational New Drug/Biologics License Application (IND/BLA) regulatory pathways for numerous new therapeutic applications of our technology.  As shareholders should be aware, we are completing the phase IIb studies on our first IND for plantar fasciitis.  We will soon be entering our phase III trials.  We have indicated our plans to very shortly file additional INDs on other sports medicine related therapies.  We have indicated some of the areas of focus that will be longer-term opportunities for the Company from the same regulatory approval process.  Your management is quite enthusiastic about our recently announced strategic focus.  We will continue to advise you as our progress in this new strategic area develops." Share Repurchase Program From the May 2014 inception of the Share Repurchase Program through December 31, 2016, the Company acquired $56.1 million in repurchased shares. During the first quarter of 2017, the Company continued to acquire its shares through the Company's Share Repurchase Program by repurchasing an additional $12.6 million of its shares. Also during the quarter, the Company's Board of Directors authorized an increase of $20 million to the Company's Share Repurchase Program. With the first quarter authorizations made by the MiMedx Board, the total amount authorized for the Company's Share Repurchase Program to date is $86 million. Liquidity and Cash Flow Cash on hand as of March 31, 2017, was $30.9 million, as compared to $15.1 million as of March 31, 2016. Net working capital as of March 31, 2017 decreased $3.5 million to $72.3 million, as compared to $75.8 million as of December 31, 2016.  The Company recorded positive net cash flow from operating activities of $10.6 million for the quarter ended March 31, 2016 due primarily to increased Adjusted EBITDA*. GAAP Earnings The Company recorded Net Income of $4.3 million for the quarter ended March 31, 2017, or $0.04 per diluted common share, as compared to Net Income of $1.2 million, or $0.01 per diluted common share, for the quarter ended March 31, 2016.  R&D expenses for the first quarter of 2017 were $4.2 million or 6% of Net Sales, an increase of $1.7 million over first quarter 2016 R&D expenses of $2.5 million. Selling, general and administrative ("SG&A") expenses for the first quarter of 2017 were $52.9 million, a $12.3 million increase over first quarter of 2016 SG&A expenses of $40.6 million.  Increases in SG&A were due to the continuation of the buildup of the Company's direct sales force in Wound Care and SSO sales channels, as well as litigation costs. Revenue Breakdown The Company distinguishes revenue in two categories: (1) Wound Care and (2) SSO, which includes Original Equipment Manufacturer ("OEM") applications. For first quarter of 2017, Wound Care revenue was $54.9 million, representing 75.6% of total revenue, and SSO (including OEM) revenue was $17.7 million, representing 24.4% of total revenue. Second Quarter and Full Year 2017 Guidance Highlights MiMedx provided its revenue guidance for the second quarter of 2017, increased the low end of its revenue guidance range for full year 2017, and reiterated the remaining full year 2017 guidance that was previously communicated. The Company's second quarter and full year 2017 guidance includes:
  • Second quarter of 2017 revenue forecasted to be in the range of $73.5 to $75 million
  • 2017 revenue guidance in the range of $303.5 to $307 million
  • Gross profit margins for 2017 expected to be in the range of 86% to 88%
  • 2017 Operating Earnings forecasted to grow by 90% or greater
  • GAAP EPS for 2017 projected to be in the range of $0.18 to $0.20
  • Adjusted EPS* for 2017 projected to be in the range of $0.31 to $0.33
  • 2017 GAAP Net Earnings expected to grow in excess of 95%
  • 2017 Adjusted EBITDA* expected to be in the range of 21% to 23% of revenue
"Our strong first quarter performance and market momentum gives us a high level of confidence in meeting or exceeding our expectations for 2017," concluded Petit. Earnings Call MiMedx management will host a live broadcast of its first quarter of 2017 results conference call on Friday, April 28, 2017, beginning at 10:30 a.m. eastern time.  A listen-only simulcast of the MiMedx Group conference call will be available on-line at the Company's website at www.mimedx.com.  A 30-day on-line replay will be available approximately one hour following the conclusion of the live broadcast.  The replay can also be found on the Company's website at www.mimedx.com. Use of Non-GAAP Financial Measures Management has disclosed adjusted financial measurements in this press announcement that present financial information that is not in accordance with generally accepted accounting principles ("GAAP").  These measurements are not a substitute for GAAP measurements, although Company management uses these measurements as aids in monitoring the Company's on-going financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against other medical technology companies. For a reconciliation of these non-GAAP financial measures to the most directly comparable GAAP financial measure, see the accompanying tables to this release.  Adjusted financial measures used by the Company may be calculated differently from, and therefore may not be comparable to, similarly titled measures used by other companies.  Investors should consider adjusted measures in addition to, and not as a substitute for, or superior to, financial performance measures prepared in accordance with GAAP. 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. 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 Company's financial expectations for the second quarter and full year 2017,  the contributions that new products will make in the Company's future performance, that shareholders are beginning to realize the  productive asset base that the Company has developed over the last six years, that the Company's development of the IT and management staff, technology and intellectual property will enable it to smoothly transition its focus towards becoming predominantly a biopharma company, that the Company's assets include the technology differentiator, that the Company has a significant head start on having the resources necessary to proceed down the IND/BLA regulatory pathways, that the Company expects to file additional INDs and the areas of focus will be longer-term opportunities for the Company, and that the strong first quarter performance and market momentum gives management a high level of confidence in its ability to meet or exceed expectations for 2017.  Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include that the Company's revenue may not grow as expected or may decline; even if revenue is achieved, the Company may not be able to achieve its other financial metrics; physician acceptance of new products may not continue and  the Company's new products may not contribute to financial results as predicted; the asset base developed by the Company may not contribute to the Company's success as predicted and/or may not help it transition to a biopharma company as predicted; new products from other companies may be commercialized which are able to achieve similar results to the Company's products; there may be delays in filing for regulatory approval or the anticipated filings may not be made at all; regulatory approvals may be delayed or may not occur at all; the benefits associated with the Company's perceived head start on proceeding down certain regulatory pathways may not materialize; the momentum gained in the first quarter may not continue for subsequent quarters; 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.  

