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Current Issues in Spine

February 2-4, 2017

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August 2, 2017 OrthoSpineNews

SAN JOSE, Calif.Aug. 2, 2017 /PRNewswire/ — SI-BONE, Inc., an innovative medical device company that pioneered the use of the iFuse Implant System® (“iFuse”), a triangular shaped minimally invasive surgical (MIS) device indicated for fusion for certain disorders of the sacroiliac (SI) joint, announced that Health Care Service Corporation (HCSC) and its divisions of Blue Cross and Blue Shield® (BCBS) in IllinoisMontanaNew MexicoOklahoma, and Texas have updated their coverage policy for MIS SI joint fusion and maintained their exclusive positive coverage for the iFuse Implant System.  The updated policy, which took effect July 15th, 2017, includes additional iFuse Implant System clinical publications and can be found at the link below.

 http://www.medicalpolicy.hcsc.net/medicalpolicy/activePolicyPage?lid=j4cm155u&corpEntCd=IL1

The policy specifically states that “use of minimally invasive or percutaneous SIJ fusion products other than titanium triangular implants/devices (e.g., iFuse Implant System) is considered experimental, investigational and/or unproven.”  In other words, only the iFuse Implant System is considered a proven MIS SI joint fusion procedure and is covered by the policy.

Blue Cross and Blue Shield® (BCBS) plans of IllinoisMontanaNew MexicoOklahoma and Texas, under the umbrella of HCSC, is the largest customer-owned health insurer in the United States and the fourth largest commercial health insurer overall, covering approximately 15 million lives. The iFuse exclusive positive coverage policy, which originally became effective January 1, 2017, is based on the large body of published clinical evidence supporting the use of the patented triangular titanium iFuse ImplantsTM for SI joint fusion.  The policy has been further strengthened with additional iFuse Implant publications demonstrating the safety and effectiveness of the iFuse ProcedureTM.  The BCBS plans in IllinoisMontanaNew MexicoOklahoma and Texas join SelectHealth in Utah and Geisinger in Pennsylvania as a growing number of commercial health plans to offer exclusive positive coverage for the iFuse Implant System.

Ralph Rashbaum, MD of the Texas Back Institute in Plano, TX commented: “this exclusive coverage policy update by the five Blue Cross and Blue Shield plans in IllinoisOklahomaNew MexicoMontana and my home state of Texas further validates the strength of the clinical evidence supporting the iFuse Implant System as the only minimally invasive SI joint fusion device with appropriate and sufficient data to support coverage.”

About SI Joint Dysfunction
The SI joint has been attributed as a source of pain in 15-30 percent of patients with chronic low back pain1-4, and in up to 43 percent of patients with new onset or persistent low back pain after lumbar fusion.5  Patients with SI joint dysfunction may feel pain in the lower back, buttocks and/or legs. This can be especially true while transitioning from sitting to standing, stepping up or down, bending and lifting, walking, sleeping or even just sitting on the affected side.

SI joint dysfunction is often misdiagnosed or the pain misattributed to other causes, as not all healthcare providers evaluate the SI joint, and most patients do not ask about it.  While not commonly diagnosed, SI joint disorders can be identified through a series of simple tests that include when a patient identifies their pain by pointing directly to the PSIS (the bony prominence overlying the SI joint), known as the Fortin Finger Test.  The diagnosis is confirmed with physical examination and image-guided diagnostic injections directly in the SI joint.

About the iFuse Implant System
The iFuse Implant System provides a minimally invasive surgical solution to fuse the SI joint using triangular titanium implants that create an interference fit within the ilium and sacrum.  The triangular implant shape and press fit insertion technique are both patented and designed to provide immediate fixation by minimizing the SI joint’s unique motion of nutation.  The implants have a porous surface that provides an environment conducive to ongrowth and ingrowth6, facilitating long-term fusion of the joint.  The iFuse Implant, marketed since 2009, is the only commercially available SI joint fusion device in the United States with published prospective clinical evidence from multiple studies that demonstrate improvement in pain, patient function and quality of life.

The iFuse Implant System® is intended for sacroiliac fusion for conditions including sacroiliac joint dysfunction that is a direct result of sacroiliac joint disruption and degenerative sacroiliitis. This includes conditions whose symptoms began during pregnancy or in the peripartum period and have persisted postpartum for more than 6 months.  There are potential risks associated with the iFuse Implant System.  It may not be appropriate for all patients and all patients may not benefit.  For information about the risks, visit: www.si-bone.com/risks

About SI-BONE, Inc.
SI-BONE, Inc. (San Jose, California) is a leading innovative medical device company dedicated to the development, manufacture and commercialization of minimally invasive surgical devices for the treatment of patients with low back symptoms related to certain sacroiliac joint disorders.  SI-BONE, Inc. first received 510(k) clearance to market its iFuse Implant System from the Food and Drug Administration in November 2008. The CE mark for European commercialization was obtained in November 2010.

SI-BONE and iFuse Implant System are registered trademarks of SI-BONE, Inc. ©2017 SI-BONE, Inc. All Rights Reserved. 9954.080217

1.

Bernard TN, Kirkaldy-Willis WH. Recognizing specific characteristics of nonspecific low back pain. Clin Orthop Relat Res. 1987;217:266–80.

2.

Schwarzer AC, Aprill CN, Bogduk N. The Sacroiliac Joint in Chronic Low Back Pain. Spine. 1995;20:31–7.

3.

Maigne JY, Aivaliklis A, Pfefer F. Results of Sacroiliac Joint Double Block and Value of Sacroiliac Pain Provocation Tests in 54 Patients with Low Back Pain. Spine. 1996;21:1889–92.

4.

Sembrano JN, Polly DW Jr. How Often is Low Back Pain Not Coming From The Back? Spine. 2009;34:E27–32.
DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

5.

DePalma M, Ketchum JM, Saullo TR. Etiology of Chronic Low Back Pain Patients Having Undergone Lumbar Fusion. Pain Med. 2011;12:732–9.

6.

MacBarb, et al., “Fortifying the Bone-Implant Interface Part II: An In Vivo Evaluation of 3D-Printed and TPS-Coated Triangular Implants,” Int J Spine Surg, 2017; 11.

 

SOURCE SI-BONE, Inc.

Related Links

http://www.si-bone.com


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August 2, 2017 OrthoSpineNews

August 02, 2017

MEQUON, Wis.–(BUSINESS WIRE)–Titan Spine, a medical device surface technology company focused on developing innovative spinal interbody fusion implants, today announced that it continues its strong revenue acceleration for the second quarter of 2017, driven by the increasing demand for the Company’s nanoLOCK® surface technology. nanoLOCK® is the company’s next-generation surface technology featuring enhanced micro and nano-scaled architecture, proven to significantly improve the osteogenic response it creates.1

The company reports the following for the second quarter:

  • Surpassed 50,000 implantations of its Endoskeleton® interbody fusion devices since inception
  • nanoLOCK® sales volume has increased by 42% since the close of the first quarter
  • nanoLOCK® has been utilized to date by 150 surgeons in 98 hospitals
  • Achieved 2,500 implantations of nanoLOCK® since launch

Ted Bird, Chief Commercial Officer of Titan Spine, commented, “Following a record first quarter, we continued to exceed expectations during the second quarter for a strong close to the mid-2017 mark. The significant demand for nanoLOCK® is a direct reflection of our expanded sales team’s ability to reach more surgeons and surgeons’ recognition of the advantages our surface technology provides at the nano-cellular level for helping patients heal faster following spine fusion surgery. In fact, we have more than doubled the number of surgeon customers using nanoLOCK in the second quarter compared to the first. We are pleased that our second quarter achievements demonstrate a growing confidence and continued adoption of nanoLOCK®.”

