March 08, 2017

March 06, 2017

Corbion reported sales of € 911.3 million in 2016, a decrease of 0.8%. Organic sales growth was -1.2%. EBITDA excluding one-off items grew by 13.2% in 2016. In Q4 2016 sales were € 226.1 million, a decrease of 1.9%. Q4 2016 EBITDA excluding one-off items increased by 6.3%. The company proposes to distribute a regular dividend of € 0.56 per share, an additional cash dividend of € 0.44 per share, and a new share buyback of € 25 million.

“In 2016 we continued to make good progress in executing our strategy and we are well on track to deliver on our 2015-2018 targets. In the past year we have made strategic choices involving our customer and product portfolios. These choices resulted in a significant margin improvement, but at the same time had an adverse, albeit temporary, impact on our top-line growth in the year. For 2017, we are confident top-line growth will return to our guidance range. A notable highlight in the second half of the year was the announcement of the PLA joint venture together with Total, a market leader with technical and marketing expertise and a leading position in polymers,” commented Tjerk de Ruiter, CEO.

Key financial highlights FY 2016

• Net sales organic growth was -1.2%; volume growth was -1.2%
• EBITDA excluding one-off items was € 170.1 million, an organic increase of 13.8%
• EBITDA margin excluding one-off items was 18.7%, up from 16.4%
• “Streamline” contributed € 20 million to EBITDA (2015: € 15 million)
• One-off items at EBITDA level of € -3.2 million in 2016, mostly in connection with the closure of our Kansas powder blending plant, partly offset by the sale of the Breddo-Likwifier activities
• Operating result was € 126.9 million, an organic increase of 17.5%
• Free cash flow was € 72.1 million (2015: € 55.2 million)
• Net debt/EBITDA at year-end was 0.6x (2015: 0.4x)
• Our € 50 million share-buyback program was finalized on 28 October 2016.

 Key figures

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/919ed3c2-7b2b-4d86-94fe-bd6dbbbedfb8

PARSIPPANY, N.J., March 06, 2017 (GLOBE NEWSWIRE) — Pacira Pharmaceuticals, Inc. (Nasdaq:PCRX) today announced that it intends to offer, subject to market and other conditions, $300 million aggregate principal amount of convertible senior notes due 2022 (the “notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”).  Pacira also intends to grant the initial purchasers of the notes a 30-day option to purchase up to an additional $45 million aggregate principal amount of notes.

The terms of the notes, including the interest rate, initial conversion rate and other terms, will be determined by negotiations between Pacira and the initial purchasers of the notes.

Pacira intends to use a portion of the net proceeds to enter into privately negotiated agreements with certain holders of its 3.25% convertible senior notes due 2019 (the “2019 Notes”) to exchange their 2019 Notes for a combination of cash and shares of Pacira common stock. The remaining net proceeds will be used for general corporate purposes, including working capital, research and development expenditures and the license or acquisition of complementary products and/or technologies.

This offering is being made to qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and the shares of Pacira common stock, if any, issuable upon conversion of the notes have not been and will not be registered under the Securities Act or any state securities laws, and, unless so registered, the notes and such shares may not be offered or sold in the United States or to U.S. persons except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall it constitute an offer, or the solicitation of any sale, of any securities in any jurisdiction in which such offer, solicitation or sale is unlawful.

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.

Forward-Looking Statements

Certain of the statements made in this press release, such as those, among others, relating to our expectations regarding the completion of the proposed offering, and other statements containing the words “believes,” “anticipates,” “plans,” “estimates,” “expects,” “intends,” “may” and similar expressions, constitute forward-looking statements.  Actual results or developments may differ materially from those projected or implied in these forward-looking statements.  Factors that may cause such a difference include, without limitation, risks and uncertainties related to whether or not we will be able to raise capital through the proposed offering, the final terms of the proposed offering, market and other conditions, the satisfaction of customary closing conditions related to the proposed offering and the impact of general economic, industry or political conditions in the United States or internationally.  There can be no assurance that we will be able to complete the proposed offering on the anticipated terms, or at all. Additional risks and uncertainties relating to the proposed offering, Pacira and our business are discussed in the “Risk Factors” section 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, except as may be required by law. 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.

