HCA Announces Agreement to Acquire Three Houston Hospitals from Tenet

May 01, 2017

NASHVILLE, Tenn.–(BUSINESS WIRE)–HCA (NYSE: HCA), which operates 171 hospitals, 119 freestanding surgery centers, and numerous other outpatient centers in 20 states and the United Kingdom, today announced an agreement to purchase three hospitals in Houston from Tenet Healthcare.

The agreement includes 423-bed Houston Northwest Medical Center, 181-bed Cypress Fairbanks Medical Center Hospital and 444-bed Park Plaza Hospital.

“The addition of these hospitals will help us expand our network to serve patients in a growing part of the Greater Houston market,” said Sam Hazen, president and chief operating officer of HCA. “We are excited about the prospect of them joining us, and we believe there’s an opportunity to add to the services they currently offer and create a more comprehensive provider network for our patients in Houston.”

HCA’s healthcare network in Houston currently includes 10 hospitals, eight surgery centers, two freestanding ERs and 10 imaging centers.

The transaction, which is subject to regulatory approval, is expected to close in the third quarter.

About HCA

Nashville-based HCA is one of the nation’s leading providers of healthcare services, operating 171 locally managed hospitals and 119 freestanding surgery centers in 20 states and the United Kingdom. With its founding in 1968, HCA created a new model for hospital care in the United States, using combined resources to strengthen hospitals, deliver patient-focused care and improve the practice of medicine. HCA has conducted a number of clinical studies, including one that demonstrated that full-term delivery is healthier than early elective delivery of babies and another that identified a clinical protocol that can reduce bloodstream infections in ICU patients by 44 percent. HCA is a learning healthcare system that uses its more than 27 million annual patient encounters to advance science, improve patient care and save lives.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the federal securities laws, which involve risks and uncertainties. Forward-looking statements include statements that do not relate solely to historical or current facts. Forward-looking statements can be identified by the use of words like “may,” “believe,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “initiative” or “continue.” These forward-looking statements are based on our current plans and expectations and are subject to a number of known and unknown uncertainties and risks, many of which are beyond our control, which could significantly affect current plans and expectations and our future financial position and results of operations. These factors include, but are not limited to, the ability to consummate and realize the benefits of the proposed acquisition as well as the risk factors described in our annual report on Form 10-K for the year ended December 31, 2016 and our other filings with the Securities and Exchange Commission. Many of the factors that will determine our future results are beyond our ability to control or predict. In light of the significant uncertainties inherent in the forward-looking statements contained herein, readers should not place undue reliance on forward-looking statements, which reflect management’s views only as of the date hereof. We undertake no obligation to revise or update any forward-looking statements, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.

All references to “Company” and “HCA” as used throughout this document refer to HCA Holdings, Inc. and its affiliates.

Contacts

HCA
Investor Contact:
Mark Kimbrough, 615-344-2688
or
Media Contact:
Ed Fishbough, 615-344-2810

Orthofix International Reports First Quarter 2017 Financial Results

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX) today reported its financial results for the first quarter ended March 31, 2017. Net sales were $102.7 million, loss per share from continuing operations was ($0.13) and adjusted earnings per share from continuing operations was $0.27.

“We are very pleased with the top-line results for the first quarter 2017 and the momentum we achieved in each of our businesses,” said Brad Mason, President and Chief Executive Officer. “The solid execution of our commercial strategies is delivering results as demonstrated by another strong quarter in our BioStim business and an earlier than expected return to growth in both Biologics and Spine Fixation. Although each strategic business unit has its own commercial strategy, our overriding corporate focus is on expanding distribution in underserved markets, improving engagement of our legacy distributors and providing our salesforce with a robust stream of new products. Our bottom-line results reflect the investments we are making in these key strategies, which are proving effective in driving our top line growth.”

Financial Results Overview

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

Three Months Ended March 31,
(Unaudited, U.S. Dollars, in thousands) 2017 2016 Change

Constant
Currency
Change

BioStim $ 44,539 $ 41,044 8.5 % 8.5 %
Biologics 14,987 14,094 6.3 % 6.3 %
Extremity Fixation 23,945 24,709 (3.1 %) (1.0 %)
Spine Fixation 19,267 18,832 2.3 % 2.3 %
Net sales $ 102,738 $ 98,679 4.1 % 4.6 %

Gross profit increased $3.6 million to $80.2 million. Gross margin increased slightly to 78.0% compared to 77.6% in the prior year period, which was in line with our expectations. Net margin (gross profit less sales and marketing expenses) was $31.6 million compared to $31.7 million in the prior year period. The decrease in net margin was primarily due to higher sales and marketing expenses, driven by a higher mix of sales from new distributors in our Biologics and Spine Fixation SBUs, who typically receive higher commission rates in their first year.

Net loss from continuing operations was ($2.3) million, or ($0.13) per share, compared to net income of $4.6 million, or $0.24 per share in the prior year period. The net loss for the quarter was impacted by strategic investments in the quarter of $7.1 million, including a pre-tax impairment of $5.6 million on our eNeura investment. Adjusted net income from continuing operations was $4.9 million, or $0.27 per share, compared to adjusted net income of $5.2 million, or $0.28 per share in the prior year period.

EBITDA was $6.6 million, compared to $13.8 million in the prior year period. Adjusted EBITDA was $15.7 million or 15.3% of net sales for the first quarter, compared to $15.5 million or 15.7% of net sales in the prior year period.

Liquidity

As of March 31, 2017, cash and cash equivalents were $41.7 million compared to $39.6 million as of December 31, 2016. As of March 31, 2017, we had no outstanding indebtedness and borrowing capacity of $125 million. Cash flow from operations decreased $1.2 million to $3.5 million, while free cash flow increased $1.3 million to ($0.4) million.

