28 Feb

SeaSpine Announces Fourth Quarter and Full-Year 2017 Results and Issues 2018 Financial Guidance

CARLSBAD, Calif., Feb. 28, 2018 (GLOBE NEWSWIRE) -- SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the three-months and full-year ended December 31, 2017 and provided guidance for 2018. Summary Fourth Quarter 2017 Financial Results and Recent Accomplishments

  • Revenue of $34.0 million, an increase of 4.5% year-over-year
  • U.S. revenue of $31.2 million, an increase of 4.8% year-over-year º  U.S. Orthobiologics revenue of $16.6 million, an increase of 10.1% year-over-year º  U.S. Spinal Implants revenue of $14.6 million, essentially unchanged year-over-year
  • International revenue of $2.8 million, an increase of approximately 1% year-over-year
  • Limited commercial launch of OsteoStrand™ and OsteoStrand Plus Demineralized Bone Fibers and OsteoBallast™ Demineralized Bone Matrix in Resorbable Mesh
  • Launch of an expanded Ventura™ NanoMetalene® posterior interbody device portfolio with sagittally oriented lordosis options to accommodate a larger range of posterior procedures and a wider variety of patient anatomies
“Our 2017 results are marked by several accomplishments underpinned by our commitment to delivering improved procedural spine solutions and clinical value through our expanding and innovative product portfolio,” said Keith Valentine, President and Chief Executive Officer. “As we enter 2018, we are well positioned to continue upgrading our global distribution footprint while we execute on our strategy and deliver accelerated revenue growth and expanded gross margins.” Fourth Quarter 2017 Financial Results Revenue for the fourth quarter of 2017 totaled $34.0 million, an increase of 4.5% compared to the same period of the prior year. U.S. revenue was $31.2 million, a 4.8% increase compared to the same period of the prior year due to strong volume growth in the U.S. Orthobiologics franchise that was driven by new distribution. Orthobiologics revenue totaled $18.1 million, an 8.8% increase compared to the fourth quarter of 2016. The increase in orthobiologics revenue was primarily driven by growth in U.S. sales across multiple product lines generated by recently added distributors. Spinal implants revenue totaled $15.9 million, essentially unchanged compared to the same period of the prior year. Spinal implant sales in the U.S. also was essentially flat compared to the prior year, as continued low single-digit price declines and decreased usage of the Company's legacy systems were mostly offset by revenue growth from recently launched products. Gross margin for the fourth quarter of 2017 was 63.3%, compared to 58.6% for the same period in 2016. The increase in gross margin was mainly driven by lower raw material and manufacturing costs for orthobiologics products manufactured at the Company's Irvine, California facility and lower provisions for excess and obsolete inventory in the fourth quarter of 2017. Operating expenses for the fourth quarter of 2017 totaled $29.2 million, compared to $28.6 million for the same period of the prior year. The $0.6 million increase was driven primarily by higher commission expense and marketing costs, partially offset by a $1.5 million non-cash gain recorded in the fourth quarter of 2017 related to the release of a foreign capital tax liability based on the passage of the statute of limitations and lower consulting expenses. Net loss for the fourth quarter of 2017 was $7.5 million, compared to a net loss of $9.8 million for the fourth quarter of 2016. Cash and cash equivalents at December 31, 2017 totaled $10.8 million, and the Company had no amounts outstanding under its $30.0 million credit facility. 2017 Financial Results Revenue for the year ended December 31, 2017 totaled $131.8 million, an increase of 2.3% compared to the prior year. U.S. revenue was $118.4 million, a 1.4% increase compared to the prior year. Orthobiologics revenue totaled $69.1 million, a 4.4% increase compared to the prior year. Spinal implant revenue totaled $62.7 million, essentially unchanged compared to the prior year. Gross margin for 2017 was 60.7%, compared to 56.9% for 2016. The increase in gross margin was mainly driven by lower raw material and manufacturing costs for orthobiologics products manufactured at the Company's Irvine, California facility, and by lower provisions for excess and obsolete inventory in 2017. Operating expenses for 2017 totaled $112.7 million, compared to $116.8 million for 2016.  The $4.1 million decrease was driven primarily by lower intangible asset amortization expense, the absence of a $0.9 million instrument impairment charge recorded in 2016, and a decrease in general and administrative expenses, all of which were partially offset by higher selling commissions and increased investment in marketing and product development in 2017.  The decrease in general and administrative expenses was driven primarily by lower consulting and legal expenses, the $1.5 million non-cash gain related to the release of a foreign capital tax liability, a $0.9 million non-cash gain recorded in 2017 related to a decrease in the fair value of contingent consideration liabilities related to the NLT acquisition, and lower facility and related operating costs resulting from the shutdown of the Company's Vista, California facility in late 2016. Net loss for 2017 was $32.1 million, compared to a net loss of $43.2 million for 2016. 2018 Financial Outlook SeaSpine continues to expect full-year 2018 revenue to be in the range of $135 million to $139 million, reflecting growth of 2.5% to 5.5% over full-year 2017 revenue. Webcast and Conference Call Information The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 7067009.  To listen to a live webcast, please visit the Investors section of the SeaSpine website at: www.seaspine.com. About SeaSpine SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide. Forward-Looking Statements SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the Company delivering improved procedural spine solutions and clinical value through an expanded and innovative product portfolio; the Company’s position to continue to upgrade its global distribution footprint; and the Company’s expectations for full-year 2018 revenue, as well as to deliver accelerated revenue growth and expanded gross margins.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use the Company’s existing products and to adopt its newly launched products, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; the Company’s ability to continue to invest in medical education and training, product development, and/or sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov. You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law. Investor Relations Contact Lynn Pieper Lewis (415) 937-5402 ir@seaspine.com
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Quarter Ended December 31, Year Ended December 31,
2017 2016 2017 2016
Total revenue, net $ 33,982 $ 32,519 $ 131,814 $ 128,860
Cost of goods sold 12,484 13,450 51,826 55,544
Gross profit 21,498 19,069 79,988 73,316
Operating expenses:
Selling, general and administrative 25,410 24,899 97,303 101,065
Research and development 2,952 2,908 12,180 11,442
Intangible amortization 792 792 3,168 4,309
Total operating expenses 29,154 28,599 112,651 116,816
Operating loss (7,656 ) (9,530 ) (32,663 ) (43,500 )
Other (income) expense net (43 ) 231 (430 ) 264
Loss before income taxes (7,613 ) (9,761 ) (32,233 ) (43,764 )
Provision (benefit) for income taxes (106 ) 7 (118 ) (552 )
Net loss $ (7,507 ) $ (9,768 ) $ (32,115 ) $ (43,212 )
Net Loss per share, basic and diluted $ (0.56 ) $ (0.87 ) $ (2.58 ) $ (3.85 )
Weighted average shares used to compute basic and diluted net loss per share 13,413 11,271 12,426 11,222
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA
 (In thousands)
December 31, 2017 December 31, 2016
Cash and cash equivalents $ 10,788 $ 14,566
Trade accounts receivable, net 21,872 20,982
Inventories 41,721 45,299
Total current liabilities 23,157 24,418
Short-term debt 445
Long-term borrowings under credit facility 3,835
Total stockholders' equity 105,653 110,977

Read More
28 Feb

K2M Group Holdings, Inc. Reports Fourth Quarter and Full Year 2017 Financial Results

LEESBURG, Va., Feb. 28, 2018 (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 Balance™, today reported financial results for its fourth quarter and fiscal year ended December 31, 2017.

