Cleveland Clinic CEO Toby Cosgrove to step down

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.

 

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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

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.

 

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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

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

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

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

Zimmer Biomet Reports First Quarter 2017 Financial Results

WARSAW, Ind., April 27, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results for the quarter ended March 31, 2017.  The Company reported first quarter net sales of $1.98 billion, an increase of 3.8% over the prior year period, and an increase of 4.5% on a constant currency basis.  Excluding approximately 220 basis points of contribution from the LDR Holding Corporation acquisition, revenue increased by 2.3% over the first quarter of 2016.  Diluted earnings per share for the quarter were $1.47 reported, an increase of 172.2% over the prior year period.  Adjusted diluted earnings per share for the quarter were $2.13, an increase of 6.0% over the prior year period.

“Zimmer Biomet delivered first quarter revenue and adjusted earnings growth consistent with our expectations, as we positioned the Company for sales acceleration in the second half of the year,” said David Dvorak, President and CEO of Zimmer Biomet.  “During the quarter, we made progress towards improving our global supply chain throughput, in concert with ongoing, focused investments to harmonize and optimize our global manufacturing and quality systems.  We will continue driving these priorities as we progress through the balance of 2017, while leveraging our specialized sales channels and advancing the commercialization of differentiated clinical offerings.”

Net earnings for the first quarter were $299.4 million, an increase of 175.2% over the prior year period, and $433.4 million on an adjusted basis, an increase of 6.4% over the prior year period.  Operating cash flow for the first quarter was $275.4 million.

In the quarter, the Company paid $48.1 million in dividends and declared a first quarter dividend of $0.24 per share.

Guidance

The Company updated its full-year 2017 constant currency revenue and adjusted earnings per share guidance.  The Company now estimates full-year, constant currency revenue to increase between 3.2% and 4.2% compared to the prior year, inclusive of approximately 120 basis points of contribution from the LDR transaction.  Previously, the Company had expected full-year, constant currency revenue to increase between 3.7% and 4.7%, inclusive of the LDR contribution.  The Company now expects foreign currency translation to decrease revenue for the full year by approximately 1.2%.  Previously, the Company had estimated foreign currency translation to decrease revenue by 1.5%.  Therefore, the Company now expects full-year 2017 revenue to increase between 2.0% and 3.0% when compared to full-year 2016, or to be in a range of $7.835 billion to $7.915 billion.  Previously, the Company had estimated revenue growth to be in a range of 2.2% to 3.2% when compared to full-year 2016, or to be in a range of $7.855 billion to $7.930 billion.  Revenue growth, excluding the contribution from LDR on a constant currency basis, is also expected to be in a range of 2.0% to 3.0% for the full-year 2017.  Previously, the Company had estimated full-year revenue growth to be in a range of 2.5% to 3.5% on a similar basis.

Additionally, the Company now expects its full-year 2017 diluted earnings per share to be in a range of $4.68 to $4.88, and in a range of $8.50 to $8.60 on an adjusted basis.  Previously, the Company had expected diluted earnings per share to be in a range of $4.37 to $4.67 on a reported basis, and in a range of $8.50 to $8.68 on an adjusted basis.

Conference Call

The Company will conduct its first quarter 2017 investor conference call today, April 27, 2017, at 8:00 a.m. Eastern Time.  The live audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com.  It will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985.  For a complete listing of international toll-free and local numbers, please visit http://investor.zimmerbiomet.com.  A digital recording will be available 24 hours after the completion of the conference call, from April 28, 2017 to May 28, 2017.  To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985.

Sales Table

The following first quarter sales table provides results by geography and product category, as well as the percentage change compared to the prior year quarter on a reported basis and a constant currency basis.

Constant

Net

Currency

Sales

% Change

% Change

Geographic Results

Americas

$            1,235

4.9

%

4.7

%

EMEA

453

(0.7)

3.1

Asia Pacific

289

6.9

5.9

Total 

$            1,977

3.8

%

4.5

%

Product Categories

Knees

   Americas

$              429

(0.1)

%

(0.2)

%

   EMEA

168

(3.4)

0.9

   Asia Pacific

105

5.0

3.1

       Total

702

(0.2)

0.6

Hips

   Americas

246

0.2

   EMEA

136

(0.5)

2.7

   Asia Pacific

93

9.5

8.9

       Total

475

1.7

2.4

S.E.T (1)

425

6.0

6.5

Dental

108

(0.7)

0.1

Spine & CMF

186

32.0

32.1

Other

81

(1.8)

(1.2)

Total

$            1,977

3.8

%

4.5

%

(1) Surgical, Sports Medicine, Foot and Ankle, Extremities and Trauma

About the Company

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Website Information

We routinely post important information for investors on our website, www.zimmerbiomet.com, in the “Investor Relations” section.  We use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD.  Accordingly, investors should monitor the Investor Relations section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts.  The information contained on, or that may be accessed through, our website is not incorporated by reference into, and is not a part of, this document.

Note on Non-GAAP Financial Measures

This press release includes non-GAAP financial measures that differ from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”).  These non-GAAP financial measures may not be comparable to similar measures reported by other companies and should be considered in addition to, and not as a substitute for, or superior to, other measures prepared in accordance with GAAP.

Sales growth information for the three-month period ended March 31, 2017 is presented on a GAAP (reported) basis and on a constant currency basis, as well as on a basis that excludes the contribution from the Company’s acquisition of LDR Holding Corporation in July 2016.  Projected revenue growth information for the year ended December 31, 2017 is presented on a GAAP basis and on a constant currency basis, as well as on a basis that excludes the contribution from the LDR transaction.  Constant currency growth rates exclude the effects of foreign currency exchange rates.  They are calculated by translating current and prior-period sales at the same predetermined exchange rate.  The translated results are then used to determine year-over-year percentage increases or decreases.

Net earnings, diluted earnings per share and projected diluted earnings per share are presented on a GAAP (reported) basis and on an adjusted basis.  Adjusted earnings and earnings per share measures exclude the effects of inventory step-up; certain inventory and manufacturing-related charges connected to discontinuing certain product lines, quality enhancement and remediation efforts; special items; intangible asset amortization; any related effects on our income tax provision associated with these items; and other certain tax adjustments.  Special items include expenses resulting directly from our business combinations and/or global restructuring, quality and operational excellence initiatives, including employee termination benefits, certain contract terminations, consulting and professional fees, dedicated project personnel, asset impairment or loss on disposal charges and other items.  Other certain tax adjustments include internal restructuring transactions that lower the tax rate on deferred tax liabilities recorded on intangible assets recognized as part of acquisition-related accounting or provide the Company access to offshore funds in a tax efficient manner.

We use these non-GAAP financial measures internally to evaluate the performance of the business and believe they are useful measures that provide meaningful supplemental information to investors to consider when evaluating the performance of the Company.  We believe these measures offer the ability to make period-to-period comparisons that are not impacted by certain items that can cause dramatic changes in reported operating results, to perform trend analysis, to better identify operating trends that may otherwise be masked or distorted by these types of items and to provide additional transparency of certain items.  In addition, certain of these non-GAAP financial measures are used as performance metrics in our incentive compensation programs.

Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures are included in this press release.

