Orthofix Reports Second Quarter 2018 Financial Results

August 06, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (previously Orthofix International N.V.) (NASDAQ:OFIX) today reported its financial results for the second quarter ended June 30, 2018. Net sales were $111.5 million, diluted earnings per share from continuing operations was $0.05 and adjusted earnings per share from continuing operations was $0.42.

“During the second quarter, we made excellent progress on our operating and margin improvement goals despite the impact of unexpected currency headwinds and order timing on topline growth,” commented Brad Mason, Orthofix president and Chief Executive Officer. “Adjusted EBITDA performance in the period demonstrated our progress in driving efficiency to reduce operating expenses and achieve our stated goal of increasing Adjusted EBITDA margin in our organic business by at least 100 basis points this year and in each of the next two years. Operationally, we completed the acquisition and integration of Spinal Kinetics, realigned our business unit structure to help further accelerate long-term growth, positioned the company for the move of our corporate domicile from Curaçao to Delaware, that was completed July 31st, and significantly reduced inventories (excluding Spinal Kinetics) over prior year. We anticipate that these accomplishments will benefit Orthofix for many years to come.”

Corporate Realignment and Domestication to Delaware

In June, the Company realigned its four strategic business units around two pillars, Spine and Extremities. The distribution, branding and leadership of our bone growth therapy, spinal implants, biologics and Spinal Kinetics business units are being combined into one Orthofix Global Spine business to maximize opportunities from the acquisition of Spinal Kinetics and, in the long-term, better leverage the full spine portfolio to achieve both revenue acceleration and cost synergies.

On July 31, subsequent to shareholder approval, the Company’s corporate domicile was moved from Curaçao to Delaware. As a result of this transition, we are reducing our non-GAAP long-term effective tax rate from 35% to 29%, simplifying our operational structure and improving financial flexibility. Additionally, the name of the Company was changed from Orthofix International N.V. to Orthofix Medical Inc.

Financial Results Overview

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

Three Months Ended June 30,
(Unaudited, U.S. Dollars, in thousands) 2018 2017 Change Constant

Currency

Change

BioStim $ 48,211 $ 47,174 2.2 % 2.2 %
Spine Fixation 23,880 21,360 11.8 % 11.3 %
Biologics 14,668 15,661 (6.3 %) (6.3 %)
Extremity Fixation 24,788 24,747 0.2 % (4.0 %)
Net sales $ 111,547 $ 108,942 2.4 % 1.3 %

 

Gross margin increased 80 basis points compared to the prior year period primarily driven by continued improvement related to inventory management initiatives, partially offset by the addition of Spinal Kinetics acquisition-related inventory fair value adjustments. Non-GAAP net margin, an internal metric that the Company defines as gross profit less sales and marketing expenses, was $37.2 million compared to $35.3 million in the prior year period. As a percentage of net sales, non-GAAP net margin increased to 33.3% as compared to 32.4% in the prior year period, primarily due to the improvement in gross margin.

Net income from continuing operations was $0.9 million, or $0.05 per share, compared to $4.7 million, or $0.26 per share in the prior year period. Adjusted net income from continuing operations was $7.9 million, or $0.42 per share, compared to adjusted net income of $7.8 million, or $0.42 per share in the prior year period. Excluding the impact of the Spinal Kinetics operating loss in the period, adjusted net income was $8.5 million, or $0.45 per share, a 7.1% increase over prior year.

EBITDA was $6.8 million, compared to $14.0 million in the prior year period. Adjusted EBITDA was $22.0 million, or 19.7% of net sales, for the second quarter, compared to $20.5 million, or 18.8% of net sales, in the prior year period.

Liquidity

As of June 30, 2018, cash and cash equivalents were $45.7 million compared to $81.2 million as of December 31, 2017. As of June 30, 2018, the Company had no outstanding indebtedness and borrowing capacity of $125 million under its existing credit facility. Cash flow from operations was $13.0 million, an increase of $17.7 million, and free cash flow was 6.4 million, an increase of $19.6 million when compared to the same prior year period.

2018 Updated Outlook

For the year ending December 31, 2018, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.

(Unaudited, U.S. Dollars, in millions, except per share data) Low High Low High
Previous Full Year 2018 Outlook Full Year 2018 Outlook
Net sales $ 458.0 $ 464.0 $ 450.0 (1 ) $ 456.0 (1 )
Net income from continuing operations $ 24.8 $ 27.1 $ 18.3 (2 ) $ 19.7 (2 )
Adjusted EBITDA $ 85.5 $ 88.0 $ 85.0 (3 ) $ 87.0 (3 )
EPS from continuing operations $ 1.31 $ 1.43 $ 0.97 (4 ) $ 1.04 (4 )
Adjusted EPS from continuing operations9 $ 1.58 $ 1.68 $ 1.66 (5 ) $ 1.72 (5 )
3rd Quarter of 2018 Outlook
Net sales $ 110.0 (6 ) $ 113.0 (6 )
EPS from continuing operations $ 0.18 (7 ) $ 0.22 (7 )
Adjusted EPS from continuing operations9 $ 0.35 (8 ) $ 0.37 (8 )

1 Represents a year-over-year increase of 3.7% to 5.1% on a reported basis

2 Represents a year-over-year increase of 151.0% to 170.2%

3 Represents a year-over-year increase of 4.2% to 6.7%

4 Represents a year-over-year increase of 148.7% to 166.7%

5 Represents a year-over-year increase of 2.5% to 6.2%

6 Represents a year-over-year increase of 4.5% to 7.4% on a reported basis

7 Represents a year-over-year increase of 0.0% to 22.2%

8 Represents a year-over-year decrease of 16.7% to 11.9%

9 Calculated using a non-GAAP tax rate of 35% for the first and second quarters of 2018 and 29% for the third and fourth quarters of 2018 to reflect the expected impact of changing the Company’s jurisdiction of organization from Curaçao to the State of Delaware

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company’s financial results for the second quarter of 2018. 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 5556977. 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 5556977. 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 Medical Inc. is a global medical device company focused on musculoskeletal products and therapies. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic extremities products are distributed in over seventy countries via the Company’s sales representatives and distributors. 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, 2017 and other SEC filings, to reflect new information, the occurrence of future events or circumstances or otherwise.

ORTHOFIX MEDICAL INC.
Condensed Consolidated Statements of Income
Three Months Ended Six Months Ended
June 30, June 30,
(Unaudited, U.S. Dollars, in thousands, except share and per share data) 2018 2017 2018 2017
Net sales $ 111,547 $ 108,942 $ 220,256 $ 211,680
Cost of sales 22,835 23,177 46,982 45,758
Gross profit 88,712 85,765 173,274 165,922
Sales and marketing 51,529 50,471 101,797 99,003
General and administrative 22,268 20,409 41,752 38,691
Research and development 7,891 6,887 14,828 14,311
Operating income 7,024 7,998 14,897 13,917
Interest income (expense), net (251 ) 76 (434 ) 121
Other income (expense), net (4,752 ) 585 (1,840 ) (3,763 )
Income before income taxes 2,021 8,659 12,623 10,275
Income tax expense (1,088 ) (3,924 ) (6,461 ) (7,848 )
Net income from continuing operations 933 4,735 6,162 2,427
Discontinued operations
Loss from discontinued operations (1,300 ) (3 ) (1,827 )
Income tax benefit (expense) (8 ) 418 (8 ) 599
Net loss from discontinued operations (8 ) (882 ) (11 ) (1,228 )
Net income $ 925 $ 3,853 $ 6,151 $ 1,199
Net income per common share—basic
Net income from continuing operations $ 0.05 $ 0.26 $ 0.33 $ 0.13
Net loss from discontinued operations (0.05 ) (0.06 )
Net income per common share—basic $ 0.05 $ 0.21 $ 0.33 $ 0.07
Net income per common share—diluted
Net income from continuing operations $ 0.05 $ 0.26 $ 0.32 $ 0.13
Net loss from discontinued operations (0.05 ) (0.06 )
Net income per common share—diluted $ 0.05 $ 0.21 $ 0.32 $ 0.07
Weighted average number of common shares:
Basic 18,413,756 18,050,551 18,409,331 18,015,308
Diluted 18,835,560 18,343,038 18,811,356 18,288,050

 

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DJO Global Announces Financial Results for Second Quarter 2018

August 06, 2018

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced financial results for its public reporting subsidiary, DJO Finance LLC (“DJOFL”), for the second quarter ended June 30, 2018.

On January 1, 2018, DJO adopted Accounting Standards Update 2014-09, Revenue From Contracts with Customers, (ASC 606). As a result of the adoption, in the second quarter the Company reclassified $5.4 million of year-to-date costs from selling, general and administrative costs to net sales. The table below summarizes net sales and growth rates with, and without, the adoption of ASC 606.

$000’s

Q2 2018 Net Sales Overview

Including ASC 606 Adoption Excluding ASC 606 Adoption Currency Constant
Revenue Growth Revenue Growth Impact Currency
Surgical $ 53,918 7.9 % $ 53,918 7.9 % 0.0 % 7.9 %
International 86,953 9.3 % 86,953 9.3 % 5.8 % 3.5 %
Recovery Sciences 37,454 -3.4 % 37,454 -3.4 % 0.0 % -3.4 %
Bracing and Vascular 126,512 0.1 % 131,942 4.4 % 0.0 % 4.4 %
Total DJO Global $ 304,837 3.4 % $ 310,267 5.3 % 1.6 % 3.7 %

Second Quarter Highlights

  • Net sales grew 5.3% to $310.3 million, or $304.8 million as reported with the adoption of ASC 606, compared to $294.7 million in the prior year period.
  • Operating income increased 296% to $35.8 million from $9.0 million in the prior year period.
  • Net loss attributable to DJOFL was $13.7 million, compared to a net loss of $34.4 million in the prior year period.
  • Adjusted EBITDA continued to expand, increasing 19.0% over the prior year quarter to $75.6 million.