Fiscal Year 2017 Financial Summary:

  • Total fiscal year 2017 revenue of $258.0 million, up 9% year-over-year on both a reported basis and on a constant currency basis.
  • Domestic fiscal year 2017 revenue of $197.3 million, up 9% year-over-year, comprised of:
    • U.S. Complex Spine growth of 8% year-over-year
    • U.S. Minimally Invasive Surgery (MIS) growth of 16% year-over-year
    • U.S. Degenerative growth of 8% year-over-year
  • International fiscal year 2017 revenue of $60.7 million, up 9% year-over-year, or 10% on a constant currency basis.
  • Net loss of $37.1 million for fiscal year 2017, compared to a net loss of $41.7 million in prior year.
  • Adjusted EBITDA loss of $0.7 million for fiscal year 2017, compared to Adjusted EBITDA of $1.4 million in the prior year.

Fourth Quarter 2017 Financial Summary:

  • Total fourth quarter revenue of $67.8 million, up 10% year-over-year on a reported basis and 9% on a constant currency basis.
  • Domestic fourth quarter revenue of $51.9 million, up 9% year-over-year, comprised of:
    • U.S. Complex Spine growth of 12% year-over-year
    • U.S. Minimally Invasive Surgery (MIS) growth of 11% year-over-year
    • U.S. Degenerative growth of 6% year-over-year
  • International fourth quarter revenue of $15.9 million, up 13% year-over-year, and 10% on a constant currency basis.
  • Net loss of $8.7 million for the fourth quarter, compared to a net loss of $12.5 million in the comparable quarter last year.
  • Adjusted EBITDA loss of $1.9 million for the fourth quarter, compared to Adjusted EBITDA loss of $28,000 in the comparable quarter last year.

Fourth Quarter Product Introductions and Strategic Highlights:

  • On October 4, 2017, the Company announced that President and Chief Executive Officer Eric Major had been elected Chairman of the Company's Board of Directors, effective immediately. Major succeeded Dan Pelak, who assumed the role of Independent Lead Director after serving as Chairman since 2010.
  • On October 23, 2017, the Company announced that it has acquired from Cardinal Spine, a privately held medical device company, the PALO ALTO® Cervical Static Corpectomy Cage System. PALO ALTO, a cervical vertebral body replacement device, is the first and only static corpectomy cage in the world to receive a cervical 510(k) clearance from the FDA. In addition to PALO ALTO, K2M has also acquired the associated intellectual property and product inventory.
  • On October 25, 2017, the Company announced a global compatibility and co-marketing agreement with Brainlab. The two companies will collaborate in the commercial release of future navigated K2M spinal systems, which would be compatible with Brainlab spinal navigation systems.
  • On November 30, 2017, the Company announced the completion of 300 surgical cases using the RHINE™ Cervical Disc System*. The RHINE Cervical Disc System* is an artificial disc replacement that features a one-piece compressible polymer core design with dome-shaped, plasma-coated endplates and a central-split keel.
  • On December 20, 2017, the Company announced that it received a CE Mark for its CAPRI® Cervical 3D Expandable Corpectomy Cage System* featuring Lamellar 3D Titanium Technology™ and the successful completion of its first surgical case.  * These products are intended for export and not sold or offered for sale in the United States.
"Our financial results for calendar year 2017 reflect total revenue growth of approximately 9% year-over-year, above the high-end of our guidance range," said Chairman, President, and Chief Executive Officer, Eric Major. "We delivered approximately 9% growth in the United States in 2017—well above-market growth rates—driven by solid execution against our strategic goal of increasing market share by introducing new and innovative spinal implant solutions and expanding our distribution footprint. We have supplemented this organic growth activity with exciting product introductions in both the complex spine and degenerative categories.  Looking out to 2018, we are excited about the opportunity of our first-of-its-kind MOJAVE™ PL 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology and our YUKON™ OCT Spinal System that can be used with the PALO ALTO Cervical Static Corpectomy Cage System, the first and only static corpectomy cage in the world to receive a cervical 510(k) clearance. We also announced an important strategic collaboration with Brainlab, one of the world's leading imaging and navigation companies, that we believe will represent additional implant sales opportunities in the second half of 2018.  Our Brainlab collaboration will complement our recent launches of the BACS® platform and the EVEREST®Minimally Invasive XT Spinal System.” Mr. Major continued, "We remain confident in our ability to drive above-market growth in the U.S., fueled by our continued focus on leading the spine market by introducing new and innovative spinal implant solutions to help surgeons care for patients around the world who suffer from debilitating spinal pathologies. We have introduced our 2018 guidance expectations for revenue growth of 9% to 10% with improved profitability."

Fourth Quarter 2017 Financial Results

Three Months Ended December 31,   Increase / Decrease
($,thousands) 2017 2016   $ Change % Change % Change
(as reported)  (constant currency)
United States $ 51,856 $ 47,669 $ 4,187 8.8 % 8.8 %
International $ 15,945 $ 14,122 $ 1,823 12.9 % 9.8 %
Total Revenue: $ 67,801 $ 61,791   $ 6,010 9.7 % 9.0 %

Total revenue for the fourth quarter of 2017 increased $6.0 million, or 9.7%, to $67.8 million, compared to $61.8 million for the fourth quarter of 2016. Total revenue increased 9% year-over-year on a constant currency basis. The increase in revenue was primarily driven by higher sales volume from domestic new surgeon users and newer product offerings, and increased set investments by our distribution partners in Australia and Denmark.

