2016: A Historic Year for VEXIM

TOULOUSE, France–(BUSINESS WIRE)–Regulatory News:

VEXIM (Paris:ALVXM) (FR0011072602 – ALVXM), a medical device company specializing in the minimally invasive treatment of vertebral fractures, today announces its consolidated annual results (IFRS1) as of December 31st, 20162.

« Our 2016 results represent a historic turning point for VEXIM. VEXIM has reached profitability and generated a positive cash flow over the second half of 2016. These excellent results validate our profitable growth strategy. This trend should continue during 2017, as we expect sales growth of 30% to 35%, and full-year profitability. We expect to launch SpineJack® in the United States – the largest market for vertebral fractures – in 2018, further generating strong sales growth. We will decide and announce our business strategy for the US, aimed at capturing market share and building shareholder value, later this year. These achievements demonstrate that VEXIM is on the right track to become a global leader in the market of spine trauma », said Vincent Gardès, CEO of VEXIM.

Strong sales increase, solid gross margin on sales and positive net income in the second half of 2016

For the first time, and in order to comply with international standards, VEXIM issues its consolidated financial statements, in accordance with International Financial Reporting Standards (IFRS). Appendixes, on page 9 of this press release, include the conversion tables from French accounting standards to IFRS for the consolidated income statements of the financial years 2015 and 2016.

IFRS consolidated statement
(in millions of Euros)

As of December 31st Variation First Half Second Half
2016 2015 2016 2016
Revenue 18.5 13.9 33% 8.6 9.9
Gross margin 13.4 9.9 35% 6.3 7.1
Gross margin (% of sales) 72.2% 71.5% 73.8% 70.9%
Operating expenses -16.5 -14.7 12% -9.2 -7.4
Operating loss -3.2 -4.8 -33% -2.9 -0.3
Income tax & finance costs, net 0.5 0.1 0.4
Profit / (loss) for the period -2.7 -4.8 -44% -2.8 0.1

2016 highlights

  • New sales record in the 4th quarter, at €5.2 million;
  • Finalized patient enrollment for the international clinical trial intended to support our 510(k) submission to the FDA – announced on February 21st, 2017;
  • Initiated a medico-economic study comparing the SpineJack® to conservative orthopedic management (bracing) on 100 patients with a 1 and 2-year follow-up;
  • Secured long-term cash position, thanks to a successful private placement of €10.4 million in January 2016;
  • Strengthened our management team with the appointments of François Cathelineau as VP Operations, Sébastien Lemoine as VP International Sales & Market Development, followed by the appointment of Russell Powers as VP & General Manager of the US activities, in January 2017.

€18.5 million in sales: VEXIM continues to expand at a steady pace (+33%)

VEXIM’s sales for 2016 have reached €18.5 million, an increase of 33% compared to 2015. This significant growth underlines the effectiveness of the direct sales strategy implemented by the company for SpineJack® in Europe, as well as the broader adoption of the technology.

The gross margin on sales (“gross margin”) also increased by 35% compared to 2015, reaching €13.4 million (€6.3 million in the first half of 2016), representing 72.2% of sales.

The gross margin maintained itself at a high percentage due to growing sales in Europe and competitive pricing, with the support of our direct-sales strategy. The 70.9% gross margin on sales in the second half of 2016 is explained by growing sales performance in countries with indirect distribution.

Impact of gross margin and cost control: strongly reducing annual losses and generating net profit in the second half of 2016

The second half of 2016 marked a historic turning point for VEXIM, which proved its ability to achieve profitable growth and financial discipline.

Operating expenses only increased by 12% in 2016, up to €16.5 million, while sales grew 33% over the same period. Such control of operating costs contributed to further decrease the operating losses, from €4.8 million loss in 2015 to €3.2 million loss to in 2016. The net loss recorded in 2016, which includes income tax and finance costs of €0.5 million, is €2.7 million compared to €4.8 million in 2015.

For the first time since its creation in 2006, VEXIM recorded a net profit of €0.1 million in the second half of 2016. This major step is the result of the strategy followed over the past two years by VEXIM, with the aim of self-financing:

  • Gained market shares in France and abroad, to drive further revenue growth;
  • Used its technological advance to support competitive pricing and a high gross margin;
  • Drew on productivity gains and effective cost control to maintain the beneficiary’s capacity and generate cash.

Positive cash flows in the second half of the year (+€0.3 million)

As of December 31st, 2016, the Group’s cash position stood at €9.8 million (vs. €9.4 million as of June 30th, 2016), boosted by a free cash flow of €0.3 million in the second half of the year. The current cash position and future cash flows should allow VEXIM to self-finance, in line with its ambitions. VEXIM plans to generate a positive free cash flow from operations over the full year in 2017.

2017 objectives: Perspectives for a strong and profitable growth

Despite an increasingly demanding “baseline” VEXIM aims to keep achieving significant sales growth in 2017, combined with full-year profitability:

  • Expected strong sales growth of +30% to +35%;
  • Achieve profitability on a full-year basis;
  • FDA 510(k) filing in the United States during the last quarter, for an expected market launch in the first half of 2018;
  • Continue to expand abroad with new partnerships in Brazil, Australia and South Korea;
  • Keep on innovating in the treatment of vertebral fractures, by developing new products to extend the current portfolio.

To support VEXIM’s accelerated development, the Board of Directors has approved a “technical”3 project to transfer VEXIM’s listing from Alternext to the regulated market of Euronext Paris.

Financial reporting schedule:
1st quarter sales: April 19th, 20174

About VEXIM, the innovative back microsurgery specialist

Based in Balma, near Toulouse (France), VEXIM is a medical device company created in February 2006. The Company has specialized in the creation and marketing of minimally invasive solutions for treating traumatic spinal pathologies. Benefitting from the financial support of it longstanding shareholder, Truffle Capital5, and from OSEO public subsidies, VEXIM has designed and developed the SpineJack®, a unique implant capable of repairing a fractured vertebra and restoring the balance of the spinal column. The company also developed the MasterflowTM, an innovative solution for mixing and injecting orthopedic cement that enhances the accuracy of the injection and optimizes the overall surgical procedure. The company counts 66 employees, including its own sales teams in Europe and a network of international distributors. VEXIM has been listed on NYSE Alternext Paris since May 3rd 2012. For further information, please visit www.vexim.com

SpineJack®6, an innovative implant for treating Vertebral Compression Fractures

The SpineJack® is designed to restore a fractured vertebra to its original shape, restore the spinal column’s optimal anatomy and thus remove pain and enable the patient to recover their functional capabilities. Thanks to a specialized range of instruments, inserting the implants into the vertebra is carried out by minimally invasive surgery, guided by X-ray, in approximately 30 minutes, which is intended to enable the patient to be discharged shortly after surgery. The SpineJack® range consists of 3 titanium implants with 3 different diameters, thus covering 95% of vertebral compression fractures and all patient morphologies. SpineJack® technology benefits from the support of international scientific experts in the field of spine surgery and worldwide patent protection through to 2029.

Nom : VEXIM
Code ISIN : FR0011072602
Code mnémonique : ALVXM

1 The results have been audited and approved by the Board of Directors of Vexim on March 21st, 2017.
2 Consolidated financial statements presented in Appendix.
3 Transfer of listing with no capital raising.
4 Indicative date, subject to changes.
5 Founded in 2001 in Paris, Truffle Capital is a leading independent European private equity firm. It is dedicated to investing in and building technology leaders in the IT, life sciences and energy sectors. Truffle Capital manages €550m via FCPRs and FCPIs, the latter offering tax rebates (funds are blocked during 7 to 10 years). For further information, please visit www.truffle.fr and www.fcpi.fr.
6 This medical device is a regulated health product that, with regard to these regulations, bears the CE mark. Please refer to the Instructions for Use.

Appendixes

IFRS consolidated financial statements

Consolidated income statements

In thousands of Euros Year ended December 31,
2015 2016
Revenue 13 888 18 504
Cost of sales (3 956) (5 143)
Gross profit 9 932 13 361
Selling and marketing expenses (8 470) (8 744)
Operations expenses (2 839) (3 041)
General and administrative expenses (3 916) (5 165)
Other gains / (losses), net 465 426
Operating loss (4 828) (3 163)
Finance income / (loss), net 2 (28)
Loss before income tax (4 826) (3 191)
Income tax expense (43) 468
Loss for the year (4 869) (2 723)
Attributable to:
Equity holders of the Company (4 869) (2 723)
Earnings per share attributable to the equity holders of the Company
Basic earnings per share (0,77) (0,36)
Diluted earnings per share (0,77) (0,36)

Consolidated balance sheet – assets

As at December 31,
In thousands of Euros 2014 2015 2016
Intangible assets 765 1 029 2 229
Property and equipment 733 935 1 382
Other receivables 231 218 171
Deferred tax assets 522
Non-current assets 1 730 2 182 4 304
Inventories 2 344 3 650 3 675
Trade receivables 2 560 3 606 4 670
Other receivables 1 336 1 829 2 255
Cash and cash equivalents 10 115 4 208 9 765
Current assets 16 355 13 293 20 365
Total assets 18 085 15 474 24 669

Consolidated balance sheet (equity and liabilities)

As at December 31,
In thousands of Euros 2014 2015 2016
Ordinary shares 634 635 762
Share premium 51 027 51 185 61 109
Other reserves (10) 423 1 204
Retained earnings (37 788) (42 658) (45 383)
Equity attributable to equity holders of the Company 13 863 9 585 17 693
Non-controlling interests
Total equity 13 863 9 585 17 693
Repayable advances 867 712 427
Retirement benefit obligations 113 148 111
Non-current liabilities 981 860 538
Repayable advances 106 210 314
Trade payables 1 385 2 586 2 365
Other payables 1 750 2 159 3 541
Provisions for other liabilities and charges 73 218
Current liabilities 3 241 5 029 6 438
Total liabilities 4 222 5 889 6 976
Total equity and liabilities 18 085 15 474 24 669