MIMEDX GROUP, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share data)

 March 31, 2017 (unaudited) 

 December 31, 2016 

ASSETS

Current assets:

Cash and cash equivalents

$            30,924

$           34,391

Accounts receivable, net

66,846

67,151

Inventory, net

16,050

17,814

Prepaid expenses 

6,878

5,894

Other current assets

1,200

1,288

   Total current assets

121,898

126,538

Property and equipment, net of accumulated depreciation

13,763

13,786

Goodwill

20,203

20,203

Intangible assets, net of accumulated amortization

22,788

23,268

Deferred tax asset, net

9,530

9,114

Deferred financing costs and other assets

309

354

    Total assets

$          188,491

$         193,263

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities:

Accounts payable

$            10,892

$           11,436

Accrued compensation

11,602

12,365

Accrued expenses

9,940

10,941

Current portion of earn out liability

8,740

8,740

Income taxes

7,839

5,768

Other current liabilities

587

1,482

    Total current liabilities

49,600

50,732

Earn out liability

8,769

8,710

Other liabilities

1,086

821

    Total liabilities

59,455

60,263

Commitments and contingencies 

Stockholders' equity:

  Preferred stock; $.001 par value; 5,000,000 shares authorized and 0  shares issued and outstanding

-

-

  Common stock; $.001 par value; 150,000,000 shares authorized; 111,195,825 issued and 110,840,873  outstanding at March 31, 2017 and 110,212,547 issued and 109,862,787 outstanding at December 31, 2016

111

110

  Additional paid-in capital

153,735

161,261

  Treasury stock at cost: 354,952 shares at March31, 2017 and 349,760 shares at December 31, 2016

(2,982)

(2,216)

  Accumulated deficit

(21,828)

(26,155)

    Total stockholders' equity

129,036

133,000

      Total liabilities and stockholders' equity

$          188,491

$         193,263

MIMEDX GROUP, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS

(in thousands, except share and per share data) 

(unaudited)

Three Months Ended March 31,

2017

2016

Net sales

$            72,607

$          53,367

Cost of sales

8,743

7,946

Gross margin

63,864

45,421

Operating expenses:

Research and development expenses

4,202

2,496

Selling, general and administrative expenses

52,951

40,648

Amortization of intangible assets

526

810

Operating income 

6,185

1,467

Other expense, net

Interest expense, net

(145)

(56)

Income before income tax provision

6,040

1,411

Income tax provision (expense) benefit

(1,713)

(214)

Net Income

$              4,327

$            1,197

Net income per common share - basic

$                0.04

$              0.01

Net income per common share -  diluted

$                0.04

$              0.01

Weighted average shares outstanding - basic

105,708,526

105,538,271

Weighted average shares outstanding -  diluted

113,730,591

112,039,860

MIMEDX GROUP, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

Three Months Ended March 31,

2017

2016

Cash flows from operating activities:

Net income

$               4,327

$              1,197

 Adjustments to reconcile net income to net cash from operating activities:

  Depreciation

946

734

  Amortization of intangible assets

526

810

  Amortization of inventory fair value step-up

75

734

  Amortization of deferred financing costs

45

49

  Share-based compensation

4,671

4,615

  Change in deferred income taxes

(416)

  Increase (decrease) in cash, net of effects of acquisition, resulting from changes in:

    Accounts receivable

305

1,874

    Inventory

1,689

(264)

    Prepaid expenses 

(984)

(2,066)

    Other current assets

87

209

    Accounts payable

(379)

(4,265)

    Accrued compensation

(763)

(5,640)

    Accrued expenses

(942)

493

    Income taxes

2,071

411

    Other liabilities

(618)

132

Net cash flows from operating activities

10,640

(977)

Cash flows from investing activities:

  Purchases of equipment

(923)

(2,008)

  Purchase of Stability Inc., net of cash acquired

-

(7,631)

  Fixed maturity securities redemption

-

500

  Patent application costs

(46)

(147)

  Net cash flows from investing activities

(969)

(9,286)

Cash flows from financing activities:

  Proceeds from exercise of stock options

1,865

1,138

  Stock repurchase under repurchase plan

(12,666)

(3,530)

  Stock repurchase for tax withholdings on vesting of restricted stock

(2,327)

(684)

  Deferred financing costs

-

(20)

  Payments under capital lease obligations

(10)

(10)

Net cash flows from financing activities

(13,138)

(3,106)

Net change in cash

(3,467)

(13,369)

Cash and cash equivalents, beginning of period

34,391

28,486

Cash and cash equivalents, end of period

$             30,924

$            15,117

MIMEDX GROUP, INC. AND SUBSIDIARIES

Non-GAAP Financial Measures and Reconciliation

In addition to our GAAP results, we provide certain Non-GAAP metrics including Adjusted EBITDA, Adjusted Gross Margin, Adjusted Net Income and Adjusted Diluted Net Income per share. We believe that the presentation of these measures provides important supplemental information to management and investors regarding our performance.   These measurements are not a substitute for GAAP measurements, although Company management uses these measurements as aids in monitoring the Company's on-going financial performance from quarter-to-quarter and year-to-year on a regular basis and for benchmarking against other medical technology companies. Adjusted EBITDA consists of GAAP Net Income excluding: (i) depreciation and amortization, (ii) interest income and expense, (iii) income taxes,  (iv) one time acquisition related costs, (v) the effect of purchase accounting due to acquisitions and (vi) share-based compensation expense.   Due to the impact of the acquisition of Stability in January 2016 and the release of the valuation allowance on the deferred tax asset on reported tax expense in 2015 on results, we have decided to provide additional adjusted non-GAAP measures to provide comparability of normal ongoing operating results. Beginning in 2016, we have reported Adjusted Gross Margin, Adjusted Net Income and Adjusted Diluted Net Income per Share to normalize results for comparison purposes.  Adjusted Gross Margin consists of GAAP gross margin excluding amortization of inventory fair value step-up. Adjusted Net Income and Adjusted Diluted Net Income per share consists of GAAP net income excluding: (i) one time acquisition related costs, (ii) amortization of inventory fair value step-up, (iii) amortization of intangible assets and (iv) share-based compensation. Reconciliations of GAAP net income to Adjusted EBITDA, GAAP Gross Margin to Adjusted Gross Margin and GAAP Net Income to Adjusted Net Income and Adjusted Diluted Net Income per Share for the three months ended March 31, 2017 and 2016 appear in the tables below (in thousands):

Three Months Ended March 31,

2017

2016

Net  Income (Per GAAP)

$         4,327

$        1,197

Add back:

  Income taxes

1,713

214

  One time costs incurred in connection with acquisition

713

  One time inventory costs incurred in connection with acquisition

75

734

  Other interest expense, net

145

56

  Depreciation expense

946

734

  Amortization of intangible assets

526

810

  Share-based compensation

4,671

4,615

Adjusted EBITDA

$       12,403

$        9,073

Reconciliation of "Adjusted Gross Margin" defined as Gross Margin before Amortization of inventory fair value step-up (in thousands):

Three Months Ended March 31,

2017

2016

Gross Margin (Per GAAP)

$             63,864

$          45,421

Non-GAAP Adjustments:

  One time inventory costs incurred in connection with acquisition

75

734

Gross Margin before Amortization of inventory fair value step-up

$             63,939

$          46,155

Adjusted Gross Margin

88.1%

86.5%

Reconciliation of "Adjusted Net Income" and "Adjusted Diluted Net Income" per share defined as Net Income less Amortization, One Time Costs and Share-Based Compensation (in thousands, except share and per share data):

Three Months Ended March 31,

2017

2016

Net income (Per GAAP)

$          4,327

$             1,197

Non-GAAP Adjustments:

  Tax rate normalization*

(355)

(350)

  One time costs incurred in connection with acquisition

713

  One time inventory costs incurred in connection with acquisition

75

734

  Amortization of intangible assets

526

810

  Share-based compensation

4,671

4,615

  Estimated income tax impact from adjustments

(1,805)

(2,777)

Adjusted Net Income

$          7,439

$             4,942

Adjusted Diluted Net Income per Share

$            0.07

$               0.04

Denominator for diluted earnings per share - weighted average shares adjusted for dilutive securities