Revenue in the United States increased $4.2 million, or 8.8% year-over-year, to $51.9 million, and international revenue increased $1.8 million, or 12.9% year-over-year, to $15.9 million. Fourth quarter 2017 international revenue increased 10% year-over-year on a constant currency basis. Foreign currency exchange positively impacted fourth quarter international revenue by $0.4 million, representing approximately 73 basis points of 2017 international growth year-over-year. The following table represents domestic revenue by procedure category.
Three Months Ended December 31,   Increase / Decrease
($,thousands) 2017 2016   $ Change % Change
Complex Spine $ 20,004 $ 17,934 $ 2,070 11.5 %
Minimally Invasive 8,906 8,058 848 10.5 %
Degenerative 22,946 21,677 1,269 5.9 %
U.S Revenue: $ 51,856 $ 47,669   $ 4,187 8.8 %
By procedure category, U.S. revenue in the Company’s complex spine, MIS and degenerative categories represented 38.6%, 17.2% and 44.2% of U.S. revenue, respectively, for the three months ended December 31, 2017. Gross profit for the fourth quarter of 2017 increased 13.6% to $43.6 million, compared to $38.4 million for the fourth quarter of 2016.  Gross margin was 64.3% for the fourth quarter of 2017, compared to 62.1% for the prior year period. Gross profit includes amortization expense on investments in surgical instruments of $3.6 million, or 5.3% of sales, for the three months ended December 31, 2017, compared to $3.6 million, or 5.8% of sales, for the comparable period last year. Operating expenses for the fourth quarter of 2017 increased $4.7 million, or 9.9%, to $52.5 million, compared to $47.7 million for the fourth quarter of 2016. The increase in operating expenses was driven primarily by a $4.9 million increase in sales and marketing expenses, compared to the comparable period last year.  The Company increased the number of domestic sales agencies who represent our products in the United States by nine agencies to a total of 109 independent sales agencies, an increase of 9% sequentially.  In addition, the Company’s U.S. and non-U.S. direct sales employees remained flat at 158 employees, despite active management of this group. Loss from operations for the fourth quarter of 2017 decreased $0.5 million to $8.9 million compared to a loss from operations of $9.4 million for the comparable period last year. Loss from operations included intangible amortization of $0.2 million for the three months ended December 31, 2017, compared to $2.6 million for the comparable period last year.  The Company recorded approximately $1.4 million in non-recurring accruals primarily reflecting legal and administrative expenses updated in 2018 and inventory adjustments. Total other expenses for the fourth quarter of 2017 decreased $1.6 million to $1.5 million, compared to $3.1 million last year. The decrease in other expense, net, was primarily attributable to a unrealized gain of $0.3 million from foreign currency remeasurement on intercompany payable balances, compared to unrealized loss of $1.3 million in the comparable period last year. Net loss for the fourth quarter of 2017 was $8.7 million, or $0.20 per diluted share, compared to a loss of $12.5 million, or $0.30 per diluted share, for the fourth quarter of 2016. Fiscal Year 2017 Financial Results
Year Ended December 31,   Increase / Decrease
($ in,thousands) 2017 2016   $ Change % Change % Change
(as reported)  (constant currency)
United States $ 197,312 $ 181,078 $ 16,234 9.0 % 9.0 %
International $ 60,719 $ 55,556 $ 5,163 9.3 % 9.7 %
Total Revenue: $ 258,031 $ 236,634   $ 21,397 9.0 % 9.1 %
For the fiscal year 2017, total revenue increased $21.4 million, or 9.0%, to $258.0 million, compared to $236.6 million for the fiscal year 2016. Total revenue increased 9.1% year-over-year on a constant currency basis. U.S. revenue increased $16.2 million, or 9.0%, to $197.3 million, compared to $181.1 million last year. International revenue increased $5.2 million, or 9.3%, to $60.7 million, compared to $55.6 million last year. International revenue increased 9.7% year-over-year on a constant currency basis. The following table represents domestic revenue by procedure category:
Year Ended December 31,   Increase / Decrease
($,thousands) 2017 2016   $ Change % Change
Complex Spine $ 77,529 $ 71,915 $ 5,614 7.8 %
Minimally Invasive 33,257 28,711 $ 4,546 15.8 %
Degenerative 86,526 80,452 $ 6,074 7.5 %
U.S Revenue: $ 197,312 $ 181,078   $ 16,234 9.0 %
Sales in our complex spine, MIS and degenerative categories represented 39.3%, 16.9% and 43.9% of U.S. revenue, respectively, for the fiscal year 2017. As of December 31, 2017, we had cash and cash equivalents of $24.0 million as compared to $45.5 million as of December 31, 2016. We had working capital of $99.6 million as of December 31, 2017 as compared to $115.9 million as of December 31, 2016. At December 31, 2017, outstanding long-term indebtedness included the carrying value of the Convertible Senior Notes of $39.2 million and the capital lease obligation of $33.8 million. The Company had unused capacity on its revolving credit facility of $49.0 million and no borrowings outstanding as of December 31, 2017. 2018 Outlook The Company is providing fiscal year 2018 revenue guidance expectations of:
  • Total revenue on an as reported basis in the range of $280.0 million to $284.0 million, representing growth of 9% to 10% year-over-year, compared to total revenue of $258.0 million in fiscal year 2017.
    • The Company expects growth in its U.S. business of approximately 10% to 11% year-over-year in 2018.
    • The Company expects growth in its International business of approximately 5% to 7% year-over-year in 2018.
    • Assuming current currency rates remain similar for the rest of the year, the Company expects currency to have a positive impact on total revenue in 2018 of approximately $2 million.
The Company is providing fiscal year 2018 guidance expectations for net loss and Adjusted EBITDA. The Company expects:
  • Total net loss of $34.0 million to $30.0 million, compared to net loss of $37.1 million in fiscal year 2017.
  • Adjusted EBITDA benefit in the range of $4.0 million to $8.0 million, compared to Adjusted EBITDA loss of $740,000 in fiscal year 2017.
Conference Call Management will host a conference call at 5:00 p.m. Eastern Time on February 28th to discuss the results of the fourth quarter and fiscal year 2017, and to host a question and answer session. Those who would like to participate may dial 844-579-6824 (734-385-2616 for international callers) and provide access code 3754359 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 855-859-2056 (404-537-3406 for international callers); access code 3754359. The webcast will be archived on the investor relations section of the Company's website.     READ THE REST HERE  

Read More
28 Feb

Heraeus Medical to Introduce Medium Viscosity Bone Cement and Vacuum Mixing System Innovations at AAOS 2018 Annual Meeting