Business Transformation

  • The previously announced business transformation continues to drive profitability, pushing Adjusted EBITDA margins up 280 basis points (excluding the impact of ASC 606 adoption) in the second quarter of 2018 compared to the prior year, and remains on track to deliver 7% to 10% annual cost reductions by end of 2018.
  • Including $24.8 million in future annual run-rate savings from transformation actions taken to date, Adjusted EBITDA for the twelve months ended June 30 was $312.6 million.

“We executed well in the second quarter, continuing to deliver sustainable value from our transformation efforts, accelerating new product introductions and overcoming market headwinds on elective procedures,” said Brady Shirley, DJO’s President and Chief Executive Officer. “I am encouraged by the momentum in our revenue growth and expanding margins, and continue to anticipate a stronger trajectory for the balance of our fiscal year.”

Mike Eklund, Chief Financial Officer and Chief Operating Officer of DJO, added, “We continue to work aggressively toward our profitability goals and are realizing the benefits, with Adjusted EBITDA for the quarter increasing 19%, or 3.6 times the growth in revenue, and margins improving about 280 basis points. Our team has worked hard on our transformation initiatives to improve operational efficiency, service levels and customer experience. This quarter’s financial metrics are continued indicators of our success.”

Sales Results

Net sales for DJOFL for the second quarter of 2018 were $310.3 million, an increase of 5.3% from the prior year period, or $304.8 million with the adoption of ASC 606. On a constant currency basis, sales increased 3.7%. For the six months ending June 30, 2018, net sales increased 3.4% to $602.9 million, or $597.5 million with the adoption of ASC 606. On a constant currency basis, net sales for the first half of 2018 increased 1.1% over net sales in the first half of 2017. The number of selling days in the quarter was the same as in the prior year period.

Net sales for DJO’s Surgical Implant segment grew 7.9% in the quarter to $53.9 million. The company’s shoulder implant product line was a key contributor with strong double-digit growth compared to the same quarter in the prior year. For the six months ending June 30, 2018, the Surgical Implant segment grew 8.0% over the prior year period to $107.5 million.

Net sales for DJO’s International segment grew 9.3% in the second quarter to $87.0 million, or 3.5% on a constant currency basis. The company’s sales growth in Germany, France and Australia were partially offset by market conditions in Canada and the United Kingdom. For the six months ending June 30, 2018, the International segment revenue was $175.6 million, an increase of 11.3%, or 2.8% on a constant currency basis.

Net sales for DJO’s Recovery Sciences segment were $37.5 million in the second quarter, a year-over-year decrease of 3.4%. Strong growth in the segment’s Regeneration CMF product line was offset by softness in the Chattanooga product line compared to the prior year period. For the six months ending June 30, 2018, the Recovery Sciences segment declined 5.1% to $73.3 million.

Net sales for DJO’s Bracing and Vascular segment grew 4.4% to $131.9 million in the second quarter, or $126.5 with the adoption of ASC 606. There was strong growth in the segment’s DonJoy product line, partially offset by weakness in the Dr. Comfort footwear product line. Strong demand for new products, strength in acute care and continued progress in transformation initiatives to improve service levels contributed to the results. For the six months ending June 30, 2018, Bracing and Vascular net sales were $246.4 million, a decline of 0.8% from the first half of 2017, or $241.0 million with the adoption of ASC 606.

Earnings Results

Operating income was $35.8 million in the quarter, an increase of 296% over the prior year period. For the six months ending June 30, 2018, operating income was $69.3 million, an increase of 341% over the prior year. Net loss attributable to DJOFL was $13.7 million in the quarter compared to $34.4 million in the prior year period. For the six months ended June 30, net loss was $31.3 million compared to $74.4 million in the six month ended July 1, 2017.

Adjusted EBITDA for the second quarter was $75.6 million, an increase of 19.0% from the prior year period, or 17.0% on the basis of constant currency. For the six months ended June 30, 2018, Adjusted EBITDA was $140.4 million, up 16.2% from the prior year, or 14.5% on a constant currency basis. Including projected future run-rate savings of $24.8 million from cost savings programs currently underway as permitted under our credit agreement and the indentures governing our outstanding notes, Adjusted EBITDA for the twelve months ended June 30, 2018 was $312.6 million.

Net cash provided by continuing operating activities was $9.0 million for the six months ended June 30, 2018 compared to $38.1 million for the six months ended July 1, 2017. The change in cash flow was primarily attributable to higher inventory balances to allow for the modernization and consolidation of distribution facilities as part of the Company’s transformation initiatives, and to the payment in 2018 of certain non-recurring costs accrued in 2017.

The Company defines Adjusted EBITDA as net (loss) income attributable to DJOFL plus net interest expense, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance under the Company’s secured term loan and revolving credit facilities (“Senior Secured Credit Facilities”) and the indentures governing its 8.125% second lien notes and its 10.75% third lien notes. A reconciliation between net loss attributable to DJOFL and Adjusted EBITDA is included in the attached financial tables.

Conference Call Information

DJO has scheduled a conference call to discuss this announcement beginning at 4:30 pm, Eastern Time Monday, August 6, 2018. Individuals interested in listening to the conference call may do so by dialing (866) 394-8509 (International callers please use (346) 265-0698), using the reservation code 22322226. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (855) 859-2056 and using the above reservation code. The live conference call and replay will be available via the Internet at www.DJOglobal.com.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and ExosTM. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for improved liquidity, estimated cost reductions associated with the execution of its business transformation plans and improved efficiencies. The words “believe,” “will,” “should,” “expect,” “target,” “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. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. 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 successful execution of the Company’s business transformation plans, including achievement of planned actions to improve liquidity, improvements in operational effectiveness, optimization of the Company’s procurement activities, improvements in manufacturing, distribution, sales and operations planning, and actions to improve the profitability of the mix of our product and customers. Other 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: business strategies relative to our Bracing and Vascular, Recovery Sciences, International and Surgical Implant segments; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payers; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission on March 16, 2018. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

DJO FINANCE LLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands)
Three Months Ended Six Months Ended

June 30,
2018

July 1,
2017

June 30,
2018

July 1,
2017

Net sales $ 304,837 $ 294,746 $ 597,466 $ 583,135
Operating expenses:
Cost of sales (exclusive of amortization of intangible assets of $6,635 and $13,293 for the three and six months ended June 30, 2018, respectively and $6,980 and $13,961 for the three and six months ended July 1, 2017, respectively) 126,443 124,885 246,379 244,454
Selling, general and administrative 117,626 135,739 232,942 269,901
Research and development 9,707 9,063 18,988 18,202
Amortization of intangible assets 15,289 16,016 29,888 34,861
269,065 285,703 528,197 567,418
Operating income 35,772 9,043 69,269 15,717
Other (expense) income:
Interest expense, net (45,779 ) (43,068 ) (89,701 ) (85,755 )
Other (expense) income, net 1,054 896 (487 ) 1,184
(44,725 ) (42,172 ) (90,188 ) (84,571 )
Loss before income taxes (8,953 ) (33,129 ) (20,919 ) (68,854 )
Income tax provision 4,635 1,095 10,019 5,173
Net loss from continuing operations (13,588 ) (34,224 ) (30,938 ) (74,027 )
Net income from discontinued operations 178 47 321 105
Net loss (13,410 ) (34,177 ) (30,617 ) (73,922 )
Net income attributable to noncontrolling interests (276 ) (206 ) (638 ) (430 )
Net loss attributable to DJO Finance LLC $ (13,686 ) $ (34,383 ) $ (31,255 ) $ (74,352 )

DJO FINANCE LLC

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

June 30,
2018

December 31,
2017

ASSETS
Current assets:
Cash and cash equivalents $ 26,789 $ 31,985
Accounts receivable, net 179,611 190,324
Inventories, net 177,273 169,137
Prepaid expenses and other current assets 32,144 20,218
Current assets of discontinued operations 511 511
Total current assets 416,328 412,175
Property and equipment, net 137,496 133,522
Goodwill 878,963 864,112
Intangible assets, net 585,268 607,088
Other assets 5,242 5,128
Total assets $ 2,023,297 $ 2,022,025
LIABILITIES AND DEFICIT
Current liabilities:
Accounts payable $ 105,144 $ 98,331
Accrued interest 18,615 18,015
Current portion of debt obligations 26,022 15,936
Other current liabilities 116,071 126,360
Total current liabilities 265,852 258,642
Long-term debt obligations 2,414,519 2,398,184
Deferred tax liabilities, net 146,108 142,597
Other long-term liabilities 20,968 13,080
Total liabilities $ 2,847,447 $ 2,812,503
Commitments and contingencies (Note 14)
Deficit:
DJO Finance LLC membership deficit:
Member capital 845,708 844,115
Accumulated deficit (1,646,850 ) (1,615,536 )
Accumulated other comprehensive loss (25,579 ) (21,072 )
Total membership deficit (826,721 ) (792,493 )
Noncontrolling interests 2,571 2,015
Total deficit (824,150 ) (790,478 )
Total liabilities and deficit $ 2,023,297 $ 2,022,025

See accompanying Notes to Unaudited Condensed Consolidated Financial Statements.

