MARIETTA, Ga., Nov. 7, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), a leading developer and marketer of regenerative and therapeutic biologics, today announced that its Board of Directors has unanimously authorized the adoption of a limited duration shareholder rights plan (the “Rights Plan”) following receipt of notification from The Nasdaq Stock Market LLC (“Nasdaq”) indicating that Nasdaq will suspend trading in the Company’s stock effective at the open of business on Thursday, November 8, 2018.

Charles R. Evans, Chairman of the Board, said, “The Rights Plan provides the Board with appropriate time to make informed decisions that are in the best long-term interests of MiMedx and our shareholders. This does not prevent us from considering any offer that is fair and maximizes value for our shareholders.”

The Rights Plan was adopted by the Board following evaluation and consultation with the Company’s advisors, and is similar to plans adopted by numerous publicly traded companies. Given the Company’s current market capitalization, the delisting of the Company’s common stock from Nasdaq and the anticipated substantial and volatile trading activity following Nasdaq’s suspension of trading in the Company’s stock, the Board determined that the Company and its shareholders are particularly vulnerable to a creeping acquisition of actual or de facto control, whereby an investor could acquire a substantial percentage of outstanding shares of MiMedx common stock prior to making any public disclosure regarding its control intent and without paying a control premium.

The Rights Plan is intended to enable all MiMedx shareholders to realize the full potential value of their investment in the Company and to protect the interests of the Company and its shareholders by reducing the likelihood that any person or group gains control of MiMedx through open market accumulation or other tactics without appropriately compensating all shareholders.

Pursuant to the Rights Plan, the Company will issue, by means of a dividend, one preferred share purchase right for each outstanding share of the Company’s common stock to shareholders of record on the close of business on November 19, 2018. Initially, these rights will not be exercisable and will trade with, and be represented by, the shares of the Company’s common stock.

Under the Rights Plan, the rights would become exercisable only if a person, group or persons acting in concert (each, an “acquiring person”) acquires beneficial ownership of 10% or more of MiMedx’s common stock in a transaction not approved by the MiMedx Board. In that situation, each holder of a right (other than the acquiring person, whose rights will become void and will not be exercisable) will have the right, upon payment of the exercise price and in accordance with the terms of the Rights Plan, to purchase additional shares of MiMedx common stock at a 50% discount.

Unless earlier redeemed, terminated or exchanged pursuant to the terms of the Rights Plan, the rights will expire at the close of business on November 6, 2019.  The Board intends to terminate the Rights Plan before that date if the Board determines that there is no longer a threat to shareholder value.

If a shareholder beneficially owns 10% or more of the Company’s outstanding common stock at the time of the announcement of the Rights Plan, then that shareholder’s existing ownership percentage will be grandfathered, although, with certain exceptions, the rights will become exercisable if at any time after the announcement of the Rights Plan such shareholder increases its ownership of the Company’s common stock.

Further details about the Rights Plan will be contained in a Form 8-K to be filed by the Company with the Securities and Exchange Commission.

PJT Partners LP is serving as financial advisor to the Company. Sidley Austin LLP, Simpson Thacher & Bartlett LLP, and Stearns Weaver Miller Weissler Alhadeff & Sitterson, P.A. are serving as legal counsel to MiMedx.

About MiMedx

MiMedx® is a leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. The Company processes the human placental tissue utilizing its proprietary PURION® process methodology, among other processes, to produce allografts by employing aseptic processing techniques in addition to terminal sterilization. MiMedx has supplied over 1.3 million allografts to date. For additional information, please visit www.mimedx.com.

Safe Harbor Statement

This press release includes forward-looking statements including statements regarding the Board’s intention to terminate the Rights Plan in certain circumstances. Forward-looking statements may be identified by words such as “believe,” “expect,” “intend,” “may,” “plan,” “potential,” “will,” “would” and similar expressions and are based on current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and the Company cautions investors against placing undue reliance on such statements.

Actual results may differ materially from those set forth in the forward-looking statements as a result of various factors. There can be no assurance that the Board will terminate the Rights Plan prior to its expiration date. For more detailed information on the risks and uncertainties that may apply to the Company’s business and the ownership of Company common stock, please review the Risk Factors section of the Company’s most recent annual report filed with the SEC. Any forward-looking statements speak only as of the date of this press release, and except as required by law, the Company assumes no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

CARLSBAD, Calif., Nov. 06, 2018 (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 quarter ended September 30, 2018.

Summary Third Quarter 2018 Financial Results and Recent Accomplishments

• Revenue of $35.8 million, an increase of 13% year-over-year
• U.S. revenue of $31.7 million, an increase of 12% year-over-year
  — U.S. Spinal Implants revenue of $15.0 million, a 13% increase year-over-year
  — U.S. Orthobiologics revenue of $16.7 million, a 12% increase year-over-year
• International revenue of $4.1 million, an 18% increase year-over-year
• Raised $54 million of net proceeds in October from an underwritten public offering of 3.7 million shares of common stock
• Initial launch of the Regatta™ Lateral System, a comprehensive, minimally invasive lateral interbody fusion system featuring proprietary NanoMetalene technology
• Transitioned OsteoStrand™ Plus Demineralized Bone Fibers to full commercial launch
• Launched a line extension of our Daytona® Small Stature Pediatric Deformity System to include additional implant options for a 4.5mm rod system

“We are pleased by our third quarter results, which reflect solid revenue growth across our business,” said Keith Valentine, President and Chief Executive Officer. “With our recently strengthened balance sheet, we now have more than $55 million of cash on hand, no debt, and immediate access to additional cash from our long-term credit facility.  We are continuing to invest in the innovation and commercialization of differentiated technologies and the expansion of our global distribution footprint that has been the catalyst for our revenue growth.  We are confident that we are well positioned to continue our growth trajectory as a market share taker and to deliver cost effective procedural solutions to surgeons and hospitals to improve the quality of patient lives.”

Third Quarter 2018 Financial Results
Total revenue for the third quarter of 2018 was $35.8 million, a 13% increase compared to the same period of the prior year. Total U.S. revenue was $31.7 million, a 12% increase compared to the same period of the prior year.

