Medovex Corporation Regains Compliance With Nasdaq Minimum Stockholders’ Equity Listing Requirement

ATLANTA, GA–(Marketwired – Mar 2, 2017) – Medovex Corp. (NASDAQ: MDVX), a developer of medical technology products, today announced that on March 1, 2017, Nasdaq issued a determination that the company has evidenced compliance with the minimum $2.5 million stockholders’ equity requirement for continued listing on The Nasdaq Capital Market. Like all NASDAQ listed companies, the Company’s future periodic reports are subject to review for continued compliance with NASDAQ listing rules.

About Medovex

Medovex was formed to acquire and develop a diversified portfolio of potentially ground breaking medical technology products. Criteria for selection include those products with potential for significant improvement in the quality of patient care combined with cost effectiveness. The Company’s first pipeline product, the DenerveX device, is intended to provide long lasting relief from pain associated with facet joint syndrome at significantly less cost than currently available options. To learn more about Medovex Corp., visit www.medovex.com

Safe Harbor Statement

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

CONTACT INFORMATION

SeaSpine Announces Fourth Quarter and Full Year 2016 Results

CARLSBAD, Calif., March 02, 2017 (GLOBE NEWSWIRE) — SeaSpine Holdings Corporation (NASDAQ:SPNE), a global medical technology company focused on surgical solutions for the treatment of spinal disorders, announced today financial results for the fourth quarter and full year ended December 31, 2016 and provided guidance for 2017.

Summary Fourth Quarter 2016 Financial Results and Recent Accomplishments

  • Revenue of $32.5 million, a decline of 6.4% year-over-year
  • U.S. revenue of $29.8 million, a decline of 4.5% year-over-year
    • U.S. orthobiologics revenue of $15.1 million
    • U.S. spinal hardware revenue of $14.7 million
  • International revenue of $2.7 million, a $0.8 million decrease year-over-year
  • Positive clinician response to initial  launches of Mariner™ Posterior Lumbar Fixation System and Shoreline™ ACS Anterior Cervical Standalone System
  • Fully launched Vu a•POD Prime NanoMetalene System, which features a zero-profile, standalone anterior lumbar interbody device that can be configured in several footprint and lordosis combinations to accommodate individual patient pathology
  • Added William Rhoda as General Manager of Process Innovation and Development

“We continue to invest in key objectives aimed at driving revenue growth while simultaneously reducing our net cash spend and extending our liquidity horizon,” said Keith Valentine, President and Chief Executive Officer. “In 2016, we significantly expanded and upgraded our product portfolio with the launch of several new products and product line extensions, and we have a healthy pipeline in development. We continue to add and strengthen our relationships with committed distributors that are excited to commercialize our innovative products. These initiatives, coupled with our investment in medical education and training, form a strong foundation for operational success and revenue growth in 2017.”

Fourth Quarter 2016 Financial Results
Revenue for the fourth quarter of 2016 totaled $32.5 million, a decrease of $2.2 million compared to $34.7 million reported for the same period of the prior year. Total revenue in the U.S. was $29.8 million, a 4.5% decrease compared to same period of the prior year.

Orthobiologics revenue totaled $16.6 million, a 6.4% decrease compared to the fourth quarter of 2015. The decline in orthobiologics revenue was primarily driven by fewer year-end stocking orders from U.S. hospitals in 2016 and lower average selling prices, due in part to a shift to the Company’s lower-cost DBM products. Spinal hardware revenue totaled $15.9 million, a 6.3% decrease compared to the fourth quarter of 2015. The decline in spinal hardware revenue was primarily driven by lower demand for the Company’s older spinal hardware products and continued pricing pressures in the U.S. market as well as lower overall demand in Europe.

Gross margin for the fourth quarter of 2016 was 58.6%, compared to 52.0% for the same period in 2015.  The increase in gross margin was primarily driven by substantially lower costs associated with the Company’s Mozaik product line, which was manufactured at the Company’s Irvine, California facility in 2016, compared to the higher cost paid in 2015 to purchase that product from Integra.  Gross margin also benefitted from lower operating costs following the transfer of the Company’s kitting and distribution operations to a third party logistics provider and the subsequent closure of its Vista, California facilities during the fourth quarter of 2016.

Operating expenses for the fourth quarter of 2016 totaled $28.6 million, compared to $31.2 million for the same period of the prior year.  The $2.6 million decrease was driven primarily by lower selling, general and administrative expenses.

Net loss for the fourth quarter of 2016 was $9.8 million, compared to a net loss of $13.8 million for the fourth quarter of 2015.

2016 Financial Results
Revenue for the year ended December 31, 2016 totaled $128.9 million, a decrease of $4.3 million, or 3.2%, compared to the prior year. Total revenue in the U.S. was $116.8 million, a 2.9% decrease compared to the prior year. Orthobiologics revenue totaled $66.2 million, a 1.6% decrease compared to the prior year. Spinal hardware revenue totaled $62.7 million, a 5.0% decrease compared to the prior year.

Gross margin in 2016 was 56.9%, compared to 54.1% in 2015.  The increase in gross margin was primarily driven by substantially lower costs associated with the Company’s Mozaik product line, which was manufactured at the Company’s Irvine, California facility in 2016, compared to the higher cost paid in 2015 to purchase that product from Integra.

Operating expenses in 2016 totaled $116.8 million, compared to $124.2 million in 2015.  The $7.4 million decrease was driven primarily by lower selling, general and administrative expenses, which was partially offset by increased investment in product development.

Net loss in 2016 was $43.2 million, compared to a net loss of $55.5 million in 2015.

Cash and cash equivalents at December 31, 2016 totaled $14.6 million and the Company had $3.8 million of outstanding borrowings against its credit facility.

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

Webcast and Conference Call Information
The Company’s management team will host a conference call beginning today at 1:30pm PT/4:30pm ET to discuss the financial results and recent business developments. Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 58687870. To listen to the webcast, please visit the investor relations section of the SeaSpine website at www.seaspine.com.

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

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

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

SEASPINE HOLDINGS CORPORATION
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
Quarter Ended December 31, Year Ended December 31,
2016 2015 2016 2015
Total revenue, net $ 32,519 $ 34,724 $ 128,860 $ 133,178
Cost of goods sold 13,450 16,671 55,544 61,119
Gross profit 19,069 18,053 73,316 72,059
Operating expenses:
Selling, general and administrative 24,899 27,492 101,065 110,551
Research and development 2,908 2,380 11,442 8,353
Intangible amortization 792 1,282 4,309 5,331
Total operating expenses 28,599 31,154 116,816 124,235
Operating loss (9,530 ) (13,101 ) (43,500 ) (52,176 )
Other expense net (231 ) (300 ) (264 ) (877 )
Loss before income taxes (9,761 ) (13,401 ) (43,764 ) (53,053 )
Provision for income taxes 7 349 (552 ) 2,479
Net loss $ (9,768 ) $ (13,750 ) $ (43,212 ) $ (55,532 )
Net Loss per share, basic and diluted $ (0.87 ) $ (1.23 ) $ (3.85 ) $ (4.99 )
Weighted average shares used to compute basic and diluted net loss per share 11,271 11,164 11,222 11,139
SEASPINE HOLDINGS CORPORATION
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET DATA
(In thousands)
December 31, 2016 December 31, 2015
Cash and cash equivalents $ 14,566 $ 33,429
Trade accounts receivable, net 20,982 25,326
Inventories 45,299 51,271
Total current liabilities 24,418 26,035
Short-term debt 445
Long-term borrowings under credit facility 3,835 328
Total stockholders’ equity 110,977 147,339

 

Investor Relations Contact 
Lynn Pieper Lewis
(415) 937-5402
ir@seaspine.com

OrthoCarolina Spine Surgery and the Mazor Robotics Renaissance Robot: 11 things to know

February 28, 2017, The OrthoCarolina Spine Center Team – Health Information » News & Research

Our surgeons are some of the best in the world, but robotics can actually increase the precision and consistency of what we do in the operating room.

