Medtronic Reports Third Quarter Financial Results

Posted On February 23, 2018 By OrthoSpineNews In Financial /

DUBLIN – February 20, 2108 – Medtronic plc (NYSE: MDT) today announced financial results for its third quarter of fiscal year 2018, which ended January 26, 2018.

The company reported third quarter worldwide revenue of $7.369 billion, an increase of 1 percent as reported, or 7 percent on a comparable, constant currency basis, which adjusts for the divestiture of its Patient Care, Deep Vein Thrombosis (Compression), and Nutritional Insufficiency businesses to Cardinal Health that occurred in the second quarter, and a $177 million positive impact from foreign currency.

As reported, third quarter GAAP net loss and loss per share (LPS) were $1.389 billion and $1.03, respectively. GAAP results included a $2.2 billion net charge primarily related to the U.S. transition tax charge as part of U.S. tax reform. As detailed in the financial schedules included through the link at the end of this release, third quarter non-GAAP net income and diluted EPS were $1.592 billion and $1.17, increases of 3 percent and 4 percent, respectively. Adjusting for the divestiture and a negative 1 cent impact from foreign currency, third quarter non-GAAP diluted EPS increased 12 percent.

Third quarter U.S. revenue of $3.912 billion represented 53 percent of company revenue and decreased 5 percent as reported, or increased 6 percent on a comparable basis. Non-U.S. developed market revenue of $2.355 billion represented 32 percent of company revenue and increased 7 percent as reported, or 5 percent on a comparable, constant currency basis. Emerging market revenue of $1.102 billion represented 15 percent of company revenue and increased 12 percent on both a reported and a comparable, constant currency basis.

“Our results reflect a solid quarter for Medtronic, and as we expected, a strong turnaround from the first half of our fiscal year,” said Omar Ishrak, Medtronic chairman and chief executive officer. “We continue to execute on our broad, sustainable growth strategy, driving therapy innovation and global market penetration, while delivering enterprise synergies to enable margin improvement.”

Cardiac and Vascular Group
The Cardiac and Vascular Group (CVG) includes the Cardiac Rhythm & Heart Failure (CRHF), Coronary & Structural Heart (CSH), and Aortic & Peripheral Vascular (APV) divisions. CVG worldwide third quarter revenue of $2.800 billion increased 10 percent, or 7 percent on a constant currency basis. CVG revenue performance was driven by strong, mid-teens growth in CSH and mid-single digit growth in CRHF and APV, all on a constant currency basis.

CRHF third quarter revenue of $1.457 billion increased 6 percent, or 4 percent on a constant currency basis. Arrhythmia Management grew in the low-single digits on a constant currency basis, driven by high-teens constant currency growth in AF Solutions, as well as strong adoption of the Micra^® Transcatheter Pacing System and TYRX^® absorbable antibacterial envelope. Heart Failure grew in the mid-single digits on a constant currency basis, driven by strong double digit constant currency growth in Mechanical Circulatory Support from sales of the HVAD(TM) System, as well as continued solid demand for the company’s portfolio of quadripolar cardiac resynchronization therapy pacemakers (CRT-P).
CSH third quarter revenue of $886 million increased 18 percent, or 14 percent on a constant currency basis, led by low-thirties constant currency growth in transcatheter aortic valves on the strength of the CoreValve^® Evolut^® PRO and U.S. intermediate risk indication. Coronary grew in the low-double digits on a constant currency basis, driven by strong demand for the company’s Resolute Onyx(TM) drug-eluting stent in the U.S. and Japan.
APV third quarter revenue of $457 million increased 7 percent, or 5 percent on a constant currency basis. Aortic grew in the low-single digits on a constant currency basis, driven by the performance of the Valiant^® Captivia^® thoracic stent graft system. Peripheral grew in the mid-single digits on a constant currency basis, driven by double digit growth in both PTA balloons and drug-coated balloons. High-single digit growth in endoVenous was driven by a strong performance of the VenaSeal(TM) closure system.

Minimally Invasive Therapies Group
The Minimally Invasive Therapies Group (MITG) includes the Surgical Innovations (SI) and the Respiratory, Gastrointestinal & Renal (RGR) divisions. MITG worldwide third quarter revenue of $2.041 billion decreased 16 percent as reported, or increased 6 percent on a comparable, constant currency basis. MITG revenue performance was driven by high-single digit growth in SI and low-single digit growth in RGR, both on a comparable, constant currency basis.

SI third quarter revenue of $1.384 billion increased 7 percent on a comparable, constant currency basis, driven by growth from new products in Advanced Energy and Advanced Stapling, including LigaSure(TM) vessel sealing instruments with nano-coating, endo stapling specialty reloads, and the Signia(TM) powered stapler.
RGR third quarter revenue of $657 million increased 3 percent on a comparable, constant currency basis. GI and Hepatology grew in the low-double digits on a comparable, constant currency basis, with strength across the GI therapeutics, diagnostics, and ablation product lines. Respiratory and Patient Monitoring grew in the low-single digits on a comparable, constant currency basis, with strength in Nellcor(TM) pulse oximetry sensors given the strong incidence of influenza in the U.S.

Restorative Therapies Group
The Restorative Therapies Group (RTG) includes the Spine, Brain Therapies, Specialty Therapies, and Pain Therapies divisions. RTG worldwide third quarter revenue of $1.944 billion increased 7 percent, or 5 percent on a constant currency basis. Group results were driven by low-double digit growth in Brain Therapies, high-single digit growth in Pain Therapies, and mid-single digit growth in Specialty Therapies, offsetting flat results in Spine, all on a constant currency basis.

Spine third quarter revenue of $661 million increased 1 percent, or was flat on a constant currency basis. Mid-single digit constant currency growth in bone morphogenetic protein (BMP) partially offset low-single digit declines in Core Spine, which were consistent with the Core Spine market.
Brain Therapies third quarter revenue of $585 million increased 13 percent, or 10 percent on a constant currency basis. Neurovascular grew in the high-teens on a constant currency basis, with strength across its stroke product portfolio. Neurosurgery grew in the low-double digits on a constant currency basis, led by strong sales of the StealthStation^® S8 surgical navigation system and O-arm^®2 surgical imaging system.
Specialty Therapies third quarter revenue of $398 million increased 8 percent, or 6 percent on a constant currency basis. High-single digit growth in Pelvic Health and ENT was partially offset by low-single digit declines in Transformative Solutions, all on a constant currency basis.
Pain Therapies third quarter revenue of $300 million increased 10 percent, or 8 percent on a constant currency basis. The division returned to growth on the strength of the recently launched Intellis(TM) platform for spinal cord stimulation, as well as growth in drug pumps.

Diabetes Group
The Diabetes Group includes the Intensive Insulin Management (IIM), Diabetes Service & Solutions (DSS), and Non-Intensive Diabetes Therapies (NDT) divisions. Diabetes Group worldwide third quarter revenue of $584 million increased 17 percent, or 13 percent on a constant currency basis. The group is experiencing strong global demand for its new sensor-augmented insulin pump systems, and has made great progress on its ability to meet this demand, as evidenced by the improved sequential revenue growth.

