Globus Medical Reports Second Quarter 2018 Results

AUDUBON, Pa., Aug. 01, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced its financial results for the second quarter ended June 30, 2018.

  • Worldwide sales were $173.4 million, an increase of 13.8% as reported
  • Second quarter net income was $45.0 million, an increase of 56.9%
  • Diluted earnings per share (EPS) and non-GAAP EPS were $0.44
  • Non-GAAP EPS increased 38.0% compared to second quarter of 2017
  • Non-GAAP adjusted EBITDA was 34.3% of sales

“The second quarter marks the third consecutive quarter of double-digit organic growth for Globus Medical, as our U.S. Spine business continues to take market share, growing by 4.2%; our international revenue increased by 7.2%; and Emerging Technologies contributed $13.8 million,” said Dave Demski, CEO.  “We are very pleased with the strong sales of our ExcelsiusGPS™ robotic system, and more importantly, the level of adoption we are seeing by surgeons in accounts that have purchased the technology.  The synergy of this transformational technology, combined with the most innovative suite of spinal implants in the industry, is expected to provide a powerful platform for our future growth.”

Worldwide sales for the second quarter were $173.4 million, an increase of 13.8% over the second quarter of 2017.  Non-GAAP diluted EPS was $0.44, an increase of 38.0%.  Revenue from Emerging Technologies was primarily due to continued demand for our ExcelsiusGPS™ robotics and navigation system.

Second quarter sales in the U.S., including robotics, increased by 15.1% compared to the second quarter of 2017.  International sales increased by 7.2% over the second quarter of 2017 on an as-reported basis and 4.3% on a constant currency basis.

Second quarter GAAP net income was $45.0 million, an increase of 56.9% over the same period last year.  Diluted EPS for the second quarter was $0.44, as compared to $0.29 for the second quarter 2017.  Non-GAAP diluted EPS for the second quarter was $0.44, compared to $0.32 in the second quarter of 2017.

The company generated net cash provided by operating activities of $33.3 million and non-GAAP free cash flow of $18.5 million in the second quarter, and ended the quarter with cash, cash equivalents and marketable securities of $516.8 million.  The company remains debt free.

2018 Annual Guidance
The company today issued new guidance for full year 2018 sales of $700 million and non-GAAP fully diluted earnings per share of $1.55.  2018 guidance was previously sales of $695 million and non-GAAP fully diluted earnings per share of $1.52.

Executive Appointment
The company also announced the promotion of Dan Scavilla to the position of Executive Vice President, Chief Commercial Officer.  In his new role, Mr. Scavilla will be responsible for all contracting and pricing; supply chain and logistics; and manufacturing operations; as well as continued oversight of all finance-related functions.  Mr. Scavilla will continue in the role of Chief Financial Officer until the company completes its search for a new CFO.

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2018 second quarter results with the investment community at 4:30 p.m. Eastern Time today.  Globus invites all interested parties to join the call by dialing:

1-855-533-7141          United States Participants
1-720-545-0060          International Participants
There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at investors.globusmedical.com.

The call will be archived until Wednesday, August 8, 2018.  The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 1012-6350.

About Globus Medical, Inc.
Based in Audubon, Pennsylvania, Globus Medical, Inc. was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at www.globusmedical.com.

Non-GAAP Financial Measures

To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures.  For example, non-GAAP adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, provisions for litigation, technology in-licensing fee, and acquisition related costs, and net gain from the sale of assets, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense.  Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.  Provision for litigation represents costs incurred for litigation settlements or unfavorable verdicts when the loss is known or considered probable and the amount can be reasonably estimated, or in the case of a favorable settlement, when income is realized.  Acquisition related costs/licensing represents the change in fair value of business acquisition related contingent consideration; costs related to integrating recently acquired businesses including but not limited to costs to exit or convert contractual obligations, severance, and information system conversion; and specific costs related to the consummation of the acquisition process such as banker fees, legal fees, and other acquisition related professional fees, as well as one time licensing fees.   Net gain from sale of assets represents the gain on sale of assets and the offsetting impact of costs incurred through the sale.