113,730,591

112,039,860

* Assumes a normalized tax rate of 40% for 2016 and 34% for 2017.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

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28 Apr

Johnson & Johnson scores $260M+ DOD orthopedics contract

by Amirah Al Idrus - April 28, 2017 The Department of Defense awarded Johnson & Johnson a contract worth up to $260.5 million to supply it with orthopedic products. The deal will see J&J providing orthopedic products to the Army, Navy, Air Force, Marine Corps and the DOD’s federal civilian agencies, according to a statement. The one-year agreement could be extended one year at a time for another four years, the DOD said. In the first quarter, J&J reported (PDF) $6.3 billion in medical device sales for the first quarter, with its Orthopaedics group and Surgery units leading the pack. The Orthopaedics business, which includes hips, knees, trauma and spine, reeled in $2.33 billion in sales, slightly down from the $2.34 billion reported the previous year.   READ THE REST HERE

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28 Apr

Intuitive Surgical Receives CE Mark for Latest da Vinci® Robotic-Assisted Surgical System

AUBONNE, Switzerland, April 26, 2017 (GLOBE NEWSWIRE) -- Intuitive Surgical, a global technology leader in robotic-assisted, minimally invasive surgery, announced today that its new da Vinci X Surgical System received CE Mark approval in Europe. The da Vinci X System will provide surgeons and hospitals with access to some of the most advanced robotic-assisted surgery technology at a lower cost. The launch of the da Vinci X System underscores Intuitive’s commitment to meeting customers’ needs with a strong value-oriented portfolio of cost-appropriate technologies and an array of financing options. “Over the past 21 years, Intuitive Surgical pioneered robotic-assisted surgery and we continue to lead the way in developing and bringing to market innovative technologies, outcomes-focused products and value-oriented solutions,” said Dr. Gary Guthart, CEO of Intuitive Surgical. “Our surgeon, hospital and healthcare customers around the world told us that robotic-assisted surgery matters for their programs and their patients while underscoring the importance of providing choice from a clinical, technological and cost standpoint. The da Vinci X product offering provides a lower-cost solution to meet the needs of customers who want a choice in price points, while offering access to many of our recent innovations.” The da Vinci X System offers surgeons and hospitals access to Intuitive’s portfolio of advanced, innovative robotic-assisted surgical technologies – and its full ecosystem of programs, support, services, and solutions –at a lower price.  The System uses the same vision cart and surgeon consoles that are found on our flagship product, the da Vinci Xi® System, enabling our customers the option of adding advanced capabilities, and providing a pathway for upgrading should they choose to do so as their practice and needs grow. The da Vinci X System enables optimized, focused-quadrant surgery including for procedures like prostatectomy, partial nephrectomy, hernia repair, benign hysterectomy and sacrocolpopexy, among others. The System features flexible port placement and state-of-the-art 3D digital optics, while incorporating the same advanced instruments and accessories as Intuitive’s flagship system. The new system drives operational efficiencies through set-up technology that uses voice and laser guidance, drape design that simplifies surgery prep, and a lightweight, fully integrated endoscope. “The da Vinci X System is a value-oriented, highly capable offering that meets – and responds to – our customers’ economic and clinical needs,” said Damien Desmedt, General Manager of Intuitive Surgical in the United Kingdom, Ireland, and Nordic countries. “In the countries we serve around the globe, we know that customers have different needs and wants, and we strive to provide an array of choices to meet their needs today and in the future. The da Vinci X System helps us to continue to do this.” About Intuitive Surgical, Inc. Intuitive Surgical, Inc. (Nasdaq:ISRG), headquartered in Sunnyvale, Calif., is a global technology leader in robotic-assisted, minimally invasive surgery. Intuitive Surgical develops, manufactures and markets the da Vinci Surgical System. About the da Vinci Surgical System There are several models of the da Vinci Surgical System. The da Vinci Surgical Systems are designed to help surgeons perform minimally invasive surgery. da Vinci Systems are not programmed to perform surgery on their own. Instead, the procedure is performed entirely by a surgeon who controls the system. da Vinci Systems offer surgeons high-definition 3D vision, a magnified view, and robotic and computer assistance. They use specialized instrumentation, including a miniaturized surgical camera and wristed instruments (i.e., scissors, scalpels and forceps) that are designed to help with precise dissection and reconstruction deep inside the body. Intended Use The Intuitive Surgical Endoscopic Instrument Control System (da Vinci X Surgical System Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures, thoracoscopically-assisted cardiotomy procedures, and trans-oral otolaryngology surgical procedures restricted to benign tumors and malignant tumors classified as T1 and T2, and for benign base of tongue resection procedures. The System can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization.  The System is indicated for adult and pediatric use (except for trans-oral otolaryngology surgical procedures).  It is intended to be used by trained physicians in an operating room environment. The da Vinci X Surgical System is a class 2b CE 0543 marked medical device under the European Medical Devices Directive (93/42/EEC) manufactured by Intuitive Surgical, Inc.  Refer to the Instructions For Use before use. Forward Looking Statement This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding regulatory clearances to market the da Vinci X System in the US. These forward-looking statements are necessarily estimates reflecting the best judgment of our management and involve a number of risks and uncertainties that could cause actual results to differ materially from those suggested by the forward-looking statements. These forward-looking statements should, therefore, be considered in light of various important factors, including those under the heading "Risk Factors" in our annual report on Form 10-K for the year ended December 31, 2016, as updated from time to time by our quarterly reports on Form 10-Q and our other filings with the Securities and Exchange Commission. Statements using words such as "estimates," "projects," "believes," "anticipates," "plans," "expects," "intends," "may," "will," "could," "should," "would," "targeted" and similar words and expressions are intended to identify forward-looking statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. We undertake no obligation to publicly update or release any revisions to these forward-looking statements, except as required by law. © 2017 Intuitive Surgical, Inc. All rights reserved. Product names are trademarks or registered trademarks of their respective holders. A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/0c20bf18-fcc5-4d29-8bab-4ada1ab29eae PN1035581rA EU 4/2017