2017 Outlook

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

Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions, except per share data) Low High Low High
Net sales $ 407.0 $ 411.0 $ 411.0

1

$ 415.0

1

Net income from continuing operations $ 24.4 $ 29.3 $ 20.6

2

$ 23.7

2

Adjusted EBITDA $ 76.0 $ 79.0 $ 76.0

3

$ 79.0

3

EPS from continuing operations $ 1.33 $ 1.59 $ 1.12

4

$ 1.29

4

Adjusted EPS from continuing operations $ 1.48 $ 1.58 $ 1.48

5

$ 1.58

5

1 Represents a year-over-year increase of 0.3% to 1.3% on a reported basis
2 Represents a year-over-year increase of 489.1% to 577.7%
3 Represents a year-over-year decrease of 0.4% to 4.2%
4 Represents a year-over-year increase of 489.5% to 578.9%
5 Represents a year-over-year increase of 1.4% to 8.2%

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company’s financial results for the first quarter of 2017. Interested parties may access the conference call by dialing (888) 364-3109 in the U.S. and (719) 457-2631 outside the U.S., and referencing the conference ID 9028875. A replay of the call will be available for two weeks by dialing (888) 203-1112 in the U.S. and (719) 457-0820 outside the U.S., and entering the conference ID 9028875. A webcast of the conference call may be accessed by going to the Company’s website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.

About Orthofix

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

Forward-Looking Statements

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

ORTHOFIX INTERNATIONAL N.V.
Consolidated Statements of Operations
Three Months Ended
March 31,
(Unaudited, U.S. Dollars, in thousands, except share and per share data) 2017 2016
Net sales $ 102,738 $ 98,679
Cost of sales 22,581 22,137
Gross profit 80,157 76,542
Sales and marketing 48,532 44,822
General and administrative 18,282 17,005
Research and development 7,424 7,640
Operating income 5,919 7,075
Interest income (expense), net 45 (38 )
Other income (expense), net (4,348 ) 1,833
Income before income taxes 1,616 8,870
Income tax expense (3,924 ) (4,294 )
Net income (loss) from continuing operations (2,308 ) 4,576
Discontinued operations
Loss from discontinued operations (527 ) (990 )
Income tax benefit 181 254
Net loss from discontinued operations (346 ) (736 )
Net income (loss) $ (2,654 ) $ 3,840
Net income (loss) per common share—basic
Net income (loss) from continuing operations $ (0.13 ) $ 0.25
Net loss from discontinued operations (0.02 ) (0.04 )
Net income (loss) per common share—basic $ (0.15 ) $ 0.21
Net income (loss) per common share—diluted
Net income (loss) from continuing operations $ (0.13 ) $ 0.24
Net loss from discontinued operations (0.02 ) (0.04 )
Net income (loss) per common share—diluted $ (0.15 ) $ 0.20
Weighted average number of common shares:
Basic 17,979,675 18,477,881
Diluted 17,979,675 18,758,751
ORTHOFIX INTERNATIONAL N.V.
Consolidated Balance Sheets
(U.S. Dollars, in thousands except share data) March 31,

2017

December 31,

2016

(unaudited)
Assets
Current assets
Cash and cash equivalents $ 41,652 $ 39,572
Restricted cash 14,369
Accounts receivable, net of allowances of $8,394 and $8,396, respectively 59,443 57,848
Inventories 66,271 63,346
Prepaid expenses and other current assets 19,478 19,238
Total current assets 186,844 194,373
Property, plant and equipment, net 47,962 48,916
Patents and other intangible assets, net 8,530 7,461
Goodwill 53,565 53,565
Deferred income taxes 41,431 47,325
Other long-term assets 16,413 20,463
Total assets $ 354,745 $ 372,103
Liabilities and shareholders’ equity
Current liabilities
Accounts payable $ 16,555 $ 14,353
Other current liabilities 46,316 69,088
Total current liabilities 62,871 83,441
Other long-term liabilities 24,740 25,185
Total liabilities 87,611 108,626
Contingencies
Shareholders’ equity
Common shares $0.10 par value; 50,000,000 shares authorized; 18,042,834 and

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

2016, respectively

1,804 1,783
Additional paid-in capital 208,686 204,095
Retained earnings 61,525 64,179
Accumulated other comprehensive loss (4,881 ) (6,580 )
Total shareholders’ equity 267,134 263,477
Total liabilities and shareholders’ equity $ 354,745 $ 372,103

ORTHOFIX INTERNATIONAL N.V.
Non-GAAP Financial Measures

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

EBITDA and Adjusted EBITDA

Three Months Ended

March 31,

(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net income (loss) from continuing operations $ (2,308 ) $ 4,576
Interest expense (income), net (45 ) 38
Income tax expense 3,924 4,294
Depreciation and amortization 5,075 4,873
EBITDA $ 6,646 $ 13,781
Share-based compensation 2,816 2,099
Foreign exchange impact (1,013 ) (1,815 )
Strategic investments 7,100 198
SEC / FCPA matters and related costs 141 245
Infrastructure investments 962
Legal judgments/settlements 227
International restructuring (239 )
Adjusted EBITDA $ 15,678 $ 15,470
As a % of net sales 15.3 % 15.7 %

Adjusted Net Income from Continuing Operations

Three Months Ended

March 31,

(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net income (loss) from continuing operations $ (2,308 ) $ 4,576
Foreign exchange impact (1,013 ) (1,815 )
Strategic investments 7,100 198
SEC / FCPA matters and related costs 141 245
Infrastructure investments 962
Legal judgments/settlements 227
International restructuring (239 )
Long-term income tax rate adjustment 948 1,079
Adjusted net income from continuing operations $ 4,856 $ 5,245

