AAHKS Looks Forward to Working with New HHS Secretary, Dr. Tom Price

ROSEMONT, Ill., Feb. 10, 2017 /PRNewswire-USNewswire/ — Following the confirmation of Congressman Tom Price as the new Secretary of the United States Department of Health and Human Services (HHS), the American Association of Hip and Knee Surgeons (AAHKS) congratulates Dr. Price on being appointed to a position for which he is uniquely suited.

Dr. Price’s experience as a physician gives him a critically important perspective on the real-world impact of health policy including the importance of access, coverage, the doctor-patient relationship, clinical decision making and challenges of navigating a complex health care environment. “We have confidence that as a physician, he will seek to put patients first in his role as HHS Secretary,” said William A. Jiranek, AAHKS President.

Working with Dr. Price in his role as a Congressional leader, we found him always willing to listen and to express concern about the impact of government programs on patients. We look forward to continuing our work with the HHS agencies, especially the Centers for Medicare and Medicaid Services (CMS) now under the leadership of Dr. Price.

About the American Association of Hip and Knee Surgeons:
Established in 1991, the mission of AAHKS is to advance hip and knee patient care through education and advocacy. AAHKS has a membership of over 3,200 surgeons and other hip and knee health care professionals.

SOURCE American Association of Hip and Knee Surgeons (AAHKS)

Related Links

http://www.aahks.org

MedTech Industry Lost Nearly 29k Jobs While Device Tax In Effect

February 8, 2017

WASHINGTON, D.C. – The U.S. medical technology industry saw its jobs ranks fall by nearly 29,000 while the medical device excise tax was in effect, according to the latest figures from the U.S. Department of Commerce. Specifically, from 2012 to 2015, the number of U.S. medtech jobs declined from 401,472 to 372,638 – a loss of 28,834 jobs or a 7.2 percent decrease for the time period.

“These numbers reveal just how devastating of an impact the device tax had on our industry and underscore the urgent need for permanent repeal,” said Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed). “At a time when American device manufacturers are ready to grow and create jobs, the best message this Congress and the Administration can send is through a full and permanent repeal.”

Based on data updated by the Commerce Department last month (Jan. 19), the chart below shows year-to-year changes, with job losses beginning to drop in 2012 in anticipation of the device tax going into effect the next year. The drop rapidly accelerated in 2014 with an additional reduction of 27,022 job losses. The medical device tax was suspended for two years beginning late 2015.

Annual Change in Total Medtech Employment: 2010-2015

Year

Total Medtech Jobs

Y-o-Y Change

Y-o-Y % Change

2010

400,232

2011

401,820

1,588

0.4%

2012

401,472

-348

-0.1%

2013

397,058

-4,414

-1.1%

2014

370,036

-27,022

-6.8%

2015

372,638

2,602

0.7%

Medtech Job Losses from 2012 to 2015

US Dept. of Commerce

-28,834

-7.2%

Last month, AdvaMed released data showing just how the industry was re-investing and producing jobs in the wake of the tax’s suspension, even as analysts were predicting greater growth with full repeal.

“While it was a positive step, suspending the device tax is only a half measure,” Whitaker warned. “For medtech companies to plan for further job creation and development of the next generation of treatments and cures, they need the certainty that this onerous tax will be gone for good.

“Bipartisan majorities in both the House and Senate are on record in support of full and permanent repeal. There is no reason for delay. We urge the Congress and Administration to take action now.”

 

PRESS RELEASE

CONTACT:
Mark E. Brager
202-434-7244
mbrager@advamed.org

 

Hospital For Special Surgery Collaborates With Stamford Health

STAMFORD, Conn. — Stamford Health and Hospital for Special Surgery (HSS) formally announced a collaboration to create the premier center for advanced orthopedic care serving Connecticut and New England.

HSS Orthopedics at Stamford Health will provide a level of inpatient and ambulatory care unrivaled in the region. Under the collaboration, Stamford Health will adopt HSS best practices across the entire orthopedic service line, and surgeons from HSS in New York City will be providing care through HSS Orthopedics at Stamford Hospital.

HSS is the world’s leading academic medical center focused on musculoskeletal health and has been ranked the No. 1 hospital for orthopedics in the U.S. for the past seven consecutive years by U.S News & World Report. HSS leads the field of orthopedics nationwide for successful outcomes, and lowest infection, complication and revision rates.

“We believe this strategic and innovative relationship with HSS will elevate our institution to the forefront of musculoskeletal services and further differentiate us from others in the region,” said Brian G. Grissler, President and CEO, Stamford Health. “Through this collaboration, we will create a new Department of Orthopedic Surgery that integrates best practices and expands our capabilities.”

“We are drawing upon the very best skills, talent and resources of HSS and Stamford Health in what is truly a transformational collaboration between our two organizations,” said Louis A. Shapiro, President and CEO, Hospital for Special Surgery. “This revolutionary alliance will bring world-class orthopedic care closer to home for thousands of Connecticut residents, so fewer will need to leave the state for such care.”

HSS Orthopedics at Stamford Health will be available on a dedicated fifth floor of the acclaimed new Stamford Hospital building late this year, and later this month at Tully Health Center.

“Stamford Health has been providing tertiary care to the residents of Fairfield County for more than 120 years,” Grissler said. “Building upon our existing foundation of service, Magnet status nursing and a brand new hospital, this collaboration will take their orthopedic services to the next level.”

