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

 

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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K2M Group Holdings, Inc. Reports Third Quarter 2017 Financial Results

LEESBURG, Va., Nov. 01, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance™, today reported financial results for its third fiscal quarter ended September 30, 2017.

Third Quarter 2017 Financial Summary:

  • Total Q3 revenue of $62.7 million, up 6% year-over-year on a reported basis and 5% on a constant currency basis
  • Domestic Q3 revenue of $48.5 million, up 5% year-over-year, comprised of:
    • U.S. Complex Spine growth of 3% year-over-year
    • U.S. Minimally Invasive Surgery (MIS) growth of 14% year-over-year
    • U.S. Degenerative growth of 5% year-over-year
  • International Q3 revenue of  $14.2 million, up 6% year-over-year, or 5% on a constant currency basis.
  • Net loss of $8.5 million for the three months ended September 30, 2017, compared to a net loss of $7.9 million in the comparable period last year.
  • Adjusted EBITDA of $0.9 million for the three months ended September 30, 2017, compared to Adjusted EBITDA of $2.8 million in the comparable period last year.

Third Quarter Product Introductions:

  • On July 6, 2017, the Company announced that its NILE® Proximal Fixation Spinal System, a spinal system specifically designed for proximal construct augmentation, received 510(k) clearance from the U.S. Food & Drug Administration (FDA) and a CE Mark.
  • On September 14, 2017, the Company announced the global launch of the EVEREST® Minimally Invasive (MI) XTower®instrumentation—an enhancement to the EVEREST MI XT Spinal System.
  • On September 29, 2017, the Company announced that it received 510(k) clearance from FDA for its YUKON OCT Spinal System.

Recent Strategic Highlights:

  • On July 10, 2017, the Company announced the signing of a new, long-term, exclusive agreement with Mitsubishi Corporation subsidiary Japan Medicalnext Co., Ltd., a wholly-owned entity of MC Healthcare, Inc. and a prominent supplier of medical devices in Japan, for the distribution of K2M’s innovative spinal technologies.
  • On August 3, 2017, the Company announced that it had acquired the exclusive license to a portfolio of 17 issued and pending patents for expandable interbody technology.
  • 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 will assume 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 24, 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.

“Our revenue results for the third quarter of 2017 reflect total revenue growth of 6% year-over-year on a GAAP basis and 5% on a constant currency basis,” said Chairman, President and Chief Executive Officer, Eric Major. “Although we continued to see growth, our third quarter revenue performance was impacted by slower initial on-boarding of the new distribution team in the U.S., disruption of account activity and canceled procedures related to the hurricanes in Texas, Florida and Puerto Rico in early September.  Third quarter deformity trends were strong in July and August and we experienced strong headwinds in September. U.S. sales growth in our degenerative procedure category continued to be fueled by our new product introductions including our industry-leading 3D-printed portfolio, offset partially by modestly weaker procedure volumes as compared to last year.”

Major continued, “We have made significant progress in 2017 toward our goal of introducing new and innovative spinal implant solutions. We have supplemented this organic growth activity with exciting strategic acquisitions of intellectual property for expandable implants and a cervical vertebral body replacement device that is 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. 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.”

Third Quarter 2017 Financial Results

Three Months Ended September 30, Increase / Decrease
2017 2016 $ Change % Change % Change
($ in thousands) (as reported) (constant currency)
United States $ 48,474 $ 45,978 $ 2,496 5.4 % 5.4 %
International 14,179 13,332 847 6.4 % 5.2 %
Total Revenue: $ 62,653 $ 59,310 $ 3,343 5.6 % 5.4 %

Total revenue for the third quarter of 2017 increased $3.3 million, or 5.6%, to $62.6 million, compared to $59.3 million for the third quarter of 2016. Total revenue increased 5.4% year-over-year on a constant currency basis. The increase in revenue was primarily driven by higher sales volume from new surgeon users in the United States, partially offset by a decrease in revenues from our existing U.S. and U.K. customer base and a reduction of revenue in Japan.

Revenue in the United States increased $2.5 million, or 5.4% year-over-year, to $48.5 million, and international revenue increased $0.8 million, or 6.4% year-over-year, to $14.2 million. Third quarter 2017 international revenue increased 5.2% year-over-year on a constant currency basis. Foreign currency exchange impacted third quarter international revenue by approximately $0.1 million, representing approximately 112 basis points of 2017 international growth year-over-year.

The following table represents domestic revenue by procedure category.

Three Months Ended September 30, Increase / Decrease
2017 2016 $ Change % Change
($ in thousands)
Complex Spine $ 20,047 $ 19,516 $ 531 2.7 %
Minimally Invasive 7,694 6,767 927 13.7 %
Degenerative and Other 20,733 19,695 1,038 5.3 %
U.S Revenue: $ 48,474 $ 45,978 $ 2,496 5.4 %

By procedure category, U.S. revenue in the Company’s complex spine, MIS and degenerative categories represented 41.4%, 15.9% and 42.7% of U.S. revenue, respectively, for the three months ended September 30, 2017.

Gross profit for the third quarter of 2017 increased 6.1% to $42.2 million, compared to $39.8 million for the third quarter of 2016.  Gross margin was 67.4% for the third quarter of 2017, compared to 67.1% for the prior year period. Gross profit includes amortization expense on investments in surgical instruments of $3.5 million, or 5.5% of sales, for the three months ended September 30, 2017, compared to $3.5 million, or 5.8% of sales, for the comparable period last year.

Operating expenses for the third quarter of 2017 increased $3.7 million, or 8.0%, to $49.6 million, compared to $45.9 million for the third quarter of 2016. The increase in operating expenses was driven primarily by a $2.2 million increase in sales and marketing expenses, compared to the comparable period last year.

Loss from operations for the third quarter of 2017 increased $1.2 million to $7.3 million compared to a loss from operations of $6.1 million for the comparable period last year. Loss from operations included intangible amortization of $1.8 million and $2.6 million for the third quarters of 2017 and 2016, respectively.

Total other expenses for the third quarter of 2017 decreased $0.8 million to $1.1 million, compared to $1.9 million last year. The decrease in other expense, net, was primarily attributable to an increase of $1.2 million in unrealized gains from foreign currency remeasurement on intercompany payable balances, partially offset by an increase in interest expense of $0.4 million from the Convertible Senior Notes issued in August 2016.

Net loss for the third quarter of 2017 was $8.5 million, or $0.20 per diluted share, compared to a loss of $7.9 million, or $0.19 per diluted share, for the third quarter of 2016.

Nine-Months 2017 Financial Results

Nine Months Ended September 30, Increase / Decrease
2017 2016 $ Change % Change % Change
($ in thousands) (as reported) (constant currency)
United States $ 145,456 $ 133,409 $ 12,047 9.0 % 9.0 %
International 44,774 41,434 3,340 8.1 % 9.6 %
Total Revenue: $ 190,230 $ 174,843 $ 15,387 8.8 % 9.2 %

For the nine months ended September 30, 2017, total revenue increased $15.4 million, or 8.8%, to $190.2 million, compared to $174.8 million for the nine months ended September 30, 2016. Total revenue increased 9.2% year-over-year on a constant currency basis. U.S. revenue increased $12.1 million, or 9.0%, to $145.5 million for the first nine months of 2017, compared to $133.4 million last year. International revenue increased $3.4 million, or 8.1%, to $44.8 million for the first nine months of 2017, compared to $41.4 million last year. International revenue increased 9.6% year-over-year on a constant currency basis.

