Spine Surgery Products Market to Reach USD $16.7 Billion by 2025, Globally: Transparency Market Research

ALBANY, New YorkJanuary 9, 2018 /PRNewswire/ —

The global Market for Spine Surgery Product was valued at USD 10.2 billion in 2016 and is estimated to reach USD 16.7 billion by 2025 at a CAGR of 5.8% from 2017 to 2025.

Spinal fusion products are used in spinal fusion surgery. The products are involved in removing the damaged disc and replacing it with any fusion products. Non-fusion products are used during spine surgery, which are implanted to treat spine conditions. This also allows the patient to retain its movement and flexibility. The non-fusion products are becoming the treatment of choice, especially for the younger, more active patient. Increase in number of spine surgeries, rise in use of bone grafts and bone morphogenetic proteins in spinal fusion surgery, growing number of spinal surgeries using electrical stimulation devices such as inductive coupling devices, captive coupling devices and other implants drives the market growth rate by 2025.

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The global spine surgery product market is categorized based on product, application, and by end user. Based on product, the markets are further classified into fusion products {cervical fusion, interbody fusion, spinal fixation, minimally invasive surgical (MIS) devices, spine biologics (demineralized bone matrix, synthetic bone graft substitutes)}; non fusion products (motion preservation, spine stimulators, and vertebral compression fracture (VCF) devices). Fusion product was a major product of segment in the spine surgery product market, which is attributed to treatment in cervical and lumbar surgery. Increase in production of regenerative healing products by companies expands its presence in spinal surgery, orthopedic trauma and dental treatments which is likely to boost the segment growth during forecast period. Commercialization of minimal invasive surgery devices in Asia Pacific countries is likely to boost the fusion product segment growth in the near future. Minimally invasive surgery devices is widely used for spine surgeries as the devices are less expensive and factors such as quicker recovery after surgery, less post-operative pain, and smaller incisions makes minimally invasive surgery as an attractive option among patients and is likely to boost the growth rate of the segment by 2025.

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Based on application, the market is segmented into vertebral fracture repair, spinal fusion, and others. Vertebral fracture repair segment is accounted to hold the largest market share in 2016, due to increase in number of spine surgeries, number of incidence of vertebral fractures, spondylitis, motor vehicle collisions, etc. is expected to drive the segment growth. Demand for spinal fusion in emerging markets such as Asia Pacific and Latin America is projected to propel the segment growth rate between 2017 and 2025. The spinal fusion segment is likely to account for second highest share by 2025 due to rise in spinal surgeries for tumors, disc degenerative problems, scoliosis, fractures, etc. According to Journal of Spine, 2017, about 75% of cases of spinal stenosis occur in the low back (lumbar spine). This causes pressure on the spinal cord and nerves; however, increasing adoption of spine biologics products, fixation devices and other use of MIS devices are likely to expand the segment growth rate and market attractiveness from 2017 to 2025. By end user, the market are further segmented into hospitals, ambulatory surgical centers, and others. The hospitals segment dominated the spine surgery product market in 2016, and is expected to continue to dominate the market by 2025.

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Increasing investments of manufacturers on the development of new spine products for spine surgery and demands for physicians for robotic system, are the drivers responsible for the remarkable market growth of the segment. Furthermore, product availability, storage capability, reimbursement of treatment cost, and increase in the number of hospitals are expected to propel the segment during the forecast period.

The major players in the spine surgery product are – Stryker, Medtronic, Zimmer Biomet, Globus Medical, K2M, NuVasive, Aesculap Implant Systems, LLC (B. Braun Company), RTI Surgical, Inc., Alphatec Holdings, Inc., Orthofix International N.V., DePuy Synthes, and others

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Orthofix Announces Preliminary 2017 Fourth Quarter and Full Year Net Sales Results

January 09, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix International N.V. (NASDAQ:OFIX), a global medical device company focused on musculoskeletal healing products and value-added services, today announced preliminary unaudited fourth quarter 2017 net sales of approximately $117 million. These preliminary results represent reported sales growth of 7.7% and constant currency sales growth of 6.1% over the fourth quarter 2016. For the full year 2017, preliminary unaudited net sales were approximately $434 million, an increase of 5.9% on a reported basis and 5.5% on a constant currency basis over the full year 2016.

Three Months Ended December 31,
(Unaudited, U.S. Dollars, in millions) 2017 2016

Reported
Change

Constant
Currency
Change

BioStim $ 49.8 $ 47.8 4.1 % 4.1 %
Extremity Fixation 29.1 26.8 8.4 % 2.2 %
Spine Fixation 21.2 18.7 13.5 % 13.2 %
Biologics 16.8 15.2 10.7 % 10.7 %
Total net sales $ 116.9 $ 108.5 7.7 % 6.1 %
Year Ended December 31,
(Unaudited, U.S. Dollars, in millions) 2017 2016

Reported
Change

Constant
Currency
Change

BioStim $ 185.9 $ 176.6 5.3 % 5.3 %
Extremity Fixation 103.2 102.7 0.5 % (0.9) %
Spine Fixation 82.0 72.6 12.8 % 12.7 %
Biologics 62.7 57.9 8.3 % 8.3 %
Total net sales $ 433.8 $ 409.8 5.9 % 5.5 %

As of December 31, 2017, cash and cash equivalents were approximately $81 million compared to $40 million as of December 31, 2016.

“In 2017 our strategy was to accelerate our organic topline growth rate while maintaining Adjusted EBITDA margins. This strategy proved very effective and resulted in us far exceeding our growth expectations for the year. Now as we look forward to 2018 and beyond, we are focused on continuing our organic growth momentum, expanding margins and actively pursuing value-accretive inorganic opportunities to further accelerate growth,” said Brad Mason, President and Chief Executive Officer.

“The keys to maintaining our organic sales momentum are, first and foremost, continuing our initiatives to further engage our legacy sales force and add new representation in under-served markets. The second key is to remain committed to investing in R&D and our rapid pace of new product introductions and value-added processes and services, such as our STIM onTrackmobile app and JuniOrtho™ pediatric care support tools. Lastly, we must educate physicians and payers through published, peer-reviewed research papers that demonstrate the safety, efficacy and cost-effectiveness of our products.

“While 2017 was a year to invest in accelerating our top-line growth rate, we can now return our focus to Adjusted EBITDA margin expansion. Our biggest opportunity is in gross margins, particularly around improving inventory and instrument set management in our Spine and Extremity Fixation businesses. We also expect to begin to realize the cost benefits of our restructuring initiatives as well as benefit from leveraging our fixed costs in SG&A.

“Lastly, Orthofix is very well positioned to grow through the acquisition of products, technologies and companies. In addition to our strong balance sheet and free cash flow, we have an experienced and proven management team, a global footprint and a reconstructed infrastructure on which to build. We have been and will remain very active in pursuing opportunities of all sizes that will drive shareholder value. However, we will remain disciplined in our investment decisions, focusing on strategic fit, near-term cash EPS accretion and ROIC.