HSS has provided pre-, post- and non-surgical care in Connecticut since 2001. The 20,000 square foot HSS Outpatient Center at Chelsea Piers Connecticut in Stamford will continue to provide those services, as will the neighboring HSS-Stamford Health Sports Rehab facility.

Smith & Nephew Directorate Change

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today  announces, in accordance with Listing Rule 9.6.11(2) R, that Brian Larcombe will retire as Senior Independent Director and Non-Executive Director at the conclusion of the Annual General Meeting on 6 April 2017.

Following the Annual General Meeting on 6 April 2017, and subject to his re-election as a Director of Smith & Nephew plc at the Annual General Meeting, Ian Barlow will be appointed as the Senior Independent Non-Executive Director, in place of Brian Larcombe.

On 1 March 2017, Ian Barlow will step down as Chairman of the Audit Committee and Robin Freestone will be appointed Chairman of the Audit Committee in his place.

Roberto Quarta, Chairman, said

“Brian Larcombe has served Smith & Nephew for many years, as our Senior Independent Director since 2014, and as a member of the Audit, Nomination & Governance and Remuneration Committees. We will miss his great wisdom and experience. On behalf of the whole Board I thank him for his service and wish him well for the future.”

Enquiries

Investors

Ingeborg Øie
Smith & Nephew

+44 (0) 20 7960 2285

Media

Charles Reynolds
Smith & Nephew

+44 (0) 20 7401 7646

Matthew Cole / Debbie Scott
FTI Consulting

+44 (0) 20 3727 1000

 

About Smith & Nephew

Smith & Nephew is a global medical technology business dedicated to helping healthcare professionals improve people’s lives. With leadership positions in Orthopaedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma & Extremities, Smith & Nephew has around 15,000 employees and a presence in more than 100 countries. Annual sales in 2015 were more than $4.6 billion. Smith & Nephew is a member of the FTSE100 (LSE:SN, NYSE:SNN).

For more information about Smith & Nephew, please visit our website www.smith-nephew.com, follow @SmithNephewplc on Twitter or visit SmithNephewplc on Facebook.com.

 

Forward-looking Statements

This document may contain forward-looking statements that may or may not prove accurate. For example, statements regarding expected revenue growth and trading margins, market trends and our product pipeline are forward-looking statements. Phrases such as “aim”, “plan”, “intend”, “anticipate”, “well-placed”, “believe”, “estimate”, “expect”, “target”, “consider” and similar expressions are generally intended to identify forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause actual results to differ materially from what is expressed or implied by the statements. For Smith & Nephew, these factors include: economic and financial conditions in the markets we serve, especially those affecting health care providers, payers and customers; price levels for established and innovative medical devices; developments in medical technology; regulatory approvals, reimbursement decisions or other government actions; product defects or recalls or other problems with quality management systems or failure to comply with related regulations; litigation relating to patent or other claims; legal compliance risks and related investigative, remedial or enforcement actions; disruption to our supply chain or operations or those of our suppliers; competition for qualified personnel; strategic actions, including acquisitions and dispositions, our success in performing due diligence, valuing and integrating acquired businesses; disruption that may result from transactions or other changes we make in our business plans or organisation to adapt to market developments; and numerous other matters that affect us or our markets, including those of a political, economic, business, competitive or reputational nature. Please refer to the documents that Smith & Nephew has filed with the U.S. Securities and Exchange Commission under the U.S. Securities Exchange Act of 1934, as amended, including Smith & Nephew’s most recent annual report on Form 20-F, for a discussion of certain of these factors. Any forward-looking statement is based on information available to Smith & Nephew as of the date of the statement. All written or oral forward-looking statements attributable to Smith & Nephew are qualified by this caution. Smith & Nephew does not undertake any obligation to update or revise any forward-looking statement to reflect any change in circumstances or in Smith & Nephew’s expectations.

 

◊  Trademark of Smith & Nephew.  Certain marks registered US Patent and Trademark Office. 

Intuitive Surgical warns of risks on Obamacare repeal, NAFTA withdrawal, Brexit

BY

Intuitive Surgical (NSDQ:ISRG) last week warned of the risks posed to its business by the geopolitical shifts of the past year, including the likely repeal of Obamacare, the U.S.’s threatened abrogation of the North American Free Trade Agreement and Great Britain’s pending exit from the European Union.

In its annual report filed Feb. 3, the robot-assisted surgery market’s leading player warned that a repeal of the Patient Protection & Affordable Care Act, enacted in 2010, “could have a negative impact on the demand for our products.”

“Any changes of, or uncertainty with respect to future reimbursement rates, or changes in hospital admission rates could impact our customers’ demand for our products and services, which in turn could impact our ability to successfully commercialize our products, or could limit or eliminate our spending on certain development projects. These changes could have a material adverse effect on our business, financial condition, results of operations or cash flows,” the company wrote in the filing. “We are unable to predict whether other healthcare policies, including policies stemming from legislation or regulations affecting our business may be proposed or enacted in the future; what effect such policies would have on our business; or the effect ongoing uncertainty about these matters will have on the purchasing decisions of our customers.”