Steve Cichy, Executive Vice President of Sales of Titan Spine, added, “The demand for nanoLOCK® has certainly fueled our significant sales growth over the first half of this year. We have recently invested significant capital to beef up our instrument set and implant inventory to meet this growing demand, which will start to pay dividends over the remainder of the year and beyond.”

Titan Spine offers a full line of Endoskeleton® titanium implants that feature its proprietary nanoLOCK® surface technology, which was launched in the U.S. in October 2016 following FDA clearance in late 2014. The nanoLOCK® surface technology consists of a unique combination of roughened topographies at the macro, micro, and nano levels (MMN™). This unique combination of surface topographies is designed to create an optimal host-bone response and actively participate in the fusion process by promoting the upregulation of osteogenic and angiogenic factors necessary for bone growth, encouraging natural production of bone morphogenetic proteins (BMPs), downregulating inflammatory factors, and creating the potential for a faster and more robust fusion.2,3,4 All Endoskeleton® devices are covered by the company’s risk share warranty.

About Titan Spine

Titan Spine, LLC is a surface technology company focused on the design and manufacture of interbody fusion devices for the spine. The company is committed to advancing the science of surface engineering to enhance the treatment of various pathologies of the spine that require fusion. Titan Spine, located in Mequon, Wisconsin and Laichingen, Germany, markets a full line of Endoskeleton® interbody devices featuring its proprietary textured surface in the U.S. and portions of Europe through its sales force and a network of independent distributors. To learn more, visit www.titanspine.com.

nanoLOCK® named the winner of Back Pain Centers of America’s 2017 Awards of Excellence for the Technology Innovation Award

1 Olivares-Navarrete, R., Hyzy S.L., Gittens, R.A., Berg, M.E., Schneider, J.M., Hotchkiss, K., Schwartz, Z., Boyan, B. D. Osteoblast lineage cells can discriminate microscale topographic features on titanium-aluminum-vanadium surfaces. Ann Biomed Eng. 2014 Dec; 42 (12): 2551-61.

Olivares-Navarrete, R., Hyzy, S.L., Slosar, P.J., Schneider, J.M., Schwartz, Z., and Boyan, B.D. (2015). Implant materials generate different peri-implant inflammatory factors: PEEK promotes fibrosis and micro-textured titanium promotes osteogenic factors. Spine, Volume 40, Issue 6, 399–404.

Olivares-Navarrete, R., Gittens, R.A., Schneider, J.M., Hyzy, S.L., Haithcock, D.A., Ullrich, P.F., Schwartz, Z., Boyan, B.D. (2012). Osteoblasts exhibit a more differentiated phenotype and increased bone morphogenetic production on titanium alloy substrates than poly-ether-ether-ketone. The Spine Journal, 12, 265-272.

4 Olivares-Navarrete, R., Hyzy, S.L., Gittens, R.A., Schneider, J.M., Haithcock, D.A., Ullrich, P.F., Slosar, P. J., Schwartz, Z., Boyan, B.D. (2013). Rough titanium alloys regulate osteoblast production of angiogenic factors. The Spine Journal, 13, 1563-1570.

Contacts

Company:
Titan Spine
Andrew Shepherd, 866-822-7800
ashepherd@titanspine.com
or
Media:
The Ruth Group
Kirsten Thomas, 508-280-6592
kthomas@theruthgroup.com


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August 1, 2017 OrthoSpineNews

CENTENNIAL, Colo., Aug. 1, 2017 /PRNewswire-USNewswire/ — AlloSource, one of the nation’s largest providers of cartilage, bone, skin, soft-tissue, and cellular allografts to advance patient healing in surgical procedures and wound care, today announced the release of AlloFuse® Select CM, a premium addition to AlloSource’s AlloFuse portfolio.

AlloFuse Select CM combines osteoconductive, osteoinductive, and osteogenic properties to initiate and nurture bone growth, delivering the benefits of autograft bone without the potential drawbacks. The product is clinically proven to activate and support bone formation and can be used in a variety of spinal, neurologic, and orthopedic procedures. This cellular allograft matrix also has good handling characteristics, as it is moldable and compressible for insertion into interbody implants or placement around anatomical structures.

“AlloFuse Select CM underscores our commitment to offering surgeons the advanced solutions they need to support their patients’ healing,” said Kerr Holbrook, AlloSource Chief Commercial Officer. “Our passion for our donors and recipients is reflected in the continued expansion of the regenerative therapies we provide.”

The addition of AlloFuse Select CM enhances the AlloFuse portfolio of demineralized bone fiber, putty, paste, and gel allografts. This line expansion provides surgeons with a premium AlloSource cellular allograft to meet a variety of needs for patients.

About AlloSource

AlloSource is one of the largest nonprofit cellular and tissue networks in the country, offering more than 200 types of precise cartilage, cellular, bone, skin and soft-tissue allografts to advance patient healing. For more than 20 years, AlloSource’s products have bridged the proven science of allografts with the advanced technology of cells, offering life-saving and life-enhancing possibilities in spine, sports medicine, foot and ankle, orthopedic, reconstructive, trauma and wound care procedures. As the world’s largest processor of cellular bone allografts, fresh cartilage tissue for joint repair and skin allografts to help patients heal from severe burns, AlloSource delivers unparalleled expertise and service to its growing network of surgeons, partners, and the country’s most reputable organ procurement organizations. The company is accredited by the American Association of Tissue Banks and is headquartered in Centennial, CO. For more information, please visit allosource.org or our educational website, allograftpossibilities.org.

Media Contact
Megan Duggan
AlloSource
720. 382. 2766
mduggan@allosource.org

 

SOURCE AlloSource


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August 1, 2017 OrthoSpineNews

PLAINSBORO, N.J., July 26, 2017 (GLOBE NEWSWIRE) — Integra LifeSciences Holdings Corporation (NASDAQ:IART), a leading global medical technology company, today reported its financial results for the second quarter ending June 30, 2017.