“We are pleased with our positioning going into 2018 and optimistic about our ability to drive shareholder value for the foreseeable future.”

2018 Outlook

For the full year 2018, the Company expects to report net sales of $450 million to $455 million based on current foreign exchange rates, which reflects reported growth of approximately 4% to 5%. This guidance includes a positive currency impact of approximately $4.0 million, offset by an estimated $4.0 million decrease in the 2018 marketing services fee the Company receives from MTF Biologics. This decrease is due to the final contractual step-down in the fee that Orthofix receives from MTF Biologics for our sales of Trinity ELITE® and Trinity Evolution® from 65% to 60%. This change, effective March 2018 in accordance with the terms of our amended 2008 agreement with MTF Biologics, coincides with the expiration of a corresponding royalty payment on our net sales of Trinity ELITE and Trinity Evolution that Orthofix currently pays to a third party. The expiration of the royalty payment substantially offsets the impact of the fee reduction to Operating Income and Adjusted EBITDA.

This 2018 net sales guidance reflects the new required revenue recognition standard that is required as of January 1, 2018. One of the primary impacts of this new standard is the timing of revenue recognition for our sales to stocking distributors that were historically accounted for using the sell-through method. This revenue will now be recorded on invoiced sales instead of deferring recognition until cash is received. While we expect that the new revenue recognition standard will provide a materially consistent revenue result on an annual basis as compared to our current revenue recognition policies, there may be some variability on a quarterly basis.

U.S. Tax Changes – Estimated Impact

The recent lowering of the U.S. corporate tax rate from 35% to 21% requires a revaluation of our U.S. deferred tax assets and liabilities. The Company expects to recognize a one-time, non-cash tax charge of $8 million – $12 million in the fourth quarter of 2017 related to this change. The new U.S. tax legislation is subject to a number of complex provisions, which we are currently reviewing. We will provide an update when we announce our fourth quarter and full year 2017 financials.

Upcoming Presentations / Conference Calls

As previously announced, the Company’s President and Chief Executive Officer, Brad Mason, will provide an investor presentation at 8:30 a.m. Pacific Time on Thursday, January 11, 2018, at the J.P. Morgan Healthcare Conference in San Francisco. A live audio webcast will be available on the Company’s website at www.orthofix.com by clicking on the Investors tab and then clicking the link on the Events and Presentations page.

The Company also expects to host a conference call in late February to discuss final fourth quarter and full year 2017 financial results and further discuss our outlook for 2018.

Non-GAAP Measures:

Constant Currency

Constant currency is a non-GAAP measure, which is calculated by using foreign currency rates from the comparable, prior-year period, to present net sales at comparable rates. Constant currency can be presented for numerous GAAP measures, but is most commonly used by management to analyze net sales without the impact of changes in foreign currency rates.

Adjusted EBITDA

Adjusted EBITDA (earnings before interest income (expense), net; income tax expense; and depreciation and amortization) is a non-GAAP financial measure, which is calculated by adjusting EBITDA by certain items such as share-based compensation, foreign exchange impact, strategic investments, SEC/FCPA matters and related costs, infrastructure investments, legal judgments/settlements, charges related to U.S. Government resolutions, restructuring, succession charges and long-term income tax rate.

Free Cash Flow

Free cash flow is a non-GAAP financial measure, which is calculated by subtracting capital expenditures from cash flow from operating activities. Free cash flow is an important indicator of how much cash is generated or used by our normal business operations, including capital expenditures. Management uses free cash flow as a measure of progress on its capital efficiency and cash flow initiatives.

Usefulness and Limitations of Non-GAAP Financial Measures

Management uses non-GAAP measures to evaluate performance period-over-period, to analyze the underlying trends in our business, to assess performance relative to competitors and to establish operational goals and forecasts that are used in allocating resources. Management uses these non-GAAP measures as the basis for assessing the ability of the underlying operations to generate cash. In addition, management uses these non-GAAP measures to further its understanding of the performance of our business units.

Material Limitations Associated with the Use of Non-GAAP Financial Measures

The non-GAAP measures used in this press release may have limitations as analytical tools, and should not be considered in isolation or as a replacement for GAAP financial measures. Some of the limitations associated with the use of these non-GAAP financial measures are that they exclude items that reflect an economic cost and can have a material effect on cash flows. Similarly, certain non-cash expenses, such as share-based compensation, do not directly impact cash flows, but are part of total compensation costs accounted for under GAAP.

Compensation for Limitations Associated with Use of Non-GAAP Financial Measures

We compensate for the limitations of our non-GAAP financial measures by relying upon GAAP results to gain a complete picture of our performance. The GAAP results provide the ability to understand our performance based on a defined set of criteria. The non-GAAP measures reflect the underlying operating results of our businesses, which we believe is an important measure of our overall performance. We provide a detailed reconciliation of the non-GAAP financial measures to our most directly comparable GAAP measures, and encourage investors to review this reconciliation.

Usefulness of Non-GAAP Financial Measures to Investors

We believe that providing non-GAAP financial measures that exclude certain items provides investors with greater transparency to the information used by senior management in its financial and operational decision-making. Management believes it is important to provide investors with the same non-GAAP metrics it uses to supplement information regarding the performance and underlying trends of our business operations in order to facilitate comparisons to its historical operating results and internally evaluate the effectiveness of our operating strategies. Disclosure of these non-GAAP financial measures also facilitates comparisons of our underlying operating performance with other companies in the industry that also supplement their GAAP results with non-GAAP financial measures.

About Orthofix

Orthofix International N.V. is a global medical device company focused on musculoskeletal healing products and value-added services. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative orthopedic and spine solutions to physicians worldwide. Headquartered in Lewisville, Texas, the Company has four strategic business units: BioStim, Extremity Fixation, Spine Fixation, and Biologics. Orthofix products are widely distributed via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains certain forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements, which may include, but are not limited to, statements concerning the projections, financial condition, results of operations and businesses of Orthofix and its subsidiaries, are based on management’s current expectations and estimates and involve risks and uncertainties that could cause actual results or outcomes to differ materially from those contemplated by the forward-looking statements.

The forward-looking statements in this release do not constitute guarantees or promises of future performance. Factors that could cause or contribute to such differences may include, but are not limited to, risks relating to: the expected sales of our products, including recently launched products; the geographic concentration of certain of our sales and accounts receivable in countries or territories that are facing severe fiscal challenges; unanticipated expenditures; changing relationships with customers, suppliers, strategic partners and lenders; changes to and the interpretation of governmental regulations; risks relating to the protection of intellectual property; changes to the reimbursement policies of third parties; the impact of competitive products; changes to the competitive environment; the acceptance of new products in the market; conditions of the orthopedic and spine industry; credit markets and the global economy; corporate development and market development activities, including acquisitions or divestitures; unexpected costs or operating unit performance related to recent or future acquisitions; and other risks described in the “Risk Factors” section of our 2016 Annual Report on Form 10-K, as well as in other reports that we file in the future. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. The Company undertakes no obligation to update or revise the information contained in this press release.