Consolidated cash-flow statement

In thousands of Euros 6-month period ended
2015 2016 June 30, 2016 December 31, 2016
Net income / (loss) (4 869) (2 723) (2 806) 83
Adjustments for:
Depreciation of tangible assets and amortization of intangible assets 168 289 136 153
Impairment of receivables (12) 74 83 (9)
Impairment of inventories (64) 121 20 101
Share-based payments 438 698 277 421
Change in retirement benefit obligation 35 55 27 28
Variation in provisions for risks 73 145 167 (22)
Income tax 43 (468) 35 (503)
Cash generated by / (used) in operations before changes in working capital (4 188) (1 809) (2 061) 252
Changes in working capital
Inventories (1 242) (147) (12) (135)
Trade receivables (1 033) (1 139) (693) (446)
Other receivables (492) (380) (436) 56
Trade payables 1 201 (221) (518) 297
Other payables 510 1 369 158 1 211
Cash generated by / (used) in changes in working capital (1 056) (518) (1 501) 983
Net cash generated by / (used) in operating activities (5 244) (2 327) (3 562) 1 235
Cash flows from investing activities
Purchases of tangible assets (384) (763) (595) (168)
Purchases of intangible assets (286) (1 164) (443) (721)
Disposal of assets 16
Net cash used in investing activities (654) (1 928) (1 038) (890)
Cash flows from financing activities
Proceeds from issuance of ordinary shares 158 10 472 10 453 19
Direct costs paid related to share issuance (421) (421)
Repayable advance (106) (210) (210)
Treasury shares (83) (55) (55)
Net cash generated by / (used) in financing activities (31) 9 786 9 822 (36)
Net increase / (decrease) in cash and cash equivalents (5 929) 5 531 5 222 309
Cash and cash equivalents at beginning of the year/ period 10 115 4 208 4 208 9 419
Effect of exchange rate fluctuations 22 26 (12) 38
Cash, cash equivalents at end of the year/ period 4 208 9 765 9 419 9 765

Conversion tables from French accounting standards to IFRS

In thousand Euros 2015
French GAAP
presented
under IAS / IFRS

Share-based
payments

R&D projects

Retirement
benefit
obligations

Others 2015
IAS/ IFRS
(1) (2) (3) (4)
Revenue 13 888 13 888
Cost of sales (3 956) (21) (3 977)
Gross profit 9 932 (21) 9 911
Selling and marketing expenses (8 316) (154) (8 470)
Operations expenses (2 788) (32) (18) (2 839)
General and administrative expenses (3 659) (252) (20) 21 (3 909)
Other gains / (losses), net 480 480
Operating loss (4 351) (438) (18) (20) (4 828)
Finance income / (loss), net 2 2
Loss before income tax (4 349) (438) (18) (20) (4 826)
Income tax expense (43) (43)
Loss for the year (4 392) (438) (18) (20) (4 869)
Attributable to:
Equity holders of the Company (4 392) (438) (18) (20) (4 869)
In thousand Euros

2016
French GAAP
presented
under IAS / IFRS

Share-based
payments

R&D projects

Retirement
benefit
obligations

Others

2016
IAS/ IFRS

(1) (2) (3) (4)
Revenue 18 504 18 504
Cost of sales (5 099) (44) (5 143)
Gross profit 13 405 (44) 13 361
Selling and marketing expenses (8 452) (293) (8 744)
Operations expenses (2 985) (56) (3 041)
General and administrative expenses (4 768) (349) (91) 44 (5 165)
Other gains / (losses), net 426 426
Operating loss (2 374) (698) (91) (3 163)
Finance income / (loss), net (28) (28)
Loss before income tax (2 402) (698) (91) (3 191)
Income tax expense 468 468
Loss for the year (1 934) (698) (91) (2 723)
Attributable to:
Equity holders of the Company (1 934) (698) (91) (2 723)
In thousand Euros First half 2016
French GAAP
presented
under IAS / IFRS

Share-based
payments

R&D projects

Retirement
benefit
obligations

Others

First half 2016
IAS/ IFRS

(1) (2) (3) (4)
Revenue 8 564 8 564
Cost of sales (2 226) (21) (2 246)
Gross profit 6 338 (21) 6 318
Selling and marketing expenses (4 787) (140) (4 927)
Operations expenses (1 604) (15) (1 619)
General and administrative expenses (2 772) (122) 21 (2 873)
Other gains / (losses), net 249 249
Operating loss (2 574) (277) (2 851)
Finance income / (loss), net 82 82
Loss before income tax (2 493) (277) (2 770)
Income tax expense (36) (36)
Loss for the year (2 529) (277) (2 806)
Attributable to:
Equity holders of the Company (2 529) (277) (2 806)

(1) Share-based payments valued in accordance with IFRS 2 and relative to BSA and BSPCE plans. Expense allocated to each department based on the employees’ affiliation.

(2) Restatement of year 2015, regarding a project which, activated according to the French accounting standards in the previous years, does not meet all 6 criteria of IAS 38.57, namely of how the intangible fixed asset will generate probable future economic benefits.

(3) Recalculated pension liabilities as of December 31st, 2015, to reveal actuarial gains pursuant to IAS 19.

(4) Reclassifications: depreciation on production equipment, namely mould manufacturing initially recorded under “General and administration costs”, which have been reclassified under “Cost of goods sold”.

Contacts

VEXIM
Vincent Gardès, CEO
José Da Gloria, Chief Financial Officer
investisseur@vexim.com
Tel.: +33 5 61 48 48 38
or
PRESS RELATIONS
ALIZE RP
Caroline Carmagnol / Wendy Rigal
vexim@alizerp.com
Tel.: +33 1 44 54 36 66
Tel.: +33 6 48 82 18 94

UnitedHealth Group Announces Extension of Exchange Offer to Acquire Surgical Care Affiliates, Inc.

March 17, 2017

MINNETONKA, Minn.–(BUSINESS WIRE)–UnitedHealth Group Incorporated (NYSE: UNH) today announced that it has extended the expiration of its previously announced exchange offer for all of the outstanding shares of Surgical Care Affiliates, Inc. (NASDAQ: SCAI) (“SCA”), a leading ambulatory surgery center and surgical hospital provider. The exchange offer, which was previously scheduled to expire at 12:01 a.m., New York City time, on Tuesday, March 21, 2017, has been extended until 12:01 a.m., New York City time, on Friday, March 24, 2017, unless further extended. All other terms and conditions of the exchange offer remain unchanged.

Wells Fargo Bank, N.A., the depositary for the exchange offer, has advised UnitedHealth Group that, as of 5:00 p.m., New York City time, on March 16, 2017, 13,211,520 shares of SCA common stock were tendered pursuant to the exchange offer, which represented approximately 32.5% of the outstanding shares of common stock of SCA. Stockholders who have already tendered their shares of SCA common stock do not have to re-tender their shares or take any other action as a result of the extension of the expiration date of the exchange offer.

The combination of SCA with OptumCare, the primary and urgent care delivery services business part of Optum (UnitedHealth Group’s services business), which works with more than 80 health plans, will position the combined organization as a comprehensive provider of ambulatory care services, while continuing expansion of SCA’s network of ASCs and surgical hospitals in partnership with leading health systems, medical groups and health payers. The combination builds upon the two companies’ successful ambulatory surgery center collaborations and expands OptumCare’s capabilities in outpatient surgical procedures.

In connection with the exchange offer, UnitedHealth Group has filed a registration statement on Form S-4, which includes a prospectus/offer to exchange and certain ancillary documentation, which have been be mailed to SCA stockholders, and a tender offer statement on Schedule TO and amendments thereto with the SEC. SCA has filed a solicitation/recommendation statement on Schedule 14D-9 that has also been mailed to SCA stockholders. These documents contain important information about the exchange offer that should be read carefully before any decision is made with respect to the exchange offer.

Requests for copies of the prospectus/offer to exchange, the accompanying letter of transmittal and other exchange offer materials may be directed to D.F. King & Co., Inc., the information agent for the exchange offer, by phone toll-free at (800) 431-9645 or by email at UNH@dfking.com.

About UnitedHealth Group

UnitedHealth Group (NYSE: UNH) is a diversified health and well-being company dedicated to helping people live healthier lives and making the health system work better for everyone. UnitedHealth Group offers a broad spectrum of products and services through two distinct platforms: UnitedHealthcare, which provides health care coverage and benefits services; and Optum, which provides information and technology-enabled health services. For more information, visit UnitedHealth Group at www.unitedhealthgroup.com or follow @UnitedHealthGrp on Twitter.

About Optum

Optum is a leading information and technology-enabled health services business dedicated to helping make the health system work better for everyone. With more than 100,000 people worldwide, Optum delivers intelligent, integrated solutions that help to modernize the health system and improve overall population health. Optum is part of UnitedHealth Group (NYSE:UNH).

About SCA

SCA (NASDAQ: SCAI), a leader in the outpatient surgery industry, strategically partners with health plans, medical groups and health systems across the country to develop and optimize surgical facilities. SCA operates 205 surgical facilities, including ambulatory surgery centers and surgical hospitals, in partnership with approximately 3,000 physicians. For more information on SCA, visit www.scasurgery.com.