Nine Months Ended September 30, Increase / Decrease
($ in thousands) 2017 2016 $ Change % Change
Complex Spine $ 57,525 $ 53,981 $ 3,544 6.6 %
Minimally Invasive 24,351 20,653 3,698 17.9 %
Degenerative and Other 63,580 58,775 4,805 8.2 %
U.S Revenue: $ 145,456 $ 133,409 $ 12,047 9.0 %

Sales in our complex spine, MIS and degenerative categories represented 39.5%, 16.7% and 43.8% of U.S. revenue, respectively, for the first nine months of 2017.

As of September 30, 2017, we had cash and cash equivalents of $33.9 million as compared to $45.5 million as of December 31, 2016. We had working capital of $107.0 million as of September 30, 2017 as compared to $115.9 million as of December 31, 2016.

At September 30, 2017, outstanding long-term indebtedness included the carrying value of the Convertible Senior Notes of $38.6 million and the capital lease obligation of $34.1 million. The Company had no borrowings outstanding on its revolving credit facility as of September 30, 2017.

2017 Outlook

The Company is reaffirming its fiscal year 2017 revenue guidance expectations which were updated in a press release on October 8, 2017. The Company expects:

  • Total revenue on an as reported basis in the range of $255.0 million to $257.0 million, representing growth of 8% to 9% year-over-year, compared to total revenue of $236.6 million in fiscal year 2016.
    • Total revenue on a constant currency basis is expected to increase 8% to 9% year-over-year in 2017.
    • The Company expects growth in its U.S. business of approximately 8% to 9% year-over-year in 2017.
    • The Company expects growth in its International business of approximately 9% on a constant currency basis in 2017.

The Company is updating its fiscal year 2017 guidance expectations for net loss and adjusted EBITDA loss. The Company now expects:

  • Total net loss of approximately $37.0 million to $35.0 million, compared to prior expectations for net loss in a range of approximately $34.0 million to $31.0 million.
  • Adjusted EBITDA in a range of $1.0 million to $3.0 million, compared to prior expectations for Adjusted EBITDA in a range of approximately $6.0 million to $10.0 million.

Conference Call

Management will host a conference call at 5:00 p.m. Eastern Time on November 1st to discuss the results of the third quarter, 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 99297954 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 99297954. The webcast will be archived on the investor relations section of the Company’s website.

About K2M Group Holdings, Inc.

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects.  In some cases, you can identify these forward-looking statements by the use of words such as, “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability in the future; our ability to demonstrate to spine surgeons the merits of our products and retain their use of our products; pricing pressures and our ability to compete effectively generally in our industry; collaboration and consolidation in hospital purchasing; inadequate coverage and reimbursement for our products from third-party payors; lack of long-term clinical data supporting the safety and efficacy of our products; dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect to our products; proliferation of physician-owned distributorships in the industry; decline in the sale of certain key products; loss of key personnel; our ability to enhance our product offerings through research and development; our ability to manage expected growth; our ability to successfully acquire or invest in new or complementary businesses, products or technologies; our ability to educate surgeons on the safe and appropriate use of our products; costs associated with high levels of inventory; impairment of our goodwill and intangible assets; disruptions to our corporate headquarters and operations facilities or critical information technology systems, distributors or surgeon users; our ability to ship a sufficient number of our products to meet demand; our ability to strengthen our brand; fluctuations in insurance cost and availability; our ability to comply with extensive governmental regulation within the United States and foreign jurisdictions; our ability  to maintain or obtain regulatory approvals and clearances within the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; recalls or serious safety issues with our products; enforcement actions by regulatory agencies for improper marketing or promotion; misuse or off-label use of our products; delays or failures in clinical trials and results of clinical trials; legal restrictions on our procurement, use, processing, manufacturing or distribution of allograft bone tissue; negative publicity concerning methods of tissue recovery and screening of donor tissue; costs and liabilities relating to environmental laws and regulations; our failure or the failure of our agents to comply with fraud and abuse laws; U.S. legislative or Food and Drug Administration regulatory reforms; adverse effects of medical device tax provisions; potential tax changes in jurisdictions in which we conduct business; our ability to generate significant sales; potential fluctuations in sales volumes and our results of operations over the course of the year; uncertainty in future capital needs and availability of capital to meet our needs; our level of indebtedness and the availability of borrowings under our credit facility; restrictive covenants and the impact of other provisions in the indenture governing our convertible  senior notes and our credit facility;  continuing worldwide economic instability; our ability to protect our intellectual property rights; patent litigation and product liability lawsuits; damages relating to trade secrets or non-competition or non-solicitation agreements; risks associated with operating internationally; fluctuations in foreign currency exchange rates; our ability to comply with the Foreign Corrupt Practices Act and similar laws; our ability to implement and maintain effective internal control over financial reporting; potential volatility in our stock price; our lack of current plans to pay cash dividends; our ability to take advantage of certain reduced disclosure requirements and exemptions as a result of being an emerging growth company; increased costs and additional regulations and requirements as a result of no longer qualifying as an emerging growth company as of December 31, 2017; potential dilution by the future issuances of additional common stock in connection with our incentive plans, acquisitions or otherwise; anti-takeover provisions in our organizational documents and our ability to issue preferred stock without shareholder approval; potential limits on our ability to use our net operating loss carryforwards; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC and our Quarterly Report filed with the SEC on August 2, 2017, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

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

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

K2M GROUP HOLDINGS, INC.
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In Thousands, Except Share and Per Share Data)
September 30, December 31,
2017 2016
ASSETS    
Current assets:    
Cash and cash equivalents $ 33,941 $ 45,511
Accounts receivable, net 45,032 46,430
Inventory, net 72,389 61,897
Prepaid expenses and other current assets 7,516 6,147
Total current assets 158,878 159,985
Property, plant and equipment, net 49,927 50,714
Goodwill 121,814 121,814
Intangible assets, net 17,247 22,758
Other assets, net 30,729 28,254
Total assets $ 378,595 $ 383,525
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Current maturities under capital lease obligation $ 1,083 $ 973
Accounts payable 22,316 15,367
Accrued expenses 18,505 15,673
Accrued payroll liabilities 9,990 12,068
Total current liabilities 51,894 44,081
Convertible senior notes 38,584 36,894
Capital lease obligation, net of current maturities 34,104 34,933
Deferred income taxes, net 5,017 5,017
Other liabilities 301 1,032
Total liabilities 129,900 121,957
Stockholders’ equity:
Common stock, $0.001 par value, 750,000,000 shares authorized; 43,343,567 and 42,291,352 shares issued and 43,327,602 and 42,282,741shares outstanding, respectively 43 42
Additional paid-in capital 487,791 474,512
Accumulated deficit (239,478 ) (211,081 )
Accumulated other comprehensive loss 650 (1,771 )
Treasury stock, at cost, 15,965 and 8,611 shares, respectively (311 ) (134 )
Total stockholders’ equity 248,695 261,568
Total liabilities and stockholders’ equity $ 378,595 $ 383,525
K2M GROUP HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In Thousands, Except Share and Per Share Data)
Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Revenue $ 62,653 $ 59,310 $ 190,230 $ 174,843
Cost of revenue 20,425 19,512 64,426 58,747
Gross profit 42,228 39,798 125,804 116,096
Operating expenses:
Research and development 5,360 5,199 16,170 15,989
Sales and marketing 29,557 27,384 91,273 84,132
General and administrative 14,659 13,312 42,937 41,343
Total operating expenses 49,576 45,895 150,380 141,464
Loss from operations (7,348 ) (6,097 ) (24,576 ) (25,368 )
Other expense, net:
Foreign currency transaction gain (loss) 671 (547 ) 1,518 (1,099 )
Interest expense (1,748 ) (1,319 ) (5,211 ) (2,705 )
Total other expense, net (1,077 ) (1,866 ) (3,693 ) (3,804 )
Loss before income taxes (8,425 ) (7,963 ) (28,269 ) (29,172 )
Income tax expense (benefit) 40 (53 ) 128 21
Net loss $ (8,465 ) $ (7,910 ) $ (28,397 ) $ (29,193 )
Basic and diluted $ (0.20 ) $ (0.19 ) $ (0.67 ) $ (0.70 )
Weighted average shares outstanding:
Basic and diluted 43,009,015 41,940,370 42,627,985 41,639,609