Contact
JPA Health Communications
kperry@jpa.com
+44203 884 0650

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28 Apr

Biologics Market to Reach $399 Billion by 2025 – Research and Markets

April 28, 2017

DUBLIN--(BUSINESS WIRE)--Research and Markets has announced the addition of the "Biologics Market, 2014-2025" report to their offering. The global biologics market is anticipated to reach USD 399.5 billion by 2025. Introduction of targeted therapies coupled with rising adoption of patient centric personalized medicine anticipated to fuel demand. Ever-increasing understanding of the cell physiology and stress, as well as the factors involved in protein production and heterologous gene expression have empowered the use of different living factories. These living factories are the prokaryotic and eukaryotic cells. Enhancement of drug functionality through achieving successful protein folding and post-translational modifications is supportive for projected progress rate. Moreover, rising adoption of biopharmaceuticals over chemically synthesized molecules is expected to propel revenue generation significantly. In addition to this, presence of several metabolic disorders that can be treated through the use of biologics is attributive to influence demand. Combination of advanced bioengineering technologies for biopharmaceutical production is expected to boost progress in pharmaceutical industry. With recent advances in automation, the selection process can be done through high throughput screening (HTS) system for selection of viable clones. Aforementioned method enables robust production of biopharmaceutical products by obtaining high-producing cell line. Advances with respect to upstream and downstream processing would directly translate into the growth in revenue for this market at a larger level. However, development of biosimilars is expected to restrain the biologics year on year growth to certain extent. Although, the regulatory approval pathway for these products is not framed yet some drug manufacturers are opting to invest in the development of biobetters. Companies Mentioned
  • Samsung BioLogics
  • Amgen
  • Novo Nordisk A/S
  • AbbVie Inc.
  • Sanofi
  • Johnson & Johnson Services, Inc
  • Pfizer Inc.
  • Merck & Co., Inc.
  • GSK group of companies
  • Celltrion
  • Precision Biologics, Inc.
  • Merck KGaA
  • Eli Lilly and Company
  • Novartis AG
  • Bayer AG
  • F. Hoffmann-La Roche Ltd
  • AstraZeneca
Key Topics Covered: 1 Research Methodology 2 Executive Summary 3 Biologics Market Variables, Trends & Scope 4 Biologics Market: Source Estimates & Trend Analysis 5 Biologics Market: Product Estimates & Trend Analysis 6 Biologics Market: Manufacturing Estimates & Trend Analysis 7 Biologics Market: Disease Category Estimates & Trend Analysis 8 Biologics Market: Regional Estimates & Trend Analysis, by Source, Product, Manufacturing, & Disease Category 9 Competitive Landscape For more information about this report visit http://www.researchandmarkets.com/research/kcqf7v/biologics_market

Contacts

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com For E.S.T Office Hours Call 1-917-300-0470 For U.S./CAN Toll Free Call 1-800-526-8630 For GMT Office Hours Call +353-1-416-8900 U.S. Fax: 646-607-1907 Fax (outside U.S.): +353-1-481-1716 Related Topics: Biopharmaceuticals

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28 Apr

TransEnterix Announces Pricing of $24.9 Million Public Offering of Common Stock and Warrants

April 28, 2017

RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--TransEnterix, Inc. (NYSE MKT:TRXC) (“TransEnterix”), a medical device company that is pioneering the use of robotics to improve minimally invasive surgery, announced the pricing of its public offering of units, each consisting of one share of the Company’s common stock, one Series A warrant to purchase one share of common stock and one Series B warrant to purchase 0.75 shares of common stock at a price of $1.00 per unit. Each Series A warrant may be exercised at any time beginning on the date of issuance, and from time to time thereafter, through and including the first anniversary of the issuance date, unless terminated earlier as provided in the Series A warrant. In the event the FDA provides clearance with respect to the company’s Senhance System 510(k) application, which was submitted to the FDA in April 2017, the holders of Series A warrants will have 10 business days following written notice to exercise, in whole or in part, their Series A warrants. Any Series A warrants that remain unexercised after such 10 business day period will expire. Each Series B warrant may be exercised at any time beginning on the date of issuance and from time to time thereafter through and including the fifth anniversary of the issuance date. TransEnterix expects the gross proceeds of the offering to be $24.9 million, before deducting underwriter’s discounts and expenses payable by TransEnterix. If a registration statement registering the resale of the shares of common stock underlying the Series A warrants under the Securities Act of 1933, as amended, is not available, the holder of such Series A warrants may, in its sole discretion, elect to exercise the warrant through a cashless exercise, in which case the holder would receive upon such exercise the net number of shares of common stock determined according to the formula set forth in the warrant. Any holder of Series B warrants may elect to exercise any such Series B warrant through a cashless exercise at any time prior to expiration. All of the securities to be sold in the offering are to be sold by TransEnterix. Stifel is acting as the sole book-running manager. The offering is expected to close on or about May 3, 2017, subject to customary closing conditions. A shelf registration statement relating to the securities offered in the public offering described above was filed with the U.S. Securities and Exchange Commission (the “SEC”) on November 7, 2014 and declared effective on December 19, 2014 (File No. 333-199998), and post-effectively amended pursuant to Post-Effective Amendment No. 1 on Form S-3, as filed with the SEC on March 8, 2016 and declared effective on June 22, 2016 and a related registration statement was filed pursuant to Rule 462(b) under the Securities Act of 1933. The offering is being made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement related to the offering has been filed with the SEC and may be obtained for free by visiting EDGAR on the SEC website at www.sec.gov. A final prospectus supplement related to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the securities being offered may also be obtained by contacting Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104 or by telephone: (415) 364-2720. This press release does not constitute an offer to sell, or a solicitation of an offer to buy, the securities in the described offering, nor will there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale is unlawful prior to registration or qualification under the securities laws of any such jurisdiction. About TransEnterix, Inc. TransEnterix is a medical device company that is pioneering the use of robotics to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options. The company is focused on the commercialization of the Senhance™ Surgical Robotic System, a multi-port robotic system that brings the advantages of robotic surgery to patients while enabling surgeons with innovative technology such as haptic feedback and eye sensing camera control. The Company also developed the SurgiBot™ System, a single-port, robotically enhanced laparoscopic surgical platform. The Senhance Surgical Robotic System has been granted a CE Mark but is not currently available for sale in the United States. Forward Looking Statements This press release includes statements relating to the proposed offering of TransEnterix’s securities. These statements and other statements regarding our future plans and goals constitute "forward looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations, including our expectations regarding the proposed offering and use of proceeds. For a discussion of the risks and uncertainties associated with TransEnterix's business, please review our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2016 and subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Contacts

For TransEnterix, Inc. Investor Contact: Mark Klausner, +1-443-213-0501 invest@transenterix.com or Media Contact: (For EU) Conrad Harrington, +44 (0)20 3178 8914 or (For US) Hannah Dunning, +1-415-618-8750 TransEnterix-SVC@sardverb.com