 

READ THE REST HERE

NuVasive Reports Fourth Quarter And Full Year 2016 Financial Results

SAN DIEGO, Feb. 9, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today financial results for the quarter and full year ended December 31, 2016. Key performance highlights included:

Fourth Quarter 2016 Highlights:

  • Revenue increased 25.9% to $271.1 million, or 25.5% on a constant currency basis;
  • GAAP operating profit margin of 11.1%; Non-GAAP operating profit margin up 90 basis points to 18.0%; and
  • GAAP diluted earnings per share of $0.11; Non-GAAP diluted earnings per share increase of 51.4% to $0.53.

Full Year 2016 Highlights:

  • Revenue increased 18.6% to $962.1 million, or 18.4% on a constant currency basis;
  • GAAP operating profit margin of 12.8%; Non-GAAP operating profit margin up 70 basis points to 16.1%; and
  • GAAP diluted earnings per share of $0.69; Non-GAAP diluted earnings per share increase of 26.7% to $1.66.

“NuVasive delivered record fourth quarter results and exceeded expectations for the full year 2016. By all measures, the Company had a tremendous year executing against our market-share taking initiatives, delivering strong revenue growth, including a return to 20% year-over-year growth in our core International markets. We exceeded our profitability targets and integrated strategic acquisitions to augment our leadership in spine and deliver the substantial growth we forecasted as part of the deal models,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “In 2017, we are committed to driving further market expansion, especially in the spine deformity area, while significantly increasing our in-sourced manufacturing capabilities and focusing on streamlining our operations to drive scale and profitability in our business.”

A full reconciliation of non-GAAP to GAAP measures can be found in the tables of this news release.

Fourth Quarter 2016 Results NuVasive reported fourth quarter 2016 total revenue of $271.1 million, a 25.9% increase compared to $215.3 million for the fourth quarter 2015. On a constant currency basis, fourth quarter 2016 total revenue increased 25.5% compared to the same period last year.

Gross profit for the fourth quarter 2016 was $204.2 million on a GAAP and non-GAAP basis, while GAAP and non-GAAP gross margin was 75.3%. These results compared to gross profit of $164.0 million on a GAAP and non-GAAP basis, and GAAP and non-GAAP gross margin of 76.2% for the fourth quarter 2015. Total GAAP and non-GAAP operating expenses for the fourth quarter 2016 were $174.1 million and $155.4 million, respectively. These results compared to GAAP and non-GAAP operating expenses of $134.5 million and $127.3 million, respectively, for the fourth quarter 2015.

The Company reported a GAAP net income of $6.4 million, or $0.11 per share, for the fourth quarter 2016 compared to a GAAP net income of $11.5 million, or $0.22 per share, for the fourth quarter 2015. On a non-GAAP basis, the Company reported net income of $27.6 million, or $0.53 per share, for the fourth quarter 2016 compared to net income of $18.0 million, or $0.35 per share, for the fourth quarter 2015.

Full Year 2016 Results NuVasive reported full year 2016 total revenue of $962.1 million, an 18.6% increase compared to $811.1 million for the full year 2015. On a constant currency basis, full year 2016 total revenue increased 18.4% compared to the same period last year.

Total GAAP and non-GAAP gross profit for the full year 2016 was $722.0 million and $736.7 million, respectively, while GAAP and non-GAAP gross margin of 75.0% and 76.6%, respectively. These results compared to gross profit of $616.6 million on a GAAP and non-GAAP basis and a GAAP and non-GAAP gross margin of 76.0% for the full year 2015. Total GAAP and non-GAAP operating expenses for the full year 2016 were $598.5 million and $581.6 million, respectively. These results compared to $477.6 million and $492.0 million, respectively, for the full year 2015.

The Company reported a GAAP net income of $37.1 million, or $0.69 per share, for the full year 2016 compared to a GAAP net income of $66.3 million, or $1.26 per share, for the full year 2015. On a non-GAAP basis, the Company reported net income of $86.5 million, or $1.66 per share, for the full year 2016 compared to net income of $66.9 million, or $1.31 per share, for the full year 2015.

Cash, cash equivalents and short and long-term marketable securities were approximately $153.6 million at December 31, 2016.

Annual Financial Guidance for 2017 The Company provided the following updated projections to its full year 2017 guidance:

2017 Guidance 1

(in Million’s; except %’s and EPS)

GAAP

Non-GAAP

Revenue

$ 1,065

$ 1,065

% Growth – Reported

10.7%

10.7%

% Growth – Constant Currency 2

11.7%

Operating margin

12.6%

17.1%

Earnings per share

$ 1.16

$ 2.00

EBITDA

23.6%

26.7%

Tax Rate

~35%

~35%

1

Current guidance reflects guidance provided February 9, 2017, as updated for the expected changes in currency.

2

Constant currency is a measure that adjusts US GAAP revenue for the impact of currency over the same period in the prior year.

  • Revenue of $1.065 billion, which includes approximately $10 million in year-over-year currency headwinds, and reflects 10.7% growth on a reported basis and 11.7% growth on a constant currency basis compared to revenue of $962.1 million for 2016;
  • Non-GAAP diluted earnings per share of $2.00, an increase of 20% compared to non-GAAP diluted earnings per share of $1.66 for 2016;
  • Non-GAAP operating profit margin of 17.1%, an increase of 100 basis points compared to 16.1% for 2016; and
  • Adjusted EBITDA margin of 26.7%, an increase of 150 basis points compared to 25.2% for 2016.