K2M GROUP HOLDINGS, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In Thousands)
Nine Months Ended September 30,
2017  2016
Operating activities
Net loss $ (28,397 ) $ (29,193 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 21,424 21,452
Provision for inventory reserves 3,187 2,817
Provision for allowance for doubtful accounts 196 (18 )
Stock-based compensation expense 4,322 5,381
Accretion of discounts and amortization of issuance costs of convertible senior notes 1,748 558
Other (14 ) (33 )
Changes in operating assets and liabilities:
Accounts receivable 2,444 (5,292 )
Inventory (9,510 ) (6,466 )
Prepaid expenses and other assets (8,200 ) (7,636 )
Accounts payable, accrued expenses, and accrued payroll liabilities 4,092 3,442
Net cash used in operating activities (8,708 ) (14,988 )
Investing activities
Purchase of surgical instruments (7,199 ) (10,986 )
Purchase of property, plant and equipment (3,242 ) (16,338 )
Changes in cash restricted for leasehold improvements 6,153
Purchase of intangible assets (1,050 ) (1,282 )
Net cash used in investing activities (11,491 ) (22,453 )
Financing activities
Borrowings on bank line of credit 19,500
Payments on bank line of credit (19,500 )
Proceeds from issuance of convertible senior notes, net of issuance costs 47,575
Principal payments under capital lease (719 )
Issuances and exercise of stock-based compensation benefit plans, net of income tax 8,781 1,262
Net cash provided by financing activities 8,062 48,837
Effect of exchange rate changes on cash and cash equivalents 567 75
Net change in cash and cash equivalents (11,570 ) 11,471
Cash and cash equivalents at beginning of period 45,511 34,646
Cash and cash equivalents at end of period $ 33,941 $ 46,117
Significant non-cash investing activities
Leasehold improvements under capital lease $ $ 598
Additions to property, plant and equipment $ 250 $
Significant non-cash financing activities
Deferred convertible senior notes issuance costs $ $ 486
Cash paid for:
Income taxes $ 132 $ 177
Interest $ 2,190 $ 339

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

Use of Non-GAAP Financial Measures

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

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

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

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

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

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

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

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

Three Months Ended September 30, Nine Months Ended September 30,
2017 2016 2017 2016
Reconciliation from Gross Profit to Adjusted Gross Profit
Gross profit $ 42,228 $ 39,798 $ 125,804 $ 116,096
Surgical instrument amortization 3,456 3,454 10,525 10,150
Adjusted gross profit (a Non-GAAP Measure) $ 45,684 $ 43,252 $ 136,329 $ 126,246
Three Months Ended September 30, Nine Months Ended September 30,
2017 2016
2017 2016
Reconciliations from Net Loss to Adjusted EBITDA
Net loss $ (8,465 ) $ (7,910 ) $ (28,397 ) $ (29,193 )
Interest expense 1,748 1,319 5,211 2,705
Income tax expense 40 (53 ) 128 21
Depreciation and amortization 6,810 7,415 21,424 21,452
Stock-based compensation expense 1,442 1,527 4,322 5,381
Foreign currency transaction (gain) loss (671 ) 547 (1,518 ) 1,099
Adjusted EBITDA (a Non-GAAP Measure) $ 904 $ 2,845 $ 1,170 $ 1,465

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

Year Ended
December 31,
2017
Net loss $ (36,000 )
Interest expense 6,900
Income tax expense 200
Depreciation and amortization 26,900
Stock-based compensation expense 6,000
Foreign currency transaction gain (2,000 )
Adjusted EBITDA $ 2,000

The reconciliation assumes the mid-point of the Adjusted EBITDA range and the mid-point of each component of the reconciliation, corresponding to guidance of $1.0 million to $3.0 million for 2017.



InVivo Therapeutics Provides Business Update and Reports 2017 Third Quarter Financial Results

October 30, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today provided a general business update and reported financial results for the quarter ended September 30, 2017.

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the third quarter, we focused our resources solely on reopening enrollment into the clinical study of the Neuro-Spinal Scaffold™ in complete thoracic spinal cord injury (SCI). As part of this focus, we reduced our workforce by 39%, which is expected to result in 2018 operating expense savings of approximately $7.3 million.”

Mr. Perrin continued, “Enrollment into the INSPIRE study is currently on hold as we engage with the United States Food & Drug Administration (FDA) to determine the most appropriate clinical path forward. We continue to engage in discussions with the FDA regarding our clinical program and will provide appropriate updates as we obtain further clarity on the issue. We remain wholly committed to our mission of redefining the life of the spinal cord injury patient and progressing the Neuro-Spinal Scaffold in the clinic toward a Humanitarian Device Exemption (HDE) submission.”

INSPIRE Update

Of the 19 patients implanted in The INSPIRE Study to date, 16 patients are in follow-up, 14 of whom have reached the six-month primary endpoint visit. Six of these 14 (42.9%) have improved from complete AIS A SCI to incomplete SCI (one patient to AIS C and five patients to AIS B) at the six-month primary endpoint visit and eight had not converted at that visit. Two of the six patients who converted and were assessed to have AIS B SCI at the six-month primary endpoint were later assessed to have improved to AIS C SCI at the 12 and 24-month visits, respectively. Two of the patients in follow-up have not yet reached the six-month primary endpoint visit although one of these patients was assessed to be AIS C at one month and two months and AIS B at three months. Three patients in the INSPIRE study have died, with the cause of death in each case determined to be unrelated to the Neuro-Spinal Scaffold or implant procedure by the respective site Principal Investigator.

Financial Results

For the three-month period ended September 30, 2017, the Company reported a net loss of approximately $9.4 million, or $0.28 per diluted share, compared to a net loss of $6.2 million, or $0.19 per diluted share, for the three-month period ended September 30, 2016. The results for the three-month period ended September 30, 2017 were unfavorably impacted by increases in general and administrative operating expenses of $804,000 and by a derivative loss of $3.1 million, due primarily to the impact of the August 2017 warrant exchange, partially offset by decreases in research and development operating expenses of $366,000. Excluding the impact of the derivative warrant liability, adjusted net loss for the three-month period ended September 30, 2017 was $6.3 million, or $0.19 per diluted share, compared to adjusted net loss of $5.9 million, or $0.18 per diluted share, for the three-month period ended September 30, 2016.

The Company ended the quarter with $17.2 million of cash, cash equivalents, and marketable securities.

For the nine-month period ended September 30, 2017, the Company reported a net loss of approximately $22.1 million, or $0.68 per diluted share, compared to a net loss of $18.0 million or $0.59 per diluted share, for the nine-month period ended September 30, 2016. The results for the nine-month period ended September 30, 2017 were unfavorably impacted by increases in research and development operating expenses of $863,000, $1.8 million in general and administrative operating expenses and by a non-cash loss on the derivative warrant liability of $2.3 million, due to the impact of the August 2017 warrant exchange and the change in the fair market value of the warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the nine-month period ended September 30, 2017 was $19.8 million, or $0.61 per diluted share, compared to adjusted net loss of $17.2 million, or $0.56 per diluted share, for the nine-month period ended September 30, 2016.