DJO FINANCE LLC

UNAUDITED SEGMENT INFORMATION

(in thousands)

Three Months Ended Six Months Ended

June 30,
2018

July 1,
2017

June 30,
2018

July 1,
2017

Net sales:
Bracing and Vascular $ 126,512 $ 126,415 $ 241,001 $ 248,468
Recovery Sciences 37,454 38,774 73,347 77,277
Surgical Implant 53,918 49,991 107,537 99,583
International 86,953 79,566 175,581 157,807
$ 304,837 $ 294,746 $ 597,466 $ 583,135
Operating income:
Bracing and Vascular $ 29,257 $ 24,225 $ 49,255 $ 45,232
Recovery Sciences 9,656 10,709 18,249 19,616
Surgical Implant 11,166 10,062 22,930 18,202
International 19,436 13,509 38,849 27,119
Expenses not allocated to segments and eliminations (33,743 ) (49,462 ) (60,014 ) (94,452 )
$ 35,772 $ 9,043 $ 69,269 $ 15,717

DJO Finance LLC
Adjusted EBITDA

For the Six Months Ended June 30, 2018 and July 1, 2017
(unaudited)

Our Senior Secured Credit Facilities, consisting of a $1,055.0 million term loan facility (including a $20.0 million delayed draw term loan facility) and a $150.0 million asset-based revolving credit facility, under which $87.5 million was outstanding as of June 30, 2018, and the Indentures governing our $1,015.0 million of 8.125% second lien notes and $298.5 million of 10.75% third lien notes (collectively, the “notes”) represent significant components of our capital structure. Under our Senior Secured Credit Facilities, we are required to maintain a specified senior secured first lien leverage ratio, which is determined based on our Adjusted EBITDA. If we fail to comply with the senior secured first lien leverage ratio under our Senior Secured Credit Facilities, we would be in default. Upon the occurrence of an event of default under the Senior Secured Credit Facilities, the lenders could elect to declare all amounts outstanding under the Senior Secured Credit Facilities to be immediately due and payable and terminate all commitments to extend further credit. If we were unable to repay those amounts, the lenders under the Senior Secured Credit Facilities could proceed against the collateral granted to them to secure that indebtedness. We have pledged substantially all of our assets as collateral under the Senior Secured Credit Facilities and under the notes. Any acceleration under the Senior Secured Credit Facilities would also result in a default under the Indentures governing the notes, which could lead to the note holders electing to declare the principal, premium, if any, and interest on the then outstanding notes immediately due and payable. In addition, under the Indentures governing the notes, our and our subsidiaries’ ability to engage in activities such as incurring additional indebtedness, making investments, refinancing subordinated indebtedness, paying dividends and entering into certain merger transactions is governed, in part, by our ability to satisfy tests based on Adjusted EBITDA. Our ability to meet the covenants specified in the Senior Secured Credit Facilities and the Indentures governing those notes will depend on future events, some of which are beyond our control, and we cannot assure you that we will meet those covenants.

Adjusted EBITDA is defined as net income (loss) attributable to DJOFL plus interest expense, net, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance and other ratios under our Senior Secured Credit Facilities and the Indentures governing the notes. We believe that the presentation of Adjusted EBITDA is appropriate to provide additional information to investors about the calculation of, and compliance with, certain financial covenants and other ratios in our Senior Secured Credit Facilities and the Indentures governing the notes. Adjusted EBITDA is a material component of these calculations.

Adjusted EBITDA should not be considered as an alternative to net income (loss) attributable to DJOFL or other performance measures presented in accordance with accounting principles generally accepted in the United States of America (“GAAP”), or as an alternative to cash flow from operations as a measure of our liquidity. Adjusted EBITDA does not represent net income (loss) attributable to DJOFL or cash flow from operations as those terms are defined by GAAP and does not necessarily indicate whether cash flows will be sufficient to fund cash needs. In particular, the definition of Adjusted EBITDA under our Senior Secured Credit Facilities and the Indentures governing the notes allows us to add back certain non-cash, extraordinary, unusual or non-recurring charges that are deducted in calculating net income (loss) attributable to DJOFL. However, these are expenses that may recur, vary greatly and are difficult to predict. While Adjusted EBITDA and similar measures are frequently used as measures of operations and the ability to meet debt service requirements, Adjusted EBITDA is not necessarily comparable to other similarly titled captions of other companies due to the potential inconsistencies in the method of calculation.

The following table provides reconciliation between net income (loss) attributable to DJOFL and Adjusted EBITDA (in thousands):

Twelve
Months
Three Months Ended Six Months Ended Ended
June 30, July 1, June 30, July 1, June 30,
2018 2017 2018 2017 2018
Net loss attributable to DJO Finance LLC $ (13,686 ) $ (34,383 ) $ (31,255 ) $ (74,352 ) $ 7,203
Income loss from discontinued operations, net (178 ) (47 ) (321 ) (105 ) (525 )
Interest expense, net 45,779 43,068 89,701 85,755 178,184
Income tax provision (benefit) 4,635 1,095 10,019 5,173 (55,873 )
Depreciation and amortization 27,871 26,942 53,376 56,716 107,921
Non-cash charges (a) 524 537 749 1,108 4,742
Non-recurring and integration charges (b) 10,737 25,195 16,257 43,584 41,922
Other adjustment items (c) (68 ) 1,142 1,888 2,911 4,242
75,614 63,549 140,414 120,790 287,816
Permitted pro forma adjustments applicable to the twelve-month period only – Note 1
Future cost savings 24,810
Adjusted EBITDA $ 75,614 $ 63,549 $ 140,414 $ 120,790 $ 312,626

________________________________________

Note 1 — Permitted pro forma adjustments include future cost savings from cost reduction actions related to our business transformation initiative, recognized as permitted under our credit agreement and the indentures governing our notes.

(a) Non-cash charges are comprised of the following (in thousands):

Twelve
Months
Three Months Ended Six Months Ended Ended
June 30, July 1, June 30, July 1, June 30,
2018 2017 2018 2017 2018
Stock compensation expense $ 447 $ 392 $ 895 $ 846 $ 3,745
(Gain) loss on disposal of fixed assets and assets held for sale, net 77 145 (146 ) 262 997
Total non-cash charges $ 524 $ 537 $ 749 $ 1,108 $ 4,742

(b) Non-recurring and integration charges are comprised of the following (in thousands):

Twelve
Months
Three Months Ended Six Months Ended Ended
June 30, July 1, June 30, July 1, June 30,
2018 2017 2018 2017 2018
Restructuring and reorganization (1) $ 7,823 $ 23,273 $ 11,492 $ 39,069 $ 32,665
Acquisition related expenses and integration (2) 379 277 749 579 2,276
Executive transition (49 ) (49 )
Litigation and regulatory costs and settlements, net 2,535 1,290 4,016 3,392 6,881
IT automation projects 404 593 100
Total non-recurring and integration charges $ 10,737 $ 25,195 $ 16,257 $ 43,584 $ 41,922

(1) Consist of costs related to the Company’s business transformation projects to improve the Company’s operational profitability and liquidity.
(2) Consists of direct acquisition costs and integration expenses related to acquired businesses and costs related to potential acquisitions.

(c) Other adjustment items before permitted pro forma adjustments are comprised of the following (in thousands):

Twelve
Months
Three Months Ended Six Months Ended Ended
June 30, July 1, June 30, July 1, June 30,
2018 2017 2018 2017 2018
Blackstone monitoring fees $ $ 1,750 $ $ 3,500 $ 2,725
Non-controlling interests 276 206 638 430 1,007
Foreign currency transaction losses (gains) and other expense (income) (1,054 ) 487 (444 )
Franchise and other tax 710 763 954
Other (1) (814 ) (1,019 )
Total other adjustment items $ (68 ) $ 1,142 $ 1,888 $ 2,911 $ 4,242

(1) Other adjustments consist primarily of net realized and unrealized foreign currency translation gains and losses.

Contacts

DJO Investor/Media Contact:
DJO Global, Inc.
David Smith
SVP and Treasurer
760.734.3075
ir@djoglobal.com

TransEnterix, Inc. Reports Operating and Financial Results for the Second Quarter 2018

August 07, 2018

RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)–TransEnterix, Inc. (NYSE American:TRXC), a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery, today announced its operating and financial results for the second quarter 2018.

Recent Highlights

  • Total revenue of $6.4 million, including the sale of four Senhance Systems
  • Received FDA clearance for expanded indications for use for Senhance System
  • Filed FDA 510(k) submission for additional Senhance System Instruments including 3mm diameter instruments
  • Entered into financing agreement providing the company with up to $40 million in term loans

“Our performance during the second quarter was solid as we continued to drive system sales both in the U.S. and abroad, while simultaneously making significant progress towards our 2018 goals, including the expansion of Senhance’s indications for use and broadening our portfolio of instruments,” said Todd M. Pope, President and CEO at TransEnterix. “We look forward to leveraging the significant progress we made during the first half of the year to drive increased global adoption of our Senhance System.”

Commercial and Clinical Update

In the quarter ended June 30, 2018, the Company sold four Senhance Systems, with one sold in the U.S. and three sold in the EMEA (Europe, Middle East, and Africa) region.

On May 29, 2018, the Company received FDA 510(k) clearance for expanded indications of its Senhance System for laparoscopic inguinal hernia and laparoscopic cholecystectomy (gallbladder removal) surgery. There are approximately 760,000 inguinal hernia and 1.2 million laparoscopic cholecystectomy procedures performed annually in the U.S. With this clearance, Senhance System’s total addressable annual procedures in the U.S. has more than doubled to over three million.

On June 7, 2018, the Company announced that it had filed an FDA 510(k) submission for additional Senhance System instruments, including 3 millimeter diameter instruments.

Second Quarter Financial Highlights

For the three months ended June 30, 2018, the Company reported revenue of $6.4 million as compared to revenue of $1.6 million in the three months ended June 30, 2017. Revenue in the second quarter of 2018 included $4.7 million in system sales, $1.5 million in instruments and accessories, and $200 thousand in services.