Supplementary Financial Information For additional financial detail, please visit the Investor Relations section of the Company’s website at www.nuvasive.com to access Supplementary Financial Information.

Reconciliation of Full Year EPS Guidance

2016 Actuals

2017 Guidance 1

GAAP net income per share

$ 0.69

$ 1.16

Impact of change to diluted share count

0.02

0.07

GAAP net income per share, adjusted to diluted Non-GAAP share count

$ 0.71

$ 1.23

Litigation liability gain

(0.83)

Business transition costs 2

0.35

0.05

Non-cash interest expense on convertible notes

0.38

0.33

Non-cash purchase accounting adjustments on acquisitions 3

0.28

Loss on repurchase of convertible notes

0.37

Amortization of intangible assets 4

0.78

0.83

Tax effect of adjustments 5

(0.38)

(0.44)

Non-GAAP earnings per share

$ 1.66

$ 2.00

GAAP Weighted shares outstanding – basic

50,077

50,967

GAAP Weighted shares outstanding – diluted

54,102

56,269

Non-GAAP Weighted shares outstanding – diluted

51,981

53,069

1

Current guidance reflects guidance provided February 9, 2017, as updated for the expected changes in currency. Effective tax expense rate of ~35% applied to GAAP earnings and ~35% applied to Non-GAAP earnings.

2

Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.

3

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

4

Excludes the amortization associated with non-controlling interest.

5

The impact on results from taxes include tax effecting the adjustments above at the statutory rate as well as taking into account discrete items and including those discrete items in the annual effective tax rate calculation. The Company also includes those adjustments that would have benefited the tax rate in lieu of the above adjustments as part of the Company’s tax filings. The impact of the changes to the tax rate results in an annual estimated rate of ~35% on a non-GAAP basis.

Reconciliation of Non-GAAP Operating Margin %

(in thousands, except %)

2016 Actuals

2017 Guidance 1

Non-GAAP Gross Margin % [A]

76.6%

76.1%

Non-cash purchase accounting adjustments on acquisitions 2

(1.5%)

0.0%

GAAP Gross Margin [B]

75.0%

76.1%

GAAP & Non-GAAP Sales, Marketing & Administrative Expense [C]

55.5%

54.0%

Non-GAAP Research & Development Expense [D]

5.0%

5.0%

In-process research & development

0.0%

0.0%

GAAP Research & Development Expense [E]

5.0%

5.0%

Litigation liability [F]

(4.5%)

0.0%

Amortization of intangible assets [G] 3

4.4%

4.3%

Business transition costs [H] 4

1.9%

0.3%

Non-GAAP Operating Margin % [A – C – D]

16.1%

17.1%

GAAP Operating Margin % [B – C – E – F – G – H]

12.8%

12.6%

1

Current guidance reflects guidance provided February 9, 2017, as updated for the expected changes in currency.

2

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

3

Excludes the amortization associated with non-controlling interest.

4

Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.

Reconciliation of EBITDA %

(in thousands, except %)

2016 Actuals

2017 Guidance 1

Net Income / (Loss)

3.9%

6.1%

Interest (income) / expense, net 2

6.1%

3.5%

Provision for income taxes

3.0%

3.1%

Depreciation and amortization 3

10.5%

10.8%

EBITDA

23.5%

23.6%

Non-cash stock based compensation

2.8%

2.9%

Business transition costs 4

1.9%

0.3%

Non-cash purchase accounting adjustments on acquisitions 5

1.5%

0.0%

In-process research & development

0.0%

0.0%

Litigation liability gain

(4.5%)

0.0%

Adjusted EBITDA

25.2%

26.7%

1

Current guidance reflects guidance provided February 9, 2017, as updated for the expected changes in currency.

2

Interest (income) / expense, net for the quarter and year ended December 31, 2016 includes loss on extinguishment of debt for $1.6 million and $19.1 million, respectively.

3

Excludes the amortization associated with non-controlling interest.

4

Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.

5

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

Reconciliation of Non-GAAP Information

Management uses certain non-GAAP financial measures such as non-GAAP earnings per share, non-GAAP net income, non-GAAP operating expenses and non-GAAP operating profit margin, which exclude amortization of intangible assets, leasehold related charges, integration related expenses associated with acquired businesses, one-time restructuring and acquisition related items, CEO transition related costs, certain litigation charges and non-cash interest expense (excluding debt issuance cost) and or losses on convertible notes. Management also uses certain non-GAAP measures which are intended to exclude the impact of foreign exchange currency fluctuations. The measure constant currency is the use of an exchange rate that eliminates fluctuations when calculating financial performance numbers.