Investor Contact:
Susan Mesco
(973) 451-4030
susan.mesco@pacira.com

LEESBURG, Va., March 06, 2017 (GLOBE NEWSWIRE) — K2M Group Holdings, Inc. (Nasdaq:KTWO) (the “Company” or “K2M”), a global leader of complex spine and minimally invasive solutions focused on achieving three-dimensional Total Body Balance^TM, today reported financial results for the fourth quarter and fiscal year ended December 31, 2016.

Fourth Quarter 2016 Financial Summary:

• Total Q4 revenue of $61.8 million, up 14.0% year-over-year. Total Q4 revenue increased 14.9% year-over-year on a constant currency basis.
• Domestic Q4 revenue of $47.7 million, up 21.5% year-over-year, comprised of:
  – U.S. Complex Spine growth of 18.0% year-over-year
  – U.S. Minimally Invasive Surgery (MIS) growth of 37.3% year-over-year
  – U.S. Degenerative growth of 19.3% year-over-year
• International Q4 revenue of $14.1 million, down approximately 5.8% year-over-year, or 2.8% on a constant currency basis.
• Net loss of $12.5 million for the three months ended December 31, 2016, compared to a net loss of $8.5 million in the comparable period last year.
• Adjusted EBITDA loss of $0.8 million for the three months ended December 31, 2016, compared to Adjusted EBITDA of $1.3 million in the comparable period last year.

Fourth Quarter 2016 Highlights:

• On October 6, 2016, the Company announced it had received 510(k) clearance from the FDA to expand its CASCADIA™ Lateral Interbody System featuring Lamellar 3D Titanium Technology™, the Company’s innovative technology that uses 3D printing with the goal of allowing for bony integration throughout the implant. The CASCADIA Lateral Interbody System line extension clearance strengthens K2M’s MIS portfolio and the Company’s leadership in the 3D printing of spinal devices, as evidenced by its having the most comprehensive 3D-printed spinal portfolio available on the market among leading spine companies.
• On October 26, 2016, the Company announced the U.S. launch of its award-winning CASCADIA Interbody Systems, featuring Lamellar 3D Titanium Technology, during the 31st North American Spine Society (NASS) Annual Meeting. K2M presented clinical background on its 3D-printed spinal devices and showcased the Company’s comprehensive CASCADIA product portfolio, which was recognized by Orthopedics This Week with a 2016 Spine Technology Award as one of the best new spine technologies of 2016.

Highlights Subsequent to Quarter-End:

• On February 15, 2017, the Company introduced Balance ACS^TM (or BACS^TM), a comprehensive platform that applies three-dimensional solutions across the entire clinical care continuum to help drive quality outcomes for patients undergoing spinal surgery. BACS provides solutions focused on achieving balance of the spine by addressing each anatomical vertebral segment with a 360-degree approach of the axial, coronal and sagittal planes, emphasizing Total Body Balance as a critical component to surgical success.

“We reported constant currency revenue growth of 14.9% year-over-year in the fourth quarter, driven by U.S. constant currency revenue growth of 21.5% year-over-year,” said President and Chief Executive Officer, Eric Major. “We delivered approximately 17% growth in the U.S. in calendar year 2016 and we believe this strong performance reflects the Company’s success in executing our strategic plan to introduce differentiated spine technologies and expand our global distribution network. Our U.S. growth reflects the clearest indication yet of the increasing adoption of our innovative products by the spine surgeon community. Outside the U.S., we successfully navigated challenging market disruptions with our distributors in Australia and Japan earlier in 2016, and look forward to building on our improving results during 2017 without the expectation of these headwinds.  We continue to anticipate our ability to grow our U.S. revenue in the mid-teens in 2017 with improved profitability.”

Fourth Quarter 2016 Financial Results

Total revenue for fourth quarter 2016 increased $7.6 million, or 14.0%, to $61.8 million, compared to $54.2 million in the fourth quarter of 2015. Total revenue increased 14.9% year-over-year on a constant currency basis. The increase in revenue was primarily driven by greater sales volume from primarily domestic new surgeon users and newer product offerings, offset by decreases in both international direct and distributor revenue compared to last year.

Revenue in the United States increased $8.4 million, or 21.5% year-over-year, to $47.7 million, and international revenue decreased $0.9 million, or 5.8% year-over-year, to $14.1 million. Fourth quarter 2016 international revenue decreased 2.8% year-over-year on a constant currency basis. Foreign currency exchange impacted fourth quarter international revenue by approximately $0.5 million, representing approximately 302 basis points of international growth year-over-year.

The following table represents domestic revenue by procedure category.