Adjusted Earnings per Share from Continuing Operations

Three Months Ended

March 31,

(Unaudited, per diluted share) 2017 2016
EPS from continuing operations $ (0.13 ) $ 0.24
Foreign exchange impact (0.06 ) (0.10 )
Strategic investments 0.39 0.01
SEC / FCPA matters and related costs 0.01 0.01
Infrastructure investments 0.05
Legal judgments/settlements 0.01
International restructuring (0.01 )
Long-term income tax rate adjustment 0.06 0.07
Adjusted EPS from continuing operations $ 0.27 $ 0.28
Weighted average number of diluted common shares 18,235,660 18,758,751

Net Margin

Three Months Ended

March 31,

(Unaudited, U.S. Dollars, in thousands) 2017 2016
Gross profit $ 80,157 $ 76,542
Sales and marketing (48,532 ) (44,822 )
Net margin $ 31,625 $ 31,720
BioStim $ 17,133 $ 16,408
Biologics 6,171 6,104
Extremity Fixation 6,412 7,175
Spine Fixation 2,007 2,335
Corporate (98 ) (302 )
Net margin $ 31,625 $ 31,720

Free Cash Flow

Three Months Ended

March 31,

(Unaudited, U.S. Dollars, in thousands) 2017 2016
Net cash from operating activities $ 3,470 $ 4,646
Capital expenditures (3,905 ) (6,399 )
Free cash flow $ (435 ) $ (1,753 )

2017 Outlook

Previous 2017 Outlook Current 2017 Outlook
(Unaudited, U.S. Dollars, in millions) Low High Low High
Net income from continuing operations $ 24.4 $ 29.3 $ 20.6 $ 23.7
Interest expense, net 0.1 0.2 0.1 0.2
Income tax expense 16.2 15.7 13.6 14.3
Depreciation and amortization 20.0 20.0 20.0 20.0
EBITDA $ 60.7 $ 65.2 $ 54.3 $ 58.2
Share-based compensation 11.8 11.8 11.8 11.8
Foreign exchange impact (1.0 ) (1.0 )
Strategic investments 1.2 0.7 8.6 8.1
SEC / FCPA matters and related costs 1.3 0.8 1.3 1.0
International restructuring 1.0 0.5 0.8 0.7
Legal judgments/settlements 0.2 0.2
Adjusted EBITDA $ 76.0 $ 79.0 $ 76.0 $ 79.0
Previous 2017 Outlook Current 2017 Outlook
(Unaudited, per diluted share) Low High Low High
EPS from continuing operations $ 1.33 $ 1.59 $ 1.12 $ 1.29
Foreign exchange impact (0.05 ) (0.05 )
Strategic investments 0.06 0.04 0.46 0.44
SEC / FCPA matters and related costs 0.07 0.04 0.07 0.05
International restructuring 0.05 0.03 0.04 0.04
Legal judgments/settlements 0.01 0.01
Long-term income tax rate adjustment (0.03 ) (0.12 ) (0.17 ) (0.20 )
Adjusted EPS from continuing operations $ 1.48 $ 1.58 $ 1.48 $ 1.58
Weighted average number of diluted common shares 18,400,000 18,400,000 18,400,000 18,400,000

Constant Currency

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

EBITDA

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

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

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

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

Net Margin

Net margin is a non-GAAP financial measure, which is calculated by subtracting sales and marketing from gross profit. Net margin is the primary metric used by our Chief Operating Decision Maker in managing our business.

Free Cash Flow

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

Usefulness and Limitations of Non-GAAP Financial Measures

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

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

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

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

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

Usefulness of Non-GAAP Financial Measures to Investors

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

Contacts

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

SeaSpine Reports First Quarter 2017 Financial Results

CARLSBAD, Calif., May 04, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the first quarter ended March 31, 2017.

First Quarter 2017 Financial Highlights and Recent Accomplishments

  • Revenue of $31.9 million, an increase of 1.6% year-over-year
  • U.S. revenue of $28.6 million, an increase of 0.2% year-over-year
    • U.S. orthobiologics revenue of $15.1 million
    • U.S. spinal hardware revenue of $13.5 million
  • International revenue of $3.3 million, an increase of 15.0% year-over-year
  • Initial launch of the reusable Rapid Graft Delivery System, which is designed to provide surgeons a cost-effective and controlled method to predictably deliver a broad range of orthobiologic grafts efficiently to the disc space
  • Initial launch of the Daytona Small Stature Pediatric Deformity System, a minimal profile version of our existing Daytona system that provides both a clinical and cosmetic benefit for pediatric patients

“Our first quarter performance reflects early traction with our strengthening distributor base and our expanding and updated product portfolio,” said Keith Valentine, President and Chief Executive Officer. “We are continuing to invest in key objectives aimed at top line performance while simultaneously reducing our net cash spend to extend our liquidity horizon.”

First Quarter 2017 Financial Results
Revenue for the first quarter of 2017 totaled $31.9 million, a 1.6% increase compared to the same period of the prior year. Total revenue in the U.S. was $28.6 million, a 0.2% increase compared to same period of the prior year.

Orthobiologics revenue totaled $17.1 million, a 2.8% increase compared to the first quarter of 2016. The increase in orthobiologics revenue was driven by an increase in both U.S. and international sales, primarily due to the addition of new distributors in both markets. Spinal hardware revenue totaled $14.8 million, a 0.2% increase compared to the first quarter of 2016. The increase in spinal hardware revenue was driven by the recent addition of a new distributor in Latin America.

Gross margin for the first quarter of 2017 was 58.7%, compared to 54.5% for the same period in 2016.  The increase in gross margin was primarily driven by a $1.7 million provision for excess orthobiologics raw material inventory recorded in the first quarter of 2016. This was somewhat offset by a $0.2 million increase in the first quarter of 2017 in non-cash amortization of technology intangible assets from the NLT acquisition and by lower gross margins associated with international sales, which were slightly higher as a percentage of total revenue compared to the same period of the prior year.

Operating expenses for the first quarter of 2017 totaled $27.8 million, compared to $29.4 million for the same period of the prior year.  The $1.6 million decrease in operating expenses was driven by lower selling, general and administrative and intangible amortization expenses.

