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

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

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

INSPIRE Update

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

Financial Results

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

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

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

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

About The INSPIRE Study

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

About the Neuro-Spinal Scaffold™ Implant

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

About InVivo Therapeutics

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

Safe Harbor Statement

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

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

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

Financial Results Overview

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

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

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

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

Liquidity

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

2017 Outlook

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

¹ Represents a year-over-year increase of 4.4% to 5.2% on a reported basis
² Represents a year-over-year increase of 306.1% to 386.1%
³ Represents a year-over-year decrease of 0.4% to an increase of 3.4%
⁴ Represents a year-over-year increase of 305.3% to 384.2%
⁵ Represents a year-over-year increase of 5.5% to 11.6%

Conference Call

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

About Orthofix

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

Forward-Looking Statements

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

ORTHOFIX INTERNATIONAL N.V.
Non-GAAP Financial Measures

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

Non-GAAP Measures:

Constant Currency

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

EBITDA

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

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

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

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

Non-GAAP Net Margin

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

Free Cash Flow

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

Usefulness and Limitations of Non-GAAP Financial Measures

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

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

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

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

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

Usefulness of Non-GAAP Financial Measures to Investors

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