The OrthoCarolina Robotics Spine Surgery Team completed its 100th Mazor Robotics Renaissance spine surgical case at Carolinas Medical Center Mercy in late 2016, performing a fusion procedure that involved inserting screws into a patient’s lumbar spine to provide stability and relieve pain. If you or a loved one may be a candidate for spine surgery, here are 11 things to know about the Mazor robot:

  1. The state-of-the-art Mazor technology makes complex spine surgery more precise by providing a pre-operative computer based planning platform to increase surgical accuracy and safety.
  2. Planning surgery through a computer and robot benefits the patient in many ways, ultimately leading to better outcomes post-surgery.
  3. Surgeons develop a precise surgical blueprint in a virtual 3D environment using the system’s intuitive interface.
  4. The robot allows precise placement of pedicle screws in patients with difficult anatomy, such as those with scoliosis deformities, and is minimally invasive.
  5. There are 145 worldwide Mazor Robotics Renaissance systems, with 91 in the United States.
  6. 23,000 cases have been performed as of early 2017 with 160,000 implants placed.
  7. In Charlotte, there have been 130 cases and 537 implants placed.
  8. The OrthoCarolina Spine Center team performed its first procedure in July 2015 and has since continued to expand the scope and complexity of procedures using Mazor robotic technology.
  9. The team is using this technique for many types of spine operations from minimally invasive procedures to larger deformity cases.
  10. Another potential advantage of the robot for patients is a reduction in radiation exposure.
  11. Patients may also see additional benefits include smaller incisions, shorter hospital stays, faster recovery and less pain from surgery.

The OrthoCarolina Spine Center Team, which celebrates its 25th year in 2017, includes surgeons Dr. Matt Chapman, Dr. Bruce Darden, Dr. Eric Laxer, Dr. Alden Milam, Dr. Al Rhyne, Dr. Leo Spector and Dr. Brad Segebarth.

 

PDL BioPharma Announces Fourth Quarter and Year End 2016 Financial Results

INCLINE VILLAGE, Nev., March 1, 2017 /PRNewswire/ — PDL BioPharma, Inc. (PDL or the Company) (NASDAQ: PDLI) today reported financial results for the fourth quarter and year ended December 31, 2016 including:

  • Total revenues of $66.5 million and $244.3 million for the three and twelve months ended December 31, 2016, respectively.
  • GAAP diluted EPS of ($0.06) and $0.39 for the three and twelve months ended December 31, 2016, respectively.
  • GAAP net loss attributable to PDL’s shareholders of $10.3 million and net income of $63.6 million for the three and twelve months ended December 31, 2016, respectively.
  • Non-GAAP net loss attributable to PDL’s shareholders of $8.6 million and net income of $108.1 million for the three and twelve months ended December 31, 2016, respectively. A full reconciliation of all components of the GAAP to non-GAAP financial results can be found in Table 4 at the end of the release.

The loss attributable to the three months ended December 31, 2016 was a result of a $51.1 million impairment charge relating to our Direct Flow Medical note receivable investment.

“2016 was a transformational year for PDL; one in which we took advantage of opportunities in the specialty pharma space as another tool to increase shareholder value,” said John P. McLaughlin, president and chief executive officer of PDL. “As we look to 2017, we will focus our efforts on Noden product commercialization, along with acquiring additional specialty pharma assets, to drive value creation for PDL and our shareholders.”

Recent Developments

  • PDL announced today that the company’s board of directors has authorized the repurchase of up to $30 million of the company’s common stock through March 2018.
  • As a result of ARIAD Pharmaceuticals, Inc. being acquired by Takeda Pharmaceuticals Company Limited on February 16, 2017, PDL exercised its put option with ARIAD and will be repaid an estimated $110 million, which is 1.2 times the original investment less any sums paid to date. We received $9.3 million of royalty payments through December 31, 2016. The cash repayment is expected in late March or early April of 2017.
  • PDL received a royalty payment for the first quarter of 2017 in the amount of $14.2 million for royalties earned on sales of Tysabri®. The duration of this royalty payment is based on the sales of product manufactured prior to patent expiry, the amount of which is uncertain.
  • In January 2017 PDL monetized $7.0 million of certain assets of Direct Flow Medical acquired through its foreclosure.

Revenue Highlights

  • Total revenues of $66.5 million for the three months ended December 31, 2016 included:
    • Royalties from PDL’s licensees to the Queen et al. patents of $15.5 million, which consisted of royalties earned on sales of Tysabri® under a license agreement;
    • Net royalty payments from acquired royalty rights and a change in fair value of the royalty rights assets of $28.1 million, which consisted of the change in estimated fair value of our royalty right assets, primarily related to the Depomed, Inc., University of Michigan, ARIAD and AcelRx Pharmaceuticals, Inc.;
    • Interest revenue from notes receivable financings to kaléo and CareView Communications of $5.5 million; and
    • Product revenues of $17.5 million from sales of Tekturna® and Tekturna HCT® in the United States and Rasilez® and Rasilez HCT® in the rest of the world (collectively, the Noden Products).
  • Total revenues decreased by 63 percent for the three months ended December 31, 2016, when compared to the same period in 2015.
    • The decrease in royalties from PDL’s licensees to the Queen et al. patents is due to the expiration of the patent license agreement with Genentech, Inc.
    • The decrease in royalty rights – change in fair value was primarily due to the $27.8 million decrease in fair value of the University of Michigan Cerdelga® royalty right asset and the decrease in fair value of the AcelRx Zalviso® royalty rights asset, partially offset by an increase in the fair value of the ARIAD Pharmaceuticals, Inc. royalty right asset.
    • PDL received $25.3 million in net cash royalty and milestone payments from its royalty rights in the fourth quarter of 2016, compared to $34.4 million for the same period of 2015.
    • The decrease in interest revenues was primarily due to the early repayment of the Paradigm Spine, LLC notes receivable investment.
    • Product revenues were derived from sales of the Noden Products.
  • Total revenues decreased by 59 percent for the twelve months ended December 31, 2016, when compared to the same period in 2015.
    • The decrease in royalties from PDL’s licensees to the Queen et al. patents is due to the expiration of the patent license agreement with Genentech, Inc.
    • The decrease in royalty rights – change in fair value was primarily driven by a $36.6 million decrease in the fair value of the University of Michigan royalty rights Cerdelga asset, a $23.1 million decrease in the fair value of the Depomed royalty rights asset and a $3.0 million decrease in the fair value of the Viscogliosi Brothers, LLC royalty right asset, partially offset by a $14.8 million increase in the fair value of the ARIAD Pharmaceuticals, Inc. royalty right asset.
    • PDL received $72.6 million in net cash royalty payments and milestone payments from its acquired royalty rights in the twelve months ended December 31, 2016, compared to $43.4 million for the same period of 2015.
    • Product revenues and interest revenue variances were the same as the three months ended December 31, 2016.