Net loss for the first quarter of 2017 was $9.1 million, compared to a net loss of $12.0 million for the first quarter of 2016.

Cash and cash equivalents at March 31, 2017 were $12.7 million and the Company had $3.9 million of outstanding borrowings against its $30 million credit facility.

2017 Financial Outlook
Consistent with prior guidance, SeaSpine expects full-year 2017 revenue to be in the range of $129 to $133 million, reflecting growth of 0% to 3% over full-year 2016 revenue.

Webcast and Conference Call Information
The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 2407268. To listen to the webcast, please visit the investor relations section of the SeaSpine website at www.seaspine.com.

About SeaSpine
SeaSpine is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal hardware solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal hardware portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive, complex, deformity and degenerative procedures. We believe expertise in both orthobiologic sciences and spinal hardware product development helps SeaSpine to offer its surgeon customers a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: revenue expectations for full-year 2017; and the Company’s ability to drive top-line performance and revenue growth while simultaneously reducing net cash spend.  Among the factors that could cause or contribute to material differences between the Company’s actual results and the expectations indicated by the forward-looking statements are risks and uncertainties that include, but are not limited to: surgeons’ willingness to continue to use our existing products and to adopt our newly launched products; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; disruption to our existing distribution network as new distributors are added and the inability of new distributors to generate growth, or even offset lost business; the risk that our products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing, including in ongoing and future studies, the outcomes of which inherently are uncertain; the lack of clinical validation of products in “alpha release” and the fact they may require substantial additional development activities, which could introduce unexpected expense and delay; the risk of supply shortages, including as a result of our dependence on a limited number of third-party suppliers for components and raw materials, or otherwise; third-party payors’ willingness to continue to provide, for our existing products, and to initiate, for our newly launched products, appropriate coverage, coding and reimbursement and uncertainty resulting from healthcare reform, both in the U.S. and abroad; unexpected expense, including as a result of developing and launching new and next generation products and product line extensions; our ability to sustain current operations and to continue to invest in product development, sales and marketing initiatives at levels sufficient to drive future revenue growth in light of cost-reduction initiatives first implemented in 2016 and that continue to impact current operations; our ability to obtain funding on a timely basis on acceptable terms, or at all, to execute our business strategy; general economic and business conditions in the markets in which we do business, both in the U.S. and abroad; and other risks and uncertainties more fully described in our news releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.

You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. SeaSpine does not intend to revise or update any forward-looking statement set forth in this news release to reflect events or circumstances arising after the date hereof, except as may be required by law.

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Three Months Ended March 31,
2017 2016
Total revenue, net $ 31,894 $ 31,399
Cost of goods sold 13,172 14,283
Gross profit 18,722 17,116
Operating expenses:
Selling, general and administrative 23,970 25,374
Research and development 3,050 2,753
Intangible amortization 792 1,281
Total operating expenses 27,812 29,408
Operating loss (9,090 ) (12,292 )
Other income (expense), net (13 ) 258
Loss before income taxes (9,103 ) (12,034 )
Benefit for income taxes (27 )
Net loss $ (9,103 ) $ (12,007 )
Net loss per share, basic and diluted $ (0.79 ) $ (1.08 )
Weighted average shares used to compute basic and diluted net loss per share 11,586 11,167
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In thousands)
March 31, 2017 December 31, 2016
Cash and cash equivalents $ 12,726 $ 14,566
Trade accounts receivable, net of allowances of $480 and $483 19,388 20,982
Inventories 42,993 45,299
Total current liabilities 22,064 24,418
Short-term debt 67 445
Long-term borrowings under credit facility 3,914 3,835
Total stockholders’ equity 106,654 110,977
Investor Relations Contact
Lynn Pieper Lewis
(415) 937-5402
ir@seaspine.com

Anika Reports First Quarter 2017 Financial Results

BEDFORD, Mass., May 03, 2017 (GLOBE NEWSWIRE) — Anika Therapeutics, Inc. (NASDAQ:ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the first quarter ended March 31, 2017, along with business progress in the periods.

“We made important progress executing our long-term growth strategy in the first quarter of 2017,” said Charles H. Sherwood, Ph.D., President and Chief Executive Officer. “We finalized the clinical study design for an additional Phase III clinical trial of CINGAL, and we commenced planning and site initiation activities for the trial in the quarter. MONOVISC continued its strong momentum with revenue growth of 24% year-over-year for the quarter, and we achieved a significant milestone in our global expansion with the launch of ORTHOVISC-T in Europe.”

First Quarter Financial Results

  • Total revenue for the first quarter of 2017 increased 5% to $23.4 million, compared to $22.3 million for the first quarter of 2016.
  • Worldwide Orthobiologics revenue grew 3% year-over-year in the first quarter of 2017. MONOVISC revenue increased 24% year-over-year in the first quarter of 2017, and it was the main revenue growth driver in the period.
  • International Orthobiologics revenue increased 12% for the first quarter of 2017, due primarily to the global expansion of MONOVISC, as well as the growth of CINGAL in Europe and Canada. Domestically, ORTHOVISC and MONOVISC continue to maintain a combined market leading position.
  • Total operating expenses for the first quarter of 2017 were $15.4 million, compared to $11.6 million for the first quarter of 2016. The increase in total operating expenses was due primarily to higher research and development spending required to advance the Company’s product pipeline, expanded operational efforts, and increased professional service fees.
  • Net income for the first quarter of 2017 was $5.5 million, or $0.37 per diluted share, compared to $6.9 million, or $0.45 per diluted share, for the first quarter of 2016. The decline in net income was due primarily to the planned increase in operating expenses previously discussed.

Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:

  • Finalizing the clinical study design for an additional Phase III clinical trial of CINGAL, and commencing site initiation activities for the trial. The trial is a randomized, double-blind, active comparator controlled, multi-center study of CINGAL to demonstrate that CINGAL provides symptomatic relief of osteoarthritis of the knee in patients who have not responded to conservative treatment.
  • Launching ORTHOVISC-T in Europe to relieve pain and restore function in tendons affected by chronic lateral epicondylosis.
  • Advancing its product pipeline with continued progress on enrolling patients in the FastTRACK Phase III HYALOFAST Study for cartilage repair, as well as the Phase III MONOVISC study for the treatment of osteoarthritis pain in the hip.
  • Progressing the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate headquarters.
  • Completing the build-out of the Company’s new European headquarters and training center in Padova, Italy.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow, Thursday, May 4th at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the “Investor Relations” section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ:ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC®, MONOVISC®, and CINGAL®, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST®, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements
The statements made in this press release, which are not statements of historical fact, are 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. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

 

Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)
     
    For the Three Months Ended March 31,
2017 2016
Product revenue $ 23,381 $ 22,278
Licensing, milestone and contract revenue 5 5
Total revenue 23,386 22,283
Operating expenses:
Cost of product revenue 6,083 5,425
Research & development 4,230 2,159
Selling, general & administrative 5,067 3,990
Total operating expenses 15,380 11,574
Income from operations 8,006 10,709
Interest income, net 58 72
Income before income taxes 8,064 10,781
Provision for income taxes 2,571 3,886
Net income $ 5,493 $ 6,895
Basic net income per share:
Net income $ 0.38 $ 0.46
Basic weighted average common shares outstanding 14,576 14,875
Diluted net income per share:
Net income $ 0.37 $ 0.45
Diluted weighted average common shares outstanding 15,043 15,307
Anika Therapeutics, Inc. and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except per share data)
(unaudited)
 
    March 31,    December 31, 
ASSETS   2017 2016
Current assets:
Cash and cash equivalents $ 119,368 $ 104,261
Investments 19,250 20,500
Accounts receivable, net of reserves of $196 and $194 at March 31,
2017 and December 31, 2016, respectively
21,079 27,598
Inventories 16,180 15,983
Prepaid expenses and other current assets 1,173 2,098
Total current assets 177,050 170,440
Property and equipment, net 51,593 52,296
Long-term deposits and other 1,234 69
Intangible assets, net 10,162 10,227
Goodwill 7,328 7,214
Total assets $ 247,367 $ 240,246
LIABILITIES AND STOCKHOLDERS’ EQUITY      
Current liabilities:  
Accounts payable $ 6,050 $ 2,303
Accrued expenses and other current liabilities 4,167 6,496
Total current liabilities 10,217 8,799
Other long-term liabilities 400 2,126
Deferred tax liability 6,722 6,548
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $.01 par value; 1,250 shares authorized, no shares
issued and outstanding at December 31, 2016 and December 31,
2015, respectively
Common stock, $.01 par value; 60,000 and 30,000 shares
authorized, 14,655 and 14,627 shares issued and outstanding at
March 31, 2017 and December 31, 2016, respectively
146 146
Additional paid-in-capital 63,719 61,735
Accumulated other comprehensive loss (7,025 ) (7,317 )
Retained earnings 173,188 168,209
Total stockholders’ equity 230,028 222,773
Total liabilities and stockholders’ equity $ 247,367 $ 240,246

 

Anika Therapeutics, Inc. and Subsidiaries
Supplemental Financial Data 
             
 
Revenue by Product Line and Product Gross Margin
(in thousands, except percentages)
(unaudited)
  For the Three Months Ended March 31, 
Product Line:  2017 %   2016 %
Orthobiologics $ 20,227 87 % $ 19,587 88 %
Surgical 1,296 5 % 1,318 6 %
Dermal 425 2 % 381 2 %
Other 1,433 6 % 992 4 %
Product Revenue $ 23,381 100 % $ 22,278 100 %
Product Gross Profit $ 17,298 $ 16,853
Product Gross Margin 74% 76%
             
Product Revenue by Geographic Region
(in thousands, except percentages)
(unaudited)
             
  For the Three Months Ended March 31, 
  2017 % 2016 %
Geographic Region:     
United States $ 18,930 81 % $ 18,011 81 %
Europe 2,829 12 % 2,565 11 %
Other 1,622 7 % 1,702 8 %
Product Revenue $ 23,381 100 % $ 22,278 100 %

CONTACT:
Anika Therapeutics, Inc.
Charles H. Sherwood, Ph.D., President and CEO
Sylvia Cheung, CFO
Tel:  781-457-9000

InVivo Therapeutics Provides Clinical Update and Reports 2017 First Quarter Financial Results

May 04, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today provided a clinical update, an update on patients in the INSPIRE study of the Neuro-Spinal Scaffold™, and reported financial results for the quarter ended March 31, 2017.

“The AIS grade improvement rate observed thus far in the INSPIRE study compares favorably to the natural history of spinal cord injury”

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Clinical/Regulatory Update

Mark Perrin, InVivo’s Chief Executive Officer and Chairman, said, “In the first quarter, we continued to make significant progress at InVivo and with the INSPIRE study. By early April, we had enrolled four new patients into the INSPIRE study, with three patients enrolled within 30 days of each other. We also announced four new clinical sites for the INSPIRE study.

In addition to progress with INSPIRE enrollment and sites, we achieved several regulatory milestones. Health Canada approved the company’s Investigational Testing Authorization application to commence a clinical study of the Neuro-Spinal Scaffold in patients with acute, complete (AIS A) cervical (C5-T1) spinal cord injuries (SCIs), and we announced the opening of our first site for the cervical study, Toronto Western Hospital. We also announced the Medicines Healthcare Products Regulatory Agency (MHRA) approval of the company’s Clinical Trial Authorization Application to commence the INSPIRE study in the United Kingdom. Finally, we submitted the first module of our Humanitarian Device Exemption (HDE) application to the FDA.