Spinal Implants revenue totaled $17.3 million, a 12% increase compared to the third quarter of 2017, and was driven by growth in recently launched products, led primarily by the Shoreline and Mariner systems. Orthobiologics revenue totaled $18.5 million, a 13% increase compared to the third quarter of 2017, and was driven by growth in recently launched products, led primarily by the OsteoStrand™ Plus product, and higher sales of legacy demineralized bone matrix products.

Gross margin for the third quarter of 2018 was 60.2%, compared to 61.6% for the same period in 2017. The decrease in gross margin was consistent with management’s expectations and was due to higher spinal implant excess and obsolete inventory charges and orthobiologics manufacturing scrap rates and other inefficiencies associated with the production ramp up of recently launched products, which were partially offset by lower raw material costs for orthobiologics products manufactured at the Company’s Irvine, California facility.

Operating expenses for the third quarter of 2018 totaled $31.0 million, compared to $27.3 million for the same period of the prior year. The $3.7 million increase in operating expenses was driven primarily by higher selling and marketing expenses and from the impact of a $1.2 million non-cash gain recorded in the third quarter of 2017 related to a decrease in the fair value of NLT contingent consideration liabilities.

Net loss for the third quarter of 2018 was $9.5 million, compared to a net loss of $7.5 million for the same period of the prior year.

Cash and cash equivalents at September 30, 2018 totaled $11.8 million. The Company borrowed $3.0 million of cash under its credit facility during the third quarter of 2018 and had $7.3 million of outstanding borrowings under its credit facility as of September 30, 2018.  The Company subsequently used a portion of the proceeds raised in its October underwritten public offering of common stock to repay all of the outstanding debt.

2018 Financial Outlook
SeaSpine continues to expect full-year 2018 revenue to be in the range of $141 to $142 million, reflecting growth of 7% to 8% over full-year 2017 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: 9786589.  To listen to the webcast, please visit the Investors section of the SeaSpine website at: www.seaspine.com.

The call will be archived until Friday, November 30, 2018. The audio archive can be accessed by calling (855) 859-2056 in the U.S. or (404) 537-3406 from outside the U.S. The passcode for the audio replay is 9786589.

About SeaSpine
SeaSpine (www.seaspine.com) 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 implants 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 implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete procedural 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: the Company’s ability to continue to invest in innovation and commercialization of differentiated technologies and the expansion of its global distribution footprint; the Company’s ability to continue its growth trajectory and deliver cost-effective procedural solutions; and the Company’s expectations for full-year 2018 revenue.  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 the Company’s existing products and to adopt its newly launched products to support expected levels of demand or pricing; the Company’s ability to continue to invest in medical education and training, product development, and/or sales and marketing initiatives at levels sufficient to drive future revenue growth; the ability of newly launched products to perform as designed and intended and to meet the needs of surgeons and patients, including as a result of the lack of clinical validation of products in limited commercial (or “alpha”) launch; the Company’s ability to attract new, high-quality distributors and potential disruption to the Company’s existing distribution network as new distributors are added; continued pricing pressure, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; the risk of supply shortages and the associated, potentially long-term disruption to product sales, including as a result of the Company’s dependence on PcoMed to supply products incorporating NanoMetalene technology and a limited number of third-party suppliers for other components and raw materials, or otherwise; unexpected expense and delay, including as a result of developing and supporting the launch of new products, the fact that newly launched products may require substantial additional development activities, which could introduce further expense and delay, or as a result of obtaining regulatory clearances; general economic and business conditions in the markets in which the Company does business, both in the U.S. and abroad; and other risks and uncertainties more fully described in the Company’s 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
(415) 937-5402
ir@seaspine.com

CAESAREA, Israel, Nov. 6, 2018 /PRNewswire/ — Mazor Robotics Ltd. (TASE: MZOR) (NASDAQGM: MZOR), a pioneer and a leader in the field of robotic guidance systems, reported financial and operating results for the third quarter and nine months ended September 30, 2018.

As announced on September 20, 2018, the Company entered into a definitive merger agreement under which Medtronic will acquire all outstanding ordinary shares of Mazor for $58.50 per American Depositary Share, or $29.25(108.0 ILS. according to current exchange rate) per ordinary share, in cash, for a total of approximately $1.64 billion. The acquisition is expected to close during Medtronic’s third fiscal quarter ending Jan. 25, 2019, subject to the satisfaction of customary closing conditions including receipt of regulatory clearances and approval by Mazor’s shareholders at the Special General Meeting of Shareholders scheduled for November 19, 2018.

In addition, the U.S. Food and Drug Administration (FDA) notified Mazor on November 2 that the Mazor X Stealth Edition system, which integrates Medtronic’s Stealth navigation with the Mazor X robotic guidance platform, received clearance in the U.S.  The integration of two best-in-class technologies will provide spine surgeons with 3D planning tools, robotic-guided execution, and real-time visualization in the operating room.

THIRD QUARTER 2018 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

Revenue for the three months ended September 30, 2018 was $10.1 million compared to $18.6 million in the year-ago third quarter.  U.S. revenue was $8.8 million compared to $16.8 million in the year-ago third quarter. This decrease is mainly attributed to the lower number of systems sold in the quarter and the lower pricing terms under the distribution agreement with Medtronic, compared to mostly direct sales in the year-ago third quarter.  International revenue was $1.3 million compared to $1.8 million in the year-ago third quarter. Recurring revenue from kit sales, services and other was $6.9 million in the third quarter of 2018, compared to $7.0 million in the year-ago third quarter.

The Company’s gross margin for the three months ended September 30, 2018 was 47.3% compared to 62.3% in the year-ago third quarter.  This decrease is attributed mainly to the pricing terms with Medtronic, following the transition to the global distribution phase of the Medtronic partnership and a result of less systems sold this quarter. Total operating expenses increased to $22.3 million compared to $15.7 million in the year-ago third quarter, mainly due to $10.8 million of costs related to the merger agreement (of which $7.0 million are non-cash expenses). These costs do not include certain costs related to the merger agreement, including costs which are contingent upon closing. This increase in operating expenses is offset by lower selling and marketing expenses, following the transition to the global distribution phase of the Medtronic partnership. Operating loss was $17.5 million compared to an operating loss of $4.1 million the year-ago third quarter. Net loss for the third quarter of 2018 was $16.9 million, or $0.32 per share, compared to a net loss of $3.9 million, or $0.08 per share, for the year-ago third quarter.