Operating Expense Highlights

  • Operating expenses were $74.2 million for the three months ended December 31, 2016, compared to $16.5 million for the same period of 2015. The increase in operating expenses for the three months ended December 31, 2016, as compared to the same period in 2015, was primarily a result of a $51.1 million impairment charge relating to our Direct Flow Medical note receivable investment and $11.4 million in expenses related to the Noden operations.
  • Operating expenses were $114.9 million for the twelve months ended December 31, 2016, compared to $40.1 million for the same period of 2015. The increase in operating expenses for the twelve months ended December 31, 2016, as compared to the same period in 2015, was the result of the Direct Flow Medical impairment and $25.6 million in expenses related to the acquisition of the Noden Products and its operations.

Other Financial Highlights

  • PDL had cash, cash equivalents, and investments of $242.1 million at December 31, 2016, compared to $220.4 million at December 31, 2015.
  • Net cash provided by operating activities in the twelve months ended December 31, 2016 was $101.7 million, compared with $301.5 million in the same period in 2015.

Conference Call and Webcast Details

PDL will hold a conference call to discuss financial results at 4:30 p.m. Eastern Time today, March 1, 2017.

To access the live conference call via phone, please dial (800) 668-4132 from the United States and Canada or (224) 357-2196 internationally. The conference ID is 77416821. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available beginning approximately one hour after the call through March 8, 2017, and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 77416821.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website at http://www.pdl.com and go to “Events & Presentations.” Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

About PDL BioPharma, Inc.

PDL BioPharma, Inc. and its subsidiaries (collectively, the “Company”) seek to provide a significant return for its shareholders by acquiring and managing a portfolio of companies, products, royalty agreements and debt facilities in the biotech, pharmaceutical and medical device industries. In 2012, the Company began providing alternative sources of capital through royalty monetizations and debt facilities, and in 2016, the Company began acquiring commercial-stage products and launching specialized companies dedicated to the commercialization of these products. To date, the Company has consummated 16 of such transactions. Of these transactions, five have concluded with an average annual internal rate of return of 18.4%: Merus Labs International, Inc., Durata Therapeutics, Inc., AxoGen, Inc., Avinger, Inc. and Paradigm Spine, LLC. The Company has four debt transactions outstanding, representing deployed and committed capital of $269.0 million and $309.0 million, respectively: CareView Communications, Inc., kaléo, Inc., Direct Flow Medical, Inc., and LENSAR, Inc.; it has one hybrid royalty/debt transaction outstanding, representing deployed and committed capital of $44.0 million: Wellstat Diagnostics, LLC; and it has six royalty transactions outstanding representing deployed and committed capital of $496.1 million and $537.1 million, respectively: KYBELLA®, AcelRx Pharmaceuticals, Inc., ARIAD Pharmaceuticals, Inc., The Regents of the University of Michigan, Viscogliosi Brothers, LLC and Depomed, Inc. The Company’s equity and loan investments in Noden Pharma DAC and Noden Pharma USA, Inc. (together, “Noden”) represent deployed and committed capital of $110.0 million and $202.0 million, respectively.

The Company was formerly known as Protein Design Labs, Inc. and changed its name to PDL BioPharma, Inc. in 2006. PDL was founded in 1986 and is headquartered in Incline Village, Nevada. PDL pioneered the humanization of monoclonal antibodies and, by doing so, enabled the discovery of a new generation of targeted treatments for cancer and immunologic diseases for which it has received significant royalty revenue.

PDL BioPharma and the PDL BioPharma logo are considered trademarks of PDL BioPharma, Inc.

Forward-looking Statements

This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from those, express or implied, in these forward-looking statements. Important factors that could impair the value of the Company’s royalty assets, restrict or impede the ability of the Company to invest in new royalty bearing assets and limit the Company’s ability to pay dividends are disclosed in the risk factors contained in the Company’s Annual Report on Form 10-K, filed with the Securities and Exchange Commission. All forward-looking statements are expressly qualified in their entirety by such factors. We do not undertake any duty to update any forward-looking statement except as required by law.

TABLE 1

PDL BIOPHARMA, INC.

CONSOLIDATED STATEMENTS OF INCOME DATA

(In thousands, except per share amounts)

Three Months Ended

Twelve Months Ended

December 31,

December 31,

2016

2015

2016

2015

Revenues

Royalties from Queen et al. patents

$

15,513

$

121,240

$

166,158

$

485,156

Royalty rights – change in fair value

28,068

49,069

16,196

68,367

Interest revenue

5,503

7,606

30,404

36,202

Product revenue, net

17,541

31,669

License and other

(133)

143

(126)

723

Total revenues

66,492

178,058

244,301

590,448

Operating Expenses

Cost of product revenue (excluding amortization of intangible assets)

4,065

4,065

Amortization of intangible assets

6,014

12,028

General and administrative expenses

12,597

12,545

39,790

36,090

Sales and marketing

527

538

Research and development

1,887

3,820

Change in fair value of anniversary payment and contingent consideration

(5,799)

(3,716)

Asset impairment loss

3,735

3,735

Acquisition-related costs

59

3,564

Loss on extinguishment of notes receivable

51,075

3,979

51,075

3,979

Total operating expenses

74,160

16,524

114,899

40,069

Operating income/(loss)

(7,668)

161,534

129,402

550,379

Non-operating expense, net

Interest and other income, net

184

74

588

368

Interest expense

(4,743)

(5,349)

(18,267)

(27,059)

Gain (loss) on extinguishment of debt

(2,353)

6,450

(2,353)

6,450

Total non-operating expense, net

(6,912)

1,175

(20,032)

(20,241)

Income/(loss) before income taxes

(14,580)

162,709

109,370

530,138

Income tax expense

(4,300)

62,135

45,711

197,343

Net income/(loss)

(10,280)

100,574

63,659

332,795

Less: Net income attributable to noncontrolling interests

56

53

Net income/(loss) attributable to PDL’s shareholders

$

(10,336)

$

100,574

$

63,606

$

332,795

Net income/(loss) per share

Basic

$

(0.06)

$

0.61

$

0.39

$

2.04

Diluted

$

(0.06)

$

0.61

$

0.39

$

2.03

Shares used to compute income per basic share

163,975

163,601

163,805

163,386

Shares used to compute income per diluted share

164,549

163,801

164,192

163,554

Cash dividends declared per common share

$

$

$

0.10

$

0.60

TABLE 2

PDL BIOPHARMA, INC.