IIM third quarter revenue grew in the high-teens on a constant currency basis, driven by the U.S. launch of the MiniMed^® 670G hybrid closed loop insulin pump system with the Guardian^® sensor 3 CGM. In international markets, IIM delivered low-twenties constant currency growth on the continued strength of the MiniMed^® 640G system.
DSS third quarter revenue grew in the mid-single digits on a constant currency basis, with growth in consumables benefitting from customer base growth and improved patient utilization.
NDT third quarter revenue declined in the mid-single digits on a constant currency basis, given the commercial focus on the MiniMed^® 670G launch and competitive pressures.

Guidance
Medtronic today reiterated its fiscal year 2018 revenue and non-GAAP guidance. The company’s guidance is given on a comparable, constant currency basis, which accounts for the divestiture of certain businesses from its prior period Patient Monitoring & Recovery division by removing the financial impact of these businesses from the second, third, and fourth quarters of fiscal year 2017, as well as removing the impact of foreign currency.

In fiscal year 2018, the company continues to expect comparable, constant currency revenue growth to be in the range of 4 to 5 percent. While the impact of foreign currency remains fluid, if current exchange rates remain similar for the remainder of the fiscal year, the company’s revenue would be positively affected by approximately $480 million to $500 million for the fiscal year, including an approximate $300 to $320 million positive impact in the fourth fiscal quarter.

In fiscal year 2018, the company continues to expect diluted non-GAAP EPS growth to be in the range of 9 to 10 percent on a comparable, constant currency basis from the prior year comparable EPS of $4.37. Assuming current exchange rates remain similar for the rest of the year, the foreign exchange impact on the company’s non-GAAP EPS would be approximately negative 4 cents for the fiscal year, including an approximate 2 cent negative impact in the fourth fiscal quarter.

“Looking ahead, we are confident in our ability to deliver mid-single digit constant currency revenue growth and strong constant currency EPS leverage, this fiscal year and beyond,” said Ishrak. “We remain keenly focused on executing to deliver dependable results as we continue to leverage our global diversification and scale to fulfill our Mission of alleviating pain, restoring health, and extending life for millions of people around the world.”

Webcast Information
Medtronic will host a webcast today, February 20, at 8:00 a.m. EST (7:00 a.m. CST) to provide information about its businesses for the public, analysts, and news media. This quarterly webcast can be accessed by clicking on the Investor Events link at investorrelations.medtronic.com and this earnings release will be archived at newsroom.medtronic.com. Medtronic will be live tweeting during the webcast on our Newsroom Twitter account, @Medtronic. Within 24 hours of the webcast, a replay of the webcast and transcript of the company’s prepared remarks will be available by clicking on the Investor Events link at investorrelations.medtronic.com.

Financial Schedules
To view the third quarter financial schedules and non-GAAP reconciliations, click here. To view the third quarter earnings presentation, click here. Both documents can also be accessed by visiting newsroom.medtronic.com.

About Medtronic
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 84,000 people worldwide, serving physicians, hospitals and patients in approximately 160 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.

FORWARD LOOKING STATEMENTS
This press release contains forward-looking statements, which are subject to risks and uncertainties, including those described in Medtronic’s periodic reports and other filings with the U.S. Securities and Exchange Commission (the “SEC”). Anticipated results only reflect information available to Medtronic at this time and may differ from actual results. Medtronic does not undertake to update its forward-looking statements or any of the information contained in this press release. Certain information in this press release includes calculations or figures that have been prepared internally and have not been reviewed or audited by our independent registered public accounting firm, including but not limited to, certain information in the financial schedules accompanying this press release. Use of different methods for preparing, calculating or presenting information may lead to differences and such differences may be material.

NON-GAAP FINANCIAL MEASURES
This press release contains financial measures and guidance, including growth rates on a comparable, constant currency basis and adjusted net income, and diluted EPS, which are considered “non-GAAP” financial measures under applicable SEC rules and regulations. References to quarterly figures increasing or decreasing are in comparison to the third quarter of fiscal year 2017.

Medtronic management believes that non-GAAP financial measures provide information useful to investors in understanding the company’s underlying operational performance and trends and to facilitate comparisons with the performance of other companies in the med tech industry. Non-GAAP net income and diluted EPS exclude the effect of certain charges or gains that contribute to or reduce earnings but that result from transactions or events that management believes may or may not recur with similar materiality or impact to operations in future periods (Non-GAAP Adjustments). Medtronic generally uses non-GAAP financial measures to facilitate management’s review of the operational performance of the company and as a basis for strategic planning. Non-GAAP financial measures should be considered supplemental to and not a substitute for financial information prepared in accordance with U.S. generally accepted accounting principles (GAAP), and investors are cautioned that Medtronic may calculate non-GAAP financial measures in a way that is different from other companies. Management strongly encourages investors to review the company’s consolidated financial statements and publicly filed reports in their entirety. Reconciliations of the non-GAAP financial measures to the most directly comparable GAAP financial measures are included in the financial schedules accompanying this press release.

Medtronic calculates forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures. For instance, forward-looking revenue growth and EPS projections exclude the impact of foreign currency fluctuations. Forward-looking non-GAAP EPS guidance also excludes other potential charges or gains that would be recorded as Non-GAAP Adjustments to earnings during the fiscal year. Medtronic does not attempt to provide reconciliations of forward-looking non-GAAP EPS guidance to projected GAAP EPS guidance because the combined impact and timing of recognition of these potential charges or gains is inherently uncertain and difficult to predict and is unavailable without unreasonable efforts. In addition, we believe such reconciliations would imply a degree of precision and certainty that could be confusing to investors. Such items could have a substantial impact on GAAP measures of financial performance.

-end-

View FY18 Third Quarter Financial Schedules & Non-GAAP Reconciliations
View FY18 Third Quarter Earnings Presentation

Contacts:
Fernando Vivanco
Public Relations
+1-763-505-3780

Ryan Weispfenning
Investor Relations
+1-763-505-4626

Amplitude Surgical: Further Strong Organic Growth in Q2, +10% – H1 2017-18 Sales of €45 Million, +8%

Posted On February 23, 2018 By OrthoSpineNews In Financial /

February 22, 2018 12:00 PM Eastern Standard Time

VALENCE, France–(BUSINESS WIRE)–Regulatory News:

Amplitude Surgical (ISIN: FR0012789667, Ticker: AMPLI, PEA-PME eligible) (Paris:AMPLI), a leading French player on the global surgical technology market for lower-limb orthopedics, today announces its sales for the first half of its 2017-18 financial year.

Olivier Jallabert, Chairman and CEO of Amplitude Surgical, says: “Quarter after quarter, our growth is continuing at a strong pace. The successful implementation of our strategy, our international deployment with a portfolio of innovative products and the strong mobilization of our teams, will allow Amplitude Surgical to record sales in excess of €100 million this year. With double-digit growth in our subsidiaries and the upcoming launch of the commercialization of our hip and knee prostheses on the American market, our target of doubling our sales in 5 years (to June 2021) is on track”.