Cautionary Note Concerning Forward-Looking Statements

This communication may contain statements that constitute “forward-looking statements,” including, for example, information related to UnitedHealth Group, SCA and the proposed acquisition of SCA by UnitedHealth Group. Generally the words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “plan,” “project,” “should” and similar expressions identify forward-looking statements, which generally are not historical in nature. Such statements reflect the current analysis of existing information and involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. The following factors, among others, could cause actual results to differ materially from those described in these forward-looking statements: the possibility that various conditions to the consummation of the UnitedHealth Group exchange offer and mergers may not be satisfied or waived, including the receipt of regulatory clearances related to the mergers; uncertainty as to how many shares of SCA common stock will be tendered into the UnitedHealth Group exchange offer; the risk that the UnitedHealth Group exchange offer and mergers will not close within the anticipated time periods, or at all; the failure to complete or receive the anticipated benefits from UnitedHealth Group’s acquisition of SCA; the possibility that the parties may be unable to successfully integrate SCA’s operations into those of UnitedHealth Group; such integration may be more difficult, time-consuming or costly than expected; customer loss and business disruption (including, without limitation, difficulties in maintaining relationships with employees, customers, clients, suppliers or physicians) may be greater than expected following the transaction; the retention of certain key employees at SCA may not be achieved; the parties may be unable to meet expectations regarding the timing, completion and accounting and tax treatments of the transactions; the effects of local and national economic, credit and capital market conditions; and the other risks and uncertainties relating to UnitedHealth Group and SCA described in their respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2016, and in their subsequent Current Reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission (the “SEC”) and available at www.sec.gov.

UnitedHealth Group and SCA assume no obligation to update the information in this communication, except as otherwise required by law. Readers are cautioned not to place undue reliance on these forward-looking statements or information, which speak only as of the date hereof.

Additional Information and Where to Find It

This communication relates to a pending business combination transaction between UnitedHealth Group and SCA. This communication is for informational purposes only and is neither an offer to sell or exchange, nor a solicitation of an offer to buy or exchange, any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

UnitedHealth Group has filed a registration statement on Form S-4 related to the transaction with the SEC and may file amendments thereto. UnitedHealth Group and a wholly-owned subsidiary of UnitedHealth Group have filed a tender offer statement on Schedule TO (including a prospectus/offer to exchange, a related letter of transmittal and other exchange offer documents) related to the transaction with the SEC and have filed amendments thereto and may file further amendments thereto. SCA has filed a solicitation/recommendation statement on Schedule 14D-9 with the SEC and has filed amendments thereto and may file further amendments thereto. SCA and UnitedHealth Group may also file other documents with the SEC regarding the transaction. This communication is not a substitute for any registration statement, Schedule TO, Schedule 14D-9 or any other document which SCA or UnitedHealth Group has filed or may file with the SEC in connection with the transaction. Investors and security holders are urged to read the registration statement, the Schedule TO (including the prospectus/offer to exchange, related letter of transmittal and other exchange offer documents), the solicitation/recommendation statement on Schedule 14D-9 and the other relevant materials with respect to the transaction carefully and in their entirety before making any decision regarding exchanging their shares, because they contain important information about the transaction. The prospectus/offer to exchange, the related letter of transmittal and certain other exchange offer documents, as well as the solicitation/recommendation statement, will be made available to all holders of SCA’s stock at no expense to them. The exchange offer materials and the solicitation/recommendation statement are available for free at the SEC’s website at www.sec.gov. Additional copies of the exchange offer materials and the solicitation/recommendation statement may be obtained for free by contacting UnitedHealth Group’s Investor Relations department at (800) 328-5979. Additional copies of the solicitation/recommendation statement may be obtained for free by contacting SCA’s Investor Relations department at (800) 768-0094.

In addition to the SEC filings made in connection with the transaction, each of UnitedHealth Group and SCA files annual, quarterly and current reports and other information with the SEC. You may read and copy any reports or other such filed information at the SEC public reference room at 100 F Street, N.E., Washington, D.C. 20549. Please call the SEC at 1-800-SEC-0330 for further information on the public reference room. UnitedHealth Group’s and SCA’s filings with the SEC are also available to the public from commercial document-retrieval services and at the website maintained by the SEC at http://www.sec.gov.

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Contacts

UnitedHealth Group
Investors:
John Penshorn, 952-936-7214
Senior Vice President
or
Brett Manderfeld, 952-936-7216
Vice President
or
Media:
Tyler Mason, 424-333-6122
Vice President
Tyler.Mason@uhg.com

Active Implants LLC Secures First Tranche of a $40 Million Equity Financing

March 16, 2017

MEMPHIS, Tenn.–(BUSINESS WIRE)–Active Implants, LLC, a company that develops orthopedic implant solutions, today announced that it completed the first $10 million tranche of a $40 million Class D Units financing. The financing is to be comprised of $30 million from first-time investor LS Health Science Partners, L.P., with another $10 million to be contributed by existing investors.

“This investment reflects our enthusiasm for the NUsurface technology and its potential to fill a large unmet need in the market,” said Haynes Morris, managing partner for LS Health Science Partners. “We are pleased to participate in this new infusion of capital to help carry the company through this important phase of product development.”

An initial investment of $10 million has been received from LS Health Science Partners, with the remaining $30 million to be funded in tranches. The company intends to use the proceeds to continue funding two clinical trials of the NUsurface® Meniscus Implant – an investigational treatment for patients with persistent knee pain following medial meniscus surgery.

“Recruitment for the SUN and VENUS clinical trials for our NUsurface Meniscus Implant is going extremely well, and we expect to complete enrollment by the end of the year,” said Ted Davis, president and CEO of Active Implants. “This additional investment will allow us to continue our research and clinical development programs as we progress in and work toward bringing the first artificial meniscus to market.”

About Meniscus Injuries

A damaged meniscus has a very limited ability to heal itself, which can eventually lead to knee replacement surgery. It has been estimated that from 700,000 to over 1 million arthroscopic partial meniscectomies are performed annually in the U.S., with annual direct medical costs estimated at $4 billion. Active Implants estimates that in the U.S. alone, more than 130,000 meniscectomy patients per year would be appropriate candidates for the NUsurface Meniscus Implant.

About the NUsurface Meniscus Implant

The NUsurface Meniscus Implant is an investigational treatment for patients with persistent knee pain following medial meniscus surgery. It is made from medical grade polymer and, as a result of its unique materials, composite structure and design, does not require fixation to bone or soft tissues. The NUsurface Meniscus Implant mimics the function of the natural meniscus and redistributes loads transmitted across the knee joint. Clinical trials are underway in the U.S., Europe and Israel to verify the safety and effectiveness of the NUsurface Meniscus Implant, which has been used in Europe under CE Mark since 2008 and in Israel since 2011.

About Active Implants

Active Implants LLC develops orthopedic implant solutions that complement the natural biomechanics of the musculoskeletal system, allowing patients to maintain or return to an active lifestyle. Active Implants is privately held with headquarters in Memphis, Tennessee. European offices are in Driebergen, The Netherlands, with R&D facilities in Netanya, Israel. For more information, visit www.activeimplants.com.

CAUTION Investigational device. Limited by United States law to investigational use.

Contacts

Merryman Communications
Joni Ramirez, 323-532-0746
joni@merrymancommunications.com

Alphatec Holdings Announces Fourth Quarter and Full Year 2016 Financial Results

CARLSBAD, Calif., March 15, 2017 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (Nasdaq:ATEC), the parent company of Alphatec Spine, Inc., a provider of spinal fusion technologies, announced today financial results for the fourth quarter and full year ended December 31, 2016.

  • Fourth quarter total net revenues of $27.1 million; revenue from the Company’s U.S. commercial business of $24.5 million.
  • Annual total net revenues of $120.2 million; revenue from the Company’s U.S. commercial business of $106.9 million.
  • Cash and cash equivalents of $19.6 million at the end of the fourth quarter.

Financial Results for the Fourth Quarter and Full Year Ended December 31, 2016

As a result of the sale of the Company’s international business in September 2016, the financial results and related assets and liabilities of such business have been excluded from continuing operations for all periods herein and reported as discontinued operations.

U.S. commercial revenues for the fourth quarter of 2016 were $24.5 million, down 16.9%, compared to $29.5 million reported for the fourth quarter of 2015.  For the full year ended December 31, 2016, U.S. commercial revenues were $106.9 million, representing a decrease of 6.7%, compared to $114.6 million reported for full year 2015.

For the fourth quarter 2016, U.S. commercial revenues decreased primarily as a result of a decrease in the Company’s stocking business, lower U.S. hospital unit volume and pricing declines.

For the full year 2016, U.S. commercial revenues decreased primarily as a result of a decrease in the Company’s stocking business and pricing declines, partially offset by higher hospital volumes.

U.S. gross profit and gross margin for the fourth quarter of 2016 were $15.2 million and 62.2%, respectively, compared to $21.4 million and 72.6%, respectively, for the fourth quarter of 2015. For the full year 2016, U.S. gross profit and gross margin were $71.7 million and 67.0%, respectively, compared to $79.5 million and 69.4%, respectively, for full year 2015.

For the fourth quarter and full year 2016, gross margins declined as compared to 2015, primarily as a result of: higher product costs driven by lower than planned sourcing volumes throughout 2016, obsolescence charges related to product portfolio management, and price declines, partially offset by the absence of one-time charges that occurred in 2015.

Total operating expenses for the fourth quarter of 2016 were $21.7 million, reflecting a decrease of $7.4 million, or approximately 25% improvement over the fourth quarter of 2015. For the full year 2016, total operating expenses were $91.5 million, reflecting a decrease of $172.4 million compared to the full year 2015, which included non-cash goodwill and intangible asset impairment charges totaling $164.3 million.