CONDENSED CONSOLIDATED BALANCE SHEET DATA

(Unaudited)

(In thousands)

December 31,

December 31,

2016

2015

Cash, cash equivalents and investments (includes restricted cash)

$

242,141

$

220,352

Total notes receivable

$

270,950

$

364,905

Total royalty rights – at fair value

$

402,318

$

399,204

Total assets

$

1,215,387

$

1,012,205

Total term loan payable

$

$

24,966

Total convertible notes payable

$

232,443

$

228,862

Total PDL’s stockholders’ equity

$

755,423

$

695,952

TABLE 3

PDL BIOPHARMA, INC.

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW DATA

(Unaudited)

(In thousands)

Twelve Months Ended

December 31,

2016

2015

Net income

$

63,659

$

332,795

Adjustments to reconcile net income to net cash provided by (used in) operating activities

52,738

(40,521)

Changes in assets and liabilities

(14,679)

9,191

Net cash provided by operating activities

$

101,718

$

301,465

TABLE 4

PDL BIOPHARMA, INC.

GAAP to NON-GAAP RECONCILIATION:

NET INCOME AND DILUTED EARNINGS PER SHARE

(Unaudited)

(In thousands, except per share amount)

A reconciliation between net income on a GAAP basis and on a non-GAAP basis is as follows:

Three Months Ended

Twelve Months Ended

December 31,

December 31,

2016

2015

2016

2015

GAAP net income/(loss) attributed to PDL’s shareholders as reported

$

(10,336)

$

100,574

$

63,606

$

332,795

Adjustments to Non-GAAP net income/(loss) (as detailed below)

1,716

(7,561)

44,518

(10,201)

Non-GAAP net income/(loss) attributed to PDL’s shareholders

$

(8,620)

$

93,013

$

108,124

$

322,594

An itemized reconciliation between net income/(loss) on a GAAP basis and on a non-GAAP basis is as follows:

Three Months Ended

Twelve Months Ended

December 31,

December 31,

2016

2015

2016

2015

GAAP net income/(loss) attributed to PDL’s shareholders as reported

$

(10,336)

$

100,574

$

63,606

$

332,795

Adjustments:

Mark-to-market adjustment to fair value assets

(2,726)

(14,632)

56,386

(24,960)

Non-cash interest revenues

(121)

(533)

(2,864)

(5,307)

Non-cash stock-based compensation expense

1,093

697

3,742

2,045

Non-cash debt offering costs

3,942

3,219

10,009

12,963

Mark-to-market adjustment on warrants held

31

(985)

906

(985)

Amortization of the intangible assets

6,014

12,028

Mark-to-market adjustment of anniversary payment and contingent consideration

(5,799)

(3,716)

Income tax effect related to above items

(718)

4,673

(31,973)

6,043

Total adjustments

1,716

(7,561)

44,518

(10,201)

Non-GAAP net income/(loss)

$

(8,620)

$

93,013

$

108,124

$

322,594

Use of Non-GAAP Financial Measures

We supplement our consolidated financial statements presented on a GAAP basis by providing additional measures which may be considered “non-GAAP” financial measures under applicable SEC rules. We believe that the disclosure of these non-GAAP financial measures provides our investors with additional information that reflects the amounts and financial basis upon which our management assesses and operates our business. These non-GAAP financial measures are not in accordance with generally accepted accounting principles and should not be viewed in isolation or as a substitute for reported, or GAAP, net income, and diluted earnings per share, and are not a substitute for, or superior to, measures of financial performance performed in conformity with GAAP.

“Non-GAAP net income” is not based on any standardized methodology prescribed by GAAP and represent GAAP net income adjusted to exclude (1) mark-to market adjustments related to the fair value election for our investments in royalty rights presented in our earnings, which include the fair value re-measurement of future discounted cash flows for each of the royalty rights assets we have acquired, (2) non-cash interest revenue from notes receivable  (3) stock-based compensation expense, (4) non-cash interest expense related to PDL debt offering costs, (5) mark-to market adjustments related to warrants held, (6) mark-to-market adjustment related to acquisition-related contingent considerations, (7) amortization of intangible assets, and to adjust (7) the related tax effect of all reconciling items within our reconciliation of our GAAP to Non-GAAP net income. Non-GAAP financial measures used by PDL may be calculated differently from, and therefore may not be comparable to, non-GAAP measures used by other companies.

Logo – http://photos.prnewswire.com/prnh/20110822/SF55808LOGO

 

SOURCE PDL BioPharma, Inc.

Pacira Pharmaceuticals Reports 2016 Financial Results and Provides Business Update

PARSIPPANY, N.J., March 01, 2017 (GLOBE NEWSWIRE) — Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) today reported financial results for 2016 and its outlook for 2017.  The company is also announcing positive topline results for its Phase 4 study of EXPAREL® in total knee arthroplasty, or TKA.

“We made important progress in 2016 advancing our three-part EXPAREL growth strategy and setting the stage for continued success,” said Dave Stack, chief executive officer and chairman of Pacira. “We have multiple, major milestones on track for 2017, including the positive topline results reported today from our Phase 4 study in TKA. Our collaboration with DePuy Synthes is off to a strong start and will allow us to maximize these important data and broaden the use of EXPAREL as an opioid-sparing solution for prolonged postsurgical pain relief.”

Recent Highlights

  • Positive topline results for Phase 4 TKA study. Pacira today announced that its Phase 4 study of EXPAREL in patients undergoing TKA has met its co-primary endpoints for postsurgical pain and opioid reduction. The study was a multicenter, randomized, double-blind, controlled, parallel group study comparing EXPAREL based local analgesia infiltration to standard bupivacaine based local analgesia infiltration each as part of a standard multimodal analgesic protocol. The co-primary efficacy endpoints were the area under the curve (AUC) of visual analog scale (VAS) pain intensity scores from 12 to 48 hours after surgery and total opioid consumption from zero to 48 hours after surgery. The EXPAREL group achieved a statistically significant reduction in AUC VAS scores compared to the group who did not receive EXPAREL (p=0.0381). In addition, patients who received EXPAREL consumed significantly fewer opioids than patients who did not receive EXPAREL during the 48 hours that followed surgery (p=0.0048). The company plans to report the statistical results for key secondary endpoints from this study in the coming weeks. Full results will be submitted for publication in a peer-reviewed medical journal.
  • Partnership with DePuy Synthes to maximize EXPAREL opportunity. In January 2017, the company announced a co-promotion agreement with DePuy Synthes to market and promote the use of EXPAREL for orthopedic procedures in the US market. The DePuy Synthes field representatives, specializing in joint reconstruction, spine, sports medicine and trauma, will expand the reach and frequency of EXPAREL education in hospital surgical suites and ambulatory surgery centers. DePuy Synthes will also include EXPAREL in the Orthopedic Episode of Care Approach, a comprehensive offering for health systems and surgeons. In addition to supporting DePuy Synthes, Pacira will focus on soft tissue surgeons in key specialties, as well as anesthesiologists. Pacira will continue to act as the overall EXPAREL account manager.
  • Additional EXPAREL patent to issue that will extend protection until December 2021. The company has received an issue notification from the United States Patent and Trademark Office (USPTO) regarding its patent application 11/678,615, which is entitled “Production of Multivesicular Liposomes.” The USPTO projects that the application will issue with the patent number 9,585,838 on March 7, 2017. The patent includes a patent term adjustment and will expire on December 24, 2021. Once listed, this will be the company’s third patent listed in the Orange Book for EXPAREL.

