Dr. Richard Rothman Recognized As 100 Great Health Care Leaders To Know In 2017

Richard H. Rothman, MD, Ph.D, Founder, Rothman Institute and Professor of Orthopaedic Surgery at Sidney Kimmel Medical College at Thomas Jefferson University, was named one of the 100 Great Health Care Leaders to Know in 2017, by Becker’s Hospital Review. The list was comprised of, “100 exemplary leaders of health care providers, government agencies, insurers and companies with successful track records leading their organizations.” Other notable leaders appearing on the list include: President of the Joint Commission, Director of the National Institutes of Health, Director of the World Health Organization, and the Secretary of Health and Human Services.

“It is an honor to be recognized by such a well-known medical publication,” said Dr. Rothman. “This list includes some of the best and brightest minds in medicine today. To be included with such select company is truly humbling.”

“Dr. Rothman is not just a leader, but a visionary in the world of orthopaedic medicine,” said Alexander R. Vaccaro, MD, Ph.D, MBA, President, Rothman Institute, Richard H. Rothman Professor and Chairman, Department of Orthopaedic Surgery, at Sidney Kimmel Medical College at Thomas Jefferson University. “He is a master clinician, a passionate educator, a dedicated researcher and a selfless philanthropist. He embodies all of the qualities a medical leader needs in this day and age. On behalf of all Rothman Institute we congratulate him on a recognition well deserved.”

 

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CEO says it’s a good time to be at Stryker in Kalamazoo

By Al Jones | ajones5@mlive.com – May 4, 2017

KALAMAZOO, MI — Stryker Corp. is strong financially and is growing, its chairman and chief executive officer says.

“It is a good time to be at Stryker and a good time to be at Stryker in Kalamazoo,” Kevin A. Lobo said, following the medical technologies company’s 38th annual shareholders meeting Wednesday afternoon in Kalamazoo.

He told the stockholders that the Kalamazoo-based company is proud to have surpassed the $11 billion mark for sales last year. It reported $11.3 billion in net sales during 2016. And he said the company’s stock price grew by 28.9 percent during 2016 versus the 9.5 percent performance of others tracked by Standard and Poor’s.

“Stryker is a growing company,” he said. “We’ve continue to outpace the med-tech (medical technologies) market, growing at the high end of med-tech.”

Lobo’s comments to more than 250 company shareholders, executives and others Wednesday came eight days after its first-quarter release of sales and earnings The company’s numbers surpassed Wall Street expectations.

On April 25, the maker of powered surgical implements, hospital beds and replacement joints reported net earnings of $444 million for the period ended March 31. That was up 10.4 percent from $401 million during the same period a year ago. Net sales for the period were $2.96 billion, up 18.4 percent over first-quarter 2016.

Stryker reported net earnings of $1.19 per fully diluted share, up 9.3 percent from $1.07 a year ago. On an adjusted basis, that was per share earnings of $1.48, which exceeded a $1.43 consensus estimate by analysts.

Sales for its three business segments grew at rates of: 36.2 percent for Medical-Surgical; 7.4 percent for Orthopaedics; and 7.3 percent for Neurotechnology and Spine.

 

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Misonix Reports Third Quarter Fiscal Year 2017 Financial Results

FARMINGDALE, N.Y., May 02, 2017 (GLOBE NEWSWIRE) — Misonix, Inc. (Nasdaq:MSON), a provider of minimally invasive therapeutic ultrasonic medical devices that enhance clinical outcomes, announced today financial results for the three and nine months ended March 31, 2017.

Financial Highlights for the Third Quarter and Nine-Months:

  • For the third quarter of fiscal year 2017, the Company reported net sales of $7.2 million, an increase of 32% compared with $5.4 million in the third quarter of fiscal 2016. For the nine-month period, net sales increased 16% to $19.4 million compared with $16.7 million in the comparable 2016 period.
  • Domestic sales increased 31% to $4.0 million versus $3.1 million in third quarter of fiscal 2017. For the nine-month period, domestic sales increased 29% to $12.0 million compared with $9.3 million in the comparable 2016 period.
  • Consumables sales in the United States increased 39% to $3.7 million for the quarter.
  • During the quarter the Company delivered its initial equipment stocking order and completed product training with the personnel of its new distributor in China.
  • The gross profit percentage in the third quarter was 71%, up from 66% in the third quarter of fiscal 2016, primarily from a stronger mix of higher margin consumables revenue. For the quarter, operating expenses increased by $1.1 million to $6.5 million driven in part by professional fees relating to the recently completed internal investigation, along with higher sales commissions related to higher sales volumes.
  • The Company reported a net loss of $0.1 million, or $(0.02) per diluted share, compared to a net loss of $0.7 million, or $(0.09) per diluted share, in the third quarter of fiscal 2016.
  • At March 31, 2017, the Company maintained cash and cash equivalents of $11.9 million with no long-term debt.

