Medacta Announces FDA Clearance and First Surgeries Utilizing 3DMetalTM Tibial Cones for Knee Revision

November 03, 2017

CASTEL SAN PIETRO, Switzerland–(BUSINESS WIRE)–Family-owned orthopedics leader Medacta International today announced the first surgeries utilizing its recently FDA-cleared 3DMetalTM Tibial Cones for knee revision surgery. The 3DMetal Tibial Cones can be used for structural support in areas of bone deficiencies that may compromise revision implant fixation, and are indicated for use with Medacta’s GMK Revision and GMK Hinge Knee systems, as well as the GMK tibial extension stems and offset. The first surgeries utilizing this technology were performed by Kevin Hardt, M.D., and David Manning, M.D., of the Northwestern University Feinberg School of Medicine in Chicago, Illinois and Dragan Jeremic, M.D., of St. Vincenz Krankenhaus Brakel in Brakel, Germany.

“Medacta’s 3DMetal Tibial Cones recreate a proximal structural foundation for the intended revision implant by achieving proximal fixation and force transmission in the remaining host bone,” said Dr. Manning, a revision knee specialist and designer of the 3DMetal Tibial Cones. Dr. Hardt added: “The instrumentation was straightforward to use and complementary to my typical revision workflow. I was impressed with the surgical press fit of the implant.”

A Medacta innovation, 3DMetal is a three-dimensional advanced biomaterial based on 3D printing technology that enables direct structural and functional connection with the bone through an interconnecting pore structure similar to the cancellous bone structure. With this new solution, the Medacta knee portfolio allows surgeons to address multiple revision scenarios, including even the most challenging of cases.

Dr. Jeremic, also an expert in primary and revision total knee replacement, commented: “I am very satisfied with this new implant and the result. From now on, this will be an excellent option for my patients.”

“It is Medacta’s mission to be a partner for our surgeons, even in the most challenging scenarios,” said Francesco Siccardi, Executive Vice President of Medacta International. “With our innovative 3DMetal technology, we have extended the range of advanced solutions for our surgeons and we will continue to do so in the future.”

Medacta will launch the 3DMetal Tibial Cones for the U.S. market at the American Academy of Orthopaedic Surgeons Annual Meeting, which will be held in New Orleans in March 2018. The Medacta Shoulder System, announced earlier this month, will also be introduced at the meeting. For more information about Medacta, please visit medacta.com or follow @Medacta on Twitter.

About Medacta International

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

Contacts

For Medacta International, Inc.
Jill Bongiorni, (516) 729-2250
Jill@torchcomllc.com

SeaSpine Reports Third Quarter 2017 Financial Results

CARLSBAD, Calif., Nov. 02, 2017 (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 third quarter ended September 30, 2017.

Third Quarter 2017 Financial Highlights and Recent Accomplishments

  • Revenue of $31.7 million, unchanged compared to the prior year
    • U.S. revenue of $28.2 million, a decrease of 0.8% year-over-year
      • U.S. Orthobiologics revenue of $14.9 million, an increase of 2.0% year-over-year
      • U.S. Spinal Implants revenue of $13.3 million, a decrease of 3.9% year-over-year
    • International revenue of $3.5 million, an increase of 7.4% year-over-year
  • Full commercial launch of the Shoreline Anterior Cervical Standalone (ACS) System, featuring TruProfile™ technology, providing surgeons the ability to intraoperatively address a wide range of anatomy, surgical situations or bone
  • Limited commercial launch of OsteoStrand™ Demineralized Bone Fibers and initial surgeries successfully completed
  • Improved liquidity position, with total cash balance $4.4 million higher than at June 30, 2017, and all outstanding debt and interest paid down during the third quarter

“We are pleased with our results this quarter and confident that our strategy to reposition SeaSpine for growth is on track,” said Keith Valentine, President and Chief Executive Officer of SeaSpine. “We are confident that our recent and upcoming product launches, combined with an even stronger distribution network, will generate growth as we head into 2018.”

Third Quarter 2017 Financial Results
Revenue for the third quarter of 2017 totaled $31.7 million, unchanged compared to the same period of the prior year. U.S. revenue was $28.2 million, a decrease of 0.8% compared to the same period of the prior year.  The decrease in U.S. revenue was primarily due to low-single digit price declines and decreased usage of SeaSpine’s legacy spinal implant systems, which outpaced the revenue growth contributed by recently launched products.

U.S. Orthobiologics revenue totaled $14.9 million, increasing 2.0% compared to the third quarter of 2016. U.S. Spinal Implants revenue totaled $13.3 million, decreasing 3.9% compared to the third quarter of 2016.

Gross margin for the third quarter of 2017 was 61.6%, compared to 56.3% for the same period in 2016.  The increase in gross margin was mainly driven by lower manufacturing costs for orthobiologics products manufactured at the Company’s Irvine, California facility.

Operating expenses for the third quarter of 2017 totaled $27.3 million, compared to $27.4 million for the same period of the prior year.  A $0.2 million increase in R&D expense was more than offset by lower selling, general and administrative and intangible amortization expenses.  SG&A expense for the third quarter of 2017 included the benefit of a $1.2 million non-cash gain related to a reduction in the fair market value of contingent consideration liabilities associated with the NLT Spine acquisition, which was mostly offset by higher selling commissions compared to the third quarter of 2016.

Net loss for the third quarter of 2017 was $7.5 million, compared to a net loss of $9.5 million for the third quarter of 2016.

Cash and cash equivalents at September 30, 2017 totaled $16.7 million, and the Company had no amounts outstanding under its $30.0 million credit facility. During the third quarter of 2017, the Company paid off all outstanding borrowings plus accrued interest totaling $4.1 million. The Company realized $11.0 million in net proceeds in the third quarter of 2017 through the sale of approximately 1,023,000 shares of its common stock under its “at the market” equity offering program and used a portion of those proceeds to fully pay down the credit facility.

2017 Financial Outlook
SeaSpine expects full-year 2017 revenue guidance to be in the range of $130 million to $132 million, reflecting growth of 1% to 2.5% over full-year 2016 revenue.

Webcast and Conference Call Information
SeaSpine will report complete financial results for the third quarter of 2017 on November 2, 2017 at 1:30 p.m. PT / 4:30 p.m. ET. 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: 97240039. To listen to a live webcast, please visit the Investors section of the SeaSpine website at: www.seaspine.com. A replay of the webcast will be available until Wednesday, November 15, 2017.