Contacts

Orthofix International N.V.
Mark Quick, 214-937-2924
markquick@orthofix.com

Wright Medical Group N.V. Announces Preliminary Fourth Quarter and Full-Year 2017 Net Sales

AMSTERDAM, The Netherlands, Jan. 08, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today announced preliminary, unaudited fourth quarter and full-year 2017 net sales results.  Unless otherwise noted, all net sales growth rates in this release are stated on a constant currency basis, which includes the benefit of the extra four business selling days in the fourth quarter of fiscal year 2017.

The company expects net sales for the fourth quarter of 2017 to be approximately $217.6 million, representing growth of 12.7% as reported and 11.2% on a constant currency basis, including the benefit from the extra four business selling days, which the company estimates to be approximately 4.5%.  For the full-year 2017, the company expects net sales to be approximately $745.0 million, representing growth of approximately 8% as reported and on a constant currency basis, including the extra four business selling days.  These preliminary, unaudited financial results for the quarter and year ended December 31, 2017 are based on current expectations and are subject to quarter-end closing adjustments; actual results may differ.

Robert Palmisano, president and chief executive officer, commented, “Our preliminary fourth quarter results represent an outstanding performance in our U.S. upper extremities business.  This performance was driven by the launch of our PERFORM Reversed glenoid and continued contribution from our SIMPLICITI shoulder system.  We anticipate that our ongoing PERFORM Reversed launch and accelerating adoption of the recently acquired BLUEPRINT enabling technology will continue to drive strong shoulder sales growth in 2018.”

Palmisano further commented, “As anticipated, we did not see any benefit in the fourth quarter in our U.S. lower extremities business from the sales force expansion.  Additionally, we had some supply constraints primarily related to a third-party coating vendor in the fourth quarter, which we believe have been addressed.  However, this affected our total ankle business during the fourth quarter.  As previously discussed, we will continue to focus on improving our execution and building our physician relationships to restore growth in our core U.S. lower extremities business and expect to see improvement in 2018 as our larger sales footprint, new products, new reps and expanding relationships begin to take effect.”

Wright plans to report its full financial results and provide more detail for its fourth quarter and full-year 2017 financial results, as well as issue its 2018 financial guidance, after the market closes on Tuesday, February 27, 2018, to be followed by its quarterly conference call at 3:30 p.m. Central Time that day.

Wright Medical to Present Today at J.P. Morgan Healthcare Conference

Wright’s management will present today, January 8, 2018, at the J.P. Morgan Healthcare Conference at 7:30 a.m. Pacific Time.  A live audio webcast of the conference presentation and the Q&A session, along with the accompanying presentation materials, will be available on Wright’s corporate website at www.wright.com, under the “Investors” link.  The presentation materials, as well as the reconciliations of its non-GAAP financial measures, will be posted prior to the presentation as soon as practicable after the issuance of this press release.  The audio webcast and accompanying presentation materials will be archived on this site under the “Investor Presentations” link following the conference.

Internet Posting of Information

Wright routinely posts information that may be important to investors in the “Investor Relations” section of its website at www.wright.com.  The company encourages investors and potential investors to consult the Wright website regularly for important information about Wright.

About Wright Medical Group N.V.

Wright Medical Group N.V. is a global medical device company focused on extremities and biologics products. The company is committed to delivering innovative, value-added solutions improving the quality of life for patients worldwide.  Wright is a recognized leader of surgical solutions for the upper extremities (shoulder, elbow, wrist and hand), lower extremities (foot and ankle) and biologics markets, three of the fastest growing segments in orthopaedics.  For more information about Wright, visit www.wright.com.

™ and ® denote trademarks and registered trademarks of Wright Medical Group N.V. or its affiliates,  registered as indicated in the United States, and in other countries.  All other trademarks and trade names referred to in this release are the property of their respective owners.

Non-GAAP Financial Measures

To supplement the company’s consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles, the company uses certain non-GAAP financial measures in this release. Reconciliations of the historical non-GAAP financial measures used in this release to the most comparable GAAP measures for the respective periods can be found in tables later in this release. Wright’s non-GAAP financial measures include net sales, excluding the impact of foreign currency. The company’s management believes that the presentation of these measures provides useful information to investors.  Management uses the non-GAAP measures in this release internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets.  Investors should consider non-GAAP financial measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “could,” “may,” “will,” “believe,” “estimate,” “continue,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, the preliminary and unaudited net sales results for fourth quarter and full year of 2017 and statements about the company’s anticipated strong shoulder sales growth in 2018 and anticipated improvement in 2018 as its larger sales footprint, new products, new reps and expanding relationships begin to take effect. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, risks that Wright’s final net sales results will deviate from the preliminary, unaudited net sales results in this release; the failure of the company’s recent U.S. sales force addition; continued supply constraints; focus on core product portfolio and incentives to drive U.S. lower extremities and biologics sales or delay in realization thereof; the failure to integrate the legacy Wright and Tornier businesses and realize net sales synergies and cost savings from the merger with Tornier or delay in realization thereof; operating costs and business disruption as a result of the merger, including adverse effects on employee retention and sales force productivity and on business relationships with third parties; integration costs; actual or contingent liabilities; adverse effects of diverting resources and attention to providing transition services to the purchaser of the large joints business; the adequacy of the company’s capital resources and need for additional financing; the timing of regulatory approvals and introduction of new products; physician acceptance, endorsement, and use of new products; failure to achieve the anticipated benefits from approval of AUGMENT® Bone Graft; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims and product recalls; pending and threatened litigation; risks associated with the metal-on-metal master settlement agreement and the settlement agreement with the three settling insurers; risks associated with the subsequent metal-on-metal settlement agreements and ability to obtain the additional new insurance proceeds contingent thereon; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 25, 2016 filed by Wright with the SEC on February 23, 2017 and subsequent SEC filings by Wright, including its Quarterly Report on Form 10-Q for the quarter ended September 24, 2017 filed by Wright with the SEC on November 2, 2017. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