Cash used in operating activities was $2.5 million compared to cash used in operating activities of $2.9 million in the year-ago third quarter. As of September 30, 2018, cash, cash equivalents and investments totaled $107.6 million.

THIRD QUARTER 2018 FINANCIAL RESULTS ON NON-GAAP BASIS

The tables below include reconciliation of the Company’s GAAP results to non-GAAP results. The reconciliation relates to non-cash expenses in the amount of $12.6 million with respect to amortization of intangible assets, to share-based payments and to costs related to the merger agreement recorded in the third quarter of 2018. On a non-GAAP basis, the net loss in the third quarter of 2018 was $4.4 million, or $0.08 per share, compared to $1.3 million, or $0.03 per share, for the year-ago third quarter.

NINE MONTHS ENDED SEPTEMBER 30, 2018 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

For the nine months ended September 30, 2018, revenue totaled $38.8 million compared to $45.8 million for the nine months ended September 30, 2017. Gross margin for the nine months ended September 30, 2018 was 54.7% compared with 65.3% in the nine months ended September 30, 2017. This decrease is attributed mainly to the pricing terms with Medtronic following the transition to the global distribution phase of the Medtronic partnership. Total operating expenses were $44.1 million compared to $43.6 million in the year-ago nine-month period, mainly due to lower selling and marketing expenses, following the transition to the global distribution phase of the Medtronic partnership and offset by costs related to the merger agreement.  Operating loss was $22.8 million compared to an operating loss of $13.7 million in the first nine months of 2017.

Net loss for the nine months ended September 30, 2018 was $22.1 million, or $0.42 per share compared to a net loss of $12.9 million, or $0.27 per share, in the first nine months of 2017.

NINE MONTHS ENDED SEPTEMBER 30, 2018 FINANCIAL RESULTS ON NON-GAAP BASIS

On a non-GAAP basis, the net loss for the first nine months of 2018 was $5.4 million, or $0.10 per share, compared to a net loss of $7.6 million, or $0.16 per share, in the first nine months of 2017.

Use of Non-GAAP Measures

In addition to disclosing financial results calculated in accordance with generally accepted accounting principles in conformity with International Financial Reporting Standards (GAAP), this press release contains Non-GAAP financial measures for gross profit, operating expenses, operating profit (loss), net income (loss) and basic and diluted earnings (loss) per share that exclude the effects of non-cash expense of amortization of intangible assets and share-based payments and costs related to the merger agreement. Management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company’s performance that enhances management’s and investors’ ability to evaluate the Company’s net income (loss) and earnings (loss) per share and to compare them to historical net income (loss) and earnings (loss) per share.

The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company’s business internally and therefore decided to make these non-GAAP adjustments available to investors.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: 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 System enables surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding the closing of the Medtronic acquisition of Mazor, statements regarding the benefits of the Mazor X–Stealth Edition system, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on April 30, 2018 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

READ THE REST HERE

BILLERICA, Mass., Oct. 31, 2018 (GLOBE NEWSWIRE) — Conformis, Inc. (NASDAQ:CFMS), a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell patient specific joint replacement implants designed to fit each patient’s unique anatomy, announced today financial results for the third quarter ended September 30, 2018.

Q3 Summary

• Total revenue of $29.0 million, up 57% year-over-year on a reported and constant currency basis, including a royalty settlement of $10.5 million
• Product revenue of $18.3 million, up 1% year-over-year on a reported and constant currency basis
  • U.S. product revenue of $16.3 million, up 5% year-over-year
  • Rest of World product revenue of $2.1 million, down 22% year-over-year on a reported basis and 23% year-over-year on a constant currency basis
• Royalty revenue of $10.7 million, including the royalty settlement of $10.5 million
• Gross margin of 68%, an increase of 2,800 basis points year-over-year, or 50%, an increase of 1,000 basis points year-over-year excluding the $10.5 million royalty settlement

“Our US growth of 5% represents a meaningful step-up in performance year-over-year. However, US sales in the fourth quarter are anticipated to be lower than previously expected, and we are taking steps to improve performance in 2019. We continue to face headwinds in our OUS business due to reimbursement challenges,” said Mark Augusti, President and Chief Executive Officer of Conformis, Inc. “Our continued gross margin expansion gives us increasing confidence that the margin improvements we have shown in previous quarters should be sustainable and we are continuing to focus on achieving operational efficiency.”

Third Quarter 2018 Financial Results

Total revenue for the three-month period ended September 30, 2018 increased $10.6 million to $29.0 million, or 57% year-over-year on a reported and constant currency basis. Total revenue in the third quarter of 2018 and 2017 includes royalty revenue of $10.7 million and $0.2 million, respectively, related to patent license agreements.  The increase in royalty revenue in the third quarter of 2018 compared to the same quarter in the prior year is primarily due to the royalty settlement of $10.5 million due from Smith & Nephew.

Product revenue increased $0.2 million to $18.3 million, or 1% year-over-year on a reported and constant currency basis. U.S. product revenue increased $0.8 million to $16.3 million, or 5% year-over-year, and Rest of World product revenue decreased $0.6 million to $2.1 million, or 22% year-over-year on a reported basis and 23% on a constant currency basis.  Product revenue from sales of iTotal PS increased $0.8 million to $6.1 million or 15% year-over-year on a reported and constant currency basis.  Product revenue from sales of iTotal CR, iDuo and iUni decreased $0.9 million to $12.0 million, or 7% year-over-year on a reported and constant currency basis.  The decrease in product revenue was primarily in attributable to reimbursement challenges in Germany. Conformis hip system sales in the third quarter of 2018 was $0.2 million in the U.S.