About SeaSpine
SeaSpine 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 ability of the Company’s recent and upcoming product launches, as well as its distribution network, to generate growth as it heads into 2018; and the Company’s expectations for full-year 2017 revenue.  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 clinical needs of surgeons and patients; 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, 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, including as a result of developing and supporting the launch of new products; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth; 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
Carrie Mendivil
(415) 937-5405
ir@seaspine.com

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Total revenue, net $ 31,742 $ 31,741 $ 97,832 $ 96,341
Cost of goods sold 12,176 13,881 39,342 42,094
Gross profit 19,566 17,860 58,490 54,247
Operating expenses:
Selling, general and administrative 23,674 23,803 71,893 76,166
Research and development 2,834 2,600 9,228 8,534
Intangible amortization 792 955 2,376 3,517
Total operating expenses 27,300 27,358 83,497 88,217
Operating loss (7,734 ) (9,498 ) (25,007 ) (33,970 )
Other income (expense), net 215 (59 ) 387 (33 )
Loss before income taxes (7,519 ) (9,557 ) (24,620 ) (34,003 )
Benefit for income taxes (57 ) (103 ) (12 ) (559 )
Net loss $ (7,462 ) $ (9,454 ) $ (24,608 ) $ (33,444 )
Net loss per share, basic and diluted $ (0.58 ) $ (0.84 ) $ (2.04 ) $ (2.98 )
Weighted average shares used to compute basic and diluted net loss per share 12,815 11,271 12,079 11,206
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In thousands)
September 30, 2017 December 31, 2016
Cash and cash equivalents $ 16,689 $ 14,566
Trade accounts receivable, net of allowances of $519 and $483 19,822 20,982
Inventories 42,276 45,299
Short-term debt 445
Total current liabilities 23,190 24,418
Long-term borrowings under credit facility 3,835
Total stockholders’ equity 110,956 110,977

 

Xtant Medical Enters into a Distribution Agreement with curasan, Inc. Bringing Matriform™ to Market

BELGRADE, Mont., Nov. 01, 2017 (GLOBE NEWSWIRE) — Xtant Medical Holdings, Inc. (NYSE American:XTNT), a leader in the development of regenerative medicine products and medical devices, today announced it has entered into a distribution agreement with curasan, Inc. adding a premium line of synthetic scaffolds to its biologics portfolio.

Matriform, Xtant’s brand of the curasan synthetic product portfolio for orthopedic applications, consists of a composition of pure phase Beta-Tricalcium Phosphate (β-TCP) and porcine collagen, and interconnected porosity with a variety of micro, meso, and macro pores. Distribution of Matriform will mark Xtant’s entrance into the US orthopedic Bone Graft Substitute market, the largest market globally with an annual market size of over $800 million.

“We are excited to be enhancing our biologic portfolio offering with a line of synthetic scaffolds, which will make us a comprehensive biologic supplier for our customers and their patients,” said Carl O’Connell, CEO of Xtant Medical. “Our team has been very strategic in finding a partner with a product that meets our expectations for superior handling and clinical efficacy with proven mechanisms of action.”

“It’s an important milestone for us to partner with such a forward-thinking company as Xtant Medical and expand our distribution footprint within North America. Adding additional private label distributors within the US and globally alongside our direct sales teams provide great opportunities for curasan and our distributor partners. Xtant has a great reputation for providing innovative and relevant products to orthopedic surgeons and we are pleased to expand our relationship further with Xtant.” said Michael Schlenk, CEO of curasan AG.

Matriform will be available in two formulations, and in various volumes for a multitude of orthopedic applications. The flexible strips are high density with high elasticity, making them easily adaptable to bony defects when hydrated. The moldable version is a low density bioceramic that becomes malleable when hydrated. The two formulations received 510k clearance for orthopedic applications in the US in December of 2016, and has been a synthetic of choice in Europe for a variety of orthopedic procedures for over 20 years.

About Xtant Medical

Xtant Medical Holdings, Inc. (NYSE American:XTNT) develops, manufactures and markets class-leading regenerative medicine products and medical devices for domestic and international markets. Xtant products serve the specialized needs of orthopedic and neurological surgeons, including orthobiologics for the promotion of bone healing, implants and instrumentation for the treatment of spinal disease, tissue grafts for the treatment of orthopedic disorders, and biologics to promote healing following cranial, and foot and ankle surgeries. With core competencies in both biologic and non-biologic surgical technologies, Xtant can leverage its resources to successfully compete in global neurological and orthopedic surgery markets. For further information, please visit www.xtantmedical.com.

About curasan AG

curasan develops, manufactures and markets biomaterials and medical devices in the field of bone and tissue regeneration, wound healing and osteoarthritis therapy. As a pioneer and global technology leader in the growing field of regenerative medicine, curasan is specialized primarily on biomimetic bone grafting materials for dental, oral/maxillofacial, orthopedic and spinal applications, i.e. materials mimicking biological structures. Numerous patents and a broad record of scientific publications demonstrate the clinical success of the products and the highly innovative strength of curasan. Dental and orthopaedic clinicians worldwide benefit from the broad range of the premium quality and easy to use portfolio offered by the technology leader curasan. curasan maintains its own high-tech facilities for research, development and manufacturing of biomaterials in Frankfurt/Main, Germany. In addition to its headquarters, the company has a subsidiary, CURASAN, Inc., in the Research Triangle Park area, near Raleigh, N.C., USA. curasan´s innovative products are cleared by the US Food and Drug Administration (FDA) and many other international authorities and available in almost 50 countries worldwide. curasan AG is a public company listed in the General Standard at the Frankfurt Stock Exchange.

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the ability to comply with covenants in the Company’s senior credit facility and to make deferred interest payments; the ability to maintain sufficient liquidity to fund operations; the ability to remain listed on the NYSE American; the ability to obtain financing on reasonable terms; the ability to increase revenue; the ability to continue as a going concern; the ability to maintain sufficient liquidity to fund operations; the ability to achieve expected results; the ability to remain competitive; government regulations; the ability to innovate and develop new products; the ability to obtain donor cadavers for products; the ability to engage and retain qualified technical personnel and members of the Company’s management team; the availability of Company facilities; government and third-party coverage and reimbursement for Company products; the ability to obtain regulatory approvals; the ability to successfully integrate recent and future business combinations or acquisitions; the ability to use net operating loss carry-forwards to offset future taxable income; the ability to deduct all or a portion of the interest payments on the notes for U.S. federal income tax purposes; the ability to service Company debt; product liability claims and other litigation to which we may be subjected; product recalls and defects; timing and results of clinical studies; the ability to obtain and protect Company intellectual property and proprietary rights; infringement and ownership of intellectual property; the ability to remain accredited with the American Association of Tissue Banks; influence by Company management; the ability to pay dividends; and the ability to issue preferred stock; and other factors.

Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

Investor Contact
CG CAPITAL
Rich Cockrell
877.889.1972
investorrelations@cg.capital

Company Contact
Xtant Medical
Molly Mason
mmason@xtantmedical.com

RTI Surgical® Announces 2017 Third Quarter Results

November 02, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, reported operating results for the third quarter, ended September 30, 2017.

RTI generated $66.7 million in revenue, driven by growth in the company’s spine, commercial and international businesses. Earnings for the third quarter totaled $16.5 million, which includes a $34.1 million gain from the sale of RTI’s Cardiothoracic closure business, which was announced on August 3, 2017.