–Tables Follow–

Wright Medical Group N.V.
Consolidated Sales Analysis
(dollars in thousands–unaudited)
Three months ended Fiscal year ended
December 31,
2017
December 25,
2016
%
change
December 31,
2017
December 25,
2016
%
change
U.S.
Lower extremities 66,816 64,064 4.3 % 228,044 222,936 2.3 %
Upper extremities 71,685 55,462 29.3 % 239,965 201,579 19.0 %
Biologics 21,814 21,436 1.8 % 78,361 74,603 5.0 %
Sports med & other 2,242 2,103 6.6 % 8,141 8,429 (3.4 )%
Total U.S. $ 162,557 $ 143,065 13.6 % $ 554,511 $ 507,547 9.3 %
International
Lower extremities 16,101 16,717 (3.7 )% 58,473 62,701 (6.7 )%
Upper extremities 28,093 24,261 15.8 % 94,699 86,502 9.5 %
Biologics 6,784 5,079 33.6 % 22,276 18,883 18.0 %
Sports med & other 4,067 3,901 4.3 % 15,030 14,729 2.0 %
Total International $ 55,045 $ 49,958 10.2 % $ 190,478 $ 182,815 4.2 %
Global
Lower extremities 82,917 80,781 2.6 % 286,517 285,637 0.3 %
Upper extremities 99,778 79,723 25.2 % 334,664 288,081 16.2 %
Biologics 28,598 26,515 7.9 % 100,637 93,486 7.6 %
Sports med & other 6,309 6,004 5.1 % 23,171 23,158 0.1 %
Total sales $ 217,602 $ 193,023 12.7 % $ 744,989 $ 690,362 7.9 %
Wright Medical Group N.V.
Supplemental Net Sales Information
(unaudited)
Three months ended December 31, 2017 net sales growth/(decline)
U.S.
as
reported
Int’l
constant
currency
Int’l
as
reported
Global
constant
currency
Global
as
reported
Product line
Lower extremities 4 % (9 %) (4 %) 2 % 3 %
Upper extremities 29 % 9 % 16 % 23 % 25 %
Biologics 2 % 30 % 34 % 7 % 8 %
Sports med & other 7 % (3 %) 4 % 0 % 5 %
Total net sales 14 % 4 % 10 % 11 % 13 %
Fiscal year ended December 31, 2017 net sales growth/(decline)
U.S.
as
reported
Int’l
constant
currency
Int’l
as
reported
Global
constant
currency
Global
as
reported
Product line
Lower extremities 2 % (7 %) (7 %) 0 % 0 %
Upper extremities 19 % 8 % 9 % 16 % 16 %
Biologics 5 % 17 % 18 % 8 % 8 %
Sports med & other (3 %) 2 % 2 % 0 % 0 %
Total net sales 9 % 4 % 4 % 8 % 8 %

Investors & Media:

Julie D. Tracy
Sr. Vice President, Chief Communications Officer
Wright Medical Group N.V.
(901) 290-5817
julie.tracy@wright.com

Primary Logo

Wright Medical Group N.V.

MiMedx Releases Preliminary 2017 Revenue of $324.5 Million representing a 32% increase over 2016

MARIETTA, Ga.Jan. 7, 2018 /PRNewswire/ — MiMedx Group, Inc. (NASDAQ: MDXG), the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare, today announced preliminary record revenue results for the fourth quarter and full-year 2017 and revenue expectations for the first quarter of 2018.

Fourth Quarter 2017 Revenue Highlights

  • Q4 2017 revenue of $90.9 Million grew 30% over Q4 2016 revenue and exceeded upper end of guidance by nearly $3 million
  • Excluding divested subsidiary, Stability Biologics, Q4 2017 revenue grew by 34% over Q4 2016
  • Q4 2017 Wound Care revenue grew 27% over Q4 2016
  • Surgical, Sports Medicine and Orthopedics (SSO) revenue for Q4 2017 grew 40% over Q4 2016

Full-Year 2017 Revenue Highlights

  • Full-year 2017 revenue of $324.5 million increased 32% over full year 2016 and exceeded upper end of guidance
  • Excluding divested subsidiary, Stability Biologics, full-year 2017 revenue grew by 36% over 2016
  • Full-year 2017 Wound Care revenue of $238.3 million increased by 30% over 2016
  • Full-year 2017 SSO revenue of $86.2 million grew 41% over 2016

The Company recorded preliminary record revenue for the year ended December 31, 2017 of $324.5 million, a $79.5 million or 32% increase over 2016 revenue of $245.0 million.  The Company recorded record revenue for the 2017 fourth quarter of $90.9 million, a $21.0 million or 30% increase over 2016 fourth quarter revenue of $69.9 million.

Management Commentary
Parker H. “Pete” Petit, Chairman and CEO stated, “The fourth quarter of 2017 makes 28 consecutive quarters of sequential revenue growth and 27 of 28 quarters of meeting or exceeding our revenue guidance.  At the end of November, we expected we would exceed our revenue forecast for the quarter, as we indicated in our press release on November 30, 2017. We forecasted December to be a solid growth month, and our sales force more than lived up to our expectations with a robust month to close out the year. We are entering 2018 with strong momentum that should produce an exciting 2018.”

Bill Taylor, President and COO, noted, “Contributing to our accelerating sales momentum is the market growth we have achieved with our refined territory analytics for the larger markets and our effective secondary market strategy. The significant prospects for Venous Leg Ulcer (VLU) reimbursement coverage being added during 2018 as a result of the publication of the compelling results confirming the clinical efficacy of EpiFix® in the treatment of VLUs, will further fuel this momentum. As we stated earlier, with our current breadth of commercial carrier reimbursement coverage primarily for Diabetic Foot Ulcers (DFUs), we expect our 2018 Wound Care growth to be aided by our ability to ultimately achieve over 100 million additional commercial lives having EpiFix coverage for the treatment of VLUs.”

“Both of our sales verticals had strong performances during the fourth quarter. Wound Care performed extremely well in the fourth quarter with 27% growth over the prior year’s fourth quarter, and SSO revenue grew significantly over 2016 with 40% quarter over quarter growth. Fourth quarter revenue from our direct sales force represented approximately 95% of total revenue, and revenue from distributors and Original Equipment Manufacturers (OEMs) accounted for less than 5% of total fourth quarter revenue,” Taylor added.

Speaking to the Company’s cash performance, Petit noted, “The fourth quarter was another quarter of very strong cash flow from operations. We are very pleased with the sustained progress we have made in this important measure of our operating effectiveness.”

“We anticipate 2018 to be another year of highly predictable quarter over quarter revenue growth, continued strengthening of our balance sheet and cash position, and significant gains in profitability. Shareholders should be reminded that the 2017 numbers reported in this press release are preliminary numbers based on management’s best estimates, and we look forward to our planned press release on February 23, 2018 detailing our 2017 financial results. We also plan to host our standard live broadcast of our 2017 financial results on February 23, 2018,” concluded Petit.