Stavros Vizirgianakis, president and chief executive officer of Misonix, said, “We turned in a solid performance in the third quarter of fiscal 2017 driven by a 39% increase in domestic consumables sales and delivery of our initial stocking order to our new distributor in the People’s Republic of China. From a strategic standpoint, we firmly believe that our business in the United States offers the best opportunity for growth and we are focused on expanding consumables sales and driving recurring revenue in this market. To that end, we have expanded the number of Clinical Sales Specialists in our domestic sales and marketing group and the results to date have been excellent, as evidenced by the strong increase in domestic consumables sales in the third quarter.

“Internationally, significant progress has been achieved with our new distributor in China with the delivery of our initial equipment stocking order, and completing product training with their personnel. I believe both parties feel we are at the starting line of a significant opportunity in a rapidly growing market.”

Mr. Vizirgianakis continued, “We had a very favorable product mix during the quarter, which was weighted in higher margin consumables products. That favorable product mix drove gross margin for the third quarter to 70.6% compared to 65.7% in last year’s third quarter; a 490-basis point increase versus last year’s comparable quarter.”

“Heading into the fourth quarter of the fiscal year, we have a strong cash position of approximately $12 million, with no long-term debt. We look forward to a strong finish in fiscal year 2017, and to head into fiscal 2018 with momentum.”

Conference Call

The Company has scheduled a conference call for Tuesday, May 2, 2017, at 4:30 pm ET to review the financial results.

Interested parties can access the conference call by dialing (844) 861-5497 or (412) 317-6579 or can listen via a live Internet webcast, which is available in the Investor Relations section of the Company’s website at www.misonix.com.

A teleconference replay of the call will be available for three days at (877) 344-7529 or (412) 317-0088, confirmation # 10106217. A webcast replay will be available in the Investor Relations section of the Company’s website at www.misonix.com for 30 days.

About Misonix

Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used in spine surgery, neurosurgery, orthopedic surgery, wound debridement, cosmetic surgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s website at www.misonix.com.

Safe Harbor Statement

With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, the impact of the pending investigation by the Department of Justice and Securities Exchange Commission, and other factors discussed in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2016, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Financial Tables to Follow

MISONIX INC. and Subsidiaries
Consolidated Balance Sheets
March 31, June 30,
2017 2016
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 11,856,503 $ 9,049,327
Accounts receivable, less allowance for doubtful accounts of $96,868 and $96,868, respectively 4,357,156 3,869,427
Inventories, net 4,909,415 5,822,935
Prepaid expenses and other current assets 664,249 530,564
Total current assets 21,787,323 19,272,253
Property, plant and equipment, net of accumulated amortization and depreciation of $7,610,152 and $6,976,282, respectively 3,413,116 2,492,815
Patents, net of accumulated amortization of $965,996 and $885,394, respectively 710,070 604,916
Goodwill 1,701,094 1,701,094
Intangible and other assets 300,341 266,603
Deferred income tax 3,581,551 3,394,690
Total assets $ 31,493,495 $ 27,732,371
Liabilities and shareholders’ equity
Current liabilities:
Accounts payable $ 1,433,608 $ 1,402,797
Accrued expenses and other current liabilities 1,994,387 1,887,337
Total current liabilities 3,427,995 3,290,134
Deferred lease liability 9,331 9,262
Deferred income 17,737 31,685
Total liabilities 3,455,063 3,331,081
Commitments and contingencies
Shareholders’ equity:
Common stock, $.01 par value-shares authorized 20,000,000; 9,162,203 and 7,948,234 shares issued and 9,023,354 and 7,809,385 outstanding in each period, respectively 91,622 79,482
Additional paid-in capital 37,410,034 32,502,521
Accumulated deficit (8,363,872 ) (7,081,361 )
Treasury stock, at cost, 138,849 shares in each period (1,099,352 ) (1,099,352 )
Total shareholders’ equity 28,038,432 24,401,290
Total liabilities and shareholders’ equity $ 31,493,495 $ 27,732,371