By procedure category, U.S. revenue in the Company’s complex spine, MIS and degenerative categories represented 37.6%, 16.9% and 45.5% of U.S. revenue, respectively, for the three months ended December 31, 2016.

Gross profit for fourth quarter of 2016 increased 6.7% to $38.4 million, compared to $35.9 million for fourth quarter 2015.  Gross margin was 62.1% for the fourth quarter of 2016, compared to 66.3% last year.  After adjusting for a medical device tax recovery of $0.7 million in 2015, Gross margin was 62.1% for the fourth quarter of 2016 as compared to 65.0% in the comparable period last year.  Gross profit includes amortization expense on investments in surgical instruments of $3.6 million, or 5.8% of sales, for the three months ended December 31, 2016, compared to $3.2 million, or 5.9% of sales, for the comparable period last year.

Operating expenses for fourth quarter 2016 increased $4.2 million, or 9.7%, to $47.7 million, compared to $43.5 million for fourth quarter 2015. The increase in operating expenses was driven primarily by a $2.5 million increase in general and administrative expenses, a $1.2 million increase in sales and marketing expenses and, to a lesser extent, a $0.5 million increase in research and development expenses compared to the comparable period last year.

Loss from operations for the fourth quarter of 2016 was $9.4 million, compared to a loss from operations of $7.6 million for the comparable period last year. Loss from operations included intangible amortization of $2.6 million for each of the fourth quarters of 2016 and 2015.

Total other expenses for the fourth quarter of 2016 increased $2.3 million to $3.1 million, compared to $0.8 million last year. The increase in other expense, net, was primarily attributable to interest expense incurred on the capital lease obligation related to our headquarters and operations facilities as well as the Convertible Senior Notes issued in August 2016, and an increase of $1.1 million in unrealized losses from foreign currency re-measurement on intercompany payable balances.  Foreign currency losses impacted operating results compared to last year due to changes in the average exchange rates of the U.S. Dollar, Pound Sterling and Euro applied to intercompany balances in both periods.

Net loss for the fourth quarter of 2016 was $12.5 million, or $(0.30) per diluted share, compared to a loss of $8.5 million, or $(0.21) per diluted share, for the fourth quarter of 2015.

Twelve-Months 2016 Financial Results

For the twelve months ended December 31, 2016, total revenue increased $20.6 million, or 9.5%, to $236.6 million, compared to $216.0 million for the twelve months ended December 31, 2015. Total revenue increased 10.2% year-over-year on a constant currency basis. U.S. revenue increased $25.8 million, or 16.6%, to $181.1 million in fiscal year 2016, compared to $155.3 million last year. International revenue decreased $5.1 million, or 8.5%, to $55.6 million in fiscal year 2016, compared to $60.7 million last year. International revenue decreased 6.6% year-over-year on a constant currency basis.

Sales in our complex spine, MIS and degenerative categories represented 39.7%, 15.9% and 44.4% of U.S. revenue, respectively, for the twelve months ended December 31, 2016.

As of December 31, 2016, we had cash and cash equivalents of $45.5 million as compared to $34.6 million as of December 31, 2015. We had working capital of $115.9 million as of December 31, 2016 as compared to $107.4 million as of December 31, 2015. At December 31, 2016, outstanding long-term indebtedness included the carrying value of the Convertible Senior Notes of $36.9 million and the capital lease obligation of $34.9 million. In addition, we had no borrowings outstanding under our credit facility.

2017 Outlook

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

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

Conference Call

Management will host a conference call at 5:00 p.m. Eastern Time on March 6th to discuss the results of the quarter, and to host a question and answer session. Those who would like to participate may dial 888-208-1814 (719-457-2552 for international callers) and provide access code 4389380 approximately 10 minutes prior to the start of the call. A live webcast of the call will also be provided on the investor relations section of the Company’s website at http://Investors.K2M.com/.

For those unable to participate, a replay of the call will be available for two weeks at 888-203-1112 (719-457-0820 for international callers); access code 4389380. The webcast will be archived on the investor relations section of the Company’s website.

About K2M Group Holdings, Inc.