The Company also uses measures such as free cash flow, which represents cash flow from operations less cash used in the acquisition and disposition of capital. Additionally, the Company uses an adjusted EBITDA measure which represents earnings before interest, taxes, depreciation and amortization and excludes the impact of stock-based compensation, leasehold related charges, integration related expenses associated with acquired businesses, CEO transition related costs, certain litigation liabilities, acquisition related items and other significant one-time items. Management calculates the non-GAAP financial measures provided in this earnings release excluding these costs and uses these non-GAAP financial measures to enable it to further and more consistently analyze the period-to-period financial performance of its core business operations. Management believes that providing investors with these non-GAAP measures gives them additional information to enable them to assess, in the same way management assesses, the Company’s current and future continuing operations. These non-GAAP measures are not in accordance with, or an alternative for, GAAP, and may be different from non-GAAP measures used by other companies. Set forth below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

Reconciliation of Fourth Quarter 2016 Results

GAAP Net Income per Share to Non-GAAP Earnings per Share

(in thousands, except per share data)

Adjustments

Diluted Earnings Per Share

GAAP net income

$ 6,376

$ 0.11

Loss on extinguishment of debt

1,641

Business transition costs 1

6,624

Non-cash interest expense on convertible notes

4,992

Amortization of intangible assets 2

11,767

Tax effect of adjustments 3

(3,843)

Adjustments to GAAP net income

21,181

Non-GAAP earnings

$ 27,557

$ 0.53

GAAP weighted shares outstanding – diluted

55,913

Non-GAAP weighted shares outstanding – diluted

52,399

1

Costs related to acquisition, integration and business transition activities which includes severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.

2

Excludes the amortization associated with non-controlling interest.

3

The impact on results from taxes include tax effecting the adjustments above at the statutory rate as well as taking into account discrete items and including those discrete items in the annual effective tax rate calculation. The Company also includes those adjustments that would have benefited the tax rate in lieu of the above adjustments as part of the Company’s tax filings. The impact of the changes to the tax rate results in an annual estimated rate of 37% on a non-GAAP basis. The result of these adjustments is a change in the annual effective tax rate from 29% to 37%. The Company adopted ASU 2016-09 Stock Compensation in Q2 2016 which was effective as of January 1, 2016 with retrospective adjustment. The result of the retrospective adjustment resulted in a change in the Q1 2016 quarterly effective tax rate on a non-GAAP basis from 41% to 36%.

Reconciliation of Year To Date 2016 Results

GAAP Net Income per Share to Non-GAAP Earnings per Share

(in thousands, except per share data)

Adjustments

Diluted Earnings Per Share

GAAP net income

$ 37,147

$ 0.69

Litigation liability gain

(43,310)

Business transition costs 1

18,138

Non-cash interest expense on convertible notes

19,539

Non-cash purchase accounting adjustments on acquisitions 2

14,747

Loss on repurchases of convertible notes

19,085

Amortization of intangible assets 3

40,712

Tax effect of adjustments 4

(19,602)

Adjustments to GAAP net income

49,309

Non-GAAP earnings

$ 86,456

$ 1.66

GAAP weighted shares outstanding – diluted

54,102

Non-GAAP weighted shares outstanding – diluted

51,981

1

Costs related to acquisition, integration and business transition activities which includes severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.

2

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

3

Excludes the amortization associated with non-controlling interest.

4

The impact on results from taxes include tax effecting the adjustments above at the statutory rate as well as taking into account discrete items and including those discrete items in the annual effective tax rate calculation. The Company also includes those adjustments that would have benefited the tax rate in lieu of the above adjustments as part of the Company’s tax filings. The impact of the changes to the tax rate results in an annual estimated rate of approximately 37% on a non-GAAP basis. The result of these adjustments is a change in the annual effective tax rate from approximately 29% to 37%. The Company adopted ASU 2016-09 Stock Compensation in Q2 2016 which was effective as of January 1, 2016 with retrospective adjustment. The result of the retrospective adjustment resulted in a change in the Q1 2016 quarterly effective tax rate on a non-GAAP basis from approximately 41% to 36%.

Reconciliation of Fourth Quarter and Twelve Months 2016 Results

GAAP net income to Adjusted EBITDA

(in thousands, except per share data)

Three months ended December 31, 2016

Twelve months ended December 31, 2016

GAAP net income

$ 6,376

$ 37,147

Interest (income) / expense, net 1

12,006

58,514

Provision for income taxes

11,899

29,282

Depreciation and Amortization 2

28,573

101,438

EBITDA

$ 58,854

$ 226,381

Litigation liability gain

(43,310)

Non-cash purchase accounting related charges 3

14,747

Business transition costs 4

6,624

18,138

Non-cash stock based compensation

7,279

26,924

Adjusted EBITDA

$ 72,757

$ 242,880

As a percentage of revenue

26.8%

25.2%

1

Interest (income) / expense, net for the quarter and year ended December 31, 2016 includes loss on extinguishment of debt for $1.6 million and $19.1 million, respectively.

2

Excludes the amortization associated with non-controlling interest.

3

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

4

Costs related to acquisition, integration and business transition activities which includes severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs and other costs directly associated with such activities.

Investor Conference Call The Company will hold a conference call today at 4:30 p.m. ET / 1:30 p.m. PT to discuss the results of its fourth quarter and full year 2016 financial performance. The dial-in numbers are 1-877-407-9039 for domestic callers and 1-201-689-8470 for international callers. A live webcast of the conference call will be available online from the Investor Relations page of the Company’s website at www.nuvasive.com.

After the live webcast, the call will remain available on NuVasive’s website through March 9, 2017. In addition, a telephone replay of the call will be available until February 16, 2017. The replay dial-in numbers are 1-844-512-2921 for domestic callers and 1-412-317-6671 for international callers. Please use pin number: 13652783.