YARDLEY, Pa.Feb. 28, 2018 /PRNewswire/ -- Heraeus Medical, a global leader in joint fixation and infection management announced today the introduction of innovations to its current PALACOS® product portfolio.  The exciting new products include the medium viscosity bone cement PALACOS MV variations, along with two mixing systems, PALAMIX® and PALABOWL®.
The innovative PALAMIX® and PALABOWL®, while created for use with PALACOS® bone cement, can be effectively used with other types of bone cements. These new products, along with the complete PALACOS® portfolio, will be displayed during the American Academy of Orthopedic Surgeons' Annual Meeting, March 6-10, 2018 in New Orleans.  AAOS attendees wanting to learn more about the medium viscosity bone cement, versatile mixing options or view other ground-breaking products are encouraged to visit Heraeus Medical at booth 1713 and participate in demonstrations and discussions. "The collaborative environment of AAOS provides an excellent opportunity to share our newest technologies with total joint arthroplasty surgeons and gain direct feedback," said Devin Childers, Vice President and General Manager of Heraeus Medical LLC. "Heraeus is excited to share our rapidly growing portfolio with attendees." In January, the company announced it would provide PALACOS® customers with earlier access to its latest technologies by selling to them directly. PALACOS®, formerly sold exclusively through a distributor in the US, is now available directly through its pioneer and manufacturer, Heraeus Medical. New and existing PALACOS® customers in the US are able to order products directly from Heraeus Medical by calling 1-833-PALACOS (725-2267). Heraeus Medical has successfully sold and supported PALACOS® customers directly in EuropeAustralia, and several other countries through an integrated ordering process that is now also available to US customers. For more information or to order PALACOS® in the US, please visit www.heraeus-medical-usa.com or call 1-833-PALACOS (725-2267). For more information during AAOS, please visit Heraeus Medical at booth 1713. About the Heraeus Medical Global Business Unit Heraeus Medical is known as a global leader in joint fixation and infection management in orthopedics and trauma surgery. This enables the company to make an important contribution to supporting surgeons and the surgical team and to improve surgery outcomes. In the area of biomaterials, Heraeus Medical focuses on products for use in bone and joint surgery. The core product PALACOS® is considered the gold standard among bone cements and has repeatedly proven itself over five decades of clinical use. About Heraeus Heraeus, the technology group headquartered in Hanau, Germany, is a leading international family-owned company formed in 1851. With expertise, a focus on innovations, operational excellence and an entrepreneurial leadership, we strive to continuously improve the businesses of our customers around the world. We create high-quality solutions for our customers and strengthen their long-term competitiveness by combining material expertise with technological know-how. Our ideas are focused on important issues such as the environment, energy, health, mobility, and industrial applications. Our portfolio ranges from components to coordinated material systems which are used in a wide variety of industries, including the steel, electronics, chemical, automotive, and telecommunications industries. In the 2016 financial year, the FORTUNE Global 500 listed company-generated revenues without precious metals of US$2.2 bn and a total revenue of US$23.8 bn. With approximately 12,400 employees worldwide in more than 100 subsidiaries in 40 countries, Heraeus holds a leading position in its global markets. In 2016, the Foundation for Family Businesses named Heraeus as one of the "Top 10 Family Businesses" in Germany.   SOURCE Heraeus Medical

Related Links

http://www.heraeus-medical-usa.com

Read More
28 Feb

Successful First in Human for OrthoSpin’s Robotic External Orthopedic Fixation System

MISGAV, IsraelFeb. 28, 2018 /PRNewswire/ -- OrthoSpin Ltd. ("OrthoSpin"), a portfolio company of The Trendlines Group Ltd. ("Trendlines") (SGX: 42T; OTCQX: TRNLY), announced that it successfully completed a first-in-human (FIH) case for its smart, robotic external fixation system for the treatment of an orthopedic deformity. The patient was a 15-year-old suffering from deformity of the tibia. The deformity caused shortening of the leg and a limp, limited his daily activity, had the potential to disrupt his growth, and had aesthetic consequences. Pediatric orthopedic surgeon Dr. Eitan Segev, of Tel Aviv Sourasky Medical Center's Dana-Dwek Children's Hospital, performed surgery to correct the deformity, which was followed by external fixation with the Taylor Spatial frame using OrthoSpin's smart automatic control system. Instead of conventional manual adjustment of the external fixator, the OrthoSpin system makes pre-programmed adjustments automatically and continuously — without the need for patient involvement. Integrated software enables physicians to chart patient progress and, if required, quickly adjust the treatment regimen. Physicians receive real-time feedback on computers or mobile devices to ensure that the prescribed course of treatment is followed. Using the system also eliminates the need for weekly x-rays to check status. The precise adjustments of OrthoSpin's system resulted in a less painful process due to smaller, more incremental changes – in this case, an eighth of a millimeter in movement – which are expected to reduce soft tissue damage. OrthoSpin CEO Oren Cohen remarked, "We are extremely pleased with the results of our FIH case. OrthoSpin's innovative system has the potential to change the outcomes of these types of orthopedic treatments. Following the first patient, we will conduct additional trials and submit for regulatory clearance during 2018 in order to bring our product to market. OrthoSpin's future plans are to enable the physician to collect many other treatment parameters due to the capabilities of the smart system." Dr. Segev, commented, "The OrthoSpin system allows for objective measurement, ease of use, and provides more piece of mind for the patient and family. We look forward to its routine integration in orthopedic treatment." Chairman and CEO of Trendlines, Todd Dollinger added, "We are very proud of this important achievement for OrthoSpin. The company has the ability to bring an automatic external fixation device to market that will significantly improve treatment and quality of life for the benefit of both patients and physicians." Meet OrthoSpin CEO Oren Cohen and see a working prototype of the OrthoSpin smart external fixation system at the AAOS Annual Meeting in New Orleans, Louisiana6-10 March 2018. For more information: Oren Cohen, CEO OrthoSpin oren@orthospin.com Phone: +972-54-334-2651 http://orthospin.com/ Photo credit: Studio Imaginet  

Read More
28 Feb

Laser Spine Institute Announces Thomas Linton as Chief Patient Empowerment Officer

February 28, 2018 (TAMPA, Fla.) – Laser Spine Institute, the leader in minimally invasive spine surgery, today announced the appointment of Thomas Linton as its first-ever Chief Patient Empowerment Officer. Linton previously served as Vice President of Customer Experience at Assurant, a Fortune 500 insurance company.

“We look forward to leveraging Thomas’ expertise to further facilitate the delivery of exemplary experiences for our patients during every step of their care journey,” said Roger Cary, President and Chief Executive Officer, Laser Spine Institute. “Creating this position and adding someone with Thomas’ track record is a testament to our commitment to patient-centered care.”