First Quarter and Full Year 2018 Guidance Highlights
The Company announced its revenue guidance for the first quarter of 2018 as follows:

  • First quarter of 2018 revenue forecasted to be in the range of $90.5 to $92.0 million

MiMedx reiterated its full year 2018 guidance that was previously communicated by the Company on December 13, 2017, which included:

  • Revenue estimated between $383 to $387 million
  • Gross profit margins expected to be in the range of 89% to 90%
  • Operating Income expected to be in the range of 15% to 17%
  • GAAP Diluted EPS projected to be in the range of $0.30 to $0.35
  • Adjusted Diluted EPS* projected to be in the range of $0.45 to $0.50
    *Adjusted Diluted Net Income per share consists of GAAP net income excluding: (i) one time acquisition related costs, (ii) amortization of inventory fair value step-up, (iii) amortization of intangible assets, (iv) share-based compensation (v) gain on divestiture and (vi) the normalization of tax expense.

The guidance above does not reflect the impact of changes in the federal tax code. Those changes, if any, will be released with the release of full year operating results.

Share Repurchase Program
The Company provided an update to its Share Repurchase Program that was initiated in May 2014. MiMedx reported that since inception, the Company’s Board of Directors has authorized $130 million in share repurchases. To date, the amount of shares purchased through the Share Repurchase Program is $124.2 million, and these repurchased shares represent in excess of 10% of the Company’s total diluted shares outstanding.

About MiMedx
MiMedx® is the leading biopharmaceutical company developing and marketing regenerative and therapeutic biologics utilizing human placental tissue allografts with patent-protected processes for multiple sectors of healthcare. “Innovations in Regenerative Medicine” is the framework behind our mission to give physicians products and tissues to help the body heal itself.  We process the human placental tissue utilizing our proprietary PURION® Process among other processes, to produce safe and effective allografts. MiMedx proprietary processing methodology employs aseptic processing techniques in addition to terminal sterilization. MiMedx is the leading supplier of placental tissue, having supplied over 1 million allografts to date for application in the Wound Care, Burn, Surgical, Orthopedic, Spine, Sports Medicine, Ophthalmic and Dental sectors of healthcare. For additional information, please visit www.mimedx.com.

Safe Harbor Statement
This press release includes forward-looking statements, including statements regarding future levels of revenues, gross profit margin, operating income, GAAP diluted EPS and adjusted diluted EPS; our expectations regarding the timing and amount of additional covered insured lives for EpiFix for VLUs and DFUs; our expectation that Wound Care revenues will grow in 2018 and be aided by additional insured lives, and our expectations regarding continued strengthening of our balance sheet, cash position, and profitability. These statements also may be identified by words such as “believe,” “expect,” “may,” “plan,” “potential,” “will,” “preliminary,” and similar expressions, and are based on our current beliefs and expectations. Forward-looking statements are subject to risks and uncertainties, and we caution investors against placing undue reliance on such statements.  Actual results may differ from those set forth in the forward-looking statements. Among the risks and uncertainties that could cause actual results to differ materially from those indicated by such forward-looking statements include the risk that we will not achieve forecast revenue, profit margin, operating income, or EPS due to slower growth, higher expenses, or other factors; third-party insurers may choose not to cover, or may be slower to decide to cover, additional insured lives for the use of EpiFix to treat VLUs and DFUs; and that changes to regulation or regulatory interpretations may adversely affect the sale and marketing of our products. For more detailed information on the risks and uncertainties, please review the Risk Factors section of our most recent annual report or quarterly report filed with the Securities and Exchange Commission.  Any forward-looking statements speak only as of the date of this press release and we assume no obligation to update any forward-looking statement.

SOURCE MiMedx Group, Inc.

Related Links

http://www.mimedx.com

Providence Medical Technology Announces Appointment of US Sales Executive and Publication of Two Additional Clinical Studies

PLEASANTON, Calif.Jan. 8, 2018 /PRNewswire/ — Providence Medical Technology, an innovator in cervical spine fusion, today announced the appointment of Jeremy Laynor as Vice President of US sales. The company also announced the publication of two new studies in the Journal of Craniovertebral Junction and Spine further demonstrating the clinical benefits of its unique cervical fusion technology.

Jeremy is an accomplished sales executive who has successfully built high-growth sales teams launching disruptive medical technology. Jeremy most recently served as Vice President of Sales at Paradigm Spine where he led a team of direct and independent distributors selling novel spinal technology. He has also held sales leadership positions at Medtronic and Cardinal Health.

“Jeremy is an excellent fit for this critical leadership position,” commented Jeff Smith, CEO of Providence Medical Technology. “He understands the challenges of selling unique devices in the spine market and brings a strong network of spine surgeons and distributor partners to Providence. Jeremy completes the buildout of our executive team that will elevate our company to new levels as we further commercialize our differentiated posterior cervical fusion technology.”

Additionally, the December issue of the Journal of Craniovertebral Junction and Spine features two studies both authored by Dr. Krzysztof Siemionow et al., that demonstrate the clinical performance of posterior fusion utilizing the company’s DTRAX® Spinal System and CAVUX® cervical cages. One study reviewed the safety profile of 89 consecutive patients diagnosed with cervical radiculopathy and surgically treated with posterior cervical fusion and bilateral cages. The study reports a median hospital stay of 29 hours and overall complication rate related to the posterior cervical fusion of only 3.4%.

A complete copy of this study can be found at http://bit.ly/2E1fKuY

The second study publishes for the first time a case series of posteriorly placed cervical cages as an adjunct to fusion in place of lateral mass screws. The study concludes that posterior cervical cages may be an alternative option to traditional lateral mass screws. These two new publications add to the growing body of evidence supporting the company’s posterior cervical fusion technology of 13 total peer-reviewed scientific publications.

A complete copy of this study can be found at http://bit.ly/2CB3vsg

“The DTRAX Spinal System has greatly increased my procedural efficiency during posterior cervical fusion surgeries,” commented Dr. Kris Siemionow, MD, PhD Orthopedic Spine Surgeon at the University of Illinois at Chicago. “The instruments allow me to perform all the steps of a cervical fusion in a controlled fashion with an intuitive workflow while the cages offer a safe alternative to traditional lateral mass screws.”

DTRAX Spinal System is a set of sterile packaged, single-use instruments designed to perform posterior cervical fusion and has been used in over 9,000 cases worldwide. The CAVUX Cervical Cage is indicated for use in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine (C3-C7) with accompanying radicular symptoms at one disc level.

About Providence Medical Technology, Inc.
Providence Medical Technology, Inc. is a privately-held medical device company focused on innovative solutions for cervical spinal conditions. The company has pioneered a proprietary approach to posterior cervical fusion and has developed surgical instrumentation and implants that offer unique benefits to the $2 billion worldwide cervical spine market. The Providence family of products includes the DTRAX® Spinal Instrumentation System, CAVUX® intervertebral implants, ALLY® line of bone, facet and cervical pedicle screws, and BIOLOGIX™ allograft cervical cages. All products are shipped-sterile and single-use to maximize perioperative efficiency and ensure consistent quality and performance. For more information, visit www.providencemt.com

 

SOURCE Providence Medical Technology

Related Links

http://www.providencemt.com

Implanet Announces Its Annual Report on the Liquidity Contract with Tradition Securities and Futures (TSAF)

January 08, 2018

BORDEAUX, France & BOSTON–(BUSINESS WIRE)–Regulatory News:

IMPLANET (Paris:ALIMP) (OTCQX:IMPZY) (Euronext Growth : ALIMP, FR0010458729, PEA-PME eligible ; OTCQX : IMPZY), a medical technology company specializing in vertebral and knee-surgery implants, today is announcing its annual report on its liquidity contract with TSAF as of December 31, 2017.

