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

HSS: Shortened KOOS is Valid

Elizabeth Hofheinz, M.P.H., M.Ed. • Wed, March 22nd, 2017

It’s a no-brainer…anyone would prefer to answer 7 survey questions as opposed to 42. Hurray for the researchers from Hospital for Special Surgery (HSS) in New York, who have confirmed that a seven-question patient survey on pain, function and quality of life is a valid and efficient tool for assessing patient outcomes following revision total knee replacement (TKR).

According to the March 14, 2017 news release, “The previous commonly used knee replacement survey was 42 questions often leaving physicians with partial, unusable information. The shorter survey, known as KOOS JR. (Knee Injury and Osteoarthritis Outcome Score), and its hip replacement counterpart, HOOS JR., have already been adopted for Medicare’s primary total joint replacement bundled payment program. HSS’ research presented at AAOS now provides peer-reviewed data that confirms KOOS JR. is a valid outcomes measure for knee replacement surgery.”

“At HSS, we are continually improving how we measure outcomes and KOOS JR. is a direct result of these efforts,” said Alexander McLawhorn, M.D., M.B.A., an orthopedic surgeon at HSS. “We saw a need for a shorter, more patient friendly survey in an area where outcomes data are essential to improving quality of care. In fact, knee replacement revisions, which are more complex than primary knee surgery, are under-studied in this regard.”

 

READ THE REST HERE

Dr. Price Brakes Bundled Payments Expansion

Walter Eisner • Tue, March 21st, 2017

Our orthopedic surgeon and Health and Human Services Secretary, Tom Price, M.D., has said he is no fan of bundled payments.

After just taking office in February, he’s already putting on the brakes to the payment model with the March 20, 2017 announcement that the expansion of hip and knee replacement bundled payment programs (Comprehensive Care for Joint Replacement – CJR) from the Centers for Medicare and Medicaid Services’ (CMS) Innovation Center will be delayed.

Last fall, then Congressman Price, said in a letter to the Obama administration that CMS had overstepped its authority, upsetting the balance between the executive and legislative branches and failing to engage stakeholders when creating the programs. He also wrote, “these mandatory models overhaul major payment systems, commandeer clinical decisionmaking and dramatically alter the delivery of care.”

According to a March 20 notice in the Federal Register, the CJR program was scheduled to expand on the 20th, but those expansions will now be delayed until May 20, 2017 to “allow time for additional review, to ensure that the agency has adequate time to undertake notice and comment [on] rulemaking to modify the policy if policy modifications are warranted,” and to make sure its participants understand the rules and how to comply with them.

 

READ THE REST HERE

Study points a way to better implantable medical devices

Science Daily, Source: Massachusetts Institute of Technology – March 20, 2017

Medical devices implanted in the body for drug delivery, sensing, or tissue regeneration usually come under fire from the host’s immune system. Defense cells work to isolate material they consider foreign to the body, building up a wall of dense scar tissue around the devices, which eventually become unable to perform their functions.

Researchers at MIT and Boston Children’s Hospital have identified a signaling molecule that is key to this process of “fibrosis,” and they have shown that blocking the molecule prevents the scar tissue from forming. The findings, reported in the March 20 issue of Nature Materials, could help scientists extend the lifespan of many types of implantable medical devices.

“This gives us a better understanding of the biology behind fibrosis and potentially a way to modulate that response to prevent the formation of scar tissue around implants,” says Daniel Anderson, an associate professor in MIT’s Department of Chemical Engineering, a member of MIT’s Koch Institute for Integrative Cancer Research and Institute for Medical Engineering and Science (IMES), an affiliate at Boston Children’s Hospital, and the senior author of the study.

The paper’s lead author is Koch Institute and JDRF postdoc Joshua Doloff.

Preventing fibrosis

Anderson’s lab has been working for several years on an implantable device that could mimic the function of the pancreas, potentially offering a long-term treatment for diabetes patients. The device encapsulates insulin-producing islet cells within a material called alginate, a polysaccharide naturally found in algae. Alginate provokes a lesser immune response than human-made materials such as metal, but it still induces fibrosis.