Cautionary Statement Regarding Forward-Looking Statements

This communication contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Forward-looking statements may be identified by the use of forward-looking terms such as “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “assumes,” “guides,” “targets,” “forecasts,” “sees” and “seeks” or the negative of such terms or other variations on such terms or comparable terminology.  All statements other than statements of historical or current fact are, or may be deemed to be, forward-looking statements.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks and uncertainties that could cause actual outcomes and results to differ materially.  These risks and uncertainties include, but are not limited to: the possibility that the anticipated synergies and other benefits from mergers and acquisitions will not be realized, or will not be realized within the expected time periods; the risks and uncertainties related to our ability to successfully integrate the operations, products, employees and distributors of acquired companies; the effect of the potential disruption of management’s attention from ongoing business operations due to integration matters related to mergers and acquisitions; the effect of mergers and acquisitions on our relationships with customers, vendors and lenders and on our operating results and businesses generally; compliance with the Deferred Prosecution Agreement entered into in January 2017; the success of our quality and operational excellence initiatives; challenges relating to changes in and compliance with governmental laws and regulations, including regulations of the U.S. Food and Drug Administration (the “FDA”) and foreign government regulators, such as more stringent requirements for regulatory clearance of products; the ability to remediate matters identified in any inspectional observations or warning letters issued by the FDA, while continuing to satisfy the demand for our products; the outcome of government investigations; price and product competition; changes in customer demand for our products and services caused by demographic changes or other factors; the impact of healthcare reform measures; reductions in reimbursement levels by third-party payors and cost containment efforts of healthcare purchasing organizations; dependence on new product development, technological advances and innovation; shifts in the product category or regional sales mix of our products and services; supply and prices of raw materials and products; control of costs and expenses; the ability to obtain and maintain adequate intellectual property protection; the ability to form and implement alliances; changes in tax obligations arising from tax reform measures or examinations by tax authorities; product liability and intellectual property litigation losses; the ability to retain the independent agents and distributors who market our products; dependence on a limited number of suppliers for key raw materials and outsourced activities; changes in general industry and market conditions, including domestic and international growth rates and general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; and the impact of the ongoing economic uncertainty affecting countries in the Euro zone on the ability to collect accounts receivable in affected countries.  For a further list and description of such risks and uncertainties, see our reports filed with the U.S. Securities and Exchange Commission.  Copies of these filings, as well as subsequent filings, are available online at www.sec.gov, www.zimmerbiomet.com or on request from us.  We disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be set forth in our periodic reports.  Readers of this communication are cautioned not to place undue reliance on these forward-looking statements, since, while management believes the assumptions on which the forward-looking statements are based are reasonable, there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this communication.

 ZIMMER BIOMET HOLDINGS, INC. 

 CONSOLIDATED STATEMENTS OF EARNINGS 

 FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016 

 (in millions, except per share amounts, unaudited) 

2017

2016

 Net Sales 

$     1,977.3

$     1,904.0

 Cost of products sold, excluding intangible asset amortization 

512.9

640.6

 Intangible asset amortization 

152.0

126.6

 Research and development 

91.1

85.7

 Selling, general and administrative 

760.8

716.9

 Special items 

110.1

88.7

      Operating expenses 

1,626.9

1,658.5

 Operating Profit 

350.4

245.5

 Other expense, net 

(2.8)

(3.8)

 Interest income  

0.5

1.3

 Interest expense 

(82.9)

(88.2)

 Earnings before income taxes 

265.2

154.8

 (Benefit) provision for income taxes 

(34.1)

46.1

 Net Earnings 

299.3

108.7

 Less: Net Loss attributable to noncontrolling interest 

(0.1)

(0.1)

 Net Earnings of Zimmer Biomet Holdings, Inc. 

$        299.4

$        108.8

 Earnings Per Common Share 

     Basic 

$          1.49

$          0.54

     Diluted 

$          1.47

$          0.54

 Weighted Average Common Shares Outstanding 

     Basic 

201.1

200.1

     Diluted 

203.1

202.2

 Cash Dividends Declared Per Common Share 

$          0.24

$          0.24

 ZIMMER BIOMET HOLDINGS, INC. 

 CONDENSED CONSOLIDATED BALANCE SHEETS 

 (in millions, unaudited) 

March 31,

December 31,

2017

2016

 Assets 

 Current Assets: 

   Cash and cash equivalents 

$            1,039.5

$               634.1

   Receivables, net 

1,600.1

1,604.4

   Inventories 

1,977.0

1,959.4

   Other current assets 

463.3

465.7

       Total current assets 

5,079.9

4,663.6

 Property, plant and equipment, net 

2,053.2

2,037.9

 Goodwill 

10,685.1

10,643.9

 Intangible assets, net 

8,650.6

8,785.4

 Other assets 

519.0

553.6

 Total Assets 

$          26,987.8

$          26,684.4

 Liabilities and Stockholders’ Equity 

 Current liabilities 

$            1,681.1

$            1,805.9

 Current portion of long-term debt 

975.0

575.6

 Other long-term liabilities 

3,859.7

3,967.2

 Long-term debt 

10,537.8

10,665.8

 Stockholders’ equity 

9,934.2

9,669.9

 Total Liabilities and Stockholders’ Equity 

$          26,987.8

$          26,684.4

 ZIMMER BIOMET HOLDINGS, INC. 

 CONSOLIDATED STATEMENTS OF CASH FLOWS 

 FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016 

 (in millions, unaudited) 

2017

2016

 Cash flows provided by (used in) operating activities 

 Net earnings 

$        299.3

$        108.7

 Depreciation and amortization 

267.6

246.9

 Share-based compensation 

14.0

12.7

 Inventory step-up 

14.6

153.7

 Changes in operating assets and liabilities, net of acquired assets and liabilities 

     Income taxes 

(86.9)

(33.7)

     Receivables 

26.8

(83.4)

     Inventories 

(11.5)

38.3

     Accounts payable and accrued expenses 

(137.0)

(116.3)

     Other assets and liabilities 

(111.5)

(54.1)

 Net cash provided by operating activities 

275.4

272.8

 Cash flows provided by (used in) investing activities 

 Additions to instruments 

(86.4)

(85.1)

 Additions to other property, plant and equipment 

(43.1)

(27.6)

 Purchases of investments 

(0.3)

 Sales of investments 

223.5

 Other investing activities 

(3.6)

(14.7)

 Net cash (used in) provided by investing activities 

(133.1)

95.8

 Cash flows provided by (used in) financing activities 

 Proceeds from multicurrency revolving facility 

400.0

 Payments on term loan 

(150.0)

(400.0)

 Net (payments) proceeds on other debt 

(0.7)

0.3

 Dividends paid to stockholders 

(48.1)

(44.6)

 Proceeds from employee stock compensation plans 

66.1

31.3

 Business combination contingent consideration payments 

(6.0)

 Restricted stock witholdings 

(5.2)

(4.4)

 Repurchase of common stock 

(415.5)

 Net cash provided by (used in) financing activities 

256.1

(832.9)

 Effect of exchange rates on cash and cash equivalents 

7.0

1.8

 Increase (decrease) in cash and cash equivalents 

405.4

(462.5)

 Cash and cash equivalents, beginning of period 

634.1

1,459.3

 Cash and cash equivalents, end of period 

$     1,039.5

$        996.8

 ZIMMER BIOMET HOLDINGS, INC. 

 NET SALES BY GEOGRAPHY 

 FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016 

 (in millions, unaudited) 

Three Months Ended March 31, 

2017

2016

% Inc /
(Dec)

 Americas 

$     1,234.8

$     1,177.3

4.9

%

 EMEA 

453.2

456.2

(0.7)

 Asia Pacific 

289.3

270.5

6.9

 Total 

$     1,977.3

$     1,904.0

3.8

 ZIMMER BIOMET HOLDINGS, INC. 