“We believe our focus to reduce complexity, drive operational excellence and accelerate growth continued to support solid financial and operational progress during the most recent quarter,” said Camille Farhat, chief executive officer, RTI. “We delivered on our financial commitments while mobilizing across our organization to mitigate the impact of the recent hurricanes, which disrupted end-user demand across many of our markets and necessitated the closure of our Florida operations for several days.”

RTI estimates a permanent loss in excess of $1.2 million of product revenue during the quarter, due to the cancellation of procedures in regions impacted by the storms. The lost revenue in conjunction with facility closure cost impacted net income by approximately $0.5 million during the quarter. “RTI’s operating team’s response was outstanding,” Farhat said. “Stellar planning and collaboration across the organization minimized the disruption and ensured we could quickly resume operations and support our customers.”

During the quarter, three highly experienced executives were added to the leadership team: Jonathon Singer as chief financial & administrative officer, Olivier Visa as head of OEM, Donor Services and Sports franchises, and Julius Aviza as leader of the quality assurance function.

“Each has a long resume of success and, we believe, will play a key role in driving the execution of our strategic objectives. Our entire leadership team has quickly aligned around accelerating initiatives to reduce complexity and drive operational excellence toward those areas that we believe will have the greatest impact on earnings growth and cash generation over the next 12-18 months,” Farhat commented. “With my confidence that our leadership team is driving these initiatives, we will expand our effort to find new and better ways to serve our customers by enhancing our product portfolio and evaluating and pursuing strategic growth opportunities intended to capitalize on our strengths and enable us to take market leadership positions.”

Third Quarter 2017

RTI’s revenues for the third quarter of 2017 were $66.7 million, a slight increase from the prior year quarter revenues of $66.5 million. Third quarter revenues were driven by growth in spine, commercial and international, partially offset by a $1.6 million reduction from the sale of substantially all the assets of the Cardiothoracic closure business. In addition, RTI estimates that the impact of domestic hurricanes during the quarter reduced revenue by approximately $1.2 million due to cancellation of procedures. Gross profit for the third quarter of 2017 was $33.5 million, or 50.3% of revenue, compared to $34.3 million, or 51.5% of revenue in the third quarter of 2016. Gross margin was impacted adversely by approximately $0.9 million in the third quarter of 2017 due to the loss of revenue and the closure of RTI’s Florida facilities due to hurricanes during the period, and by $1.3 million due to the sale of the Cardiothoracic closure business.

During the third quarter of 2017, RTI completed the sale of substantially all the assets related to its Cardiothoracic closure business for total consideration of $54 million, plus an additional $6 million in contingent cash consideration. In conjunction with the sale of the Cardiothoracic closure business, the company recognized a gain of $34.1 million, or $18.2 million after-tax.

During the third quarter of 2017, RTI incurred $2.8 million in severance charges predominantly to support executive leadership transition and our efforts to enhance our strategic focus to reduce complexity and drive operational excellence.

Net income applicable to common shares was $16.5 million, or $0.23 per fully diluted common share in the third quarter of 2017, compared to a net loss applicable to common shares of $4.5 million, or $0.08 per fully diluted common share in the third quarter of 2016. As outlined in the reconciliation tables that follow, excluding the impact of the Cardiothoracic closure sale gain and severance charges in the third quarter of 2017, adjusted net income applicable to common shares was $0.4 million, or $0.01 per fully diluted common share in the third quarter of 2017.

Adjusted earnings before interest, taxes, depreciation and amortization (Adjusted EBITDA) of $8.1 million was comparable to the third quarter of 2016.

Fiscal 2017 Outlook

RTI has developed its guidance based on the company’s ongoing restructuring and operational improvement program, its current business profile and existing market conditions.

Within this context, based on third quarter 2017 results and the transition of the Cardiothoracic closure business from a direct business to a commercial business due to the sale, RTI continues to expect full year revenues for 2017 to be between $274 million and $280 million. Due primarily to the third quarter impact of the hurricanes, RTI has narrowed the guidance range for adjusted full year net income per fully diluted common share to be between $0.05 and $0.07 based on 61 million fully diluted shares outstanding when adjusted for non-recurring activity as detailed in the reconciliation provided below.

Conference Call

RTI will host a conference call and simultaneous audio webcast to discuss its third quarter 2017 results at 8:30 a.m. ET today. The conference call can be accessed by dialing (877) 383-7419. The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on the RTI website following the call.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory actions or approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Operations
(Unaudited, in thousands, except share and per share data)
For the Three Months Ended For the Nine Months Ended
September 30, September 30,
2017 2016 2017 2016
Revenues $ 66,688 $ 66,547 $ 208,747 $ 201,518
Costs of processing and distribution 33,177 32,273 102,494 97,270
Gross profit 33,511 34,274 106,253 104,248
Expenses:
Marketing, general and administrative 27,678 28,724 86,845 84,678
Research and development 2,801 3,789 10,229 12,034
Severance charges 2,820 328 10,623 1,039
Restructuring charges 1,107
Strategic review costs 650 650
CEO Retirement and transition costs 4,107 4,107
Contested proxy expenses 2,680
Gain on cardiothoracic closure business divestiture (34,090 ) (34,090 )
Total operating expenses (791 ) 37,598 73,607 106,295
Operating income (loss) 34,302 (3,324 ) 32,646 (2,047 )
Total other expense – net (681 ) (374 ) (2,470 ) (1,112 )
Income (loss) before income tax (provision) benefit 33,621 (3,698 ) 30,176 (3,159 )
Income tax (provision) benefit (16,135 ) 92 (16,251 ) (338 )
Net Income (loss) 17,486 (3,606 ) 13,925 (3,497 )
Convertible preferred dividend (938 ) (883 ) (2,772 ) (2,611 )
Net income (loss) applicable to common shares $ 16,548 $ (4,489 ) $ 11,153 $ (6,108 )
Net income (loss) per common share – basic $ 0.28 $ (0.08 ) $ 0.19 $ (0.10 )
Net income (loss) per common share – diluted $ 0.23 $ (0.08 ) $ 0.19 $ (0.10 )
Weighted average shares outstanding – basic 59,704,533 58,353,110 59,045,372 58,173,580
Weighted average shares outstanding – diluted 75,188,161 58,353,110 59,954,964 58,173,580
RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of Net Income (Loss) Applicable to Commons Shares to Adjusted EBITDA
(Unaudited, in thousands)
For the Three Months For the Nine Months
Ended September 30, Ended September 30,
2017 2016 2017 2016
Net income (loss) $ 16,548 $ (4,489 ) $ 11,153 $ (6,108 )
Interest expense, net 741 307 2,475 1,053
Provision (benefit) for income taxes 16,135 (92 ) 16,251 338
Depreciation 2,623 3,459 7,947 10,295
Amortization of intangible assets 952 934 2,757 2,792
EBITDA 36,999 119 40,583 8,370
Reconciling items for Adjusted EBITDA
Preferred dividend 938 883 2,772 2,611
Non-cash stock based compensation 2,305 1,975 4,113 3,075
Foreign exchange (gain) loss (60 ) 67 (5 ) 59
Other reconciling items(1)
Severance charges excluding stock based compensation 2,000 328 9,470 1,039
Restructuring charges 1,107
Strategic review costs 650 650
CEO Retirement and transition costs 4,107 4,107
Contested proxy expenses 2,680
Gain on cardiothoracic closure business divestiture (34,090 ) (34,090 )
Adjusted EBITDA $ 8,092 $ 8,129 $ 22,843 $ 23,698
Adjusted EBITDA as a percent of revenues 12 % 12 % 11 % 12 %

(1) See explanations in Use of Non-GAAP Financial Measures section later in this release.

RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of Net Income (Loss) Applicable to Common Shares and Net Income (Loss) Per Diluted Share to
Adjusted Net Income Applicable to Common Shares and Adjusted Net Income Per Diluted Share
(Unaudited, in thousands, except per share data)
For the Three Months Ended
September 30, 2017 September 30, 2016
Net Net
Income Amount Income Amount
Applicable to per Diluted Applicable to per Diluted
Common Shares Share Common Shares Share
As reported $ 16,548 $ 0.23 $ (4,489 ) $ (0.08 )
Severance charges 2,820 0.04 328 0.01
Strategic review costs 650 0.01
CEO Retirement and transition costs 4,107 0.07
European net operating loss valuation reserve 1,224 0.02
Gain on cardiothoracic closure business divestiture (34,090 ) (0.45 )
Tax effect on adjustments 15,159 0.20 (1,773 ) (0.03 )
Adjusted * $ 437 $ 0.01 $ 47 $ 0.00
For the Nine Months Ended
September 30, 2017 September 30, 2016
Net Net
Income Amount Income Amount
Applicable to per Diluted Applicable to per Diluted
Common Shares Share Common Shares Share
As reported $ 11,153 $ 0.19 $ (6,108 ) $ (0.10 )
Severance charges 10,623 0.18 1,039 0.02
Restructuring charges 1,107 0.02
Strategic review costs 650 0.01
CEO Retirement and transition costs 4,107 0.07
Contested proxy expenses 2,680 0.05
European net operating loss valuation reserve 1,224 0.02
Gain on cardiothoracic closure business divestiture (34,090 ) (0.57 )
Tax effect on adjustments 13,855 0.23 (3,128 ) (0.05 )
Adjusted * $ 1,541 $ 0.03 $ 1,571 $ 0.03
* See explanations in Use of Non-GAAP Financial Measures section later in this release.
Amount Per Diluted Share may not foot due to rounding.

Fiscal 2017 Outlook

Full year net income per fully diluted common share is expected to be in the range of $0.21 to $0.23, based on 61 million fully diluted shares outstanding. Excluding severance charges and the gain from the sale of the Company’s Cardiothoracic closure business taken in 2017, full year net income per fully diluted common share is expected to be in the range of $0.05 to $0.07.

RTI SURGICAL, INC. AND SUBSIDIARIES
Reconciliation of GAAP Guidance Net Income Per Common Share – Diluted to
Adjusted Non-GAAP Guidance Net Income Per Common Share – Diluted
(Unaudited)
Twelve Months Ended
December 31, 2017
$ Amount
Per Common
Share – Diluted
GAAP Guidance Net Income Per Common Share – Diluted $ 0.21 – 0.23
Severance charges, net of tax effect 0.14
Gain on Cardiothoracic closure business divestiture, net of tax effect (0.30 )
Adjusted Non-GAAP Guidance Net Income Per Common Share – Diluted $ 0.05 – 0.07

Use of Non-GAAP Financial Measures

To supplement the Company’s unaudited condensed consolidated financial statements presented on a GAAP basis, the Company discloses certain non-GAAP financial measures that exclude certain amounts, including EBITDA, Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share – Diluted. The calculation of the tax effect on the adjustments between GAAP net (loss) income applicable to common shares and non-GAAP net income applicable to common shares is based upon our estimated annual GAAP tax rate, adjusted to account for items excluded from GAAP net (loss) income applicable to common shares in calculating Adjusted Net Income Applicable to Common Shares-Diluted. A reconciliation of the non-GAAP financial measures to the corresponding GAAP measures is included in the tables listed above.

The following is an explanation of the adjustments that management excluded as part of adjusted measures for the three and nine month periods ended September 30, 2017 and 2016 as well as the reason for excluding the individual items:

Severance charges – This adjustment represents charges relating to the termination of former employees. Management removes the amount of these costs from our operating results to supplement a comparison to our past operating performance.

Restructuring charges – This adjustment represents the closure of our French distribution and tissue procurement office. Management removes the amount of these costs from our operating results to supplement a comparison to our past operating performance.

Strategic review costs – This adjustment represents charges relating to a comprehensive strategic review of the Company’s business lines and operations intended to leverage the Company’s expertise, technology and products and identify opportunities to increase stockholder value. Management removes the amount of these expenses from our operating results to supplement a comparison to our past operating performance.

CEO Retirement and transition costs – This adjustment represents charges relating to the retirement of our former Chief Executive Officer, and the resulting financial impact of such resignation under the Executive Transition Agreement dated August 29, 2012 and Executive Separation Agreement dated August 15, 2016. Management removes the amount of these expenses from our operating results to supplement a comparison to our past operating performance.

Contested proxy expenses – This adjustment represents charges relating to contested proxy expenses. Management removes the amount of these costs from our operating results to supplement a comparison to our past operating performance.

Gain on Cardiothoracic closure business divestiture – This adjustment represents the gain relating to the sale of substantially all the assets of our Cardiothoracic closure business to A&E. Management removes the amount of this gain from our operating results to supplement a comparison to our past operating performance.

Material Limitations Associated with the Use of Non-GAAP Financial Measures

EBITDA, Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share – Diluted should not be considered in isolation, or as a replacement for GAAP measures.

Usefulness of Non-GAAP Financial Measures to Investors

The Company believes that presenting EBITDA, Adjusted EBITDA, Adjusted Net Income Applicable to Common Shares and Adjusted Net Income per Common Share – Diluted in addition to the related GAAP measures provide investors greater transparency to the information used by management in its financial decision-making. The Company further believes that providing this information better enables the Company’s investors to understand the Company’s overall core performance and to evaluate the methodology used by management to assess and measure such performance.

RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Revenues
(Unaudited, in thousands)
For the Three Months Ended For the Nine Months Ended
September 30, September 30,
2017 2016 2017 2016
Revenues:
Spine $ 18,131 $ 17,775 $ 57,888 $ 52,514
Sports medicine and orthopedics 11,286 11,874 37,179 36,956
Surgical specialties 1,437 1,168 4,673 2,985
Cardiothoracic 1,340 2,893 8,164 8,332
International 5,077 4,352 16,739 15,532
Subtotal direct 37,271 38,062 124,643 116,319
Global commercial 26,807 25,297 76,225 75,396
Other revenues 2,610 3,188 7,879 9,803
Total revenues $ 66,688 $ 66,547 $ 208,747 $ 201,518
RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Balance Sheets
(Unaudited, in thousands)
September 30, December 31,
2017 2016
Assets
Cash and cash equivalents $ 17,744 $ 13,849
Accounts receivable – net 36,188 41,488
Inventories – net 114,568 119,743
Prepaid and other current assets 9,806 5,213
Assets held for sale 1,750
Total current assets 180,056 180,293
Property, plant and equipment – net 82,794 83,298
Goodwill 46,242 54,887
Other assets – net 44,190 49,553
Total assets $ 353,282 $ 368,031
Liabilities and Stockholders’ Equity
Accounts payable $ 24,445 $ 26,112
Accrued expenses and other current liabilities 25,275 26,772
Current portion of long-term obligations 4,268 6,080
Total current liabilities 53,988 58,964
Deferred revenue 4,959 6,612
Long-term liabilities 47,787 77,523
Total liabilities 106,734 143,099
Preferred stock, including accrued dividends 62,925 60,016
Stockholders’ equity:
Common stock and additional paid-in capital 419,505 416,570
Accumulated other comprehensive loss (6,469 ) (8,316 )
Accumulated deficit (229,413 ) (243,338 )
Total stockholders’ equity 183,623 164,916
Total liabilities and stockholders’ equity $ 353,282 $ 368,031
RTI SURGICAL, INC. AND SUBSIDIARIES
Condensed Consolidated Statements of Cash Flows
(Unaudited, in thousands)
For the Three Months For the Nine Months
Ended September 30, Ended September 30,
2017 2016 2017 2016
Cash flows from operating activities:
Net income (loss) $ 17,486 $ (3,606 ) $ 13,925 $ (3,497 )
Adjustments to reconcile net income (loss) to net cash
(used in) provided by operating activities:
Depreciation and amortization expense 3,575 4,393 10,704 13,087
Stock-based compensation 2,203 1,975 4,011 3,075
Amortization of deferred revenue (1,141 ) (1,216 ) (3,601 ) (3,650 )
Gain on cardiothoracic closure business divestiture (34,090 ) (34,090 )
Other items to reconcile to net cash
provided by operating activities (1,504 ) (4,721 ) 6,193 1,019
Net cash (used in) provided by operating activities (13,471 ) (3,175 ) (2,858 ) 10,034
Cash flows from investing activities:
Purchases of property, plant and equipment (3,198 ) (3,371 ) (10,358 ) (12,774 )
Patent and acquired intangible asset costs (279 ) (804 ) (2,124 ) (2,195 )
Cardiothoracic closure business divestiture 51,000 51,000
Net cash provided by (used in) investing activities 47,523 (4,175 ) 38,518 (14,969 )
Cash flows from financing activities:
Proceeds from long-term obligations 2,000 8,000 6,000 15,000
Net payments from short-term obligations (662 ) (1,511 )
Payments on long-term obligations (32,000 ) (1,125 ) (39,375 ) (9,424 )
Other financing activities (18 ) 1,415 (94 )
Net cash (used in) provided by financing activities (30,018 ) 6,213 (31,960 ) 3,971
Effect of exchange rate changes on cash and cash equivalents 35 7 195 (26 )
Net increase (decrease) in cash and cash equivalents 4,069 (1,130 ) 3,895 (990 )
Cash and cash equivalents, beginning of period 13,675 12,754 13,849 12,614
Cash and cash equivalents, end of period $ 17,744 $ 11,624 $ 17,744 $ 11,624

Contacts

RTI Surgical Inc.
Jonathon Singer
Chief Financial & Administrative Officer
jsinger@rtix.com
or
Roxane Wergin
Director, Corporate Communications
rwergin@rtix.com
386-418-8888

Zimmer Biomet Reports Third Quarter 2017 Financial Results

WARSAW, Ind.Nov. 1, 2017 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results for the quarter ended September 30, 2017.  The Company reported third quarter net sales of $1.818 billion, a decrease of 0.8% from the prior year period, and a decrease of 1.2% on a constant currency basis.  Excluding approximately 30 basis points of contribution from the LDR Holding Corporation acquisition, third quarter 2017 revenues decreased 1.1% from the third quarter of 2016, or 1.5% on a constant currency basis.

Diluted earnings per share for the quarter were $0.48, a decrease of 38.5% from the prior year period.  Adjusted diluted earnings per share for the quarter were $1.72, a decrease of 3.9% from the prior year period.

“Our top line results remained challenged during the third quarter, due to the pace of supply recovery of certain key brands, as well as softened domestic market conditions and slower than anticipated sales recapture, particularly in the United States,” said Daniel P. Florin, Interim Chief Executive Officer, Senior Vice President and Chief Financial Officer of Zimmer Biomet.  “While we are not satisfied with our overall performance during the quarter, we remain confident in the Company’s dedicated sales forces, the breadth of our portfolio and our strategic innovation pipeline.  Looking forward, our global teams will continue to make progress towards increasing supply availability and enabling commercial execution, which we expect will translate into accelerated sales growth.”

Net earnings for the third quarter were $98.8 million, a decrease of 37.8% from the prior year period, and $349.9 million on an adjusted basis, a decrease of 3.4% from the prior year period.  Operating cash flow for the third quarter was $455.1 million.

In the quarter, the Company paid $48.5 million in dividends and declared a third quarter dividend of $0.24 per share.  The Company has repaid approximately $950 million of debt year-to-date in 2017.

Guidance

The Company is updating its full-year 2017 constant currency revenue and adjusted earnings per share guidance.  For the full year, the Company now expects revenue in the range of $7.76 billion to $7.80 billion, representing growth of 1.0% to 1.5% compared to the prior year and constant currency revenue growth of 0.9% to 1.4% compared to the prior year, inclusive of approximately 120 basis points of contribution from the LDR transaction.  Previously, the Company had expected full-year, constant currency revenue growth between 1.8% and 2.7%, inclusive of approximately 120 basis points of contribution from the LDR transaction.  Additionally, the Company now expects its full-year 2017 diluted earnings per share to be in a range of $3.80 to $3.93, and in a range of $8.01 to $8.07 on an adjusted basis.  Previously, the Company had expected full-year 2017 diluted earnings per share to be in a range of $4.15 to $4.35, and in a range of $8.20 to $8.30 on an adjusted basis.

For the fourth quarter of 2017, the Company expects revenue in the range of $2.01 billion to $2.05 billion, representing growth of 0% to positive 2.0% compared to the prior year period and constant currency revenue growth of negative 1.8% to positive 0.2% compared to the prior year period.  Additionally, the Company expects its diluted earnings per share for the fourth quarter to be in a range of $0.94 to $1.08, and in a range of $2.08 to $2.14 on an adjusted basis.