GAAP net loss for the fourth quarter of 2016 was $4.7 million or ($0.56) per share (basic and diluted), compared to a net loss of $9.9 million, or ($1.18) per share (basic and diluted) for the fourth quarter of 2015.  For the full year, 2016 GAAP net loss was $30.3 million or ($3.57) per share (basic and diluted), compared to a net loss of $178.7 million, or ($21.53) per share basic and diluted for full year 2015. GAAP net loss for full year 2015 was unfavorably impacted by $164.3 million of non-cash impairment charges.

Adjusted EBITDA in the fourth quarter of 2016 was $(2.2) million, compared to $3.4 million for the fourth quarter of 2015.  For the full year 2016, Adjusted EBITDA was $1.1 million, compared to $10.5 million for the full year 2015.  Please refer to the table, “Alphatec Holdings, Inc. Reconciliation of Non-GAAP Financial Measures” that follows for more detailed information.

Total Current and Long-term debt, includes $34.8 million in term debt and $12.5 million outstanding under the Company’s revolving credit facility at December 31, 2016. This compares to $29.9 million in term debt and $12.2 million outstanding under the Company’s revolving credit facility at September 30, 2016.

Cash and cash equivalents were $19.6 million at December 31, 2016, compared to $25.6 million reported at September 30, 2016.

“Through our actions in 2016, we positioned the organization to be more responsive to today’s world-class spine surgeons, our employees and shareholders,” said Terry Rich, Chief Executive Officer of Alphatec.  “We look forward to providing you with a company update and more details on our plans in connection with the announcement of our first quarter 2017 results.”

Non-GAAP Information

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

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc., is a medical device company that designs, develops and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities and trauma. The Company’s mission is to improve lives by delivering advancements in spinal fusion technologies.  The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www.alphatecspine.com.

Forward Looking Statements

This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Alphatec cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward looking statements include the references to the optimization of the Company’s product portfolio through active product lifecycle management and the Company positioning itself to be more responsive to surgeons, employees and shareholders.  In addition, the unaudited financial results for the fourth quarter and year ended December 31, 2016 included in this press release are preliminary and represent the most current information available to management. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  adjustments to the unaudited financial results reported for the fourth quarter and year ended December 31, 2016 in connection with the completion of the Company’s final closing process and procedures, final adjustments, completion of the audit by the Company’s independent registered public accounting firm and other developments that may arise during the preparation of the Company’s Annual Report on Form 10-K; the uncertainty of success in developing new products or products currently in Alphatec Spine’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of Alphatec Spine’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA clearance or approval or international regulatory approvals for new products, or unexpected or prolonged delays in the process; continuation of favorable third party payor reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  Please refer to the risks detailed from time to time in Alphatec’s SEC reports, including its Annual Report Form 10-K for the year ended December 31, 2015, filed on March 15, 2016 with the Securities and Exchange Commission, and its Amended Annual Report Form 10-K/A filed on April 29, 2016, as well as other filings on Form 10-Q and periodic filings on Form 8-K. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
  (in thousands, except per share amounts – unaudited) 
Three Months Ended Year Ended
December 31, December 31,
2016 2015 2016 2015
Revenues $ 27,090 $ 34,791 $ 120,248 $ 134,388
Cost of revenues 12,463 11,192 44,114 46,366
Gross profit 14,627 23,599 76,134 88,022
54.0 % 67.8 % 63.3 % 65.5 %
Operating expenses:
Research and development 2,449 8,077 9,248 17,615
In-process research and development 274
Sales and marketing 11,464 13,937 50,962 51,801
General and administrative 7,092 6,547 26,339 28,126
Amortization of intangible assets 172 304 934 1,200
Impairment of goodwill and intangibles 1,736 164,263
Restructuring expenses 514 246 2,292 597
Total operating expenses 21,691 29,111 91,511 263,876
Operating loss (7,064 ) (5,512 ) (15,377 ) (175,854 )
Interest and other income (expense), net (2,689 ) (769 ) (15,558 ) 3,455
Pretax loss (9,753 ) (6,281 ) (30,935 ) (172,399 )
Income tax provision (benefit) 474 182 (4,488 ) (1,146 )
Loss from continuing operations (10,227 ) (6,463 ) (26,447 ) (171,253 )
Income (loss) from discontinued operations 5,481 (3,440 ) (3,870 ) (7,423 )
Net loss $ (4,746 ) $ (9,903 ) $ (30,317 ) $ (178,676 )
Net loss per share continuing operations $ (1.21 ) $ (0.77 ) $ (3.11 ) $ (20.64 )
Net income (loss) per share discontinued operations 0.65 (0.41 ) (0.46 ) (0.89 )
Net loss per share  – basic and diluted $ (0.56 ) $ (1.18 ) $ (3.57 ) $ (21.53 )
Weighted-average shares – basic and diluted 8,465 8,376 8,495 8,298
ALPHATEC HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands – unaudited) 
December 31, December 31,
2016 2015
ASSETS
Current assets:
Cash and cash equivalents $ 19,593 $ 6,295
Restricted cash 2,350
Accounts receivable, net 18,512 26,870
Inventories, net 30,093 32,632
Prepaid expenses and other current assets 4,262 3,138
Current assets of discontinued operations 364 30,210
Total current assets 72,824 101,495
Property and equipment, net 15,076 16,067
Intangibles, net 5,711 8,806
Other assets 516 502
Noncurrent assets of discontinued operations 61 19,471
Total assets $ 94,188 $ 146,341
LIABILITIES AND STOCKHOLDERS’ DEFICIT
Current liabilities:
Accounts payable $ 8,701 $ 13,542
Accrued expenses 27,981 21,175
Common stock warrant liabilities 687
Current portion of long-term debt 3,113 79,742
Current liabilities of discontinued operations 732 9,891
Total current liabilities 40,527 125,037
Total long-term liabilities 71,954 32,761
Long-term liabilities of discontinued operations 1,516
Redeemable preferred stock 23,603 23,603
Stockholders’ deficit (41,896 ) (36,576 )
Total liabilities and stockholders’ deficit $ 94,188 $ 146,341

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF NON-GAAP FINANCIAL MEASURES
(in thousands, except per share amounts – unaudited) 
Three Months Ended Year Ended
December 31, December 31,
2016 2015 2016 2015
Operating loss, as reported $  (7,064 ) $  (5,512 ) $ (15,377 ) $ (175,854 )
Add back:
Depreciation 1,735 3,310 7,387 10,802
Amortization of intangible assets 693 327 1,608 2,968
Total EBITDA (4,636 ) (1,875 ) (6,382 ) (162,084 )
Add back significant items:
Stock-based compensation 1,931 5,004 3,441 7,444
In-process research and development 274
Goodwill and intangible impairment 1,736 164,263
Restructuring and other charges 514 246 2,292 597
EBITDA, as adjusted for significant items $ (2,191 ) $ 3,375 $ 1,087 $ 10,494

 

ALPHATEC HOLDINGS, INC.
RECONCILIATION OF REVENUES AND GROSS PROFIT
(in thousands, except percentages – unaudited) 
Three Months Ended
December 31, % Change
2016 2015
Revenues by source
U.S. commercial revenue $ 24,487 $ 29,479 -16.9 %
Other 2,603 5,312 -51.0 %
Total revenues $ 27,090 $ 34,791         -22.1 %
Gross profit by source
U.S. $ 15,243 $ 21,396
Other (616 ) 2,203
Total gross profit $ 14,627 $ 23,599
Gross profit margin by source
U.S. 62.2 % 72.6 %
Other -23.7 % 41.5 %
Total gross profit margin 54.0 % 67.8 %
Year Ended
December 31, % Change
2016 2015
Revenues by source
U.S. commercial revenue $ 106,932 $ 114,578 -6.7 %
Other 13,316 19,810 -32.8 %
Total revenues $   120,248 $   134,388 -10.5 %
Gross profit by source
U.S. $ 71,669 $ 79,501
Other 4,465 8,521
Total gross profit $ 76,134 $ 88,022
Gross profit margin by source
U.S. 67.0 % 69.4 %
Other 33.5 % 43.0 %
Total gross profit margin 63.3 % 65.5 %
CONTACT: Investor/Media Contact:

Christine Zedelmayer
Investor Relations 
Alphatec Spine, Inc.
(760) 494-6610
czedelmayer@alphatecspine.com

Medacta International Expands Relationship With OREF to Advance Orthopedic Research and Innovation

March 16, 2017

CHICAGO–(BUSINESS WIRE)–Medacta International, the privately held, family-owned global leader in the design of innovative joint replacement and spine surgery products, today reaffirmed its partnership with the Orthopaedic Research and Education Foundation (OREF) to advance new frontiers of orthopedic discovery. Effective immediately, and building upon their work together over the past two years, Medacta has increased its support and will now match resident gifts two-to-one, up from its original commitment of one-to-one. Importantly, this program encourages residents to engage in charitable giving at an early state in their careers and prioritizes OREF as a beneficiary of their philanthropy.

Since the program started in 2015, the Medacta Challenge raised more than $150,000 for OREF. This includes contributions to OREF’s Research Fund from Francesco Siccardi, Executive Vice President of Medacta International, and Eric Dremel, President of Medacta USA, who each pledged $20,000 to kick off the partnership and demonstrate their commitment to the initiative. Mr. Siccardi and Mr. Dremel were recognized for their gifts as members of OREF’s Visionary Research Society.

“We believe the next big innovation is always just around the corner and are excited that our expanded partnership with OREF will make already generous resident contributions even more impactful,” said Siccardi. “This partnership drives Medacta and OREF’s shared goal of providing the best possible care to improve the lives of patients around the globe.”