 NET SALES BY PRODUCT CATEGORY 

 FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016 

 (in millions, unaudited) 

 Three Months Ended March 31, 

2017

2016

% Inc /
(Dec)

 Knees 

$        701.8

$        703.2

(0.2)

%

 Hips 

475.7

467.9

1.7

 S.E.T 

425.1

401.0

6.0

 Dental 

107.8

108.6

(0.7)

 Spine & CMF 

186.3

141.2

32.0

 Other 

80.6

82.1

(1.8)

 Total 

$     1,977.3

$     1,904.0

3.8

ZIMMER BIOMET HOLDINGS, INC.

 RECONCILIATION OF REPORTED NET SALES % CHANGE TO

CONSTANT CURRENCY % CHANGE AND

% CHANGE EXCLUDING LDR HOLDING CORPORATION

(unaudited)

For the Three Months Ended

March 31, 2017

Foreign

Constant

Exchange

Currency

 % Change 

Impact

% Change

Geographic Results

Americas

4.9

%

0.2

%

4.7

%

EMEA

(0.7)

(3.8)

3.1

Asia Pacific

6.9

1.0

5.9

Total 

3.8

%

(0.7)

%

4.5

%

Product Categories

Knees

   Americas

(0.1)

%

0.1

%

(0.2)

%

   EMEA

(3.4)

(4.3)

0.9

   Asia Pacific

5.0

1.9

3.1

       Total

(0.2)

(0.8)

0.6

Hips

   Americas

0.2

0.2

   EMEA

(0.5)

(3.2)

2.7

   Asia Pacific

9.5

0.6

8.9

       Total

1.7

(0.7)

2.4

S.E.T

6.0

(0.5)

6.5

Dental

(0.7)

(0.8)

0.1

Spine & CMF

32.0

(0.1)

32.1

Other

(1.8)

(0.6)

(1.2)

       Total

3.8

%

(0.7)

%

4.5

%

Impact of LDR Holding Corporation

(2.2)

(2.2)

% Change excluding LDR Holding Corporation

1.6

%

(0.7)

%

2.3

%

 ZIMMER BIOMET HOLDINGS, INC. 

 RECONCILIATION OF NET EARNINGS TO ADJUSTED NET EARNINGS 

 FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016 

 (in millions, unaudited) 

 Three Months 

 Ended March 31, 

2017

2016

Net Earnings of Zimmer Biomet Holdings, Inc.

$       299.4

$       108.8

Inventory step-up and other inventory 

   and manufacturing-related charges

23.2

178.3

Intangible asset amortization

152.0

126.6

Special items

   Biomet merger-related

37.0

79.1

   Other special items

73.1

9.6

Merger-related expense in other expense, net

1.5

Taxes on above items (1)

(83.1)

(109.5)

Other certain tax adjustments(2)

(69.7)

14.3

Adjusted Net Earnings

$       433.4

$       407.2

(1) The tax effect for the U.S. jurisdiction is calculated based on an effective rate considering federal and state taxes,
as well as permanent items.  For jurisdictions outside the U.S., the tax effect is calculated based upon the statutory
rates where the items were incurred. 

(2) In 2017, other certain tax adjustments relate to a tax restructuring that lowered the tax rate on deferred tax liabilities recorded on intangible assets recognized in acquisition-related accounting.  The 2016 adjustment relates to internal restructuring transactions that provide the Company access to cash in a tax efficient manner. 

 ZIMMER BIOMET HOLDINGS, INC. 

      RECONCILIATION OF DILUTED EPS TO ADJUSTED DILUTED EPS 

 FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016 

 (unaudited) 

 Three Months 

 Ended March 31, 

2017

2016

Diluted EPS

$                   1.47

$                       0.54

Inventory step-up and other inventory 

   and manufacturing-related charges

0.11

0.87

Intangible asset amortization

0.75

0.63

Special items

   Biomet merger-related

0.18

0.39

   Other special items

0.36

0.05

Merger-related expense in other expense, net

0.01

Taxes on above items (1)

(0.41)

(0.54)

Other certain tax adjustments(2)

(0.34)

0.07

Adjusted Diluted EPS

$                   2.13

$                       2.01

(1) The tax effect for the U.S. jurisdiction is calculated based on an effective rate considering federal and state taxes, as well as permanent items.  For jurisdictions outside the U.S., the tax effect is calculated based upon the statutory rates where the items were incurred.

(2) In 2017, other certain tax adjustments relate to a tax restructuring that lowered the tax rate on deferred tax liabilities recorded on intangible assets recognized in acquisition-related accounting.  The 2016 adjustment relates to internal restructuring transactions that provide the Company access to cash in a tax efficient manner. 

 

 

ZIMMER BIOMET HOLDINGS, INC.
SUMMARY OF EXPENSES INCLUDED IN SPECIAL ITEMS
FOR THE THREE MONTHS ENDED MARCH 31, 2017 and 2016
(in millions, unaudited)
 

 Three Months 

 Ended March 31, 

2017

2016

 Biomet merger-related 

 Consulting and professional fees 

$     18.7

$     36.1

 Employee termination benefits 

(3.0)

4.1

 Dedicated project personnel 

8.7

21.7

 Relocated facilities 

2.8

1.7

 Contract terminations 

10.1

 Information technology integration 

2.3

1.4

 Other 

7.5

4.0

 Total Biomet merger-related 

37.0

79.1

 Other 

 Consulting and professional fees 

50.4

6.9

 Employee termination benefits 

1.2

 Dedicated project personnel 

12.8

1.8

 Relocated facilities 

2.4

0.2

 Certain litigation matters 

7.0

 Information technology integration 

0.5

0.1

 Contingent consideration adjustments 

(3.6)

 Other 

2.4

0.6

 Total Other 

73.1

9.6

 Special items 

$   110.1

$     88.7

ZIMMER BIOMET HOLDINGS, INC.
RECONCILIATION OF 2017 PROJECTED REVENUE % GROWTH TO

2017 PROJECTED CONSTANT CURRENCY % GROWTH

(unaudited)

 Projected Year Ended December 31, 2017: 

 High 

 Low 

 Revenue % growth 

3.0

%

2.0

%

 Foreign exchange impact 

1.2

1.2

    Constant currency % growth 

4.2

%

3.2

%

 Impact of LDR Holding Corporation 

(1.2)

(1.2)

    Constant currency % growth excluding LDR Holding Corporation 

3.0

%

2.0

%

 ZIMMER BIOMET HOLDINGS, INC. 

 RECONCILIATION OF 2017 PROJECTED DILUTED EPS 

 AND PROJECTED ADJUSTED DILUTED EPS 

 (unaudited) 

Projected Year Ended December 31, 2017:

High

Low

Diluted EPS

$                      4.88

$            4.68

Inventory step-up and other inventory and manufacturing related

   charges, intangible asset amortization, special items and other expense 

5.80

5.94

Taxes on above items(1) and other certain tax adjustments

(2.08)

(2.12)

Adjusted Diluted EPS

$                      8.60

$            8.50

(1) The tax effect for the U.S. jurisdiction is estimated based on an effective rate considering federal and state taxes, as well as permanent items.  For jurisdictions outside the U.S., the tax effect is estimated based upon the statutory rates where the items are projected to be incurred.

 

SOURCE Zimmer Biomet Holdings, Inc.

CONMED Corporation Announces First Quarter 2017 Financial Results

April 26, 2017

UTICA, N.Y.–(BUSINESS WIRE)–CONMED Corporation (Nasdaq:CNMD) today announced financial results for the first quarter ended March 31, 2017.