Adjusted net loss and adjusted net loss per share are non-GAAP financial measures that exclude the impact of the derivative warrant liability. A reconciliation of these measures to the comparable GAAP measure is included with the tables contained in this release. The Company believes a presentation of these non-GAAP measures provides useful information to investors to better understand the Company’s operations, on a period-to-period comparable basis, with financial amounts both including and excluding the identified items.

About The INSPIRE Study

The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval.

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold™ within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural repair within and around the healed wound epicenter. The Neuro-Spinal Scaffold™, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury.

About InVivo Therapeutics

InVivo Therapeutics Holdings Corp. is a research and clinical-stage biomaterials and biotechnology company with a focus on treatment of spinal cord injuries. The company was founded in 2005 with proprietary technology co-invented by Robert Langer, Sc.D., Professor at Massachusetts Institute of Technology, and Joseph P. Vacanti, M.D., who then was at Boston Children’s Hospital and who now is affiliated with Massachusetts General Hospital. In 2011, the company earned the David S. Apple Award from the American Spinal Injury Association for its outstanding contribution to spinal cord injury medicine. In 2015, the company’s investigational Neuro-Spinal Scaffold™received the 2015 Becker’s Healthcare Spine Device Award. The publicly-traded company is headquartered in Cambridge, MA. For more details, visit www.invivotherapeutics.com.

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the status of the clinical program, the timing for re-opening enrollment in the INSPIRE Study and the submission of an HDE application to the FDA, and the impact of the restructuring and the reduction in force on the Company’s balance sheet, financial position and cash burn. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully re-open clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended September 30, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets
Unaudited
As of

September 30, 
2017

December 31,
2016

ASSETS:
Current assets:
Cash and cash equivalents 16,434 21,464
Restricted cash 361 361
Marketable securities 734 11,577
Prepaid expenses and other current assets 475 451
Total current assets 18,004 33,853
Property, equipment and leasehold improvements, net 190 510
Other assets 402 421
Total assets 18,596 34,784
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable 1,270 1,011
Loan payable, current portion 444 423
Derivative warrant liability 41 1,314
Deferred rent, current portion

30

141
Accrued expenses 1,784 1,959
Total current liabilities 3,569 4,848
Loan payable, net of current portion 516 852
Deferred rent, net of current portion 208 135
Other liabilities 52
Total liabilities 4,345 5,835
Stockholders’ equity:

Common stock, $0.00001 par value, authorized 100,000,000 shares; 34,234,580 shares
issued and outstanding at September 30, 2017; 32,044,087 shares issued and outstanding at
December 31, 2016

1

1

Additional paid-in capital 193,493 185,955
Accumulated deficit (179,243 ) (157,007 )
Total stockholders’ equity 14,251 28,949
Total liabilities and stockholders’ equity 18,596 34,784

InVivo Therapeutics Holdings Corp.

Consolidated Statements of Operations and Comprehensive Loss

(Unaudited)

Three Months Ended

September 30,

Nine Months Ended

September 30,

2017 2016 2017 2016
Operating expenses:
Research and development 2,928 3,294 9,522 8,659
General and administrative 3,388 2,584 10,389 8,573
Total operating expenses 6,316 5,878 19,911 17,232
Operating loss (6,316 ) (5,878 ) (19,911 ) (17,232 )
Other income (expense):
Interest income 43 50 152 133
Interest expense (18 ) (32 ) (58 ) (117 )
Derivatives gain (loss) (3,059 ) (336 ) (2,264 ) (788 )
Other income (expense), net (3,034 ) (318 ) (2,170 ) (772 )
Net loss (9,350 ) (6,196 ) (22,081 ) (18,004 )
Net loss per share, basic and diluted (0.28 ) (0.19 ) (0.68 ) (0.59 )
Weighted average number of
common shares outstanding, basic and diluted 33,445,002 31,968,357 32,516,190 30,687,263
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp.
(In thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2017 2016 2017 2016
Reported GAAP net income (loss) (9,350 ) (6,196 ) (22,081 ) (18,004 )
Add Back: Derivative (Gain)/ Loss 3,059 336 2,264 788
Adjusted Net Loss (6,291 ) (5,860 ) (19,817 ) (17,216 )
Reported GAAP net loss per diluted share (0.28 ) (0.19 ) (0.68 ) (0.59 )
Derivative loss per diluted share 0.09 0.01 0.07 0.03
Adjusted net loss per diluted share (0.19 ) (0.18 ) (0.61 ) (0.56 )

Contacts

InVivo Therapeutics Holdings Corp.
Heather Hamel, 617-863-5530
Investor Relations
Investor-relations@invivotherapeutics.co

OrthoPediatrics Corp. to Report Third Quarter 2017 Financial Results on November 8, 2017

WARSAW, Ind., Oct. 30, 2017 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (“OrthoPediatrics”) (NASDAQ:KIDS), an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market, announced today that the Company plans to release its third quarter 2017 financial results on Wednesday, November 8, 2017 after the market closes.

OrthoPediatrics will host a conference call on Thursday, November 9, 2017 at 8:00 a.m. ET to discuss the results. The dial-in numbers are (855) 289-4603 for domestic callers and (614) 999-9389 for international callers. The conference ID number is 9169647. A live webcast of the conference call will be available online from the investor relations page of the OrthoPediatrics’ corporate website at www.orthopediatrics.com.

A replay of the webcast will remain available on OrthoPediatrics’ website, www.orthopediatrics.com, until the Company releases its fourth quarter and full year 2017 financial results. In addition, a telephonic replay of the call will be available until November 16, 2017. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the replay conference ID number 9169647.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is the only diversified orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market.  The Company is dedicated to the cause of improving the lives of children with orthopedic conditions. OrthoPediatrics currently markets 22 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, complex spine and ACL reconstruction procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 35 countries outside the United States.

Investor Contact
The Ruth Group
Zack Kubow
(646) 536-7020
zkubow@theruthgroup.com

Orthofix International Reports Third Quarter 2017 Financial Results

October 30, 2017

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX) today reported its financial results for the third quarter ended September 30, 2017. Net sales were $105.2 million, diluted earnings per share from continuing operations was $0.18 and adjusted earnings per share from continuing operations was $0.42.

“We continue to execute on our strategy of increasing the organic growth and profitability of each of our four strategic business units while rationalizing corporate costs in all areas. This has resulted in an accelerating sales growth rate each quarter thus far this year, and positioned us for solid mid-single digit organic revenue growth and the opportunity for meaningful margin expansion in the years to come,” said Brad Mason, President and Chief Executive Officer.

Financial Results Overview

The following table provides net sales by strategic business unit (“SBU”):

Three Months Ended September 30,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 Change Constant

Currency

Change

BioStim $ 44,427 $ 42,956 3.4 % 3.4 %
Biologics 15,218 14,335 6.2 % 6.2 %
Extremity Fixation 25,447 24,314 4.7 % 1.4 %
Spine Fixation 20,155 16,892 19.3 % 19.1 %
Net sales $ 105,247 $ 98,497 6.9 % 6.0 %

Gross profit increased $2.9 million to $81.5 million. Gross margin decreased to 77.5% compared to 79.8% in the prior year period due primarily to sales mix, the impact of converting to stocking distributors in Brazil in our Extremity Fixation SBU, and $0.6 million of non-recurring expenses relating to our U.S. restructuring plan. Non-GAAP net margin, an internal metric that we define as gross profit less sales and marketing expenses, was $34.0 million compared to $36.9 million in the prior year period. The decrease in non-GAAP net margin was primarily due to higher commission expenses from geographic mix in Extremity Fixation and higher rates from Spine Fixation and Biologics distributors, as well as increased sales and use tax benefits realized in the third quarter of 2016.

