PARIS–(BUSINESS WIRE)–EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI), the pioneer in 2D/3D orthopaedic medical imaging, today announced its consolidated sales revenue for the fourth quarter and full year ended December 31, 2017. Sales in the last quarter amounted to €12.2 million, up 22% from the fourth quarter of 2016. Excluding the impact of the exchange rate, the fourth quarter sales across North America, Middle East Europe and Asia Pacific grew 35%.

Marie Meynadier, CEO of EOS imaging, said: “2017 was a year of execution in which we delivered sustainable top-line growth while significantly reshaping our presence in North America, the most strategic market for our Company. The important commercial investment we made there in 2017 has enabled us to set up a first-rate organization, and is already reflected in our significant growth in the fourth quarter. Our remarkable progress in the Europe-Middle East and Asia-Pacific regions, with 45% and 83% respective growth in 2017, continues to demonstrate the demand for our solutions from hospitals and health professionals worldwide. We approach 2018 very confident in our ability to accelerate our growth in all our priority markets and continue to deploy EOS as a standard of care.”

• Sales Trend by Product Line

EOS imaging recorded annual revenue of €37.1 million, up 21% compared to the full year 2016. The Company sold 77 EOS® systems in 2017, compared to 60 in the same period last year. Revenue from equipment sales was €30.0 million, up 20% compared to 2016.

Recurring revenues grew 25% to €7.1 million. They include €6.0 million maintenance revenue and €1.2 million revenue of consumables and services. Recurring revenues in 2017 represented 19% of total sales, compared to 18% of total sales in 2016.

• Full Year 2017 Sales by Geography: strong momentum in priority markets

In 2017, EOS imaging’s sales in Europe, Middle East and Africa grew 45% to €16.6 million and accounted for 45% of the Company’s sales, compared to 37% in 2016.

Following the reorganization and strengthening of the second and third quarters, North America resumed 40% growth in the last quarter, in line with the growth observed in 2016. North America sales in USD increased by 53% in the fourth quarter. For the whole year, sales amounts to €14.6 million and represent 39% of total sales, compared with 50% in 2016.

Asia Pacific sales grew 83% to €5.9 million, notably due to the China and Australia markets.

There was no sale in Latin America, which was not a priority area of exploration. Excluding Latin America, full year revenue increased 24% and fourth quarter revenue increased 32% (35% at constant exchange rate).

• Quarterly Sales by Product Line

EOS imaging sold 26 systems and recorded revenue of €12.2 million in the fourth quarter of 2017.

• Amendment of the Company Financing Agreement with IPF

In order to secure and accelerate sales growth in 2018, EOS imaging entered into an amendment with International Personal Finance (IPF) to modify the terms of its ongoing financing agreement. As part of the amendment, the amortization of the first three tranches is suspended from December 2017 until June 2019 and the last repayment is deferred from December 2020 to June 2022. In addition, a new tranche of €5.0 million can be subscribed by the end of June 2018 with amortization between December 2021 and December 2022 (60% bullet) under conditions comparable to those of the previous tranche and no additional warrant issuance.

For more information, please visit www.eos-imaging.com.

EOS imaging has been chosen to be included in the new EnterNext© PEA-PME 150 index, composed of 150 French companies and listed on Euronext and Alternext markets in Paris.

EOS imaging is listed on Compartment C of Euronext Paris
ISIN: FR0011191766 – Ticker: EOSI

About EOS imaging

EOS imaging designs, develops, and markets EOS^®, an innovative medical imaging system dedicated to osteoarticular pathologies and orthopaedics, as well as associated solutions. The Company is authorized to market in 51 countries, including the United States (FDA), Japan and the European Union (EC). The Group posted 2017 sales of €37.1 million and employs 152 people at December 2017. The Group is based in Paris and has five subsidiaries in Besançon (France), Cambridge (Massachusetts), Montreal (Canada), Frankfurt (Germany) and Singapore.

Next press release: 2017 Results and Q1 Sales, April 11, 2018 (after market close)

ERAGNY-SUR-OISE, France–(BUSINESS WIRE)–Regulatory News:

SAFE ORTHOPAEDICS (Paris:SAFOR) (FR0012452746 – SAFOR), a company specialized in the design and marketing of single-use implants and instruments facilitating the minimally invasive treatment of spinal fracture conditions, is today announcing its revenues for the fourth quarter of 2017 and for the financial year ended to December 31, 2017, together with its cash position at December 31, 2017.

“In 2017, we successfully continued our commercial realignment to focus on both the fastest-growing regions, such as France and Germany, and on the most promising technologies, such as the minimally invasive treatment of spinal fractures”, said Pierre Dumouchel, Chief Executive Officer and co-founder of Safe Orthopaedics. “Our adjusted¹ revenues recorded strong growth of 37%, while the steady pace of additions to our sales and marketing teams, which now account for 45% of our headcount, continues to pay off handsomely. Following on recent recruitments, we expect to maintain this strong growth momentum during 2018, as well as launching new technologies to provide even safer treatment options for vertebral fractures.”

Adjusted revenues¹ in the financial year to December 31, 2017 came to €3,110 K, representing a strong increase of 37% compared to the previous year.