 

READ THE REST HERE

The robotic have-not: How J&J plans to woo hospitals, knee surgeons

By ARUNDHATI PARMAR – MedCity News, March 17, 2017

Johnson & Johnson and Verily Life Sciences (formerly Google Life Sciences) have a joint venture to create the next generation of robotic surgery souped up with digital technologies in the future. (Watch out Intuitive Surgical.)

But when it comes to hip and knee replacement today, J&J Depuy Synthes is a robotic have-not.

Competitors have robots or are close to having something robotic in joint replacement.

On Tuesday, Stryker launched its total knee application on the expensive Mako robotduring the annual meeting of the American Academy of Orthopaedic Surgeons in San Diego. That same day at AAOS, Smith & Nephew previewed its hand-held robot-assisted device for total knee replacements in advance of a market release in the second quarter. And Zimmer-Biomet was also proudly displaying its robot on the exhibit floor — the Rosa robot acquired with the purchase of French firm Medtech SA – although the robot won’t be doing total knee replacements until 2018.

There is a general notion that robotics will gain ground in orthopedic surgery though the predictions around adoption pace vary greatly.

One analyst — Brandon Henry from RBC Capital Markets — believes Stryker will be the clear winner with the launch of its total knee on its Mako robotic system and will take market share away from Johnson & Johnson DePuy Synthes and Zimmer-Biomet in the next few years. Another — Richard Newitter from Leerink Partners — believes robotics adoption will be much more gradual and only in complex cases but still having one in the short term is better than not having one.

So in the meantime without a robot, how can J&J DePuy Synthes woo hospitals and knee surgeons, some of whom are part of Medicare’s mandatory 90-day bundled payment program called the Comprehensive Care for Joint Replacement.

Company executives are relying on the wide breadth of J&J’s knee offerings, its services chops and a new company-sponsored whitepaper that touts the economic value of its Attune Knee.

 

READ THE REST HERE

Spineway : First Mont-Blanc MIS implant in the USA

 Ecully, 21 March 2017

Spineway, French specialist in surgical implants and instruments for treating disorders of the spinal column (spine), announces the completion of the first minimally invasive surgery using its Mont-Blanc MIS product line in the United States. The operation was performed by Dr. Ludwig Orozco, neurosurgeon in Dallas (Texas). It is a perfectly demonstrative achievement, given the patient condition was more complex than a typical lumbar osteoarthritis. A recent distribution agreement signed with SLR Medical Consulting was a driving force in this realization.

This first implantation of the Mont-Blanc MIS was performed on a patient presenting with degeneration on several vertebral levels. Its surgical treatment required the use of 8 pedicle screws and 2 titanium-alloy rods from Spineway’s innovative Mont Blanc MIS line. These instruments are perfectly adapted to meet practitioners’ growing needs for increasingly technological tools, like constructs involving over 3 vertebral levels, as in the present case. This line provides surgeons with highly technical instruments, all based on Spineway’s expertise in correcting spinal curvatures. The new Mont Blanc MIS instruments already allow for the treatment of several types of lumbar-spine disorders.

Minimally invasive surgery is currently the most dynamic segment of the worldwide market for spinal implants. Less traumatic for the patient, this type of surgery is less painful, and allows for a faster recovery and shorter hospital stays. This operating technique should, in the medium-term, become the standard technique for most surgeries.

This first successful operation allows Spineway to position itself in the US market on a high-growth segment with an innovative line offering surgeons a multitude of possibilities. Based on the success of its international launch, Spineway is continuing the commercial marketing and deployment of its already highly-technical products and plans to accelerate its R&D in order to widen the scope of application of its technologies, to cover a larger range of disorders.