In addition, for the period ended June 30, 2018 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represents net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs/licensing, net gain from the sale of assets and the tax effects of such adjustments.  We believe these non-GAAP measures are also useful indicators of our operating performance, and particularly as additional measures of comparative operating performance from period to period as they remove the effects of litigation, amortization of intangibles, acquisition related costs/licensing, net gain from the sale of assets and the tax effects of such adjustments, which we believe are not reflective of underlying business trends.  Additionally, for the periods ended June 30, 2018 and for other comparative periods, we also define the non-GAAP measure of free cash flow as the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment.  We believe that this financial measure provides meaningful information for evaluating our overall financial performance for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions.  Furthermore, the non-GAAP measure of constant currency sales growth is calculated by translating current year sales at the same average exchange rates in effect during the applicable prior year period.  We believe constant currency sales growth provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth are not calculated in conformity with U.S. GAAP.  Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP.  These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results.  Our definitions of non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth may differ from that of other companies and therefore may not be comparable.  Additionally, we have recast prior periods for non-GAAP net income and non-GAAP diluted earnings per share.

Safe Harbor Statements

All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms.  These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends.  Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted.  These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks.  For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission.  These documents are available at www.sec.gov.  Moreover, we operate in an evolving environment.  New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements.  Forward-looking statements contained in this press release speak only as of the date of this press release.  We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
Three Months Ended Six Months Ended
(In thousands, except per share amounts) June 30,
2018
June 30,
2017
June 30,
2018
June 30,
2017
Sales $ 173,384 $ 152,390 $ 347,795 $ 308,199
Cost of goods sold 37,637 37,199 75,607 72,799
Gross profit 135,747 115,191 272,188 235,400
Operating expenses:
Research and development 13,523 10,713 26,210 21,379
Selling, general and administrative 77,125 64,438 152,819 131,497
Provision for litigation 243 243
Amortization of intangibles 2,178 1,809 4,365 3,591
Acquisition related costs 782 617 1,021 1,005
Total operating expenses 93,608 77,820 184,415 157,715
Operating income 42,139 37,371 87,773 77,685
Other income/(expense), net 8,165 2,186 10,609 4,286
Income before income taxes 50,304 39,557 98,382 81,971
Income tax provision 5,327 10,890 13,866 24,590
Net income $ 44,977 $ 28,667 $ 84,516 $ 57,381
Earnings per share:
Basic $ 0.46 $ 0.30 $ 0.87 $ 0.60
Diluted $ 0.44 $ 0.29 $ 0.84 $ 0.59
Weighted average shares outstanding:
Basic 97,830 96,161 97,337 96,079
Diluted 101,510 97,818 101,005 97,483

 

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The global orthopedic devices market size is expected to reach USD 43.1 billion by 2024

NEW YORK, August 1, 2018 /PRNewswire/ — Orthopedic Devices Market Size, Share & Trends Analysis Report By Application (Hip, Knee, Spine, Dental, Craniomaxillofacial, Sports Injuries, Extremities, and Trauma), By Product, And Segment Forecasts, 2018 – 2024

Read the full report: https://www.reportlinker.com/p05479699 

The global orthopedic devices market size is expected to reach USD 43.1 billion by 2024, according to a study by Grand View Research, Inc. It is anticipated to expand at a CAGR of 4.4% over the forecast period. Major market drivers include rising demand for orthopedic surgeries owing to rise in road accidents and high prevalence of orthopedic ailments.

Growth in geriatric population prone to orthopedic conditions is primarily pushing demand for orthopedic solutions globally. Effects of aging, such as diminishing bone density and weakening bones due to excessive loss of bone mass, make their presence felt from 35 years of age and become more prominent after 55 years.

High adoption of minimally invasive surgeries and increasing number of sport-related injuries and road accidents are expected to fuel demand for orthopedic devices during the forecast period.Arthroscopy, minimally invasive total joint replacement, and spine surgeries are some of the newly adopted minimally invasive surgeries driving the market.

On the down side, stringent regulatory approval procedures are key factors restraining market growth. In addition, high cost of these devices and surgical procedures threaten the growth of the market.