The robust top-line growth continued in France, with sales totaling €1,582 K versus €1,182 K in 2016. That represents an increase of 34% over the full year and of 36% in the fourth quarter of 2017. In the second half of 2017, Safe Orthopaedics hired two new sales representatives, who will have a positive impact on business in 2018.

Sales in the Rest of the world (excluding United States) continued to grow, with the top line advancing 41% to €1,527 K in 2017. High growth was mainly generated by longstanding distributors and rapid expansion in Latin America. Following very strong revenue growth in the third quarter, orders were affected by a minor catch-up effect in the fourth quarter due to a business contraction in the Middle East. As a result, Safe Orthopaedics decided together with its distributor to respond by introducing fresh commercial initiatives to revitalize sales in the region in 2018. During the fourth quarter of 2017, Safe Orthopaedics also hired a 25year experience sales manager covering export markets.

Safe Orthopaedics expanded into Germany during 2017, and the company intends to extend its French in selling its products on this territory. A team of sales Director and two sales representatives was hired to develop business in Germany. Their knowledge of the local market and their long experience in the spinal surgery sector will be valuable assets for its development. Safe Orthopaedics also attended the DWG German Spine Congress, during which the company presented its innovative product ranges and comforted its position on the German market.

Safe Orthopaedics reinforced its marketing team and implemented a European action plan. Plan will be mostly focused on boosting sales support and provide surgeons with a number of training courses to treat vertebral fractures.

Cash position

At December 31, 2017, Safe Orthopaedics had €3,725 thousands in available cash, compared with €3,664 thousands at December 31, 2016. Its cash position was strengthened by the successful completion in June 2017 of a €5.8 million rights issue. The capital it raised gave Safe Orthopaedics the requisite additional resources to bolster its French and international sales teams and to convince surgeons of the benefits of single-use instruments in each market segment.

Next report:

• Full-year 2017 results on Monday, April 30, 2018 (before the market opening)
• First-quarter 2018 revenues: Monday, May 14, 2018 (after the market close)

About Safe Orthopaedics

Founded in 2010, Safe Orthopaedics is a French medical technology company that offers the safest technologies to treat spinal fracture. Delivered sterile, all implants and respective disposable instrumentation are available to the surgeon at any time, any place. These technologies enable minimally invasive approaches, reducing risks of cross contamination and infection in the interest of the patient. Protected by 17 patent families, the SteriSpine™ Kits are CE marked and FDA cleared. The company is based at Eragny-Sur-Oise (France), and has 34 employees.
For more information, visit: www.SafeOrtho.com

¹ Revenues adjusted for operations discontinued in the United States since March 1, 2016

LYON, France & New York–(BUSINESS WIRE)–The MEDICREA Group (Euronext Growth: FR0004178572 – ALMED), pioneering the convergence of healthcare IT and next-generation, outcome-centered device design and manufacturing with UNiD^™ ASI technology, today announced full year 2017 sales.

_{Changes in exchange rates had a negative impact of 1% on year-to-year comparison}

The Group reported varied commercial performance depending on the geographic area:

• In France, under stable market conditions, Medicrea achieved a turnover of 6 million euros in 2017, up 15% compared to 2016 driven by the adoption of its UNiD^™ ASI technology by a growing number of surgeons.
• Following the need to regain registration for all products in the range with the Brazilian health authorities and obtain validation of the new manufacturing facility, no sales were made in this market during 2017 (turnover of 2 million euros in 2016). Since the authorizations were re-issued in December, the activity should return to a normative level from 2018. Excluding Brazil, the distribution business grew by 6%, generating a turnover of 3.6 million euros.
• In the United States, the Group’s primary market, the commercial efforts in 2017 focused exclusively on the development of the UNiD^™ ASI patient-specific implant technology and resulted in a 36% increase in the number of surgeries performed (472) compared to 2016, generating a revenue of $8.3 million ($7.2 million in 2016). Overall, sales in the U.S. were down 8% due to a downswing in the traditional sales activity with historic products, which no longer represents a strategic objective.

“We have invested heavily in 2017 in the development and adoption of our UNiD^™ ASI technology, particularly in the United States, where the sales and marketing teams have been mobilized to deploy tools and services that will provide surgeons with advanced treatment solutions, fully planned and customized for each patient, focused on improving clinical outcomes. This development has a distinct impact on the development of our sales in our priority market, but given our success in France, where we have tested, prepared and refined our strategy, I am convinced that the pace of our technology’s adoption will increase significantly in the United States in the coming quarters. The recent FDA clearances for our new PASS TULIP^® fixation system and our 3D-printed titanium interbody devices will allow us to take a position on markets where we were not yet present and thus expand our business,” stated Denys Sournac, President and CEO of Medicrea.

Equity financing

On December 22, 2017, MEDICREA raised €7.2 million in ABSA (ordinary shares with warrants attached) from US institutional investors. The exercise of all warrants would generate additional proceeds of €3.7 million.

Next publication: 2017 Annual results: March 27, 2018, after market.

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 150,000 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: www.medicrea.com

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

Medicrea is listed on
EURONEXT Growth Paris
ISIN: FR 0004178572
Ticker: ALMED
LEI: 969500BR1CPTYMTJBA37

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.

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 onTrack^™mobile 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.