H1 2017-18 sales	31/12/2017	31/12/2016	Δ actual	Δ constant currency
€ thousands – IFRS	31/12/2017	31/12/2016	Δ actual	Δ constant currency
France	28,019	25,923	8.1%	8.1%
International	16,643	15,960	4.3%	8.2%
of which: Subsidiaries	12,848	11,470	12.0%	17.5%
of which: Distributors	3,795	4,490	-15.5%	-15.4%
Total	44,662	41,883	6.6%	8.1%

Q2 2017-18 sales	31/12/2017	31/12/2016	Δ actual	Δ constant currency
€ thousands – IFRS	31/12/2017	31/12/2016	Δ actual	Δ constant currency
France	17,228	15,434	11.6%	11.6%
International	9,242	9,181	0.7%	6.2%
of which: Subsidiaries	6,779	6,376	6.3%	14.2%
of which: Distributors	2,463	2,805	-12.2%	-12.1%
Total	26,471	24,615	7.5%	9.6%

Over the 1^st half (July to December) of its 2017-18 financial year, Amplitude Surgical recorded sales of €44.7 million, up +6.6%. At constant currency, the increase was +8.1% over the first half and +9.6% over the second quarter, a significant acceleration compared with the +6.1% growth recorded in the first quarter.

The Group’s performance remained affected by a high basis for comparison (+19.8% at constant currency in H1 2016-17); thus, at constant currency, the average half-yearly growth over the last two years was close to +14%.

On the French market, half-year sales totaled €28 million, up +8.1%, with sales for the second quarter alone increasing by +11.6% to €17.2 million. This performance incorporates a 3.5% decrease applied to all implants in August 2017, on the initiative of the previous Health Minister (CEPS, the Economic Committee for Healthcare Products that governs pricing). Furthermore, the recent acquisition of commercial agents directly managing key regions in Eastern France and the Paris area will soon have a positive impact while enabling Amplitude Surgical to strengthen our sales presence in these regions.
The Group’s international activity also recorded solid growth over the half: +8.2% at constant currency to €16.7 million. This performance was driven by the growth of the Group’s subsidiaries, notably in Europe and in Australia, whose sales totaled €12.9 million, up 17.5% at constant currency, and accounted for 77% of international sales. Our distributors’ activity suffered from a very high basis for comparison (+65.5% in H1 2016-17) and thus fell -15.4%. Amplitude Surgical’s direct activity – the French market and international subsidiaries – increased by +11% at constant currency and accounted for almost 92% of total Group sales.
Novastep, which markets innovative solutions for extremities (foot and ankle) surgery, saw its sales continue to grow, notably in France (+38%), with international sales accounting for 60% of its total sales over the first half. Globally, 4 years after its first products were marketed, Novastep’s activity accounts for over 7% of Amplitude Surgical’s sales.

Moreover, Amplitude Surgical has a solid financial structure, with Cash & Cash Equivalents of almost €34 million at end-December 2017.

Upcoming event

Within the framework of establishing a sales network in the United States, Amplitude will again participate in the AAOS (American Academy of Orthopaedic Surgeons) Annual Meeting, from March 6 to 10, 2018 in New Orleans.

Next financial press release: H1 2017-18 results, on Wednesday March 28, 2018, after market.

About Amplitude Surgical
Founded in 1997 in Valence, France, Amplitude Surgical is a leading French player on the global surgical technology market for lower-limb orthopedics. Amplitude Surgical develops and markets high-end products for orthopedic surgery covering the main disorders affecting the hip, knee and extremities, and notably foot and ankle surgery. Amplitude Surgical develops, in close collaboration with surgeons, numerous high value-added innovations in order to best meet the needs of patients, surgeons and healthcare facilities. A leading player in France, Amplitude Surgical is developing abroad through its subsidiaries and a network of exclusive distributors and agents distributing its products in more than 30 countries. Amplitude Surgical operates on the lower-limb market through the intermediary of its Novastep subsidiaries in France and the United States. At June 30, 2017, Amplitude Surgical had a workforce of nearly 370 employees and recorded sales of over 93 million euros.

Contacts

Amplitude Surgical
Philippe Garcia, +33 (0)4 75 41 87 41
CFO
finances@amplitude-surgical.com
or
NewCap
Investor Relations
Marc Willaume, +33 (0)1 44 71 00 13
amplitude@newcap.eu
or
NewCap
Media Relations
Nicolas Merigeau, +33 (0)1 44 71 98 55
amplitude@newcap.eu

Centinel Spine and Performance Tech Announce Plan for a Season of Success

Posted On February 22, 2018 By OrthoSpineNews In Spine /

NEW YORK, Feb. 22, 2018 /PRNewswire/ — Centinel Spine, LLC is pleased to announce that it has extended an endorsement agreement with Performance Tech Motorsports for the entirety of the 2018 IMSA WeatherTech SportsCar Championship season. Centinel Spine first joined the Performance Tech family in January for the Rolex 24 At Daytona. This partnership will support the creation of a platform to educate the public on spinal disease and options that allow individuals to continue to function at a high level.

Centinel Spine, the pioneer of the No-Profile®, Integrated Interbody™ has a 30 year global clinical history of success behind these devices for treatment of degenerative disc disease. The company recently announced the acquisition of the worldwide assets of the prodisc® Total Disc Replacement portfolio. The prodisc line of products represents the most extensive total disc replacement (TDR) portfolio in the world with the longest history of use. The acquisition is the next step in the evolution of Centinel Spine executing on its mission to become the worldwide leading company addressing spinal disease through anterior access to the spine with the widest breadth and depth of technology platforms.

Performance Tech opens up a new type of athlete and patient population that Centinel Spine Chairman & CEO John Viscogliosi can reach and educate. Performance Tech and Team Principal Brent O’Neill are readily supplying athletes to Centinel Spine for examples of athleticism and the wear of high performance endurance.

“Centinel Spine is really an amazing company,” O’Neill said. “Everything they do to give people life after spinal disease is important. If you’re in a sport long enough or in racing long enough, you’ll have an injury and a lot of times it’s to the spine. This is as important to my drivers as it is my crew guys—you can’t do anything with a bad back. Having them as a sponsor is as much about helping a good cause as it is anything else. John and everyone at Centinel are great people and we’re excited to build something with them.”

Centinel Spine is making it an essential goal for 2018 to educate the public, not just the surgeons using its products. Viscogliosi has aligned the company with Performance Tech, as well as PGA Tour golfers, to help reach the masses. Performance Tech will play a primary role in creating the Centinel Spine platform. Viscogliosi is planning on learning as much from Performance Tech as he is educating.

“We are excited to extend our partnership with Performance Tech and continue to get the word out that Centinel Spine has solutions to address spine disease and to allow individuals get their lives back and function at a high level,” Viscogliosi. “The teamwork and commitment to excellence exhibited by the Performance Tech team at the Rolex 24 At Daytona last month confirmed that this is the right partnership to support our mission to raise awareness that spinal injury or disease does not need to result in a change in lifestyle. We are proud to be part of the Performance Tech family and look forward to working as a team to better educate race fans and the general public.”