About NuVasive NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $962 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements NuVasive cautions you that statements included in this news release or made on the investor conference call referenced herein that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. In addition, this news release contains selected financial results from the fourth quarter and full year 2016, as well as projections for 2017 financial guidance and longer-term financial performance goals. The Company’s results for the fourth quarter and full year 2016 are prior to the completion of review and audit procedures by the Company’s external auditors and are subject to adjustment. In addition, the Company’s projections for 2017 financial guidance and longer-term financial performance goals represent initial estimates, and are subject to the risk of being inaccurate because of the preliminary nature of the forecasts, the risk of further adjustment, or unanticipated difficulty in selling products or generating expected profitability. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

NuVasive, Inc.

Consolidated Statements of Operations

(in thousands, except per share data)

Three Months Ended December 31,

Year Ended December 31,

2016

2015

2016

2015

(Unaudited)

(Unaudited)

Revenue

$ 271,109

$ 215,282

$ 962,072

$ 811,113

Cost of goods sold (excluding below amortization of intangible assets)

66,926

51,233

240,093

194,479

Gross profit

204,183

164,049

721,979

616,634

Operating expenses:

Sales, marketing and administrative

142,413

118,837

533,624

457,280

Research and development

12,983

8,606

47,999

35,833

Amortization of intangible assets

12,089

3,479

42,001

12,516

Litigation liability (gain) loss

681

(43,310)

(41,826)

Business transition costs

6,624

2,902

18,138

13,748

Total operating expenses

174,109

134,505

598,452

477,551

Interest and other expense, net:

Interest income

167

464

1,091

1,589

Interest expense

(10,532)

(7,403)

(40,520)

(29,078)

Loss on repurchases of convertible notes

(1,641)

(19,085)

Other (expense) income, net

(203)

(105)

(305)

425

Total interest and other expense, net

(12,209)

(7,044)

(58,819)

(27,064)

Income before income taxes

17,865

22,500

64,708

112,019

Income tax expense

(11,899)

(11,397)

(29,282)

(46,729)

Consolidated net income

$ 5,966

$ 11,103

$ 35,426

$ 65,290

Add back net loss attributable to non-controlling interests

$ (410)

$ (400)

$ (1,721)

$ (1,001)

Net income attributable to NuVasive, Inc.

$ 6,376

$ 11,503

$ 37,147

$ 66,291

Net income per share attributable to NuVasive, Inc.:

Basic

$ 0.13

$ 0.23

$ 0.74

$ 1.36

Diluted

$ 0.11

$ 0.22

$ 0.69

$ 1.26

Weighted average shares outstanding:

Basic

50,394

49,205

50,077

48,687

Diluted

55,913

53,087

54,102

52,424

NuVasive, Inc.

Consolidated Balance Sheets

(in thousands, except par values and share amounts)

December 31,

2016

2015

ASSETS

Current assets:

Cash and cash equivalents

$ 153,643

$ 192,339

Short-term marketable securities

165,423

Accounts receivable, net of allowances of $8,912and $5,320, respectively

171,595

127,595

Inventory, net

208,249

168,140

Prepaid income taxes

31,926

40,540

Prepaid expenses and other current assets

10,030

8,790

Total current assets

575,443

702,827

Property and equipment, net

181,524

141,441

Long-term marketable securities

112,332

Intangible assets, net

291,143

85,076

Goodwill

485,685

154,281

Deferred tax assets

5,810

83,691

Restricted cash and investments

7,405

5,615

Other assets

23,794

17,404

Total assets

$ 1,570,804

$ 1,302,667

LIABILITIES AND EQUITY

Current liabilities:

Accounts payable and accrued liabilities

$ 77,585

$ 60,986

Contingent consideration liabilities

49,742

Accrued payroll and related expenses

51,000

37,640

Income tax liabilities

2,469

990

Short-term senior convertible notes

61,701

Total current liabilities

242,497

99,616

Long term senior convertible notes

564,412

372,920

Deferred and income tax liabilities, non-current

18,607

8,602

Non-current litigation liabilities

88,261

Other long-term liabilities

44,764

14,425

Commitments and contingencies

Stockholders’ equity:

Preferred stock, $0.001 par value; 5,000,000 shares authorized, none outstanding

Common stock, $0.001 par value; 120,000,000 shares authorized at December 31, 2016 and December 31, 2015, 55,184,660and 52,616,471 issued and outstanding at December 31, 2016 and December 31, 2015, respectively

55

53

Additional paid-in capital

1,010,238

989,387

Accumulated other comprehensive loss

(10,631)

(12,112)

Accumulated deficit

(66,859)

(104,006)

Treasury stock at cost; 4,758,828shares and 3,316,794 shares at December 31, 2016 and December 31, 2015, respectively

(237,867)

(161,788)

Total NuVasive, Inc. stockholders’ equity

694,936

711,534

Non-controlling interests

5,588

7,309

Total equity

700,524

718,843

Total liabilities and equity

$ 1,570,804

$ 1,302,667

NuVasive, Inc.