Further key findings from the study suggest:

• The knee surgery segment captured the largest revenue share in 2016 accredited to rising knee surgeries, ranging from common knee injuries to total knee replacements

• The hip surgery segment captured second largest revenue share in 2016, fueled by availability of a wide range of treatment products

• North America is expected to maintain its dominance throughout the forecast period. Presence of a large number of major players and high adoption of advanced technologies are regional growth drivers

• Asia Pacific is expected to exhibit a lucrative CAGR during the forecast period. Presence of untapped opportunities, coupled with supportive government regulations, is expected to attract global players

• Some of the major market players are NuVasive, Inc.; Medtronic PLC; Zimmer-Biomet Holdings; DePuy Synthes Companies; Stryker Corporation; Aesculap Implant Systems, Inc.; Donjoy, Inc.; and Conmed Corporation.

Read the full report: https://www.reportlinker.com/p05479699 

About Reportlinker 

ReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need – instantly, in one place. 

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Medtronic exec: Google looms large as next great rival

May 7, 2014 by Brian Johnson

Medtronic executive Dr. Stephen Oesterle thinks Google will be a force to be reckoned with in the medical technology space in coming years.

As Medtronic‘s  (NYSE:MDT) resident technology scout and visionary, Dr. Stephen Oesterle’s job is to challenge the status quo at the world’s largest pure-play medical device company.

This morning Oesterle’s challenge to the medical device industry, issued at a meeting of the Massachusetts Medical Device Industry Council, was a sobering one.

 “Our arch-competitor in 20 years will not be Boston Scientific (NYSE:BSX) or St. Jude Medical (NYSE:STJ) or Covidien (NYSE:COV) or HeartWare (NSDQ:HTWR). It will be Google(NSDQ:GOOG). I am certain of it,” Oesterle told the audience at MassMEDIC’s annual conference today in Boston.

Oesterle, Medtronic’s senior vice president for medicine and technology, travels a quarter-million miles a year scouting new technologies, potential partnerships and other unique opportunities for Minnesota’s medtech Goliath. He also has access to an R&D budget that would make many of his colleagues jealous, but that’s nothing compared to what Google is spending, Oesterle said.

 

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North American Spine’s AccuraScope Procedure Featured on The Doctors TV Show

DALLASApril 8, 2015 /PRNewswire/ — North American Spine™, the exclusive provider of the AccuraScope® Procedure, was featured on The Doctors TV ShowApril 8, 2015. The segment was a follow up of a show that featured North American Spine on the program back in Dec. of 2013. Immediately after airing, North American Spine and the show received a flood of inquiries from viewers wanting to learn more about how the AccuraScope® Procedure changed lives.

Bernard Gonzalez was one of those callers. Gonzalez initially injured his back in high school and the pain got progressively worse over the years. He saw several specialists regarding his chronic pain but the physicians would only prescribe him medicine for pain management. Gonzalez and his wife Kim were at a standstill until they watched an episode of The Doctors TV Show featuring the AccuraScope procedure.

He called North American Spine and was confirmed as a candidate for the procedure. Gonzalez underwent the minimally invasive decompression procedures and it completely transformed his well-being. The Gonzalez family was invited to appear on the show and describe his inspiring story as a result of getting the AccuraScope procedure.

“We always keep searching and you never know when you’re going to find either your cure or the one thing that is going to improve your life drastically,” Dr.Travis Stork said to the Gonzalez family. “Clearly you found it.”

The Doctors TV Show’ original segment opened the world’s eyes to North American Spine’s innovative procedure that has relieved so many people from unbearable back pain.

“It’s so nice to see success stories like this one,” said Jon Sasser of North American Spine. “Bernie’s story is similar to hundreds we see each year. Helping to get people’s lives back to normal is our greatest reward at North American Spine. Watching the pure emotion from his wife about the pain he was in before the AccuraScope Procedure and how he’s pain-free now, is what drives us each day.”

To date, more than 8,000 AccuraScope procedures have been performed by board-certified physicians with specialty training. Medical research has shown that the AccuraScope procedure has an 82% success rate and saves patients an average of $23,190 in out-of-pocket costs over 5 years by reducing expenses including medical visits and medications.

“For The Doctors TV Show to feature a segment about the successes of North American Spine shows how popular the AccuraScope Procedure has become,” explained Sasser. “It’s giving hope to people suffering from chronic back pain.”