Highlights:

  • The company is tightening full-year 2017 revenue guidance to a new range of $1.125 billion to $1.140 billion, reflecting changes in foreign currency expectations and overperformance in Derma Sciences.  The company is also revising 2017 full-year organic sales growth to a new range of 6.0% to 7.0% from its previous guidance of 7.0% to 8.5%, which reflects expectations for lower organic sales growth from Dural Repair;
  • The company is maintaining previously issued 2017 full-year GAAP and adjusted earnings per share guidance;
  • Second quarter revenue increased 13.2% over the prior year quarter to $282.2 million, and organic revenue increased 4.6%. Derma Sciences contributed $23.8 million of revenue to second quarter results;
  • Second quarter GAAP gross margin increased 80 basis points over the prior year’s quarter to 64.9% due to lower purchase accounting adjustments from the TEI acquisition. Adjusted gross margin decreased 80 basis points to 68.4%, primarily due to dilution from Derma Sciences;
  • Second quarter GAAP net income decreased by $1.9 million to $10.8 million compared to the prior year’s second quarter, largely because of acquisition and integration expenses. Adjusted net income increased 17.0% to $35.4 million based on higher revenues, G&A expense leverage and a lower tax rate; and
  • Second quarter Operating cash flow was $28.9 million, a decrease from $38.1 million in the prior year’s quarter largely resulting from higher cash outlays for acquisition and integration expenses.  Trailing twelve month free cash flow conversion was 72.4%, compared to 59.8% in the prior-year period.

Total revenues for the second quarter were $282.2 million, reflecting an increase of $32.9 million, or 13.2%, over the second quarter of 2016. Sales in Orthopedics and Tissue Technologies increased by 34.2%, which includes the acquired sales from Derma Sciences and strength in our regenerative product portfolio. Sales in Specialty Surgical Solutions increased 1.1% compared to the prior-year period.

Excluding the revenue contribution from acquisitions and the effect of currency exchange rates and discontinued products, revenues increased 4.6% over the second quarter of 2016.

“Profitability and cash flows were strong in the second quarter, while revenues came in at the low end of our guidance range,” said Peter Arduini, Integra’s president and chief executive officer. “While Dural Repair underperformed, new product introductions and acquisitions performed well, giving us confidence that revenue growth will accelerate in the second half of this year. We also made significant progress on the planned acquisition of Codman Neurosurgery, and look forward to closing the transaction in the fourth quarter.”

The company reported GAAP net income of $10.8 million, or $0.14 per diluted share, for the second quarter of 2017, compared to a GAAP net income of $12.8 million, or $0.16 per diluted share, in the prior year’s quarter. The year-over-year declines largely resulted from acquisition and integration expenses associated with the Derma Sciences and Codman Neurosurgery transactions.

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

Adjusted EBITDA for the second quarter of 2017 was $62.7 million, or 22.2% of revenue, compared to $54.6 million, or 21.9% of revenue, in the second quarter of 2016. The adjusted EBITDA margin in the second quarter of 2017 includes over 100 basis points of dilution from Derma Sciences.

Adjusted net income for the second quarter of 2017 was $35.4 million, an increase of 17.0% over the prior year, and compares to adjusted net income of $30.3 million in the second quarter of 2016. Adjusted earnings per share for the second quarter of 2017 was $0.45, an increase of 12.5% over the prior year quarter.

2017 Full-Year Outlook

The company is tightening full-year 2017 revenue guidance to a new range of $1.125 billion to $1.140 billion, from $1.120 billion to $1.140 billion, reflecting changes in foreign currency expectations and overperformance in Derma Sciences. The company is maintaining its full-year GAAP and adjusted earnings per share guidance ranges of $0.49 to $0.55 and $1.88 to $1.94, respectively.

Based on second quarter results and the outlook for the remainder of the year, the company is lowering its full-year 2017 organic revenue growth range to 6.0% to 7.0%, down from its previous range of 7.0% to 8.5%, which reflects slower growth in Dural Repair.

“Despite the temporary slowdown in Specialty Surgical organic growth, we were pleased with the strong profitability generated in the quarter, which led to adjusted net income growth of 17.0% versus the prior year’s quarter and a double-digit increase in adjusted earnings per share,” said Glenn Coleman, Integra’s chief financial officer. “New product introductions including several regenerative products, the Cadence (R) Total Ankle System and the CUSA(R) Clarity are expected to drive organic growth acceleration in the second half of the year.”

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, July 26, 2017, to discuss financial results for the second 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 (323) 794-2093 and using the passcode 1833148. The call can also be accessed via a webcast link provided on investor.integralife.com.  A replay of the call will be available through July 31, 2017, by dialing (719) 457-0820 and using the passcode 1833148. The webcast will also be archived on the website.

About Integra

Integra LifeSciences is dedicated to limiting uncertainty for clinicians, so they can concentrate on providing the best patient care. Integra offers innovative solutions, including leading plastic and regenerative technologies, in specialty surgical solutions and orthopedics and tissue technologies. For more information, 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, uncertainties and reflect the Company’s judgment as of the date of this release.  Forward-looking statements include, but are not limited to, statements concerning future financial performance, including projections for revenues, GAAP and adjusted net income, GAAP and adjusted (loss)/earnings per diluted share, non-GAAP adjustments such as global enterprise resource planning (“ERP”) system implementation charges, acquisition-related 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. 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 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 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 for 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 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 Company’s ability to integrate acquired businesses; 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 convertible notes and 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, 2016 and information contained in subsequent filings with the Securities and Exchange Commission.  In addition, with respect to the Codman Neurosurgery acquisition, forward-looking statements in this document may include without limitation any statements regarding the planned completion of the proposed acquisition, the costs and benefits of the proposed acquisition, including future financial and operating results, Integra’s or the Codman Neurosurgery business’s plans, objectives, expectations and intentions and the expected timing of completion of the proposed acquisition.   It is important to note that Integra’s goals and expectations are not predictions of actual performance.  Actual results may differ materially from Integra’s current expectations depending upon a number of factors affecting the Codman Neurosurgery business and Integra’s business and risks and uncertainties associated with acquisition transactions.  These factors include, among other things, the following: successful closing of the proposed acquisition; the ability to obtain required regulatory approvals for the proposed acquisition (including the approval of antitrust authorities necessary to complete the proposed acquisition), the timing of obtaining such approvals and the risk that such approvals may result in the imposition of conditions, including with respect to divestitures, that could materially adversely affect Integra, the Codman Neurosurgery business and the expected benefits of the proposed acquisition; the risk that a condition to closing of the proposed acquisition may not be satisfied on a timely basis or at all, the failure of the proposed acquisition to close for any other reason and the risk liability to Integra in connection therewith; access to available financing (including financing for the acquisition) on a timely basis and on reasonable terms; the effects of disruption caused by the proposed acquisition making it more difficult for Integra to execute its operating plan effectively or to maintain relationships with employees, vendors and other business partners; stockholder litigation in connection with the proposed acquisition; and  Integra’s ability to successfully integrate the Codman Neurosurgery business and other acquired businesses.