SPINEWAY IS ELIGIBLE FOR THE PEA-PME (EQUITY SAVINGS PLAN FOR SMES)
Find out all about Spineway at www.spineway.com

Next communication:
2016 Annual Results – 25 April 2017, after market closes

Spineway designs, manufactures and markets innovative implants and surgical instruments for treating severe disorders of the spinal column.
Spineway has an international network of over 50 independent distributors and 90% of its turnover comes from exports.
Spineway, which is eligible for investment through FCPIs (French unit trusts specializing in innovation), received the OSEO Excellence award as well as the Deloitte Fast 50 award in 2011. Rhône Alpes INPI Patent Innovation Award (2013) – Talent INPI award (2015).
ISIN code: FR0011398874 – ALSPW     

Contacts:

Investor Relations
David Siegrist – Finance Director
Tel: +33 (0)4 72 77 01 52
finance.dsg@spineway.com
Financial Communication
Jérôme Gacoin / Solène Kennis
Tel: +33 (0)1 75 77 54 68
skennis@aelium.fr

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/5e2e8d19-9523-4a51-896e-71446127fe6b

Obamacare Replacement Will Permanently Remove Medical Device Tax

By Jof Enriquez – March 9, 2017

Republican leaders in the U.S. House of Representatives have unveiled proposed legislation to repeal and replace the Affordable Care Act, which, among several tax cuts, will eliminate permanently the 2.3 percent excise tax on medical devices and products.

The device tax has been suspended since December 2015, but GOP lawmakers and industry lobbyists have been pushing for a permanent repeal of a tax that they claim is detrimental to U.S. medtech innovation, as well as a jobs killer. A House of Representatives bill seeking to fully repeal the tax was filed in January.

Unveiled this week, the replacement of Obamacare known as the American Health Care Act (AHCA), will likely achieve the full repeal, beginning Jan. 1, 2018, according to RAPS.

The bill would repeal nearly all Obamacare taxes that would have cost health insurance firms, medical device makers, and other healthcare companies tens of billions of dollars over the next decade, reports The Washington Post.

 

READ THE REST HERE

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

Spinal Elements® Announces Initial Procedures with Lucent® XP Expandable Interbody Implant

March 20, 2017

CARLSBAD, Calif.–(BUSINESS WIRE)–Spinal Elements, a spine technology company, announced that the first procedures with its Lucent XP expandable interbody implant have been successfully completed.

The Lucent XP System is an interbody device that can expand in height and increase in lordotic angle after it has been surgically implanted. The height expansion helps restore the height of the spinal disc space and the lordotic angling helps correct the curvature of the spine. With the Lucent XP device, surgeons can achieve up to 15 degrees of lordotic angle, helping restore sagittal balance for the patient.

The Lucent XP system is made primary of polyetheretherketone (PEEK), a radiolucent material with a lower modulus of elasticity than titanium, the primary material of many competitive systems. The PEEK mechanical properties along with the design of the device allow for a more load-sharing construct. The radiolucency allows for post-operative evaluation of the fusion progression. Additionally, the device is coated with Spinal Elements’ Ti-Bond® porous titanium coating. Ti-Bond is a hydrophilic coating applied at the bone-contacting endplates of the implant.

Hyun Bae, MD, a leading spine surgeon who practices at The Spine Institute in Los Angeles, California, had this to say about his experience with the Lucent XP System: “The ease of use of this system and the ability of the device to expand in height and restore lordotic angle are exactly what I need to address the challenges spinal fusion surgery for my patients.

Paul Kim, MD, of the Spine Institute of San Diego, added, “The clinical importance of height restoration and spinal curvature cannot be understated. Spinal Elements’ system provides these features without making sacrifices relative to construct rigidity or post-operative ability to monitor the progress of a fusion. Furthermore, I was able deploy the system safely and efficiently with a minimally invasive surgical approach.”

Spinal Elements will be more widely launching the Lucent XP expandable interbody device in the summer of 2017. The company has seen over 20% growth of the past year in its core technologies, fueled by demand for its advanced technologies including Ti-Bond coated implants.

About Spinal Elements

Spinal Elements, headquartered in Carlsbad, CA, is a spine technology company for spine surgeons who demand innovative, extremely high quality surgical solutions. From the company’s early work which helped make PEEK commonplace throughout the spine industry to recent advancements in Ti-Bond® porous titanium coated PEEK interbody implants and controlled delivery technology, Spinal Elements has built a reputation for being trustworthy, innovative and different. The company is focused on the development and marketing of progressive spinal treatment options and markets a complete portfolio of advanced spinal implant technologies. Additionally, the company distributes Hero® Allograft, the net proceeds from which are donated to charities benefiting children with life-threatening medical conditions. The company recently launched a warranty program for its Ti-Bond technology based on the success of over 10,000 devices implanted. For more information, please visit www.spinalelements.com.