All gifts made to OREF through the Medacta Challenge help OREF achieve its mission of funding new and seasoned investigators in the orthopedic field. This funding may be used to support research in orthopedic trauma, total joint arthroplasty, soft tissue repair and regeneration, among other important topics. With Medacta’s increased commitment, the impact of resident donations will be tripled to provide investigators with necessary resources to conduct these important studies.

“OREF relies on the generosity of organizations like Medacta to continue supporting research in orthopaedics,” said David Lewallen, MD, OREF Board President. “The grants we provide enable innovators to push the envelope and be bold, effectively creating change in the orthopaedic discipline – ultimately providing patients with safer, better options, and a higher quality of life. None of this would be possible without our committed partners such as Medacta.”

Richard Santore, MD, Trustee and Chair of OREF’s Individual Development Committee, added, “We are particularly excited that Medacta’s matching gift program will not only support our investigators, but will encourage other individuals and companies to consider establishing additional creative concepts for making gifts to OREF. Working together to promote new studies and drive creative solutions will benefit us all and, most importantly, the patients we serve together. Medacta is to be commended for their leadership and generosity for this multi-year commitment to OREF.”

Since Medacta’s founding in 1999, the company has maintained a long tradition of prioritizing research and training, the foundations of orthopedics. Through training initiatives, such as the company’s M.O.R.E. Institute, Medacta promotes surgeon education and provides the tools for physicians to refine their skills. The company has trained over 5,000 surgeons at its learning centers, while its biennial M.O.R.E. International Symposium consistently attracts hundreds of renowned surgeons from across the world.

For more information about Medacta, please visit medacta.com or follow @Medacta on Twitter.

About Medacta

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

About the Orthopaedic Research and Education Foundation

Founded in 1955, the Orthopaedic Research and Education Foundation is a charitable 501(c)(3) organization committed to improving lives by supporting excellence in orthopaedic research. OREF is dedicated to supporting new investigators and is the premiere orthopaedic organization funding research across all specialties. A list of research and funding priorities is available at oref.org/grants. To learn more about OREF, please visit www.oref.org or follow @OREFtoday on Twitter.

Contacts

For Medacta International, Inc.
Jill Bongiorni, 516-729-2250
Jill@torchcomllc.com
or
For OREF
Karen Pubentz, 847-430-5113
pubentz@oref.org

InVivo Therapeutics Reports 2016 Year-end Financial Results and Business Update

March 10, 2017

CAMBRIDGE, Mass.–(BUSINESS WIRE)–InVivo Therapeutics Holdings Corp. (NVIV) today reported financial results for the year ended December 31, 2016.

Mark Perrin, InVivo’s CEO and Chairman, said, “2016 was a year marked by meaningful and significant progress. In 2016, we:

  • received approval for converting the Neuro-Spinal Scaffold™ pilot study to the pivotal INSPIRE study;
  • received approval to initiate the INSPIRE study in Canada (1st global step for InVivo);
  • added 13 new clinical sites, including our first ex-U.S. sites (both in Canada);
  • enrolled seven new patients, with three of those patients achieving the primary endpoint of conversion to partial paralysis by six months post-injury1;
  • continued our spinal cord injury (SCI) thought leadership by attending and presenting at international conferences, where we presented 13 scientific abstracts to renowned leaders within the neurosurgical, neuroscience, and SCI communities;
  • raised $32 million (gross), which is the company’s largest fund raising to date;
  • successfully developed a preclinical prototype of the TrailMaker™ for the chronic spinal cord injury market and filed two patent applications;
  • garnered unique media coverage about InVivo and the Neuro-Spinal Scaffold in 18 widely-read outlets resulting in nearly 30 million media impressions;
  • and continued to make great strides in strengthening our research and intellectual property portfolio.

We ended the year with approximately $33 million in cash, cash equivalents, and marketable securities that we project will fund us into the second quarter of 2018, by which time we expect to be able to submit the HDE application for marketing approval of the Neuro-Spinal Scaffold. Over the coming quarters, we will continue to make progress toward this goal by enrolling more patients, increasing sites, expanding into the U.K., and completing enrollment of the INSPIRE study, which we are now projecting will occur in the third quarter of 2017.

In addition to the progress with INSPIRE, we also plan to initiate our first study in cervical SCI in Canada in the coming months. Cervical SCI represents a higher risk, higher reward indication in which the effects of neural preservation, regeneration or remyelination may be more dramatically demonstrated. I am excited at the prospect of building upon last year’s advances and continuing our journey to redefine the lives of patients with spinal cord injuries.”

Financial Results

For the year ended December 31, 2016, the Company reported a net loss of approximately $23,438,000, or $0.76 per share, compared to a net loss of approximately $33,314,000, or $1.26 per share, for the year ended December 31, 2015. Included in results for the years ended December 31, 2016 and 2015 were non-cash gain of $593,000 and a non-cash loss of $10,804,000, respectively, reflecting changes in the fair market value of the derivative warrant liability. Excluding the impact of the derivative warrant liability, adjusted net loss for the year ended December 31, 2016, was $24,031,000, or $0.78 per share, compared to an adjusted net loss of $22,510,000, or $0.85 per share, for the year ended December 31, 2015. The Company ended the year with $33,041,000 of cash, cash equivalents, and marketable securities as of December 31, 2016.

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

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 pivotal probable benefit study for the treatment of patients with thoracic complete (AIS A) traumatic acute 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 Scaffoldreceived 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” and similar expressions, and include statements regarding expected enrollment in its pivotal INSPIRE study in 2017, expansion of clinical sites into the UK and Canada, initiation of a cervical spinal cord injury study, and the benefits of the Neuro-Spinal Scaffold.. 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 obtain FDA approval 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 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 Annual Report on Form 10-K for the year ended December 31, 2016, 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

(In thousands, except share and per-share data)

December 31,
2016 2015
ASSETS:
Current assets:
Cash and cash equivalents $21,464 $14,920
Restricted cash 361 361
Marketable securities 11,577 5,274
Prepaid expenses and other current assets 451 184
Total current assets 33,853 20,739
Property, equipment and leasehold improvements, net 510 938
Other assets 421 115
Total assets $34,784 $21,792
LIABILITIES AND STOCKHOLDERS’ EQUITY:
Current liabilities:
Accounts payable $1,011 $521
Loan payable, current portion 423 395
Derivative warrant liability 1,314 1,907
Deferred rent, current portion 141 115
Accrued expenses 1,959 374
Total current liabilities 4,848 3,312
Loan payable, net of current portion 852 1,275
Deferred rent, net current portion 135 276
Total liabilities 5,835 4,863
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.00001 par value, authorized—100,000,000 shares, issued and outstanding 32,044,087 shares at December 31, 2016; and authorized 50,000,000 shares, issued and outstanding 27,555,948 shares at December 31, 2015 1 1
Additional paid-in capital 185,955 150,497
Accumulated deficit (157,007) (133,569)
Total stockholders’ equity 28,949 16,929
Total liabilities and stockholders’ equity $34,784 $21,792

InVivo Therapeutics Holdings Corp.

Consolidated Statements of Operations

(In thousands, except share and per-share data)

Years Ended December 31,
2016 2015 2014
Operating expenses:
Research and development $12,557 $10,058 $10,273
General and administrative 11,506 12,340 7,566
Total operating expenses 24,063 22,398 17,839
Operating loss (24,063) (22,398) (17,839)
Other income (expense):
Interest income 187 60 5
Interest expense (155) (172) (136)
Derivatives gain (loss) 593 (10,804) (376)
Other income (expense), net 625 (10,916) (507)
Net loss $(23,438) $(33,314) $(18,346)
Net loss per share, basic and diluted $(0.76) $(1.26) $(0.83)
Weighted average number of common shares outstanding, basic and diluted 31,025,585 26,461,374 22,080,761
Reconciliation of GAAP to non-GAAP measures
InVivo Therapeutics Holdings Corp.
(In thousands, except share and per share data)
Three Months Ended Year Ended
December 31, December 31,
2016 2015 2016 2015
Reported GAAP net income (loss) (5,435 ) (4,733 ) (23,438 ) (33,314 )
Derivative (gain)/loss (1,381 ) (544 ) (593 ) 10,804
Adjusted net loss (6,816 ) (5,277 ) (24,031 ) (22,510 )
Reported GAAP net loss per diluted share (0.17 ) (0.17 ) (0.76 ) (1.26 )
Derivative (gain)/loss per diluted share (0.04 ) (0.02 ) (0.02 ) 0.41
Adjusted net loss per diluted share (0.21 ) (0.19 ) (0.78 ) (0.85 )

1 two patients passed away and one unconverted patient has less than six months of follow-up.

Contacts

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

No Bones About It, Bundled Payments Reduce Costs: Study Shows 20% Cost Reduction

By Remedy Partners – February 1, 2017

A significant study published in the JAMA Internal Medicine at the beginning of the year demonstrates how a health system effectively reduced episodic expenditures through bundled payments by 20 percent. Notwithstanding the rising national costs of joint replacements, Baptist Health System (BHS) saved $20 million over seven years with bundled payments.

The study, from the Perelman School of Medicine at the University of Pennsylvania, co-authored by Dr. Ezekiel Emanuel, combines hospital and Medicare data to evaluate the costs and care quality for nearly 4,000 hip and knee replacement episodes from July 2008 to June 2015. The five-hospital Baptist Health System in San Antonio, Texas saved more than $5,000 per episode, or $20 million in total savings. BHS also improved outcomes during the study by reducing readmissions, emergency department visits, and inpatient prolonged lengths of stay.