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

Forward-Looking Statements

This press release contains forward-looking statements that reflect current views with respect to, among other things, operations and financial performance.  Forward-looking statements include all statements that are not historical facts such as our statements about our expected financial results and guidance and our expectations for future business prospects, including with respect to our international distribution partners in Australia and Japan.  In some cases, you can identify these forward-looking statements by the use of words such as “outlook,” “guidance,” “believes,” “expects,” “potential,” “continues,” “may,” “will,” “should,” “could,” “seeks,” “predicts,” “intends,” “plans,” “estimates,” “anticipates” or the negative version of these words or other comparable words.  Such forward-looking statements are subject to various risks and uncertainties including, among other things: our ability to achieve or sustain profitability; our ability to successfully demonstrate the merits of our technologies; pricing pressure from our competitors, hospitals and changes in third-party coverage and reimbursement; competition and our ability to develop and commercialize new products; aggregation of hospital purchasing from collaboration and consolidation; hospitals and other healthcare providers may be unable to obtain adequate coverage and reimbursement for procedures performed using our products; the safety and efficacy of our products is not yet supported by long-term clinical data; our dependence on a limited number of third-party suppliers; our ability to maintain and expand our network of direct sales employees, independent sales agencies and international distributors and their level of sales or distribution activity with respect our products; the proliferation of physician-owned distributorships; concentration of sales from a limited number of spinal systems or products that incorporate these technologies; loss of the services of key members of our senior management, consultants or personnel; ability to enhance our product offerings through our research and development efforts; failure to properly manage our anticipated growth; acquisitions of or investments in new or complementary businesses, products or technologies; ability to train surgeons on the safe and appropriate use of our products; requirements to maintain high levels of inventory; impairment of our goodwill or intangible assets; disruptions in our information technology systems; any disruption or delays in operations at our facilities, including our new headquarter facility; or an ability to ship a sufficient number of our products to meet demand; ability to strengthen our brand; fluctuations in insurance cost and availability; extensive governmental regulation; in the United States and foreign jurisdictions; failure to obtain or maintain regulatory approvals and clearances; requirements for new 510(k) clearances, premarket approvals or new or amended CE Certificates of Conformity; medical device reporting regulations in the United States and foreign jurisdictions; voluntary corrective actions by us or our distribution or other business partners or agency enforcement actions; a recall of our products; withdrawal or restrictions on our products or the discovery of serious safety issues with our products; possible enforcement action if we engage in improper marketing or promotion of our products; the misuse or off-label use of our products; delays or failures in any future clinical trials;  the results of clinical trials; procurement and use of allograft bone tissue; environmental laws and regulations; compliance by us or our sales representatives with FDA regulations or fraud and abuse laws; U.S. legislative or regulatory healthcare reforms; medical device tax provisions in the healthcare reform laws; our need to generate significant sales to become profitable; potential fluctuations in sales volumes and our results of operations may fluctuate over the course of the year; uncertainty in our future capital needs; failure to comply with restrictions in our revolving credit facility; continuing worldwide economic instability; our inability to protect our intellectual property rights; our reliance on patent rights that we either license from others or have obtained through assignments; our patent litigation; the outcome of potential claims that we, our employees, our independent sales agencies or our distributors have wrongfully used or disclosed alleged trade secrets or are in breach of non-competition or non-solicitation agreements with our competitors; potential product liability lawsuits; operating risks relating to our international operations; foreign currency fluctuations; our ability to comply with the Foreign Corrupt Practices Act and similar laws associated with our activities outside the United States; possible conflicts of interest with our large shareholders; increased costs and additional regulations and requirements as a result of becoming a public company; our ability to implement and maintain effective internal control over financial reporting in the future; the potential impact of any future acquisitions, mergers, dispositions, joint ventures, investments or other strategic transactions we may make; and other risks and uncertainties, including those described under the section entitled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the SEC, as such factors may be updated from time to time in our periodic filings with the SEC, which are accessible on the SEC’s website at www.sec.gov.  Accordingly, there are or will be important factors that could cause actual outcomes or results to differ materially from those indicated in these statements.  These factors should not be construed as exhaustive and should be read in conjunction with the other cautionary statements that are included in this release and our filings with the SEC.

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

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

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

Use of Non-GAAP Financial Measures

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

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

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

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

Adjusted EBITDA represents net loss plus interest expense, income tax (benefit) expense, depreciation and amortization, stock-based compensation expense, foreign currency transaction loss and a deduction for cash payments made for rent on the capital lease of the Company’s new headquarters and operations facilities, which commenced in October 2016.

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

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

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

The following table presents a reconciliation of net loss to Adjusted EBITDA for our 2017 guidance ($ in thousands):

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

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

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.

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

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)

* 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.