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, adjusted diluted weighted average shares outstanding, 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 from continuing operations, excluding: (i) depreciation and amortization; (ii) other income (expense); (iii) interest income and expense; (iv) income taxes; and (v) those operating expenses also excluded from adjusted net income.  The measure of adjusted net income consists of GAAP net income from continuing operations, excluding: (i) global enterprise resource planning (“ERP”) implementation charges; (ii) structural optimization charges; (iii) certain employee severance charges; (iv) acquisition-related charges; (v) convertible debt non-cash interest; (vi) intangible asset amortization expense; and (vii) discontinued product lines charges; and (viii) income tax impact from adjustments and other items.  The measure of adjusted diluted weighted average shares outstanding is calculated by adding the economic benefit of the convertible note hedge transactions relating to Integra’s 2016 convertible notes.  The adjusted earnings per diluted share measure is calculated by dividing adjusted net income attributable to diluted shares by adjusted diluted weighted average shares outstanding.  The measure of free cash flow consists of GAAP net cash provided by continuing operating activities from continuing operations 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 from continuing operations to adjusted EBITDA, and adjusted net income, and GAAP earnings per diluted share to adjusted earnings per diluted share all for the Three Months Ended June 30, 2017 and 2016, and the free cash flow and free cash flow conversion for the Three Months Ended June 30, 2017 and 2016 and the twelve months ended June 30, 2017 and 2016, appear in the financial tables in this release.

The Company believes that the presentation of organic revenues and the various adjusted EBITDA, adjusted net income, adjusted earnings per diluted share, adjusted diluted weighted average shares outstanding, free cash flow and free cash flow conversion 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)
 Three Months Ended
June 30,
2017 2016
Total revenues, net $   282,164 $   249,309
Costs and expenses:
Cost of goods sold 98,998 89,565
Research and development 15,747 14,679
Selling, general and administrative 145,015 119,217
Intangible asset amortization 5,419 3,471
Total costs and expenses 265,179 226,932
Operating income 16,985 22,377
Interest income 64 6
Interest expense (6,181 ) (6,588 )
Other income (expense), net (2,866 ) (852 )
Income from continuing operations before taxes 8,002 14,943
Income tax expense (benefit) (2,833 ) 2,188
Net income $ 10,835 $ 12,755
Net income per share:
Income from continuing operations $ 0.14 $ 0.16
Diluted net income per share $ 0.14 $ 0.16
Weighted average common shares outstanding for diluted net income per share 78,963 78,710

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

(In thousands)

Three Months Ended June 30,
 2017 2016 Change
Specialty Surgical Solutions $   159,857 $   158,163 1.1 %
Orthopedics and Tissue Technologies 122,307 91,146    34.2 %
Total revenues $ 282,164 $ 249,309 13.2 %
Impact of changes in currency exchange rates $ 1,160 $
Less contribution of revenues from acquisitions* (24,028 )
Less contribution of revenues from discontinued products (514 ) (1,805 )
Total organic revenues $ 258,782 $ 247,504 4.6 %

* Acquisitions include Derma Sciences and TGX Medical

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

(In thousands)

Three Months Ended June 30, 2017
Item Total Amount COGS(a) SG&A(b) Amort.(c) OI&E(d) Tax(e)
Global ERP implementation charges $ 834 $ $ 834 $ $ $
Structural optimization charges 1,806 974 832
Acquisition-related charges* 23,698 1,887 19,548 2,263
Intangible asset amortization expense 12,497 7,078 5,419
Estimated income tax impact from above adjustments and other items (14,276 ) (14,276 )
Total adjustments $ 24,559 $     9,939 $     21,214 $     5,419 $   2,263 $  (14,276 )
Depreciation expense 9,097

a) COGS – Cost of goods sold
b) SG&A – Selling, general and administrative
c) Amort. – Intangible asset amortization
d) OI&E – Interest (income) expense, net and other (income) expense, net
e) Tax – Income tax expense

* Acquisition related charges are primarily associated with the Derma Sciences and Codman Neurosurgery acquisitions and include banking, legal, consulting and other expenses

Three Months Ended June 30, 2016
(In thousands)
Item Total Amount COGS (a) SG&A (b) Amort. (c) OI&E (d) Tax (e)
Global ERP implementation charges $ 5,696 $ $ 5,696 $ $ $
Structural optimization charges 1,838 1,008 830
Acquisition-related charges 6,020 4,644 1,376
Certain employee severance charges 617 317 300
Intangible asset amortization expense 10,351 6,880 3,471
Convertible debt noncash interest 2,104 2,104
Estimated income tax impact from above adjustments and other items (9,120 ) (9,120 )
Total adjustments $  17,506 $    12,849 $     8,202 $     3,471 $    2,104 $   (9,120 )
Depreciation expense 7,663

a) COGS – Cost of goods sold
b) SG&A – Selling, general and administrative
c) Amort. – Intangible asset amortization
d) OI&E – Interest (income) expense, net and other (income) expense, net
e) Tax – Income tax expense

RECONCILIATION OF NON-GAAP ADJUSTMENTS – GAAP NET INCOME FROM CONTINUING OPERATIONS TO ADJUSTED EBITDA
(UNAUDITED)
(In thousands, except per share amounts)
Three Months Ended June 30,
2017 2016
GAAP net income from continuing operations $ 10,835 $ 12,755
Non-GAAP adjustments:
Depreciation and intangible asset amortization expense 21,594 18,014
Other (income) expense, net 603 852
Interest expense, net 6,117 6,582
Income tax expense (benefit) (2,833 ) 2,188
Global ERP implementation charges 834 5,696
Structural optimization charges 1,806 1,838
Acquisition-related charges 23,698 6,020
Certain employee severance charges 617
Total of non-GAAP adjustments 51,819 41,807
Adjusted EBITDA $ 62,654 $ 54,562
RECONCILIATION OF NON-GAAP ADJUSTMENTS – GAAP NET INCOME FROM CONTINUING OPERATIONS TO
MEASURES OF ADJUSTED NET INCOME AND ADJUSTED EARNINGS PER SHARE
(UNAUDITED)
(In thousands, except per share amounts)
Three Months Ended June 30,
 2017  2016
GAAP net income from continuing operations $ 10,835 $ 12,755
Non-GAAP adjustments:
Global ERP implementation charges 834 5,696
Structural optimization charges 1,806 1,838
Acquisition-related charges 23,698 6,020
Certain employee severance charges 617
Intangible asset amortization expense 12,497 10,351
Convertible debt noncash interest 2,104
Estimated income tax impact from adjustments and other items (14,276 ) (9,120 )
Total of non-GAAP adjustments 24,559 17,506
Adjusted net income $ 35,394 $ 30,261
Adjusted diluted net income per share $ 0.45 $ 0.40
Weighted average common shares outstanding for diluted net income per share 78,963 78,710
Weighted average common shares outstanding adjustment for economic benefit of convertible bond hedge transactions (2,284 )
Weighted average common shares outstanding for adjusted diluted net income per share 78,963 76,426
CONDENSED BALANCE SHEET DATA
(UNAUDITED)
(In thousands)
June 30,
2017
 December 31,
2016
Cash and cash equivalents $ 154,600 $ 102,055
Accounts receivable, net 171,323 148,186
Inventories, net 234,680 217,263
Bank line of credit 880,000 665,000
Stockholders’ equity $    894,555 $ 839,667
CONDENSED STATEMENT OF CASH FLOWS
(UNAUDITED)
(In thousands)
Six Months Ended June 30,
 June 30, 2017  June 30, 2016
Net cash provided by operating activities $ 57,753 $ 63,109
Net cash used in investing activities (230,660 ) (14,773 )
Net cash provided by (used in) financing activities 218,363 (9,082 )
Effect of exchange rate changes on cash and cash equivalents 7,089 (583 )
Net increase in cash and cash equivalents $ 52,545 $ 38,671
RECONCILIATION OF NON-GAAP ADJUSTMENTS – GAAP OPERATING CASH FLOW TO
MEASURES OF FREE CASH FLOW AND FREE CASH FLOW CONVERSION
(UNAUDITED)
(In thousands)
Three Months Ended June 30,
2017 2016
GAAP net cash provided by continuing operating activities $ 28,871 $ 38,079
Purchases of property and equipment from continuing operations (12,819 ) (8,267 )
Free cash flow 16,052 29,812
Adjusted net income * $ 35,394 $ 30,261
Adjusted free cash flow conversion 45.4 % 98.5 %
Twelve Months Ended June 30,
2017 2016
GAAP net cash provided by continuing operating activities** $ 111,046 $ 108,362
Accreted interest payment associated with the 2016 convertible note 42,786
Purchases of property and equipment from continuing operations (50,174 ) (37,622 )
Adjusted free cash flow 103,658 70,740
Adjusted net income * $ 143,122 $ 118,243
Adjusted free cash flow conversion 72.4 % 59.8 %