Remedy Partners has achieved similar results in a shorter period of time with engaged, aligned, and motivated provider partners across the country. Our experience has shown that hospitals and physician group practices can replicate this success by developing local, focused networks of cooperating providers and committing to optimized workflows.

 

READ THE REST HERE

 

 

Secretary Price: A Strong Supporter of Voluntary Bundled Payments

March 1, 2017  – By Nick Bluhm, Director of Strategy & Government Policy at Remedy Partners

When Secretary Price said “people have coverage, but they don’t have care,” he underscored his commitment to one of the core values of bundled payments: patient-centered care.  Dr. Price believes that “patients and doctors should be in control of healthcare”; which is why he does not support mandatory pilot programs.” He understands that providers need flexibility, not dictations, to accommodate the needs of their patients.

Dr. Price knows that physicians will need Medicare to accommodate their diverse, local needs in designing payment models. Notably, Secretary Price sees value in voluntary pilot programs, especially the Bundled Payments for Care Improvement initiative (BPCI). During his confirmation hearing, Secretary Price expressed support for voluntary bundled payment models and highlighted the role of the CMS Innovation Center in sponsoring pilot programs, saying that “for certain patients, bundled payments make a lot of sense.”

Expansion and extension of the framework of the BPCI initiative could create a more competitive and long-term approach to bundled payments. Voluntary models should be agnostic to the sponsoring provider; physician groups, post-acute providers and third-party risk-bearing entities have proven highly successful in government and private sector bundled payment programs. For instance, Accountable Care Organizations can use voluntary bundled payments to improve relationships with hospital-based physicians and integrate acute care management into their population health strategy.

 

READ THE REST HERE

Xtant™ Medical Reports Record Fourth Quarter Revenue of $24.5 million, 10% Growth Compared to Prior Year Period

Fourth Quarter 2016 Highlights:

  • Consolidated total revenue increased 9.9% to a record $24.5 million compared to fourth quarter 2015 revenue of $22.3 million
  • Consolidated gross profit increased 17.4% to $17.5 million compared to fourth quarter 2015 gross profit of $14.9 million
  • Consolidated gross margins improved to 71.6%, compared to 67.0% reported in the fourth quarter of 2015

Full-Year 2016 Highlights:

  • Consolidated gross profit increased 10.1% to $62.3 million compared to pro forma 2015 gross profit of $56.6 million
  • Consolidated gross margins for the year were 69.2%, compared to pro forma 2015 gross margin of 65.4%

BELGRADE, Mont., March 09, 2017 (GLOBE NEWSWIRE) — Xtant™ Medical Holdings, Inc. (NYSE MKT:XTNT), a leader in the development of regenerative medicine products and medical devices, today reported its financial results for the period ended December 31st, 2016. The Company reported annual revenues of approximately $90.0 million and a net loss for the year of approximately $19.5 million.

Revenue

Consolidated fourth quarter 2016 revenue was approximately $24.5 million, an increase of 9.9% compared to revenue of approximately $22.3 million for the same period during 2015.

Consolidated revenue for the full year 2016 was approximately $90.0 million, compared to pro forma 2015 revenue of approximately $86.5 million, representing an increase of 4.0% over the prior year.

Gross Profit

Consolidated gross profit for the fourth quarter of 2016 was $17.5 million or 71.6% of revenues, compared to gross profit of $14.9 million or 67.0% of revenues for the fourth quarter of 2015.

For the year, gross profit was approximately $62.3 million, compared with pro forma 2015 gross profit of $56.6 million. Gross margin for the year was 69.2%, compared to 2015 pro forma gross margin of 65.4%

Sales and Marketing Expenses

Consolidated fourth quarter 2016 sales and marketing expenses increased to $11.9 million, as compared to sales and marketing expenses of $10.6 million during the same period in 2015. For the quarter, sales and marketing as a percentage of revenues increased slightly to 48.8%, compared to 47.6% in the fourth quarter of 2015.

For the year, sales and marketing expenses increased to $44.1 million for 2016, as compared to pro forma 2015 sales and marketing expenses of $39.3 million. As a percentage of revenues, sales and marketing expenses increased to 48.9% compared to 45.5% reported for the pro forma full year 2015.

General and Administrative Expenses

In the fourth quarter, consolidated general and administrative expenses remained flat at $4.5 million as compared to general and administrative expenses of $4.2 million reported for the same period last year. As a percentage of revenues, general and administrative expenses were 18.3% during the period as compared to 18.9% for the same period during 2015.

2016 general and administrative expenses decreased to $15.8 million as compared with $16.6 million reported for the pro forma period last year. As a percentage of revenues, general and administrative expenses were 17.5% as compared to 19.2% for 2015.

Net Income / Loss

The fourth quarter 2016 consolidated net loss was $4.5 million, compared to the same period a year-ago net income of $11.6 million. The decrease was primarily due to a one-time recording of a deferred tax benefit of $17.5 million that occurred during the fourth quarter 2015.

The fourth quarter 2016 consolidated loss per share of $0.31 compared to earnings per share of $0.97 in the fourth quarter of 2015.

For the full-year 2016, the Company had a net loss of $19.5 million compared to a pro forma net loss of $5.8 million for 2015. Net loss per share for the full-year 2016 was $1.54 a share compared to pro forma net loss per share of $0.65 for 2015.

EBITDA

The Company defines earnings before interest, taxes, depreciation and amortization (“EBITDA”) as net income/loss from operations before depreciation, amortization, impairment charges, non-recurring expenses and non-cash stock-based compensation. Consolidated EBITDA for the fourth quarter of 2016 was a gain of $1.2 million compared to a loss of $350,000 for the same period during 2015.

Full year 2016 EBITDA was a gain of $2.0 million compared to a zero pro forma loss in the prior year.

Financial Liquidity

Cash on hand as of December 31, 2016, was $2.6 million, as compared to $6.4 million as of December 31, 2015. Net working capital as of December 31, 2016 decreased $5.7 million to $17.9 million, as compared to $23.6 million as of December 31, 2015.

Outlook for Full Year 2017

The Company plans to have an immediate focus on operational and cash flow efficiencies throughout 2017. As a result, we have reduced revenue guidance while expanding projected EBITDA margins as we get to the latter part of 2017. The Company’s revised full year 2017 revenue and EBITDA guidance is based on the following:

Stated in 000’s FY ’15* FY ’16 2017 Guidance
Revenue $ 86,518 $ 90,003 $96,000 – $98,000
Growth 4 % 6.7% – 8.9%
EBITDA $ (33 ) $ 2,050 $6,900 – $7,700
*Pro forma results

Conference Call to be Held March 10, 2017

An accompanying listen-only conference call will be hosted by Carl O’Connell, Chief Executive Officer, and John Gandolfo, Chief Financial Officer, to discuss the results. The call will be held at 10:00 AM ET, on March 10, 2017. Please refer to the information below for conference call dial-in information and webcast registration.

Conference date: March 10, 2017, 10:00 AM ET
Conference dial-in: 877-269-7756
International dial-in: 201-689-7817
Conference Call Name: Xtant Medical’s Fourth Quarter 2016 Results Call Webcast Registration: Click Here

Following the live call, a replay will be available on the Company’s website, www.xtantmedical.com, under “Investor Info.”

Use of Pro Forma Financial Information
On July 31,2015, Bacterin International Holdings, Inc. acquired all of the issued and outstanding stock of X-Spine Systems, Inc. and the combined company was renamed Xtant Medical Holdings, Inc. Except for the financial results for the three months ended December 31, 2015, the results presented for the full 2015 year are on a pro forma basis as if the two companies were combined for the periods shown. Certain pro forma adjustments have been made to reflect the impact of the purchase transaction, primarily consisting of amortization of intangible assets with determinable lives and interest expense on long-term debt. In addition, certain historical expenses, such as warrant expense and interest expense associated with debt that was immediately repaid, were eliminated from these pro-forma results. The pro forma information does not necessarily reflect the actual results of operations had the acquisition been consummated at the beginning of the fiscal reporting period indicated nor is it indicative of future operating results. The pro forma information does not include any adjustment for potential revenue enhancements, cost synergies or other operating efficiencies that could result from the acquisition.

Additional information regarding the business combination and its impact on the Company’s financial position will be set forth in the Company’s Form 10-K for the fiscal year ended December 31, 2016, which will be filed with the Securities and Exchange Commission on or about March 30, 2017 and will include the Company’s audited consolidated financial statements as of and for the years ended December 31, 2016 and December 31, 2015

About Xtant™ Medical Holdings, Inc.

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

Important Cautions Regarding Forward-looking Statements

This press release contains certain disclosures that may be deemed forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to significant risks and uncertainties. Forward-looking statements include statements that are predictive in nature, that depend upon or refer to future events or conditions, or that include words such as “continue,” “efforts,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” “projects,” “forecasts,” “strategy,” “will,” “goal,” “target,” “prospects,” “potential,” “optimistic,” “confident,” “likely,” “probable” or similar expressions or the negative thereof. Statements of historical fact also may be deemed to be forward-looking statements. We caution that these statements by their nature involve risks and uncertainties, and actual results may differ materially depending on a variety of important factors, including, among others: the Company’s ability to successfully integrate the acquisition of X-spine; the ability of the Company’s sales force to achieve expected results; the Company’s ability to meet its existing and anticipated contractual obligations, including financial covenant and other obligations contained in the Company’s secured lending facility; the Company’s ability to manage cash flow; the Company’s ability to develop, market, sell and distribute desirable applications, products and services and to protect its intellectual property; the ability of the Company’s customers to pay and the timeliness of such payments; the Company’s ability to obtain financing as and when needed; changes in consumer demands and preferences; the Company’s ability to attract and retain management and employees with appropriate skills and expertise; the impact of changes in market, legal and regulatory conditions and in the applicable business environment, including actions of competitors; and other factors. Additional risk factors are listed in the Company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q under the heading “Risk Factors.” The Company undertakes no obligation to release publicly any revisions to any forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events, except as required by law.