Net income from continuing operations was $3.3 million, or $0.18 per share, compared to $10.4 million, or $0.56 per share in the prior year period. Adjusted net income from continuing operations was $7.7 million, or $0.42 per share, compared to adjusted net income of $6.6 million, or $0.36 per share in the prior year period.

EBITDA was $14.5 million, compared to $14.1 million in the prior year period. Adjusted EBITDA was $21.1 million, or 20.1% of net sales, for the third quarter, compared to $23.5 million, or 23.9% of net sales, in the prior year period.

Liquidity

As of September 30, 2017, cash and cash equivalents were $53.9 million compared to $39.6 million as of December 31, 2016. As of September 30, 2017, we had no outstanding indebtedness and borrowing capacity of $125 million. Cash flow from operations was $23.5 million, a decrease of $14.9 million, and free cash flow was $10.2 million, a decrease of $13.9 million when compared to the prior year period.

2017 Outlook

For the year ending December 31, 2017, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.

Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions, except per share data) Low High Low High
Net sales $ 422.0 $ 425.0 $ 428.0

(1)

$ 431.0

(1)

Net income from continuing operations $ 17.7 $ 21.4 $ 14.2

(2)

$ 17.0

(2)

Adjusted EBITDA $ 79.0 $ 81.0 $ 79.0

(3)

$ 82.0

(3)

EPS from continuing operations $ 0.96 $ 1.16 $ 0.77

(4)

$ 0.92

(4)

Adjusted EPS from continuing operations $ 1.54 $ 1.60 $ 1.54

(5)

$ 1.63

(5)

Represents a year-over-year increase of 4.4% to 5.2% on a reported basis
Represents a year-over-year increase of 306.1% to 386.1%
Represents a year-over-year decrease of 0.4% to an increase of 3.4%
Represents a year-over-year increase of 305.3% to 384.2%
Represents a year-over-year increase of 5.5% to 11.6%

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company’s financial results for the third quarter of 2017. Interested parties may access the conference call by dialing (844) 809-1992 in the U.S. and (612) 979-9886 outside the U.S., and referencing the conference ID 2078866. A replay of the call will be available for two weeks by dialing (855) 859-2056 in the U.S. and (404) 537-3406 outside the U.S., and entering the conference ID 2078866. A webcast of the conference call may be accessed by going to the Company’s website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.

About Orthofix

Orthofix International N.V. is a diversified, global medical device company focused on improving patients’ lives by providing superior reconstructive and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Biologics, Extremity Fixation and Spine Fixation. Orthofix products are widely distributed via the Company’s sales representatives and distributors. In addition, Orthofix is collaborating on research and development activities with leading clinical organizations such as Brown University, Sinai Hospital of Baltimore, Cleveland Clinic, Texas Scottish Rite Hospital for Children, and the Musculoskeletal Transplant Foundation. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (“the Exchange Act”), and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict. Therefore, our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to further update any such statement, or the risk factors described in Part I, Item 1A under the heading Risk Factors in our Form 10-K for the year ended December 31, 2016, to reflect new information, the occurrence of future events or circumstances or otherwise.

ORTHOFIX INTERNATIONAL N.V.

Condensed Consolidated Statements of Operations
Three Months Ended Nine Months Ended
September 30, September 30,
(Unaudited, U.S. Dollars, in thousands, except share and per share data) 2017 2016 2017 2016
Net sales $ 105,247 $ 98,497 $ 316,927 $ 301,251
Cost of sales 23,717 19,880 69,475 64,533
Gross profit 81,530 78,617 247,452 236,718
Sales and marketing 47,493 41,717 146,496 132,582
General and administrative 18,068 19,272 56,759 54,822
Research and development 6,935 6,858 21,246 21,294
Charges related to U.S. Government resolutions 1,499 14,369
Operating income 9,034 9,271 22,951 13,651
Interest income (expense), net (15 ) 471 106 320
Other income (expense), net 479 (634 ) (3,284 ) 1,346
Income before income taxes 9,498 9,108 19,773 15,317
Income tax benefit (expense) (6,150 ) 1,276 (13,998 ) (6,703 )
Net income from continuing operations 3,348 10,384 5,775 8,614
Discontinued operations
Income (loss) from discontinued operations 65 (1,018 ) (1,762 ) (3,580 )
Income tax benefit 43 530 642 1,258
Net income (loss) from discontinued operations 108 (488 ) (1,120 ) (2,322 )
Net income $ 3,456 $ 9,896 $ 4,655 $ 6,292
Net income (loss) per common share—basic
Net income from continuing operations $ 0.18 $ 0.57 $ 0.32 $ 0.47
Net income (loss) from discontinued operations 0.01 (0.02 ) (0.06 ) (0.13 )
Net income per common share—basic $ 0.19 $ 0.55 $ 0.26 $ 0.34
Net income (loss) per common share—diluted
Net income from continuing operations $ 0.18 $ 0.56 $ 0.31 $ 0.46
Net income (loss) from discontinued operations 0.01 (0.02 ) (0.06 ) (0.12 )
Net income per common share—diluted $ 0.19 $ 0.54 $ 0.25 $ 0.34
Weighted average number of common shares:
Basic 18,180,845 18,091,650 18,071,093 18,238,533
Diluted 18,572,791 18,382,118 18,394,542 18,569,861
ORTHOFIX INTERNATIONAL N.V.
Condensed Consolidated Balance Sheets
(U.S. Dollars, in thousands except share data) September 30,

2017

December 31,

2016

(unaudited)
Assets
Current assets
Cash and cash equivalents $ 53,925 $ 39,572
Restricted cash 14,369
Accounts receivable, net of allowances of $8,925 and $8,396, respectively 61,187 57,848
Inventories 80,124 63,346
Prepaid expenses and other current assets 18,172 19,238
Total current assets 213,408 194,373
Property, plant and equipment, net 46,678 48,916
Patents and other intangible assets, net 9,915 7,461
Goodwill 53,565 53,565
Deferred income taxes 47,052 47,325
Other long-term assets 15,683 20,463
Total assets $ 386,301 $ 372,103
Liabilities and shareholders’ equity
Current liabilities
Accounts payable $ 13,352 $ 14,353
Other current liabilities 60,718 69,088
Total current liabilities 74,070 83,441
Other long-term liabilities 26,920 25,185
Total liabilities 100,990 108,626
Contingencies
Shareholders’ equity
Common shares $0.10 par value; 50,000,000 shares authorized; 18,212,916 and

17,828,155 issued and outstanding as of September 30, 2017 and December 31,

2016, respectively

1,821 1,783
Additional paid-in capital 215,778 204,095
Retained earnings 68,834 64,179
Accumulated other comprehensive loss (1,122 ) (6,580 )
Total shareholders’ equity 285,311 263,477
Total liabilities and shareholders’ equity $ 386,301 $ 372,103

ORTHOFIX INTERNATIONAL N.V.
Non-GAAP Financial Measures

The following tables present reconciliations of net income (loss) from continuing operations, earnings per share (“EPS”) from continuing operations, gross profit, and net cash from operating activities, in each case calculated in accordance with U.S. generally accepted accounting principles (“GAAP”), to, as applicable, non-GAAP financial measures, referred to as “EBITDA,” “Adjusted EBITDA,” “Adjusted net income from continuing operations,” “Adjusted earnings per share from continuing operations,” “Non-GAAP net margin” and “Free cash flow” that exclude items specified in the tables. A more detailed explanation of the items excluded from these non-GAAP financial measures, as well as why management believes the non-GAAP financial measures are useful to them, is included following the reconciliations.