* Adjusted net income for quarters ended June 30, 2017 and 2016 are reconciled above.  Adjusted net income for remaining quarters in the trailing twelve months calculation have been previously reconciled and are publicly available in the Quarterly Earnings Call Presentations and the Historical Financial Results: Continuing Operations presentation on our website at investor.integralife.com under Events & Presentations.
** Operating cash flow excludes $42.8M of accreted interest payment associated with the 2016 Convertible Notes.

The Company calculates adjusted free cash flow conversion by dividing its free cash flow by adjusted net income.  The Company believes this measure is useful in evaluating the significance of the cash special charges in its adjusted earnings measures.

INTEGRA LIFESCIENCES HOLDINGS CORPORATION
RECONCILIATION OF NON-GAAP ADJUSTMENTS – GUIDANCE
 Recorded Year
to Date
Projected Year Ended
(In thousands, except per share amounts) June 30, 2017 December 31, 2017
Low High
GAAP net income $ 17,230 $ 39,250 $ 43,750
Non-GAAP adjustments:
Global ERP implementation charges 3,261 3,261 3,261
Structural optimization charges 3,392 11,392 11,392
Acquisition-related charges 44,015 90,247 90,247
Certain employee severance charges 125 125 125
Discontinued product lines charges 1,025 1,025 1,025
Intangible asset amortization expense 23,464 47,800 47,800
Estimated income tax impact from adjustments and other items (26,226 )   (44,000 )   (44,000 )
Total of non-GAAP adjustments 49,056 109,850 109,850
Adjusted net income $ 66,286 $ 149,100 $ 153,600
GAAP diluted net income per share $ 0.22 $ 0.49 $ 0.55
Non-GAAP adjustments detailed above (per share) $ 0.62 $ 1.39 $ 1.39
Adjusted diluted net income per share $ 0.84 $ 1.88 $ 1.94
Weighted average common shares outstanding for diluted net income per share 78,703 79,500 79,000
GUIDANCE – SPECIAL CHARGES
Item  YTD
Amount
 FY
Guidance
COGS SG&A R&D Amort.  Interest
(Inc)Exp
Tax
Global ERP implementation charges $ 3,261 $ 3,261 $ $ 3,261 $    — $       — $         — $     —
Structural optimization charges 3,392 11,392   10,500 892
Acquisition-related charges    44,015     90,247 9,000    81,247
Certain employee severance charges 125 125 125
Discontinued product lines charges 1,025 1,025 1,025
Intangible asset amortization expense 23,464 47,800 31,000 16,800
Convertible debt non-cash interest
Estimated income tax impact from adjustments and other items (26,226 ) (44,000 )   (44,000 )
Total 49,056 109,850 51,525 85,525   16,800 (44,000 )
Contact:

Investor Relations:
Michael Beaulieu
(609) 750-2827
michael.beaulieu@integralife.com

Media:
Laurene Isip
(609) 750-7984
laurene.isip@integralife.com

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August 1, 2017 OrthoSpineNews

July 31, 2017

LYON, France & NEW YORK–(BUSINESS WIRE)–The Medicrea Group (Euronext Growth Paris: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD™ ASI technology, announced today that the world’s first minimally-invasive spine surgery using patient-specific implants was performed by Dr. C.J. Kleck at the University of Colorado Hospital using the company’s UNiD™ MIS Rod.

The limited visualization of the spine associated with Minimally-Invasive Spine (MIS) techniques poses unique challenges for surgeons whose goal is segmental sagittal balance, while offering known benefits to patients which include reduced muscle damage during surgery and improved recovery time post-operatively. Such advantages have led MIS solutions to be an area of particular growth in the spine market. Surgeons trained in MIS techniques are able to treat a growing number of spinal conditions due to recent advancements in imaging and device offerings. The UNiD™ MIS Rod is the first and only spinal implant in the world that is manufactured specially for the patient prior to minimally-invasive surgery. The UNiD™ MIS Rod is compatible with percutaneous and mini-open MIS applications, removing the need to modify implants intra-operatively.

“As one of the early adopters of UNiD™ ASI, I have seen firsthand the associated benefits of the technology in open deformity cases. I am pleased to extend it now to my MIS cases where I see the potential for increased utility in degenerative indications.” stated Dr. Kleck following the surgery. “With each patient-specific implant designed utilizing Medicrea’s support services, machine learning and predictive analytics, my colleagues and I have seen an improved efficiency in our pre-surgical as well as our surgical practice. I believe this scientific, data-driven model is the best approach available to optimize long-term patient results and represents the future of value-based spinal care.”

Denys Sournac, President and CEO of Medicrea, stated, “We are now able to respond to the growing demand for personalized UNiD™ ASI technology in minimally-invasive surgery by introducing the UNiD™ MIS Rod to our UNiD™ TEK line of FDA-cleared patient-specific implants. We are the only company in Spine able to generate Adaptive Spine Intelligence powered by proprietary data science and remain committed to driving improved outcomes and efficiencies for patients, surgeons, hospitals and payers with our platform of UNiD™ ASI implants, services and IT.”

Today, more than 1,500 UNiD™ Rod surgeries have been performed worldwide. The range of patient-specific implants available as UNiD™ TEK are fully compatible with Medicrea’s platform of innovative procedurally-integrated solutions.

About Medicrea (www.Medicrea.com)

Through the lens of predictive medicine, Medicrea leads the design, integrated manufacture, and distribution of 30+ FDA approved spinal implant technologies that have been utilized in over 100,000 spinal surgeries to date. By leveraging its proprietary software analysis tools with big data and machine learning technologies and supported by an expansive collection of clinical and scientific data, Medicrea is well-placed to streamline the efficiency of spinal care, reduce procedural complications and limit time spent in the operating room.

Operating in a $10 billion marketplace, Medicrea is a Small and Medium sized Enterprise (SME) with 175 employees worldwide, which includes 50 who are based in the U.S. The Company has an ultra-modern manufacturing facility in Lyon, France housing the development and production of 3D-printed titanium patient-specific implants.