As Chief Patient Empowerment Officer, Linton will have oversight of the organization’s patient-facing teammates who serve as the first touch in the patient experience, those who are the patient’s main contact throughout their journey and liaisons with physicians in local markets. Linton will also help identify patients’ interactions, which are critical moments of truth, to improve their overall experience.

Linton has more than 20 years of experience in marketing, sales and customer experience, with a focus on delivering customer-centered solutions. Prior to joining Laser Spine Institute, Linton also held leadership positions at AT&T, Bank of America and General Electric. Linton’s years of experience have made him known for his effectiveness in driving growth, improving efficiencies and finding customer solutions.

“I’m thrilled to be joining a purpose-driven organization and to play a part in continuing Laser Spine Institute’s mission to provide exceptional patient experiences and care,” Linton said. “We are known as the leader in minimally invasive spine surgery for a reason, and the impact our teammates and innovative medicine plays on our patients’ lives was instrumental in my decision to join the organization.”

Linton received his Master of Business Administration in marketing and strategic planning from the Wharton School at University of Pennsylvania. He also holds a Bachelor of Science in electrical engineering and a Master of Engineering from the University of Louisville. He serves on the Board of Directors for the George M. Hughes Foundation, which provides college scholarships to deserving high school seniors.

For more information, visit http://news.laserspineinstitute.com/.

Media Contact: Maura Devetski, Edelman Phone: 404-832-6788 Email: maura.devetski@edelman.com

About Laser Spine Institute Headquartered in Tampa, Florida, Laser Spine Institute currently operates seven regional surgery centers across the country, in Tampa, Florida; Scottsdale, Arizona; Philadelphia; Oklahoma City; Cleveland, St. Louis and Cincinnati. Laser Spine Institute has helped more than 75,000 patients find relief from debilitating neck and back pain caused by spinal stenosis, degenerative disc disease, pinched nerves, bone spurs, bulging/herniated discs, sciatica and other chronic conditions. Patients often refer a friend or family member to have surgery at Laser Spine Institute; we have a patient recommendation score of 97 out of 100. Additionally, Laser Spine Institute has been repeatedly recognized for outstanding patient satisfaction and reports an enterprise patient satisfaction score of more than 96.

Laser Spine Institute has been named a top employer by Modern Healthcare, Tampa Bay Times, Tampa Bay Business Journal, Philly.com and okc.BIZ and a Most Admired Company by BestCompaniesAZ. Opening in Tampa in 2005 with one operating room and nine employees, Laser Spine Institute now has nearly 1,000 corporate and health care professionals across the country.

Read More
28 Feb

Leader Biomedical announces acquisition of International Orthopaedics Holding GmbH

Amsterdam | Geisingen | 27 February 2018 Leader Biomedical is pleased to announce the phased acquisition of International Orthopaedics Holding GmbH (International Orthopaedics), a manufacturer and distributor of orthopaedic implants based in Geisingen, Germany. The companies have entered into a notarial deed on the 20th of February, 2018. This phased acquisition is in line with Leader Biomedical’s vision to expand its therapeutic solutions offering in Germany and to enhance its infrastructure for global operations. “I am excited to partner with Leader Biomedical. We see that with the support of Leader Biomedical’s team, we will be able to increase our offerings of orthopaedic implants to our customers to include cements, bone grafts, and additional biomaterials for spine and sports. Leader Biomedical’s investments into International Orthopaedics will further help us strengthen our position on the German market in offering value-added services to our customers,” shares Marc Bittenbinder, Founder and Managing Director of International Orthopaedics Holding GmbH. “We are eager to welcome International Orthopaedics to the Leader Biomedical Group,” says Mr. Leo Liyeung, Group Executive Director of Leader Biomedical Group. “International Orthopaedics has been a reliable partner for Leader Biomedical from the start. Their strengths are highly complementary to ours, and together, we can create myriad opportunities for further growth.” Customers in Germany will benefit from International Orthopaedics’ infrastructure, complemented by Leader Biomedical’s solutions portfolio, next generation technologies, and dedicated customer service. International Orthopaedics’ current portfolio of orthopaedic implants will be supplemented with C-ment®, a high-quality line of PMMA bone cements with and without gentamycin, the X-Grip® system, a leading ACL reconstruction solution, eTiss® allografts processed with Leader Biomedical’s proprietary eCOO® Technology using supercritical carbon dioxide, as well as the Ossfinity® and OssGro® line of synthetic grafts produced with MBCP™ Technology, a proprietary method which combines 60% HA and 40% βTCP. “The acquisition of International Orthopaedics is consistent with Leader Biomedical’s ambitions to expand our on-ground operations in Europe. We are pursuing strategic opportunities in catering to local healthcare establishments and in providing affordable healthcare services with International Orthopaedics. We shall be investing in the infrastructure of International Orthopaedics to integrate Leader Biomedical’s supply chain and after sales capabilities. Over the next years, we envision to further develop customer management in the DACH region through Geisingen“, adds Basil Babychan, Group Business Director Leader Biomedical Group. This acquisition reaffirms Leader’s vision for the DACH region after the discontinuation of the partnership with aap Joints GmbH in 2017 and an increased investment into BioTiss GmbH in early 2018. The acquisition of International Orthopaedics is the latest investment by Leader Biomedical and follows its earlier expansions into India, Brazil, Russia, and Malaysia in 2016 and the U.S.A. in 2017. About International Orthopaedics Holding GmbH: “Innovation in Orthopaedics” International Orthopaedics Holding GmbH is dedicated to safety in procedures by providing innovation and performance to patients as well as offering education and great service support to healthcare professionals. IO Holding GmbH offers high performance implants and instruments from trusted, high-Quality German and other European manufacturers (www.io-holding.com) About Leader Biomedical: “Extending Your Reach” Leader Biomedical is committed to contributing to the betterment of the global healthcare community with proven solutions and continuous innovation, and extending the reach of patients and caregivers by improving global access to reliable, targeted therapeutic solutions and new technologies. Leader Biomedical’s portfolio offers therapeutic solutions; focusing on orthopaedic, dental, spine, trauma and sports medicine (www.leaderbiomedical.com) Leader Biomedical Europe B.V. Herikerbergweg 300, Diana Building 1101 CT Amsterdam The Netherlands Sandy Plat Group Marketing & Communications Manager +31 (0)6 2972 6530 This release was published on openPR.