Pursuant to the liquidity contract entrusted by the IMPLANET group to TSAF, the following assets appeared on the liquidity account as of December 31, 2017:

• 156,000 shares

• Cash balance of the liquidity account: €35,509.25

As a reminder, at the time of the half-year statement of the liquidity contract as of June 30, 2017, the following resources were booked to the liquidity account, which was then entrusted to ODDO Corporate Finance:

• 134,950 shares

• Cash balance of the liquidity account: €46,060.29

About IMPLANET
Founded in 2007, IMPLANET is a medical technology company that manufactures high-quality implants for orthopedic surgery. Its flagship product, the JAZZ® latest-generation implant, aims to treat spinal pathologies requiring vertebral fusion surgery. Protected by four families of international patents, JAZZ® has obtained 510(k) regulatory clearance from the Food and Drug Administration (FDA) in the United States and the CE mark. IMPLANET employs 48 staff and recorded 2016 sales of €7.8 million. For further information, please visit www.implanet.com.
Based near Bordeaux in France, IMPLANET established a US subsidiary in Boston in 2013.
IMPLANET is listed on Euronext™ Growth market in Paris. The Company would like to remind that the table for monitoring the BEOCABSA, OCA, BSA and the number of shares outstanding, is available on its website: http://www.implanet-invest.com/suivi-des-actions-80

Contacts

IMPLANET
Ludovic Lastennet, Tel. : +33 (0)5 57 99 55 55
CEO
investors@implanet.com
or
NewCap
Investor Relations
Julie Coulot, Tel. : +33 (0)1 44 71 20 40
implanet@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, Tel. : +33 (0)1 44 71 94 98
implanet@newcap.eu
or
AlphaBronze
US-Investor Relations
Pascal Nigen, Tel.: +1 917 385 21 60
implanet@alphabronze.net

Mazor Robotics Received 27 System Orders During Q4 2017; Expects to Report Record Full Year and Quarterly Revenue

CAESAREA, Israel, Jan.  8, 2018 /PRNewswire/ — Mazor Robotics Ltd. (TASE: MZOR) (NASDAQGM: MZOR), a pioneer and a leader in the field of surgical robotic systems, expects to report record revenue of approximately $65 million for the full year ended December 31, 2017.  In addition, the Company expects to report record revenue of approximately $19 million for the fourth quarter, which is the Company’s strongest quarter for system orders and revenue.

In the fourth quarter of 2017, the Company received purchase orders for 27 robotic guidance systems. This is the first full quarter since Medtronic assumed exclusive worldwide distribution of the Mazor X™ system for spine surgeries, as as part of the second phase of the commercial agreement between the companies.

The 27 orders are comprised of:

  • 24 Mazor X systems, of which 23 were ordered by Medtronic.
  • Three Renaissance system purchase orders from a U.S. customer and distribution partners in Germany and Thailand.

The Company’s system backlog on December 31, 2017 was 16 systems (14 Mazor X and two Renaissance systems).

“The fourth quarter results demonstrate the successful and smooth transition of the Mazor X sales and marketing activities to Medtronic,” commented Ori Hadomi, Chief Executive Officer.  “In addition, the co-development of innovative robotic spine solutions with Medtronic continues to make progress. At the same time, we are maximizing the market opportunities for Renaissance and evaluating potential new indications for our technologies.”

For the 2017 full year, the Company received purchase orders for 73 systems, of which 64 were for the Mazor X system.  The Company anticipates that Medtronic’s assumption of global commercial responsibility for the Mazor X will lead to increased market penetration and an accelerated number of Mazor X system installations during the coming years. As previously reported, from a financial results perspective, the anticipated revenue from Mazor X capital systems and disposables will be affected by the distribution model pricing with Medtronic. Therefore, the Company is currently anticipating modest revenue growth for 2018 compared to the preliminary 2017 record revenue of $65 million. As previously disclosed, the distribution agreement with Medtronic is expected to reduce the Company’s full year 2018 sales and marketing expenses and deliver significant savings. Beyond 2018, revenue growth is expected to accelerate and be driven primarily by the expanding installed base and increased recurring revenues.

Effective with the first quarter of 2018, due to the commencement of the exclusive worldwide distribution agreement with Medtronic and consistent with industry practice, the Company will no longer provide preliminary results for revenue, orders received and backlog. This information will be reported in full, as part of the quarterly and annual financial results releases.

The Company intends to report its financial results for the fourth quarter and full year ended December 31, 2017 in mid-February and will issue a press release with the specific time, dial-in credentials and webcast details.  The full year results are expected to include an adjusted increase in 2017 third quarter revenue from $17.2 million to $18.6 million due to system deliveries to Medtronic which had been incorrectly recorded as delivered after the third quarter ended on September 30, 2017.  Amended financial results for three and nine months ended September 30, 2017 are available through the Company’s website at https://www.mazorrobotics.com/index.php/investors-relations/financial-reports.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary robotic technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance Systems enable surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit 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 Mazor, including without limitation, statements regarding the expected revenue for the full year and fourth quarter of 2017, the evaluation of new indications for its technologies, the increased market penetration and accelerated number of Mazor X installation during the coming years, the effect of the distribution model pricing with Medtronic on the anticipated  revenue from Mazor X capital systems and disposables, the expected adjustment in third quarter 2017 revenues, the timing of reporting of full year and fourth quarter financial results, the expected reduction in sales and marketing expense in 2018, the expected modest revenue growth for 2018 compared to preliminary 2017 record revenue, the expected growth beyond 2018, 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.

U.S. Contacts: EVC Group

Michael Polyviou/Doug Sherk – Investors
mpolyviou@evcgroup.comdsherk@evcgroup.com
732-232-6914; 646-445-4800

SOURCE Mazor Robotics Ltd.

Related Links

http://www.mazorrobotics.com/

SeaSpine Announces Preliminary Results for Fourth Quarter and Full-Year 2017

CARLSBAD, Calif., Jan. 08, 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 preliminary financial results for fourth quarter and full-year 2017.

Preliminary and unaudited revenue for fourth quarter 2017 is expected to be in the range of $34.2 million to $34.4 million, reflecting approximately 6% growth compared to the prior year period.  Compared to fourth quarter 2016, total U.S. revenue is expected to increase 6% to approximately $31.5 million, with U.S. orthobiologics revenue expected to increase approximately 12% to $16.9 million and U.S. spinal implants revenue expected to be essentially flat at $14.6 million.