For further information, please visit: Medicrea.com.

Connect with Medicrea:
FACEBOOK | INSTAGRAM | TWITTER | WEBSITE | YOUTUBE

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED

Contacts

Medicrea
Denys Sournac
Founder, Chairman and CEO
dsournac@Medicrea.com
or
Fabrice Kilfiger,
Chief Financial Officer
fkilfiger@Medicrea.com
Tel: +33 (0)4 72 01 87 87


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August 1, 2017 OrthoSpineNews

August 01, 2017

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc., a leading global provider of medical technologies designed to get and keep people moving, today announced the following information for the release of its second quarter 2017 financial results and a conference call to discuss those results.

Date: Thursday, August 10, 2017

Time: Financial Results: 4:05 PM Eastern Time | Conference Call: 4:30 PM Eastern Time; 1:30 PM Pacific Time

Dial In: (866) 394-8509 (International callers please use (706) 643-6833) and use reservation code: 22322226. Please dial in 5 to 10 minutes prior to scheduled start time.

Replay: (855) 859-2056 for all callers. Enter reservation code: 22322226. Replay ends 48 hours after call.

Live Internet: www.DJOglobal.com, accessed through the Investor Relations page of the Company’s website. The webcast will be archived after the completion of the call.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. Its products are used by orthopedic surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMFTM, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort®, Bell-Horn® and ExosTM. For additional information on the Company, please visit www.DJOglobal.com.

Contacts

DJO Investor/Media Contact:
David Smith
SVP and Treasurer
760.734.3075
ir@djoglobal.com

 


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August 1, 2017 OrthoSpineNews

August 01, 2017

ALACHUA, Fla.–(BUSINESS WIRE)–RTI Surgical Inc. (RTI) (Nasdaq: RTIX), a global surgical implant company, announced today that it plans to release financial results from the second quarter 2017 on Tuesday, August 8, 2017, prior to the market open.

RTI will host a conference call and simultaneous audio webcast to discuss second quarter results at 8:30 a.m. ET the same day. The conference call can be accessed by dialing (877) 383-7419 (U.S.) or (760) 666-3754 (International). The webcast can be accessed through the investor section of RTI’s website at www.rtix.com. A replay of the conference call will be available on RTI’s website for one month following the call.

About RTI Surgical Inc.

RTI Surgical is a leading global surgical implant company providing surgeons with safe biologic, metal and synthetic implants. Committed to delivering a higher standard, RTI’s implants are used in sports medicine, general surgery, spine, orthopedic, trauma and cardiothoracic procedures and are distributed in nearly 50 countries. RTI is headquartered in Alachua, Fla., and has four manufacturing facilities throughout the U.S. and Europe. RTI is accredited in the U.S. by the American Association of Tissue Banks and is a member of AdvaMed. For more information, please visit www.rtix.com.

Forward Looking Statement

This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management’s current expectations, estimates and projections about our industry, our management’s beliefs and certain assumptions made by our management. Words such as “anticipates,” “expects,” “intends,” “plans,” “believes,” “seeks,” “estimates,” variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, except for historical information, any statements made in this communication about anticipated financial results, growth rates, new product introductions, future operational improvements and results or regulatory approvals or changes to agreements with distributors also are forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties, including the risks described in public filings with the U.S. Securities and Exchange Commission (SEC). Our actual results may differ materially from the anticipated results reflected in these forward-looking statements. Copies of the company’s SEC filings may be obtained by contacting the company or the SEC or by visiting RTI’s website at www.rtix.com or the SEC’s website at www.sec.gov.

Contacts

RTI Surgical Inc.
Robert Jordheim, 386-418-8888
Executive Vice President and Chief Financial Officer
rjordheim@rtix.com
or
Roxane Wergin, 386-418-8888
Director, Corporate Communications
rwergin@rtix.com



August 1, 2017 OrthoSpineNews

August 01, 2017

SAN DIEGO–(BUSINESS WIRE)–Samumed, a leader in Wnt research and development, has been selected for an oral presentation at the 2017 Gordon Research Conference, “Wnt Signaling: A Pathway Implicated in Animal Development, Stem Cell Control and Cancer,” to be held in Stowe, Vermont on August 6-11, 2017.

“We are excited to be presenting at the prestigious Gordon Research Conference, which provides an international forum for the discussion of cutting-edge research in life sciences,” said Dr. Yusuf Yazici, Samumed’s Chief Medical Officer. “The preclinical research that formed the basis of our promising investigational drug for the treatment of osteoarthritis is an example of how innovative science can translate into clinical benefit.”

Samumed’s presentation, “Discovery of a Small Molecule Inhibitor of the Wnt Pathway (SM04690) as a Potential Disease Modifying Treatment for Knee Osteoarthritis,” will be available on the company website after the conference at: http://bit.ly/2hhTp68.

About Gordon Research Conferences

Gordon Research Conferences is an organization that coordinates renowned international scientific conferences dedicated to advancing the frontiers of scientific research in the biological, chemical, and physical sciences, and their related technologies. To attend a meeting, scientists must apply to that respective research conference. The conference chair carefully considers every applicant and hand-selects 200 attendees for each conference. Further information can be found at: https://www.grc.org.

About Samumed, LLC

Based in San Diego, CA, Samumed (www.samumed.com) is a pharmaceutical platform company focused on advancing regenerative medicine and oncology applications through research and innovation. Samumed has discovered new targets and biological processes in the Wnt pathway, allowing the team to develop small molecule drugs that potentially address numerous degenerative conditions as well as many forms of cancer.

Contacts

For Samumed
Chrissy Randall, 202-393-7337
crandall@brunswickgroup.com


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August 1, 2017 OrthoSpineNews

August 01, 2017

LEXINGTON, Ky.–(BUSINESS WIRE)–Based on 12-month follow-up clinical data from its safety and feasibility study, Intralink-Spine, Inc. (ILS) indicates that the Réjuve™ System continues to effectively eliminate or reduce low back pain and disability associated with degenerative disc disease.

“We continue to be very pleased with the patient outcomes,” states Dr. Tom Hedman, Ph.D., the inventor and Adjunct Associate Professor in the F. Joseph Halcomb III, M.D. Department of Biomedical Engineering at the University of Kentucky. “Twelve months after the Réjuve procedure, three of the four (3/4) patients eligible for this follow-up assessment have no (zero) low back pain and no (zero) disability. And, the fourth patient has minimal pain and disability. These initial clinical results demonstrate a long-lasting, significant reduction or elimination of pain and disability, not just a slight reduction, and these benefits began within days of the initial procedure. We also have objective imaging data demonstrating the elimination of clinical instability. This is great news, especially as we begin our larger pivotal clinical studies.” (Video – Dr. Hedman discusses recent clinical data.)

“With the reduction or elimination of low back pain coming so quickly after the procedure, skeptics were reluctant to believe that the Réjuve treatment would actually stay the course. And, I understand their skepticism, because alternative treatments with good early results have turned out to only be temporary and with biologic treatments, good results require months or years to take effect, if they come at all,” says Lyle Hawkins, CEO of Intralink-Spine, Inc. “Now, they see data from us that patients improve within days of treatment and continue to enjoy a better quality of life 12 months post procedure. So, yes, they were skeptical. However, we’re beginning to turn skeptics into believers.”