Total gross profit increased $12.4 million to $19.7 million, or 68% of revenue, in the third quarter of 2018, compared to $7.3 million, or 40% of revenue, in the third quarter of 2017. This 2,800 basis point increase in gross margin year-over-year was driven primarily by the $10.5 million royalty settlement, which contributed 1,800 basis points of the increase, and by cost reductions as a result of vertical integration and manufacturing efficiencies.

Total operating expenses increased $6.0 million to $26.2 million, or 30% year-over-year. This increase in expenses was driven primarily by an increase in general and administrative expense due to the non-cash write-off of $1.9 million of unused manufacturing equipment and a non-cash write-off of $6.7 million related to impairment of goodwill due to the Company’s market capitalization and cash flow position. These expenses were partially offset by $2.8 million of reductions in patent litigation expense, business insurance expense, personnel costs and other administrative expenses.

Net loss was $7.4 million, or $0.12 per basic share, in the third quarter of 2018, compared to a net loss of $12.5 million, or $0.29 per basic share, for the same period last year. Net loss in the third quarter of 2018 included foreign currency exchange expense of $272,000 compared to foreign currency exchange income of $1.1 million in the same period last year.  Net loss per basic share calculations assume weighted average basic shares outstanding of 60.2 million for the third quarter of 2018, compared to 43.5 million for the same period last year.

As of September 30, 2018, cash and cash equivalents and investments totaled $36.9 million, which does not include the $10.5 million royalty settlement payment received in October, compared to $45.2 million as of December 31, 2017.

2018 Financial Guidance

For the full year 2018, the Company expects total revenue in a range of $88.6 million to $89.1 million. Excluding the $10.5 million royalty settlement, the Company expects total revenue in a range of $78.1 million to $78.6 million. This is updated from previous guidance in a range of $79.6 million to $83.6 million.  The Company’s 2018 revenue guidance assumes the following:

• Product revenue in a range of $77.5 million to $78.0 million, representing year-over-year increase of 1% on a reported basis and flat on a constant currency basis.  This is updated from previous guidance in a range of $79.0 million to $83.0 million, representing year-over-year growth of 2% to 8% on a reported basis and 2% to 7% on a constant currency basis.
• Royalty revenue of approximately $11.1 million, including the $10.5 million royalty settlement. This is updated from previous guidance of approximately $0.6 million related to ongoing patent license royalty payments.
• Excluding the $10.5 million royalty settlement, we believe we will finish the year ahead of our total gross margin guidance of 44 to 46% and well ahead of our 2017 gross margin of 37%.

Note on Non-GAAP Financial Measures

In addition to disclosing financial measures prepared in accordance with U.S. generally accepted accounting principles (GAAP), the Company provides certain information regarding the Company’s financial results or projected financial results on a non-GAAP “constant currency basis.” This information estimates the impact of changes in foreign currency rates on the translation of the Company’s current or projected future period financial results as compared to the applicable comparable period. This impact is derived by taking the adjusted current or projected local currency results and translating them into U.S. dollars based upon the foreign currency exchange rates for the applicable comparable period. It does not include any other effect of changes in foreign currency rates on the Company’s results or business. Non-GAAP information is not a substitute for, and is not superior to, information presented on a GAAP basis.

Conference Call

As previously announced, Conformis will conduct a webcast today at 4:30 PM Eastern Time. Management will discuss financial results and strategic matters. The webcast will be live at https://edge.media-server.com/m6/p/7axt74hp and at the investor relations section of the company’s website at ir.conformis.com.

The online archive of the webcast will be available on the company’s website for 30 days.

About Conformis, Inc.

Conformis is a medical technology company that uses its proprietary iFit Image-to-Implant technology platform to develop, manufacture and sell joint replacement implants that are individually sized and shaped, or customized, to fit each patient’s unique anatomy. Conformis offers a broad line of customized knee and hip implants and customized pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, Conformis iTotal CR knee replacement system demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants.  Conformis owns or exclusively in-licenses issued patents and pending patent applications that cover customized implants and customized patient-specific instrumentation for all major joints.

For more information, visit www.conformis.com. To receive future releases in e-mail alerts, sign up at http://ir.conformis.com/.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release about our future expectations, plans and prospects, including statements about the anticipated timing of our product launches, and our financial position and results, total revenue, product revenue, gross margin, operations, as well as other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” or “would” and similar expressions, constitute forward-looking statements within the meaning of the safe harbor provisions of The Private Securities Litigation Reform Act of 1995. We may not actually achieve the forecasts disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual financial results could differ materially from the projections disclosed in the forward-looking statements we make as a result of a variety of risks and uncertainties, including whether our cash resources will be sufficient to fund our continuing operations for the periods anticipated; risks related to our estimates and expectations regarding our revenue, gross margin, expenses, revenue growth and other results of operations; and the other risks and uncertainties described in the “Risk Factors” sections of our public filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent our views as of the date hereof. We anticipate that subsequent events and developments may 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 hereof.

CONTACT:
Investor contact
Oksana Bradley
ir@conformis.com
(781) 374-5598

November 01, 2018

WARSAW, Ind., Oct. 31, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ: KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, today announced financial results for the third quarter ended September 30, 2018 and increased revenue guidance for full year 2018.

Third Quarter & Recent Highlights

• Increased total revenue to $15.8 million for third quarter 2018, up 27.8% from $12.4 million in third quarter 2017
• Deployed $2.3 million of consignment sets during the third quarter 2018
• Converted Canada to sales agency model
• Fully launched Pediatric Nailing Platform | FEMUR and announced expanded indications for FIREFLY® Pedicle Screw Navigation Guides, patient-specific, 3D printed guides, in July
• Received FDA 510(k) clearance for 26th surgical system, RESPONSE 4.5/5.0mm System, to treat smaller stature, younger patients with complex scoliosis in October
• Increased revenue growth guidance to a range of 25.0% to 25.5% and investment in consignment sets to $12.0 million for full year 2018

Mark Throdahl, Chief Executive Officer of OrthoPediatrics, stated, “Our strong performance represents another consecutive quarter of record revenues, driven by continued strength across all segments of our business. In the third quarter, we further consolidated our leading position in pediatric orthopedics with particularly strong domestic sales, led by our U.S. scoliosis business and reflecting the initial benefits from increased investment in consigned sets. With the additional $2.3 million of set deployment during the quarter, we continue to address the robust demand for our surgical systems. Furthermore, our demonstrated ability to develop a consistent cadence of innovative products provides further expansion opportunities. We are very pleased with our steady execution that led to another quarter of outperformance and supports our increased guidance for the full year.”