First Quarter 2017 Highlights

  • Sales of $186.6 million increased 3.0% as reported compared to the first quarter of 2016. On a constant currency basis, sales increased 3.7%.
  • International revenue grew 2.4% as reported and 3.9% in constant currency, driven by continued growth in General Surgery and Orthopedics.
  • Domestic General Surgery sales grew 9.5%, contributing to 3.5% overall domestic revenue growth.
  • Diluted net loss per share (GAAP) was $0.16, compared to diluted net loss per share (GAAP) of $0.08 in the first quarter of 2016.
  • Adjusted diluted net earnings per share(1) were $0.38 versus $0.42 in the prior-year period.

“We are encouraged by our first quarter results, which exhibited continued strength across our key international markets, as well as solid performance within our U.S. General Surgery business. While our domestic Orthopedics business remains a challenge, the first quarter represents improved sequential performance, and we remain focused on returning this business to positive growth,” commented Curt R. Hartman, CONMED’s President and Chief Executive Officer.

Sales Analysis

For the quarter ended March 31, 2017, domestic sales, which represented 53.3% of total revenue, increased 3.5%, as year-over-year growth of 9.5% in General Surgery was partially offset by a decline of 3.7% in Orthopedics. International sales, which represented 46.7% of total revenue, increased 2.4% compared to the first quarter of 2016 on a reported basis. Foreign currency exchange rates, including the effects of the FX hedging program, had a negative impact of $1.3 million on first quarter sales. In constant currency, international sales increased 3.9% versus the prior-year period.

Earnings Analysis

For the quarter ended March 31, 2017, reported net loss totaled $4.5 million, compared to a reported net loss of $2.3 million a year ago. Reported diluted net loss per share was $0.16 in the quarter, compared to a reported diluted net loss per share of $0.08 in the prior-year period. Reported net loss for 2017 includes litigation, business acquisition, and restructuring costs, and reported net loss for 2016 includes business acquisition, restructuring, and debt refinancing costs. The increase in reported net loss resulted primarily from the $12.2 million Lexion case jury verdict against the Company in 2017, which was partially offset by lower acquisition related costs when compared to the prior period. The effect of each of these items on reported net loss and reported diluted net loss per share appears in the reconciliation of GAAP to non-GAAP measures below.

The Company excludes the after-tax costs of special items including litigation, acquisitions, restructurings, gains on the sale of assets, debt refinancings, as well as amortization of intangible assets, net of tax, from its adjusted diluted net earnings per share. Excluding the impact of these items, adjusted net earnings(2) of $10.6 million decreased 8.7% year over year and adjusted diluted net earnings per share(1) of $0.38 decreased 9.5% year over year. The decrease in adjusted net earnings resulted primarily from the unfavorable impact of foreign exchange rates, partially offset by higher sales growth.

2017 Outlook

There is no change to CONMED’s previously issued financial guidance. The Company continues to expect 2017 constant currency sales growth in the range of 1% to 3%. Based on exchange rates as of April 21, 2017, the negative impact to 2017 sales from foreign exchange is still anticipated to be approximately 0.5%.

In addition, the Company continues to expect adjusted diluted net earnings per share in the range of $1.85 to $1.95, which includes an estimated negative impact from foreign exchange based on exchange rates as of April 21, 2017. The adjusted diluted net earnings per share estimates for 2017 exclude the cost of special items including acquisition costs, litigation costs, and restructuring costs, which are now estimated in the range of $16.5 to $18.5 million, net of tax, and amortization of intangible assets, which are still estimated in the range of $12 to $14 million, net of tax.

Supplemental Financial Disclosures

(1) A reconciliation of reported diluted net loss per share to adjusted diluted net earnings per share, a non-GAAP financial measure, appears below.

(2) A reconciliation of reported net loss to adjusted net earnings, a non-GAAP financial measure, appears below.

Conference Call

The Company’s management will host a conference call today at 4:30 p.m. ET to discuss its first quarter 2017 results.

To participate in the conference call, dial 844-889-7792 (domestic) or 661-378-9936 (international) and enter the passcode 4521460.

This conference call will also be webcast and can be accessed from the “Investors” section of CONMED’s web site at www.conmed.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A recording of the call will also be available from 7:30 p.m. ET on Wednesday, April 26, 2017, until 7:30 p.m. ET on Wednesday, May 10, 2017. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) and enter the passcode 4521460.

About CONMED Corporation

CONMED is a medical technology company that provides surgical devices and equipment for minimally invasive procedures. The Company’s products are used by surgeons and physicians in a variety of specialties, including orthopedics, general surgery, gynecology, neurosurgery and gastroenterology. CONMED has a direct selling presence in 17 countries, and international sales constitute approximately 50% of the Company’s total sales. Headquartered in Utica, New York, the Company employs approximately 3,300 people. For more information, visit www.conmed.com.

Forward-Looking Statements

This press release and today’s conference call may contain forward-looking statements based on certain assumptions and contingencies that involve risks and uncertainties, which could cause actual results, performance, or trends to differ materially from those expressed in the forward-looking statements herein or in previous disclosures. For example, in addition to general industry and economic conditions, factors that could cause actual results to differ materially from those in the forward-looking statements may include, but are not limited to, the risk factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016. Any and all forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and relate to the Company’s performance on a going-forward basis. The Company believes that all forward-looking statements made by it have a reasonable basis, but there can be no assurance that management’s expectations, beliefs or projections as expressed in the forward-looking statements will actually occur or prove to be correct.

Supplemental Information – Reconciliation of GAAP to Non-GAAP Financial Measures

The Company supplements the reporting of its financial information determined under accounting principles generally accepted in the United States (GAAP) with certain non-GAAP financial measures, including percentage sales growth in constant currency; adjusted gross profit; cost of sales excluding specified items; adjusted selling and administrative expenses; adjusted operating income; adjusted income tax expense; adjusted effective income tax rate; adjusted net earnings and adjusted diluted net earnings per share (EPS). The Company believes that these non-GAAP measures provide meaningful information to assist investors and shareholders in understanding its financial results and assessing its prospects for future performance. Management believes percentage sales growth in constant currency and the other adjusted measures described above are important indicators of its operations because they exclude items that may not be indicative of, or are unrelated to, its core operating results and provide a baseline for analyzing trends in the Company’s underlying business. Further, the presentation of EBITDA is a non-GAAP measurement that management considers useful for measuring aspects of the Company’s cash flow. Management uses these non-GAAP financial measures for reviewing the operating results and analyzing potential future business trends in connection with its budget process and bases certain management incentive compensation on these non-GAAP financial measures.

To measure percentage sales growth in constant currency, the Company removes the impact of changes in foreign currency exchange rates that affect the comparability and trend of sales. To measure earnings performance on a consistent and comparable basis, the Company excludes certain items that affect the comparability of operating results and the trend of earnings. These adjustments are irregular in timing, may not be indicative of past and future performance and are therefore excluded to allow investors to better understand underlying operating trends.

Because non-GAAP financial measures are not standardized, it may not be possible to compare these financial measures with other companies’ non-GAAP financial measures having the same or similar names. These adjusted financial measures should not be considered in isolation or as a substitute for reported sales growth, gross profit, cost of sales, selling and administrative expenses, operating income, income tax expense, effective income tax rate, net earnings (loss) and diluted net earnings (loss) per share, the most directly comparable GAAP financial measures. These non-GAAP financial measures are an additional way of viewing aspects of the Company’s operations that, when viewed with GAAP results and the reconciliations to corresponding GAAP financial measures below, provide a more complete understanding of the business. The Company strongly encourages investors and shareholders to review its financial statements and publicly-filed reports in their entirety and not to rely on any single financial measure.