Read More
28 Feb

Diamond Orthopedic Announces New Clinical Milestone

Diamond Orthopedic, a medical device company that is pioneering the use of an innovative faceted threadform in orthopedics, today announced that their faceted technology was successfully used in an intercalary tibial allograft.

The surgeon who utilized Diamond’s faceted bone screw noted that, “stable, durable fixation was paramount to this type of reconstruction. I chose the Diamond threadform for its superior fixation and pullout strength, and for what I like to call its ‘bone friendly’ design. The faceted threadform not only made insertion of the screws easier, but also gave me confidence that the innovative biomechanical features of this technology will help lead to a successful patient outcome.”

Diamond’s patented faceted design allows surgeons to insert faceted screws into bone with less insertional torque and lower compressive stress, which can be particularly important when working with osteopenic bone. The faceted thread design enables an improved bone-screw interface versus traditional helical threadforms.

Roy Bivens, CEO, stated, “Faceted bone screws offer unparalleled fixation that is especially valuable in compromised bone. Diamond Orthopedic was proud to support a case of this type. Better patient outcomes are our ultimate goal. This technology has the potential to change numerous paradigms within orthopedics including with plate and screw applications and with uni-cortical fixation possibilities.”

About Diamond Orthopedic  Diamond Orthopedic, LLC, headquartered in Charlotte, NC, is a medical device company that offers a revolutionary fixation technology to achieve better patient outcomes at a lower total cost. Diamond Orthopedic is the exclusive provider of faceted threadform technology for orthopedic applications worldwide. With proven superiority over traditional helical threadforms, Diamond Orthopedic is the new fixation standard in orthopedics.

Media Contact: Guillaume Viallaneix MedTech Momentum Phone: 407-960-2994 Email: guillaume@medtechmomentum.com

Diamond Orthopedic Contact: 1600 Camden Road Charlotte, NC, 28203 Phone: 704-585-8270 Email: info@diamondortho.com

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 risk factors contain certain forward-looking statements that involve risks and uncertainties. These statements relate to the Company’s future plans, objectives, expectations and intentions. The Company’s actual results could differ materially from those discussed in these statements. It is difficult to accurately predict the impact of each of these risks on the Company due to the dependence on many factors outside the Company’s control. These risks and uncertainties include, but are not limited to, factors affecting our financial 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 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. 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.

Read More
27 Feb

Simplify Medical Announces 50th U.S. Patent for Innovative Cervical Disc Replacement Portfolio

February 27, 2018

SUNNYVALE, Calif.--(BUSINESS WIRE)--Simplify Medical Pty Ltd, maker of the Simplify® cervical artificial disc, today announced receipt of the company’s 50th U.S. patent for its innovative cervical motion preservation intellectual property (IP) portfolio. The Simplify Disc is designed to minimize patient risk associated with radiation, optimize long-term durability, simplify implantation and increase access to cervical disc replacement for patients with smaller anatomies. The company’s 50th patent, U.S. Patent No. 9,883,945, is entitled “Artificial Intervertebral Disc with Lower Height” and relates to the unique low-profile and more anatomically-shaped disc design. Other recent patents include U.S. Patent No. 9,839,532, covering Simplify Medical’s proprietary methods for inserting intervertebral discs in a less traumatic manner, and U.S. Patent No. 9,839,525, relating to implanting intervertebral discs with a movable core and a protrusion for holding the core captive between endplates. “Simplify Medical is committed to innovation that improves clinical outcomes for patients with degenerative disc disease,” said Simplify Medical CEO David Hovda. “We believe Simplify Medical has the largest and most impactful IP portfolio in the spine motion preservation space, and we continue to invest in technology to further optimize patient outcomes and surgical ease of use.” The Simplify Disc is anatomically designed with low height implant options, as low as four millimeters, to treat a broad range of patients, including patients with smaller cervical disc spaces. Composed of primarily non-metal materials (PEEK-on-ceramic), the Simplify Disc is designed to be viewed on magnetic resonance imaging (MRI) in order to minimize post-operative patient exposure to radiation from computed tomography (CT) scans currently necessary to view metal discs. While MRI is widely used pre-operatively for surgical planning, spine surgeons often switch to CT scans post-operatively in order to accommodate metal components, which can make it difficult to view the devices, as well as the facets and adjacent disc levels. However, CT scans have been shown to expose patients to ionizing radiation that equates to 400 to 550 chest X-rays per scan. The device is considered MRI-conditional, posing no known hazard in an MRI environment within prescribed conditions of use. The Simplify Disc is being studied in two U.S. pivotal trials. The one-level, prospective trial comparing Simplify Disc with cervical fusion surgery at one level between C3 to C7 has completed enrollment. Use of the Simplify Disc in two levels of the spine is being studied in a second IDE trial in the U.S., which is approximately 40 percent enrolled, and enrollment is expected to be completed by the end of 2018. The two-level, prospective pivotal trial will encompass up to 200 patients at up to 18 centers, comparing cervical implantation of the device in two contiguous discs from C3 to C7 with two-level cervical fusion surgery. For information about eligibility or enrollment in the two-level pivotal trial, please visit http://www.simplifytrial.com/. The Simplify Disc has received the CE Mark and is commercially available in select European markets. Early clinical data has shown substantial improvement in patient pain scores and functional improvement after treatment. ABOUT SIMPLIFY MEDICAL Simplify Medical is focused on cervical spinal disc arthroplasty, using innovative, MRI-friendly materials designed to decrease the need for ionizing radiation and enhance patient options. Simplify Medical is located in Sunnyvale, California. To learn more, visit http://www.simplifymedical.com/. Caution: The Simplify Disc is an investigational device in the United States and is limited by law to investigational use.