Third Quarter 2018 Financial Results

Total revenue for the third quarter 2018 was $15.8 million, representing 27.8% growth, compared to total revenue of $12.4 million for the third quarter 2017. U.S. revenue for the third quarter of 2018 increased 30.0% to $12.4 million, compared to $9.6 million for the same period last year, and represented 78.5% of total revenue. International revenue increased 20.6% to $3.4 million, compared to $2.8 million for the same period last year and represented 21.5% of total revenue.

Trauma and Deformity revenue for third quarter 2018 increased 21.0% to $10.6 million compared to $8.7 million for the same period last year. Scoliosis revenue increased 52.4% to $5.0 million compared to $3.3 million for the third quarter 2017. Sports Medicine/Other revenue for the third quarter of 2018 decreased 33.2% to $0.2 million compared to $0.3 million for the same period last year.

Gross profit for the third quarter of 2018 was $12.0 million, a 26.2% increase compared to $9.5 million for the same period last year. Gross profit margin for the third quarter of 2018 was 75.7%, compared to 76.7% for the same period last year due to lower international margins.

Total operating expenses for the third quarter of 2018 were $13.1 million, a 28.3% increase compared to $10.2 million for the same period last year. The increase in operating expenses was driven by a 26.9% increase in sales and marketing, including higher commissions, and unusually higher, non-recurring professional fees associated with legal expense. Operating loss for the quarter increased to ($1.2) million from ($0.8) million for the same period last year.

Net interest expense for the third quarter of 2018 was $0.6 million, a 20.1% decrease compared to $0.8 million for the same period last year.

Net loss attributable to common stock holders for the period was ($1.9) million, compared to ($3.0) million for the third quarter of 2017. Net loss per share attributable to common stockholders for the third quarter of 2018 was ($0.15) per basic and diluted share compared to ($1.70) per basic and diluted share for the same period prior year.

Adjusted EBITDA for the third quarter of 2018 was $1.0 million as compared to $0.3 million for the third quarter of 2017. The change was primarily driven by the significant increase in revenue. See below for additional information and a reconciliation of non-GAAP financial information.

The weighted average number of diluted shares outstanding as of September 30, 2018 was 12,624,858 shares.

In the third quarter of 2018, our independent sales agencies in the United States employed 86 full-time equivalent sales representatives specifically focused on pediatrics.

Purchases of property and equipment during the third quarter of 2018 were essentially flat at $1.1 million when compared to the same period last year, reflecting the deployment of consigned sets that included procedure specific implants, instruments, and cases and trays. Including the implants, $2.3 million of consigned sets were deployed during the third quarter of 2018. This compared to $2.2 million during the third quarter of 2017 most of which were international set sales due to the conversion to an agency model from a stocking distributor in select markets.

As of September 30, 2018, cash and cash equivalents were $24.5 million, compared to $26.5 million as of June 30, 2018, and the Company had approximately $25.4 million in total outstanding indebtedness, including $3.9 million outstanding under the revolving credit facility.

Full Year 2018 Financial Guidance

OrthoPediatrics is updating financial guidance for the full year 2018, as follows:

• Revenue growth in a range of 25.0% to 25.5%, up from prior guidance of 23% to 24%.
• Consigned set investments of approximately $12.0 million, up from prior guidance of $11.0 million.

Conference Call

OrthoPediatrics will host a conference call on Thursday, November 1, 2018, at 8:00 a.m. ET to discuss the results. The dial-in numbers are (855) 289-4603 for domestic callers and (614) 999-9389 for international callers. The conference ID number is 6099725. A live webcast of the conference call will be available online from the investor relations page of the OrthoPediatrics’ corporate website at www.orthopediatrics.com.

A replay of the webcast will remain available on OrthoPediatrics’ website, www.orthopediatrics.com, until the Company releases its full year 2018 financial results. In addition, a telephonic replay of the call will be available until November 8, 2018. The replay dial-in numbers are (855) 859-2046 for domestic callers and (404) 537-3406 for international callers. Please use the replay conference ID number 6099725.

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 15, 2018. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

Use of Non-GAAP Financial Measures

This press release includes the non-GAAP financial measure of Adjusted EBITDA, which differs from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). Adjusted EBITDA in this release represents net loss, plus interest expense (income), net plus other expense (income), depreciation and amortization, stock-based compensation expense, accelerated vesting of restricted stock upon our IPO, public company costs and initial public offering costs. Adjusted EBITDA is presented because the Company believes it is a useful indicator of its operating performance. Management uses the metric as a measure of the Company’s operating performance and for planning purposes, including financial projections. The Company believes this measure is useful to investors as supplemental information because it is frequently used by analysts, investors and other interested parties to evaluate companies in its industry. The Company believes Adjusted EBITDA is useful to its management and investors as a measure of comparative operating performance from period to period. Adjusted EBITDA is a non-GAAP financial measure and should not be considered as an alternative to, or superior to, net income or 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 to imply that the Company’s future results will be unaffected by unusual or non-recurring items. In addition, the measure 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 debt service requirements, capital expenditures and other cash costs that may recur in the future. Adjusted EBITDA contains certain other limitations, including the failure to reflect our cash expenditures, cash requirements for working capital needs and other potential cash requirements. In evaluating Adjusted EBITDA, you should be aware that in the future the Company may incur expenses that are the same or similar to some of the adjustments in this presentation. The Company’s presentation of Adjusted EBITDA should not be construed to imply that its future results will be unaffected by any such adjustments. Management compensates for these limitations by primarily relying on the Company’s GAAP results in addition to using Adjusted EBITDA on a supplemental basis. The Company’s definition of this measure is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation. The schedules below contain a reconciliation of Net Loss to non-GAAP Adjusted EBITDA.