Viscogliosi and O’Neill get to work this March for the Mobil 1 Twelve Hours of Sebring Presented by Advance Auto Parts. The race week begins Wednesday, March 14, with the crescendo coming at 10:40 a.m. and p.m. Saturday, March 17. The second installment of the Tequila Patròn North American Endurance Championship will air live on various FOX channels. Viewers can catch the start of the Twelve Hours of Sebring on FOX Sports 1 and the finish on FOX Sports 2.

About Centinel Spine, LLC.

Centinel Spine, LLC. is a privately-held spinal device company leading the development and commercialization of the No- Profile, Integrated Interbody fusion technologies. The company recently acquired the prodisc® Total Disc Replacement portfolio, an extensive cervical and lumbar disc replacement platform with the longest history of global clinical use. For more information on Centinel Spine products and technologies, please visit the Company’s website at www.CentinelSpine.com.

The Company began operations in August 2008, through the merger-acquisition of two pioneering medical device companies: Raymedica LLC and Surgicraft LTD. Today, Centinel Spine still embraces the pioneering culture developed at both originating companies and continues its corporate mission of becoming the leading anterior column reconstruction spine franchise, providing elegantly simple implants and instruments that are tissue-sparing and generate superior clinical outcomes.

Centinel Spine derived its name from the “Sentinel Sign” the radiographic confirmation of a successful fusion anterior to the interbody device.

For more information, please contact:

Varun Gandhi
SVP, Corporate Finance & Strategic Planning Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8871
Email: v.gandhi@centinelspine.com

Wendy F. DiCicco
Chief Operating and Chief Financial Officer Centinel Spine, LLC
900 Airport Road, Suite 3B
West Chester, PA 19380
Phone: 484-887-8837
Email: w.dicicco@centinelspine.com

LBL 444 Rev 1 (02/2018)

SOURCE Centinel Spine

Related Links
http://www.centinelspine.com

Astura Medical Announces Initial Cases and Full Commercial Release For BRIDALVEIL OCT Stabilization System

Posted On February 22, 2018 By OrthoSpineNews In Spine, Top Stories /

CARLSBAD, CA – February 21, 2018 – Astura Medical, a high growth, innovative spine technology company, announced today the completion of the initial surgeries and full commercial release for its BRIDALVEIL Occipital-Cervico-Thoracic (OCT) System. The first cases were successfully completed at multiple hospitals across the country, including at the University of Colorado Hospital by Dr. David Ou-Yang, Assistant Professor of Orthopedics.

“Our practice addresses a wide range of complex conditions, so I’m always looking for the most advanced technology to meet our surgical demands,” said Dr. Ou-Yang. “Bridalveil OCT has not only met those demands, but it has continued to exceed my expectations. The versatility of the instrumentation, coupled with the breadth of implants offered has enhanced our ability to treat even the most complex cases. It is the most comprehensive and one of the most user friendly posterior cervical systems I’ve used from any company, large or small.”

“We are extremely proud of the feedback and success we’ve seen with Bridalveil OCT since our initial release of the system,” said Joel Gambrell, President and CEO of Astura Medical. “It allows us to continue to expand upon our goal of providing market leading technology to our growing network of surgeon and distributor partners.”

Designed with the most complex and demanding cases in mind, BRIDALVEIL OCT provides a comprehensive offering of screw options (single-lead, dual-lead, high-top, and smooth shank) ranging from 3.5mm to 5.5mm in diameter that are compatible with either a 3.5mm or 4.0mm rod in titanium or cobalt chrome. The system additionally provides an extensive line of connectors, transition rods, and instrumentation options to allow surgeons the ability to seamlessly transition across multiple segments of the spine.

About Astura Medical
Astura Medical was formed in 2014 with the objective of creating a disciplined, multi-phased approach to developing, manufacturing, and distributing medical devices. With surgeon input and feedback at every stage of development, Astura has created an extensive line of devices of the highest quality and sleekest design.

The two essential pillars that contribute to Astura Medical’s success are high quality products and robust distribution channels. These pillars, combined with passion and innovation, are what drive the Astura team to achieve great success with developing devices and entering them into the marketplace.

For more information, please visit www.asturamedical.com or find us on LinkedIn.

Media Contact:
Steve Haayen
Astura Medical
858.472.8825
steve@asturamedical.com

SeaSpine to Report Fourth Quarter and Full Year 2017 Financial Results on February 28, 2018

Posted On February 22, 2018 By OrthoSpineNews In Financial /

CARLSBAD, Calif., Feb. 21, 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 that it will release fourth quarter and full year 2017 financial results after the close of trading on Wednesday, February 28, 2018. The Company’s management team will host a corresponding conference call beginning at 1:30pm PT / 4:30pm ET to discuss the financial results and recent business developments.

Individuals interested in listening to the conference call may do so by dialing (877) 418-4766 for domestic callers or (614) 385-1253 for international callers, using Conference ID: 7067009. To listen to a live webcast, please visit the Investors section of the SeaSpine website at: www.seaspine.com.

The call will be archived until Thursday March 15, 2018. The audio archive can be accessed by calling (855) 859-2056 in the U.S. or (404) 537-3406 from outside the U.S. The passcode for the audio replay is 70677009.

About SeaSpine

SeaSpine (www.seaspine.com) is a global medical technology company focused on the design, development and commercialization of surgical solutions for the treatment of patients suffering from spinal disorders. SeaSpine has a comprehensive portfolio of orthobiologics and spinal implants solutions to meet the varying combinations of products that neurosurgeons and orthopedic spine surgeons need to perform fusion procedures on the lumbar, thoracic and cervical spine. SeaSpine’s orthobiologics products consist of a broad range of advanced and traditional bone graft substitutes that are designed to improve bone fusion rates following a wide range of orthopedic surgeries, including spine, hip, and extremities procedures. SeaSpine’s spinal implants portfolio consists of an extensive line of products to facilitate spinal fusion in minimally invasive surgery (MIS), complex spine, deformity and degenerative procedures. Expertise in both orthobiologic sciences and spinal implants product development allows SeaSpine to offer its surgeon customers a differentiated portfolio and a complete solution to meet their fusion requirements. SeaSpine currently markets its products in the United States and in over 30 countries worldwide.

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

Globus Medical Reports Full Year and Fourth Quarter 2017 Results

Posted On February 21, 2018 By OrthoSpineNews In Financial /

AUDUBON, Pa., Feb. 21, 2018 (GLOBE NEWSWIRE) — Globus Medical, Inc. (NYSE:GMED), a leading musculoskeletal solutions company, today announced its financial results for the fourth quarter and year ended December 31, 2017.