According to Hawkins, “We understand that we need to evaluate this injectable device in a much larger group of patients in a multisite study, but we are very optimistic as we pursue that next milestone. We believe the Réjuve System which structurally reinforces the native intervertebral disc itself is going to be a better treatment option for many patients with low back pain. Réjuve has the procedural simplicity of an epidural steroid injection, but with potential long-term positive effects similar to a successful fusion.”

About Intralink-Spine, Inc. (ILS): Formed to manufacture and exclusively sell the Réjuve™ injectable medical device to treat Degenerative Disc Disease (DDD), low back pain, and related spinal diseases such as scoliosis, ILS is currently conducting a Round C fundraising event for accredited investors.

Contacts

Intralink-Spine Inc.
Lyle Hawkins, 502-419-8099
LHawkins@IntralinkSpine.com


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August 1, 2017 OrthoSpineNews

August 1, 2017 – CAESAREA, Israel–(BUSINESS WIRE)–

Mazor Robotics Ltd. (TASE: MZOR; NASDAQGM: MZOR), a pioneer and a leader in the field of surgical guidance systems, reported record second quarter revenue of $15.5 million. As previously announced, the Company received purchase orders for 19 systems in the 2017 second quarter and ended the quarter with a backlog of 14 systems.

“Our Q2 performance is highlighted by record quarterly revenue and a year-over-year increase of 87%, which reflects the market’s excitement for Mazor X and the successful sales execution with our partner,” commented Ori Hadomi, Chief Executive Officer. “The market traction and recognition of the system’s benefits is generating robust demand for our surgical guidance systems, which strengthens our leadership position in the U.S. market. Our sales team is continuing to pursue these opportunities and during the first few weeks of the third quarter we have received purchase orders for six systems.”

SECOND QUARTER 2017 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

Revenue for the three months ended June 30, 2017 increased 87% to $15.5 million compared to $8.3 million in the year-ago second quarter. U.S. revenue increased 110% to $14.1 million compared to $6.7 million in the year-ago second quarter, as the Company recognized revenue from 14 Mazor X systems compared to 5 Renaissance systems in the 2016 second quarter. The Company ended the quarter with a backlog of 14 systems, which are expected to be shipped and recorded as revenues in the second half of 2017. International revenue was $1.4 million compared to $1.6 million in the year-ago second quarter. Recurring revenue from kit sales, services and others increased 50% to $6.3 million in the second quarter of 2017 compared to $4.2 million in the year-ago second quarter. The growth is attributed mainly to the increase of the installed base.

The Company’s gross margin for the three months ended June 30, 2017 was 69.4% compared to 76.9% in the year-ago second quarter. This expected decrease is attributed mainly to the higher manufacturing costs of the Mazor X compared to the Renaissance system and the inclusion of four Renaissance trade-ins to Mazor X. Total operating expenses were $14.6 million compared to $10.3 million in the year-ago second quarter primarily reflecting the Company’s increased investment in sales and marketing activities. Operating loss was $3.9 million compared to an operating loss of $4.0 million in the year-ago second quarter. Net loss for the second quarter of 2017 was $3.7 million, or $0.08 per share, compared to a net loss of $4.1 million, or $0.09 per share, for the year-ago second quarter.

Cash used in operating activities during the 2017 second quarter was $7.4 million compared to $0.6 million cash used in operating activities in the year-ago second quarter. The Increase in cash used in the period is due to increase of Accounts receivable and Inventory to support the growing installed base and backlog orders in the second quarter of 2017. As of June 30, 2017, cash, cash equivalents and investments totaled $57.4 million.

SECOND QUARTER 2017 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 $1.3 million with respect to amortization of intangible assets and to share-based expenses recorded in the second quarter of 2017. On a non-GAAP basis, the net loss in the second quarter of 2017 was $2.4 million, or $0.05 per share, compared to $3.9 million, or $0.09 per share, for the year-ago second quarter.

SIX MONTHS ENDED JUNE 30, 2017 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

For the six months ended June 30, 2017, revenue increased 85% and totaled $27.2 million compared to $14.7 million for the six months ended June 30, 2016, due to higher system sales and an increase in recurring revenue. Recurring revenue totaled $11.5 million, an increase of 44% compared to $8.0 million in the six months ended June 30, 2016. The growth in recurring revenue is attributed to the increase in the installed base and high utilization of the Company’s surgical guidance systems, both in the U.S. and globally. Gross margin for the six months ended June 30, 2017 was 67.3% compared with 75.7% in the six months ended June 30, 2016. This expected decrease is attributed mainly to the higher manufacturing costs of the Mazor X compared to the Renaissance system and the inclusion of six Renaissance trade-ins to Mazor X. Net loss for the six months ended June 30, 2017 was $8.9 million, or $0.19 per share, compared to a net loss of $9.2 million, or $0.21 per share, in the first six months of 2016.

SIX MONTHS ENDED JUNE 30, 2017 FINANCIAL RESULTS ON NON-GAAP BASIS

On a non-GAAP basis, the net loss for the first six months of 2017 was $6.3 million, or $0.13 per share, compared to a net loss of $8.1 million, or $0.19 per share, in the first six months of 2016.

CONFERENCE CALL INFORMATION

The Company will host a conference call to discuss its second quarter financial results as well as recent corporate developments on August 1, 2017 at 8:30 AM EDT (3:30 PM IDT). Investors within the United States interested in participating are invited to call 888-539-3679. Participants in Israel can use the toll-free dial-in number 1-80-924-6042. All other international participants can use the dial-in number 719-325-2322. For all callers, refer to Conference ID 8824893.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-866-375-1919 and reference the Replay Access Code: 8824893. All international callers can dial +1-719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.com and select ‘Investor Relations.’

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 loss, net loss and basic and diluted earnings per share that exclude the effects of capitalization of development costs, non-cash expense of amortization of intangible assets and share-based payments. 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 and earnings per share and to compare them to historical net income and earnings 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 robust demand for the Company’s products, third quarter purchase orders, the amount of and timing of recording of additional revenue from backlog, 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 May 1, 2017 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.