For the three months ended June 30, 2018, total net operating expenses were $18.5 million, as compared to $13.1 million in the three months ended June 30, 2017.

For the three months ended June 30, 2018, net loss was $34.2 million, or $0.17 per share, as compared to a net loss of $14.7 million, or $0.11 per share, in the three months ended June 30, 2017.

For the three months ended June 30, 2018, adjusted net loss was $11.7 million, or $0.06 per share, as compared to an adjusted net loss of $11.2 million, or $0.08 per share in the three months ended June 30, 2017, after adjusting for expenses related to the sale of SurgiBot assets, loss on extinguishment of debt, and non-cash charges for amortization of intangible assets, change in fair value of contingent consideration, and change in fair value of warrant liabilities.

On May 23, 2018, the Company entered into a loan and security agreement providing the company with up to $40.0 million in term loans. The initial tranche of the term loan, $20 million, was received at closing. The Company will be eligible to draw on the second tranche of $10 million upon achievement of certain Senhance System revenue-related milestones for its 2018 fiscal year, and a third tranche of $10 million upon achievement of designated trailing six months GAAP net revenue from Senhance sales. On the date of closing, the Company repaid all amounts owed under their previous loan provider.

The Company had cash and restricted cash of approximately $98.5 million as of June 30, 2018. The Company now anticipates that it has sufficient cash to fund the business into 2020, exclusive of the $20 million in potential future debt tranches.

Conference Call

TransEnterix, Inc. will host a conference call on Tuesday, August 7, 2018 at 8:30 AM ET to discuss its second quarter 2018 operating and financial results. To listen to the conference call on your telephone, please dial (844) 804-5261 for domestic callers or (612) 979-9885 for international callers and reference conference ID 4388237 approximately ten minutes prior to the start time. To access the live audio webcast or archived recording, use the following link http://ir.transenterix.com/events.cfm. The replay will be available on the Company’s website.

About TransEnterix

TransEnterix is a medical device company that is digitizing the interface between the surgeon and the patient to improve minimally invasive surgery by addressing the clinical and economic challenges associated with current laparoscopic and robotic options in today’s value-based healthcare environment. The Company is focused on the commercialization of the Senhance™ Surgical System, which digitizes laparoscopic minimally invasive surgery. The system allows for robotic precision, haptic feedback, surgeon camera control via eye sensing and improved ergonomics while offering responsible economics. The Senhance Surgical System is available for sale in the US, the EU and select other countries. For more information, visit www.transenterix.com.

Non-GAAP Measures

The adjusted net loss and adjusted net loss per share presented in this press release are non-GAAP measures. The adjustments relate to the gain from sale `of SurgiBot assets, amortization of intangible assets, change in fair value of contingent consideration, change in fair value of warrant liabilities, and loss on extinguishment of debt. These financial measures are presented on a basis other than in accordance with U.S. generally accepted accounting principles (“Non-GAAP Measures”). In the tables that follow under “Reconciliation of Non-GAAP Measures,” we present adjusted net loss and adjusted net loss per share, reconciled to their comparable GAAP measures. These items are adjusted because they are not operational or because these charges are non-cash or non-recurring and management believes these adjustments are meaningful to understanding the Company’s performance during the periods presented. These Non-GAAP Measures should be considered a supplement to, not a substitute for, or superior to, the corresponding financial measures calculated in accordance with GAAP.

Forward-Looking Statements

This press release includes statements relating to the 2018 second quarter results and plans for 2018 and beyond. These statements and other statements regarding our future plans and goals constitute “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, and are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties that are often difficult to predict, are beyond our control and which may cause results to differ materially from expectations and include whether we have made significant progress towards our 2018 goals, including the expansion of Senhance’s indications for use and broadening our portfolio of instruments; whether we can leverage the significant progress from the first half of the year to drive increased global adoption of our Senhance System and whether the Company has sufficient cash to fund the business into 2020, exclusive of the $20 million in potential future debt tranches. For a discussion of the risks and uncertainties associated with TransEnterix’s business, please review our filings with the Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2017, filed with the SEC on March 8, 2018 and our other filings we make with the SEC. You are cautioned not to place undue reliance on these forward looking statements, which are based on our expectations as of the date of this press release and speak only as of the origination date of this press release. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

TransEnterix, Inc.

Consolidated Statements of Operations and Comprehensive Loss
(in thousands except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2018 2017 2018 2017
Revenue $ 6,389 $ 1,584 $ 11,156 $ 3,530
Cost of revenue 3,732 972 6,287 2,306
Gross profit 2,657 612 4,869 1,224
Operating Expenses (Income)
Research and development 5,281 5,070 10,546 11,925
Sales and marketing 6,046 3,749 12,016 7,472
General and administrative 3,627 2,719 6,303 5,768
Amortization of intangible assets 2,743 1,687 5,570 3,323
Change in fair value of contingent consideration 812 (774 ) 1,439 453
Issuance costs for warrants 627 627
Gain from sale of SurgiBot assets, net 37 (11,959 )
Total Operating Expenses (Income) 18,546 13,078 23,915 29,568
Operating Loss (15,889 ) (12,466 ) (19,046 ) (28,344 )
Other Income (Expense)
Change in fair value of warrant liabilities (17,507 ) (2,326 ) (15,678 ) (2,326 )
Interest expense, net (1,736 ) (622 ) (2,122 ) (956 )
Other income (expense) 1 (40 ) (57 ) (100 )
Total Other Income (Expense), net (19,242 ) (2,988 ) (17,857 ) (3,382 )
Loss before income taxes $ (35,131 ) $ (15,454 ) $ (36,903 ) $ (31,726 )
Income tax benefit 883 741 1,773 1,599
Net loss $ (34,248 ) $ (14,713 ) $ (35,130 ) $ (30,127 )
Other comprehensive loss
Foreign currency translation (loss) gain (4,398 ) 5,430 (2,090 ) 6,563
Comprehensive loss $ (38,646 ) $ (9,283 ) $ (37,220 ) $ (23,564 )
Net loss per share – basic and diluted $ (0.17 ) $ (0.11 ) $ (0.17 ) $ (0.24 )

Weighted average common shares outstanding – basic and

diluted

204,504 132,386 202,214 127,052
TransEnterix, Inc.
Consolidated Balance Sheets
(in thousands, except share amounts)
June 30, December 31,
2018 2017
(unaudited)
Assets
Current Assets
Cash and cash equivalents $ 97,743 $ 91,217
Accounts receivable, net 2,210 1,536
Inventories 11,040 10,817
Interest receivable 104 80
Other current assets 7,243 9,344
Total Current Assets 118,340 112,994
Restricted cash 750 6,389
Property and equipment, net 6,676 6,670
Intellectual property, net 45,909 52,638
Goodwill 70,813 71,368
Other long term assets 259 192
Total Assets $ 242,747 $ 250,251
Liabilities and Stockholders’ Equity
Current Liabilities
Accounts payable $ 4,108 $ 3,771
Accrued expenses 10,270 10,974
Deferred revenue 1,083 1,088
Deferred gain from sale of SurgiBot assets 7,500
Contingent consideration – current portion 547 719
Notes payable – current portion, net of debt discount 4,788
Total Current Liabilities 16,008 28,840
Long Term Liabilities
Contingent consideration – less current portion 12,915 11,699
Notes payable – less current portion, net of debt discount 18,952 8,385
Warrant liabilities 22,708 14,090
Net deferred tax liabilities 6,446 8,389
Total Liabilities 77,029 71,403
Commitments and Contingencies
Stockholders’ Equity
Common stock $0.001 par value, 750,000,000 shares authorized at

June 30, 2018 and December 31, 2017; 207,712,291 and 199,282,003

shares issued and outstanding at June 30, 2018 and

December 31, 2017, respectively

207 199
Additional paid-in capital 645,332 621,261
Accumulated deficit (482,759 ) (447,640 )
Accumulated other comprehensive income 2,938 5,028
Total Stockholders’ Equity 165,718 178,848
Total Liabilities and Stockholders’ Equity $ 242,747 $ 250,251
TransEnterix, Inc.
Consolidated Statements of Cash Flows
(in thousands)
(Unaudited)
Six Months Ended
June 30,
2018 2017
Operating Activities
Net loss $ (35,130 ) $ (30,127 )
Adjustments to reconcile net loss to net cash and cash equivalents used in

operating activities:

Gain from sale of SurgiBot assets, net (11,959 )
Depreciation 1,277 1,142
Amortization of intangible assets 5,570 3,323
Amortization of debt discount and debt issuance costs 495 43
Stock-based compensation 4,204 3,679
Deferred tax benefit (1,799 ) (1,580 )
Loss on extinguishment of debt 1,400 308
Change in fair value of warrant liabilities 15,678 2,326
Change in fair value of contingent consideration 1,439 453
Changes in operating assets and liabilities:
Accounts receivable (762 ) (487 )
Interest receivable (24 ) 39
Inventories (1,560 ) (862 )
Other current and long term assets 1,905 (1,473 )
Accounts payable 404 (1,909 )
Accrued expenses (359 ) (390 )
Deferred revenue 31
Net cash and cash equivalents used in operating activities (19,190 ) (25,515 )
Investing Activities
Proceeds related to sale of SurgiBot assets, net 4,496
Purchase of property and equipment (358 ) (1,397 )
Purchase of intellectual property (398 )
Proceeds from sale of property and equipment 32
Net cash and cash equivalents provided by (used in) investing activities 4,170 (1,795 )
Financing Activities
Payment of notes payable (15,305 ) (13,343 )
Proceeds from issuance of debt and warrants, net of issuance costs 18,870 13,196
Payment of contingent consideration (395 )
Proceeds from issuance of common stock and warrants, net of issuance costs 2 29,193
Taxes paid related to net share settlement of vesting of restricted stock units (168 )
Proceeds from issuance of common stock related to sale of SurgiBot assets 3,000
Proceeds from exercise of stock options and warrants 9,813
Net cash and cash equivalents provided by financing activities 15,985 28,878
Effect of exchange rate changes on cash and cash equivalents (78 ) 2
Net increase in cash, cash equivalents and restricted cash 887 1,570
Cash, cash equivalents and restricted cash, beginning of period 97,606 34,590
Cash, cash equivalents and restricted cash, end of period $ 98,493 $ 36,160
Supplemental Disclosure for Cash Flow Information
Interest paid $ 599 $ 368
Supplemental Schedule of Noncash Investing and Financing Activities
Transfer of inventories to property and equipment $ 1,055 $
Issuance of common stock as contingent consideration $ $ 5,227
Relative fair value of warrants issued with debt $ $ 300
Reclass of warrant liability to common stock and additional paid-in capital $ 7,060 $
TransEnterix, Inc.
Reconciliation of Non-GAAP Measures
Adjusted Net Loss and Net Loss per Share
(in thousands except per share amounts)
(Unaudited)
Three Months Ended Six Months Ended
June 30, June 30,