Consolidated Condensed Statements of Loss

(in thousands, except per share amounts, unaudited)

Three Months Ended

March 31,

2017 2016
Net sales $ 186,567 $ 181,201
Cost of sales 86,682 83,461
Gross profit 99,885 97,740
% of sales 53.5 % 53.9 %
Selling and administrative expense 94,761 85,943
Research & development expense 7,618 8,258
Income (loss) from operations (2,494 ) 3,539
% of sales -1.3 % 2.0 %
Other expense 2,942
Interest expense 4,119 3,830
Loss before income taxes (6,613 ) (3,233 )
Benefit from income taxes (2,068 ) (968 )
Net loss $ (4,545 ) $ (2,265 )
Basic EPS $ (0.16 ) $ (0.08 )
Diluted EPS (0.16 ) (0.08 )
Basic shares 27,867 27,721
Diluted shares 27,867 27,721

Consolidated Condensed Balance Sheets

(in thousands, unaudited)

March December

2017

2016

Assets:
Cash and cash equivalents $ 34,660 $ 27,428
Accounts receivable, net 139,855 148,244
Inventories 140,083 135,869
Other current assets 18,905 18,971
Total Current Assets 333,503 330,512
Property, plant and equipment, net 119,742 122,029
Goodwill 398,154 397,664
Other intangible assets, net 414,766 419,549
Other assets 61,860 59,229
Total Assets $ 1,328,025 $ 1,328,983
Liabilities and Shareholders’ Equity:
Current liabilities $ 125,445 $ 113,952
Long-term debt, excluding current maturities 487,045 488,288
Other liabilities 140,013 146,167
Shareholders’ equity 575,522 580,576
Total Liabilities and Shareholders’ Equity $ 1,328,025 $ 1,328,983

Consolidated Condensed Statements of Cash Flows

Three Months Ended March 31, 2017 and 2016

(in thousands, unaudited)

2017 2016
Operating Activities
Net loss $ (4,545 ) $ (2,265 )
Depreciation and amortization 13,924 13,258
Stock-based compensation expense 1,955 2,489
Deferred income taxes (4,266 ) (2,942 )
Changes in operating assets and liabilities and other, net 8,230 (27,098 )
Net cash provided by (used in) operating activities 15,298 (16,558 )
Investing Activities
Payments related to business acquisitions (256,424 )
Purchases of property, plant and equipment (2,584 ) (2,789 )
Net cash used in investing activities (2,584 ) (259,213 )
Financing Activities
Payments on term loan (2,188 ) (2,188 )
Proceeds from term loan 175,000
Proceeds from revolving line of credit 38,000 137,000
Payments on revolving line of credit (36,000 ) (58,995 )
Payments related to debt issue costs (5,556 )
Payment related to distribution agreement (16,667 )
Dividend payments on common stock (5,566 ) (5,542 )
Other, net (512 ) (612 )
Net cash provided by (used in) financing activities (6,266 ) 222,440
Effect of exchange rate changes on cash and cash equivalents 784 721
Net increase (decrease) in cash and cash equivalents 7,232 (52,610 )
Cash and cash equivalents at beginning of period 27,428 72,504
Cash and cash equivalents at end of period $ 34,660 $ 19,894

Sales Summary

(in millions, unaudited)

Three Months Ended March 31,
% Change
Domestic International

As

Constant

As

As

Constant

2017 2016

Reported

Currency

Reported

Reported

Currency

Orthopedic Surgery $ 103.8 $ 105.3 -1.4% -0.7% -3.7% 0.2% 1.5%
General Surgery 82.8 75.9 9.1% 9.7% 9.5% 8.0% 10.1%
$ 186.6 $ 181.2 3.0% 3.7% 3.5% 2.4% 3.9%
Single-use Products $ 149.8 $ 144.9 3.3% 4.0% 3.6% 3.0% 4.5%
Capital Products 36.8 36.3 1.5% 2.4% 2.9% 0.1% 1.9%
$ 186.6 $ 181.2 3.0% 3.7% 3.5% 2.4% 3.9%
Domestic $ 99.4 $ 96.1 3.5% 3.5%
International 87.2 85.1 2.4% 3.9%
$ 186.6 $ 181.2 3.0% 3.7%

Reconciliation of Reported Net Loss to Adjusted Net Earnings

(in thousands, except per share amounts, unaudited)

Three Months Ended March 31, 2017

Selling &

Operating

Tax

Effective

Net

Gross

Administrative

Income

Other

Expense

Tax

Income

Diluted

Profit

Expense

(Loss)

Expense

(Benefit)

Rate

(Loss)

EPS

As reported $ 99,885 $ 94,761 $ (2,494 ) $ $ (2,068 ) 31.3 % $ (4,545 ) $ (0.16 )
% of sales 53.5 % 50.8 % -1.3 %
Restructuring costs (1) 1,169 (1,322 ) 2,491 782 1,709 0.06
Business acquisition costs (2) (1,488 ) 1,488 467 1,021 0.04

Patent settlement costs and other(3)

(1,048 ) 1,048 329 719 0.02

SurgiQuest litigation verdict (4)

(12,200 ) 12,200 3,831 8,369 0.30
$ 101,054 $ 78,703 $ 14,733 $ $ 3,341 31.5 % $ 7,273 $ 0.26
% of sales 54.2 % 42.2 % 7.9 %
Amortization of intangible assets $ 1,500 $ (3,650 ) $ 5,150 $ $ 1,821 3,329 0.12
Adjusted earnings $ 10,602 $ 0.38
Three Months Ended March 31, 2016

Selling &

Tax

Effective

Net

Gross

Administrative

Operating

Other

Expense

Tax

Income

Diluted

Profit

Expense

Income

Expense

(Benefit)

Rate

(Loss)

EPS

As reported $ 97,740 $ 85,943 $ 3,539 $ 2,942 $ (968 ) 29.9 % $ (2,265 ) $ (0.08 )
% of sales 53.9 % 47.4 % 2.0 %
Restructuring costs (1) 864 (2,791 ) 3,655 1,156 2,499 0.09
Business acquisition costs (2) (9,045 ) 9,045 2,872 6,173 0.22

Debt refinancing costs (5)

(2,942 ) 930 2,012 0.07
$ 98,604 $ 74,107 $ 16,239 $ $ 3,990 32.2 % $ 8,419 $ 0.30
% of sales 54.4 % 40.9 % 9.0 %
Amortization of intangible assets $ 1,500 $ (3,496 ) $ 4,996 $ $ 1,799 3,197 0.12
Adjusted earnings $ 11,616 $ 0.42
(1) In 2017 and 2016, the Company restructured certain operations, sales, marketing and administrative functions and incurred severance and other related costs.
(2) In 2017 and 2016, the Company incurred investment banking fees, consulting fees, legal fees, and integration related costs associated with the acquisition of SurgiQuest, Inc.
(3) In 2017, the Company incurred patent settlement costs and other legal related fees.
(4) In 2017, the Company incurred litigation fees as a result of the unfavorable verdict in the Lexion vs. SurgiQuest, Inc. case.
(5) In 2016, in conjunction with the acquisition of SurgiQuest, Inc., the Company refinanced its existing credit facility and incurred one-time fees associated with a back stop arrangement, as well as costs associated with the early extinguishment of debt.