 

MISONIX INC. and Subsidiaries
Consolidated Statements of Operations
For the three months ended For the nine months ended
March 31, March 31,
2017 2016 2017 2016
Net sales $ 7,177,763 $ 5,426,147 $ 19,379,768 $ 16,716,487
Cost of goods sold, exclusive of depreciation from consigned product 2,112,099 1,859,749 5,842,778 5,578,349
Gross profit 5,065,664 3,566,398 13,536,990 11,138,138
Operating expenses:
Selling expenses 3,587,859 3,319,385 10,184,680 8,967,352
General and administrative expenses 2,484,962 1,515,559 6,504,202 4,994,569
Research and development expenses 465,863 548,278 1,398,311 1,340,339
Total operating expenses 6,538,684 5,383,222 18,087,193 15,302,260
Loss from operations (1,473,020 ) (1,816,824 ) (4,550,203 ) (4,164,122 )
Other income (expense):
Interest income 18 19 56 63
Royalty income and license fees 953,235 963,025 2,846,351 2,969,557
Other (6,940 ) (5,464 ) (15,576 ) (16,898 )
Total other income 946,313 957,580 2,830,831 2,952,722
Loss from operations before income taxes (526,707 ) (859,244 ) (1,719,372 ) (1,211,400 )
Income tax benefit (219,000 ) (15,000 ) (275,000 ) (322,000 )
Loss from continuing operations (307,707 ) (844,244 ) (1,444,372 ) (889,400 )
Discontinued operations:
Income from discontinued operations net of tax expense of $88,139 and $85,000 respectively 161,861 165,000 161,861 165,000
Net income from discontinued operations 161,861 165,000 161,861 165,000
Net loss from operations (145,846 ) (679,244 ) (1,282,511 ) (724,400 )
Net loss per share – Basic continuing Operations $ (0.04 ) $ (0.11 ) $ (0.17 ) $ (0.11 )
Net loss per share – Diluted continuing operations $ (0.04 ) $ (0.11 ) $ (0.17 ) $ (0.11 )
Net income per share – Basic discontinued operations $ 0.02 $ 0.02 $ 0.02 $ 0.02
Net income per share – Diluted discontinued operations $ 0.02 $ 0.02 $ 0.02 $ 0.02
Net loss per share – Basic $ (0.02 ) $ (0.09 ) $ (0.16 ) $ (0.09 )
Net loss per share – Diluted $ (0.02 ) $ (0.09 ) $ (0.16 ) $ (0.09 )
Weighted average shares – Basic 8,613,354 7,789,174 8,263,343 7,772,761
Weighted average shares – Diluted 8,613,354 7,789,174 8,263,343 7,772,761

 

Corporate Contact
Joe DwyerMisonix, Inc.
631-927-9113
jdwyer@misonix.com

Investor Contact
Joe DiazLytham Partners
602-889-9700
mson@lythampartners.com

Source: Misonix, Inc.

Read more: http://www.nasdaq.com/press-release/misonix-reports-third-quarter-fiscal-year-2017-financial-results-20170502-01489#ixzz4g7ch1M67

Smith & Nephew signs exclusive worldwide distribution agreement for the revolutionary MolecuLight i:XTM imaging device

3 May 2017

Smith & Nephew plc (LSE:SN, NYSE:SNN), the global medical technology business, today announces it has signed a worldwide distribution agreement with MolecuLight®, Inc., a developer of innovative imaging technology for the clinical assessment of wounds.

This agreement supports Smith & Nephew’s strategic priority to innovate for value by delivering solutions that help healthcare professionals better improve the lives of their patients.

“Smith & Nephew, through products such as ACTICOAT antimicrobial silver dressings and IODOSORB cadexomer gel ,has long been committed to helping customers manage infection in chronic and acute wounds,” said Andy Weymann, MD, Chief Medical Officer at Smith & Nephew.  “The MolecuLight i:X imaging device enables healthcare professionals to see what they have never been able to see before, the actual accumulation of several common bacteria in a wound, even when not visible to the naked eye.  Moleculight  i:X enhances clinicians’ ability to choose the right therapy, at the right time for their patient 1,2 In addition, it has also the potential to enhance other areas of current wound care practice such as helping to guide wound sampling and debridement, monitoring of  wound progression, providing more insight in conversation between the clinician and the patient, and greater detail when documenting treatment decisions.”