Medtech’s ROSA Robotic Surgery System to be Featured at the 84th American Association of Neurological Surgeons (AANS) Annual Meeting

MONTPELLIER, France, April 25, 2016 (GLOBE NEWSWIRE) — MEDTECH (Euronext, FR0010892950 – ROSA), a company specialized in designing, developing and marketing innovative surgical assistance robots, today announced that it will showcase its ROSA™ robotic surgery systems at the upcoming 84thAmerican Association of Neurological Surgeons (AANS) Annual Meeting, being held April 30 – May 4 in Chicago, IL.

Medtech’s ROSA™ robotic surgery system was developed to assist in a variety of minimally invasive neurological procedures while simultaneously increasing safety and reliability for the surgeon and patient. During the conference, Medtech will demonstrate the ROSA™ system at Booth #5035.

In addition, the ROSA™ robot will be featured at a workshop during the conference. Details of the workshop follow:

Title: 018 Stereotactic and Functional Neurosurgery – Hands-on Workshop
Date: May 1, 2016
Time: 7:30 a.m. – 4:30 p.m.

A ROSA™ robotic surgery system will be highlighted during functional neurosurgery sessions at AANS. The sessions will include discussions highlighting the minimally invasive approach that surgeons are able to utilize through ROSA™. Details of the sessions follow:

Title: Scientific Session III: Stereotactic and Functional
Date: May 2, 2016
Time: 2 p.m. – 5:30 p.m.

Title: AANS/CNS Section on Stereotactic and Functional Surgery
Date: May 3, 2016
Time: 2 p.m. – 5:30 p.m.

About the 2016 AANS Annual Scientific Meeting

Attended by neurosurgeons, neurosurgical residents, medical students, neuroscience nurses, clinical specialists, physician assistants, allied health professionals and other medical professionals, the AANS Annual Scientific Meeting is the largest gathering of neurosurgeons in the nation, with an emphasis on the field’s latest research and technological advances. More than 1,200 scientific abstracts were submitted for the 2015 AANS Annual Scientific Meeting. The scientific presentations accepted for the 2016 event will represent cutting-edge examples of the incredible developments taking place within the field of neurosurgery. Additional information about the 2016 AANS Annual Scientific Meeting and the meeting program can be found here.

About MEDTECH

Founded in 2002 by Bertin NAHUM and based in Montpellier, MEDTECH is a European specialist in the design, development and marketing of innovative robotic appliances to assist surgeons during their medico-surgical interventions, thus contributing to the implementation of safer, more efficient, less-invasive treatment.

In 2007, MEDTECH developed ROSA™,  an innovative technological device devoted to  brain surgery procedures.  ROSA™ has been approved in Europe,  the United States and Canada.

In 2013 MEDTECH received the “European Company of the Year Award” in the “robotic neurosurgery” category from Frost & Sullivan.

In July 2014, MEDTECH obtained the CE marking for its new product ROSA™ Spine, a robotic- assistive device for minimally invasive surgery of the spine.

In October 2014, MEDTECH won the “Révélation” prize in the Mediterranean Deloitte Technology Fast 50 Awards.

In 2015 MEDTECH received the “2016 Company of the Year Award” in the “robotic neurosurgery” category from Frost & Sullivan.

In November 2015, MEDTECH was honored by Deloitte In Extenso for its excellent performance in the Technology Fast 50 Mediterranean Awards, in the “listed company” category.

In January 2016, MEDTECH obtained the FDA clearance for its new product, ROSA™ Spine, a robotic-assistive device for minimally invasive surgery of the spine.

CONTACT: CONTACT MEDTECH
Christophe Sibillin
Chief Financial Officer
Tel : +33 (0)4 67 10 77 40

INVESTORS
Corinne Puissant
Tel : +33 (0)1 53 67 36 77
cpuissant@actus.fr

PRESS
Alexandra Prisa (EU)          
Tel. : +33(0)1 53 67 36 90 
aprisa@actus.fr                  

Joanna Zimmerman (US)
Tel : +1 646-536-7006
jzimmerman@theruthgroup.com

Osiris Therapeutics, Inc. to Re-list on The Nasdaq Global Market on August 1, 2018

COLUMBIA, Md., Aug. 01, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, today announced that The Nasdaq Stock Market LLC has approved its application to list its common stock on The Nasdaq Global Market. Osiris’s common stock will commence trading at the market open today, Wednesday, August 1, 2018, under the ticker symbol “OSIR”.