Looking forward, we anticipate completing enrollment in the INSPIRE study in the third quarter and filing an HDE application for marketing approval of the Neuro-Spinal Scaffold in early 2018.”

INSPIRE Patient Updates

There are currently 14 INSPIRE patients in follow-up, and eight have reached the six-month primary endpoint. Of these eight patients, five had an AIS grade improvement (compared to baseline) and three did not have an AIS grade improvement at 6 months post-injury (a 62.5% conversion rate at 6 months). The INSPIRE AIS improvement rate remains considerably higher than rates observed in a range of SCI natural history databases.

InVivo announced in January 2017 that a patient enrolled into INSPIRE in December 2016 had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury at the one-month evaluation. At a recent follow-up visit (the first since January), the patient was assessed to have reverted back to a complete AIS A spinal cord injury.

Separately, in March 2017 InVivo announced that a patient enrolled in January 2017 had improved from a complete AIS A spinal cord injury to an incomplete AIS B spinal cord injury at the two-month evaluation. At the recent three-month follow-up evaluation, the patient was assessed to have reverted back to a complete AIS A spinal cord injury.

There are previously published examples of patients with baseline AIS A spinal cord injury that are assessed to have an AIS grade improvement followed by a return to complete AIS A status within the first year after injury. In a 2009 article, 12.5% (2/16) of baseline AIS A spinal cord injury patients (cervical and thoracic) who experienced an AIS grade improvement were later assessed to return to complete AIS A status within the first year after injury. Of those two patients, one patient improved back to an incomplete AIS grade within the same year.*

“The AIS grade improvement rate observed thus far in the INSPIRE study compares favorably to the natural history of spinal cord injury,” CEO and Chairman Mark Perrin said. “We look forward to monitoring these patients’ progress as they reach the primary endpoint at six months post-injury and as we work towards completing enrollment of INSPIRE.”

Financial Results

For the three-month period ended March 31, 2017, the Company reported a net loss of approximately $6.4 million, or $0.20 per diluted share, compared to a net loss of $6.6 million, or $0.24 per diluted share, for the three-month period ended March 31, 2016. The results for the three-month period ended March 31, 2017 were unfavorably impacted by increases in operating expenses of $816,000 in research and development and $286,000 in general and administrative, partially offset by a non-cash gain on the derivative warrant liability of $241,000 reflecting changes in the fair market value of the derivative warrant liability. The results for the three-month period ended March 31, 2016 were unfavorably impacted by a non-cash loss on the derivative warrant liability of $1.0 million. Excluding the impact of the derivative warrant liability, adjusted net loss for the three-month period ended March 31, 2017 was $6.6 million, or $0.21 per diluted share, compared to adjusted net loss of $5.6 million, or $0.20 per diluted share, for the three-month period ended March 31, 2016.

The Company ended the quarter with $26.8 million of cash, cash equivalents, and marketable securities.

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

* Spiess et al. Conversion in ASIA Impairment Scale during the First Year after Traumatic Spinal Cord Injury. Journal of Neurotrauma 26: 2027-2036 (November 2009).

About The INSPIRE Study

The INSPIRE Study: InVivo Study of Probable Benefit of the Neuro-Spinal Scaffold™ for Safety and Neurologic Recovery in Subjects with Complete Thoracic AIS A Spinal Cord Injury, is designed to demonstrate the safety and probable benefit of the Neuro-Spinal Scaffold™ for the treatment of complete T2-T12/L1 spinal cord injury in support of a Humanitarian Device Exemption (HDE) application for approval. The FDA has recommended that InVivo include a control arm in the study as part of a Study Design Consideration. We are in discussions with the FDA on this recommendation, and we continue to believe that our current study design is sufficient to demonstrate safety and probable benefit in support of an HDE application for marketing approval. For more information, refer to https://clinicaltrials.gov/ct2/show/study/NCT02138110.

About the Neuro-Spinal Scaffold™ Implant

Following acute spinal cord injury, surgical implantation of the biodegradable Neuro-Spinal Scaffold within the decompressed and debrided injury epicenter is intended to support appositional healing, thereby reducing post-traumatic cavity formation, sparing white matter, and allowing neural regeneration across the healed wound epicenter. The Neuro-Spinal Scaffold, an investigational device, has received a Humanitarian Use Device (HUD) designation and currently is being evaluated in The INSPIRE Study for the treatment of patients with acute, complete (AIS A), thoracic traumatic spinal cord injury and a pilot study for acute, complete (AIS A), cervical (C5-T1) traumatic spinal cord injury. For more information on the cervical study, refer to https://clinicaltrials.gov/ct2/show/study/NCT03105882.

About InVivo Therapeutics

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

Safe Harbor Statement

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements within the meaning of the federal securities laws. These statements can be identified by words such as “believe,” “anticipate,” “intend,” “estimate,” “will,” “may,” “should,” “expect,” “designed to,” “potentially,” and similar expressions, and include statements regarding the safety and effectiveness of the Neuro-Spinal Scaffold and the progress of the clinical program. Any forward-looking statements contained herein are based on current expectations, and are subject to a number of risks and uncertainties. Factors that could cause actual future results to differ materially from current expectations include, but are not limited to, risks and uncertainties relating to the company’s ability to successfully open additional clinical sites for enrollment and to enroll additional patients; the timing of the Institutional Review Board process; the company’s ability to complete The INSPIRE Study, submit an HDE application, and receive regulatory approval for the Neuro-Spinal Scaffold, the company’s ability to commercialize its products; the company’s ability to develop, market and sell products based on its technology; the expected benefits and efficacy of the company’s products and technology in connection with the treatment of spinal cord injuries; the availability of substantial additional funding for the company to continue its operations and to conduct research and development, clinical studies and future product commercialization; and other risks associated with the company’s business, research, product development, regulatory approval, marketing and distribution plans and strategies identified and described in more detail in the company’s Quarterly Report of the three months ended March 31, 2017, and its other filings with the SEC, including the company’s Form 10-Qs and current reports on Form 8-K. The company does not undertake to update these forward-looking statements.