Contacts

Chronic Communications Inc. Michelle McAdam, (949) 545-6654 michelle@chronic-comm.com

Read More
27 Feb

Orthofix International Reports Fourth Quarter and Fiscal 2017 Financial Results

Fourth Quarter Highlights

  • Net sales of $116.9 million, an increase of 7.7% compared to prior year and 6.1% on a constant currency basis
  • Net income from continuing operations of $1.5 million; compared to net loss of $5.1 million in the prior year
  • Adjusted EBITDA of $24.3 million; an increase of $3.2 million, or 15.1%, over prior year
Fiscal Year 2017 Highlights
  • Net sales of $433.8 million, an increase of 5.9% compared to prior year and 5.5% on a constant currency basis
  • Net income from continuing operations of $7.3 million; an increase of $3.8 million over prior year
  • Adjusted EBITDA of $81.6 million; an increase of $2.3 million, or 2.9%, over prior year
LEWISVILLE, Texas--(BUSINESS WIRE)-- Orthofix International N.V. (NASDAQ:OFIX) today reported its financial results for the fourth quarter and fiscal year ended December 31, 2017. For the fourth quarter of 2017, net sales were $116.9 million, earnings per share from continuing operations was $0.08 and adjusted earnings per share from continuing operations was $0.52. For fiscal year 2017, net sales were $433.8 million, earnings per share from continuing operations was $0.39 and adjusted earnings per share from continuing operations was $1.62. "2017 was a very strong year for Orthofix. We exceeded our topline expectations and finished the year with a solid margin improvement trajectory. We also made significant progress in the transformation of our Spine Fixation business and completed our worldwide restructuring initiatives," said Brad Mason, President and Chief Executive Officer. "With 2017 in the rear-view mirror, we are now focused fully on executing our 2018 global and business unit strategies. Globally, we expect to drive shareholder value through three pillars, topline organic growth better than market growth rates, margin expansion through operational improvements, and strategic deployment of our capital in ways that we believe will accelerate topline growth in our core businesses. We are well positioned and expect to execute in each of these areas in 2018." Financial Results Overview Fourth Quarter The following table provides net sales by strategic business unit ("SBU"):
Three Months Ended December 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 Change Constant Currency Change
BioStim $ 49,760 $ 47,803 4.1 % 4.1 %
Extremity Fixation 29,103 26,843 8.4 % 2.2 %
Spine Fixation 21,175 18,664 13.5 % 13.2 %
Biologics 16,858 15,227 10.7 % 10.7 %
Net sales $ 116,896 $ 108,537 7.7 % 6.1 %
Gross profit increased $8.1 million to $93.3 million. Gross margin increased to 79.8% compared to 78.5% in the prior year period, primarily due to increased revenue from international Extremity Fixation stocking distributors, as well as our domestic and international restructuring initiatives during 2017. Non-GAAP net margin (gross profit less sales and marketing expenses) was $41.5 million, an increase of 13.6% compared to $36.5 million in the prior year period. The increase in non-GAAP net margin was primarily due to the increase in gross margin and a slight decrease in sales and marketing expenses as a percent of sales. Net income from continuing operations was $1.5 million, or $0.08 per share, compared to net loss of $5.1 million, or ($0.29) per share in the prior year period. Adjusted net income from continuing operations was $9.7 million, or $0.52 per share, compared to adjusted net income of $7.7 million, or $0.42 per share in the prior year period. EBITDA was $21.8 million, compared to $8.6 million in the prior year period. Adjusted EBITDA was $24.3 million or 20.8% of net sales for the fourth quarter, compared to $21.1 million or 19.4% of net sales in the prior year period. Fiscal Year 2017 The following table provides net sales by SBU:
Year Ended December 31,
(U.S. Dollars, in thousands) 2017 2016 Change Constant Currency Change
BioStim $ 185,900 $ 176,561 5.3 % 5.3 %
Extremity Fixation 103,242 102,683 0.5 % (0.9 %)
Spine Fixation 81,957 72,632 12.8 % 12.7 %
Biologics 62,724 57,912 8.3 % 8.3 %
Net sales $ 433,823 $ 409,788 5.9 % 5.5 %
Driven by the increase in net sales, gross profit increased $18.9 million to $340.8 million, while gross margin was flat at 78.6% compared to the prior year period. Non-GAAP net margin was $142.4 million, an increase of 1.3% compared to $140.6 million in the prior year period. The increase in Non-GAAP net margin was due to the increase in net sales, partially offset by higher commission expenses from geographic mix in Extremity Fixation and higher commission rates from Biologics and Spine Fixation distributors. Net income from continuing operations was $7.3 million, or $0.39 per share, compared to net income of $3.5 million, or $0.19 per share in the prior year. Adjusted net income from continuing operations was $30.1 million, or $1.62 per share, compared to adjusted net income of $27.0 million, or $1.46 per share in the prior year. EBITDA was $56.9 million in 2017, compared to $39.1 million in the prior year. Adjusted EBITDA was $81.6 million or 18.8% of net sales for the year, compared to $79.3 million or 19.4% of net sales in the prior year. Adoption of Revenue Recognition Standard ASU 2014-09 On January 1, 2018, the Company adopted the new revenue recognition standard, ASU 2014-09, as amended, using a cumulative effect adjustment, which resulted in a significant increase in accounts receivable, a decrease in inventories, and a related change to deferred income taxes. These changes were offset by an adjustment to the Company's opening retained earnings of approximately $5 million. One of the primary impacts of this new standard is the timing of revenue recognition for our sales to international Extremity Fixation and Spine Fixation stocking distributors that were historically accounted for using the sell-through method. This revenue will now be recorded on invoiced sales instead of deferring recognition until cash is received. If the Company were to have adopted the new standard as of January 1, 2017, pro-forma net sales for the year ended December 31, 2017 would have been approximately $431 million. Refer to the table under the subheading "2017 Pro-forma Net Sales Under the New Revenue Recognition Standard" for the detail of pro-forma 2017 net sales by quarter as would have been reported under the new revenue recognition standard. Liquidity As of December 31, 2017, cash and cash equivalents were $81.2 million compared to $39.6 million as of December 31, 2016. As of December 31, 2017, we had no outstanding indebtedness and borrowing capacity of $125 million. Cash flow from operations increased $8.6 million to $53.3 million, while free cash flow increased $10.0 million to $36.4 million. Redomicile The Company is in the final stages of evaluating the impact of moving its parent company's domicile from Curacao to the United States. Based on the analysis to date, including the assessment of the recent U.S. tax reform, the Company believes that executing this change could provide a number of benefits to Orthofix, including organizational simplification, more efficient cash deployment, a lower tax rate and increased cash flow. Subject to the outcome of final diligence, the Company currently anticipates requesting shareholder approval for this move in conjunction with its annual shareholder meeting later this year. The Company also expects to incur costs this year to complete all of the underlying steps required for this transition. These estimated costs are included in our 2018 guidance. 2018 Outlook For the year ending December 31, 2018, the Company expects the following results, assuming exchange rates are the same as those currently prevailing. This guidance reflects the new revenue recognition standard that is required as of January 1, 2018 and discussed above, for which net sales will be recorded on invoiced sales instead of deferring recognition until cash is received.
2018 Outlook
(Unaudited, U.S. Dollars, in millions, except per share data) Low High
Net sales $ 450.0 1 $ 455.0 1
Net income from continuing operations $ 28.3 2 $ 30.6 2
Adjusted EBITDA $ 89.0 3 $ 91.0 3
EPS from continuing operations $ 1.50 4 $ 1.62 4
Adjusted EPS from continuing operations $ 1.76 5 $ 1.84 5
1 Represents a year-over-year increase of 3.7% to 4.9% on a reported basis
2 Represents a year-over-year increase of 288.1% to 319.7%
3 Represents a year-over-year decrease of 9.1% to 11.6%
4 Represents a year-over-year increase of 284.6% to 315.4%
5 Represents a year-over-year increase of 8.6% to 13.6%
    READ THE REST HERE  