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, researches, develops, manufactures and commercializes regenerative medicine products intended to improve the health and lives of patients and lower overall healthcare costs. We have achieved commercial success with products in orthopedics, sports medicine and wound care, including the Grafix product line, Stravix®, BIO and Cartiform®. We continue to advance our research and development by focusing on innovation in regenerative medicine, including the development of bioengineered stem cell and tissue‑based products. Osiris®, Grafix® and Cartiform® are our trademarks. BIO4® is a trademark of Howmedica Osteonics Corp., a subsidiary of Stryker Corporation. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

For additional information, please contact:

Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com

NuVasive Announces Second Quarter 2018 Financial Results

SAN DIEGOJuly 31, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced financial results for the quarter ended June 30, 2018.

Second Quarter 2018 Highlights

  • Revenue increased 8.5% to $281.6 million, or 7.7% on a constant currency basis;
  • GAAP operating profit margin of 10.1%; Non-GAAP operating profit margin of 16.3%; and
  • GAAP diluted earnings per share increase of 5% to $0.22; Non-GAAP diluted earnings per share increase of 29% to $0.58.

“We are pleased with our second quarter total revenue growth of 8.5% year-over-year driven by momentum in our U.S. Spinal Hardware business where we saw spine case volumes up nearly 7% versus prior year,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “We continue to see strong demand for new product introductions from late last year and positive surgeon conversion efforts as our new Lateral Single-Position Surgery procedure gains traction in the market. Our International business also delivered a solid performance with 21% year-over-year growth.”

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

Second Quarter 2018 Results

NuVasive reported second quarter 2018 total revenue of $281.6 million, an 8.5% increase compared to $259.4 million for the second quarter 2017. On a constant currency basis, second quarter 2018 total revenue increased 7.7% compared to the same period last year.

For the second quarter 2018, GAAP and non-GAAP gross profit was $204.5 million and $204.9 million, respectively, and GAAP and non-GAAP gross margin was 72.6% and 72.8%, respectively. These results compared to both GAAP and non-GAAP gross profit of $193.2 million, and both GAAP and non-GAAP gross margin of 74.5% for the second quarter 2017. Gross margins for the second quarter 2018 were impacted by the Company’s in-source manufacturing efforts at the West Carrollton facility, which are expected to improve over the second half of 2018.

The Company reported GAAP net income of $11.5 million, or $0.22 per share, for the second quarter 2018 compared to GAAP net income of $12.2 million, or $0.21 per share, for the second quarter 2017. On a non-GAAP basis, the Company reported net income of $30.3 million, or $0.58 per share, for the second quarter 2018 compared to net income of $23.6 million, or $0.45 per share, for the second quarter 2017.

Annual Financial Guidance for 2018 

The Company updated its full-year 2018 guidance as follows:

2018 Guidance Range 1

Prior

Current

(in million’s; except %’s and EPS)

 GAAP 

 Non-GAAP 

 GAAP 

 Non-GAAP 

Revenue

$    1,095

$    1,105

$ 1,095

$    1,105

$ 1,095

$ 1,105

$ 1,095

$ 1,105

  % Growth – Reported 2

6.7%

7.6%

6.7%

7.6%

6.7%

7.6%

6.7%

7.6%

% Growth – Constant Currency 2, 3

5.7%

6.6%

6.3%

7.3%

Operating margin

9.6%

9.7%

17.6%

17.6%

8.0%

8.1%

16.7%

16.7%

Earnings per share

$      0.71

$      0.74

$   2.44

$      2.47

$   0.45

$   0.48

$   2.37

$   2.40

EBITDA

19.5%

19.5%

26.9%

26.9%

18.7%

18.7%

25.9%

25.9%

Tax Rate

~31%

~31%

~23%

~23%

~33%

~33%

~21%

~21%

  1

Prior guidance reflects the range provided May 1, 2018. Current guidance reflects the range provided July 31, 2018.