Fourth Quarter:

Worldwide sales increased 16.1% as reported to $176.0 million
Fourth quarter net income was $24.4 million, or 13.8% of sales, including a one-time tax reform expense of $11.0 million
Diluted earnings per share (EPS) were $0.25
Non-GAAP diluted EPS were $0.38
Non-GAAP adjusted EBITDA was 34.9% of sales

Full Year 2017:

Worldwide sales increased 12.8% as reported to $636.0 million
Net income for the year was $107.3 million, or 16.9% of sales, including a one-time tax reform expense of $11.0 million
Diluted EPS were $1.10
Non-GAAP diluted EPS were $1.31
Non-GAAP adjusted EBITDA was 35.6% of sales

“Fourth quarter sales were a record $176.0 million, a year-over-year increase of 16.1%,” said Dave Demski, CEO. “We also delivered non-GAAP EPS of $0.38, despite increased investments to support our robotics and trauma launches. Sales growth was strong across all parts of the business in the fourth quarter, with U.S. spine up 6.5%, international spine up 16.2% and Imaging, Navigation and Robotics posting revenue for the first time.”

“Full year 2017 sales were $636.0 million, a 12.8% increase over 2016 and non-GAAP EPS was $1.31. In 2017, we not only recorded our first sales of the ExcelsiusGPS™ robotic and navigation system, we also launched 9 new products in spine, received FDA clearance for 10 systems in trauma, further expanded our in-house manufacturing capacity, recruited a record number of competitive sales reps into our U.S. spine sales force, made tremendous progress on the Alphatec International integration, and smoothly completed the CEO transition.”

Fourth quarter sales in the U.S. increased 16.1% compared to the fourth quarter of 2016 as a result of mid-single digit core spine growth plus a successful robotic launch. International sales increased by 16.2% over the fourth quarter of 2016 on an as reported basis.

Fourth quarter GAAP net income was $24.4 million, flat compared to the same period last year including a one-time tax reform expense of $11.0 million. Diluted EPS for the fourth quarter was $0.25, also flat compared to the same period last year. Non-GAAP diluted EPS was $0.38 for the fourth quarter, an increase of 20.6%, compared to $0.31 in the fourth quarter of 2016.

The company generated operating cash flow of $44.8 million and non-GAAP free cash flow of $31.4 million in the fourth quarter of 2017. Full year 2017 operating cash flow was $159.5 million and non-GAAP free cash flow was $107.8 million. Cash, cash equivalents and marketable securities ended the quarter at $429.8 million. The company remains debt free.

2018 Annual Guidance
The company confirms 2018 full year sales of $690 million and non-GAAP fully diluted earnings per share of $1.50.

Conference Call Information
Globus Medical will hold a teleconference to discuss its 2017 fourth quarter and full year results with the investment community at 4:30 p.m. Eastern Time today. Globus invites all interested parties to join the call by dialing:

1-855-533-7141 United States Participants
1-720-545-0060 International Participants
There is no pass code for the teleconference.

For interested parties who do not wish to ask questions, the teleconference will be webcast live and may be accessed through a link on the Globus Medical website at investors.globusmedical.com.

The call will be archived until Wednesday, February 28, 2018. The audio archive can be accessed by calling 1-855-859-2056 in the U.S. or 1-404-537-3406 from outside the U.S. The passcode for the audio replay is 716-5819.

About Globus Medical, Inc.
Based in Audubon, Pennsylvania, Globus Medical, Inc. was founded in 2003 by an experienced team of professionals with a shared vision to create products that enable surgeons to promote healing in patients with musculoskeletal disorders. Additional information can be accessed at www.globusmedical.com.

Non-GAAP Financial Measures
To supplement our financial statements prepared in accordance with U.S. generally accepted accounting principles (“U.S. GAAP”), management uses certain non-GAAP financial measures. For example, non-GAAP adjusted EBITDA, which represents net income before interest income, net and other non-operating expenses, provision for income taxes, depreciation and amortization, stock-based compensation, provisions for litigation, technology in-licensing fee, and acquisition related costs, is useful as an additional measure of operating performance, and particularly as a measure of comparative operating performance from period to period, as it is reflective of changes in pricing decisions, cost controls and other factors that affect operating performance, and it removes the effect of our capital structure, asset base, income taxes and interest income and expense. Our management also uses non-GAAP adjusted EBITDA for planning purposes, including the preparation of our annual operating budget and financial projections. Provision for litigation represents costs incurred for litigation settlements or unfavorable verdicts when the loss is known or considered probable and the amount can be reasonably estimated, or in the case of a favorable settlement, when income is realized. Acquisition related costs/licensing represents the change in fair value of business acquisition related contingent consideration; costs related to integrating recently acquired businesses including but not limited to costs to exit or convert contractual obligations, severance, and information system conversion; and specific costs related to the consummation of the acquisition process such as banker fees, legal fees, and other acquisition related professional fees, as well as one time licensing fees.

In addition, for the period ended December 31, 2017 and for other comparative periods, we are presenting non-GAAP net income and non-GAAP diluted earnings per share, which represents net income and diluted earnings per share excluding the provision for litigation, amortization of intangibles, acquisition related costs/licensing, prior period adjustment and the tax effects of such adjustments. Prior period adjustments represent the cumulative impact of prior year adjustments related to depreciation, scrap and provision for excess and obsolete inventory, none of which were individually material to the related year’s financial position or results of operations. We believe these non-GAAP measures are also useful indicators of our operating performance, and particularly as additional measures of comparative operating performance from period to period as they remove the effects of litigation, amortization of intangibles, acquisition related costs/licensing, prior period adjustments and the tax effects of such adjustments, which we believe are not reflective of underlying business trends. Additionally, for the periods ended December 31, 2017 and for other comparative periods, we also define the non-GAAP measure of free cash flow as the net cash provided by operating activities, adjusted for the impact of restricted cash, less the cash impact of purchases of property and equipment. We believe that this financial measure provides meaningful information for evaluating our overall financial performance for comparative periods as it facilitates an assessment of funds available to satisfy current and future obligations and fund acquisitions. Furthermore, the non-GAAP measure of constant currency sales growth is calculated by translating current year sales at the same average exchange rates in effect during the applicable prior year period. We believe constant currency sales growth provides insight to the comparative increase or decrease in period sales, in dollar and percentage terms, excluding the effects of fluctuations in foreign currency exchange rates.

Non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth are not calculated in conformity with U.S. GAAP. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for financial measures prepared in accordance with U.S. GAAP. These measures do not include certain expenses that may be necessary to evaluate our liquidity or operating results. Our definitions of non-GAAP adjusted EBITDA, non-GAAP net income, non-GAAP diluted earnings per share, free cash flow and constant currency sales growth may differ from that of other companies and therefore may not be comparable. Additionally, we have recast prior periods for non-GAAP net income and non-GAAP diluted earnings per share.