Preliminary and unaudited full-year 2017 revenue is expected to be in the range of $132.0 million to $132.2 million, reflecting growth of approximately 2.5% over full-year 2016.

Cash and cash equivalents at December 31, 2017 are expected to be approximately $10.8 million and the Company had no outstanding borrowings under its $30 million credit facility.  The Company did not sell any shares of its common stock under its “at the market” equity offering program during fourth quarter 2017.

“We are encouraged by our revenue growth in the fourth quarter and, in particular, the strong performance of our U.S. orthobiologics franchise,” said Keith Valentine, President and Chief Executive Officer of SeaSpine.  “As we continue to launch innovative products and gain traction with our distributor base, we expect our spinal implants franchise to deliver top line growth in 2018. We are confident that focused execution of our commercial strategy, investments in new products, and our growing distribution network position SeaSpine for sustained and accelerating revenue growth beginning in the second half of 2018.”

2018 Financial Outlook
SeaSpine expects full-year 2018 revenue to be in the range of $135 million to $139 million.

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 instrumentation product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

Forward-Looking Statements
SeaSpine cautions you that statements included in this news release that are not a description of historical facts are forward-looking statements that are based on the Company’s current expectations and assumptions. Such forward-looking statements include, but are not limited to, statements relating to: the spinal implants franchise delivering top line growth in 2018; the Company’s ability to generate sustained and accelerating revenue growth beginning in the second half of 2018; and the Company’s expectations for full-year 2018 revenue.  In addition, this release contains preliminary financial results for fourth quarter and full-year 2017.  Preliminary results for 2017 are provided prior to completion of all internal and external review and audit procedures and therefore are subject to adjustment.  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, including the risk that the Company’s products do not demonstrate adequate safety or efficacy, independently or relative to competitive products, to support expected levels of demand or pricing; 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, whether as a result of inability to reach agreement on financial or other contractual terms or otherwise, disruption to the Company’s existing distribution network as new distributors are added, and the ability of new distributors to generate growth or offset disruption to existing distributors; continued pricing pressure, whether as a result of consolidation in hospital systems, competitors or others, as well as exclusion from major healthcare systems, whether as a result of unwillingness to provide required pricing or otherwise; 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 a limited number of third-party suppliers for 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; the Company’s ability to continue to invest in product development and sales and marketing initiatives at levels sufficient to drive future revenue growth, including as a result of its inability to obtain funding on a timely basis on acceptable terms, or at all; 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 Lewis
(415) 937-5402
ir@seaspine.com

Alphatec Announces Preliminary Fourth Quarter and Full Year 2017 Revenue and Corporate Updates

CARLSBAD, Calif., Jan. 08, 2018 (GLOBE NEWSWIRE) — Alphatec Holdings, Inc. (“Alphatec” or the “Company”) (Nasdaq:ATEC), a provider of innovative spine surgery solutions with a mission to improve patient lives through the relentless pursuit of superior outcomes, today announced preliminary estimates of revenue for the fourth quarter and full year ended December 31, 2017.  The Company also provided several corporate updates.

Preliminary, Unaudited Revenue

Quarter Ended
 December 31, 2017
  Year Ended 
December 31, 2017
Total revenue $25.9 million to $26.3 million $101.4 million to $101.8 million
U.S. commercial revenue $20.8 million to $21.0 million $86.8 million to $87.0 million

During the fourth quarter, preliminary U.S. commercial sales generated by dedicated agents and distributors expanded to more than 40%, in line with expectations, and up significantly from about 5% at the start of the year.

The Company ended the year with a cash balance of approximately $22.5 million. Operating cash burn improved for the fourth consecutive quarter.

“The fourth quarter marked continued execution of our strategy to build top line predictability and sustainability by strengthening the ATEC distribution channel,” said Terry Rich, Chief Executive Officer of Alphatec.  “Our team has substantial work ahead of us as we transform Alphatec, but I am confident that our unmatched organizational spine expertise and relentless dedication to better surgical outcomes will drive continued progress in this new year.”

Closing of Equity Investments in Alphatec Common Shares

In December 2017, the Company generated cash proceeds of $4.0 million as the result of personal financial commitments made by Patrick Miles and Quentin Blackford pursuant to common stock purchase agreements granted in conjunction with their appointments on October 2, 2017. Per the agreements, Mr. Miles purchased 1.3 million shares of common stock and Mr. Blackford purchased 0.4 million shares of common stock, all at a purchase price of $2.26 per share (the consolidated closing bid price of Alphatec common shares on September 29, 2017).

Additional Spine-Experienced Talent Joins Leadership Team

Lance DeNardin Named Area Vice President, West

DeNardin strengthens Alphatec’s distribution channel in the West, contributing his 30 years of expertise in the spine and medical device industry to the sales and distribution transformation that is well underway.  DeNardin has held marketing and sales leadership roles in spine since the mid-1980s, with Stryker, Medtronic and Lanx, Inc., where he was Senior Vice President, responsible for converting the company’s distribution channel to dedicated representation. Most recently, DeNardin was Co-Founder of CareCycle Solutions, an operating room fluid management reprocessing company, and a Partner at Genesis Medical Solutions, LLC, a medical management consulting company.

Michael Dendinger Named Vice President of Operations

Dendinger brings over 20 years of finance, supply chain, and operations experience to the Alphatec operational functions.  He joins the Company from NuVasive, Inc., where he served most recently as Director of Global Operations, following roles as NuVasive’s Ireland Managing Director and Supply Chain Director.  Prior to joining NuVasive, Dendinger held various supply chain and financial management roles at Cymer, Inc. and Intel Corporation.

Scott Lish Named Vice President of Development

With over ten years of experience designing and developing spine and orthopedic solutions, Lish will drive continued advancement of Alphatec’s surgical outcome-focused innovation.  Lish joins Alphatec from NuVasive, Inc., where he was most recently the Director of Development, after advancing through various development and engineering roles during his eight-year tenure.  Prior to joining NuVasive, Lish held engineering roles with Zimmer Dental and Toppan Optical Products, Inc.

Inducement Awards Granted

As an inducement to entering into employment with the Company, the Compensation Committee of the Board of Directors of Alphatec approved the following inducement grants under under Alphatec’s 2016 Employment Inducement Award Plan (the “Plan”):

  • Mr. DeNardin: 25,000 restricted stock units (“RSUs”) and an option to purchase 25,000 shares of common stock at a strike price of $2.49 per share, the fair market value on the grant date.
  • Mr. Dendinger: 25,000 RSUs and an option to purchase 25,000 shares of common stock at a strike price of $3.63 per share, the fair market value on the grant date.
  • Mr. Lish: 25,000 RSUs and an option to purchase 25,000 shares of common stock at a strike price of $3.63 per share, the fair market value on the grant date.