Mazor Robotics Ltd.
CONSOLIDATED STATEMENT OF PROFIT OR LOSS
(in thousands, except per share data)
(UNAUDITED)
Six month period Three month period
ended June 30, ended June 30,
2017 2016 2017 2016
Revenue $ 27,174 $ 14,703 $ 15,455 $ 8,284
Cost of revenue $ 8,875 $ 3,566 $ 4,726 $ 1,912
Gross profit $ 18,299 $ 11,137 $ 10,729 $ 6,372
Operating expenses:
Research and development, net $ 4,034 $ 3,242 $ 2,242 $ 1,111
Selling and marketing $ 20,209 $ 14,656 $ 10,316 $ 7,783
General and administrative $ 3,657 $ 2,412 $ 2,086 $ 1,429
Total operating cost and expenses $ 27,900 $ 20,310 $ 14,644 $ 10,323
Loss from operations $ (9,601) $ (9,173) $ (3,915) $ (3,951)
Financing income, net $ 443 $ 203 $ 232 $ 28
Loss before taxes on income $ (9,158) $ (8,970) $ (3,683) $ (3,923)
Income tax expense (benefit) $ (250) $ 209 $ (7) $ 144
Net loss $ (8,908) $ (9,179) $ (3,676) $ (4,067)
Net loss per share – Basic and diluted $ (0.19) $ (0.21) $ (0.08) $ (0.09)
Weighted average common shares outstanding – Basic and diluted 47,990 42,880 48,227 43,347
Mazor Robotics Ltd.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION AS OF
(U.S. Dollars in thousands)
June 30, December 31,
2017 2016
(Unaudited) (Audited)
Current assets
Cash and cash equivalents $ 20,347 $ 14,954
Short-term investments 33,267 37,862
Trade receivables 6,298 8,225
Other current assets 2,411 1,728
Inventory 7,365 4,715
Total current assets 69,688 67,484
Non-current assets
Long-term investments 3,800 9,017
Property and equipment, net 4,168 3,615
Intangible assets, net 2,093 2,258
Other non-current assets 981 351
Total non-current assets 11,042 15,241
Total assets $ 80,730 $ 82,725
Current liabilities
Trade payables $ 2,526 $ 5,018
Deferred revenue 3,481 4,031
Other current liabilities 11,772 8,462
Total current liabilities 17,779 17,511
Non-current liabilities
Employee benefits 461 325
Total non-current liabilities 461 325
Total liabilities 18,240 17,836
Equity
Share capital 126 124
Share premium 180,318 174,647
Capital reserve for share-based payment transactions 10,695 9,859
Foreign currency translation reserve 2,119 2,119
Accumulated loss (130,768) (121,860)
Total equity 62,490 64,889
Total liabilities and equity $ 80,730 $ 82,725
Mazor Robotics Ltd.
CONSOLIDATED CASH FLOW STATEMENTS
(U.S. Dollars in thousands)
(UNAUDITED)
Six months ended Three months ended
June 30, June 30,
2017 2016 2017

2016

Cash flows from operating activities:
Loss for the period $ (8,908) $ (9,179) $ (3,676) $ (4,067)
Adjustments:
Depreciation and amortization $ 714 $ 296 $ 372 $ 150
Finance income, net $ (119) $ (173) $ (69) $ (31)
Share-based payments $ 2,422 $ 2,134 $ 1,221 $ 1,218
Income tax expense (tax benefit) $ (250) $ 209 $ (7) $ 144
$ 2,767 $ 2,466 $ 1,517 $ 1,481
Change in inventory $ (2,950) $ (635) $ (1,588) $ (610)
Change in trade and other accounts receivable $ 1,260 $ 2,377 $ (3,511) $ 639
Change in prepaid lease fees $ (22) $ (4) $ (1) $ 6
Change in trade and other accounts payable $ 792 $ 1,333 $ (311) $ 1,869
Change in employee benefits $ 136 $ 68 $ 58 $ (8)
$ (784) $ 3,139 $ (5,353) $ 1,896
Interest received $ 183 $ 137 $ 111 $ 73
Income tax paid $ (15) $ (39) $ (15) $ (2)
$ 168 $ 98 $ 96 $ 71
Net cash used in operating activities $ 6,757 $ 3,476 $ 7,416 $ 619
Cash flows from investing activities:
Proceeds from (investment in) short-term investments and deposits, net $ 10,435 $ (2,377) $ 1,478 $ (9,023)
Investment in long-term investments $ (623) $ (1,125) $ (525) $ (629)
Purchase of property and equipment $ (1,313) $ (1,203) $ (504) $ (785)
Capitalization of development costs $ $ (597) $ $ (597)
Net cash provided by (used in) investing activities $ 8,499 $ (5,302) $ 449 $ (11,034)
Cash flows from financing activities:
Proceeds from issuance of ADRs, net $ $ 11,895 $ $ 11,895
Proceeds from exercise of share options by employees $ 3,719 $ 123 $ 1,460 $ 48
Proceeds from exercise of share options and warrants, net $ $ 481 $ $
Net cash provided by financing activities $ 3,719 $ 12,499 $ 1,460 $ 11,943
Net increase (decrease) in cash and cash equivalents $ 5,461 $ 3,721 $ (5,507) $ 290
Cash and cash equivalents at the beginning of the period $ 14,954 $ 13,519 $ 25,896 $ 17,008
Effect of exchange rate differences on balances of cash and cash equivalents $ (68) $ 37 $ (42) $ (21)
Cash and cash equivalents at the end of the period $ 20,347 $ 17,277 $ 20,347 $ 17,277
Supplementary cash flows information:
Purchase of property and equipment in credit $ (55) $ (32) $ (55) $ (32)
Issuance costs in credit $ $ (199) $ $ (199)
Capitalization of development expenses on credit $ $ (414) $ $ (414)
Classification of inventory to fixed assets $ 300 $ $ 164 $
Mazor Robotics Ltd.
RECONCILIATIONS OF GAAP TO NON-GAAP FINANCIAL MEASURES
(U.S. Dollars in thousands, except per share data)
(UNAUDITED)
Six month period Three month period
ended June 30, ended June 30,
2017 2016 2017 2016
GAAP gross profit $ 18,299 $ 11,137 $ 10,729 $ 6,372
Amortization of intangible assets 165 83
Share-based payments 108 83 55 47
Non-GAAP gross profit $ 18,572 $ 11,220 $ 10,867 $ 6,419
GAAP gross profit as percentage of revenues 67.3% 75.7% 69.4% 76.9%
Non-GAAP gross profit as percentage of revenues 68.3% 76.3% 70.3% 77.5%
GAAP operating expenses $ 27,900 $ 20,310 $ 14,644 $ 10,323
Share-based payments:
Research and development $ 352 $ 347 $ 194 $ 197
Selling and marketing $ 851 $ 1,215 $ 411 $ 695
General and administrative $ 1,111 $ 489 $ 561 $ 279
Development costs capitalization $ $ (1,011) $ $ (1,011)
Non-GAAP operating expenses $ 25,586 $ 19,270 $ 13,478 $ 10,163
GAAP operating loss $ (9,601) $ (9,173) $ (3,915) $ (3,951)
Non-GAAP operating loss $ (7,014) $ (8,050) $ (2,611) $ (3,744)
GAAP net loss $ (8,908) $ (9,179) $ (3,676) $ (4,067)
Amortization of intangible assets $ 165 $ $ 83 $
Share-based payments $ 2,422 $ 2,134 $ 1,221 $ 1,218
Development costs capitalization $ $ (1,011) $ $ (1,011)
Non-GAAP net loss $ (6,321) $ (8,056) $ (2,372) $ (3,860)
GAAP basic and diluted loss per share $ (0.19) $ (0.21) $ (0.08) $ (0.09)
Non-GAAP basic and diluted loss per share $ (0.13) $ (0.19) $ (0.05) $ (0.09)