2018

2017

2018

2017

(Unaudited, U.S. Dollars, in thousands)
Net loss $ (34,248) $ (14,713) $ (35,130) $ (30,127)
Adjustments
Gain from sale of SurgiBot assets, net 37 (11,959)
Amortization of intangible assets 2,743 1,687 5,570 3,323
Change in fair value of contingent consideration 812 (774) 1,439 453
Change in fair value of warrant liabilities 17,507 2,326 15,678 2,326
Loss on extinguishment of debt 1,400 308 1,400 308
Adjusted net loss $ (11,749) $ (11,166) $ (23,002) $ (23,717)
Three Months Ended Six Months Ended
June 30, June 30,
(Unaudited, per diluted share)

2018

2017

2018

2017

Net loss per share $ (0.17) $ (0.11) $ (0.17) $ (0.24)
Adjustments
Gain from sale of SurgiBot assets 0.00 (0.06)
Amortization of intangible assets 0.01 0.02 0.03 0.03
Change in fair value of contingent consideration 0.00 (0.01) 0.00 0.00
Change in fair value of warrant liabilities 0.09 0.02 0.08 0.02
Loss on extinguishment of debt 0.01 0.00 0.01 0.00
Adjusted net loss per share $ (0.06) $ (0.08) $ (0.11) $ (0.19)

The non-GAAP financial measures for the three and six months ended June 30, 2018 and 2017 provide management with additional insight into its results of operations and are calculated using the following adjustments:

a) Gain from sale of SurgiBot assets relates to amounts received from Great Belief International Limited in excess of the carrying amount of the assets sold.

b) Intangible assets that are amortized consist of developed technology and purchased patent rights recorded at cost and amortized over 5 to 10 years.

c) Contingent consideration in connection with the acquisition of the Senhance System in 2015 is recorded as a liability and is the estimate of the fair value of potential milestone payments related to business acquisitions. Contingent consideration is measured at fair value using a discounted cash flow model utilizing significant unobservable inputs including the probability of achieving each of the potential milestones and an estimated discount rate associated with the risks of the expected cash flows attributable to the various milestones. Significant increases or decreases in any of the probabilities of success or changes in expected timelines for achievement of any of these milestones would result in a significantly higher or lower fair value of these milestones, respectively, and commensurate changes to the associated liability. The contingent consideration is revalued at each reporting period and changes in fair value are recognized in the consolidated statements of operations and comprehensive loss.

d) The Company’s Series A and Series B Warrants are measured at fair value using a simulation model which takes into account, as of the valuation date, factors including the current exercise price, the expected life of the warrant, the current price of the underlying stock, its expected volatility, holding cost and the risk-free interest rate for the term of the warrant. The warrant liability is revalued at each reporting period and changes in fair value are recognized in the consolidated statements of operations and comprehensive loss.

e) In May 2018 in connection with its entrance into the Hercules Loan Agreement, the Company repaid its existing loan and security agreement with Innovatus Life Sciences Lending Fund I, LP. The Company recognized a loss of $1.4 million on the extinguishment of notes payable which is included in interest expense on the consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2018. In May 2017 in connection with its entrance into the Innovatus Loan Agreement, the Company repaid its then-existing credit facility with Silicon Valley Bank and Oxford Finance LLC. The Company recognized a loss of $308,000 on the extinguishment of notes payable which is included in interest expense on the consolidated statements of operations and comprehensive loss for the three and six months ended June 30, 2017.

Contacts

For TransEnterix, Inc.
Investors:
Mark Klausner, +1 443-213-0501
invest@transenterix.com
or
Media:
Joanna Rice, +1 951-751-1858
joanna@greymattermarketing.com

Fuse Medical, Inc. Completes Acquisition of Maxim Surgical

August 03, 2018

RICHARDSON, Texas–(BUSINESS WIRE)–Fuse Medical, Inc. (OTC: FZMD) (“Fuse” or the “Company”), announced the completion of the acquisition of Palm Springs Partners, LLC d/b/a Maxim Surgical (“Maxim”), a manufacturing company in the spinal fusion device market and full-service medical device and distribution company (the “Acquisition”). The effective date of Acquisition was August 1, 2018.

Formed in April 2011, Maxim designs and manufactures its own spinal interbody spacers and distributes a wide variety of spine, sports medicine, and biologics product lines. Inclusive in the Maxim portfolio of spinal implant products is the Maxim Surgical X-Treme Interbody Fusion System that previously received 510(k) clearance from the U.S. Food & Drug Administration (“FDA”). Maxim’s long-term strategy is to bring more innovative spinal implant products to market for retail and wholesale distribution.

Management Commentary on Acquisition

Christopher C. Reeg, Chief Executive Officer of Fuse said, “We are very excited that Maxim has become part of the Fuse family. Maxim’s portfolio of products bolsters our strategy of expanding Fuse into medical device design and manufacturing.”

“We believe that integrating Maxim with our operations will enhance Fuse’s earnings immediately and allow us to be even better positioned to meet our customers’ needs,” added Mr. Reeg.

About Fuse Medical, Inc.

Fuse provides a broad portfolio of orthopedic implants including internal and external fixation products; upper and lower extremity plating; total joint reconstruction; soft tissue fixation and augmentation for sports medicine procedures; full spinal implants for trauma, degenerative disc disease, and deformity indications. Our biologics offerings include human allografts, substitute bone materials, and tendons, as well as, regenerative tissues and fluids to augment orthopedic surgeries. For more information about Fuse, please visit:www.fusemedical.com.

About Maxim Surgical

Maxim Surgical, based in Richardson, Texas, is a privately-held medical device manufacturing company which is focused on the development of innovative solutions for the spinal fusion device market. Founded in 2011, the company’s primary mission is to provide surgeons and their patients with high-quality medical implants with a value approach. Maxim has close partnerships with key industry leaders and a world-class development team to manufacture cutting-edge implant products at a cost savings for the surgical spinal fusion market. Learn more at www.maximsurgical.com.

Forward Looking Statements

Certain statements in this press release, including those related to an anticipated purchase of all of the outstanding membership units and plans for the consolidated company, constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based only on information available to the Company as of the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the Securities and Exchange Commission; the failure of the Company to close the transaction; and integration issues with the consolidated company. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events, or otherwise, except as required by law.

Contacts

Fuse Medical, Inc.
Devon Peddie, 469-862-3030
Investor Relations Analyst
Facsimile: 469-862-3035
info@Fusemedical.com

Mazor Robotics Reports Second Quarter and First Half 2018 Results

Newly Published Data Demonstrate Bone In-Growth Potential of Stryker’s 3D-Printed Tritanium® Cage

August 02, 2018

ALLENDALE, N.J.–(BUSINESS WIRE)–Stryker’s Spine division today announced the publication of a pre-clinical animal study comparing the performance of spinal implants made from a variety of materials, which illustrated the bone in-growth and biological fixation capabilities of its 3D-printed Tritanium cages. The study was published in the July issue of The Spine Journal.

The purpose of the study was to compare the bone in-growth and biomechanical differences of interbody cages with various material technologies in an ovine lumbar interbody fusion model. The cages involved in this study included traditional PEEK cages, plasma-sprayed titanium-coated PEEK cages, and Stryker’s 3D-printed porous Tritanium cages.1

The results demonstrated that the Tritanium cages exhibited significantly greater total bone volume within the graft window at both 8 and 16 weeks compared to the PEEK cages (p<0.01).1Tritanium cages also were the only cages that showed a decrease in range of motion and an increase in stiffness across all three loading directions (axial rotation, flexion-extension, and lateral bending) between the 8-week and 16-week time points (p-value ≤0.01). 1

“The results of this study provide an evidence-based approach to decision-making regarding interbody materials for spinal fusion, as there is significant variability in the materials commonly used for interbody cages in spine surgery,” said Sigurd H. Berven, M.D., orthopaedic surgeon at the University of California, San Francisco. “The study showed the potential for bone in-growth into and around the Tritanium cages.”

According to Michael Carter, vice president and general manager of Stryker’s Spine division, 3D printing, also known as additive manufacturing, allows the creation of a material with “precisely randomized”2 porous structures designed to mimic bone.2 “Stryker’s proprietary Tritanium Technology, a novel, highly porous titanium alloy material designed for bone in-growth and biological fixation, is based on additive manufacturing techniques for orthopaedic surgery pioneered by Stryker over 15 years ago,” Carter said. “This important study reinforces the value of our growing line of Tritanium interbody cages and demonstrates Stryker’s commitment to bringing the latest in advanced technologies to our customers.”