Fourth Quarter 2016 Financial Results

  • EXPAREL net product sales were $71.4 million in the fourth quarter of 2016, a 6% increase over the $67.2 million reported for the fourth quarter of 2015.
  • Total revenues were $72.9 million in the fourth quarter of 2016, a 5% increase over the $69.3 million reported for the fourth quarter of 2015.
  • Total operating expenses were $75.4 million in the fourth quarter of 2016, compared to $70.1 million in the fourth quarter of 2015.
  • GAAP net loss was $4.0 million, or $0.11 per share (basic and diluted), in the fourth quarter of 2016, compared to a GAAP net loss of $2.5 million, or $0.07 per share (basic and diluted), in the fourth quarter of 2015.
  • Non-GAAP net income was $3.6 million, or $0.10 per share (basic) and $0.09 per share (diluted), in the fourth quarter of 2016, compared to non-GAAP net income of $8.3 million, or $0.22 per share (basic) and $0.20 per share (diluted), in the fourth quarter of 2015.
  • Pacira had 37.4 million basic weighted average shares of common stock outstanding in the fourth quarter of 2016.
  • For non-GAAP measures, Pacira had 39.7 million diluted weighted average shares of common stock outstanding in the fourth quarter of 2016.

Full-Year 2016 Financial Results

  • EXPAREL net product sales were $265.8 million in 2016, an 11% increase over the $239.9 million in 2015.
  • Total revenues were $276.4 million in 2016, an 11% increase over the $249.0 million in 2015.
  • Total operating expenses were $308.4 million in 2016, compared to $239.5 million in 2015.
  • GAAP net loss was $37.9 million, or $1.02 per share (basic and diluted), in 2016, compared to GAAP net income of $1.9 million, or $0.05 per share (basic) and $0.04 (diluted), in 2015.
  • Non-GAAP net income was $25.2 million, or $0.68 per share (basic) and $0.62 per share (diluted), in 2016, compared to non-GAAP net income of $39.4 million, or $1.08 per share (basic) and $0.95 per share (diluted), in 2015.
  • Pacira ended 2016 with cash, cash equivalents and short-term investments (“cash”) of $172.6 million.
  • Pacira had 37.2 million basic weighted average shares of common stock outstanding in 2016.
  • For non-GAAP measures, Pacira had 40.5 million diluted weighted average shares of common stock outstanding in 2016.

2017 Outlook

Pacira announces its full year 2017 financial guidance as follows. Pacira expects:

  • EXPAREL net product sales of $290 million to $310 million.
  • Non-GAAP gross margins of approximately 70%.
  • Non-GAAP research and development (R&D) expense of $50 million to $60 million.
  • Non-GAAP selling, general and administrative (SG&A) expense of $145 million to $155 million.
  • Stock-based compensation of $30 million to $35 million.

See “Non-GAAP Financial Information” and “Reconciliations of GAAP to Non-GAAP 2017 Financial Guidance” below.

Today’s Conference Call and Webcast Reminder

The Pacira management team will host a conference call to discuss the company’s financial results and recent developments today, Wednesday, March 1, 2017, at 8:30 a.m. ET. The call can be accessed by dialing 1-877-845-0779 (domestic) or 1-720-545-0035 (international) ten minutes prior to the start of the call and providing the Conference ID 40628335.

A replay of the call will be available approximately two hours after the completion of the call and can be accessed by dialing 1-855-859-2056 (domestic) or 1-404-537-3406 (international) and providing the Conference ID 40628335. The replay of the call will be available for two weeks from the date of the live call.

The live, listen-only webcast of the conference call can also be accessed by visiting the “Investors & Media” section of the company’s website at investor.pacira.com. A replay of the webcast will be archived on the Pacira website for two weeks following the call.

Non-GAAP Financial Information

This press release contains financial measures that do not comply with U.S. generally accepted accounting principles (GAAP), such as non-GAAP net income, non-GAAP cost of goods sold, non-GAAP gross margins, non-GAAP R&D and non-GAAP SG&A expenses, because such measures exclude stock-based compensation, amortization of debt discount, loss on extinguishment of debt, a termination fee with CrossLink BioScience, LLC and inventory and related reserves from the stability testing out of specification. These measures supplement our financial results prepared in accordance with GAAP. Pacira management uses these measures to better analyze its financial results, estimate its future cost of goods sold, gross margins, R&D and SG&A outlook for 2017 and to help make managerial decisions. In management’s opinion, these non-GAAP measures are useful to investors and other users of our financial statements by providing greater transparency into the operating performance at Pacira and the company’s future outlook. Such measures should not be deemed to be an alternative to GAAP requirements or a measure of liquidity for Pacira. Non-GAAP measures are also unlikely to be comparable with non-GAAP disclosures released by other companies. See the tables below for a reconciliation of GAAP to non-GAAP measures, and a reconciliation of our GAAP to non-GAAP 2017 financial guidance for gross margins, R&D and SG&A.

About Pacira

Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) is a specialty pharmaceutical company focused on the clinical and commercial development of new products that meet the needs of acute care practitioners and their patients. The company’s flagship product, EXPAREL® (bupivacaine liposome injectable suspension), indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia, was commercially launched in the United States in April 2012. EXPAREL and two other products have successfully utilized DepoFoam®, a unique and proprietary product delivery technology that encapsulates drugs without altering their molecular structure, and releases them over a desired period of time. Additional information about Pacira is available at www.pacira.com.

About EXPAREL®

EXPAREL (bupivacaine liposome injectable suspension) is currently indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. The product combines bupivacaine with DepoFoam®, a proven product delivery technology that delivers medication over a desired time period. EXPAREL represents the first and only multivesicular liposome local anesthetic that can be utilized in the peri- or postsurgical setting. By utilizing the DepoFoam platform, a single dose of EXPAREL delivers bupivacaine over time, providing significant reductions in cumulative pain score with up to a 45 percent decrease in opioid consumption; the clinical benefit of the opioid reduction was not demonstrated. Additional information is available at www.EXPAREL.com.

Important Safety Information

EXPAREL is contraindicated in obstetrical paracervical block anesthesia. EXPAREL has not been studied for use in patients younger than 18 years of age. Non-bupivacaine-based local anesthetics, including lidocaine, may cause an immediate release of bupivacaine from EXPAREL if administered together locally. The administration of EXPAREL may follow the administration of lidocaine after a delay of 20 minutes or more. Other formulations of bupivacaine should not be administered within 96 hours following administration of EXPAREL. Monitoring of cardiovascular and neurological status, as well as vital signs should be performed during and after injection of EXPAREL as with other local anesthetic products. Because amide-type local anesthetics, such as bupivacaine, are metabolized by the liver, EXPAREL should be used cautiously in patients with hepatic disease. Patients with severe hepatic disease, because of their inability to metabolize local anesthetics normally, are at a greater risk of developing toxic plasma concentrations. In clinical trials, the most common adverse reactions (incidence greater-than or equal to 10%) following EXPAREL administration were nausea, constipation, and vomiting.