  2

2017 has been recasted and presented based on our full retrospective method of adoption of ASC 606.

 3

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

  • Full-year 2018 revenue remains in the range of $1,095 million to $1,105 million reflecting reported growth of 6.7% to 7.6%, and growth in the range of 4.7% to 5.7%, exclusive of the SafePassage acquisition;
  • Non-GAAP diluted earnings per share in a range of $2.37 to $2.40 compared with the prior expectation of $2.44 to $2.47;
  • Non-GAAP operating profit margin of approximately 16.7% compared with the prior expectation of 17.6%;
  • Adjusted EBITDA margin of approximately 25.9% compared with the prior expectation of 26.9%;
  • Non-GAAP effective tax expense rate of approximately 21%, compared with the prior expectation of approximately 23%;
  • The Company expects currency to have a positive impact on revenue in 2018 of approximately $3 million compared with the prior expectation of $10 million; and
  • The Company expects to drive an adjusted EBITDA of approximately $283 million to $293 million.

The above guidance assumes a full-year benefit of U.S. tax reform, suspension of the medical device tax and the SafePassage acquisition.

Supplementary Financial Information

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

Reconciliation of Full Year EPS Guidance

2017

Actuals1, 2

2018 Guidance Range

Prior1, 3, 4

Current  1, 3, 5

GAAP net income per share

$       1.48

$  0.71

$  0.74

$  0.45

$  0.48

Impact of change to diluted share count

0.08

0.01

0.01

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

$       1.56

$  0.72

$  0.75

$  0.45

$  0.48

Business transition costs 6

0.08

0.07

0.07

0.13

0.13

Non-cash purchase accounting adjustments on acquisitions 7

0.01

0.02

0.02

0.02

0.02

Non-cash interest expense on convertible notes

0.33

0.32

0.32

0.32

0.32

Litigation related expenses and settlements 8

0.09

0.55

0.55

0.60

0.60

Non-recurring consulting fees 9

0.12

0.12

0.13

0.13

Impairment of strategic investment

0.17

0.17

0.17

0.17

Amortization of intangible assets 10

0.89

0.89

0.89

0.95

0.95

Tax effect of adjustments 11

(1.08)

(0.42)

(0.42)

(0.40)

(0.40)

Non-GAAP earnings per share

$       1.89

$  2.44

$  2.47

$  2.37

$  2.40

GAAP Weighted shares outstanding – basic

50,874

51,025

51,025

51,397

51,397

GAAP Weighted shares outstanding – diluted

55,193

52,647

52,647

52,131

52,131

Non-GAAP Weighted shares outstanding – diluted 12

52,345

52,185

52,185

52,131

52,131

1

Items may not foot due to rounding.

2

2017 has been recasted and presented based on our full retrospective method of adoption of ASC 606 as well as for expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Company’s intellectual property.

3

Prior guidance reflects the range provided May 1, 2018. Current guidance reflects the range provided July 31, 2018.

4

Effective tax expense rate of ~31% applied to GAAP earnings and ~23% applied to Non-GAAP earnings.

5

Effective tax expense rate of ~33% applied to GAAP earnings and ~21% applied to Non-GAAP earnings.

6

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

7

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.

8

Related to the Medtronic litigation matter for fiscal year 2017. Represents the settlement loss in connection with the Madsen Medical, Inc. litigation matter as well as expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Company’s intellectual property for fiscal year 2018.

9

Non-recurring consulting fees associated with the implementation of our state tax-planning strategy.

10

2017 results exclude the amortization associated with non-controlling interest.

11

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 ~33% on a GAAP basis and ~21% on a non-GAAP basis.

12

Adjusted non-GAAP diluted WASO excludes the impact of dilutive convertible notes and warrants for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

Michigan Neurosurgeon Featured as a “Spine Surgeon to Know” by Becker’s Spine Review

MADISON HEIGHTS, MICHIGAN (PRWEB) FEBRUARY 22, 2017
Becker’s Spine Review, the leading publication featuring news and analysis of issues related to spine practices, is featuring Michigan neurosurgeon Jay Jagannathan, M.D., as a “Spine Surgeon to Know.” Dr. Jagannathan is known as one of a small number of neurosurgeons in Michigan performing minimally invasive back surgery that often results in less post-operative discomfort and a quicker recovery for patients.