Rosemary Hill, BSN, CWOCN, CETN(C), of Lions Gate Hospital (Vancouver, Canada) added ‘’The MolecuLight i:X is more than a bacteria visualization device. The information it is providing is positively impacting our antimicrobial stewardship program and empowering my overall wound treatment decision making.’’

The MolecuLight i:X  is a handheld point-of-care imaging device that uses fluorescence imaging to display potentially harmful concentrations of bacteria that fluoresce in violet light on screen, in real-time.  Clinicians can capture and view still images and video, as well as measure the surface area of a wound and then save and add those images to the patient’s electronic health record 2,3.

“When combined with clinical best practice, the information provided by the MolecuLight i:X on bacterial presence and distribution can guide early interventions to potentially reduce bioburden and promote wound healing2,” said Craig Kennedy, CEO MolecuLight.  “Partnering with Smith & Nephew, a world leader in advanced wound care, allows this revolutionary technology to rapidly reach a worldwide customer base and begin the process of becoming a routine step in wound assessment.”

The MolecuLight i:X is currently available in Canada and the European Union with regulatory clearance in the U.S. pending.

Enquiries

Media
Dave Snyder +1 (978) 749-1440
Kirsti Harefallet +44 (771) 008 5253
Smith & Nephew

 

About MolecuLight Inc. 

MolecuLight Inc. is a privately owned, Canadian medical imaging company delivering real-time fluorescence image-guidance solutions that provide clinicians with new information about wound bacterial burden and wound surface area to assist clinicians in making improved diagnostic and treatment decisions1,2,4,5,6,7,8,9,10.  The company was founded in 2012 by Dr. Ralph DaCosta, Principal Investigator and Scientist at the Princess Margaret Cancer Center, University Health Network (Toronto, Canada), currently the company’s Chief Scientific Officer and Director. MolecuLight’s premiere product – the MolecuLight i:X is a Wound imaging Device that allows clinicians to quickly, safely and easily visualize  bacteria that fluoresce in violet light and measure wound surface area at the point of care so they have maximum insights for accurate treatment and accelerated healing 2.

The MolecuLight i:X™ Imaging Device is approved by Health Canada (Medical License #95784) and has CE Marking (Certificate # G1160292355002) for sale in the European Union. The MolecuLight i:X™ Imaging Device is pending US FDA De Novo approval and is not available in the US.

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.

To learn more about what we do to help reduce wound infections, please visit www.closertozero.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.

 References:

  1. Wu YC, Smith M, Chu A, Lindvere-Teene L, Starr D, Tapang K, Wong O, Linden R, DaCosta RS. Handheld fluorescence imaging device detects subclinical wound infection in an asymptomatic patient with chronic diabetic foot ulcer: a case report. Int Wound J. 2016 Aug;13(4):449-53.
  2. DaCosta RS, Kulbatski I, Lindvere-Teene L, Starr D, Blackmore K, Silver JI, Opoku J, Wu YC, Medeiros PJ, Xu W, et al. Point-of-care autofluorescence imaging for real-time sampling and treatment guidance of bioburden in chronic wounds: first-in-human results. PLoS One. 2015 Mar 19;10(3).
  3. Hill R and Douglas JJ. Effect of bacterial fluorescence imaging on patient care and wound management in a hospital setting: a pilot study. Proceedings of the Annual Symposium on Advanced Wound Care (SAWC); 2017 Apr 5-9; San Diego, CA. (accepted poster)
  4. Ottolino-Perry K, Chamma E, Blackmore KM, Lindvere-Teene L, Starr D, Tapang K, Rosen CF, Pitcher B, Panzarella T, Linden R, DaCosta RS. Improved detection of clinically relevant wound bacteria using autofluorescence image-guided sampling in diabetic foot ulcers. Int Wound J. 2017; doi: 10.1111/iwj.12717.
  5. MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.
  6. Rennie MY. A prospective, single-blind evaluation of the positive predictive value (PPV) of the MolecuLight i:X device to predict the presence of porphyrin-producing bacteria in chronic wounds. MolecuLight final report TR054. 2017 Jan.
  7. MolecuLight Inc. Case Study 0051 Track Wound Size and Bacterial Presence with the MolecuLight i:X. 2016.
  8. Raizman R. Point-of-care fluorescence imaging device guides care and patient education in obese patients with surgical site infections. Presented at: CAWC 2016. Proceedings of the 22nd Annual Canadian Association of Wound Care Conference; 2016 Nov 3-6, Niagara Falls, ON.
  9. Raizman R. Fluorescence imaging positively predicts bacterial presence and guides wound cleaning and patient education in a series of pilonidal sinus patients. Proceedings of the Annual Wounds UK Conference; 2016 Nov 14-16; Harrogate, UK.
  10. Hoeflok J, Teene L, Chamma E, Chu A, DaCosta RS. Pilot clinical evaluation of surgical site infections with a novel handheld fluorescence imaging device. Proceedings of the Annual Military Health System Research Symposium (MHSRS); 2014 Aug 18-21; Fort Lauderdale, FL.  