About OrthoPediatrics Corp.

Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

PLAINSBORO, N.J., Oct. 31, 2018 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, today reported financial results for the third quarter ending September 30, 2018.

Third Quarter 2018 Consolidated Results

• Reported revenue was $365.9 million, an increase of 31.2% compared to the third quarter of 2017 with the acquisition of Codman contributing $78.9 million, and organic revenues increased 6.2% over the third quarter of 2017;
• GAAP earnings per share was $0.15, compared to $0.04 in the third quarter of 2017;
• Adjusted earnings per share was $0.59, reflecting an increase of 31.1% compared to the third quarter of 2017;
• The company is revising its full-year 2018 guidance as follows:
  • Total revenue is now expected to be a range of $1.467 billion to $1.472 billion (previously $1.475 billion to $1.490 billion);
    • Guidance range reflects lower forecasted revenue from extremities orthopedics, Codman revenue in select countries outside the U.S. where commercial operations have not yet transferred to Integra (“Day 2 Countries”), and a lower foreign currency benefit;
  • Organic revenue growth guidance is now expected to be approximately 4% (previously approximately 5%);
• The company is reiterating its full-year 2018 GAAP earnings per share of $0.71 to $0.77 and adjusted earnings per share of $2.36 to $2.42.

Total revenues for the third quarter of 2018 were $365.9 million, reflecting an increase of 31.2% over the third quarter of 2017. Sales in the Codman Specialty Surgical segment increased 45.1% compared to the third quarter of 2017, driven by the Codman acquisition and strong performance in the Dural Access and Repair, Advanced Energy, and Neuro Monitoring businesses.  Sales in the Orthopedics and Tissue Technologies segment increased 11.2%, reflecting continued strength in our Regenerative Technologies and Private Label businesses.

Total organic revenues increased 6.2% over the third quarter of 2017, excluding acquisitions, divestitures and the effect of currency exchange rates.

“Despite some revenue softness in the second half of the year, we continue to make solid progress with the Codman integration and the channel expansion efforts, particularly in Regenerative Technologies,” said Peter Arduini, Integra’s president and chief executive officer.  “We remain confident that 2019 organic sales will grow within our targeted long-term range of 5% to 7% and accelerate from our full-year 2018 results.”

The company reported GAAP net income of $13.3 million, or $0.15 per diluted share, for the third quarter of 2018, compared to GAAP net income of $3.2 million, or $0.04 per diluted share, in the third quarter of 2017. The increase in GAAP net income is a result of higher revenues, better operating expense leverage and a lower tax rate.

The adjusted measures discussed below are computed with the adjustments to GAAP reporting that are set forth in the attached reconciliation.

Adjusted EBITDA for the third quarter of 2018 was $84.3 million, or 23.0% of revenue, compared to $63.0 million, or 22.6% of revenue, in the third quarter of 2017. The margin improvement was largely based on better operating expense leverage, mostly from selling, general and administrative costs.

Adjusted net income for the third quarter of 2018 was $50.6 million, an increase of 40.2% from the prior year’s third quarter. Adjusted earnings per share for the third quarter of 2018 was $0.59, an increase of 31.1% over the prior year’s quarter.

2018 Full-Year Outlook

The company is revising its full-year 2018 total revenue guidance to a new range of $1.467 billion to $1.472 billion.  This includes an expectation for organic growth of approximately 4% for the full year 2018 versus the previous guidance of approximately 5%.

The company is reiterating its full-year 2018 GAAP earnings per share guidance range of $0.71 to $0.77, and adjusted earnings per share guidance range of $2.36 to $2.42.

In the future, the company may record, or expects to record, certain additional revenues, gains, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 AM ET today, Wednesday, October 31, 2018, to discuss financial results for the third quarter and forward-looking financial guidance. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the call.

Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.

Access to the live call is available by dialing (334) 323-0522 and using the passcode 3216000. The call can also be accessed via a webcast link provided on investor.integralife.com.  A replay of the call will be available through November 5, 2018 by dialing (719) 457-0820 and using the passcode 3216000. The webcast will also be archived on the website.

About Integra

Integra LifeSciences is a global leader in regenerative technologies, neurosurgical and extremity orthopedic solutions dedicated to limiting uncertainty for clinicians, so they can focus on providing the best patient care. Integra offers a comprehensive portfolio of high quality, leadership brands that include AmnioExcel®, Bactiseal®, Cadence®, Certas™, Codman®, CUSA®, DuraGen®, DuraSeal®, ICP Express®, Integra®, MediHoney®, MicroFrance®, PriMatrix®, Salto Talaris®, SurgiMend®, TCC-EZ®, Titan™ and VersaTru™.  For the latest news and information about Integra and its brands, please visit www.integralife.com.