Dr. Jagannathan founded and heads the Jagannathan Neurosurgical Institute – with clinical-office locations in the Detroit area (Madison Heights, Garden City, Dearborn and soon in Troy), central Michigan (West Branch) and far-northern Michigan (Sault Sainte Marie). The practice has specialists in neurosurgery, neurology and pain management and provides interdisciplinary treatment for patients with spine and other neurological disorders throughout the state of Michigan. “It is a great honor to be featured by Becker’s Spine Review,” said Dr. Jagannathan of the Jagannathan Neurosurgical Institute. “We are recognized for the specialty expertise in minimally invasive spine surgery, which our patients really appreciate, and also our unusual reach in the state of Michigan – with office locations and my ability and willingness to travel to be nearby just about anyone in Michigan, regardless of where they live in the state.”

Dr. Jagannathan is a Diplomate of the American Board of Neurological Surgery, the American Academy of Neurological and Orthopedic Surgery and the American Board of Spinal Surgery. He has been a “Featured Neurosurgeon” in Hour Detroit magazine’s ‘Top Docs’ issue in 2014, 2015 and 2016. He received the Patients’ Choice Award and Compassionate Doctor Recognition from Vitals.com in 2014, 2015 and 2016. In 2016 he was rated the Top Neurosurgeon in Metro Detroit by RateMDs.com. Dr. Jagannathan received his M.D. degree from the University of Maryland School of Medicine. His neurosurgery residency was at the University of Virginia Health Sciences Center and the Wayne State University School of Medicine where he was Chief Resident. He is a Fellow of the American Association of Neurological Surgeons.

Dr. Jagannathan has published numerous papers and book chapters in the areas of spine surgery, radiosurgery and neuro-oncology and has been the recipient of numerous awards including the Synthes Award for craniofacial research as well as the Cone Pevehouse Award for socioeconomic research, both from the American Association of Neurological Surgeons. He was named a ‘rising star’ in spine surgery by In-Spine magazine.

He is actively involved in organized neurosurgery and served as a member of the American Association of Neurological Surgeons (AANS) Young Neurosurgeons Committee and on the Executive Committee of the Section on Tumors. He also represented Michigan on the Council of State Neurosurgical Societies.

Dr. Jagannathan is a resident of Birmingham, Mich.

Histogenics Corporation Appoints E. Lynne Kelley, M.D., FACS As Chief Medical Officer

WALTHAM, Mass., July 31, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, today announced the appointment of E. Lynne Kelley, M.D., FACS as its Chief Medical Officer. Dr. Kelley brings more than 20 years of executive management and surgical experience in medical affairs, clinical operations, regulatory affairs and product development to Histogenics. Dr. Kelley will join Histogenics’ executive team and assume responsibility for leading medical affairs strategy and building out the department in anticipation of NeoCart’s potential commercial launch. Dr. Kelley will also work with the team on preparing the anticipated Biologics License Application (BLA) for NeoCart and spearheading related discussions with the United States Food and Drug Administration (FDA).

“Lynne’s experience as a surgeon, medical affairs executive and educator across a wide variety of therapeutic areas and indications will be critical for Histogenics as we prepare for our top-line data, potential BLA submission and FDA review of NeoCart,” stated Adam Gridley, President and Chief Executive Officer of Histogenics. “We are pleased to have Lynne join us at this exciting time to educate our customers and patients about the benefits of our novel restorative cell therapy platform through training, medical education and collaboration with our future commercial team. In addition, she will be working closely with our team to help drive additional product development initiatives, such as future trials in the U.S. and internationally.”