Please see the full Prescribing Information for more details available at:
http://www.exparel.com/hcp/pdf/EXPAREL_Prescribing_Information.pdf.

Forward Looking Statements

Any statements in this press release about our future expectations, plans, outlook and prospects, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including risks relating to: the success of our sales and manufacturing efforts in support of the commercialization of EXPAREL; the rate and degree of market acceptance of EXPAREL and our other products; the size and growth of the potential markets for EXPAREL and our ability to serve those markets; our plans to expand the use of EXPAREL to additional indications and opportunities, and the timing and success of any related clinical trials; the related timing and success of United States Food and Drug Administration supplemental New Drug Applications; the outcome of the U.S. Department of Justice inquiry; our plans to evaluate, develop and pursue additional DepoFoam-based product candidates; clinical trials in support of an existing or potential DepoFoam-based product; our plans to continue to manufacture and provide support services for our commercial partners who have licensed DepoCyt(e); our commercialization and marketing capabilities; our and Patheon UK Limited’s ability to successfully and timely construct dedicated EXPAREL manufacturing suites; and other factors discussed in the “Risk Factors” of our most recent Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in other filings that we periodically make with the SEC. In addition, the forward-looking statements included in this press release represent our views as of the date of this press release. Important factors could cause our actual results to differ materially from those indicated or implied by forward-looking statements, and as such we anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

(Tables to Follow)

Pacira Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
December 31,
2016
December 31,
2015
ASSETS
Current assets:
  Cash, cash equivalents and short-term investments $ 172,597 $ 158,965
  Accounts receivable, net 29,937 25,855
  Inventories, net 31,278 61,645
  Prepaid expenses and other current assets 9,277 6,117
  Total current assets 243,089 252,582
Long-term investments 13,462
Fixed assets, net 101,016 90,324
Goodwill 46,737 30,880
Intangible assets, net 81
Other assets 624 406
  Total assets $ 391,466 $ 387,735
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
  Accounts payable $ 7,511 $ 8,739
  Accrued expenses 36,666 35,375
  Convertible senior notes * 104,040
  Current portion of deferred revenue 595 1,426
  Income taxes payable 66 208
  Total current liabilities 44,838 149,788
Convertible senior notes * 108,738
Deferred revenue 7,487 8,082
Other liabilities 11,427 11,473
Total stockholders’ equity 218,976 218,392
  Total liabilities and stockholders’ equity $ 391,466 $ 387,735

* The convertible senior notes are contractually due in 2019. At December 31, 2016, the note holders did not have the ability to convert their notes at any time during the quarter ended March 31, 2017. However, because of certain conditions that were met during the three months ended December 31, 2015, the note holders could have converted their notes any time during the quarter ended March 31, 2016.

Pacira Pharmaceuticals, Inc.
Consolidated Statements of Operations
(in thousands, except per share amounts)
(unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
2016 2015 2016 2015
 Net product sales:
  EXPAREL $ 71,428 $ 67,194 $ 265,802 $ 239,851
  DepoCyt(e) and other product sales 337 995 4,271 4,636
 Total net product sales 71,765 68,189 270,073 244,487
 Collaborative licensing and milestone revenue 357 357 3,426 1,426
 Royalty revenue 780 774 2,872 3,084
  Total revenues 72,902 69,320 276,371 248,997
Operating expenses:
  Cost of goods sold 23,621 19,427 110,104 71,837
  Research and development 17,069 13,153 45,678 28,662
  Selling, general and administrative 34,673 37,553 152,613 139,043
  Total operating expenses 75,363 70,133 308,395 239,542
Income (loss) from operations (2,461 ) (813 ) (32,024 ) 9,455
Other (expense) income:
  Interest income 401 175 1,323 678
  Interest expense (1,859 ) (1,884 ) (7,061 ) (7,725 )
  Loss on early extinguishment of debt (1 ) (52 )
  Royalty interest obligation (71 )
  Other, net (75 ) (83 ) (82 ) (165 )
  Total other expense, net (1,533 ) (1,793 ) (5,820 ) (7,335 )
Income (loss) before income taxes (3,994 ) (2,606 ) (37,844 ) 2,120
  Income tax benefit (expense) 21 108 (105 ) (264 )
Net income (loss) $ (3,973 ) $ (2,498 ) $ (37,949 ) $ 1,856
Net income (loss) per share:
  Basic net income (loss) per common share $ (0.11 ) $ (0.07 ) $ (1.02 ) $ 0.05
  Diluted net income (loss) per common share $ (0.11 ) $ (0.07 ) $ (1.02 ) $ 0.04
Weighted average common shares outstanding:
  Basic 37,431 36,783 37,236 36,540
  Diluted 37,431 36,783 37,236 41,301
Pacira Pharmaceuticals, Inc.
Reconciliation of GAAP to Non-GAAP Financial Information
(in thousands, except per share amounts)
(unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
2016 2015 2016 2015
GAAP net income (loss) $ (3,973 ) $ (2,498 ) $ (37,949 ) $ 1,856
Non-GAAP adjustments:
  Stock-based compensation 7,733 9,728 31,248 33,368
  Inventory and related reserves (1) (1,219 ) 20,731
  Loss on early extinguishment of debt 1 52
  Amortization of debt discount 1,022 1,022 4,088 4,102
  CrossLink contract termination fee 7,062
  Total Non-GAAP adjustments 7,536 10,751 63,129 37,522
Non-GAAP net income $ 3,563 $ 8,253 $ 25,180 $ 39,378
GAAP basic net income (loss) per common share $ (0.11 ) $ (0.07 ) $ (1.02 ) $ 0.05
GAAP diluted net income (loss) per common share $ (0.11 ) $ (0.07 ) $ (1.02 ) $ 0.04
Non-GAAP basic net income per common share $ 0.10 $ 0.22 $ 0.68 $ 1.08
Non-GAAP diluted net income per common share $ 0.09 $ 0.20 $ 0.62 $ 0.95
Weighted average common shares outstanding – basic 37,431 36,783 37,236 36,540
Weighted average common shares outstanding – diluted 39,729 40,937 40,490 41,301
Cost of goods sold reconciliation:
GAAP cost of goods sold $ 23,621 $ 19,427 $ 110,104 $ 71,837
  Stock-based compensation (1,652 ) (1,633 ) (6,438 ) (6,012 )
  Inventory and related reserves (1) 1,219 (20,731 )
Non-GAAP cost of goods sold $ 23,188 $ 17,794 $ 82,935 $ 65,825
Research and development reconciliation:
GAAP research and development $ 17,069 $ 13,153 $ 45,678 $ 28,662
  Stock-based compensation (699 ) (1,994 ) (3,297 ) (5,134 )
Non-GAAP research and development $ 16,370 $ 11,159 $ 42,381 $ 23,528
Selling, general and administrative reconciliation:
GAAP selling, general and administrative $ 34,673 $ 37,553 $ 152,613 $ 139,043
  Stock-based compensation (5,382 ) (6,101 ) (21,513 ) (22,222 )
  CrossLink contract termination fee (7,062 )
Non-GAAP selling, general and administrative $ 29,291 $ 31,452 $ 124,038 $ 116,821

(1) – In 2016, the Company recorded a $20.7 million charge to cost of goods sold to fully reserve $20.5 million for the cost of EXPAREL batches impacted by a routine stability test that did not meet required specifications and $0.2 million for replacement boxes and other related costs.