EBITDA and Adjusted EBITDA

Three Months Ended

September 30,

Nine Months Ended

September 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Net income from continuing operations $ 3,348 $ 10,384 $ 5,775 $ 8,614
Interest expense (income), net 15 (471 ) (106 ) (320 )
Income tax expense (benefit) 6,150 (1,276 ) 13,998 6,703
Depreciation and amortization 4,974 5,480 15,421 15,483
EBITDA $ 14,487 $ 14,117 $ 35,088 $ 30,480
Share-based compensation 3,632 7,862 9,124 11,874
Foreign exchange impact (794 ) 566 (2,425 ) (1,434 )
Strategic investments 293 (62 ) 9,619 342
SEC / FCPA matters and related costs 1,150 691 1,851 1,481
Infrastructure investments 827 3,073
Legal judgments/settlements 179 (3,000 ) 1,798 (3,000 )
Charges related to U.S. Government resolutions 1,499 14,369
Restructuring 2,160 2,242
Succession charges 1,026 1,026
Adjusted EBITDA $ 21,107 $ 23,526 $ 57,297 $ 58,211
As a % of net sales 20.1 % 23.9 % 18.1 % 19.3 %

Adjusted Net Income from Continuing Operations

Three Months Ended

September 30,

Nine Months Ended

September 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Net income from continuing operations $ 3,348 $ 10,384 $ 5,775 $ 8,614
Foreign exchange impact (794 ) 566 (2,425 ) (1,434 )
Strategic investments 293 (62 ) 9,619 342
SEC / FCPA matters and related costs 1,150 691 1,851 1,481
Infrastructure investments 827 3,073
Legal judgments/settlements 179 (3,000 ) 1,798 (3,000 )
Charges related to U.S. Government resolutions 1,499 14,369
Restructuring 2,160 2,242
Succession charges 1,026 1,026
Long-term income tax rate adjustment 1,405 (5,325 ) 1,512 (5,143 )
Adjusted net income from continuing operations $ 7,741 $ 6,606 $ 20,372 $ 19,328

Adjusted Earnings per Share from Continuing Operations

Three Months Ended

September 30,

Nine Months Ended

September 30,

(Unaudited, per diluted share) 2017 2016 2017 2016
EPS from continuing operations $ 0.18 $ 0.56 $ 0.31 $ 0.46
Foreign exchange impact (0.04 ) 0.03 (0.13 ) (0.08 )
Strategic investments 0.02 0.52 0.02
SEC / FCPA matters and related costs 0.06 0.04 0.10 0.08
Infrastructure investments 0.04 0.17
Legal judgments/settlements 0.01 (0.16 ) 0.10 (0.16 )
Charges related to U.S. Government resolutions 0.08 0.77
Restructuring 0.12 0.12
Succession charges 0.06 0.06
Long-term income tax rate adjustment 0.07 (0.29 ) 0.09 (0.28 )
Adjusted EPS from continuing operations $ 0.42 $ 0.36 $ 1.11 $ 1.04
Weighted average number of diluted common shares 18,572,791 18,382,118 18,394,542 18,569,861

Non-GAAP Net Margin

Three Months Ended

September 30,

Nine Months Ended

September 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016 2017 2016
Gross profit $ 81,530 $ 78,617 $ 247,452 $ 236,718
Sales and marketing (47,493 ) (41,717 ) (146,496 ) (132,582 )
Non-GAAP net margin $ 34,037 $ 36,900 $ 100,956 $ 104,136
BioStim $ 18,285 $ 19,996 $ 54,887 $ 54,980
Biologics 6,010 6,821 18,651 19,642
Extremity Fixation 7,723 8,834 20,901 24,170
Spine Fixation 2,122 1,388 6,825 5,925
Corporate (103 ) (139 ) (308 ) (581 )
Non-GAAP net margin $ 34,037 $ 36,900 $ 100,956 $ 104,136

Free Cash Flow

Nine Months Ended

September 30,

(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net cash from operating activities $ 23,494 $ 38,396
Capital expenditures (13,290 ) (14,261 )
Free cash flow $ 10,204 $ 24,135

2017 Outlook

Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions) Low High Low High
Net income from continuing operations $ 17.7 $ 21.4 $ 14.2 $ 17.0
Interest expense, net 0.2 0.1
Income tax expense 15.7 15.5 16.7 17.0
Depreciation and amortization 20.0 20.0 20.2 20.2
EBITDA $ 53.6 $ 57.0 $ 51.1 $ 54.2
Share-based compensation 13.0 13.0 13.0 13.0
Foreign exchange impact (1.6 ) (1.6 ) (2.4 ) (2.4 )
Strategic investments 10.3 9.3 10.2 10.2
SEC / FCPA matters and related costs 1.2 1.0 2.4 2.4
Legal judgments/settlements 1.6 1.6 1.8 1.8
Restructuring 0.9 0.7 2.9 2.8
Adjusted EBITDA $ 79.0 $ 81.0 $ 79.0 $ 82.0
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, per diluted share) Low High Low High
EPS from continuing operations $ 0.96 $ 1.16 $ 0.77 $ 0.92
Foreign exchange impact (0.09 ) (0.09 ) (0.13 ) (0.13 )
Strategic investments 0.56 0.51 0.55 0.55
SEC / FCPA matters and related costs 0.07 0.05 0.13 0.13
Legal judgments/settlements 0.09 0.09 0.10 0.10
Restructuring 0.05 0.04 0.16 0.15
Long-term income tax rate adjustment (0.10 ) (0.16 ) (0.04 ) (0.09 )
Adjusted EPS from continuing operations $ 1.54 $ 1.60 $ 1.54 $ 1.63
Weighted average number of diluted common shares 18,400,000 18,400,000 18,400,000 18,400,000

Non-GAAP Measures:

Constant Currency

Constant currency is a non-GAAP measure, which is calculated by using foreign currency rates from the comparable, prior-year period, to present net sales at comparable rates. Constant currency can be presented for numerous GAAP measures, but is most commonly used by management to analyze net sales without the impact of changes in foreign currency rates.

EBITDA

EBITDA is a non-GAAP financial measure, which is calculated by adding interest income (expense), net; income tax expense; and depreciation and amortization to net income (loss) from continuing operations. EBITDA provides management with additional insight to its results of operations.

Adjusted EBITDA, Adjusted Net Income from Continuing Operations and Adjusted Earnings per Share from Continuing Operations

These non-GAAP financial measures provide management with additional insight to its results of operations and are calculated using the following adjustments:

  • Share-based compensation – costs related to our share-based compensation plans, which include stock options, restricted stock awards, performance-based restricted stock awards, market-based restricted stock awards and our stock purchase plan
  • Foreign exchange impact – gains and losses related to foreign currency transactions; guidance presented does not include the impact of any future foreign exchange fluctuations
  • Strategic investments – costs related to our strategic investments, including our investment in eNeura, Inc.
  • SEC / FCPA matters and related costs – legal and other professional fees associated with the SEC Investigation, Securities Class Action Complaint and Brazil subsidiary compliance review
  • Infrastructure investments – costs associated with our multi-year process and systems improvement effort, “Bluecore,” which was completed in 2016
  • Legal judgments/settlements – adverse or favorable legal judgments or negotiated legal settlements
  • Charges related to U.S. Government resolutions – charges related to the settlement with the SEC as further discussed in our Form 10-K for the year ended December 31, 2016
  • Restructuring – costs related to a planned restructuring, primarily consisting of severance charges and the write-down of certain assets
  • Succession charges – costs related to the succession of certain of our former named executive officers
  • Long-term income tax rate adjustment – reflects management’s expectation of a long-term normalized effective tax rate of 38%, which is based on current tax law and current expected income. Actual tax expense will ultimately be based on GAAP performance and may differ from the 38% effective tax rate due to a variety of factors, including jurisdictions in which profits are determined to be earned and taxed, and discrete items, such as the resolutions of issues arising from tax audits with various tax authorities and the ability to realize deferred tax assets

Non-GAAP Net Margin

Non-GAAP net margin is an internal non-GAAP metric, which we define as gross profit less sales and marketing expense. Non-GAAP net margin is the primary metric used by our Chief Operating Decision Maker in managing our business.