XTANT MEDICAL HOLDINGS, INC.
Condensed Consolidated Statements of Operations
Unaudited Actual and Proforma Results
For the Three Months Ended December 31, For the Year Ended December 31,
2016 Unaudited 2015 Unaudited 2016 Unaudited 2015 Pro Forma
% of % of % of % of
Amount Revenue Amount Revenue Amount Revenue Amount Revenue
Orthopedic Product Sales $ 24,362,237 99.6 % $ 21,771,750 97.8 % $ 89,388,145 99.3 % $ 85,235,170 98.5 %
Other 108,621 0.4 % 494,072 2.2 % 614,591 0.7 % 1,282,429 1.5 %
Total Revenue 24,470,858 100.0 % 22,265,822 100.0 % 90,002,736 100.0 % 86,517,599 100.0 %
Cost of sales 6,960,634 28.4 % 7,353,446 33.0 % 27,710,014 30.8 % 29,913,686 34.6 %
Gross Profit 17,510,223 71.6 % 14,912,376 67.0 % 62,292,722 69.2 % 56,603,913 65.4 %
Operating Expenses
General and administrative 4,484,419 18.3 % 4,201,394 18.9 % 15,762,531 17.5 % 16,612,883 19.2 %
Sales and marketing 11,940,049 48.8 % 10,607,475 47.6 % 44,055,813 48.9 % 39,334,250 45.5 %
Research and development 798,198 3.3 % 1,027,166 4.6 % 3,410,600 3.8 % 3,840,958 4.4 %
Depreciation and amortization 1,250,436 5.1 % 2,019,258 9.1 % 4,940,955 5.5 % 6,220,316 7.2 %
Acquisition and Integration related expenses 131,755 0.5 % 1,079,236 4.8 % 1,401,367 1.6 % 4,935,755 5.7 %
Gain from the Extinguishment of Debt 0 0.0 % 0 0.0 % 0 0.0 % (2,345,019 ) -2.7 %
Impairment of Assets 0 0.0 % 0 0.0 % 0 0.0 % 233,748 0.3 %
Non-cash consulting 0 0.0 % 55,296 0.2 % 266,721 0.3 % 246,165 0.3 %
Total Operating Expenses 18,604,856 76.0 % 18,989,824 85.3 % 69,837,986 77.6 % 69,079,056 79.8 %
Net Gain (Loss) from Operations (1,094,633 ) -4.5 % (4,077,448 ) -18.3 % (7,545,264 ) -8.4 % (12,475,142 ) -14.4 %
Other Income (Expense)
Interest expense (3,287,855 ) -13.4 % (2,802,807 ) -12.6 % (12,262,750 ) -13.6 % (10,948,845 ) -12.7 %
Change in warrant derivative liability 0 0.0 % 348,943 1.6 % 716,738 0.8 % 270,020 0.3 %
Non-cash consideration associated with stock purchase agreement 0 0.0 % 0 0.0 % 0 0.0 % (558,185 ) -0.6 %
Other income (expense) (103,990 ) -0.4 % 582,123 2.6 % (351,914 ) -0.4 % 395,006 0.5 %
Total Other Income (Expense) (3,391,845 ) -13.9 % (1,871,740 ) -8.4 % (11,897,926 ) -13.2 % (10,842,004 ) -12.5 %
Net Gain (Loss) from Operations Before Benefit (Provision) for Income Taxes (4,486,478 ) -18.3 % (5,949,188 ) -26.7 % (19,443,190 ) -21.6 % (23,317,146 ) -27.0 %
Benefit (Provision) for Income Taxes
Current (50,362 ) -0.2 % 0 0.0 % (50,362 ) -0.1 % (65,387 ) -0.1 %
Deferred 0 0.0 % 17,537,408 78.8 % 0 0.0 % 17,537,408 20.3 %
Net Income (Loss) $ (4,536,840 ) -18.5 % $ 11,588,220 52.0 % $ (19,493,552 ) -21.7 % $ (5,845,125 ) -6.8 %
Net Income (loss) per share:
Basic $ (0.31 ) $ 0.97 $ (1.54 ) $ (0.65 )
Dilutive $ (0.31 ) $ 0.97 $ (1.54 ) $ (0.65 )
Shares used in the computation:
Basic 14,479,201 11,890,104 12,671,685 9,055,483
Dilutive 14,479,201 11,890,104 12,671,685 9,055,483

 

XTANT MEDICAL HOLDINGS, INC.
Condensed Consolidated Statements of Operations
Audited and Unaudited Actual Results
For the Three Months Ended December 31, For the Year Ended December 31,
2016 Actual Unaudited 2015 Actual Unaudited 2016 Actual Unaudited 2015 Actual Audited
% of % of % of % of
Amount Revenue Amount Revenue Amount Revenue Amount Revenue
Orthopedic Product Sales $ 24,362,237 99.6 % $ 21,771,750 97.8 % $ 89,388,145 99.3 % $ 58,194,249 98.1 %
Other 108,621 0.4 % 494,072 2.2 % 614,591 0.7 % 1,151,468 1.9 %
Total Revenue 24,470,858 100.0 % 22,265,822 100.0 % 90,002,736 100.0 % 59,345,717 100.0 %
Cost of sales 6,960,634 28.4 % 7,353,446 33.0 % 27,710,014 30.8 % 20,262,728 34.1 %
Gross Profit 17,510,223 71.6 % 14,912,376 67.0 % 62,292,722 69.2 % 39,082,989 65.9 %
Operating Expenses
General and administrative 4,484,419 18.3 % 4,201,394 18.9 % 15,762,531 17.5 % 12,993,307 21.9 %
Sales and marketing 11,940,049 48.8 % 10,607,475 47.6 % 44,055,813 48.9 % 28,731,184 48.4 %
Research and development 798,198 3.3 % 1,027,166 4.6 % 3,410,600 3.8 % 2,546,362 4.3 %
Depreciation and amortization 1,250,436 5.1 % 2,019,258 9.1 % 4,940,955 5.5 % 3,819,588 6.4 %
Acquisition and Integration related expenses 131,755 21.8 % 1,079,236 4.8 % 1,401,367 1.6 % 4,935,755 8.3 %
Gain from the Extinguishment of Debt 0 0.0 % 0 0.0 % 0 0.0 % (2,345,019 ) -4.0 %
Impairment of Assets 0 0.0 % 0 0.0 % 0 0.0 % 233,748 0.4 %
Non-cash consulting 0 0.0 % 55,296 0.2 % 266,721 0.3 % 246,165 0.4 %
Total Operating Expenses 18,604,856 76.0 % 18,989,824 85.3 % 69,837,986 77.6 % 51,161,091 86.2 %
Net Gain (Loss) from Operations (1,094,633 ) -4.5 % (4,077,448 ) -18.3 % (7,545,264 ) -8.4 % (12,078,101 ) -20.4 %
Other Income (Expense)
Interest expense (3,287,855 ) -13.4 % (2,802,807 ) -12.6 % (12,262,750 ) -13.6 % (7,733,748 ) -13.0 %
Change in warrant derivative liability 0 0.0 % 348,943 1.6 % 716,738 0.8 % 270,020 0.5 %
Non-cash consideration associated with stock purchase agreement 0 0.0 % 0 0.0 % 0 0.0 % (558,185 ) -0.9 %
Other income (expense) (103,990 ) -0.4 % 582,123 2.6 % (351,914 ) -0.4 % 388,177 0.7 %
Total Other Income (Expense) (3,391,845 ) -13.9 % (1,871,740 ) -8.4 % (11,897,926 ) -13.2 % (7,633,736 ) -12.9 %
Net Gain (Loss) from Operations Before Benefit (Provision) for Income Taxes (4,486,478 ) -18.3 % (5,949,188 ) -26.7 % (19,443,190 ) -21.6 % (19,711,838 ) -33.2 %
Benefit (Provision) for Income Taxes
Current (50,362 ) -0.2 % 0 0.0 % (50,362 ) -0.1 % 0 0.0 %
Deferred 0 0.0 % 17,537,408 78.8 % 0 0.0 % 17,537,408 29.6 %
Net Income (Loss) $ (4,536,840 ) -18.5 % $ 11,588,220 52.0 % $ (19,493,552 ) -21.7 % $ (2,174,430 ) -3.7 %
Net Income (loss) per share:
Basic $ (0.31 ) $ 0.97 $ (1.54 ) $ (0.24 )
Dilutive $ (0.31 ) $ 0.97 $ (1.54 ) $ (0.24 )
Shares used in the computation:
Basic 14,479,201 11,890,104 12,671,685 9,055,483
Dilutive 14,479,201 11,890,104 12,671,685 9,055,483

 