Conference Call and Earnings Release Information

The Company will conduct its third quarter 2017 investor conference call today, November 1, 2017 at 8:00 a.m. Eastern Time.  The audio webcast and earnings release information, including the Company’s third quarter investor presentation, can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com.  The audio webcast will be archived for replay following the conference call.

Individuals in the U.S. and Canada who wish to dial into the conference call may do so by dialing (888) 312-9837 and entering conference ID 7278985.  For a complete listing of international toll-free and local numbers, please visit http://investor.zimmerbiomet.com.  A digital recording will be available 24 hours after the completion of the conference call, from November 2, 2017 to December 1, 2017.  To access the recording, U.S. callers should dial (888) 203-1112 and international callers should dial +1 (719) 457-0820, and enter the Access Code ID 7278985.

Sales Tables

The following sales tables provide results by geography and product category, as well as the percentage change compared to the prior year quarter and nine months, on both a reported and a constant currency basis.

NET SALES – THREE MONTHS ENDED SEPTEMBER 30, 2017

(in millions, unaudited)

Constant

Net

Currency

Sales

% Change

% Change

Geographic Results

Americas

$

1,142

(2.9)

%

(3.0)

%

EMEA

381

3.3

(0.4)

Asia Pacific

295

2.4

5.2

Total

$

1,818

(0.8)

%

(1.2)

%

Product Categories

Knees

Americas

$

383

(3.8)

%

(3.9)

%

EMEA

135

3.7

0.6

Asia Pacific

106

2.3

3.9

Total

624

(1.2)

(1.7)

Hips

Americas

228

(4.5)

(4.7)

EMEA

115

2.4

(1.5)

Asia Pacific

91

2.1

6.1

Total

434

(1.4)

(1.7)

S.E.T (1)

407

1.2

1.1

Dental

93

(3.2)

(4.4)

Spine & CMF

185

0.7

0.3

Other

75

(4.8)

(5.3)

Total

$

1,818

(0.8)

%

(1.2)

%

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

NET SALES – NINE MONTHS ENDED SEPTEMBER 30, 2017

(in millions, unaudited)

Constant

Net

Currency

Sales

% Change

% Change

Geographic Results

Americas

$

3,586

1.5

%

1.4

%

EMEA

1,272

(1.0)

0.4

Asia Pacific

892

4.8

6.0

Total

$

5,750

1.4

%

1.8

%

Product Categories

Knees

Americas

$

1,217

(2.2)

%

(2.2)

%

EMEA

463

(2.2)

(0.1)

Asia Pacific

326

3.5

3.8

Total

2,006

(1.3)

(0.8)

Hips

Americas

$

720

(1.9)

(1.9)

EMEA

382

(1.5)

(0.6)

Asia Pacific

278

5.3

7.2

Total

1,380

(0.4)

0.2

S.E.T (1)

1,255

3.3

3.7

Dental

311

(3.5)

(3.4)

Spine & CMF

565

20.1

20.1

Other

233

(4.9)

(4.5)

Total

$

5,750

1.4

%

1.8

%

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

About the Company

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

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

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

Website Information

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

Note on Non-GAAP Financial Measures

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

Sales change information for the three- and nine-month periods ended September 30, 2017 is presented on a GAAP (reported) basis and on a constant currency basis, as well as on a basis that excludes the contribution from the Company’s acquisition of LDR Holding Corporation in July 2016.  Projected revenue change information is also presented on a GAAP basis and on a constant currency basis.  Constant currency rates exclude the effects of foreign currency exchange rates.  They are calculated by translating current and prior-period sales at the same predetermined exchange rate.  The translated results are then used to determine year-over-year percentage increases or decreases.  Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP measures are included in this press release.

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

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

Cautionary Statement Regarding Forward-Looking Statements

This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding sales and earnings guidance and any statements about our expectations, plans, strategies or prospects.  We generally use the words “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “assumes,” “guides,” “targets,” “forecasts,” “sees,” “seeks,” “should,” “could,” “intends” and similar expressions to identify forward-looking statements.  Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  These risks, uncertainties and changes in circumstances include, but are not limited to: our chief executive officer transition, including disruptions and uncertainties related thereto, our ability to appoint a permanent successor with the desired level of experience and expertise in a timely manner, the potential impact on our business and future strategic direction resulting from our transition to a new chief executive officer, and our ability to retain other key members of senior management; the possibility that the anticipated synergies and other benefits from mergers and acquisitions will not be realized, or will not be realized within the expected time periods; the risks and uncertainties related to our ability to successfully integrate the operations, products, employees and distributors of acquired companies; the effect of the potential disruption of management’s attention from ongoing business operations due to integration matters related to mergers and acquisitions; the effect of mergers and acquisitions on our relationships with customers, vendors and lenders and on our operating results and businesses generally; compliance with the Deferred Prosecution Agreement entered into in January 2017; the success of our quality and operational excellence initiatives, including ongoing quality enhancement and remediation efforts at the legacy Biomet Warsaw facility; challenges relating to changes in and compliance with governmental laws and regulations affecting our U.S. and international businesses, including regulations of the U.S. Food and Drug Administration (FDA) and foreign government regulators, such as more stringent requirements for regulatory clearance of products; the ability to remediate matters identified in any inspectional observations or warning letters issued by the FDA, while continuing to satisfy the demand for our products; the outcome of government investigations; competition; pricing pressures; changes in customer demand for our products and services caused by demographic changes or other factors; the impact of healthcare reform measures; reductions in reimbursement levels by third-party payors and cost containment efforts of healthcare purchasing organizations; dependence on new product development, technological advances and innovation; shifts in the product category or regional sales mix of our products and services; supply and prices of raw materials and products; control of costs and expenses; the ability to obtain and maintain adequate intellectual property protection; the ability to form and implement alliances; changes in tax obligations arising from tax reform measures, including European Union rules on state aid, or examinations by tax authorities; product liability and intellectual property litigation losses; the ability to retain the independent agents and distributors who market our products; dependence on a limited number of suppliers for key raw materials and outsourced activities; changes in general industry and market conditions, including domestic and international growth rates; changes in general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; and the impact of the ongoing financial and political uncertainty on countries in the Euro zone on the ability to collect accounts receivable in affected countries.  For a further list and description of such risks and uncertainties, see our reports filed with the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2016 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2017.  Copies of these filings, as well as subsequent filings, are available online at www.sec.govwww.zimmerbiomet.com or on request from us.  Forward-looking statements speak only as of the date they are made, and we disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release.

ZIMMER BIOMET HOLDINGS, INC.