Globus Medical Reports First Quarter 2017 Results

AUDUBON, Pa., May 03, 2017 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal implant manufacturer, today announced its financial results for the first quarter ended March 31, 2017.

  • Worldwide sales were $155.8 million, an increase of 11.9% as reported, or 12.1% in constant currency
  • First quarter net income was $28.7 million, or 18.4% of sales
  • Diluted earnings per share (EPS) were $0.30
  • Non-GAAP diluted EPS were $0.32
  • Non-GAAP adjusted EBITDA was 37.1% of sales

David Paul, Chairman and CEO said, “Our worldwide sales for the first quarter were $155.8 million, an increase of 11.9% over the first quarter of 2016.  Our adjusted EBITDA margins remained at an outstanding 37.1% and we also delivered non GAAP EPS of $0.32.

“We are very pleased with our performance during the first quarter.  We launched three new spine products, received our first trauma 510(k) clearance, had a strong competitive rep hiring quarter, further expanded our in-house manufacturing capacity, and continued to run an extremely efficient organization with best in class adjusted EBITDA margins.  We remain confident in our long-term growth prospects and our ability to sustain industry-leading profitability by continuing to execute on our strategy of rapid product introduction, expansion of our U.S. and international sales footprints, and diligent expense control.”

First quarter sales in the U.S. increased by 1.6% compared to the first quarter of 2016.  International sales increased by 123.4% over the first quarter of 2016 on an as reported basis and 126.5% on a constant currency basis due to the Alphatec acquisition included in the first quarter of 2017.  Sales from the Alphatec acquisition contributed $15.2 million in the quarter.

First quarter GAAP net income was $28.7 million, an increase of 2.5% over the same period last year.  Diluted EPS for the first quarter was $0.30, as compared to $0.29 for the first quarter 2016.  Non-GAAP diluted EPS for the first quarter was $0.32, compared to $0.30 in the first quarter of 2016.

The company generated net cash provided by operating activities of $53.4 million and non-GAAP free cash flow of $41.9 million in the first quarter.  Cash, cash equivalents and marketable securities ended the quarter at $389.2 million.  The company remains debt free.

2017 Annual Guidance
The company reaffirms guidance for full year 2017 sales of $625 million and non-GAAP fully diluted earnings per share of $1.27.

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2017 first quarter results with the investment community at 5:30 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, May 9, 2017.  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 6940-2658.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA.  The company 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.

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, provision for litigation, and acquisition related costs, 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 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.