The study titled “Bony Ingrowth Potential of 3D Printed Porous Titanium Alloy: A Direct Comparison of Interbody Cage Materials in an In Vivo Ovine Lumbar Fusion Model,” can be accessed here.

About Stryker

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at stryker.com and builttofuse.com. Follow the Spine division on Twitter @stryker_spine.

References

  1. McGilvray, Kirk C., et al. Bony ingrowth potential of 3D printed porous titanium alloy: a direct comparison of interbody cage materials in an in vivo ovine lumbar fusion model, Spine J. 2018; Volume 18, Issue 7, 1250-1260.
  2. Karageorgiou V, Kaplan D. (2005) Porosity of 3D biomaterial scaffolds and osteogenesis. Biomaterials, 26, 5474-5491.

Content ID TRITA-PB-2_18140

Dr. Berven is a paid consultant of Stryker. His statements represent his own opinions based on personal experience and are not necessarily those of Stryker. Individual experiences may vary. A surgeon must always rely on his or her own professional clinical judgment when deciding whether to use a particular product when treating a particular patient. Stryker does not dispense medical advice and recommends that surgeons be trained in the use of any particular product before using it in surgery.

The information presented is intended to demonstrate the breadth of Stryker product offerings. A surgeon must always refer to the package insert, product label and/or instructions for use before using any Stryker product. Products may not be available in all markets because product availability is subject to the regulatory and/or medical practices in individual markets. Please contact your Stryker representative if you have questions about the availability of Stryker products in your area.

Contacts

Sullivan & Associates
Andrea Sampson, 714-374–6174
asampson@sullivanpr.com

BONESUPPORT Signs Agreement with MTF Biologics to Expand US Product Offering

Lund, Sweden, 08:00am CET, 2 August 2018 – BONESUPPORT™, an emerging leader in orthobiologics for the management of bone voids, has signed an agreement with MTF Biologics, the world’s largest tissue bank, to extend and strengthen its US product offering.

The agreement will give BONESUPPORT US rights to two forms of bone graft materials comprised of 100% demineralized bone matrix (DBM), which offer improved osteoinductivity when compared to many other DBM products. These products, which are both osteoinductive and osteoconductive, complement CERAMENT BVF (osteoconductive) and the products gained from the Company’s recent strategic agreement with Collagen Matrix Inc. (osteoinductive and osteogenic)

BONESUPPORT plans to launch the products supplied by MTF Biologics under the BONESUPPORT brand name and through its own US distribution network.

MTF Biologics is a non-profit service organization dedicated to providing clinically sound, safe allograft tissue. MTF Biologics is comprised of a national consortium of academic medical institutions, organ procurement organizations and tissue recovery organizations. It is based in Edison, NJ, USA.

Emil Billbäck, CEO of BONESUPPORT said, “Today’s deal with MTF Biologics is a further important step in creating the broad and complementary US product offering that will address the needs of orthopedic surgeons managing bone voids. We are pleased that MTF Biologics, the world’s leading tissue bank, has chosen to partner with BONESUPPORT, and we look forward to marketing products based on their high-quality demineralized bone matrix. With our expanded product portfolio and new broad US distribution channel, that we are on track to have in place in late October, we are well placed to significantly improve our competitive position and rapidly grow sales ahead of the planned US launch of CERAMENT G in 2021.”

“MTF Biologics is pleased to be partnering with BONESUPPORT on the promotion of our demineralized bone matrix fiber technology. We are excited for this opportunity to work together to deliver biologic solutions that serve the needs of surgeons and their patients.” said Tom Shaffer, MTF Biologics EVP, Global Sales & Marketing.

For more information contact:

Emil Billbäck, CEO

+46 (0) 46 286 53 70

Björn Westberg, CFO

+46 (0) 46 286 53 60

ir@bonesupport.com

Citigate Dewe Rogerson

Pip Batty, David Dible, Shabnam Bashir

+44 (0)20 7282 1022

bonesupport@citigatedewerogerson.com

About MTF Biologics

MTF Biologics is a nonprofit organization based in Edison, N.J. It is a national consortium comprised of leading organ procurement organizations, tissue recovery organization and academic medical institutions, and governed by a board of surgeons who are leading experts in tissue transplantation. As the world’s largest tissue bank, MTF Biologics saves and heals lives by honoring donated gifts, serving patients and advancing science. Since its inception in 1987, the organization has received tissue from more than 120,000 donors and distributed more than 7.5 million allografts for transplantation. Through its IIAM subsidiary, it has placed more than 55,000 non-transplantable organs for research. Through its Statline subsidiary, it has managed more than 10 million donor referrals.

For more information, visit www.mtf.org.

About BONESUPPORT™

BONESUPPORT is an innovative and rapidly growing commercial stage orthobiologics company, based in Lund, Sweden. The Company develops and commercializes innovative injectable bio-ceramic bone graft substitutes that remodel to the patient’s own bone and have the capability of eluting drugs directly into the bone void.

BONESUPPORT’s bio-ceramic bone graft substitutes CERAMENT® BONE VOID FILLER (BVF), CERAMENT® G* and CERAMENT® V* are all based on the Company’s novel and proprietary technology platform.

The Company’s products are targeting a large addressable market opportunity across trauma, chronic osteomyelitis (bone infection), revision arthroplasty (replacement of a joint prosthesis) and infected diabetic foot.

BONESUPPORT’s total sales increased from SEK 62 million in 2015 to SEK 129 million in 2017, representing a compound annual growth rate of 45%.

The Company’s research and development is focused on the continuing development and refinement of its CERAMENT technology to extend its use into additional indications by the elution of drugs and therapeutic agents. The Company currently has a pipeline of pre-clinical product candidates that have been designed to promote bone growth.

In addition, BONESUPPORT is looking to expand its product offering in the US and has entered into strategic agreements with Collagen Matrix Inc. and MTF Biologics to market and distribute products that are complementary to CERAMENT BVF.

BONESUPPORT is listed on Nasdaq Stockholm and trades under the ticker “BONEX” (ISIN code: SE0009858152). Further information is available at www.bonesupport.com

*CERAMENT G: Not available in the United States, for investigational use only.
CERAMENT V: Not available in the United States.

BONESUPPORT™ and CERAMENT® are registered trademarks.

This information is such information as BONESUPPORT HOLDING AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above, at 08.00 CET on 2 August 2018.

Alphatec Reports Second Quarter 2018 Financial Results

CARLSBAD, Calif., Aug. 02, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc.  (“ATEC” 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 reported financial results for the second quarter ended June 30, 2018.

Second Quarter 2018 Financial Highlights

  • Total net revenue of $22.0 million; U.S. commercial revenue of $20.4 million, up 6% compared to the first quarter of 2018
  • U.S. commercial gross margin of 69.5%
  • Cash and cash equivalents of $44.9 million at June 30, 2018
  • Operating cash burn (excluding debt service and transaction-related costs) of $3.0 million

Second Quarter Organizational, Commercial, and Product Highlights

  • Continued transition of sales organization and increased contribution from dedicated distribution partners and agents to 57% of U.S. commercial revenue
  • Increased revenue attributable to newly converted surgeons, which more than doubled sequentially
  • Obtained FDA 510(k) clearance for IdentiTi porous titanium interbody implants; successfully completed first surgery in conjunction with alpha launch
  • Obtained two significant, favorable rulings in the patent litigation brought by NuVasive, Inc.
  • Made three key additions to ATEC leadership team: David Sponsel, Area Vice President, South Central United States; Emory Rooney, Vice President, Sales Channel Development; and Robert Judd, Vice President, Finance & Controller, who collectively bring decades of  additional spine industry experience to ATEC

“Our second quarter results, and numerous leading indicators, drive our growing confidence in the bright future for ATEC,” said Pat Miles, Chairman and Chief Executive Officer.  “While we continue to anticipate some short-term variability, we expect that our organic product development machine will accelerate growth. The spine market needs surgeon-driven, outcome-focused innovation, and we are absolutely committed to providing it. We are confident that we are building an organization that will create significant, long-term value.”

Comparison of Financial Results for the Second Quarter 2018 to First Quarter 2018

The following table compares key second quarter 2018 results to first quarter 2018 results.

Change
June 30, 2018   March 31, 2018 $   %
(unaudited) (unaudited)
U.S. commercial revenue $   20,409 $   19,201 $   1,208 6 %
U.S. gross profit   14,178   13,432   746 6 %
U.S. gross margin 69.5 % 70.0 %
Operating Expenses
Research and development $   2,009 $   1,786 $   223 12 %
Sales and marketing   10,673   10,060   613 6 %
General and administrative   7,815   6,442   1,373 21 %
Amortization of intangible assets   187   177   10 6 %
Transaction-related expenses   (62 )   1,542   (1,604 ) (104 %)
Gain on settlement   –   (6,168 )   6,168 (100 %)
Restructuring   193   398   (205 ) (52 %)
Total operating expenses $   20,815 $   14,237 $   6,578 46 %
Operating loss $   (6,545 ) $   (667 ) $   (5,878 ) 881 %
Interest and other expense $   (1,784 ) $   (1,645 ) $   (139 ) 8 %
Loss from continuing operations $   (7,064 ) $   (1,854 ) $   (5,210 ) 281 %
Non-GAAP Adjusted EBITDA $   (3,677 ) $   (2,390 ) $   (1,287 ) 54 %

U.S. commercial revenue for the second quarter of 2018 was $20.4 million, compared to $19.2 million in the first quarter of 2018.  Results reflect the continued transition of the Company’s distribution channel to more dedicated, scalable partners. Revenue growth generated by the expansion of the dedicated sales channel, coupled with new surgeon adoption, offset the revenue losses associated with the intentional reduction of non-strategic distributor relationships.