Free Cash Flow

Free cash flow is a non-GAAP financial measure, which is calculated by subtracting capital expenditures from cash flow from operating activities. Free cash flow is an important indicator of how much cash is generated or used by our normal business operations, including capital expenditures. Management uses free cash flow as a measure of progress on its capital efficiency and cash flow initiatives.

Usefulness and Limitations of Non-GAAP Financial Measures

Management uses non-GAAP measures to evaluate performance period-over-period, to analyze the underlying trends in our business, to assess performance relative to competitors and to establish operational goals and forecasts that are used in allocating resources. Management uses these non-GAAP measures as the basis for assessing the ability of the underlying operations to generate cash. In addition, management uses these non-GAAP measures to further its understanding of the performance of our business units.

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

The non-GAAP measures used in this press release may have limitations as analytical tools, and should not be considered in isolation or as a replacement for GAAP financial measures. Some of the limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost and can have a material effect on cash flows. Similarly, certain non-cash expenses, such as share-based compensation, do not directly impact cash flows, but are part of total compensation costs accounted for under GAAP.

Compensation for Limitations Associated with Use of Non-GAAP Financial Measures

We compensate for the limitations of our non-GAAP financial measures by relying upon GAAP results to gain a complete picture of our performance. The GAAP results provide the ability to understand our performance based on a defined set of criteria. The non-GAAP measures reflect the underlying operating results of our businesses, which we believe is an important measure of our overall performance. We provide a detailed reconciliation of the non-GAAP financial measures to our most directly comparable GAAP measures, and encourage investors to review this reconciliation.

Usefulness of Non-GAAP Financial Measures to Investors

We believe that providing non-GAAP financial measures that exclude certain items provides investors with greater transparency to the information used by senior management in its financial and operational decision-making. Management believes it is important to provide investors with the same non-GAAP metrics it uses to supplement information regarding the performance and underlying trends of our business operations in order to facilitate comparisons to its historical operating results and internally evaluate the effectiveness of our operating strategies. Disclosure of these non-GAAP financial measures also facilitates comparisons of our underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.

Contacts

Orthofix International N.V.
Mark Quick, 214-937-2924
markquick@orthofix.com

Exactech Q3 Revenue $61.4 Million

October 30, 2017

GAINESVILLE, Fla.–(BUSINESS WIRE)–Exactech, Inc. (Nasdaq: EXAC), a developer and producer of bone and joint restoration products and biologic solutions for extremities, knee and hip, announced today that revenue for the third quarter of 2017 increased 2% to $61.4 million from $59.9 million in the third quarter of 2016, and 2% on a constant currency basis. Domestic revenue increased 2% to $43.3 million, and international revenue increased 2% to $18.1 million in the third quarter of 2017. Diluted earnings per share for the third quarter was $0.20 based on net income of $2.9 million, compared to third quarter 2016 net income of $3.2 million and diluted earnings per share of $0.22.

Third Quarter Segment Performance

  • Extremities revenue increased 18% to $27.7 million from $23.4 million, an 18% constant currency increase
  • Knee revenue decreased 3% to $16.5 million, a 3% constant currency decrease
  • Hip revenue decreased 3% to $11.3 million from $11.6 million, a 3% constant currency decrease
  • Other revenue decreased 25% to $5.9 million from $7.9 million, a 27% constant currency decrease. The Other segment includes an aggregation of the former Biologics and Spine segment

Nine Months Highlights and Segment Performance

For the first nine months of 2017, revenue was $198.2 million, an increase of 4% over $191.3 million for the comparable period last year. On a constant currency basis, revenue for the first nine months of 2017 was up 4%. Net income for the first nine months of 2017 was $12.3 million, or $0.84 per diluted share compared to $12.0 million, or $0.84 per diluted share, for the first nine months of 2016. First nine month product revenue was as follows:

  • Extremities revenue increased 19% to $87.1 million, a 19% constant currency increase
  • Knee revenue was flat at $56.2 million, flat on constant currency
  • Hip revenue decreased 2% to $35.0 million, a 1% constant currency decrease
  • Other revenue decreased 24% to $20.0 million, a 24% constant currency decrease

Management Comment

Exactech CEO and President David Petty said, “For the first nine months of 2017, we reported a 4% increase in our revenue. During the third quarter, we continued to work on launch plans for the new Truliant® knee system, Vantage® ankle, ExactechGPS® shoulder application, and Alteon® H.A. hip stem and are very pleased with the early response we hear from surgeon users,” Petty said.

Chief Financial Officer Jody Phillips said, “Gross margins increased to 70.3% from 68.7% for the third quarter a year ago. Total operating expenses for the quarter increased 7% to $39.2 million. As a result, our net income decreased 10% to $2.9 million and $0.20 diluted EPS for the third quarter which was in the range of our expectations.”

On October 23, 2017, Exactech announced that it had entered into a definitive agreement with TPG Capital to go private. It is expected the transaction will be closed in early 2018.

The financial statements are below.

About Exactech

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

This release contains various forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, which represent the company’s expectations or beliefs concerning future events of the company’s financial performance. These forward-looking statements are further qualified by important factors that could cause actual results to differ materially from those in the forward-looking statements. These factors include the effect of competitive pricing, the company’s dependence on the ability of third party manufacturers to produce components on a basis which is cost-effective to the company, market acceptance of the company’s products and the effects of government regulation. Results actually achieved may differ materially from expected results included in these statements.

EXACTECH, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS
(in thousands)
(unaudited) (audited)
September 30, December 31,
2017 2016

ASSETS

CURRENT ASSETS:
Cash and cash equivalents $ 11,718 $ 13,052
Trade receivables, net of allowances of $2,043 and $1,473 56,940 53,051
Prepaid expenses and other assets, net 3,585 3,075
Income taxes receivable 895 2,140
Inventories, current 69,885 65,264
Assets held for sale 6,477
Total current assets 143,023 143,059
PROPERTY AND EQUIPMENT:
Land 4,550 4,474
Machinery and equipment 45,622 42,034
Surgical instruments 146,827 132,134
Furniture and fixtures 4,715 4,700
Facilities 23,062 21,726
Projects in process 6,739 2,473
Total property and equipment 231,515 207,541
Accumulated depreciation (111,434 ) (100,234 )
Net property and equipment 120,081 107,307
OTHER ASSETS:
Deferred financing, deposits and other 4,416 968
Equity investment 1,916 2,047
Deferred tax asset 887
Non-current inventory 12,799 15,723
Product licenses and designs, net 8,994 9,102
Patents and trademarks, net 664 821
Customer relationships, net 452 476
Goodwill 14,860 13,819
Total other assets 44,101 43,843

TOTAL ASSETS

$ 307,205 $ 294,209
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Accounts payable $ 18,338 $ 17,566
Income taxes payable 568 780
Accrued expenses 13,547 11,832
Other current liabilities 2,616 2,927
Total current liabilities 35,069 33,105
LONG-TERM LIABILITIES:
Deferred tax liabilities 4,181 1,773
Long-term debt, net of current portion 14,000 20,000
Other long-term liabilities 3,653 5,089
Total long-term liabilities 21,834 26,862
Total liabilities 56,903 59,967
COMMITMENTS AND CONTINGENCIES
SHAREHOLDERS’ EQUITY:
Common stock 145 144
Additional paid-in capital 91,051 87,319
Treasury Stock (3,042 ) (3,042 )
Accumulated other comprehensive loss, net of tax (8,561 ) (8,611 )
Retained earnings 170,709 158,432
Total shareholders’ equity 250,302 234,242
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 307,205 $ 294,209