In addition, for the period ended March 31, 2017 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 and the tax effects of such adjustments.  The tax impact of these non-GAAP adjustments is calculated based on the consolidated effective tax rate on a GAAP basis, applied to the non-GAAP adjustments, unless the underlying item has a materially different tax treatment, in which case the estimated tax rate applicable to the adjustment is used.  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, and the tax effects of such adjustments, which we believe are not reflective of underlying business trends.  Additionally, for the periods ended March 31, 2017 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 liquidity 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 within the meaning of Item 10(e) of Regulation S-K.  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
(In thousands, except per share amounts) March 31,
2017
March 31,
2016
Sales $ 155,809 $ 139,264
Cost of goods sold 35,600 31,519
Gross profit 120,209 107,745
Operating expenses:
Research and development 10,666 10,030
Selling, general and administrative 67,059 53,798
Amortization of intangibles 1,782 392
Acquisition related costs 388 674
Total operating expenses 79,895 64,894
Operating income 40,314 42,851
Other income, net 2,100 760
Income before income taxes 42,414 43,611
Income tax provision 13,700 15,601
Net income $ 28,714 $ 28,010
Earnings per share:
Basic $ 0.30 $ 0.29
Diluted $ 0.30 $ 0.29
Weighted average shares outstanding:
Basic 95,996 95,398
Diluted 97,148 96,293
GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value) March 31,
2017
December 31,
2016
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 182,435 $ 132,639
Restricted cash 477 477
Short-term marketable securities 143,663 157,673
Accounts receivable, net of allowances of $3,627 and $2,771, respectively 94,232 91,983
Inventories 113,037 112,692
Prepaid expenses and other current assets 7,008 14,502
Income taxes receivable 47 3,800
Total current assets 540,899 513,766
Property and equipment, net of accumulated depreciation of $173,890 and $166,711, respectively 124,840 124,229
Long-term marketable securities 63,066 60,444
Note receivable 30,000 30,000
Intangible assets, net 61,343 61,706
Goodwill 106,215 105,926
Other assets 954 928
Deferred income taxes 33,104 30,638
Total assets $ 960,421 $ 927,637
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable $ 17,013 $ 17,472
Accrued expenses 37,409 46,401
Income taxes payable 11,708 1,911
Business acquisition liabilities, current 9,239 14,108
Total current liabilities 75,369 79,892
Business acquisition liabilities, net of current portion 6,087 5,972
Deferred income taxes 8,261 7,876
Other liabilities 1,819 1,819
Total liabilities 91,536 95,559
Commitments and contingencies
Equity:
Common stock; $0.001 par value.  Authorized 785,000 shares; issued and outstanding 96,077 and 95,930 shares at March 31, 2017 and December 31, 2016, respectively 96 96
Additional paid-in capital 217,257 211,725
Accumulated other comprehensive loss (6,081 ) (8,642 )
Retained earnings 657,613 628,899
Total equity 868,885 832,078
Total liabilities and equity $ 960,421 $ 927,637
GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
Cash flows from operating activities:
Net income $ 28,714 $ 28,010
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 12,240 6,676
Amortization of premium on marketable securities 1,008 953
Write-down for excess and obsolete inventories 1,671 2,225
Stock-based compensation expense 3,491 2,770
Allowance for doubtful accounts 794 88
Change in fair value of contingent consideration 478
Change in deferred income taxes (2,399 ) 391
(Increase)/decrease in:
Restricted cash 15,668
Accounts receivable (2,225 ) 2,201
Inventories (2,102 ) (2,252 )
Prepaid expenses and other assets 8,628 1,209
Increase/(decrease) in:
Accounts payable (172 ) (1,238 )
Accrued expenses and other liabilities (10,170 ) (15,661 )
Income taxes payable/receivable 13,493 14,517
Net cash provided by operating activities 53,449 55,557
Cash flows from investing activities:
Purchases of marketable securities (51,215 ) (104,208 )
Maturities of marketable securities 55,280 69,656
Sales of marketable securities 6,505 7,798
Purchases of property and equipment (11,533 ) (9,366 )
Net cash used in investing activities (963 ) (36,120 )
Cash flows from financing activities:
Payment of business acquisition liabilities (5,001 ) (300 )
Proceeds from exercise of stock options 1,990 1,895
Net cash (used in)/provided by financing activities (3,011 ) 1,595
Effect of foreign exchange rate on cash 321 91
Net increase in cash and cash equivalents 49,796 21,123
Cash and cash equivalents, beginning of period 132,639 60,152
Cash and cash equivalents, end of period $ 182,435 $ 81,275
Supplemental disclosures of cash flow information:
Interest paid 8 1
Income taxes paid $ 2,656 $ 774
Supplemental Financial Information
Sales by Geographic Area:
(Unaudited) Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
United States $ 129,663 $ 127,560
International 26,146 11,704
Total sales $ 155,809 $ 139,264
Sales by Product Category:
(Unaudited) Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
Innovative Fusion $ 81,872 $ 70,046
Disruptive Technology 73,937 69,218
Total sales $ 155,809 $ 139,264
Liquidity and Capital Resources:
(Unaudited) March 31,
2017
December 31,
2016
(In thousands)
Cash and cash equivalents $ 182,435 $ 132,639
Short-term marketable securities 143,663 157,673
Long-term marketable securities 63,066 60,444
Total cash, cash equivalents and marketable securities $ 389,164 $ 350,756
Available borrowing capacity under revolving credit facility 50,000 50,000
Working capital $ 465,530 $ 433,874

The following tables reconcile GAAP to Non-GAAP financial measures.