Consolidated Statements of Cash Flows

(in thousands)

Year Ended December 31,

2016

2015

Operating activities:

Consolidated net income

$ 35,426

$ 65,290

Adjustments to reconcile net income to net cash provided by operating activities:

Depreciation and amortization

102,713

65,915

Deferred income tax expense

26,265

34,757

Loss on repurchases of convertible notes

19,085

Amortization of non-cash interest

22,721

17,851

Stock-based compensation

26,924

26,203

Reserves on current assets

11,408

9,454

Other non-cash adjustments

16,928

17,581

Changes in operating assets and liabilities, net of effects from acquisitions:

Accounts receivable

(33,250)

(9,463)

Inventory

(22,636)

(25,984)

Prepaid expenses and other current assets

(5,665)

1,239

Accounts payable and accrued liabilities

11,854

7,742

Accrued royalties

471

(46,092)

Accrued payroll and related expenses

8,849

(192)

Litigation liability

(88,450)

(36,270)

Income taxes

23,652

(39,304)

Net cash provided by operating activities

156,295

88,727

Investing activities:

Acquisition of Ellipse Technologies, net of cash acquired

(380,080)

Other acquisitions and investments

(108,591)

(1,357)

Purchases of intangible assets

(5,918)

(32,020)

Proceeds from sales of property and equipment

40

Purchases of property and equipment

(88,372)

(75,772)

Purchases of marketable securities

(128,956)

(427,945)

Proceeds from sales of marketable securities

407,032

411,471

Proceeds from sales of restricted investments

180,694

Purchases of restricted investments

(62,625)

Net cash used in investing activities

(304,885)

(7,514)

Financing activities:

Incremental tax benefits related to stock-based compensation awards

15,185

Proceeds from the issuance of common stock

9,492

12,106

Payment of contingent consideration

(422)

(514)

Purchase of treasury stock

(24,734)

(56,929)

Proceeds from issuance of convertible debt, net of issuance costs

634,140

Proceeds from sale of warrants

44,850

Purchase of convertible note hedge

(111,150)

Repurchases of convertible notes

(439,519)

Proceeds from revolving line of credit

50,000

Repayments on revolving line of credit

(50,000)

Other financing activities

(1,834)

(192)

Net cash provided by (used in) financing activities

110,823

(30,344)

Effect of exchange rate changes on cash

(929)

(917)

(Decrease) increase in cash and cash equivalents

(38,696)

49,952

Cash and cash equivalents at beginning of year

192,339

142,387

Cash and cash equivalents at end of year

$ 153,643

$ 192,339

Contact: Stefanie Mazer 1-858-320-5243 smazer@nuvasive.com

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

Interspinous Spacer Market Analysis by Worldwide Segments, Size and Forecast 2016 – 2024

Albany, NY — (SBWIRE) — 02/09/2017 — The Interspinous spacer market is segmented as device type, end user and geography. The product type segment is further divided in two type’s statics or compressible and dynamic or non-compressible respectively. The examples of static devices include X STOP, ExtenSure and Wallis implants. These are made up of non-compressible material such as bone, metal or synthetics. The devices produce constant amount of distraction between the spinous processes due to their non-compressible nature. Dynamic Interspinous spacer devices have a degree of compressibility. The example of dynamic devices is Coflex device formally known as Interspinous ‚U.’ it is U shaped piece of metal composed of axially compressible, which is interposed between the spinous processes. It is inserted in a compressed mode so that it exerts a distraction force between the bones. As the devices are technologically improved devices hence the market of Interspinous spacer will grow in the forecast period due to high adoption of technology in developed as well as developing countries. However, the Interspinous spacers have risk such as dislodged of implant, or sometimes requires additional surgery for the management of pain or other symptoms, which may anticipate the growth of market.

The increasing prevalence of spinal stenosis due to aging, arthritis, heredity and increased demand of surgical procedures that improved lifestyle and comfort will drive the Interspinous spacer market. The adoption of spacers are increasing due to low complication rate as compared to decompression and spinal fusion. The Interspinous spacers are widely used in geriatric population as per Medicare data due to old age patient are not comfortable with surgery due to their health conditions.

The Interspinous spacer are implanted between those vertebrae in such a way that it prevents the patient from bending too far backward which causes pain by surgical procedure. The procedure is very small and sometimes patient can go home within a day.

 

READ THE REST HERE

Medacta International Acquires Vivamed to Strengthen Presence in Austria

February 09, 2017

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Medacta International, the privately held, family-owned global designer of innovative joint replacement and spine surgery products, is proud to announce the acquisition of Austrian distributor Vivamed GmbH, effective 01 February 2017.

This acquisition aims to strengthen the company’s presence in Austria by facilitating future development and investments in this market while ensuring the continued delivery of high-level products and services that Medacta customers have come to expect. As part of the acquisition, Vivamed Chief Executive Officer and Co-founder Herbert Brandstätter will transition to Medacta Austria General Manager.

“Medacta’s growth, including expansion of the product portfolio in the areas of spine, shoulder and sports medicine, requires a substantial structural investment in the Austrian market,” said Alberto Siccardi, President and Founder of Medacta International. “We look forward to continuing our collaboration with Mr. Brandstätter, who will help us expand and strengthen our business in Austria.”

“After 15 years of close collaboration with Medacta International, Vivamed has become one of the main players in the Austrian joint replacement market,” said Herbert Brandstätter. “We have shared the pillars of Medacta’s mission and identity since the beginning of our partnership and are eager to join our talented teams.”

For more information about Medacta, please visit www.medacta.com.