EXACTECH, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF INCOME

(in thousands, except per share amounts)

(Unaudited)
Three Month Periods Nine Month Periods
Ended September 30, Ended September 30,
2017 2016 2017 2016
NET SALES $ 61,404 $ 59,919 $ 198,213 $ 191,341
COST OF GOODS SOLD 18,232 18,772 59,927 59,408
Gross profit 43,172 41,147 138,286 131,933
OPERATING EXPENSES:
Sales and marketing 22,713 21,684 71,335 68,838
General and administrative 5,908 5,186 18,065 16,740
Research and development 5,729 5,096 17,333 15,495
Depreciation and amortization 4,892 4,592 14,283 13,326
Total operating expenses 39,242 36,558 121,016 114,399
INCOME FROM OPERATIONS 3,930 4,589 17,270 17,534
OTHER INCOME (EXPENSE):
Interest income 32 29 87 35
Other income (loss) (28 ) 43 300 115
Interest expense (229 ) (186 ) (693 ) (716 )
Foreign currency exchange gain 470 73 1,200 665
Total other income (expenses) 245 (41 ) 894 99
INCOME BEFORE INCOME TAXES 4,175 4,548 18,164 17,633
PROVISION FOR INCOME TAXES 1,277 1,383 5,756 5,680
INCOME BEFORE EQUITY IN LOSS OF INVESTEE 2,898 3,165 12,408 11,953
EQUITY IN LOSS OF INVESTEE, NET OF TAX (36 ) (131 )
NET INCOME $ 2,862 $ 3,165 $ 12,277 $ 11,953
BASIC EARNINGS PER SHARE $ 0.20 $ 0.22 $ 0.86 $ 0.85
DILUTED EARNINGS PER SHARE $ 0.20 $ 0.22 $ 0.84 $ 0.84
SHARES – BASIC 14,352 14,123 14,315 14,108
SHARES – DILUTED 14,613 14,370 14,578 14,303

Contacts

Exactech
Investor contacts:
Jody Phillips, 352-377-1140
Executive Vice President of Finance & Chief Financial Officer
or
Priscilla Bennett, 352-377-1140
Priscilla@exac.com

RTI Surgical® Schedules 2017 Third Quarter Earnings Call for November 2, 2017

October 26, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, today announced that it plans to release financial results from the third quarter 2017 on Thursday, November 2, 2017 prior to the market open.

RTI will host a conference call and simultaneous audio webcast to discuss third quarter results at 8:30 a.m. ET the same day. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). 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 RTI’s website for one month 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 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.

Contacts

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

Alphatec Announces Preliminary Third Quarter 2017 Financial Results And Corporate Updates

CARLSBAD, Calif., Oct. 24, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec” or the “Company”) (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced preliminary estimates of financial results for the third quarter ended September 30, 2017.  The Company also announced several corporate updates.

Preliminary, Unaudited Third Quarter 2017 Financial Results

  • Total revenue of $22.8 million to $23.1 million
  • U.S. commercial revenue of $20.4 million to $20.7 million
  • U.S. commercial gross margin of 68% to 69%
  • Total operating expenses decreased to a range of $15.7 million to $16.0 million
  • Cash burn improved to approximately $3.7 million; cash balance of approximately $15.4 million at September 30, 2017

“Third quarter revenue was down sequentially due to the impacts of the hurricanes in Texas, Florida, and Puerto Rico, and fewer selling days in the quarter,” said Terry Rich, Alphatec’s Chief Executive Officer. “In spite of the weather-related challenges, we successfully managed operating expenses and substantially decreased cash burn for a fourth consecutive quarter.  As well, with the momentum we are experiencing in our sales channel, we expect to drive sequential revenue growth in the fourth quarter.”

The Company will report final third quarter 2017 financial results and will hold a conference call on Thursday, November 9, 2017, at 1:30 p.m. PT / 4:30 p.m. ET to discuss the results. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. The conference ID number is 4698936. A live webcast of the conference call will be available online from the investor relations page of the Company’s corporate website at www.atecspine.com.

A replay of the webcast will remain available on the Company’s website, www.atecspine.com, until the Company releases its fourth quarter and full year 2017 financial results. In addition, a telephonic replay of the call will be available until November 16, 2017. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the replay conference ID number 4698936.

Ward W. Woods Appointed to Board of Directors

Alphatec has appointed Ward W. Woods to its board, adding his decades of capital markets and business expertise. Mr. Woods is former President and Chief Executive Officer of Bessemer Securities Corporation and Founding Partner of Bessemer Holdings, L.P., a private equity firm, a senior partner and member of the Management Committee of Lazard Freres & Company, and Managing Director, Partner and co-head of the Corporate Finance Department at Lehman Brothers. Mr. Woods currently serves as Chairman of the Advisory Board of the Stanford Woods Institute, as Chair Emeritus and trustee of the Wildlife Conservation Society and as a trustee of the David & Lucille Packard Foundation. He is a former Trustee of Stanford University, former Chairman of The Stanford Management Company and a former trustee of the National Fish and Wildlife Foundation. Mr. Woods has also served as former Governor and Treasurer of The Nature Conservancy, Vice-Chair and trustee of The Asia Society and a trustee of The Boys Club of New York.  Mr. Woods graduated from Stanford University.

“The new leadership team at Alphatec has begun to execute an important mission to improve patient outcomes and expand market share. I look forward to contributing to the Company’s advancement into a major spine market player,” said Woods.

Mike Plunkett, President and Chief Operating Officer Resigns

On October 18, 2017, the Company accepted the resignation of its President and Chief Operating Officer, Mike Plunkett, who is stepping down from his position to pursue other interests. Mr. Plunkett’s resignation is effective as of November 15, 2017, and it is anticipated that he will remain available to the Company in a consulting capacity through the end of 2017 to transition his duties.

Mr. Rich stated, “Mike has contributed solidly to the commencement of the Alphatec transformation.  We sincerely appreciate his years of service and leadership, and wish him the best in his future endeavors.”

Shelf Registration Filed

Alphatec has filed a shelf registration statement with the Securities and Exchange Commission (SEC).  The filing will register up to $100 million in aggregate of equity, debt, or other types of securities described in the registration statement in one or more offerings.  The terms of any future offering will be established at the time of the offering, subject to market conditions and approval by the Company’s board of directors.  Each time securities are offered and sold, the Company will provide a supplement to the registration statement with specific information about the offering and the amounts, prices, and terms of the securities. The supplement may also add, update or change information contained in the registration statement. The filing may enable the Company to offer and sell securities on an expedited basis if market opportunities present themselves.

A registration statement relating to these securities has been filed with the SEC, but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted prior to the time the registration statement becomes effective. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities, and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.
Additional information can be found at www.atecspine.com.

Disclosure Regarding Preliminary Unaudited Results

The preliminary financial results presented above reflect Alphatec’s estimates based solely upon information available to it as of the date hereof, is not a comprehensive statement of its financial results or position as of or for the three months ended September 30, 2017, and has not been audited, reviewed or compiled by its independent registered public accounting firm, Mayer Hoffman McCann P.C. (“MHM”). Accordingly, MHM does not express an opinion or any other form of assurance with respect thereto. Alphatec’s actual third quarter results may differ materially from these estimates. Accordingly, investors should not place undue reliance upon these estimates

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the  Securities and Exchange Commission. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:
Zack Kubow
The Ruth Group
(646) 536-7000
alphatec@theruthgroup.com

Company Contact:
Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
(760) 431-9286
Investorrelations@alphatecspine.com