Non-GAAP Adjusted EBITDA Reconciliation Table:
(Unaudited) Three Months Ended
(In thousands, except percentages) March 31,
2017
March 31,
2016
Net income $ 28,714 $ 28,010
Interest income, net (1,418 ) (496 )
Provision for income taxes 13,700 15,601
Depreciation and amortization 12,240 6,676
EBITDA 53,236 49,791
Stock-based compensation expense 3,491 2,770
Acquisition related costs 1,086 674
Adjusted EBITDA $ 57,813 $ 53,235
Net income as a percentage of sales 18.4 % 20.1 %
Adjusted EBITDA as a percentage of sales 37.1 % 38.2 %
Non-GAAP Net Income Reconciliation Table:
(Unaudited) Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
Net income $ 28,714 $ 28,010
Amortization of intangibles 1,782 392
Acquisition related costs 1,086 674
Tax effect of adjusting items (926 ) (382 )
Non-GAAP net income $ 30,656 $ 28,694
Non-GAAP Diluted Earnings Per Share Reconciliation Table:
(Unaudited) Three Months Ended
(Per share amounts) March 31,
2017
March 31,
2016
Diluted earnings per share, as reported $ 0.30 $ 0.29
Amortization of intangibles 0.02
Acquisition related costs 0.01 0.01
Tax effect of adjusting items (0.01 )
Non-GAAP diluted earnings per share $ 0.32 $ 0.30
Non-GAAP Free Cash Flow Reconciliation Table:
(Unaudited) Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
Net cash provided by operating activities $ 53,449 $ 55,557
Adjustment for impact of restricted cash (15,668 )
Purchases of property and equipment (11,533 ) (9,366 )
Non-GAAP free cash flow $ 41,916 $ 30,523
Non-GAAP Sales on a Constant Currency Basis Comparative Table:
(Unaudited) Three Months Ended Reported
Growth
Currency
Impact on
Current Period
Constant
Currency
Growth
(In thousands, except percentages) March 31,
2017
March 31,
2016
United States $ 129,663 $ 127,560 1.6 % 1.6 %
International 26,146 11,704 123.4 % $ (364 ) 126.5 %
Total sales $ 155,809 $ 139,264 11.9 % $ (364 ) 12.1 %

 

Contact:
Daniel Scavilla
Senior Vice President, Chief Financial Officer
Phone: (610) 930-1800
Email: investors@globusmedical.com
www.globusmedical.com

Global Knee Replacement Devices Market to Grow at a CAGR of 3.25% by 2021: Growing Demand for Cementless Knee Replacement – Research and Markets

DUBLIN, May. 03, 2017 /PRNewswire/ —

Research and Markets has announced the addition of the “Global Knee Replacement Devices Market 2017-2021” report to their offering.

The global Knee Replacement Devices market to grow at a CAGR of 3.25% during the period 2017-2021.

The report, Global Knee Replacement Devices Market 2017-2021, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market.

The latest trend gaining momentum in the market is growing demand for cementless knee replacement. Globally, among all knee replacement procedures, the majority of surgeons use cemented knee replacements devices. However, these cemented knee replacement devices have many post-operative complications after they have been implanted in the body.

According to the report, one of the major drivers for this market is high prevalence of knee-related issues. Knee-related disorders are some of the major global health issues, which affect most people above 40 years and are more specific for people aged above 60 years. Arthritis, trauma, back pain, and osteoporosis are the most common joint problems globally. Limited physical activity and unhealthy eating habits can negatively influence the body’s homeostasis.