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28 Apr

Lennart Johansson to Join BONESUPPORT™ Board of Directors

LUND, Sweden, April 28, 2017 /PRNewswire/ --

BONESUPPORT AB, an emerging leader in innovative injectable bioceramic bone scaffolds to treat bone voids caused by trauma, infection, disease or related surgery, announces the election of Lennart Johansson to its Board of Directors.
Mr Johansson has been a Senior Advisor at Patricia Industries AB since 2015, and was previously Managing Director (Business Development, Operating and Financial Investments) at Investor AB (2006-2015). Before that, he was Partner and Chief Executive Officer of Emerging Technologies ET AB. He is currently Board Member of Swedish Orphan Biovitrum AB and Hi3G Access AB; Deputy Board Member of Mölnlycke Health Care AB; and Chairman of Vectura AB. Mr Johansson holds an MBA from the Stockholm School of Economics (1980). Håkan Björklund, Chairman of BONESUPPORT, said: "We are pleased to welcome Lennart to the BONESUPPORT Board. This is an exciting period for the Company and we are confident that Lennart's experience will be a valuable asset assisting us to achieve our goals." Mr Johansson added: "I very much look forward to working with the BONESUPPORT management team and Board to help capitalize on the Company's potential to become a global leader in the management and treatment of bone disease via its unique CERAMENT[]platform." About BONESUPPORT™ BONESUPPORT has developed CERAMENT as an innovative range of radiopaque injectable osteoconductive bioceramic products that have a proven ability to heal defects by remodeling to host bone in six to 12 months. Our products are effective in treating patients with fractures and bone voids caused by trauma, infection, disease or related surgery. Our lead product, CERAMENT BONE VOID FILLER (BVF) addresses important issues facing health care providers, such as avoiding hospital readmissions and revision surgery that result from failed bone healing and infection caused by residual bone voids. CERAMENT BVF is commercially available in the U.S., EU, SE Asia and the Middle East. CERAMENT's distinctive properties as a drug eluting material have been validated in clinical practice by CERAMENT G and CERAMENT V, the first CE-marked injectable antibiotic eluting bone graft substitutes. These products provide local sustained delivery of gentamicin and vancomycin, respectively. The local delivery feature enables an initial high concentration of antibiotics to the bone defect and then a longer sustainable dose above the minimal inhibitory concentration (MIC) to protect bone healing and promote bone remodeling. CERAMENT G and CERAMENT V have demonstrated good results in patients with problematic bone infections including osteomyelitis. They are also used prophylactically in patients who are at risk for developing infection. CERAMENT G and CERAMENT V are available in the EU. BONESUPPORT was founded in 1999 by Prof. Lars Lidgren, an internationally respected scientist who has been the President of various musculoskeletal societies. BONESUPPORT's mission is to bring people with bone and joint diseases back to an active life. The Company is based in Lund, Sweden. www.bonesupport.com BONESUPPORT™ and CERAMENT™ are registered trademarks. Contact Information Björn Westberg Chief Financial Officer +46-(0)-46-286-53-24 info@bonesupport.com SOURCE BONESUPPORT AB

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28 Apr

Safe Orthopaedics Reports Its Full-Year Results for 2016

April 28, 2017

ERAGNY-SUR-OISE, France--(BUSINESS WIRE)--Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company offering an innovative range of sterile implants combined with their single-use instruments for spinal surgery, has today reported its full-year results for 2016. Audit procedures of the FY 2016 financial statements are being performed, and Safe Orthopaedics’ annual financial report will be available in the Investors > Documentation > Documents and Publications section of the Company’s website (www.SafeOrtho.com) from April 29, 2017.
in thousands of euros

financial statements under audit, report non-issued

FY 2016 FY 2015
Revenues 2,365 2,498
Purchases used and change in inventories (1,559) (2,023)
External costs (2,820) (2,682)
Personnel costs (3,633) (3,903)
Taxes (70) (59)
Depreciation, amortization and charges to provisions (162) (883)
Other operating income/(expense) (224) (167)
Operating income/(loss) before non-recurring items (6,104) (7,218)
Other income/(expense) (183) -
Operating income/(loss) (6,287) (7,218)
Net financial income 282 656
Net income (6,005) (6,566)
€1.1 million improvement in operating performance before non-recurring items FY 2016 revenues declined slightly to €2.4 million. Even so, when adjusted for the operations in the United States discontinued effective March 1, 2016, Safe Orthopaedics’ revenues grew 10% to €2.3 million from €2.1 million in FY 2015. Revenues continued to grow in France, rising 16% to €1.2 million in 2016 despite its limited sales and marketing resources. The refocusing drive launched in the first quarter led to the reassignment of certain sales and marketing resources to the region, with new sales staff hired in the second half of the year. Although they did not contribute to FY 2016 revenues, these new staff should have a positive impact in 2017, especially following the recent listing of Safe Orthopaedics’ products in AP-HP’s 39 hospitals in the Paris region, which account for roughly one-quarter of the French market1. In the Rest of the World (excluding the United States), revenue growth was fairly sedate during FY 2016 (+3%). The recent launch of sales and marketing operations in Germany should boost the Company’s growth in 2017. Following the withdrawal from the United States in 2016, Safe Orthopaedics unlocked various savings, which led to a €1.1 million improvement in operating performance before non-recurring items. After the decline in net financial income due to a negative foreign exchange impact, the FY 2016 net loss totaled €6.0 million versus a loss of €6.6 million in FY 2015. Reduced cash consumption and financial position Following its withdrawal from the United States in March 2016, Safe Orthopaedics set about reducing its cash consumption so that it could invest more in expanding its sales and marketing operations, chiefly in France, Germany and other European and emerging markets. As a result, it used €5.8 million in cash in FY 2016, down from €6.5 million in 2015. Safe Orthopaedics’ net cash2 at December 31, 2016 stood at €2.7 million, compared with €5.9 million at December 31, 2015. During 2017, based on its projections, the Company will need to attract new financing in order to fulfill its funding requirements. The company is working on several scenarios:
  • A round of fundraising take the form of a capital increase, public or private, or the issuance of bonds, convertible or not
  • The use of drawings on the Yorkville OCABSA program or on the Pacéo (currently suspended).
No decision has been made between these scenarios at this stage. However, the Board of April 20th 2017 has approved the principle of a round of fundraising. Some historical shareholders of the Company, including funds managed by Kurma Partners, have signaled their interest in a participation in this transaction, if it were launched by the Company, at a level of 1M€, in the shape of subscriptions and/or guarantees, the format of which would be adapted to the type of transaction, it being understood that this expression of interest does not equate to a commitment on their part. The accounts of the Company have therefore been established, in this context, by applying the business continuity principle. However, even though the Company estimates that based on its track record and discussions carried out to date, it is likely that this refinancing would be completed, there subsists in fact an uncertainty regarding its business continuity. Acceleration in business development and Outlook During 2016 and since the beginning of 2017, Safe Orthopaedics has continued its realignment from an R&D-oriented company to one focused in priority on marketing its innovative technologies and delivering sales growth. By strengthening its sales and marketing teams, which now account for over one-third of its headcount, Safe Orthopaedics intends to maintain this momentum. Following the recent hires of very experienced managers, such as Jochen Esser (Head of Sales Germany, see press release dated March 6, 2017) and Pascale Davis (Global Head of Marketing, see press release dated April 24, 2017), Safe Orthopaedics plans to recruit additional talents in its priority markets during 2017. “2016 marked a change in Safe Orthopaedics’ strategy. Thanks to our decision to withdraw from the United States to refocus in priority on the European market, we successfully managed to reduce our cash consumption in less than a year, while also delivering growth, as demonstrated by our fourth-quarter 2016 performance,said Pierre Dumouchel, Chief Executive Officer of Safe Orthopaedics since March 2016. “I intend to keep moving firmly in the same direction during 2017. AP-HP’s recent decision to list our products and the commercial launch of our product range in Germany, Europe’s largest market by far, have made me even more confident in our ability to maintain a solid pace of growth and further improve our financial performance in the current year.Next financial release: First-quarter 2017 revenues: May 9, 2017 (before the market opens) About Safe Orthopaedics Founded in 2010, Safe Orthopaedics is a French medical technology company that aims to make spinal surgeries safer by using sterile implants and associated single-use instruments. Through this approach, these products eliminate all risk of contamination, reduce infection risks and facilitate a minimally-invasive approach for trauma and degenerative pathologies—benefiting patients. Protected by 17 patent families, the SteriSpineTM kits are CE-marked and FDA approved. The company is based at Eragny-sur-Oise (Val d’Oise department), and has 30 employees. For more information, visit: www.SafeOrtho.com 1 Source: Company 2 Net cash represents cash and cash equivalents less short-term debt