U.S. gross profit and gross margin for the second quarter of 2018 were $14.2 million and 69.5%, respectively, compared to $13.4 million and 70.0%, respectively, for the first quarter of 2018. U.S. gross margin stabilized as the Company continued to reduce product costs and optimize its supply chain.

Total operating expenses for the second quarter of 2018 were $20.8 million, compared to $14.2 million in the first quarter of 2018.  The increase is primarily the result of a $6.2 million contract settlement gain recorded in the first quarter of 2018.  On a non-GAAP basis (excluding restructuring charges, stock-based compensation, transaction-related expenses, and the contract settlement gain), total operating expenses in the second quarter increased to $19.5 million, compared to $17.9 million in the first quarter of 2018.  The increase primarily reflects increased sales expenses, litigation support costs, and investments in product development.

Operating loss for the second quarter of 2018 was $6.5 million, compared to a loss of $0.7 million for the first quarter of 2018. The increase is primarily the result of the $6.2 million contract settlement gain recorded in the first quarter of 2018.

Non-GAAP Adjusted EBITDA for the second quarter of 2018 was $(3.7) million, compared to $(2.4) million in the first quarter of 2018.  For more detailed information, please refer to the table, “Alphatec Holdings, Inc. Reconciliation of Non-GAAP Financial Measures,” that follows.

Current and long-term debt includes $30.6 million in term debt and $8.2 million outstanding under the Company’s revolving credit facility at June 30, 2018. This compares to $31.5 million in term debt and $8.4 million outstanding under the Company’s revolving credit facility at March 31, 2018.

Cash and cash equivalents were $44.9 million at June 30, 2018, compared to $47.6 million reported at March 31, 2018.

Comparison of Financial Results for the Three and Six Months Ended June 30, 2018 and 2017

Revenue decreased on a year-over-year basis as a result of the continued transition of the Company’s distribution channel to more dedicated, scalable partners and the discontinuation of non-strategic distributor relationships. The year-over-year increase in operating expenses was attributable to litigation support costs, transaction-related expenses associated with the Company’s acquisition of SafeOp Surgical, Inc., and increased investment in product development initiatives as the Company expands its product pipeline. For additional information, please reference the following financial statement tables and the Company’s Quarterly Report on Form 10-Q to be filed with the Securities and Exchange Commission on or before August 3, 2018.

2018 Financial Outlook

ATEC continues to anticipate total revenue in 2018 to approximate $95.0 million, with revenue growth expected to accelerate in the second half of the year.

Favorable Patent Litigation Rulings

ATEC obtained two significant, favorable rulings in the patent litigation brought by NuVasive, Inc.: the first dismissed NuVasive’s design patent counts, covering the implant and sequential dilators used in lateral surgery; the second denied NuVasive’s Motion for Preliminary Injunction, finding that NuVasive had not met its burden of proving either likelihood of success or irreparable harm.  The latter ruling allows ATEC to continue to sell its lateral surgery offering while the lawsuit is pending.

Key Executive Additions

Mr. Sponsel has nearly 20 years’ sales experience, including 13 years in the spine industry.  He spent a decade with Stryker Spine, before leaving to lead Medacta USA’s Spine Division. Mr. Rooney has accumulated over a decade of leadership in spine sales. He joins ATEC from Stryker Spine, where he most recently served as Vice President, Sales, Southeast.  Mr. Judd brings nearly 15 years of accounting and strategic finance experience to ATEC. He joins ATEC following three years with NuVasive, Inc., where he served most recently as Vice President, Finance – Global Process Transformation, after holding finance and accounting leadership positions with Thermo Fisher Scientific, Life Technologies, Allergan, and KPMG.

Non-GAAP Information

To supplement the Company’s financial statements presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company reports certain non-GAAP financial measures such as Adjusted EBITDA.  Adjusted EBITDA included in this press release is a non-GAAP financial measure that represents net income (loss), excluding the effects of interest, taxes, depreciation, amortization, stock-based compensation expenses, and other non-recurring income or expense items, such as sale of assets, settlement gains, impairments, restructuring expenses, severance expenses and transaction-related expenses.  The Company believes that non-GAAP Adjusted EBITDA provides investors with an additional tool for evaluating the Company’s core performance, which management uses in its own evaluation of continuing operating performance, and a baseline for assessing the future earnings potential of the Company.  For completeness, management uses non-GAAP Adjusted EBITDA in conjunction with GAAP earnings and earnings per common share measures.  The Company’s Adjusted EBITDA measure may not provide information that is directly comparable to that provided by other companies in the Company’s industry, as other companies in the industry may calculate non-GAAP financial results differently, particularly related to non-recurring, unusual items. Adjusted EBITDA should be considered in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.   Included below are reconciliations of the non-GAAP financial measures to the comparable GAAP financial measure.

Investor Conference Call

ATEC will hold a conference call today at 1:30 p.m. PT / 4:30 p.m. ET to discuss second quarter 2018 results. The dial-in numbers are (877) 556-5251 for domestic callers and (720) 545-0036 for international callers. The conference ID number is 1956197. A live webcast of the conference call will also 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 third quarter 2018 financial results. In addition, a telephonic replay of the call will be available until November 2, 2018. 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 1956197.

Inducement Awards Granted

As an inducement to accepting employment with the Company, and in accordance with applicable Nasdaq listing requirements, the Compensation Committee of the Board of Directors approved grants of inducement stock options to purchase, collectively, an aggregate of 115,000 shares of the Company’s common stock (“Options”) and approved the grants of, collectively, 115,000 restricted stock units (RSUs) to the three new employees noted above.  The grants are dated as of May 29, June 18, and July 16, 2018 — the respective dates of employment of each new employee.

The RSUs will vest in equal annual installments on each of the first four anniversaries of the respective dates of employment set forth above.  The Options, which have exercise prices of $3.86, $3.01 and $2.84 per share (based on the closing prices of the Company’s common stock on the respective effective dates of the grants), will vest 25 percent on the first anniversary of the grants and in equal monthly installments of 1/36th of the balance of the Options, provided the recipient remains continuously employed by ATEC as of such vesting date. In addition, the RSUs and Options will fully vest upon a change in control of ATEC.

ATEC is providing this information in accordance with Nasdaq Listing Rule 5635(c)(4).

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiaries, Alphatec Spine, Inc. and SafeOp Surgical, Inc., is a medical device company that designs, develops, and markets technology 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.

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 ATEC 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. ATEC 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:

Tina Jacobsen
Investor Relations
tjacobsen@moreeffectiveir.com

Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.
ir@atecspine.com

 

ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
  (in thousands, except per share amounts – unaudited)
Three Months Ended Six Months Ended
June 30, June 30,
2018 2017 2018 2017
Revenues $ 22,042 $ 24,379 $ 43,349 $ 52,357
Cost of revenues 7,772 8,631 15,509 19,830
Gross profit 14,270 15,748 27,840 32,527
Operating expenses:
Research and development 2,009 990 3,795 2,439
Sales and marketing 10,673 10,298 20,733 21,401
General and administrative 7,815 5,351 14,257 11,574
Amortization of intangible assets 187 172 364 344
Transaction-related expenses (62 ) 1,480
Gain on settlement (6,168 )
Gain on sale of assets (856 ) (856 )
Restructuring expenses 193 528 591 1,759
Total operating expenses 20,815 16,483 35,052 36,661
Operating loss (6,545 ) (735 ) (7,212 ) (4,134 )
Other income (expense):
Interest expense, net (1,709 ) (1,881 ) (3,416 ) (3,862 )
Other income, net (75 ) 2 (13 ) 7
Total other expense, net (1,784 ) (1,879 ) (3,429 ) (3,855 )
Loss from continuing operations before taxes (8,329 ) (2,614 ) (10,641 ) (7,989 )
Income tax (benefit) provision (1,265 ) 15 (1,723 ) 64
Loss from continuing operations (7,064 ) (2,629 ) (8,918 ) (8,053 )
Loss from discontinued operations (12 ) (68 ) (74 ) (159 )
Net loss $ (7,076 ) $ (2,697 ) $ (8,992 ) $ (8,212 )
Net loss per share, basic and diluted:
Continuing operations $ (0.21 ) $ (0.24 ) $ (0.32 ) $ (0.80 )
Discontinued operations (0.00 ) (0.01 ) (0.00 ) (0.02 )
Net loss per share, basic and diluted $ (0.21 ) $ (0.24 ) $ (0.33 ) $ (0.82 )
Shares used in calculating basic and diluted net loss per share
34,030 11,047 27,656 10,033
Stock-based compensation included in:
Cost of revenue 11 11 33 14
Research and development 129 (20 ) 13 291
Sales and marketing 193 151 304 224
General and administrative 815 269 1,417 690
$ 1,148 $ 411 $ 1,767 $ 1,219
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands) 
June 30, December 31,
 2018  2017
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $   44,912 $   22,466
Accounts receivable, net 11,405 14,822
Inventories, net 28,177 27,292
Prepaid expenses and other current assets 1,778 1,767
Current assets of discontinued operations 251 131
Total current assets 86,523 66,478
Property and equipment, net 12,060 12,670
Goodwill 14,250   –
Intangibles, net 26,382 5,248
Other assets 225 208
Noncurrent assets of discontinued operations 55 56
Total assets $   139,495 $   84,660
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
Current liabilities:
Accounts payable $   3,354 $   3,878
Accrued expenses 24,607 22,246
Current portion of long-term debt 6,682 3,306
Current liabilities of discontinued operations 385 312
Total current liabilities 35,028 29,742
Total long term liabilities   50,644   57,973
Redeemable preferred stock   23,603   23,603
Stockholders’ equity   30,220   (26,658 )
Total liabilities and stockholders’ deficit $   139,495 $   84,660
ALPHATEC HOLDINGS, INC.
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(in thousands – unaudited)
Three
Months
Ended
Three Months Ended Six Months Ended
March 31, June 30, June 30,
2018 2018 2017 2018 2017
Operating expenses 14,237 20,815 16,483 35,052 36,661
Adjustments:
Stock-based compensation (597 ) (1,137 ) (400 ) (1,734 ) (1,205 )
Restructuring (398 ) (193 ) (528 ) (591 ) (1,759 )
Transaction-related expenses (1,542 ) 62 (1,480 )
Gain on settlement 6,168 6,168
Gain on sale of assets 856 856
Non-GAAP operating expenses $ 17,868 $ 19,547 $ 16,411 $ 37,415 $ 34,553
Three
Months
Ended
Three Months Ended Six Months Ended
March 31, June 30, June 30,
2018 2018 2017 2018 2017
Operating loss, as reported $ (667 ) $ (6,545 ) $ (735 ) $ (7,212 ) $ (4,134 )
Add back:
Depreciation 1,592 1,457 1,636 3,049 3,270
Amortization of intangible assets 294 132 234 426 468
Total EBITDA 1,219 (4,956 ) 1,135 (3,737 ) (396 )
Add back significant items:
Stock-based compensation 619 1,148 411 1,767 1,219
Restructuring 398 193 528 591 1,759
Transaction-related expenses 1,542 (62 ) 1,480
Gain on settlement (6,168 ) (6,168 )
Gain on sale of assets (856 ) (856 )
Adjusted EBITDA $ (2,390 ) $ (3,677 ) $ 1,218 $ (6,067 ) $ 1,726
ALPHATEC HOLDINGS, INC.
RECONCILIATION OF GEOGRAPHIC SEGMENT REVENUES AND GROSS PROFIT
(in thousands, except percentages – unaudited) 
Three Months Ended Six Months Ended
June 30, June 30,
2018 2017 2018 2017
Revenues by source
U.S. commercial revenue $   20,409 $   21,877 $   39,610 $   45,314
Other 1,633 2,502 3,739 7,043
Total revenues $   22,042 $   24,379 $   43,349 $   52,357
Gross profit by source
U.S. $   14,178 $   15,521 $   27,610 $   31,789
Other   92   227   230   738
Total gross profit $   14,270 $   15,748 $   27,840 $   32,527
Gross profit margin by source
U.S. 69.5 % 70.9 % 69.7 % 70.2 %
Other 5.6 % 9.1 % 6.1 % 10.5 %
Total gross profit margin 64.7 % 64.6 % 64.2 % 62.1 %