Key vendors

  • Zimmer Biomet
  • DePuy Synthes
  • Stryker
  • Smith & Nephew
  • Exactech
  • ConforMis

Other prominent vendors

  • Aesculap Implant Systems
  • Arthrex
  • Arthrosurface
  • Baumer
  • Corentec
  • Others

Key Topics Covered:

PART 01: Executive summary

PART 02: Scope of the report

PART 03: Research Methodology

PART 04: Introduction

PART 05: Market landscape

PART 06: Market segmentation by procedure type

PART 07: Market segmentation by end-user

PART 08: Geographical segmentation

PART 09: Decision framework

PART 10: Drivers and challenges

PART 11: Market trends

PART 12: Vendor landscape

PART 13: Key vendor analysis

PART 14: Appendix

For more information about this report visit http://www.researchandmarkets.com/research/l9kldn/global_knee

Media Contact:

Research and Markets
Laura Wood, Senior Manager
press@researchandmarkets.com

For E.S.T Office Hours Call +1-917-300-0470
For U.S./CAN Toll Free Call +1-800-526-8630
For GMT Office Hours Call +353-1-416-8900

U.S. Fax: 646-607-1907
Fax (outside U.S.): +353-1-481-1716

SOURCE Research and Markets

Related Links

http://www.researchandmarkets.com

NuVasive Announces Sponsorship Of EPOSNA 2017 And Launches New Monthly Pediatric Spinal Deformity Podcast

SAN DIEGO, May 2, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced the Company is a leading sponsor of EPOSNA 2017, the combined meeting of the EPOS (European Paediatric Orthopaedic Society) and POSNA (Pediatric Orthopaedic Society of North America) annual meetings, held this week in Barcelona, Spain. NuVasive also announced the launch of a monthly podcast, MAGEC Matters, featuring interviews with the leading surgeons in pediatric deformity and sharing clinical insights on the treatment of early-onset scoliosis.

“At NuVasive, we are not only passionate about the world-class innovation we are bringing to market to help improve pediatric spinal deformity, but we’re also passionate about the education and research that is necessary to provide surgeons with the information they need to advance the care options available to pediatric patients,” said Jason Hannon, NuVasive’s president and chief operating officer. “We’ve made tremendous investments in building a comprehensive pediatric deformity portfolio, with our MAGEC® system, RELINE®posterior fixation platform and PRECICE® limb lengthening system. By supporting events such as EPOSNA, we are able to connect surgeons from around the world and help improve the lives of children.”

EPOSNA is the world’s largest pediatric orthopaedic scientific meeting with over 1,300 abstracts submitted. The Company’s sponsorship of the event includes exhibit floor presence featuring pediatric spine and orthopedic solutions and the following workshops:

  • “MAGEC Masters Roundtable: Key Principles for Challenging Applications”; Wednesday, May 3, 2017 from 12:45 – 13:35 p.m. (CEST); Featuring Michael Vitale, M.D., Peter Sturm, M.D., Burt Yaszay, M.D. and Jeff Sawyer, M.D.
  • “So You’re Not Sure You Can Do Limb Lengthening”; Thursday, May 4, 2017 from 12:45 – 13:35 p.m. (CEST); Featuring Christof Radler, M.D. and Frank Schiedel, M.D.

As a key education initiative for the pediatric spinal deformity community, NuVasive also announced the launch of a monthly podcast series, MAGEC Matters, featuring interviews with leading surgeons in pediatric deformity discussing tips for the treatment of early-onset scoliosis, which is now available on iTunes, SoundCloud and other leading podcast platforms.

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 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. 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, 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 described in NuVasive’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.

 

SOURCE NuVasive, Inc.

Related Links

http://www.nuvasive.com

Implanet’s new JAZZ™ Standalone implant receives European marketing clearance (CE)

May 03, 2017

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

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

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

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

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

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

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

IMPLANET will participate this week in two major Congresses:

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

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

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

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

1 Source : Company

Contacts

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

K2M Group Holdings, Inc. Reports First Quarter 2017 Financial Results and Announces Key Product Approvals in Japan

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

First Quarter 2017 Financial Summary:

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

Year-to-Date 2017 Highlights:

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

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

First Quarter 2017 Financial Results

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

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

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

The following table represents domestic revenue by procedure category.

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

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

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

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

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

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

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

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

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

2017 Outlook

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

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

Conference Call

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

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

About K2M Group Holdings, Inc.

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

Forward-Looking Statements

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

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

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

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

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

Use of Non-GAAP Financial Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

Expanding Orthopedics Inc (EOI)-Announces Record Q1 Growth & Revenue

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

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

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

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

About Expanding Orthopedics Inc.

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

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

SOURCE Expanding Orthopedics Inc. (EOI)