Safe Harbor Statements
All statements included in this press release other than statements of historical fact are forward-looking statements and may be identified by their use of words such as “believe,” “may,” “might,” “could,” “will,” “aim,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “plan” and other similar terms. These forward-looking statements are based on our current assumptions, expectations and estimates of future events and trends. Forward-looking statements are only predictions and are subject to many risks, uncertainties and other factors that may affect our businesses and operations and could cause actual results to differ materially from those predicted. These risks and uncertainties include, but are not limited to, factors affecting our quarterly results, our ability to manage our growth, our ability to sustain our profitability, demand for our products, our ability to compete successfully (including without limitation our ability to convince surgeons to use our products and our ability to attract and retain sales and other personnel), our ability to rapidly develop and introduce new products, our ability to develop and execute on successful business strategies, our ability to successfully integrate the international operations acquired from Alphatec, both in general and on our anticipated timeline, our ability to transition Alphatec’s international customers to Globus products, our ability to realize the expected benefits to our results from the Alphatec acquisition, our ability to comply with laws and regulations that are or may become applicable to our businesses, our ability to safeguard our intellectual property, our success in defending legal proceedings brought against us, trends in the medical device industry, general economic conditions, and other risks. For a discussion of these and other risks, uncertainties and other factors that could affect our results, you should refer to the disclosure contained in our most recent annual report on Form 10-K filed with the Securities and Exchange Commission, including the sections labeled “Risk Factors” and “Cautionary Note Concerning Forward-Looking Statements,” and in our Forms 10-Q, Forms 8-K and other filings with the Securities and Exchange Commission. These documents are available at www.sec.gov. Moreover, we operate in an evolving environment. New risk factors and uncertainties emerge from time to time and it is not possible for us to predict all risk factors and uncertainties, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. Given these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements. Forward-looking statements contained in this press release speak only as of the date of this press release. We undertake no obligation to update any forward-looking statements as a result of new information, events or circumstances or other factors arising or coming to our attention after the date hereof.

GLOBUS MEDICAL, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
Three Months Ended							Year Ended
*(In thousands, except per share amounts)*	December 31, 2017			December 31, 2016			December 31, 2017		December 31, 2016
Sales	$	176,034	$	151,590	$	635,977	$	563,994
Cost of goods sold	40,856		39,002		150,453		134,705
Gross profit	135,178		112,588		485,524		429,289
Operating expenses:
Research and development	11,413		13,643		43,679		44,532
Selling, general and administrative	72,958		60,839		267,817		222,156
Provision for litigation	(112		)	100		2,668		3,156
Amortization of intangibles	2,238		1,805		7,909		3,478
Acquisition related costs	321		479		1,611		1,826
Total operating expenses	86,818		76,866		323,684		275,148
Operating income	48,360		35,722		161,840		154,141
Other income, net	2,240		755		8,088		3,138
Income before income taxes	50,600		36,477		169,928		157,279
Income tax provision	26,224		12,179		62,580		52,938
Net income	$	24,376	$	24,298	$	107,348	$	104,341
Earnings per share:
Basic	$	0.25	$	0.25	$	1.12	$	1.09
Diluted	$	0.25	$	0.25	$	1.10	$	1.08
Weighted average shares outstanding:
Basic	96,489		95,862		96,243		95,647
Diluted	98,726		96,513		97,887		96,432

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EOS imaging Announces First System Installation within Asklepios Private Hospital Group in Germany

Posted On February 21, 2018 By OrthoSpineNews In Spine /

February 21, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – PME), the pioneer of 2D/3D imaging and data solutions for orthopedics, today announced the first installation of an EOS® system within the Asklepios Hospital Group, the second largest private hospital network in Germany. The EOS system is available at the Asklepios Paulinen Hospital, enabling 3D full-body imaging at a low-dose of radiation, and reinforcing the hospital’s mission as a “Center of Excellence” for back disorders and treatment. The Asklepios Paulinen Hospital hosted a ceremony to celebrate the installation and introduce the community to the EOS system on February 21, 3:00 – 5:00 pm CET.

The Asklepios Paulinen Hospital is a general hospital with 316 beds located in Wiesbaden, Germany that specializes in state-of-the-art methods for improved patient care. In order to diagnose and treat patients in an interdisciplinary manner, it established several specialized medical centers including spinal surgery and orthopedics. With the installation of the EOS system, the spine and orthopedic team has taken another step towards an integrative “Center of Excellence” for the diagnosis and treatment of back disorders. The new device represents a major advance in diagnostics, the subsequent treatment planning and the treatment control of malpositions and deformities of the musculoskeletal system.

“I am thrilled with the new system, which opens up a whole new range of diagnostic options, including more than 100 3D clinical parameters that provide information on the spine’s angular and axial relationships with unprecedented precision. Particularly for patients with deformities like scoliosis, the Micro Dose option is a clear advantage, allowing us to take pictures with minimal radiation while maintaining excellent image quality,” commented Professor Dr. Thomas Niemeyer, Head of the Spine Surgery Department.

“We are pleased to expand our presence in Germany with this installation,” commented Marie Meynadier, Chief Executive Officer of EOS imaging. “The Asklepios Hospital Group is committed to advancing the orthopedic standard of care, as evidenced by building a Center of Excellence for the diagnosis and treatment of back disorders at the Asklepios Paulinen Hospital. We look forward to our technology contributing to this commitment.”

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.

EOS imaging has been selected to integrate the EnterNext © PEA – PME 150 index, composed of 150 French, listed companies on the Euronext markets in Paris.

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

Contacts

EOS imaging
Pierre Schwich, +33 (0)1 55 25 61 24
CFO
investors@eos-imaging.com
or
The Ruth Group (US)
Press relations
Joanna Zimmerman, 646-536-7006
jzimmerman@theruthgroup.com

Anika Reports Fourth Quarter and Full Year 2017 Financial Results

Posted On February 21, 2018 By OrthoSpineNews In Financial /

February 21, 2018

BEDFORD, Mass.–(BUSINESS WIRE)–Anika Therapeutics, Inc. (NASDAQ: ANIK), a global, integrated orthopedic medicines company specializing in therapeutics based on its proprietary hyaluronic acid (“HA”) technology, today reported financial results for the fourth quarter and full year ended December 31, 2017, along with business progress in the periods.

“2017 was a year of significant achievement for Anika, highlighted by double-digit revenue growth, expansion of MONOVISC® and CINGAL® into new international markets, completion of the CINGAL Phase III trial enrollment ahead of schedule, and the strengthening of our executive team,” said Charles H. Sherwood, Ph.D., Chief Executive Officer. “As we look to 2018, we are poised to complete the CINGAL Phase III trial and submit a New Drug Application to the FDA. Our strategic objectives are focused on global commercial expansion, pipeline advancement, and the development of a direct commercialization capability in the U.S. to accelerate our revenue and earnings growth in the years ahead and to create sustained value for our shareholders.”