Reconciliation of Reported Net Loss to EBITDA & Adjusted EBITDA

(in thousands, unaudited)

2017 2016
Net loss $ (4,545 ) $ (2,265 )
Benefit from income taxes (2,068 ) (968 )
Interest expense 4,119 3,830
Depreciation 4,866 4,986
Amortization 8,798 8,012
EBITDA $ 11,170 $ 13,595
Stock based compensation 1,955 1,769
Restructuring costs 2,491 3,655
Business acquisition costs 1,488 9,045
Patent settlement costs and other 1,048
SurgiQuest litigation verdict 12,200
Debt refinancing costs 2,942
Adjusted EBITDA $ 30,352 $ 31,006
EBITDA Margin
EBITDA 6.0 % 7.5 %
Adjusted EBITDA 16.3 % 17.1 %

Contacts

CONMED Corporation
Luke A. Pomilio, 315-624-3202
Chief Financial Officer
LukePomilio@conmed.com

Integra LifeSciences Reports First Quarter 2017 Financial Results

PLAINSBORO, N.J., April 26, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today reported its financial results for the first quarter ending March 31, 2017.

Highlights:

  • First quarter revenue increased 9.2% over the prior year quarter to $258.6 million, and organic revenue increased 6.4%. Derma Sciences contributed $10.4 million of revenue to first quarter results;
  • GAAP gross margin increased 230 basis points over the prior year quarter to 66.5%, and adjusted gross margin increased 100 basis points to 70.2%;
  • Operating cash flow increased 15.4% over the prior year quarter to $28.9 million, resulting in free cash flow conversion of 85.1% on a trailing twelve month basis, compared to 65.4% in the prior year period;
  • Closed Derma Sciences acquisition and on track to complete commercial integration by mid-year;
  • Secured financing for the planned acquisition of Codman Neurosurgery; and,
  • Maintaining previously issued 2017 full-year sales, organic growth, EPS and cash flow guidance.

Total revenues for the first quarter were $258.6 million, reflecting an increase of $21.9 million, or 9.2%, over the first quarter of 2016. Both global segments contributed to the growth, with revenue in Orthopedics and Tissue Technologies and Specialty Surgical Solutions increasing by 19.6% and 3.4%, respectively, compared to the prior year.

Excluding the revenue contribution from acquisitions and the effect of currency exchange rates and discontinued products, revenues increased 6.4% over the first quarter of 2016.

“We are off to a solid start in 2017, which gives us increased confidence in delivering on our full-year 2017 financial guidance,” said Peter Arduini, Integra’s president and chief executive officer. “We completed the acquisition of Derma Sciences, launched several new products that will drive growth in the second half of the year, and remain on track to complete the planned acquisition of Codman Neurosurgery in the fourth quarter of 2017.”

The company reported GAAP net income of $6.4 million, or $0.08 per diluted share, for the first quarter of 2017, compared to a GAAP net income of $13.4 million, or $0.18 per diluted share, for the first quarter of 2016. The year-over-year declines largely resulted from acquisition-related expenses associated with the Derma Sciences and Codman Neurosurgery transactions.

The adjusted measures discussed below are computed with the adjustments to GAAP reporting set forth in the attached reconciliation.

Adjusted net income for the first quarter of 2017 was $30.9 million, an increase of 9.3% over the prior year, and compares to adjusted net income of $28.3 million in the first quarter of 2016. Adjusted earnings per share for the first quarter of 2017 was $0.39, compared to $0.38, in the first quarter of 2016.

Adjusted EBITDA for the first quarter of 2017 was $55.2 million, or 21.3% of revenue, compared to $52.1 million, or 22.0% of revenue, in the first quarter of 2016. The slight decrease in adjusted EBITDA margin primarily resulted from the dilution caused by the Derma Sciences acquisition.

Operating cash flow for the first quarter was $28.9 million, an increase of 15.4% from the prior-year period.  Trailing twelve-month adjusted free cash flow conversion ended March 31, 2017 was 85.1%, versus 65.4% in the prior year.

Outlook for 2017

Based on first quarter results and the outlook for the remainder of the year, the company is maintaining its full-year 2017 revenue guidance range of $1.12 billion to $1.14 billion, and full-year 2017 organic revenue growth range of 7.0% to 8.5%. The company also is maintaining its full-year GAAP and adjusted earnings per share guidance ranges of $0.49 to $0.55 and $1.88 to $1.94, respectively.

“Based on our first quarter results and the sequential improvements that we expect over the course of the year, we remain confident that we will achieve our full-year projections,” said Glenn Coleman, Integra’s chief financial officer. “We also successfully executed and secured an extension of our term loan facility with favorable terms, which we will use to pay for the planned acquisition of Codman Neurosurgery later this year.”

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 AM ET today, Wednesday, April 26, 2017, to discuss financial results for the first quarter and forward-looking financial guidance.  The conference call will be hosted by Integra’s senior management team and will be open to all listeners.  Additional forward-looking information may be discussed in a question and answer session following the call.

Integra’s management team will reference a presentation during the conference call.  That presentation can be found on investor.integralife.com.

Access to the live call is available by dialing (719) 457-2618 and using the passcode 3686388. The call can also be accessed via a webcast link provided on investor.integralife.com.  Access to the replay will be available through May 1, 2017, by dialing (719) 457-0820 and using the passcode 3686388. The webcast will also be archived on the website.

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

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and reflect the Company’s judgment as of the date of this release.  Forward-looking statements include, but are not limited to, statements concerning future financial performance, including projections for revenues, GAAP and adjusted net income, GAAP and adjusted (loss)/earnings per diluted share, non-GAAP adjustments such as global enterprise resource planning (“ERP”) system implementation charges, acquisition-related charges, goodwill impairment charges, non-cash amortization of imputed interest for convertible debt, intangible asset amortization, and income tax expense (benefit) related to non-GAAP adjustments. Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Such risks and uncertainties include, but are not limited to the following: the Company’s ability to execute its operating plan effectively; the Company’s ability to manufacture and ship sufficient quantities of its products to meet its customers’ demand; the ability of third-party suppliers to supply us with raw materials and finished products; global macroeconomic and political conditions; the Company’s ability to manage its direct sales channels effectively; the Company’s ability to maintain relationships with customers of acquired entities; physicians’ willingness to adopt and third-party payors’ willingness to provide or maintain reimbursement for the Company’s recently launched, planned and existing products; initiatives launched by the Company’s competitors; downward pricing pressures for customers; the Company’s ability to secure regulatory approval for products in development; the Company’s ability to remediate quality systems violations; fluctuations in hospitals spending for capital equipment; the Company’s ability to comply with and obtain approvals for products of human origin and comply with recently enacted regulations regarding products containing materials derived from animal sources; difficulties in controlling expenses, including costs to procure and manufacture our products; the impact of changes in management or staff levels; the Company’s ability to integrate acquired businesses; the impact of goodwill and intangible asset impairment charges if future operating results of acquired businesses are significantly less than the results anticipated at the time of the acquisitions, the Company’s ability to leverage its existing selling organizations and administrative infrastructure; the Company’s ability to increase product sales and gross margins, and control non-product costs; the Company’s ability to achieve anticipated growth rates, margins and scale and execute its strategy generally; the amount and timing of acquisition, and integration-related costs; the geographic distribution of where the Company generates its taxable income; the effect of legislation effecting healthcare reform in the United States and internationally; fluctuations in foreign currency exchange rates; the amount of our convertible notes and bank borrowings outstanding and other factors influencing liquidity; and the economic, competitive, governmental, technological, and other risk factors and uncertainties identified under the heading “Risk Factors” included in Item 1A of Integra’s Annual Report on Form 10-K for the year ended December 31, 2016 and information contained in subsequent filings with the Securities and Exchange Commission.  In addition, with respect to the Codman Neurosurgery acquisition, forward-looking statements in this document may include without limitation any statements regarding the planned completion of the proposed acquisition, the costs and benefits of the proposed acquisition, including future financial and operating results, Integra’s or the Codman Neurosurgery business’s plans, objectives, expectations and intentions and the expected timing of completion of the proposed acquisition.   It is important to note that Integra’s goals and expectations are not predictions of actual performance.  Actual results may differ materially from Integra’s current expectations depending upon a number of factors affecting the Codman Neurosurgery business and Integra’s business and risks and uncertainties associated with acquisition transactions.  These factors include, among other things, the following: successful closing of the proposed acquisition; the risk that competing offers will be made for the Codman Neurosurgery business before the binding offer is accepted; the risk that the binding offer may not be accepted on a timely basis or at all; the ability to obtain required regulatory approvals for the proposed acquisition (including the approval of antitrust authorities necessary to complete the proposed acquisition), the timing of obtaining such approvals and the risk that such approvals may result in the imposition of conditions, including with respect to divestitures, that could materially adversely affect Integra, the Codman Neurosurgery business and the expected benefits of the proposed acquisition; the risk that a condition to closing of the proposed acquisition may not be satisfied on a timely basis or at all; the failure of the proposed acquisition to close for any other reason and the risk liability to Integra in connection therewith; access to available financing (including financing for the acquisition) on a timely basis and on reasonable terms; the effects of disruption caused by the proposed acquisition making it more difficult for Integra to execute its operating plan effectively or to maintain relationships with employees, vendors and other business partners; stockholder litigation in connection with the proposed acquisition; and  Integra’s ability to successfully integrate the Codman Neurosurgery business and other acquired businesses.