InVivo Therapeutics Holdings Corp.
Consolidated Balance Sheets
Unaudited
As of

March 31, 2017

December 31, 2016
ASSETS:
Current assets:
Cash and cash equivalents 14,440 21,464
Restricted cash 361 361
Short-term marketable securities 11,649 11,577
Prepaid expenses and other current assets 940 451
Total current assets 27,390 33,853
Long-term marketable securities 751
Property, equipment and leasehold improvements, net 395 510
Other assets 415 421
Total assets 28,951 34,784
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable 1,038 1,011
Loan payable, current portion 430 423
Derivative warrant liability 1,073 1,314
Deferred rent, current portion 147 141
Accrued expenses 1,421 1,959
Total current liabilities 4,109 4,848
Loan payable, net of current portion 742 852
Deferred rent, net of current portion 95 135
Other liabilities 36
Total liabilities 4,982 5,835
Stockholders’ equity:
Common stock, $0.00001 par value, authorized 100,000,000 shares; issued and

outstanding 32,123,392 shares at March 31, 2017; issued and outstanding 32,044,087

shares at December 31, 2016

1

1

Accumulated other comprehensive loss (2)
Additional paid-in capital 187,523 185,955
Accumulated deficit (163,553) (157,007)
Total stockholders’ equity 23,969 28,949
Total liabilities and stockholders’ equity 28,951 34,784
InVivo Therapeutics Holdings Corp.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)
Three Months Ended March 31,
2017 2016
Operating expenses:
Research and development 3,384 2,568
General and administrative 3,285 2,999
Total operating expenses 6,669 5,567
Operating loss (6,669) (5,567)
Other income (expense):
Interest income 57 54
Interest expense (20) (63)
Derivatives gain (loss) 241 (1,047)
Other income (expense), net 278 (1,056)
Net loss (6,391) (6,623)
Net loss per share, basic and diluted (0.20) (0.24)
Weighted average number of
common shares outstanding, basic and diluted 32,080,141 28,171,606
Other comprehensive loss:
Net loss (6,391) (6,623)
Other comprehensive loss:
Unrealized loss on marketable securities (2)
Comprehensive loss (6,393) (6,623)
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp.
(In thousands, except share and per share data)
Three Months Ended
March 31,
2017 2016
Reported GAAP net loss (6,391) (6,623)
Derivatives (gain) loss (241) 1,047
Adjusted net loss (6,632) (5,576)
Reported GAAP net loss per diluted share (0.20) (0.24)
Derivative (gain) loss per diluted share (0.01) 0.04
Adjusted net loss per diluted share (0.21) (0.20)

Contacts

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

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

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

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

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

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

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

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

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

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

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

 

READ THE REST HERE

Misonix Reports Third Quarter Fiscal Year 2017 Financial Results

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

Financial Highlights for the Third Quarter and Nine-Months:

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

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

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

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

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

Conference Call

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

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

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

About Misonix

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

Safe Harbor Statement

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

Financial Tables to Follow

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

 

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

 

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

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

Source: Misonix, Inc.

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

Globus Medical Reports First Quarter 2017 Results

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

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

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

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

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

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

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

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

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2017 first quarter results with the investment community at 5:30 p.m. Eastern Time today.  Globus invites all interested parties to join the call by dialing:

1-855-533-7141  United States Participants
1-720-545-0060  International Participants
There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at investors.globusmedical.com.

The call will be archived until Wednesday, May 9, 2017.  The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 6940-2658.

About Globus Medical, Inc.
Globus Medical, Inc. is a leading musculoskeletal implant company based in Audubon, PA.  The company was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders.

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures.  For example, non-GAAP adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, provision for litigation, and acquisition related costs, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense.  Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections.  Provision for litigation represents costs incurred for litigation settlements or unfavorable verdicts when the loss is known or considered probable and the amount can be reasonably estimated, or in the case of a favorable settlement, when income is realized.  Acquisition related costs represents the change in fair value of business-acquisition-related contingent consideration; costs related to integrating recently acquired businesses including but not limited to costs to exit or convert contractual obligations, severance, and information system conversion; and specific costs related to the consummation of the acquisition process such as banker fees, legal fees, and other acquisition- related professional fees.