Fourth Quarter and Full Year Financial Results

Total revenue for the fourth quarter of 2017 was $29.4 million, compared to $28.7 million for the fourth quarter of 2016. Total revenue for the full year of 2017 grew 10% to $113.4 million, compared to $103.4 million for the full year of 2016. Total revenue for the full year of 2017 included $5.0 million in milestone revenue earned in the second quarter as a result of MONOVISC achieving $100 million in U.S. end-user sales within a consecutive 12-month period ending in June 2017.
Product revenue increased 2% year-over-year in the fourth quarter of 2017. MONOVISC revenue grew 21% year-over-year in the fourth quarter of 2017, which was partially offset by the decline in ORTHOVISC® revenue in the same period, following the industry shift from multiple to single injection therapies. For the full year of 2017, product revenue increased 5% and MONOVISC global revenue grew 29%, which was the primary overall revenue growth driver.
International Orthobiologics revenue increased 22% for the full year of 2017, due primarily to the global expansion of MONOVISC, as well as the growth of CINGAL in international markets. Domestically, ORTHOVISC and MONOVISC continued to maintain a combined market-leading position.
Total operating expenses for the fourth quarter of 2017 were $19.7 million, compared to $16.0 million for the fourth quarter of 2016. The increase in total operating expenses was due primarily to higher research and development investments required to advance the Company’s growing pipeline towards regulatory approvals and to expand the commercial team in anticipation of those product launches. Total operating expenses for the full year of 2017 were $67.7 million, compared to $52.8 million for the full year of 2016.
Net income for the fourth quarter of 2017 was $8.1 million, or $0.53 per diluted share, compared to $8.1 million, or $0.54 per diluted share, for the fourth quarter of 2016. Net income for the fourth quarter of 2017 included a one-time tax benefit of $2.3 million, or $0.15 per diluted share, resulting from the recently enacted U.S. tax reform legislation. Net income for the full year of 2017 was $31.8 million, or $2.11 per diluted share, compared to $32.5 million, or $2.15 per diluted share, for the full year of 2016.

Recent Business Highlights
The Company made key commercial, operational, pipeline, and financial advancements, including:

Expanding CINGAL and MONOVISC international presence, with MONOVISC product approvals and related commercial launches in India, Australia, and Taiwan.
Advancing its product pipeline with completion of patient enrollment in the CINGAL Phase III clinical study, and continued progress on enrolling patients in the FastTRACK Phase III HYALOFAST® Study for cartilage repair.
Expanding Anika’s regenerative medicine portfolio with 510(k) clearance from the FDA for its injectable HA-based bone repair treatment.
Expanding its strategic collaboration with the Institute for Applied Life Sciences at the University of Massachusetts Amherst to continue the development of an innovative therapy for the treatment of rheumatoid arthritis, and with the Institute of Integrative Biology at the University of Liverpool to collaborate on research to develop an injectable mesenchymal stem cell therapy for the treatment of osteoarthritis.
Completed all planned activities related to the consolidation of the Company’s global manufacturing operations at Anika’s Bedford, Massachusetts corporate headquarters.

Full Year 2018 Corporate Outlook
Looking forward to 2018, the Company expects total revenue growth to be around the mid-single digit percentage range for the full year of 2018. Licensing, milestone and contract revenue is expected to be $5 million for the year. The Company also anticipates continued headway on several key initiatives including:

Completion of the Phase III clinical trial of CINGAL, and the submission of a New Drug Application to the FDA for CINGAL;
International expansion of MONOVISC and CINGAL;
Continued progress toward the development of a direct commercialization capability in the U.S.; and
Expanding Anika’s regenerative medicine pipeline with a new product candidate for rotator cuff repair.

Conference Call Information
Anika’s management will hold a conference call and webcast to discuss its financial results and business highlights tomorrow, Thursday, February 22 at 9:00 am ET. The conference call can be accessed by dialing 1-855-468-0611 (toll-free domestic) or 1-484-756-4332 (international). A live audio webcast will be available in the “Investor Relations” section of Anika’s website, www.anikatherapeutics.com. An accompanying slide presentation may also be accessed via the Anika website. A replay of the webcast will be available on Anika’s website approximately two hours after the completion of the event.

About Anika Therapeutics, Inc.
Anika Therapeutics, Inc. (NASDAQ: ANIK) is a global, integrated orthopedic medicines company based in Bedford, Massachusetts. Anika is committed to improving the lives of patients with degenerative orthopedic diseases and traumatic conditions with clinically meaningful therapies along the continuum of care, from palliative pain management to regenerative cartilage repair. The Company has over two decades of global expertise developing, manufacturing, and commercializing more than 20 products based on its proprietary hyaluronic acid (HA) technology. Anika’s orthopedic medicine portfolio includes ORTHOVISC, MONOVISC, and CINGAL, which alleviate pain and restore joint function by replenishing depleted HA, and HYALOFAST, a solid HA-based scaffold to aid cartilage repair and regeneration. For more information about Anika, please visit www.anikatherapeutics.com.

Forward-Looking Statements
The statements made in the last sentence of the second paragraph and those made in the section titled “Full Year 2018 Corporate Outlook” of this press release, which are not statements of historical fact, are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements include, but are not limited to, those relating to the completion of the Company’s CINGAL clinical trial and associated regulatory submission, the Company’s development of, and goals associated with, its direct commercial capability, the Company’s expectations regarding its 2018 financial performance, the international expansion of the Company’s viscosupplementation product lines, and the expansion of the Company’s regenerative medicine portfolio. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks, uncertainties, and other factors. The Company’s actual results could differ materially from any anticipated future results, performance, or achievements described in the forward-looking statements as a result of a number of factors including, but not limited to, (i) the Company’s ability to successfully commence and/or complete clinical trials of its products on a timely basis or at all; (ii) the Company’s ability to obtain pre-clinical or clinical data to support domestic and international pre-market approval applications, 510(k) applications, or new drug applications, or to timely file and receive FDA or other regulatory approvals or clearances of its products; (iii) that such approvals will not be obtained in a timely manner or without the need for additional clinical trials, other testing or regulatory submissions, as applicable; (iv) the Company’s research and product development efforts and their relative success, including whether we have any meaningful sales of any new products resulting from such efforts; (v) the cost effectiveness and efficiency of the Company’s clinical studies, manufacturing operations, and production planning; (vi) the strength of the economies in which the Company operates or will be operating, as well as the political stability of any of those geographic areas; (vii) future determinations by the Company to allocate resources to products and in directions not presently contemplated; (viii) the Company’s ability to successfully commercialize its products, in the U.S. and abroad; (ix) the Company’s ability to provide an adequate and timely supply of its products to its customers; and (x) the Company’s ability to achieve its growth targets. Additional factors and risks are described in the Company’s periodic reports filed with the Securities and Exchange Commission, and they are available on the SEC’s website at www.sec.gov. Forward-looking statements are made based on information available to the Company on the date of this press release, and the Company assumes no obligation to update the information contained in this press release.