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties, and reflect the Company’s judgment as of the date of this release.  All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements. Some of these forward-looking statements may contain words like “will,” “believe,” “may,” “could,” “would,” “might,” “possible,” “should,” “expect,” “intend,” “plan,” “anticipate,” or “continue,” the negative of these words, other terms of similar meaning or they may use future dates. Forward-looking statements contained in this news release include, but are not limited to, statements concerning future financial performance, including projections for revenues, expected revenue growth (both reported and organic), GAAP and adjusted net income, GAAP and adjusted earnings per diluted share, non-GAAP adjustments such as global enterprise resource planning (“ERP”) system implementation charges, acquisition-related charges, litigation charges, goodwill impairment charges, non-cash amortization of imputed interest for convertible debt, intangible asset amortization, and income tax expense (benefit) related to non-GAAP adjustments.  It is important to note that the Company’s goals and expectations are not predictions of actual performance.  Such forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from predicted or expected results. Such risks and uncertainties include, but are not limited, to the following: the Company’s ability to execute its operating plan effectively; the Company’s ability to achieve sales growth in a timely fashion and successfully complete its channel expansion in its Orthopedics and Tissue Technologies segment; the Company’s ability to successfully integrate the Codman Neurosurgery business and other acquired businesses, including the realignment of acquired global sales territories; the Company’s ability to manufacture and ship sufficient quantities of its products to meet its customers’ demands; the ability of third-party suppliers to supply us with raw materials and finished products; global macroeconomic and political conditions; the Company’s ability to manage its direct sales channels effectively; the sales performance of third-party distributors on whom the Company relies to generate revenue for certain products and geographic regions; the Company’s ability to maintain relationships with customers of acquired entities and businesses; physicians’ willingness to adopt and third-party payors’ willingness to provide or maintain reimbursement for the Company’s recently launched, planned and existing products; initiatives launched by the Company’s competitors; downward pricing pressures from customers; the Company’s ability to secure regulatory approval for products in development; the Company’s ability to remediate quality systems violations; fluctuations in hospitals’ spending for capital equipment; the Company’s ability to comply with and obtain approvals for products of human origin and comply with regulations regarding products containing materials derived from animal sources; difficulties in controlling expenses, including costs to procure and manufacture our products; the impact of changes in management or staff levels; the impact of goodwill and intangible asset impairment charges if future operating results of acquired businesses are significantly less than the results anticipated at the time of the acquisitions, the Company’s ability to leverage its existing selling organizations and administrative infrastructure; the Company’s ability to increase product sales and gross margins, and control non-product costs; the Company’s ability to achieve anticipated growth rates, margins and scale and execute its strategy generally; the amount and timing of acquisition and integration-related costs; the geographic distribution of where the Company generates its taxable income; the effect of legislation effecting healthcare reform in the United States and internationally; fluctuations in foreign currency exchange rates; the amount of our bank borrowings outstanding and other factors influencing liquidity; and the economic, competitive, governmental, technological, and other risk factors and uncertainties identified under the heading “Risk Factors” included in Item 1A of Integra’s Annual Report on Form 10-K for the year ended December 31, 2017 and information contained in subsequent filings with the Securities and Exchange Commission, including in Item 1A of Integra’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2018.

These forward-looking statements are made only as of the date hereof, and the Company undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events, or otherwise.

Discussion of Adjusted Financial Measures

In addition to our GAAP results, we provide organic revenues, adjusted earnings before interest, taxes, depreciation and amortization (“EBITDA”), adjusted net income, adjusted earnings per diluted share, free cash flow and adjusted free cash flow conversion.  Organic revenues consist of total revenues excluding the effects of currency exchange rates, acquired revenues and product discontinuances.  Adjusted EBITDA consists of GAAP net income excluding: (i) depreciation and amortization; (ii) other income (expense); (iii) interest income and expense; (iv) income tax expense (benefit); and (v) those operating expenses also excluded from adjusted net income.  The measure of adjusted net income consists of GAAP net income, excluding: (i) hurricane related expenses; (ii) structural optimization charges; (iii) acquisition- and integration-related charges; (iv) litigation charges; (v) intangible asset amortization expense; (vi) discontinued product lines charges; (vii) income tax impact from adjustments; and (viii) impairment charges.  The adjusted earnings per diluted share measure is calculated by dividing adjusted net income attributable to diluted shares by diluted weighted average shares outstanding.  The measure of free cash flow consists of GAAP net cash provided by operating activities from less purchases of property and equipment.  The adjusted free cash flow conversion measure is calculated by dividing free cash flow by adjusted net income.

Reconciliations of GAAP revenues to adjusted revenues and GAAP Adjusted Net Income to adjusted EBITDA, and adjusted net income, and GAAP earnings per diluted share to adjusted earnings per diluted share all for the quarters ended September 30, 2018 and 2017, and the free cash flow and free cash flow conversion for the quarters ended September 30, 2018 and 2017, appear in the financial tables in this release.

The Company believes that the presentation of organic revenues and the other non-GAAP measures provide important supplemental information to management and investors regarding financial and business trends relating to the Company’s financial condition and results of operations.  For further information regarding why Integra believes that these non-GAAP financial measures provide useful information to investors, the specific manner in which management uses these measures, and some of the limitations associated with the use of these measures, please refer to the Company’s Current Report on Form 8-K regarding this earnings press release filed today with the Securities and Exchange Commission.  This Current Report on Form 8-K is available on the SEC’s website at www.sec.gov or on our website at www.integralife.com.

INTEGRA LIFESCIENCES HOLDINGS CORPORATION

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(UNAUDITED)

(In thousands, except per share amounts)

Segment revenues and growth in total revenues excluding the effects of currency exchange rates, acquisitions, and discontinued products are as follows:

(In thousands)

(1) Acquisitions include Codman Neurosurgery
(2) Organic Revenues have been adjusted to reflect revenues under the TMA to Natus in the current year and restated for prior year 2017 to account for divestitures to Natus related to the Codman acquisition.

Items included in GAAP net income and location where each item is recorded are as follows:

(In thousands)

Three Months Ended September 30, 2018

Three Months Ended September 30, 2017

(In thousands)

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Kalamazoo, Michigan – October 25, 2018 – Stryker (NYSE:SYK) reported operating results for the third quarter of 2018:

Third Quarter Highlights

“We had another impressive quarter, as our talented teams continue to deliver strong results and execute on acquisitions,” said Kevin A. Lobo, Chairman and Chief Executive Officer. “The strength of our operating model and culture is evident in the consistency of our performance over time, and we remain optimistic about the future.”

Sales Analysis (percentages exclude ASC 606⁽²⁾ adoption impact)

Consolidated net sales of $3.2 billion increased 8.8% in the quarter and 9.8% in constant currency. Organic net sales increased 7.9% in the quarter including 9.5% from increased unit volume partially offset by 1.6% from lower prices.

Orthopaedics net sales of $1.2 billion increased 4.0% in the quarter and 5.0% in constant currency. Organic net sales increased 5.0% in the quarter including 7.6% from increased unit volume partially offset by 2.6% from lower prices.

MedSurg net sales of $1.4 billion increased 9.5% in the quarter and 10.4% in constant currency. Organic net sales increased 8.8% in the quarter including 9.5% from increased unit volume partially offset by 0.7% from lower prices.