CONSOLIDATED STATEMENTS OF EARNINGS

FOR THE THREE MONTHS ENDED SEPTEMBER 30, 2017 and 2016

(in millions, except per share amounts, unaudited)

2017

2016

Net Sales

$

1,818.1

$

1,832.8

Cost of products sold, excluding intangible asset amortization

500.9

479.3

Intangible asset amortization

152.7

164.3

Research and development

91.2

95.6

Selling, general and administrative

694.5

727.7

Special items

165.4

170.4

Operating expenses

1,604.7

1,637.3

Operating Profit

213.4

195.5

Other expense, net

(4.5)

(1.1)

Interest income

0.6

0.6

Interest expense

(82.3)

(91.5)

Earnings before income taxes

127.2

103.5

Provision (benefit) for income taxes

28.4

(54.4)

Net Earnings

98.8

157.9

Less: Net Loss attributable to noncontrolling interest

(0.9)

Net Earnings of Zimmer Biomet Holdings, Inc.

$

98.8

$

158.8

Earnings Per Common Share

Basic

$

0.49

$

0.79

Diluted

$

0.48

$

0.78

Weighted Average Common Shares Outstanding

Basic

202.3

200.1

Diluted

204.0

202.9

Cash Dividends Declared Per Common Share

$

0.24

$

0.24

 

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SeaSpine Announces Limited Commercial Launch of OsteoStrand™ Demineralized Bone Fibers

CARLSBAD, Calif., Nov. 01, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, today announced the limited commercial launch and completion of initial surgeries for its OsteoStrand™ Demineralized Bone Fibers. The first implantations were completed by Dr. Khalid Abbed, Vice Chair of Neuro Surgery and Director of Minimally Invasive Spine Surgery at Yale School of Medicine and orthopedic spine surgeon Michael W. Cluck, M.D., PhD, at the Bay Area Spine Care in San Jose, CA.

OsteoStrand fibers are the latest innovation in SeaSpine’s demineralized bone matrix (DBM) product family, which facilitate and aid in fusion.  OsteoStrand fibers provide 100% demineralized bone fibers to maximize the osteoinductive content while providing a vastly improved conductive matrix.  These fibers were developed through a disciplined R&D process that evaluated a variety of fiber geometries to deliver intraoperative handling and controlled expansion, to facilitate surgical placement, to maintain surgical position and to allow the fibers to better fill the surgical defect with the overriding goal to improve fusion potential.

“The handling properties of OsteoStrand Demineralized Bone Fibers are excellent; it is easily compressible and expands to fill the surgical defect upon implantation,” said Dr. Cluck. “The handling and 100% demineralized bone composition give me a high level of confidence for my fusion procedures.”

Dr. Khalid Abbed added, “The handling properties of OsteoStrand Demineralized Bone Fibers are excellent, and improved compared to other 100% DBM products that I have used in my practice. I believe this tissue product could lead to significant cost savings for my hospital and I look forward to evaluating the OsteoStrand Plus with Accell Bone Matrix.”

“OsteoStrand fibers will serve as a development platform for continued innovation in our orthobiologics portfolio and will further strengthen our top-three position in the U.S. DBM market while also providing operational leverage through our Irvine manufacturing facility,” said Keith Valentine, Chief Executive Officer and President of SeaSpine.  “We plan to launch the OsteoStrand Plus Demineralized Bone Fibers with our proprietary Accell™ Bone Matrix on a limited basis in early 2018.  We believe these product offerings deliver clinical value as payors and hospitals seek more cost effective orthobiologic solutions.”

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 implant 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 fusion hardware product development helps SeaSpine to offer its surgeon customers 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 potential benefits of the OsteoStrand Demineralized Bone Fibers product, including to improve fusion; the ability of the OsteoStrand Demineralized Bone Fibers to strengthen SeaSpine’s top-three position in the U.S. DBM market and provide operational leverage; the timing of launch of the OsteoStrand Plus Demineralized Bone Fibers product in early 2018; and the potential for new product offerings to clinical value to payors and hospitals.  Among the factors that could cause or contribute to material differences between our actual results and the expectations indicated by our forward-looking statements are risks and uncertainties that include, but are not limited to: the ability of newly launched products to perform as designed and intended and to meet the clinical needs of surgeons and patients; the limited clinical experience supporting the commercial launch of new products and the risk that such products may require substantial additional development activities, which could introduce unexpected expense and delay; the lack of long-term clinical data supporting the safety and efficacy of the Company’s products; and other risks and uncertainties more fully described in our 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
(415) 937-5402
ir@seaspine.com

New Studies Look At Cost And Benefits Of Robotic Surgery

As robotics in medicine becomes more widely adopted, two new studies look at the cost and advantages and disadvantages of robotic surgery versus freehand surgery.

University of Stanford researchers conducted a multiyear analysis and study with 24,000 patients with kidney cancer who needed laparoscopic surgery to remove a patient’s kidney indicated that the two approaches had comparable patient outcomes and hospital stays. Researchers analyzed data from 416 hospitals across the country from 2003 to 2015 for the study.

Robotic-assisted laparoscopic procedures have increased since 2015 and surpassed conventional laparoscopic procedures according to Dr. Benjamin Chung, Associate Professor of Urology at the University of Stanford. Dr. Chung said in a press release that although there was no statistical difference in outcome or length of hospital stay, the robotic-assisted surgeries cost more and had a higher probability of prolonged operative time. Over the 13-year period of Stanford study, robotic surgeries cost on average $2,700 more per patient.

Mazor Robotics, a publicly-traded Israeli company that makes robotic guidance systems for spine and brain surgeries, conducted a small controlled study on the use of robotic-guided spine surgery with 379 patients. These results and the remaining data from the study, collected by 10 surgeons from nine states indicated that relative risk for a complication was 5.3 times higher in fluoro-guided surgeries compared to the robotic guidance; and relative risk for revision surgery was 7.1 times higher for a fluoro-guided surgery compared to the robotic guided cases.

“We believe the study takes a significant step forward in shifting the conversation of whether robotics have a place in the spine operating room,” said Ori Hadomi, CEO, Mazor Robotics.

 

 

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Corin completes Joint Venture Agreement with Ossis to deliver life-changing personalised reconstructive solutions

Corin, a global orthopaedic manufacturer and leader in functional implant positioning has announced a joint venture agreement with Ossis, a New Zealand-based implant maker. With more than 15 years clinical history Ossis is one of the leaders in design and manufacturing of personalised solutions for complex revision surgery and tumour resection.

Since 2007 Ossis has used advanced technologies to custom design and manufacture titanium bone and joint implants with over 200 successful implantations to date worldwide. Corin has recently developed an advanced 3D printing technology to manufacture their upcoming revision hip acetabular solution Trinity Plus™. The two companies are now partnering to provide the same cutting-edge technology for customised implants.

“With Corin’s portfolio we are able to provide personalised hip and knee solutions from bone preserving primary implants to revisions. Through this agreement we will extend our ability to support surgeons in the treatment of patients that require massive reconstruction” said Stefano Alfonsi, Chief Executive Officer of Corin. “The objective is to combine the long experience of Ossis in custom-made implants with our connected information infrastructure to improve surgeons’ abilities to perform these life-changing procedures worldwide”.