Anika Therapeutics, Inc. and Subsidiaries
Consolidated Statements of Operations
(in thousands, except per share data)
(unaudited)

	For the Three Months Ended December 31,				For the Twelve Months Ended December 31,
	2017		2016		2017		2016
Product revenue	$	28,884	$	28,296	$	107,783	$	102,932
Licensing, milestone and contract revenue		504		430		5,637		447
Total revenue		29,388		28,726		113,420		103,379

Operating expenses:
Cost of product revenue		8,716		7,539		27,364		24,027
Research and development		4,266		2,959		18,787		10,732
Selling, general and administrative		6,678		5,488		21,540		18,013
Total operating expenses		19,660		15,986		67,691		52,772
Income from operations		9,728		12,740		45,729		50,607
Interest income, net		138		49		473		263
Income before income taxes		9,866		12,789		46,202		50,870
Provision for income taxes		1,799		4,704		14,386		18,323
Net income	$	8,067	$	8,085	$	31,816	$	32,547

Basic net income per share:
Net income	$	0.55	$	0.56	$	2.18	$	2.22
Basic weighted average common shares outstanding		14,596		14,538		14,575		14,682
Diluted net income per share:
Net income	$	0.53	$	0.54	$	2.11	$	2.15
Diluted weighted average common shares outstanding		15,141		14,979		15,068		15,116

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The biomaterial of next-gen spinal implants

Posted On February 21, 2018 By OrthoSpineNews In Biologics /

19 February 2018 – Medical Plastics News

A wealth of research and clinical experience is confirming that the use of PEEK-Optima polymer-based spinal implants confers advantages that can, potentially, enhance the efficacy of spinal implants and improve patient outcomes. Combined data from three clinical studies that directly compared PEEK-Optima with titanium devices for cervical fusion showed fusion rates between 88-100% for PEEK-Optima versus 47-93% for titanium devices.^1-3 The high-performing polymer was the first implantable PEEK and introduced by Invibio Biomaterial Solutions (Invibio) in 1999. Since that time the company has pioneered further innovations and supported its partner companies with pre-clinical study results and clinical outcome data to achieve regulatory clearances and to help educate the medical community.

One such recent PEEK-based innovation was Invibio´s PEEK-Optima HA Enhanced polymer. It combines PEEK-Optima polymer with hydroxyapatite (HA) for medical applications where bone on-growth is required. Hydroxyapatite, a well-known osteoconductive material that enhances bone apposition and a constituent of human bone, is fully integrated, not coated, into the PEEK matrix, making it available on all surfaces of a finished device, which also eliminates the time and expense of applying coatings to the manufactured implant.

Invibio´s enhanced biomaterial offers all the clinical advantages of PEEK-Optima Natural, including a modulus close to that of human bone, reduced stress shielding, and artifact-free imaging, whether by X-ray, MRI or CT scanning, allowing clear visual assessment of the fusion mass.

Pre-clinical studies demonstrate the potential benefits of PEEK-Optima HA Enhanced

The performance of PEEK-Optima HA Enhanced has been studied in pre-clinical studies, and has demonstrated a greater amount of new bone formation and a higher quality of new bone bridging, within early stages of treatment, compared with the results obtained when using PEEK-Optima Natural.

Invibio commissioned an independent cervical fusion study in sheep, to compare outcomes between interbody fusion devices composed of PEEK- Optima HA Enhanced, PEEK- Optima Natural and allograft bone. Results indicate that PEEK- Optima HA Enhanced may provide several advantages⁴:

Greater new bone formation. PEEK- Optima HA Enhanced resulted in greater new bone formation at six weeks, compared with PEEK- Optima Natural.
Higher quality new bone bridging. PEEK- Optima HA Enhanced provided a more favorable environment, with higher quality local bone at six and 12 weeks compared with PEEK-OPTIMA Natural.
Enhanced mechanical performance. PEEK- Optima HA Enhanced devices outperformed allograft, with fracture of the allograft devices in 6/13 (46%) instances.

A previous study had evaluated and compared the bone ongrowth that resulted from the use of the two implantable polymers in a bone defect model in sheep, and revealed that PEEK- Optima HA Enhanced resulted in approximately 75% direct bone apposition as early as four weeks following implantation compared with PEEK- Optima Natural.⁵

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Spine Wave Launches Proficient® Posterior Cervical Spine System Implants for Complex Posterior Cervical-Thoracic Procedures

Posted On February 21, 2018 By OrthoSpineNews In Spine, Top Stories /

SHELTON, Conn., Feb. 21, 2018 (GLOBE NEWSWIRE) — Spine Wave is increasing the Proficient^®Posterior Cervical Spine System’s product offering to further serve the posterior cervical spine market. The system is gaining rapid adoption by spine surgeons, primarily due to its patented tri-lobe polyaxial screw design which offers a best in class 120 degrees of angulation. Now, the Proficient® Posterior Cervical Spine System is expanded to include a range of new implants that make the system even more versatile for complex posterior cervical-thoracic procedures.

The Proficient® Posterior Cervical Spine System is now offered with a unique translation screw that provides medial-to-lateral translation to facilitate improved rod placement in posterior cervical-thoracic fixation procedures. Other new Proficient® Posterior Cervical Spine System implants include screw-to-rod lateral connectors, rod-to-rod connectors, and smooth-shank screws as an alternative for fixation of the uppermost cervical spine levels. Taken together, these new implants make the Proficient® Posterior Cervical Spine System even more appealing for complex posterior cervical-thoracic procedures.

“The Proficient^® Posterior Cervical Spine System is an excellent alternative for spine surgeons treating complex posterior cervical-thoracic pathology,” said Peter G. Passias, M.D., FACS, Associate Professor of Orthopaedic and Neurological Surgery, NYU Health, New York, NY. “The anatomy of the cervical-thoracic junction can make posterior cervical fixation procedures crossing that junction very challenging. The Proficient® Posterior Cervical Spine System is versatile by design and these new implants make it even more so.” “In particular,” Dr. Passias continued, “the system’s new translational screw makes rod placement in these procedures faster and easier in my practice because of the unique medial-to-lateral translation capability that it offers.”

“We have been very pleased with how well the Proficient® System has been received in the marketplace. The 120 degrees of angulation has been the biggest selling point and now the system is even more versatile with the advent of the translational screws,” said Mark LoGuidice, Spine Wave CEO. “Historically, Spine Wave has focused on thoraco-lumbar technologies. The Proficient® System is our first internally developed cervical offering and our engineers and surgeon designers have done a phenomenal job with this system. In addition, we plan to launch a unique anterior cervical technology in the middle of this year. This important anterior system is currently in a limited market release and based on the early feedback, we have high expectations for this system as well.”

/EIN News/ — About Spine Wave

Spine Wave is a leader in expandable fusion technologies and is committed to continually delivering highly differentiated products to enable more efficient and less invasive solutions for spine surgeons and their patients. In addition to the Proficient® Posterior Cervical Spine System, Spine Wave also offers a broad portfolio of expandable devices marketed under the StaXx®, Velocity® and Leva® brand names. The expandable technologies can be utilized in posterior, anterior and lateral surgical approaches. To complement the expandable spacers, Spine Wave offers a comprehensive line of pedicle screws for both minimally invasive and traditional open approaches. Additionally, Spine Wave recently launched the GraftMag® Graft Delivery System which is being very well received because it is designed to make interbody bone grafting procedures faster and easier for surgeons. The company is expanding rapidly and continues to recruit sales managers and independent distributors to fuel growth. For more information on Spine Wave and its products, please visit www.spinewave.com.

Contact

Terry Brennan, Chief Financial Officer
tbrennan@spinewave.com
(203) 712-1810

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