Contacts

Safe Orthopaedics Thierry Lambert CFO Tél.: +33 (0)1 34 21 50 00 investors@safeorthopaedics.com or NewCap Julien Perez / Valentine Brouchot Investor Relations Nicolas Merigeau Media Relations Tél.: +33 (0)1 44 71 94 94 SafeOrtho@newcap.eu

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28 Apr

RTI Surgical® Announces 2017 First Quarter Results

April 27, 2017

ALACHUA, Fla.--(BUSINESS WIRE)--RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, reported operating results for the first quarter of 2017. In addition, the company outlined progress against the initial stages of its transformation toward long-term profitable growth. RTI’s first quarter 2017 financial results, as described in greater detail below, reflect that the company’s initial actions are beginning to yield positive results. RTI has delivered double-digit revenue growth across its direct business, including its spine, surgical specialties and cardiothoracic segments. The company reported continued strong performance in its International business, with revenue growth in Europe and Asia-Pacific. The Commercial/other business continues to see signs of stabilization despite a decline in revenues. Under the leadership of Camille Farhat, who assumed the CEO position on March 15, 2017, RTI’s management is implementing a series of actions to return the company to sustainable profitable growth. These initiatives include improving execution, reducing costs and directing resources to those businesses, products and markets with the greatest growth potential. The initial phase of the company’s restructuring program remains on target to yield annualized savings of approximately $8 million, starting in the second quarter. “I am pleased that our initial strategic initiatives are taking hold, as evidenced by two consecutive quarters of improving performance. While these results are a positive sign, we still have significant work ahead of us,” said Camille Farhat, chief executive officer, RTI. “We are in the early stages of what will be a long-term transformation of the company. Our current focus is on cost reduction, disciplined execution and targeted innovation to better position RTI’s operating platform for growth and profitability.” He added, “Longer-term, we are completing a thorough evaluation of RTI, its businesses, markets and products. Although we are in the initial phases of this evaluation, there are three central themes that standout: 1) continue investment in our spine business and build scale, 2) increase investment in our commercial business to drive innovation and create new growth opportunities, and, 3) improve margins of our tissue-based implants. We have a talented team, outstanding products and a fierce dedication to meeting our customers’ needs. I am confident that we are on the right path toward setting up RTI for long-term profitable growth and improved cash flow generation.” First Quarter 2017 RTI reported a net loss applicable to common shares of $2.8 million in the first quarter of 2017, or $0.05 per fully diluted common share, primarily due to a previously disclosed pre-tax charge for severance-related expenses totaling $4.4 million. As outlined in the reconciliation tables that follow, excluding these charges, adjusted net income applicable to common shares was $139,000. Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA) were $6.5 million. Worldwide revenues were $69.9 million for the first quarter of 2017, an increase of 4 percent, domestic revenues were $63.3 million, an increase of 3 percent, and International revenues were $6.6 million, an increase of 8 percent when compared to the first quarter of 2016. The increase in domestic revenues was primarily due to strong performance in the domestic direct business. The increase in International revenues was mainly driven by growth in Asia, primarily in Spine, and in Europe, primarily in Biologics. Direct revenues were $43.8 million for the first quarter of 2017, an increase of 13 percent compared to the first quarter of 2016, with double-digit growth reported in RTI’s spine, surgical specialties and cardiothoracic direct business segments. Commercial/other revenues were $26.1 million for the first quarter of 2017, a decline of 9 percent compared to the first quarter of 2016, partly due to lower orders in RTI’s OEM trauma business. Commercial/other revenues continue to stabilize on a sequential basis. Fiscal 2017 Outlook RTI’s focus for 2017 will remain squarely on disciplined execution, targeted innovation, and ongoing implementation of strategic actions to achieve profitable growth across each of its business lines and geographies. The company has developed its guidance based on its ongoing restructuring and operational improvement program, its current business profile and existing market conditions. Within this context, based on first quarter results, RTI expects full year revenues for 2017 to be between $274 million and $285 million, in line with prior communication, with direct revenues anticipated to grow mid-to-high single digits on a percentage basis compared to 2016, while commercial/other revenues are expected to be relatively flat to low single-digit decline on a percentage basis. As detailed in the reconciliation provided later in this release, excluding the $4.4 million pre-tax charge for severance-related expenses in 2017 as noted above, RTI expects adjusted full year net income per fully diluted common share to be between $0.05 and $0.10, in line with prior communication, based on 59.5 million fully diluted shares outstanding. RTI will continue to evaluate its operating platform throughout the year and will update its top and bottom line guidance as its actions might warrant. Conference Call RTI will host a conference call and simultaneous audio webcast to discuss its first quarter 2017 results at 8:30 a.m. ET today. The conference call can be accessed by dialing (877) 383-7419. The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on the RTI website following the call. About RTI Surgical Inc. RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com. Forward-Looking Statement This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.
RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
For the Three Months Ended
March 31,
2017 2016
Revenues $ 69,939 $ 67,351
Costs of processing and distribution 34,160 31,326
Gross profit 35,779 36,025
Expenses:
Marketing, general and administrative 29,671 27,552
Research and development 3,688 4,161
Severance charges 4,403 -
Contested proxy expenses - 308
Total operating expenses 37,762 32,021
Operating (loss) income (1,983 ) 4,004
Total other expense - net (799 ) (314 )
(Loss) income before income tax provision (2,782 ) 3,690
Income tax benefit (provision) 910 (1,289 )
Net (loss) income (1,872 ) 2,401
Convertible preferred dividend (910 ) (858 )
Net (loss) income applicable to common shares $ (2,782 ) $ 1,543
Net (loss) income per common share - basic $ (0.05 ) $ 0.03
Net (loss) income per common share - diluted $ (0.05 ) $ 0.03
Weighted average shares outstanding - basic 58,495,796 57,914,893
Weighted average shares outstanding - diluted 58,495,796 58,211,644
RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of Net (Loss) Income Applicable to Commons Shares to Adjusted EBITDA
(Unaudited, in thousands)
For the Three Months
Ended March 31,
2017 2016
Net (loss) income $ (2,782 ) $ 1,543
Interest expense, net 819 360
Provision for income taxes (910 ) 1,289
Depreciation 2,672 3,382
Amortization of intangible assets 896 928
EBITDA 695 7,502
Reconciling items for Adjusted EBITDA
Preferred dividend 910 858
Non-cash stock based compensation 834 500
Foreign exchange gain (20 ) (46 )
Other reconciling items(1)
Severance charges excluding stock based compensation 4,070 -

Contested proxy expenses - 308
Adjusted EBITDA $ 6,489 $ 9,122
Adjusted EBITDA as a percent of revenues 9 % 14 %

(1) See explanations in Use of Non-GAAP Financial Measures section later in this release.

RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of Net (Loss) Income Applicable to Common Shares and Net (Loss) Income Per Diluted Share to
Adjusted Net Income Applicable to Common Shares and Adjusted Net Income Per Diluted Share
(Unaudited, in thousands, except per share data)
For the Three Months Ended
March 31, 2017 March 31, 2016
Net Net
Income Amount Income Amount
Applicable to per Diluted Applicable to per Diluted
Common Shares Share Common Shares Share
As reported $ (2,782 ) $ (0.05 ) $ 1,543 $ 0.03
Severance charges (1) 4,403 $ 0.07 - -
Contested proxy expenses (2) - $ 308 0.01
Tax effect on adjustments (1,482 ) $ (0.03 ) (125 ) (0.00 )
Adjusted * $ 139 $ 0.00 $ 1,726 $ 0.03

*

See explanations in Use of Non-GAAP Financial Measures section later in this release.

Amount Per Diluted Share may not foot due to rounding.
Fiscal 2017 Outlook Full year net income per fully diluted common share is expected to be in the range of $0.01 to $0.06, based on 59.5 million fully diluted shares outstanding. Excluding severance charges taken in 2017, full year net income per fully diluted common share is expected to be in the range of $0.05 to $0.10.
RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP Guidance Net Income Per Common Share - Diluted to
Adjusted Non-GAAP Guidance Net Income Per Common Share - Diluted
(Unaudited)
Twelve Months Ended
December 31, 2017
$ Amount
Per Common
Share - Diluted
GAAP Guidance Net Income Per Common Share - Diluted $ 0.01 - 0.06
Severance charges, net of tax effect 0.04
Adjusted Non-GAAP Guidance Net Income Per Common Share - Diluted $ 0.05 - 0.10
Use of Non-GAAP Financial Measures To supplement the Company’s unaudited condensed consolidated financial statements presented on a GAAP basis, the Company discloses certain non-GAAP financial measures that exclude certain amounts, including Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share - Diluted. The calculation of the tax effect on the adjustments between GAAP net (loss) income applicable to common shares and non-GAAP net income applicable to common shares is based upon our estimated annual GAAP tax rate, adjusted to account for items excluded from GAAP net (loss) income applicable to common shares in calculating Adjusted Net Income Applicable to Common Shares-Diluted. A reconciliation of the non-GAAP financial measures to the corresponding GAAP measures is included in the tables listed above. The following is an explanation of the adjustments that management excluded as part of adjusted measures for the three month period ended March 31, 2017 and 2016 as well as the reason for excluding the individual items: (1) Severance charges – This adjustment represents charges relating to the termination of former employees. Management removes the amount of these costs from our operating results to supplement a comparison to our past operating performance. (2) Contested proxy expenses – This adjustment represent charges relating to contested proxy expenses. Management removes the amount of these costs from our operating results to supplement a comparison to our past operating performance. Material Limitations Associated with the Use of Non-GAAP Financial Measures Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share - Diluted should not be considered in isolation, or as a replacement for GAAP measures. Usefulness of Non-GAAP Financial Measures to Investors The Company believes that presenting Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share - Diluted in addition to the related GAAP measures provide investors greater transparency to the information used by management in its financial decision-making. The Company further believes that providing this information better enables the Company’s investors to understand the Company’s overall core performance and to evaluate the methodology used by management to assess and measure such performance.
RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Revenues
(Unaudited, in thousands)
For the Three Months Ended
March 31,
2017 2016
Revenues:
Spine $ 20,338 $ 17,094
Sports medicine and orthopedics 12,896 12,520
Surgical specialties 1,780 1,015
Cardiothoracic 3,151 2,534
International 5,657 5,517
Subtotal direct 43,822 38,680
Global commercial 23,581 25,330
Other revenues 2,536 3,341
Total revenues $ 69,939 $ 67,351
Domestic revenues 63,307 61,184
International revenues 6,632 6,167
Total revenues $ 69,939 $ 67,351
RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
March 31, December 31,
2017 2016
Assets
Cash and cash equivalents $ 17,598 $ 13,849
Accounts receivable - net 36,294 41,488
Inventories - net 117,392 119,743
Prepaid and other current assets 5,888 5,213
Total current assets 177,172 180,293
Property, plant and equipment - net 85,118 83,298
Goodwill 54,887 54,887
Other assets - net 51,472 49,553
Total assets $ 368,649 $ 368,031

Liabilities and Stockholders Equity

Accounts payable $ 28,360 $ 26,112
Accrued expenses and other current liabilities 27,345 26,772
Current portion of long-term obligations 5,301 6,080
Total current liabilities 61,006 58,964
Deferred revenue 7,394 6,612
Long-term liabilities 76,068 77,523
Total liabilities 144,468 143,099
Preferred stock, including accrued dividends 60,972 60,016

Stockholders’ equity:

Common stock and additional paid-in capital 416,415 416,570
Accumulated other comprehensive loss (7,996 ) (8,316 )
Accumulated deficit (245,210 ) (243,338 )

Total stockholders’ equity

163,209 164,916

Total liabilities and stockholders’ equity

$ 368,649 $ 368,031
RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited, in thousands)
For the Three Months
Ended March 31,
2017 2016
Cash flows from operating activities:
Net (loss) income $ (1,872 ) $ 2,401

Adjustments to reconcile net (loss) income to net cash provided by operating activities:

Depreciation and amortization expense 3,568 4,310
Stock-based compensation 834 500
Amortization of deferred revenue (1,274 ) (1,217 )

Other items to reconcile to net cash provided by operating activities

8,321 429
Net cash provided by operating activities 9,577 6,423
Cash flows from investing activities:
Purchases of property, plant and equipment (3,283 ) (4,637 )
Patent and acquired intangible asset costs (319 ) (1,196 )
Net cash used in investing activities (3,602 ) (5,833 )
Cash flows from financing activities:
Proceeds from long-term obligations 2,000 3,000
Net payments from short-term obligations - (249 )
Payments on long-term obligations (4,250 ) (4,133 )
Other financing activities (34 ) (108 )
Net cash used in financing activities (2,284 ) (1,490 )
Effect of exchange rate changes on cash and cash equivalents 58 14
Net increase (decrease) in cash and cash equivalents 3,749 (886 )
Cash and cash equivalents, beginning of period 13,849 12,614
Cash and cash equivalents, end of period $ 17,598 $ 11,728

Contacts

RTI Surgical Inc. Robert Jordheim Chief Financial Officer rjordheim@rtix.com or Roxane Wergin Director, Corporate Communications rwergin@rtix.com 386-418-8888

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28 Apr

Amplitude Surgical: Record Activity in Q3: Sales of €27 Million – 9-Month Sales of €69 Million, +16% Organic Growth

April 26, 2017

VALENCE, France--(BUSINESS WIRE)--Regulatory News:

Amplitude Surgical (Paris:AMPLI) (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible), a leading French player on the global surgical technology market for lower-limb orthopedics, announces its sales for the third quarter of its 2016-17 financial year. Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “Amplitude Surgical is continuing to record a high level of growth, driven by all its markets. This performance results from the successful implementation of the Group’s development strategy, supported by all members of staff, and, beyond that, our strengthened positioning on the largest markets with an innovative offering to meet the many challenges facing surgeons and their patients represents the bedrock of our future growth.