Follow us on Twitter @SpinalElements and on LinkedIn for continuous company updates.

Contacts

For Spinal Elements
Laura Charlton (formerly Johnson)
760.450.7749
laurajohnsonpr@yahoo.com

NuVasive announces new evidence-based recommendation released from NICE (U.K.) for Lateral Interbody Fusion

SAN DIEGO, March 20, 2017 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), a leading medical device company focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced updated guidance from the National Industry for Clinical Excellence (NICE) in the U.K. for lateral interbody fusion in the lumbar spine. NICE stated the evidence on efficacy for lateral interbody fusion is adequate in quality and quantity and the procedure may be used provided that standard arrangements are in place for clinical governance, consent and audit. The majority of the evidence submitted to and reviewed by the panel was peer-reviewed journal articles describing the now 14-year experience with and outcomes following the Company’s eXtreme Lateral Interbody Fusion (XLIF®) procedure, the leading global lateral approach spine surgical technique.

“Our continued investment into clinical research and outcomes data from our XLIF procedure was supportive in NICE releasing updated guidance for this innovative surgical approach,” said Jason Hannon, NuVasive’s president and chief operating officer. “Our team has worked diligently with NICE since 2015 to gather, analyze and review the available evidence. The updated guidance further supports the clinical efficacy of XLIF and will help expand the availability of XLIF to back pain sufferers in the U.K. and around the world.”

With more than 150,000 successful surgeries around the world, XLIF is the leading global lateral approach procedure. First introduced in the U.S. in 2003, XLIF is a minimally invasive surgical procedure performed through the side of the body, utilizing proprietary neuromonitoring and an integrated portfolio of instruments and specialized implants for treating a range of spinal pathologies.

Initial NICE guidance for lateral interbody fusion was published in 2009 with additional special measures that impacted adoption of the procedure in the UK. In response to a request for input prior to a planned re-review of NICE guidance, NuVasive submitted a large body of evidence for the XLIF procedure, including data outlining safety profile, rate of fusion, and improvements in pain and disability. The updated guidance was supported by a systematic literature review of more than 200 previously published studies as a high-quality summary of the safety and efficacy of the XLIF procedure1. For more information on the updated NICE guidance for lateral interbody fusion, visit https://www.nice.org.uk/guidance/ipg574.

About NuVasive

NuVasive, Inc. (NASDAQ: NUVA) is a world leader in minimally invasive, procedurally-integrated spine solutions. From complex spinal deformity to degenerative spinal conditions, NuVasive is transforming spine surgery with innovative technologies designed to deliver reproducible and clinically proven surgical outcomes. NuVasive’s highly differentiated, procedurally-integrated solutions include access instruments, implantable hardware and software systems for surgical planning and reconciliation technology that centers on achieving the global alignment of the spine. With $956 million in revenues (2016), NuVasive has an approximate 2,300 person workforce in more than 40 countries around the world. For more information, please visit www.nuvasive.com.

Forward-Looking Statements

NuVasive cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors which, if they do not materialize or prove correct, could cause NuVasive’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. The potential risks and uncertainties which contribute to the uncertain nature of these statements include, among others, risks associated with acceptance of the Company’s surgical products and procedures by spine surgeons, development and acceptance of new products or product enhancements, clinical and statistical verification of the benefits achieved via the use of NuVasive’s products (including the iGA™ platform), the Company’s ability to effectually manage inventory as it continues to release new products, its ability to recruit and retain management and key personnel, and the other risks and uncertainties described in NuVasive’s news releases and periodic filings with the Securities and Exchange Commission. NuVasive’s public filings with the Securities and Exchange Commission are available at www.sec.gov. NuVasive assumes no obligation to update any forward-looking statement to reflect events or circumstances arising after the date on which it was made.

1 Lehmen JA et al. Eur Spine J 2015;24(Suppl 3):S287–S313

 

 

CONTACT:  Investor Contact: Suzanne Hatcher, NuVasive, Inc., 858-458-2240, investorrelations@nuvasive.com; or Media Contact: Stefanie Mazer, NuVasive, Inc., 858-320-5243, media@nuvasive.com