About Medacta

Medacta® International is a world leading manufacturer of orthopedic implants, neurosurgical systems, and instrumentation. Medacta’s revolutionary approach and responsible innovation have resulted in standard of care breakthroughs in hip replacement with the AMIS®system and total knee replacement with MyKnee® patient matched technology. Over the last 10 years, Medacta has grown dramatically by taking a different approach and placing value on all aspects of the care experience from design to training to sustainability. Medacta is headquartered in Castel San Pietro, Switzerland, and operates in over 30 countries. To learn more about Medacta International, please visit www.medacta.com or follow @Medacta on Twitter.

Contacts

for Medacta International
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com

TransEnterix to Present at the RBC Capital Markets Global Healthcare Conference

February 09, 2017

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE MKT:TRXC) announced today that Todd M. Pope, President and Chief Executive Officer, and Joseph P. Slattery, Executive Vice President and Chief Financial Officer, will present at the RBC Capital Markets Global Healthcare Conference at the Lotte New York Palace Hotel in New York. The presentation is scheduled to take place at 11:00 am Eastern Time on Thursday, February 23, 2017.

About TransEnterix

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 is also developing 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. For more information, visit the TransEnterix website at www.transenterix.com.

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

Arlington Orthopedic Associates, P.A. Performs First Meniscus Replacements in Texas with NUsurface® Meniscus Implant

February 09, 2017

ARLINGTON, Texas–(BUSINESS WIRE)–Arlington Orthopedic Associates, P.A., one of the largest orthopedic practices in North Texas, and Active Implants, a company that develops orthopedic implant solutions, today announced that the first meniscus replacement procedures in Texas were successfully performed by Dr. Joseph Berman. Arlington Orthopedic Associates and its affiliate Baylor Orthopedic and Spine Hospital is the only center in the state – and one of just 10 sites nationwide – enrolling patients with persistent knee pain caused by injured or deteriorating meniscus cartilage in the SUN trial, which is designed to assess the safety and effectiveness of the NUsurface® Meniscus Implant (pronounced “new surface”) in restoring function similar to that of a natural, healthy meniscus.

One of the recipients was 44-year-old Denton resident Jon Foerster, who tore his meniscus five years ago while running the bases during a kickball game. Although he underwent a partial meniscectomy to treat the tear, he continued to suffer from aching pain while running or playing sports. His pain persisted to the point where he had to discontinue all high impact activities, including the sports he loved like soccer, kickball and skiing. Gradually, Foerster found that even with a high pain tolerance level, his knee pain became so severe he found it taxing to walk more than one mile and also had trouble sleeping at night.

The meniscus is a tissue pad between the thigh and shin bones. Once damaged, the meniscus has a very limited ability to heal. Over 1 million partial meniscectomies to remove or repair a torn meniscus are performed in the U.S. every year, about the same as the total number of hip and knee replacement surgeries combined. However, many patients still experience persistent knee pain following meniscus surgery.

“There aren’t many options for patients like Jon who experience persistent knee pain following meniscus surgery,” said Dr. Joseph Berman, orthopedic surgeon at the Joint Preservation Center of Arlington Orthopedic Associates. “The NUsurface implant offers the hope of alleviating pain and swelling in these patients with chronic problems. We may well be able to help delay or even avoid knee replacement surgery, allowing these patients to get back to activities they love.”

Foerster received the NUsurface Meniscus Implant on January 16 through a small incision in his knee and he is now undergoing a six-week rehabilitation program. Foerster is looking forward to getting back into boating, skiing and spending time with his family once he recovers from the NUsurface surgery.

“Receiving the NUsurface Meniscus Implant will help me to look forward to my future with my kids,” Foerster said. “I want keep up as they continue to grow and be able to play sports with them.”

The NUsurface Meniscus Implant has been used in Europe under CE Mark since 2008 and Israel since 2011.

About the Clinical Trial

The SUN study (Safety Using NUsurface®) will enroll approximately 120 patients as part of regulatory process to gain approval from FDA to sell the device in the U.S. All patients who meet study requirements and agree to enter the trial are offered the NUsurface Meniscus Implant as treatment. Treatment with NUsurface in the SUN trial is eligible for coverage by Medicare and some private insurance companies. To be eligible for the study, participants must be between the ages of 30 and 75 and have pain after medial meniscus surgery that was performed at least six months ago. To learn more about the SUN study, please visit http://sun-trial.com or call (844) 680-8951.

About the NUsurface® Meniscus Implant

The NUsurface® Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade plastic and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant.

About Arlington Orthopedic Associates

Arlington Orthopedic Associates, P.A. is one of the largest orthopedic practices in North Texas providing orthopedic care to the Dallas and Fort Worth area. AOA has four offices in Arlington, Mansfield, Irving and Odessa. We specialize in sports medicine, orthopedic surgery, spine care, joint replacement and reconstruction, and the care of bones, ligaments, tendons, muscles and nerves in adults and children. Additional services include physical medicine and rehabilitation, as well as state-of-the-art imaging and diagnostics services, all at four suitable locations. For more information, visit www.arlingtonortho.com or call 817-375-5200.

About Active Implants

Active Implants, LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications for Active Implants
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com
or
Arlington Orthopedic Associates, P.A.
Stacie Duncan Berlin, 817-375-5355
sberlin@arlingtonortho.com