The Compensation Committee approved the grants to Messrs. Dendinger and Lish on November 7, 2017, and the grant to Mr. DeNardin on December 11, 2017.  Under the Plan, the RSUs will vest in equal installments annually over four years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the RSUs will fully vest upon a change in control of Alphatec. The stock options will vest over four years, with 25% of the options vesting on the first anniversary of the date of grant and the remainder of the options vesting monthly over the subsequent three years, assuming in each case the employee remains continuously employed by Alphatec as of such vesting date. In addition, the options will fully vest upon a change in control of Alphatec.

Alphatec is providing this information in accordance with NASDAQ Listing Rule 5635(c)(4).

About Alphatec Holdings, Inc.

Alphatec Holdings, Inc., through its wholly owned subsidiary Alphatec Spine, Inc., is a medical device company that designs, develops, and markets spinal fusion technology products and solutions for the treatment of spinal disorders associated with disease and degeneration, congenital deformities, and trauma. The Company’s mission is to improve lives by providing innovative spine surgery solutions through the relentless pursuit of superior outcomes. The Company markets its products in the U.S. via independent sales agents and a direct sales force.

Additional information can be found at www. atecspine.com.

Disclosure Regarding Preliminary Unaudited Results

The preliminary financial results presented above reflect Alphatec’s estimates based solely upon information available to it as of the date hereof, is not a comprehensive statement of its financial results or position as of or for the three months and full year ended December 31, 2017, and has not been audited, reviewed or compiled by its independent registered public accounting firm, Mayer Hoffman McCann P.C. (“MHM”). Accordingly, MHM does not express an opinion or any other form of assurance with respect thereto. Alphatec’s actual fourth quarter and full year results may differ materially from these estimates. Accordingly, investors should not place undue reliance upon these estimates.

Forward Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainty. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The Company cautions investors that there can be no assurance that actual results or business conditions will not differ materially from those projected or suggested in such forward-looking statements as a result of various factors. Forward-looking statements include the references to the Company’s strategy in significantly repositioning the Alphatec brand and turning the Company into a growth organization.  The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to:  the uncertainty of success in developing new products or products currently in the Company’s pipeline; the uncertainties in the Company’s ability to execute upon its strategic operating plan; the uncertainties regarding the ability to successfully license or acquire new products, and the commercial success of such products; failure to achieve acceptance of the Company’s products by the surgeon community, including Battalion and Arsenal Deformity; failure to obtain FDA or other regulatory clearance or approval for new products, or unexpected or prolonged delays in the process; continuation of favorable third party reimbursement for procedures performed using the Company’s products; unanticipated expenses or liabilities or other adverse events affecting cash flow or the Company’s ability to successfully control its costs or achieve profitability; uncertainty of additional funding; the Company’s ability to compete with other competing products and with emerging new technologies; product liability exposure; an unsuccessful outcome in any litigation in which the Company is a defendant; patent infringement claims; claims related to the Company’s intellectual property and the Company’s ability to meet its financial obligations under its credit agreements and the Orthotec settlement agreement. The words “believe,” “will,” “should,” “expect,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement.  A further list and description of these and other factors, risks and uncertainties can be found in the Company’s most recent annual report, and any subsequent quarterly and current reports, filed with the  Securities and Exchange Commission. Alphatec disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, unless required by law.

Investor/Media Contact:

Lee Roth / Emma Poalillo
The Ruth Group
(646) 536-7000


Company Contact:

Jeff Black
Executive Vice President and Chief Financial Officer
Alphatec Holdings, Inc.

ConforMIS Reports Preliminary Fourth Quarter and Year-End 2017 Revenue Results; Provides 2018 Financial Guidance

BILLERICA, Mass., Jan. 08, 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 joint replacement implants that are customized to fit each patient’s unique anatomy, announced today preliminary, unaudited, revenue results for the fourth quarter and the year ended December 31, 2017.

Expected Q4 Summary:

  • Total revenue of approximately $20.8 million, down 4% year-over-year on a reported basis and 5% on a constant currency basis
  • Product revenue of approximately $20.5 million, down 4% year-over-year on a reported basis and 5% on a constant currency basis
    – U.S. product revenue of approximately $17.7 million, consistent year-over-year
    – Rest of World product revenue of approximately $2.8 million, down 24% year-over-year on a reported basis and 29% year-over-year on a constant currency basis

Expected 2017 Summary:

  • Total revenue of approximately $78.1 million, down 2% year-over-year on a reported and constant currency basis
  • Product revenue of approximately $77.1 million, down 2% year-over-year on a reported and constant currency basis
    – U.S. product revenue of approximately $64.4 million, up 3% year-over-year
    – Rest of World product revenue of approximately $12.7 million, down 23% year-over-year on a reported basis and 22% year-over-year on a constant currency basis

These preliminary results are being provided in advance of the Company’s presentation at the 36th Annual J.P. Morgan Healthcare Conference at the Westin St. Francis Hotel in San Francisco. Mark Augusti, the Company’s President and Chief Executive Officer, will present at the conference at 2:00 p.m. PT on Wednesday, January 10, 2018.

“We expect to achieve the high end of our revenue guidance and are pleased with the Company’s performance to close out our fiscal year,” said Mr. Augusti.

The preliminary unaudited revenue results described in this press release are estimates only and are subject to revision. The Company will report its full financial results, including gross margin, for the fourth quarter and the year ended 2017 on February 7, 2018.

2018 Financial Guidance

For the full year 2018, the Company expects total revenue 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 $79 million to $83 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 $0.6 million related to ongoing patent license royalty payments.

For the full year 2018, the Company expects total gross margin in a range of 44% to 46%.

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.

Earnings Conference Call Details

The Company will release full results for the fourth quarter and the year ended December 31, 2017 via conference call on Wednesday, February 7, 2018 at 4:30 p.m. Eastern Time.

The conference call releasing full quarterly and year end results will be hosted by Mark Augusti, President and Chief Executive Officer and Paul Weiner, Chief Financial Officer.

To participate in the conference call, please call 877-809-6331 (or 615-247-0224 for international) and use conference ID number 4065099 or listen to the webcast in 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 implants and pre-sterilized, single-use instruments delivered in a single package to the hospital. In clinical studies, ConforMIS iTotal CR demonstrated superior clinical outcomes, including better function and greater patient satisfaction, compared to traditional, off-the-shelf implants. ConforMIS owns or exclusively in-licenses approximately 420 issued patents and pending patent applications that cover customized implants and 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 ir.conformis.com.

Cautionary Statement Regarding Forward-Looking Statements

Statements in this press release about our future expectations, plans and prospects, including statements about our financial position and results, total revenue, product revenue, gross margin, 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 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.

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