Neurotechnology and Spine net sales of $0.6 billion increased 17.4% in the quarter and 18.3% in constant currency. Organic net sales increased 11.9% in the quarter including 13.5% from increased unit volume partially offset by 1.6% from lower prices.

Earnings Analysis

Reported net earnings of $590 million increased 35.9% in the quarter. Reported net earnings per diluted share of $1.55 increased 36.0% in the quarter. Reported net earnings include certain items, such as charges for acquisition and integration-related activities, the amortization of purchased intangible assets, restructuring-related and other charges, costs to comply with European Medical Devices Regulation, Rejuvenate and other recall-related matters, regulatory and legal matters and tax matters. The effect of each of these matters on reported net earnings and net earnings per diluted share appear in the reconciliation of GAAP to non-GAAP financial measures. Excluding the aforementioned items decreases gross profit margin from 66.5% to 66.3% in the quarter and increases operating income margin from 17.8% to 24.9%⁽¹⁾, including a 20 basis point favorable impact related to the adoption of the new revenue recognition standard⁽²⁾. Excluding the impact of the items described above, adjusted net earnings⁽⁴⁾ of $643 million increased 11.2% in the quarter. Adjusted net earnings per diluted share⁽³⁾ of $1.69 increased 11.2% in the quarter.

2018 Outlook

Based on our year-to-date performance we now expect 2018 organic net sales growth, which excludes the impact related to adoption of the new revenue recognition standard⁽²⁾, to be at the high end of the range of 7.0% to 7.5% and expect adjusted net earnings per diluted share⁽⁵⁾ to be in the range of $7.25to $7.30. In 2018 our calculation of organic net sales growth excludes the impact of adopting ASC 606⁽²⁾, which includes primarily the reclassification of costs previously reported within selling expenses to a reduction of sales, which for 2017 was approximately $112 million ($28 million per quarter). For the fourth quarter we expect adjusted net earnings per diluted share⁽⁵⁾ to be in the range of $2.13 to $2.18. If foreign currency exchange rates hold near current levels, we expect net sales in the fourth quarter will be negatively impacted by approximately 1.0% and full year will be positively impacted by approximately 0.5%, and net earnings per diluted share will be neutral in the fourth quarter and positively impacted by $0.05 in the full year.

(1) A reconciliation of operating income to adjusted operating income, a non-GAAP financial measure, and other important information accompanies this press release.

(2) Consistent with previous press releases and financial disclosures, we adopted Accounting Standards Update 2014-09, Revenue From Contracts with Customers, as well as related amendments (ASC 606), issued by the Financial Accounting Standards Board on a modified retrospective basis, effective January 1, 2018. The impact of the adoption of ASC 606 related primarily to the reclassification of certain costs previously presented as selling, general and administrative expenses to net sales.

(3) A reconciliation of reported net earnings per diluted share to adjusted net earnings per diluted share, a non-GAAP financial measure, and other important information accompanies this press release.

(4) A reconciliation of reported net earnings to adjusted net earnings, a non-GAAP financial measure, and other important information accompanies this press release.

(5) We are unable to present a quantitative reconciliation of our expected net earnings per diluted share to expected adjusted net earnings per diluted share as we are unable to predict with reasonable certainty and without unreasonable effort the impact and timing of restructuring-related and other charges, acquisition-related expenses and fair value adjustments to inventory and the outcome of certain regulatory, legal and tax matters. The financial impact of these items is uncertain and is dependent on various factors, including timing, and could be material to Stryker’s Consolidated Statements of Earnings.

Conference Call on Thursday, October 25, 2018

As previously announced, Stryker will host a conference call on Thursday, October 25, 2018 at 4:30 p.m., Eastern Time, to discuss the Company’s operating results for the quarter ended September 30, 2018 and provide an operational update.

To participate in the conference call dial (844) 826-0610 (domestic) or (973) 453-3249 (international) and be prepared to provide conference ID number 9086309 to the operator.

A simultaneous webcast of the call will be accessible via the Company’s website at www.stryker.com. The webcast will be archived on the Investor Relations page of this site.

A recording of the call will also be available from 8:00 p.m., Eastern Time, on Thursday, October 25, 2018, until 11:59 p.m., Eastern Time, on Thursday, November 1, 2018. To hear this recording, you may dial (855) 859-2056 (domestic) or (404) 537-3406 (international) and enter conference ID number 9086309.

Forward-Looking Statements

This press release contains information that includes or is based on forward-looking statements within the meaning of the federal securities laws that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: weakening of economic conditions that could adversely affect the level of demand for our products; pricing pressures, including cost-containment measures that could adversely affect the price of or demand for our products; changes in foreign exchange markets; legislative and regulatory actions; the failure to satisfy any of the closing conditions of the K2M Group Holdings, Inc. merger agreement, including the receipt of any required regulatory approvals or approval by K2M’s stockholders of the merger; unexpected charges or expenses in connection with the acquisition of K2M; unanticipated issues arising in connection with clinical studies and otherwise that affect U.S. Food and Drug Administration approval of new products; potential supply disruptions; changes in reimbursement levels from third-party payors; a significant increase in product liability claims; the ultimate total cost with respect to the Rejuvenate and ABG II matter; the impact of investigative and legal proceedings and compliance risks; resolution of tax audits; the impact of the federal legislation to reform the United States healthcare system; costs to comply with the European Medical Devices regulation; changes in financial markets; changes in the competitive environment; our ability to integrate acquisitions, including the acquisition of K2M; and our ability to realize anticipated cost savings. Additional information concerning these and other factors is contained in our filings with the U.S. Securities and Exchange Commission, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q.

Stryker is one of the world’s leading medical technology companies and, together with its customers, is driven to make healthcare better. The Company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes. More information is available at www.stryker.com.

For investor inquiries please contact:

Katherine A. Owen, Stryker, 269-385-2600 or katherine.owen@stryker.com

For media inquiries please contact:

Yin Becker, Stryker, 269-385-2600 or yin.becker@stryker.com