Pacira Pharmaceuticals, Inc.
Reconciliation of GAAP to Non-GAAP 2017 Financial Guidance
(dollars in millions)
GAAP to Non-GAAP Guidance GAAP Stock-Based
Compensation
Non-GAAP
EXPAREL net product sales $290 to $310
Gross margin Approx. 68% Approx. 2% Approx. 70%
Research and development expense $52 to $64 $2 to $4 $50 to $60
Selling, general and administrative expense $167 to $180 $22 to $25 $145 to $155
Stock-based compensation $30 to $35

 

Investor Contact:
Susan Mesco
(973) 451-4030
susan.mesco@pacira.com
            
Media Contact:
Coyne Public Relations
Alyssa Schneider
(973) 588-2270
aschneider@coynepr.com

SPINEWAY: New distribution contract in the USA Appointment of Philippe Laurito as head of the US subsidiary

 Ecully, 1 March 2017

Spineway, specialist in surgical implants and instruments for treating disorders of the spinal column (spine,) announces the signature of a contract with a new US distributor for the sale of its implants and instruments.

The distributor is based in the Midwest and has a client portfolio that includes several hospitals and surgical centers. Spineway USA Inc. received a 1st order for a hospital in the region and should receive a 2nd order in April. These orders are for items from the Mont Blanc and the Twin Peaks lines, which are the Spineway Group’s mid-range offerings.

This new distribution contract is in addition to the two already signed, one with a California distributor (September 2016) and the other with a Texas distributor (January 2017), thus allowing Spineway to create a network that is slowly expanding throughout the United States.

Philippe Laurito becomes President of Spineway USA Inc.

In order to steer and roll out Spineway’s offer in the US, Philippe Laurito, Managing Director of Spineway, will become President of the Group’s US subsidiary as from 1 March 2017.

His expertise and in-depth knowledge of the American continent will allow him to guide and expedite the sale of Spineway products on the largest market in the world for spinal surgery. Philippe Laurito remains Deputy Managing Directory and member of the Spineway Group’s Executive Committee.

Thanks to these three distribution contracts and the in-situ steering of its US subsidiary, Spineway should increase its presence on the territory and see its sales grow quickly to represent at a short term almost 40% of the total sales of the group.

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

Michel Orsinger Joins Lima Corporate’s Advisory Board

SAN DANIELE DEL FRIULI, Italy, March 1, 2017 /PRNewswire/ —

Lima Corporate further strengthens the Advisory Board. Following the announcement regarding Mr. Bruno Melzi, Lima Corporate is proud to announce the arrival of another new Board Member: Michel Orsinger, former Chairman of Global Orthopedics Johnson & Johnson (J&J), has decided to join the Lima Advisory Board starting 1st of March, 2017.

Michel Orsinger held the position of Worldwide Chairman DePuy Synthes Companies at J&J from 2012 to 2015.  He was also a member of J&J’s Global Management Team.  Michel Orsinger joined J&J following the sale of Synthes Inc. for $20 billion, the largest acquisition ever realized by Johnson & Johnson.  Subsequently, Michel Orsinger established the worldwide’s largest and most comprehensive orthopedic company.  Prior to his leadership role at Johnson & Johnson, Mr. Orsinger was COO and CEO of Synthes Inc for eight years, and spent eleven years with Novartis.

Today, Michel Orsinger is an investor as well as board member of several start-up companies and an advisor to EQT.

“The addition of Michel has further strengthened what was already one of the strongest Advisory Boards in the industry and is another proof of Lima’s attractiveness,” said Valentin Chapero, Chairman of the Advisory Board. “I am convinced that Michel’s outstanding industry knowledge and leadership experience will allow the Advisory Board to contribute additional value to Lima and its management team, specifically in further supporting growth,” Mr. Chapero concluded.

“I am very happy that Michel as another high quality veteran of our industry has decided to join the Advisory Board,” said Luigi Ferrari, CEO of Lima Corporate. “Michel’s expertise in the orthopaedic as well as medical device industry and track record of growing companies will accelerate our development,” Mr. Ferrari commented.

About Lima Corporate

Lima Corporate is a global medical device company providing reconstructive orthopaedic solutions to surgeons who face the challenges of improving the quality of life of their patients.  Based in Italy, Lima Corporate is committed to the development of innovative products and procedures to enable surgeons to select ideal solution for every individual patient.  Lima Corporate’s product range includes large joint revision and primary implants and complete extremities solutions including fixation.

For additional information on the Company, please visit http://www.limacorporate.com .

http://limacorporate.com/repo/transfers/8/Lima_Corporate_Press_Release_New_Board_Member_Orsinger.pdf

SOURCE Lima Corporate

OrthAlign, Inc. Appoints Eric B. Timko As New Chief Executive Officer and Chairman of the Board

OrthAlign, Inc., a privately held U.S.-based medical device and technology company, announced today the appointment of Eric B. Timko as its new Chief Executive Officer and Chairman of the Board.

Mr. Timko is an accomplished medical device executive with more than 25 years of experience in the healthcare industry. He assumes his new leadership role at OrthAlign after serving on the company’s Board of Directors since July 2016. He previously served as President and Chief Executive Officer of Blue Belt Technologies, which under his leadership, was sold to Smith & Nephew in October 2015.

“I am very appreciative and excited to join OrthAlign as Chairman and CEO,” said Mr. Timko. “With close to 60,000 cases of consistent clinical outcomes completed, OrthAlign’s technology has made a positive impact on improving patient outcomes in joint replacement and will continue to do so for many years to come. Our immediate focus will be to expand our customer reach and our application pipeline so that more physicians and healthcare facilities can utilize our clinically beneficial and economically friendly portfolio of products.”

Prior to joining Blue Belt Technologies, Mr. Timko served as President and Chief Executive Officer of NeuroVasx, Inc., President of Carl Zeiss Surgical, Inc., and as Vice President of Siemens Medical Systems, Inc.

“As OrthAlign hits another inflection point in its successful history, the Board of Directors is delighted to have Eric take the reigns as Chairman and CEO of the company,” said Carter McNabb, OrthAlign Board Member and Managing Director of River Cities Capital Funds. “Eric’s prior leadership experience throughout his career is tailor made for the next stage of growth that lies ahead for OrthAlign. He is one of the medical technology industry’s most respected and innovative executives and we are confident that his leadership and vision will help fulfill the promise that our unique technology can bring to the changing orthopedic landscape.”

“The Board of Directors would also like to recognize outgoing OrthAlign CEO William Maya for his leadership over the past six years,” continues Mr. McNabb. “He has been instrumental in helping guide the organization through a critical growth period and effectively helped put OrthAlign technology on the global map. The OrthAlign family is extremely grateful for his service.”

About OrthAlign, Inc.

OrthAlign is a privately held medical device and technology company, committed to providing orthopedic surgeons with cutting edge, user-friendly, surgical navigation products for precise alignment and positioning. We believe that our technology will raise the standard of care in Joint Arthroplasty surgeries by making consistent and measurable results accessible and affordable to all surgeons, hospitals, and patients. Our strategy is to leverage this technology to provide simple and precision-driven solutions for a broad range of orthopedic procedures. For more information regarding OrthAlign, please visit http://www.orthalign.com.