Ossis Managing Director Paul Morrison said “Communication, lead-time, and accuracy are all considered the enemy of a successful outcome for customised implants. Corin has several technology platforms that will complement and enhance the Ossis Custom Implant Service. We see this as an exceptional opportunity for those surgeons who consider custom implants the best option for their patient’s future quality of life.”

The joint venture with Ossis represents another important milestone for Corin in the creation of an interconnected network of technologies to provide solutions that maximises value for patients, surgeons and healthcare providers.

For more information, visit www.coringroup.com.

About Ossis

Ossis is Australasia’s only ISO 13485 certified medical technology company, dedicated to the design and manufacture of Patient Specific Custom Implants. We offer over 15 years of clinical experience and expertise to our customers, helping them protect, restore or improve their patient’s long-term mobility.

Our team of engineers are recognised, not only for the quality and effectiveness of our products, but also for the high level of support we provide to our customers.  Great results are achieved through a combination of a good anatomical understanding and listening to our surgeons. We aspire to be recognised as a leader in the design and manufacture of custom orthopaedic implants.

Maxx Orthopedics Announces First International Surgeries of its Freedom® PCK Revision System

Ahead of the AAHKS 2017 Annual Meeting this week in Dallas, TX, Maxx Orthopedics, Inc., today announced that the Freedom® PCK Revision System has now been made available globally, with the first surgeries performed in India and several Gulf countries, including Oman and the United Arab Emirates.

The Freedom PCK Revision System combines the Freedom Stemmed Tibial components with the patent-pending PCK femoral components and constrained liners, to create one of the most bone conserving, versatile revision knee systems available on the market. Designed in collaboration with a global surgeon team, the PCK Revision System has been available for use in the United States since early 2016.

The first case in India was performed by Dr. Hemant Wakankar at Max Elite Hospital in Chandigarh. “The design of the PCK is exceptional and its features are particularly well suited for my patients. I believe they will have better range of motion even after a revision surgery because of this unique progressive constraint system. It gives me the opportunity to provide better results for my patients,” said Dr. Wakankar.

Dr. Carl Becker, a leading surgeon at Penn Medicine’s Lancaster General Hospital in Lancaster, PA, is one of the key design surgeons for the PCK, and has traveled internationally for peer-to-peer discussions on the system.  “I have had the pleasure of working with Maxx’s global team to help design a revision implant which delivers significant benefits for the surgeon and patient. Furthermore, our instruments make the surgery intuitive, and I am excited that this solution is now being offered to my colleagues all over the world.”

“Our team is thrilled by the early clinical success of this system and we are excited to continue our global rollout. The PCK is a revision knee designed with the needs of today’s patients AND today’s economic realities in mind. It’s smart innovation, and this has become a hallmark for our company,” said Ashesh Shah, CEO of Maxx Orthopedics.

For more information please visit http://maxxmed.com.

About Maxx Medical Maxx Medical Pvt. Ltd. (“Maxx Medical”) develops and markets innovative orthopedic medical devices on an international scale. The company is focused on providing state-of-the-art implants and related solutions that best restore patient mobility while accommodating lifestyle, anatomical and economic needs. Maxx Medical is the parent company of Maxx Orthopedics, Inc., the manufacturer of the Freedom Knee® System.

Consensus Orthopedics launches TracPatch Australia at the Australian AOA meeting in partnership with CUER

Consensus Orthopedics, developer of the latest wearable technology, TracPatch™, has partnered with Neil Thomas and Peter Mackie of CUER, who have come together to cofound TracPatch Australia to distribute this wearable technology throughout Australia and New Zealand. The Australian market is in need of a device that will allow healthcare providers the ability to plan and monitor their patients’ orthopedic recovery. TracPatch can also be applied in ethics studies related to total knee replacements and in conjunction with sports injury reconstruction surgery.

Michael T. Droege, Vice President of Global Business Development, says “Just the idea that both Peter Mackie and Neil Thomas have collaborated together to put all of their career experiences to create TracPatch Australia is an amazing opportunity. We are extremely fortunate to have them as part of our global TracPatch team.”

TracPatch™ is revolutionizing evidence-based surgical care management in orthopedics. The changing dynamics of healthcare has called for transforming patient care through connected health solutions. TracPatch is a cutting-edge remote monitoring device designed to make recovering at home easily accessible, connected, and more predictable. The development of TracPatch, with its availability worldwide, will revolutionize the way data-capturing is used in orthopedics. Surgeons and healthcare providers will be able to monitor their patients in real time during the post-acute care period following surgery. Through data collection, monitoring, and analysis, TracPatch™ ensures patients will receive effective care based on their individual needs.

TracPatch Australia will be the official Australia and New Zealand distributor. TracPatch Australia aims to develop business opportunities throughout the Oceania region. Together, Consensus Orthopedics and Tracpatch Australia presented TracPatch at the Australian Orthopedic Association Annual Scientific Meeting on 8-12 October 2017. TracPatch was well received to the international audience as an exceptional solution to post-surgical monitoring in orthopedics and as a market leader in Australia.

Neil Thomas, Business Development Manager at CUER, says “The need for not only remote monitoring of patients but of evidence based care management makes TracPatch a truly unique product. Australia is ready for an innovative way to create new care standards in orthopedics and TracPatch can help alleviate costs and unnecessary burdens to our healthcare system.”

Peter Mackie, Principle at CUER, states “TracPatch can dramatically shift how healthcare providers approach total joint surgeries in the future. Being able to monitor your patients and proactively get ahead of potential issues involved during a post-acute care period is a tremendous advantage. We are excited to be offering this new product to all Australian healthcare providers and we are looking forward to the future of orthopedics.”

For more Information on Tracpatch Australia please contact Neil Thomas at neil.thomas@cuer.com.au

About Consensus® Orthopedics, Inc.
Consensus Orthopedics was founded in 1992 as a medical device consulting company located in California. In 1996, Consensus Orthopedics acquired US Medical Products becoming a global manufacturer of reliable large joint orthopedic devices. Since 1996, Consensus Orthopedics has been providing the orthopedic industry with exceptional hip and knee joint replacement devices. Its signature knee system, the Consensus Knee System, has over 20 years of reliable and reproducible results. With a deep understanding of the orthopedic industry, Consensus launched its innovative TracPatch Technology division focusing on orthopedic wearable technology, which combines Consensus Orthopedics 25 years of orthopedic experience with innovative Big Data capabilities. TracPatch is a revolutionary new device empowering at-home patient recovery and remote monitoring for effective managed care. With a focus on evidence based medicine, Consensus Orthopedics is changing patient care and the future of orthopedics. Learn more at http://www.consensusortho.com.

About CUER Australia
CUER is a well connected and highly motivated company determined to be the market leaders in wearable technology in Australasia. CUER was founded with the purpose of developing business opportunities and sourcing new devices that are at the cutting edge of technology.