Total Knee Replacement Market worth over $10 billion by 2024: Global Market Insights, Inc.

Sellbyville, Delaware, Aug. 02, 2018 (GLOBE NEWSWIRE) —

Global Total Knee Replacement Market is projected to cross USD 10 billion by 2024; according to a new research report by Global Market Insights, Inc. Total knee replacement market will witness a CAGR of 3.7% during the forecast period owing to expanding ageing population pool worldwide coupled with increasing prevalence of degenerative diseases. Geriatric population is more prone to suffer from degenerative diseases such as osteoporosis resulting in demand for total knee replacement procedures. As per International Osteoporosis Foundation estimates, 200 million women worldwide suffer from osteoporosis; therefore, the demand should only increase during the projection years.

Additionally, technological upgradation of implant material with evolution of customized replacement implants is augmenting market growth. The increased benefits of knee replacement surgery in restoration of normal functioning of knee has led to growth of younger population undergoing knee replacement surgeries. Presently, 3D printed surgical implants along with customized inserts, jigs devices are used in surgery to deliver better results escalating the industry growth. With increasing use of 3D technology, the knee replacement market will witness rapid growth over the forecast timeframe.

Request for a sample of this research report @ https://www.gminsights.com/request-sample/detail/2804

Although presence of numerous growth opportunities has influenced the industry growth positively, high costs associated with the surgical procedures has affected the same. However, steady development in reimbursement scenario and government initiatives have lowered the costs of knee replacement surgery proving beneficial for industry growth.

Partial knee replacement system market accounted for largest market share in 2016 and anticipated to grow at 3.4% CAGR over the projection years, owing to its advantages such as replacement of only damaged component of knee along with minimal erosion of healthy tissues.

Browse key industry insights spread across 120 pages with 106 market data tables & 9 figures & charts from the report, “Total Knee Replacement Market” in detail along with the table of contents:

https://www.gminsights.com/industry-analysis/total-knee-replacement-market

Tibial knee component market segment will be the fastest growing segment with expected growth of 4.0% CAGR by 2024. This component provides intraoperative flexibility to the replaced component proving to be beneficial in revision replacement surgery. Also, polyethylene tibial component is known to provide significant long-lasting clinical results with reduced probability of osteolysis; therefore, the demand for the same should rapidly rise in coming years.

 Ambulatory surgical centers market segment is expected to experience a CAGR of over 5% during the forecast period owing to overall low costs associated with surgery in this facility. Timely procedures without long delay in ambulatory centers attract more patients, resulting in rapid expansion of the same. Moreover, personalized care offering by ambulatory healthcare facilities surges the segment growth.

U.S. knee replacement market valued at USD 3,294 in 2017 and will expand significantly with growth of than 3.8% from 2018-2024. The growing geriatric population base suffering from degenerative diseases such as osteoarthritis and availability of superior quality medical devices and components will favor market growth. Also, increase in the disposable income across the nation will positively affect market growth.

Germany knee replacement market will grow at a CAGR of 4.0% during the projection period, owing to increasing healthcare spending, technological advancement and high disposable income. Growing healthcare awareness will increase number of knee replacement surgeries favoring market growth.

 Some of the major industry players operating in knee replacement market include Stryker, Smith & Nephew, Medacta, MicroPort Scientific, B. Barun, ConforMIS, DePuy Synthes, Corin, DJO Global and Zimmer Biomet. These manufacturing companies have focused their efforts on R&D that have helped them to evolve as major industry players.

 Key industry players undertake certain strategic initiatives such as new product launch and collaborations to maintain their market position. For instance, Smith & Nephew launched GENESIS II total knee system that is the most preferred and comprehensive system improving surgical performance. Launching this product has rendered company with competitive advantage and improved the company’s market share.

Make an inquiry for purchasing this report @ https://www.gminsights.com/inquiry-before-buying/2804

Browse Related Reports:

  • Orthopedic Devices Market Size 2017 – 2024

Orthopedic Devices Market outlook was at over USD 39 billion in 2016 and is forecast to witness more than 3% CAGR from 2017 to 2024. The growing geriatric population base is highly susceptible for developing bone related diseases such as osteoporosis and osteoarthritis.
https://www.gminsights.com/industry-analysis/orthopedic-devices-market

  • Orthobiologics Market Size 2018 – 2024

Orthobiologics Market share is projected to experience significant growth from 2018 to 2024. Increasing number of orthopedic procedures owning to the rising geriatric population, accidents and obesity is driving the market growth.
https://www.gminsights.com/industry-analysis/orthobiologics-market

About Global Market Insights

Global Market Insights, Inc., headquartered in Delaware, U.S., is a global market research and consulting service provider; offering syndicated and custom research reports along with growth consulting services. Our business intelligence and industry research reports offer clients with penetrative insights and actionable market data specially designed and presented to aid strategic decision making. These exhaustive reports are designed via a proprietary research methodology and are available for key industries such as chemicals, advanced materials, technology, renewable energy and biotechnology.

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Conformis announces election of Carrie Bienkowski to its Board of Directors

BILLERICA, Mass., Aug. 02, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are customized to fit each patient’s unique anatomy, announced today that its Board of Directors elected Carrie Bienkowski to the Board effective July 31, 2018.  Ms. Bienkowski will serve as a class I director until the Conformis 2019 Annual Meeting of Stockholders.

“We welcome the addition of Carrie Bienkowski to our Board of Directors,” said Kenneth P. Fallon, III, Chairman of the Board of Directors of Conformis. “Her knowledge in consumer marketing and digital innovation will be a great asset for Conformis.” “Carrie’s experience is consistent with the opportunity we have to position the Conformis brand among today’s active and engaged patients that are seeking orthopedic treatment,” added Mark Augusti, Conformis’ President and Chief Executive Officer.

Ms. Bienkowski is a dynamic operational and strategic leader with over 20 years of experience working across e-commerce, retail, blue-chip fast-moving consumer goods and management consulting. She has a proven track record of delivering results in diverse industries and international markets and is skilled in executive level strategic business planning, new product development, customer experience strategy and brand management.

Ms. Bienkowski has served as Chief Marketing Officer of Peapod since 2014. Prior to joining Peapod, Ms. Bienkowski served as the Head of Buyer Experience for eBay’s Fashion vertical in the European markets. From 2002-2009, at C&E Advisory in London, Ms. Bienkowski counseled businesses and brands including L’Oreal, Sky Media, HSBC, Boots Pharmacy and Vodafone in sustainability strategies. Earlier in her career, Ms. Bienkowski spent nearly a decade at Procter & Gamble, where she served in various brand management roles.

Ms. Bienkowski received her degree in finance and business economics from the University of Notre Dame.

About Conformis, Inc.

Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. Conformis offers a broad line of customized knee implants and customized pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, Conformis iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. Conformis owns or exclusively in-licenses issued patents and pending patent applications that cover customized implants and customized patient-specific instrumentation for all major joints.
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Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release about our future expectations, plans and prospects, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. You should not place undue reliance on our forward-looking statements. Actual results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including risks related to our estimates and expectations regarding our results of operations, and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date hereof.

CONTACT:
Investor contact
Oksana Bradley
ir@conformis.com
(781) 374-5598