“ORTHALIGN®, ORTHALIGN PLUS®, KNEEALIGN®, KNEEALIGN® 2, HIPALIGN®, and UNIALIGN™ are [registered] trademarks of OrthAlign, Inc.”

Alphatec’s Arsenal™ Deformity Adolescent Scoliosis (AIS) System Launched in Limited Markets in the U.S.

CARLSBAD, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) — Alphatec Spine, Inc., (Nasdaq:ATEC), a global provider of spinal fusion technologies, announced today that the Company has launched its new Arsenal Deformity Adolescent Idiopathic Scoliosis (AIS) System and has successfully completed initial patient cases.  The limited release further expands the Company’s Arsenal Spinal Fixation System and targets the $650M U.S. deformity spine market.

The Arsenal AIS System gives surgeons a complete solution to address complex deformity pathologies, including unique uniplanar screws, which enable easier screw positioning and rod placement through a tulip that has 360 degrees of rotation, while restricting motion in the medial/lateral plane for derotation correction.  Additionally, the AIS system includes a wide variety of low-profile implants providing a better anatomical fit and increased ability to address patient pathologies, ergonomically designed instrumentation to improve surgical efficiency and comfort during complex surgeries, and proven biomechanical strength necessary to achieve a solid fusion.

Terry Rich, Alphatec Spine’s Chief Executive Officer commented, “With the launch of our differentiated AIS Deformity System we are able to compete directly with the market leaders in complex spine and it opens up a new segment for us in pediatric procedures.  This unique system extends our Arsenal platform and provides surgeons with easy-to-use, differentiated surgical tools for corrective maneuvers to better treat adolescent patients who are diagnosed with idiopathic scoliosis.  These successful initial patient cases demonstrate ATEC’s ongoing commitment to developing innovative solutions that are targeted at improving overall patient outcomes and surgeon experience.  The Arsenal AIS system gives us the opportunity to gain greater share in the deformity market and to benefit a vast number patients who are suffering today.”

Dr. Sheldon St. Clair, a pediatric orthopedic surgeon, and Dr. John Birknes, a pediatric neurosurgeon,  co-directors of the Spine Program at the Children’s Hospital of the King’s Daughters in Virginia, have partnered to treat pediatric spine deformities and performed the first deformity correction using the Arsenal AIS system. The patient was a skeletally immature 13-year-old with a hypokyphotic 49-degree thoracic scoliosis.  Drs. St. Clair and Birknes performed the surgery using the Arsenal uniplanar implants and cobalt-chromium alloy rods on a long construct across 9 levels from thoracic vertebrae T3 to T12.  Post-surgery, the patient’s thoracic curve has been eliminated, appropriate kyphosis has been restored, and the patient’s rib hump is no longer present.

“The entire Arsenal Deformity AIS set is fantastic, but the shining star is the ability to spin the uniplanar bodies independent of the screw shank, which allows surgeons to achieve optimal fixation and placement of the pedicle screws,” said Dr. St. Clair. “This unique feature enables the tulips to be placed at the perfect height and orientation to accept the rod and correct the deformity.  The slotted reduction towers are used both to reduce the rod into the tulips as well as to perform vertebral column manipulation to correct the spine in three planes of deformity. The reduction towers and transverse links are designed to be attached and removed with ease. The Arsenal AIS system provides strong, reliable implants, and two choices of cobalt chrome rods, enabling the surgeon to obtain excellent spinal deformity correction, which improves quality of life for the patient both now and for the future.”

About Alphatec Spine

Alphatec Spine, Inc., a wholly owned subsidiary of Alphatec Holdings, Inc. (Nasdaq:ATEC), is a medical device company that designs, develops, manufactures 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 and its affiliates market products in the U.S. via a direct sales force and independent distributors.

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 Spine 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 Company’s ability to achieve profitable growth; the Company’s ability to achieve both domestic and international growth and future profitability.  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.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to; the uncertainty of success in developing new products or products currently in Alphatec Spine’s pipeline within forecast timeframes, or at all, including without limitation the products discussed in this press release; the Company’s ability to compete directly with the market leaders in complex spine and open up a new segment for the Company in pediatric procedures; the Company’s ability to gain greater share in the deformity market and to benefit a vast number patients in such market; the acceptance of Alphatec Spine’s products by the surgeon community, including without limitation the products discussed in this press release;  and Alphatec Spine’s ability to develop and expand its U.S. revenues.  Please refer to the risks detailed from time to time in Alphatec Spine’s SEC reports, including its Annual Report Form 10-K, as well as other filings on Form 10-Q and periodic filings on Form 8-K.  Alphatec Spine 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.

CONTACT: Investor/Media Contact:

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

Mazor Robotics to Exhibit New Mazor X™ Surgical Assurance Platform at AANS/CNS Spine Summit Meeting

ORLANDO, FL–(Marketwired – March 01, 2017) – Mazor Robotics (TASE: MZOR) (NASDAQ: MZOR), a pioneer and leader in the field of surgical guidance systems, will demo the new Mazor X system at Spine Summit 2017, the Annual Meeting of the Section on Disorders of the Spine and Peripheral Nerves in Las Vegas, March 8-11.

Visit booth #1110 during exhibit hours or attend the following special presentations to learn more about Mazor X:

Lunch Seminar: Introducing Mazor X™: Mazor Robotics’ Next-Gen System
Moderator: Dr. Michael Steinmetz
Location: Valencia Ballroom
Date: Wednesday, March 8
Time: 12:30 – 1:30 pm

“What’s New” Session: Clinical Experience of Mazor Robotics Guidance Systems and O-Arm® Imaging in Degenerative and Deformity Cases
Faculty: Dr. Jeffrey L. Gum
Location: Demo Theater
Date: Friday, March 10
Time: 9:47 – 9:57 am

The Mazor X system consists of sophisticated 3D planning tools and an intra-op guidance system with a precision Surgical Arm indicated for implant and instrument positioning in spine surgery — the core of the Surgical Assurance Platform.

“Mazor’s core technology has been used in over 23,000 procedures. This unparalleled clinical and operating room experience has provided us with deep insight into what the surgeons want next for themselves and their patients,” said Mazor Robotics CEO Ori Hadomi. “So, we pushed the envelope, moving from a precise mechanical system, to a complete expandable platform that incorporates integrated analytics and state-of-the art guidance.”

“You plan your surgery and there is no heartache anymore,” said Orthopedic Surgeon Kornelis Poelstra, MD, PhD. “You know exactly where the screws are going to go.” Click here to watch full testimonial

Following Spine Summit, Mazor Robotics will also be exhibiting Mazor X at AAOS Annual Meeting in San Diego, March 14-18 (booth #2339).

About Mazor

Mazor Robotics (TASE: MZOR) (NASDAQ: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit MazorRobotics.com.

Image Available: http://www.marketwire.com/library/MwGo/2017/2/28/11G131731/Images/mazor_bot-81c042b0c45195a0b5cfdad64568b31a.jpg

CONTACT INFORMATION