In addition, for the period ended March 31, 2017 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represents net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs and the tax effects of such adjustments.  The tax impact of these non-GAAP adjustments is calculated based on the consolidated effective tax rate on a GAAP basis, applied to the non-GAAP adjustments, unless the underlying item has a materially different tax treatment, in which case the estimated tax rate applicable to the adjustment is used.  We believe these non-GAAP measures are also useful indicators of our operating performance, and particularly as additional measures of comparative operating performance from period to period as they remove the effects of litigation, amortization of intangibles, acquisition related costs, and the tax effects of such adjustments, which we believe are not reflective of underlying business trends.  Additionally, for the periods ended March 31, 2017 and for other comparative periods, we also define the non-GAAP measure of free cash flow as the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment.  We believe that this financial measure provides meaningful information for evaluating our overall liquidity for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions.  Furthermore, the non-GAAP measure of constant currency sales growth is calculated by translating current year sales at the same average exchange rates in effect during the applicable prior year period.  We believe constant currency sales growth provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth are not calculated in conformity with U.S. GAAP within the meaning of Item 10(e) of Regulation S-K.  Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP.  These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results.  Our definitions of non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth may differ from that of other companies and therefore may not be comparable.  Additionally, we have recast prior periods for non-GAAP net income and non-GAAP diluted earnings per share.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms.  These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends.  Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted.  These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks.  For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission.  These documents are available at www.sec.gov.  Moreover, we operate in an evolving environment.  New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements.  Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements.  Forward-looking statements contained in this press release speak only as of the date of this press release.  We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
Three Months Ended
(In thousands, except per share amounts) March 31,
2017
March 31,
2016
Sales $ 155,809 $ 139,264
Cost of goods sold 35,600 31,519
Gross profit 120,209 107,745
Operating expenses:
Research and development 10,666 10,030
Selling, general and administrative 67,059 53,798
Amortization of intangibles 1,782 392
Acquisition related costs 388 674
Total operating expenses 79,895 64,894
Operating income 40,314 42,851
Other income, net 2,100 760
Income before income taxes 42,414 43,611
Income tax provision 13,700 15,601
Net income $ 28,714 $ 28,010
Earnings per share:
Basic $ 0.30 $ 0.29
Diluted $ 0.30 $ 0.29
Weighted average shares outstanding:
Basic 95,996 95,398
Diluted 97,148 96,293
GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except par value) March 31,
2017
December 31,
2016
ASSETS (unaudited)
Current assets:
Cash and cash equivalents $ 182,435 $ 132,639
Restricted cash 477 477
Short-term marketable securities 143,663 157,673
Accounts receivable, net of allowances of $3,627 and $2,771, respectively 94,232 91,983
Inventories 113,037 112,692
Prepaid expenses and other current assets 7,008 14,502
Income taxes receivable 47 3,800
Total current assets 540,899 513,766
Property and equipment, net of accumulated depreciation of $173,890 and $166,711, respectively 124,840 124,229
Long-term marketable securities 63,066 60,444
Note receivable 30,000 30,000
Intangible assets, net 61,343 61,706
Goodwill 106,215 105,926
Other assets 954 928
Deferred income taxes 33,104 30,638
Total assets $ 960,421 $ 927,637
LIABILITIES AND EQUITY
Current liabilities:
Accounts payable $ 17,013 $ 17,472
Accrued expenses 37,409 46,401
Income taxes payable 11,708 1,911
Business acquisition liabilities, current 9,239 14,108
Total current liabilities 75,369 79,892
Business acquisition liabilities, net of current portion 6,087 5,972
Deferred income taxes 8,261 7,876
Other liabilities 1,819 1,819
Total liabilities 91,536 95,559
Commitments and contingencies
Equity:
Common stock; $0.001 par value.  Authorized 785,000 shares; issued and outstanding 96,077 and 95,930 shares at March 31, 2017 and December 31, 2016, respectively 96 96
Additional paid-in capital 217,257 211,725
Accumulated other comprehensive loss (6,081 ) (8,642 )
Retained earnings 657,613 628,899
Total equity 868,885 832,078
Total liabilities and equity $ 960,421 $ 927,637
GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
Cash flows from operating activities:
Net income $ 28,714 $ 28,010
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization 12,240 6,676
Amortization of premium on marketable securities 1,008 953
Write-down for excess and obsolete inventories 1,671 2,225
Stock-based compensation expense 3,491 2,770
Allowance for doubtful accounts 794 88
Change in fair value of contingent consideration 478
Change in deferred income taxes (2,399 ) 391
(Increase)/decrease in:
Restricted cash 15,668
Accounts receivable (2,225 ) 2,201
Inventories (2,102 ) (2,252 )
Prepaid expenses and other assets 8,628 1,209
Increase/(decrease) in:
Accounts payable (172 ) (1,238 )
Accrued expenses and other liabilities (10,170 ) (15,661 )
Income taxes payable/receivable 13,493 14,517
Net cash provided by operating activities 53,449 55,557
Cash flows from investing activities:
Purchases of marketable securities (51,215 ) (104,208 )
Maturities of marketable securities 55,280 69,656
Sales of marketable securities 6,505 7,798
Purchases of property and equipment (11,533 ) (9,366 )
Net cash used in investing activities (963 ) (36,120 )
Cash flows from financing activities:
Payment of business acquisition liabilities (5,001 ) (300 )
Proceeds from exercise of stock options 1,990 1,895
Net cash (used in)/provided by financing activities (3,011 ) 1,595
Effect of foreign exchange rate on cash 321 91
Net increase in cash and cash equivalents 49,796 21,123
Cash and cash equivalents, beginning of period 132,639 60,152
Cash and cash equivalents, end of period $ 182,435 $ 81,275
Supplemental disclosures of cash flow information:
Interest paid 8 1
Income taxes paid $ 2,656 $ 774
Supplemental Financial Information
Sales by Geographic Area:
(Unaudited) Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
United States $ 129,663 $ 127,560
International 26,146 11,704
Total sales $ 155,809 $ 139,264
Sales by Product Category:
(Unaudited) Three Months Ended
(In thousands) March 31,
2017
March 31,
2016
Innovative Fusion $ 81,872 $ 70,046
Disruptive Technology 73,937 69,218
Total sales $ 155,809 $ 139,264
Liquidity and Capital Resources:
(Unaudited) March 31,
2017
December 31,
2016
(In thousands)
Cash and cash equivalents $ 182,435 $ 132,639
Short-term marketable securities 143,663 157,673
Long-term marketable securities 63,066 60,444
Total cash, cash equivalents and marketable securities $ 389,164 $ 350,756
Available borrowing capacity under revolving credit facility 50,000 50,000
Working capital $ 465,530 $ 433,874

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

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

 

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

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

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

First Quarter 2017 Financial Summary:

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

Year-to-Date 2017 Highlights:

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

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

First Quarter 2017 Financial Results

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

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

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

The following table represents domestic revenue by procedure category.

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

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

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

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

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

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

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

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

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

2017 Outlook

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

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

Conference Call

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

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

About K2M Group Holdings, Inc.

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

Forward-Looking Statements

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

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

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

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

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

Use of Non-GAAP Financial Measures

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

About Expanding Orthopedics Inc.

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

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

SOURCE Expanding Orthopedics Inc. (EOI)