Q3 2016-17 sales

31/03/2017 31/03/2016 Δ actual

Δ constant currency

€ thousands - IFRS
France 18,338 16,930 8.3% 8.3%
International 8,947 7,339 21.9% 14.4%
of which: Subsidiaries 6,510 5,136 26.7% 16.0%
of which: Distributors 2,437 2,202 10.7% 10.6%
Total 27,285 24,269 12.4% 10.2%

9M 2016-17 sales

31/03/2017 31/03/2016 Δ actual

Δ constant currency

€ thousands - IFRS
France 44,261 39,378 12.4% 12.4%
International 24,907 19,308 29.0% 22.8%
of which: Subsidiaries 17,980 14,392 24.9% 16.6%
of which: Distributors 6,927 4,916 40.9% 40.9%
Total 69,168 58,686 17.9% 15.8%
Over the first 9 months (to end-March 2017) of the Group’s 2016-17 financial year, Amplitude Surgical recorded sales of €69.2 million, up +17.9% in actual terms and +15.8% in organic terms. The buoyant growth at the start of the year has continued at a solid pace, with organic growth of +10.2% in Q3 2016-17, nevertheless affected by a particularly demanding basis of comparison (organic growth of +18.6% in Q3 2015-16). In France, Amplitude Surgical is continuing to make market share gains, notably by winning over numerous new clients. Sales thus totaled €18.4 million in the 3rd quarter, up +8.3%, and €44.3 million over the first 9 months of 2017, up +12.4%. The Group is continuing to record buoyant International growth, both via its subsidiaries and through its distributors. In the 3rd quarter, sales totaled almost €9 million, up 21.9% in actual terms and 14.4% at constant currency. Over the first 9 months of 2017, sales totaled €24.9 million, up +29.0% in actual terms and +22.8% at constant currency, with 24.9% growth for its subsidiaries, which accounted for 72% of activity, and 40.9% growth for distributors. The sales performance was particularly satisfactory on most markets, and notably the Group’s European markets, while the first contribution of its new subsidiaries in South Africa and Japan came to almost €1 million. Marketed since mid-2014, the Novastep range for lower-limb (foot and ankle) surgery continued to record very strong growth. Over the first 9 months to the end of March, its sales totaled €4.5 million, up almost 70%, and accounted for almost 7% of Group activity. Sales were doubled in the United States, which now accounts for over 40% of this activity, while in France they increased by almost 50%. Recent highlights: In the last quarter, Amplitude Surgical completed the setting up of an Iso 7 and Iso 5 clean room in Valence for the cleaning and packaging of surgical implants. As soon as the equipment was received, manufacturing was launched with a view to passing validation tests over a 6-month period. In accordance with the initial schedule, this equipment should thus be certified in time to become operational during the fall of 2017. Next financial press release: 2016-17 annual sales, on Wednesday July 26, 2017, after market. About Amplitude Surgical Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. Amplitude Surgical distributes its products in more than 30 countries. At June 30, 2016, Amplitude Surgical had a workforce of almost 300 employees and recorded sales of over 80 million euros.

Contacts

Amplitude Surgical Philippe Garcia, +33 (0)4 75 41 87 41 CFO finances@amplitude-surgical.com or NewCap Investor Relations Marc Willaume, +33 (0)1 44 71 00 13 amplitude@newcap.eu or NewCap Media Relations Nicolas Merigeau, +33 (0)1 44 71 98 55 amplitude@newcap.eu

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28 Apr

SANUWAVE Announces Cooperation With Ortho-Medico in Europe and Exhibition at EWMA

SUWANEE, GA--(Marketwired - Apr 27, 2017) - SANUWAVE Health, Inc. ( OTCQB : SNWV ) is pleased to announce that the company will exhibit, in conjunction with Ortho-Medico, at EWMA (European Wound Management Association) in Amsterdam, The Netherlands on 3-5 May 2017. With renewed energy and focus, SANUWAVE is intent on continuing to strengthen our association with doctors, hospitals and wound care centers and re-establishing the Company's products into the EU market.

The Company is using this occasion to promote our lead wound care product dermaPACE®. This Extracorporeal Shockwave Technology (ESWT) device, based upon electrohydraulic principles, is CE Marked and has enjoyed success in certain markets within the European Union treating a wide variety of skin conditions such as pressure ulcers, burns, post-operative wounds, and scar reduction. dermaPACE has been proven, in two US based clinical trials enrolling 336 subjects, to be safe and effective in the treatment of Diabetic Foot Ulcers. Within a few weeks of initial treatment, wounds treated with dermaPACE reduce in area at superior rates compared to control subjects. dermaPACE exhibits superiority in wound area reduction within 12 weeks of initial treatment and exhibits superiority in wound closure within 20 weeks of initial treatment. The use of dermaPACE allows the clinician to more easily, and more cost-effectively, manage wounds. More importantly, the patient's quality of life improves significantly.

For more information on SANUWAVE's technology, please read our blog, "Shock This", on our website at www. sanuwave.com.

SANUWAVE and Ortho-Medico cordially invite you to our booth Number 3 E14 to discuss how dermaPACE can work for you. Our booth is located on the side of the floorplan which can be accessed at: https://www.ewmaexhibition2017.org/ehome/index.php?eventid=155542&.

The conference will be held at: Amsterdam RAI, Europaplein 22, NL 1078 GZ Amsterdam, The Netherlands, www.rai.nl.

Mr. Pete Stegagno and Mr. André Mouton from SANUWAVE and Mr. Jo Schops from Ortho-Medico will be on hand to talk about some new opportunities for 2017 which will be very important for your business or practice and we welcome your visit to our booth. If you are attending EWMA, we thank you for informing us about the timing of your potential visit to our booth to ensure we organize our meeting with you.

About SANUWAVE Health, Inc.

SANUWAVE Health, Inc. ( OTCQB : SNWV ) (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue and vascular structures. SANUWAVE's portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body's normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia and New Zealand. In the U.S., dermaPACE is currently under the FDA's Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers. SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron, Evotron® and orthoPACE® devices in Europe, Asia and Asia/Pacific. In addition, there are license/partnership opportunities for SANUWAVE's shock wave technology for non-medical uses, including energy, water, food and industrial markets.

About Ortho-Medico

Ortho-Medico has been a known player in the Benelux since 1987 with its full range of orthopedic aids and specific treatments as Shockwave. Ortho-Medico's final aim, its mission, is to keep the patient as dynamic and active as possible, therefor our innovative expansion in the field of wound care and neurology. Ortho-Medico's success is founded on a very high-quality, complete product portfolio, very close collaboration with specialists and orthopedic technicians, very quick terms of delivery, reliable advice and an attitude which is aimed at finding solutions.

Forward-Looking Statements

This press release may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company's ability to control. Actual results may differ materially from those projected in the forward-looking statements. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are risks associated with the regulatory approval and marketing of the Company's product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company's ability to manage its capital resource issues, competition, and the other factors discussed in detail in the Company's periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.

For additional information about the Company, visit www.sanuwave.com.

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