Read More
26 Feb

NuVasive Reports Fourth Quarter and Full Year 2017 Financial Results

SAN DIEGOFeb. 26, 2018 /PRNewswire/ -- NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, transforming spine surgery with minimally disruptive, procedurally-integrated solutions, announced today financial results for the quarter and full year ended Dec. 31, 2017.
Fourth Quarter 2017 Highlights: 
  • Revenue remained flat at $271.7 million compared to prior year, with strong international growth of 34% on a constant currency basis;
  • GAAP operating profit margin of 11.0%; Non-GAAP operating profit margin of 18.2%; and
  • GAAP diluted earnings per share of $0.46; Non-GAAP diluted earnings per share increase of 5.7% to $0.56.
Full Year 2017 Highlights: 
  • Revenue increased to $1,029.5 million, or 7.0% on a reported and constant currency basis;
  • GAAP operating profit margin of 11.0%; Non-GAAP operating profit margin up 50 basis points to 16.6%; and
  • GAAP diluted earnings per share of $1.50; Non-GAAP diluted earnings per share increase of 15.1% to $1.91.
"2017 was a milestone year for NuVasive as we surpassed the $1 billion revenue mark driven by impressive international sales growth of more than 20 percent, and achieved record profitability of 18.2% non-GAAP operating margins in the fourth quarter," said Gregory T. Lucier, chairman and chief executive officer of NuVasive. "As we set the stage for 2018, we remain focused on accelerating our growth momentum by furthering our investment in R&D to bring innovative offerings to the market, developing our differentiated intraoperative neurophysiological monitoring services business with the completed acquisition of SafePassage and growing the number of surgeons worldwide who use NuVasive technologies to improve patients' quality of life." A full reconciliation of non-GAAP to GAAP measures can be found in the tables of this news release. Fourth Quarter 2017 Results NuVasive reported fourth quarter 2017 total revenue of $271.7 million, indicating flat year-over-year growth on a reported and constant currency basis, compared to $271.1 million for the fourth quarter 2016. For the fourth quarter 2017, GAAP and non-GAAP gross profit was $196.3 million and $196.7 million, respectively, and GAAP and non-GAAP gross margin was 72.2% and 72.4%, respectively. These results compared to gross profit of $204.2 million on a GAAP and non-GAAP basis, and GAAP and non-GAAP gross margin of 75.3% for the fourth quarter 2016. Total GAAP and non-GAAP operating expenses for the fourth quarter 2017 were $166.5 million and $147.2 million, respectively. These results compared to GAAP and non-GAAP operating expenses of $174.1 million and $155.4 million, respectively, for the fourth quarter 2016. The Company reported a GAAP net income of $24.0 million, or $0.46 per share, for the fourth quarter 2017 compared to a GAAP net income of $6.4 million, or $0.11 per share, for the fourth quarter 2016. On a non-GAAP basis, the Company reported net income of $29.1 million, or $0.56 per share, for the fourth quarter 2017 compared to net income of $27.6 million, or $0.53 per share, for the fourth quarter 2016. Full Year 2017 Results NuVasive reported full year 2017 total revenue of $1,029.5 million, a 7.0% increase on both a reported and constant currency basis, compared to $962.1 million for the full year 2016. Total GAAP and non-GAAP gross profit for the full year 2017 was $760.5 million and $761.1 million, respectively, and both GAAP and non-GAAP gross margin was 73.9%. These results compared to gross profit of $722.0 million and $736.7 million on a GAAP and non-GAAP basis, respectively, and a GAAP and non-GAAP gross margin of 75.0% and 76.6%, respectively, for the full year 2016. Total GAAP and non-GAAP operating expenses for the full year 2017 were $647.2 million and $590.3 million, respectively. These results compared to GAAP and non-GAAP operating expenses of $598.5 million and $581.6 million, respectively, for the full year 2016. The Company reported a GAAP net income of $83.0 million, or $1.50 per share, for the full year 2017 compared to a GAAP net income of $37.1 million, or $0.69 per share, for the full year 2016. On a non-GAAP basis, the Company reported net income of $99.9 million, or $1.91 per share, for the full year 2017 compared to net income of $86.5 million, or $1.66per share, for the full year 2016. Cash and cash equivalents were approximately $72.8 million at December 31, 2017. Annual Financial Guidance for 2018 The Company estimates revenue for full-year 2018 to be in range of $1,095 million to $1,105 million reflecting organic growth in the range of 4.4% to 5.4% and reported growth of 6.4% to 7.3% inclusive of the recent acquisition of SafePassage. Assuming current exchange rates remain similar for the rest of the year, the Company expects currency to have a positive impact in 2018 of approximately $5 million. The Company estimates full-year 2018 net income on a GAAP basis in a range of $1.56 to $1.59 per share and non-GAAP earnings per share in a range of $2.44 to $2.47. Additionally, the Company continues to expect to drive at least 100 basis points in non-GAAP operating margin expansion and adjusted EBITDA of approximately $295 million to $305 million. The above guidance assumes a full-year benefit of U.S. tax reform, suspension of the medical device tax and the recent acquisition of SafePassage.

2018 Guidance Range 1

(in million's; except %'s and EPS)

 GAAP 

 Non-GAAP 

Revenue

$            1,095

$          1,105

$            1,095

$          1,105

  % Growth - Reported 2

6.4%

7.3%

6.4%

7.3%

  % Growth - Constant Currency 2, 3

5.9%

6.9%

Operating margin

13.0%

13.0%

17.6%

17.6%

Earnings per share

$               1.56

$            1.59

$              2.44

$            2.47

EBITDA margin

23.4%

23.4%

26.9%

26.9%

Tax Rate

~19%

~19%

~24%

~24%

1 Guidance reflects the range provided February 26, 2018.

2 2017 as reported, does not include adoption of revenue recognition Accounting Standards Codification 606 (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.

Supplementary Financial Information

For additional financial detail, please visit the Investor Relations section of the Company's website at

www.nuvasive.com to access Supplementary Financial Information.

Read More