XTANT MEDICAL HOLDINGS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
 
For the twelve months ended December 31,
2016 Unaudited 2015 Audited
Operating activities:
Net loss $ (19,493,552 ) $ (2,174,430 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 7,241,870 4,889,272
Purchase accounting valuation allowance 0 (17,537,408 )
Non-Cash Interest 6,784,785 4,814,506
Impairment of Assets 0 956,395
Gain (Loss) on sale of fixed assets 25,458 (596,883 )
Non-cash consulting expense/stock option expense 522,987 836,741
Provision for losses on accounts receivable and inventory 223,538 700,234
Change in derivative warrant liability (716,738 ) (270,020 )
Non-cash consideration associated with stock purchase agreement 0 558,185
Extinguishment of debt 0 (2,345,019 )
Changes in operating assets and liabilities:
Accounts receivable (2,680,405 ) (5,512,429 )
Inventories (4,074,086 ) (545,713 )
Prepaid and other assets (484,061 ) (1,044,962 )
Accounts payable 319,091 644,149
Accrued liabilities (2,076,183 ) 7,527,514
Net cash used in operating activities (14,407,296 ) (9,099,868 )
Investing activities:
Acquisition of X-spine Systems, Inc. 0 (72,975,200 )
Purchases of property and equipment and intangible assets (5,832,690 ) (2,263,033 )
Proceeds from sale of fixed assets 16,400 1,667,195
Net cash used in investing activities (5,816,290 ) (73,571,038 )
Financing activities:
Proceeds from long-term and convertible debt, net of deferred and financing costs 3,238,166 83,897,361
Net proceeds from equity private placement 0 515,395
Payment on royalty obligation 0 (542,905 )
Payments on Long-term debt 0 (1,325,814 )
Payments on capital leases (144,600 ) (101,760 )
Net proceeds from the issuance of stock 3,087,462 2,116,937
Net Proceeds from the revolving line of credit 10,252,809 0
Proceeds from exercise of options 0 11,500
Net cash provided by financing activities 16,433,837 84,570,714
Net change in cash and cash equivalents (3,789,749 ) 1,899,808
Cash and cash equivalents at beginning of period 6,368,016 4,468,208
Cash and cash equivalents at end of period $ 2,578,267 $ 6,368,016

 

XTANT MEDICAL HOLDINGS, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
As of December 31, 2015 and 2016
As of Dec. 31, As of Dec. 31,
2016  Unaudited 2015 Audited
ASSETS
Current Assets:
Cash and cash equivalents $ 2,578,267 $ 6,368,016
Trade accounts receivable, net of allowance for doubtful accounts of $1,635,385 and $2,579,634, respectively 18,991,872 15,385,218
Inventories, net 26,266,457 22,684,716
Prepaid and other current assets 1,149,616 601,697
Total current assets 48,986,211 45,039,647
Non-current inventories 971,854 1,607,915
Property and equipment, net 15,840,730 11,816,629
Goodwill 41,534,626 41,534,626
Intangible assets, net 35,940,810 40,237,289
Other assets 827,372 791,221
Total Assets $ 144,101,605 $ 141,027,327
LIABILITIES & STOCKHOLDERS’ (DEFICIT) EQUITY
Current Liabilities:
Accounts payable $ 10,471,944 $ 9,386,531
Accounts payable – related party 640,441 1,406,763
Accrued liabilities 8,982,187 9,595,851
Revolving Line of Credit 10,448,283 0
Warrant derivative liability 333,613 1,050,351
Current portion of capital lease obligations 244,847 35,139
Total current liabilities 31,121,316 21,474,635
Long-term Liabilities:
Capital lease obligation, less current portion 832,152 7,800
Long term convertible debt, less current portion 68,937,247 66,436,647
Long-term debt, less current portion 50,284,187 44,231,718
Total Liabilities 151,174,902 132,150,800
Commitments and Contingencies
Stockholders’ Equity
Preferred stock
Common stock 17 11
Additional paid-in capital 85,461,210 81,917,488
Accumulated deficit (92,534,524 ) (73,040,973 )
Total Stockholders’ Equity (Deficit) (7,073,297 ) 8,876,527
Total Liabilities & Stockholders’ Equity $ 144,101,605 $ 141,027,327

 

XTANT MEDICAL HOLDINGS, INC.
Calculation of Consolidated EBITDA for the Three and Twelve Months Ended December 31, 2016
 and for the Three and Pro Forma Twelve Months Ended December 31, 2015
Unaudited
For the three months ended December 31, For the twelve months ended December 31,
2016 2015 2016 2015
Net Loss (4,536,840 ) 11,588,220 (19,493,552 ) (5,845,125 )
(Benefit) Provision 50,362 (17,537,408 ) 50,362 (17,472,021 )
Other (Income) Expense 103,990 (582,123 ) 351,914 (395,006 )
Change in warrant derivative liability 0 (348,943 ) (716,738 ) (270,020 )
Non-cash consideration associated with stock purchase agreement 0 0 0 558,185
Interest expense 3,287,855 2,802,807 12,262,750 10,948,845
Acquisition and Integration related expenses 131,755 0 1,401,367 233,748
Extinguishment of Debt 0 1,079,236 0 4,935,755
Impairment of Assets 0 0 0 (2,345,019 )
Non-Cash Compensation 0 163,124 522,987 794,358
Depreciation & Amortization 1,690,020 2,485,321 7,241,870 8,822,994
One Time Inventory Reserves and Accounts Receivables Allowances 426,355 0 426,355 0
EBITDA Gain (Loss) 1,153,497 (349,767 ) 2,047,315 (33,306 )

 

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

Company Contact
Xtant Medical 
Molly Mason
mmason@xtantmedical.com

Vertiflex, Inc. Completes $40 Million Financing Round

March 08, 2017

CARLSBAD, Calif.–(BUSINESS WIRE)–Vertiflex, Inc., a leading innovator of advanced, minimally invasive interventions for spinal stenosis, today announced completion of a $40M financing round. New investors, Endeavour Vision and H.I.G. BioHealth Partners led the financing alongside existing investors, New Enterprise Associates; Thomas, McNerney & Partners; and Alta Partners. Proceeds from the financing will primarily be used to fund U.S. commercial expansion of the company’s Superion® Indirect Decompression System, a minimally invasive spinal implant designed to treat moderate lumbar spinal stenosis, a painful and often debilitating condition that affects an estimated 500,000 new patients every year in the United States.

“Vertiflex has seen tremendous early success in the commercialization of the Superion System,” said Earl Fender, President and CEO of Vertiflex. “With favorable long-term clinical outcomes, a new Category I AMA CPT code and broad reimbursement in place, adoption of Superion has continued at a rapid and steady pace, driven by significant interest from both patients and treating physicians.”

Once implanted, Superion is intended to reduce pressure on the affected nerves and allow patients to return to a more active lifestyle. Following completion of a successful 391 patient randomized controlled trial, the Superion System received Premarket Approval (PMA) from the U.S. Food and Drug Administration (FDA), and starting January 2017 the system is described by a new American Medical Association (AMA) Current Procedural Terminology (CPT) Category I code.

“I’m also excited to see continued momentum with our current investors who have steadfastly supported the company to date, and look forward to working closely with our new investors to realize the potential for the Superion System, as we further invest in the commercial expansion of an important treatment option for physicians and patients,” Fender added.

To accommodate its accelerating growth, Vertiflex recently relocated its corporate headquarters from San Clemente, CA, to a larger facility in Carlsbad, CA. The new location includes expanded distribution capability, and a state-of-the-art physician education center, as part of the company’s commitment to supporting physicians by providing didactic as well as hands-on cadaver training with Superion.

Nick Shamie, M.D., Chief of Orthopedic Spine Surgery and Professor of Orthopedic Surgery and Neurosurgery at UCLA School of Medicine, stated, “The Superion System offers patients a minimally invasive solution to treat leg pain associated with spinal stenosis. The implant, placed through a small tube the size of a dime, does not deconstruct any of the anatomical elements and provides immediate relief. I incorporated this treatment into my practice after seeing the clinical data from the FDA IDE clinical trial. The safety, efficacy, and five-year durability that the data presented made it a procedure I can stand behind.”

About Vertiflex, Inc.

Vertiflex is a privately held medical device company dedicated to the advancement of minimally invasive solutions for the treatment of lumbar spinal stenosis, which is the leading cause of spinal surgery in the elderly. Founded in 2005 and headquartered in Carlsbad, CA, Vertiflex has developed proprietary, minimally invasive technologies for performing both indirect and direct decompressions of the lumbar spine. These procedures fill the gap in the stenosis treatment continuum between conservative care and traditional spine surgery. To date, Vertiflex has compiled the largest, most rigorous body of device clinical evidence related to lumbar spinal stenosis. For more information, visit www.vertiflexspine.com.

About New Enterprise Associates

As one of the world’s largest and most active venture capital firms, NEA has developed deep domain expertise and insight into multiple industries. The NEA team channels that knowledge into every technology and healthcare investment they make – at any stage, in any location, around the globe. Visit www.nea.com.

About Endeavour Vision SA

Endeavour Vision is a growth investor in exceptional private medtech companies, and an ideal partner for medtech entrepreneurs. Headquartered in Geneva, Switzerland, with a presence in the United States, the Endeavour Vision team comprises experienced investors, seasoned entrepreneurs, and medtech specialists, all committed to helping entrepreneurs grow and develop thriving businesses. Endeavour’s latest $275 million fund is fully dedicated to investing in European and U.S. medtech companies that seek worldwide growth and aim to improve the quality and cost of care for patients across the globe.

About H.I.G. BioHealth Partners

H.I.G. BioHealth Partners is the dedicated life-science investment affiliate of H.I.G. Capital. H.I.G. BioHealth Partners invests in a broad range of healthcare opportunities across sectors and stages, principally in companies developing therapeutic drugs, medical devices, and diagnostics for significant unmet medical needs. With approximately $400 million in committed capital, H.I.G. BioHealth Partners invests $5 million to $40 million per company over the life of an investment. Visit www.higbio.com.

Contacts

Vertiflex, Inc.
Kathryn Larson, (442) 325 5900
info@vertiflexspine.com