Dr. Kelley is a board certified general and vascular surgeon having received her medical degree from Dartmouth Medical School and completed her Residency in General Surgery at Dartmouth Hitchcock Medical Center. During her training she was awarded an NIH-sponsored basic science research grant at Harvard Medical School. She completed a Fellowship in Vascular Surgery at Harvard Medical School, Massachusetts General Hospital and was awarded the Marco Polo Fellowship providing advance training in Endovascular Surgery at the University Paris Hospital, Henri Mondor. Dr. Kelley also received a B.A. in Biology from Boston University. Prior to Histogenics, Dr. Kelley held various medical affairs roles within the industry including: Chief Medical Officer at Senseonics, World Wide Vice President of Medical Affairs at Becton Dickinson & Company Medical Surgical Systems Division, Vice President and Medical Director at Kimberly Clark, and Medical Director at Boston Scientific Corporation’s (Boston Scientific) Peripheral Interventions and Vascular Surgery division. Prior to her work at Boston Scientific, Dr. Kelley was an assistant professor of vascular surgery and radiology at Yale University.

“I am thrilled to join the talented, cutting edge team at Histogenics.  The potential of NeoCart in restoring function and thus improving the lives of patients with debilitating joint pain is extraordinary,” shared Dr. Kelley. “I look forward to collaborating with the physician community globally to bring this exciting therapy to our patients.”

In connection with the hiring of Dr. Kelley, the Compensation Committee of Histogenics’ Board of Directors approved a grant to Dr. Kelley of a stock option to purchase 200,000 shares of Histogenics’ common stock. The option was granted pursuant to the Nasdaq inducement grant exception as a component of Dr. Kelley’s employment compensation, and was granted as an inducement material to her acceptance of employment with Histogenics in accordance with Nasdaq Listing Rule 5635(c)(4). The option will have an exercise price equal to the closing price of Histogenics’ common stock on July 31, 2018. The option has a ten year term and vests with respect to 25% of the shares of common stock underlying the option on the one year anniversary of Dr. Kelley’s first day of employment with Histogenics and with respect to the remaining shares in equal monthly installments over the following 36 months, subject to Dr. Kelley’s continued service with Histogenics through the applicable vesting dates.

About Histogenics Corporation

Histogenics (Nasdaq: HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function. Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis. NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics completed enrollment of its NeoCart Phase 3 clinical trial in the second quarter of 2017 and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial , including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; MEDINET’s ability to initiate NeoCart clinical development in Japan in a timely manner; NeoCart’s regulation as a Regenerative Medical Product in Japan; the market size and potential patient population in Japan; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; the sufficiency of Histogenics’ cash resources and the availability of additional financing on commercially reasonable terms; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, to be filed with the SEC in the third quarter of 2018.  In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

OrthoPediatrics Announces Expanded Indication for FIREFLY® Pedicle Screw Navigation Guides

WARSAW, Ind., July 31, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, is pleased to announce that FIREFLY® Pedicle Screw Navigation Guides (“FIREFLY”) received additional FDA 510(k) clearance for an expanded indication to include S2AI [screw] trajectory for sacral-iliac fixation in complex spinal reconstruction surgeries, including scoliosis. When applied to the challenging S2AI trajectory, the precise and personalized mechanical guidance enabled by FIREFLY minimizes complexities associated with crossing the sacral-iliac joint while eliminating the need for excessive radiation/fluoroscopy.

OrthoPediatrics is the exclusive distributor of FIREFLY technology in children’s hospitals in the US. FIREFLY is FDA-cleared for use in adult and pediatric populations and is manufactured by Mighty Oak Medical.

The patient-specific, 3D printed FIREFLY Pedicle Screw Navigation Guides are a novel solution to complex and costly navigation systems. This patented navigation technology is designed to increase OR efficiency and eliminate the need for intraoperative radiation, making it the optimal choice in more complicated spinal construct cases, such as those involving the S2AI trajectory.

David Bailey, Executive Vice President of OrthoPediatrics, commented, “We are pleased our partners at Mighty Oak Medical have received additional FDA clearance for this enhancement of the FIREFLY technology. This signifies another pediatric patient segment that surgeons now can treat efficiently and effectively. Ensuring our customers and their patients have access to this novel technology is one more way we continue leading innovation in pediatric orthopedics.”

About Mighty Oak Medical
Mighty Oak Medical is an independent incubator focused on developing and marketing spinal technologies that improve operating room efficiencies, surgical outcomes, and the overall patient experience, by leveraging the talents of experienced surgeons and biomedical engineers. They are located in Englewood, Colorado. For more information, call 720-398-9703 or send an inquiry to info@mightyoakmedical.com.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com