These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise.

Discussion of Adjusted Financial Measures

In addition to our GAAP results, we provide organic revenues, adjusted earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted net income, adjusted earnings per diluted share, adjusted diluted weighted average shares outstanding, free cash flow and adjusted free cash flow conversion.  Organic revenues consist of total revenues excluding the effects of currency exchange rates, acquired revenues and product discontinuances.  Adjusted EBITDA consists of GAAP net income from continuing operations, excluding: (i) depreciation and amortization; (ii) other income (expense); (iii) interest income and expense; (iv) income taxes; and (v) those operating expenses also excluded from adjusted net income.  The measure of adjusted net income consists of GAAP net income from continuing operations, excluding: (i) global enterprise resource planning (“ERP”) implementation charges; (ii) structural optimization charges; (iii) certain employee severance charges; (iv) acquisition-related charges; (v) convertible debt non-cash interest; (vi) intangible asset amortization expense; (vii) discontinued product lines charges; and (viii) income tax impact from adjustments and other items.  The measure of adjusted diluted weighted average shares outstanding is calculated by adding the economic benefit of the convertible note hedge transactions relating to Integra’s 2016 convertible notes.  The adjusted earnings per diluted share measure is calculated by dividing adjusted net income attributable to diluted shares by adjusted diluted weighted average shares outstanding.  The measure of free cash flow consists of GAAP net cash provided by continuing operating activities from continuing operations less purchases of property and equipment.  The adjusted free cash flow conversion measure is calculated by dividing free cash flow by adjusted net income.

Reconciliations of GAAP revenues to adjusted revenues and GAAP Adjusted Net Income from continuing operations to adjusted EBITDA, and adjusted net income, and GAAP earnings per diluted share to adjusted earnings per diluted share all for the three months ended March 31, 2017 and 2016, and the free cash flow and free cash flow conversion for the three months ended March 31, 2017 and 2016 and the twelve months ended March 31, 2017 and 2016, appear in the financial tables in this release.

The Company believes that the presentation of organic revenues and the various adjusted EBITDA, adjusted net income, adjusted earnings per diluted share, adjusted diluted weighted average shares outstanding, free cash flow and free cash flow conversion measures provide important supplemental information to management and investors regarding financial and business trends relating to the Company’s financial condition and results of operations.  For further information regarding why Integra believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company’s Current Report on Form 8-K regarding this earnings press release filed today with the Securities and Exchange Commission.  This Current Report on Form 8-K is available on the SEC’s website at www.sec.gov or on our website at www.integralife.com.

INTEGRA LIFESCIENCES HOLDINGS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
(In thousands, except per share amounts)
Three Months Ended March 31,
2017 2016
Total revenues, net $ 258,636 $ 236,770
Costs and expenses:
Cost of goods sold 86,585 84,773
Research and development 15,494 14,451
Selling, general and administrative 142,497 111,975
Intangible asset amortization 4,101 3,471
Total costs and expenses 248,677 214,670
Operating income 9,959 22,100
Interest income 7 6
Interest expense (5,131 ) (6,373 )
Other income (expense), net (90 ) (738 )
Income from continuing operations before taxes 4,745 14,995
Income tax expense (1,649 ) 1,576
Net income $ 6,394 $ 13,419
Net income per share:
Diluted net income per share $ 0.08 $ 0.18
Weighted average common shares outstanding for diluted net income per share 78,394 76,466

Segment revenues and growth in total revenues excluding the effects of currency exchange rates, acquisitions, and discontinued products are as follows:

(In thousands)
   Three Months Ended March 31,
2017 2016 Change
Specialty Surgical Solutions $ 156,290 $ 151,175 3.4 %
Orthopedics and Tissue Technologies 102,346 85,595 19.6 %
Total revenue $ 258,636 $ 236,770 9.2 %
Impact of changes in currency exchange rates $ 1,365 $
Less contribution of revenues from acquisitions* (10,404 )
Less contribution of revenues from discontinued products (433 ) (2,541 )
Total organic revenues $ 249,164 $ 234,229 6.4 %
* Acquisitions include Derma Sciences

Items included in GAAP net income from continuing operations and location where each item is recorded are as follows:

(In thousands)
Three Months Ended March 31, 2017
Item   Total Amount   COGS(a)   SG&A(b)   R&D(c)   Amort.(d)   OI&E(e) Tax(f)
Global ERP implementation charges $ 2,427 $ $ 2,427 $ $ $ $
Structural optimization charges 1,586 898 688
Acquisition-related charges* 20,317 643 19,674
Certain employee severance charges 125 125
Discontinued product lines charges 1,025 1,025
Intangible asset amortization expense 10,966 6,865 4,101
Estimated income tax impact from above adjustments and other items (11,951) (11,951)
Total adjustments $ 24,495 $ 9,431 $ 22,914 $ $ 4,101 $ $ (11,951)
Depreciation expense 8,751
a)  COGS – Cost of goods sold
b)  SG&A – Selling, general and administrative
c)  R&D- Research and development
d)  Amort. – Intangible asset amortization
e)  OI&E – Interest (income) expense, net and other (income) expense, net
f)  Tax – Income tax expense
* Acquisition related charges are primarily associated with the Derma Sciences and Codman Neurosurgery acquisitions and include banking, legal, consulting and other expenses
Three months ended March 31, 2016
(In thousands)
Item   Total Amount   COGS (a)   SG&A (b)   Amort. (c)   OI&E (d)  Tax (e)
Global ERP implementation charges $ 3,324 $ $ 3,324 $ $ $
Structural optimization charges 1,709 985 724
Acquisition-related charges 6,041 3,652 2,389
Certain employee severance charges 650 211 439
Intangible asset amortization expense 10,536 7,065 3,471
Convertible debt noncash interest 2,064 2,064
Estimated income tax impact from above adjustments and other items (9,480) (9,480)
Total adjustments $ 14,844 $ 11,913 $ 6,876 $ 3,471 $ 2,064 $ (9,480)
Depreciation expense 7,717
a)  COGS – Cost of goods sold
b)  SG&A – Selling, general and administrative
c)  Amort. – Intangible asset amortization
d)  OI&E – Interest (income) expense, net and other (income) expense, net
e)  Tax – Income tax expense
RECONCILIATION OF NON-GAAP ADJUSTMENTS – GAAP NET INCOME FROM CONTINUING OPERATIONS TO ADJUSTED EBITDA
(UNAUDITED)
(In thousands, except per share amounts)
Three Months Ended March 31,
 2017  2016
GAAP net income from continuing operations $ 6,394 $ 13,419
Non-GAAP adjustments:
Depreciation and intangible asset amortization expense 19,717 18,253
Other (income) expense, net 90 738
Interest expense, net 5,124 6,367
Income tax expense (1,649 ) 1,576
Global ERP implementation charges 2,427 3,324
Structural optimization charges 1,586 1,709
Acquisition-related charges 20,317 6,041
Certain employee severance charges 125 650
Discontinued product lines charges 1,025
Total of non-GAAP adjustments 48,762 38,658
Adjusted EBITDA $ 55,156 $ 52,077
RECONCILIATION OF NON-GAAP ADJUSTMENTS – GAAP NET INCOME FROM CONTINUING OPERATIONS TO
MEASURES OF ADJUSTED NET INCOME AND ADJUSTED EARNINGS PER SHARE
(UNAUDITED)
(In thousands, except per share amounts)
Three Months Ended March 31,
2017 2016
GAAP net income from continuing operations $ 6,394 $ 13,419
Non-GAAP adjustments:
Global ERP implementation charges 2,427 3,324
Structural optimization charges 1,586 1,709
Acquisition-related charges 20,317 6,041
Certain employee severance charges 125 650
Discontinued product lines charges 1,025
Intangible asset amortization expense 10,966 10,536
Convertible debt noncash interest 2,064
Estimated income tax impact from adjustments and other items (11,951 ) (9,480 )
Total of non-GAAP adjustments 24,495 14,844
Adjusted net income $ 30,889 $ 28,263
Adjusted diluted net income per share $ 0.39 $ 0.38
Weighted average common shares outstanding for diluted net income per share 78,394 76,466
Weighted average common shares outstanding adjustment for economic benefit of convertible bond hedge transactions (1,306 )
Weighted average common shares outstanding for adjusted diluted net income per share 78,394 75,160
CONDENSED BALANCE SHEET DATA
(UNAUDITED)
(In thousands)
  March 31,
2017
December 31,
2016
Cash and cash equivalents $ 124,113 $ 102,055
Accounts receivable, net 158,234 148,186
Inventories, net 239,809 217,263
Bank line of credit 855,000 665,000
Stockholders’ equity $ 852,491 $ 839,667

 

CONDENSED STATEMENT OF CASH FLOWS
(UNAUDITED)
(In thousands)
Three Months Ended
March 31, 2017 March 31, 2016
Net cash provided by operating activities $ 28,882 $ 25,030
Net cash used in investing activities (193,143 ) (6,730 )
Net cash provided by financing activities 185,039 9,952
Effect of exchange rate changes on cash and cash equivalents 1,280 702
Net increase in cash and cash equivalents $ 22,058 $ 28,954
RECONCILIATION OF NON-GAAP ADJUSTMENTS – GAAP OPERATING CASH FLOW TO
MEASURES OF FREE CASH FLOW AND FREE CASH FLOW CONVERSION
(UNAUDITED)
(In thousands)
Three Months Ended
March 31,
 2017  2016
GAAP net cash provided by continuing operating activities $   28,880 $   25,030
Purchases of property and equipment from continuing operations (9,191 ) (10,895 )
Free cash flow 19,689 14,135
Adjusted net income * $   30,889 $   28,263
Adjusted free cash flow conversion   63.7 %   50.0 %
Twelve Months Endied
March 31,
 2017  2016
GAAP net cash provided by continuing operating activities** $   163,040 $   112,792
Purchases of property and equipment from continuing operations (45,624 ) (38,978 )
Free cash flow 117,416 73,814
Adjusted net income * $   137,990 $   112,921
Adjusted free cash flow conversion   85.1 %   65.4 %
* Adjusted net income for quarters ended March 31, 2017 and 2016 are reconciled above.  Adjusted net income for remaining quarters in the trailing twelve months calculation have been previously reconciled and are publicly available in the Quarterly Earnings Call Presentations and the Historical Financial Results: Continuing Operations presentation on our website at investor.integralife.com under Events & Presentations.
** Operating cash flow excludes $42.8M of accreted interest payment associated with the 2016 Convertible Notes.
The Company calculates adjusted free cash flow conversion by dividing its free cash flow by adjusted net income.  The Company believes this measure is useful in evaluating the significance of the cash special charges in its adjusted earnings measures.
INTEGRA LIFESCIENCES HOLDINGS CORPORATION
RECONCILIATION OF NON-GAAP ADJUSTMENTS – GUIDANCE
Recorded Year to Date Projected Year Ended
(In thousands, except per share amounts) March 31, 2017 December 31, 2017
Low High
GAAP net income $   6,394 $   39,250 $   43,750
Non-GAAP adjustments:
Global ERP implementation charges 2,427 7,400 7,400
Structural optimization charges 1,586 19,000 19,000
Acquisition-related charges 20,317 78,500 78,500
Certain employee severance charges 125 125 125
Discontinued product lines charges 1,025 1,025 1,025
Intangible asset amortization expense 10,966 47,800 47,800
Estimated income tax impact from adjustments and other items (11,951 ) (44,000 ) (44,000 )
Total of non-GAAP adjustments 24,495 109,850 109,850
Adjusted net income $   30,889 $   149,100 $   153,600
GAAP diluted net income per share $ 0.08 $ 0.49 $ 0.55
Non-GAAP adjustments detailed above (per share) $ 0.31 $ 1.39 $ 1.39
Adjusted diluted net income per share $ 0.39 $ 1.88 $ 1.94
Weighted average common shares outstanding for diluted net income per share 78,394 79,500 79,000

 

GUIDANCE – SPECIAL CHARGES
Item YTD
Amount
FY
Guidance
COGS SG&A  R&D  Amort. Interest
(Inc)Exp
Tax
Global ERP implementation charges $   2,427 $   7,400 $  — $   7,400  $  —  $  — $  — $  —
Structural optimization charges 1,586 19,000 10,500 8,500
Acquisition-related charges 20,317 78,500 9,000 69,500
Certain employee severance charges 125 125 125
Discontinued product lines charges 1,025 1,025 1,025
Intangible asset amortization expense 10,966 47,800 31,000 16,800
Convertible debt non-cash interest
Estimated income tax impact from adjustments and other items (11,951 ) (44,000 ) (44,000 )
Total 24,495 109,850 51,525 85,525 16,800 (44,000 )

 

Contact:

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

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

Media:
Laurene Isip
(609) 750-7984
laurene.isip@integralife.com