Osiris Therapeutics, Inc. to Present Advanced Clinical and Scientific Abstracts at Symposium on Advanced Wound Care (SAWC) Fall Meeting, November 2-4, 2018, in Las Vegas, Nevada

COLUMBIA, Md., Oct. 30, 2018 (GLOBE NEWSWIRE) — Osiris Therapeutics, Inc. (NASDAQ: OSIR), a regenerative medicine company focused on developing and marketing products for wound care, orthopedics, and sports medicine, will present advanced clinical and scientific research at the Symposium on Advanced Wound Care (SAWC) Fall Conference. A total of six studies (three clinical and three scientific studies) will be presented.

The clinical studies highlight the benefits of Osiris’s placenta-based products, Stravix®, Grafix® and GrafixPL®, for use in covering a variety of wound types. The scientific studies describe methods of cell viability evaluation in placental tissue and the structure and properties of tissues preserved using Osiris’s Prestige Lyotechnologysm, which retain all components of the native tissue including living cells but can be conveniently stored at ambient temperature.  Key presentations and events are highlighted below.

Dr. Eric Johnson, MD, will present a lecture entitled “Scientific and Clinical Evidence for Grafix and GrafixPL: Cryopreserved and Lyopreserved Placental Membranes” on Friday, November 2, at 7:30am (Milano V-VI Ballroom, onsite registration available). Lecture objectives include:

  • Information on how placental membranes benefit wound management
  • An overview of how different tissue preservation methods impact the final composition of placental membrane products
  • An introduction to Prestige Lyotechnology for ambient storage of placental membranes
  • Clinical evidence for wound management with Grafix and GrafixPL

Dr. Charles E. Ananian, DPM, will present a poster summarizing results of a recently completed multicenter, prospective, randomized, single-blind trial comparing clinical outcomes and product cost between Grafix and Dermagraft®(1) in the treatment of chronic diabetic foot ulcers (DFUs)(2).

Dr. Alexander Reyzelman, DPM, FAPWCA, will present a poster describing the first prospective cases series evaluating clinical outcomes of GrafixPL, Osiris’s lyopreserved placental membrane, for the management of chronic wounds of various etiologies. This study demonstrates similar closure rates to previous studies utilizing Grafix, Osiris’s cryopreserved placental membrane, but with convenience of ambient storage.

Dr. Kathryn Davis, PhD, and Dr. Lawrence Lavery, DPM, MPH, will present a poster comparing amnion lyophilized by the Prestige Lyotechnology method (PL) to cryopreserved amnion. Data shows that the structure and cell viability of PL-lyophilized amnion is equivalent to those of cryopreserved viable amnion.

Scientific and clinical posters will be presented at the SAWC fall poster reception from 5:30 pm to 6:15 pm on Saturday, November 3 in the Forum Ballroom, Room 12.

The complete list of scientific and clinical abstracts includes:

  • A Multicenter, Randomized, Single-Blind Trial Comparing the Efficacy of Viable Cryopreserved Placental Membrane to Human Fibroblast-Derived Dermal Substitute for the Treatment of Chronic Diabetic Foot Ulcers (Abstract CR-001)
  • A Prospective, Single-Center, Open-Label Case Series Evaluating the Clinical Outcomes of Viable Lyopreserved Placental Membrane in the Treatment of Chronic Wounds (Abstract CS-063)
  • Contralateral Limb Salvage in a Diabetic Amputee with Necrotizing Fasciitis: A Case Report Supporting the Use of Viable Cryopreserved Umbilical Tissue to Prevent Bilateral Amputation (Abstract CS-080)
  • Structure and Cell Viability of Lyophilized Amniotic Membrane are Equivalent to Those of Cryopreserved Viable Amnion (Abstract LB-009)
  • Structural Properties of Viable Lyophilized Placental Tissues (Abstract LB-020)
  • Assessment of Human Amniotic Tissue Cell Viability (Abstract LB-028)

Osiris Therapeutics, Inc. will also be exhibiting at the Symposium on Advanced Wound Care Fall Meeting at booth 321. The event runs from November 2 through November 4, 2018 at Caesars Palace in Las Vegas, Nevada.

References:
1-Dermagraft® is a registered trademark of Organogenesis, Inc. (Canton, MA)
2-www.clinicaltrials.gov: NCT02675855

About Osiris Therapeutics

Osiris Therapeutics, Inc., based in Columbia, Maryland, researches, develops, manufactures and commercializes regenerative medicine products intended to improve the health and lives of patients and lower overall healthcare costs.  We have achieved commercial success with products in orthopedics, sports medicine and wound care, including the Grafix product line, Stravix®, BIO and Cartiform®.  We continue to advance our research and development by focusing on innovation in regenerative medicine, including the development of bioengineered stem cell and tissue‑based products.  Osiris®, Grafix®, GrafixPL®, GrafixPL PRIME Cartiform®, and Prestige Lyotechnologysm are our trademarks. BIO is a trademark of Howmedica Osteonics Corp., a subsidiary of Stryker Corporation. More information can be found on the Company’s website, www.Osiris.com. (OSIR-G)

Forward-Looking Statements

Statements herein relating to the future of Osiris Therapeutics, Inc. and the ongoing research and development of our products are forward-looking statements.  Osiris Therapeutics, Inc. cautions that these forward-looking statements are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements.  These risks and uncertainties include those identified under the heading “Risk Factors” in the Osiris Therapeutics Inc. Annual Report on Form 10-K for the years ended December 31, 2017, 2016 and 2015 and Quarterly Report on Form 10-Q for the quarters ended March 31, 2018 and June 30, 2018, as filed with the Securities and Exchange Commission (SEC).  We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.  Examples of forward-looking statements may include, without limitation, statements regarding the anticipated efficiencies and advantages of products and the likelihood of customer clinical adoption of any new products.  Although well characterized in scientific literature and studies, preservation of tissue integrity, including cells, may not be indicative of clinical outcome.  Accordingly, you should not unduly rely on these forward-looking statements. You are encouraged to read our filings with the SEC, available at sec.gov, for a discussion of these and other risks and uncertainties.  The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements.  Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

For additional information, please contact:
Diane Savoie
Osiris Therapeutics, Inc.
(443) 545-1834
OsirisPR@Osiris.com

Bone Grafts and Substitutes Market is expected to surpass the value of US$ 3.9 bn by 2026, Says TMR

Albany, New York, Oct. 30, 2018 (GLOBE NEWSWIRE) — Transparency Market Research (TMR) has published a new report titled ‘Bone Grafts and Substitutes Market – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast, 2018–2026.’ According to the report, the global bone grafts and substitutes market was valued at US$ 2.7 Bn in 2017. It is projected to expand at a CAGR of 4.3% from 2018 to 2026. Factors such as rapid technological changes from autografts to allografts and penetration of synthetic and tissue-engineered bone grafts are propelling the growth of the bone grafts and substitutes market. Moreover, an increase in demand from customers and rise in industry standards are spurring the global bone grafts and substitutes market. North America and Europe are projected to dominate the global bone grafts and substitutes market, owing to a higher rate of adoption of and awareness regarding bone grafts and substitute products. Asia Pacific, Latin America, and Middle East & Africa are regions with high potential for the bone grafts and substitutes market. The market in Asia Pacific is expected to expand at a CAGR of 5.0 % from 2018 to 2026.

Request to View Sample of Report – https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=6200

Cost-effective Bone Grafts and Substitutes That Treat Complex Disorders to Drive Global Market

Increase in the number of cases of various bone disorders across the globe drives the bone grafts and substitutes market. According to the International Osteoporosis Foundation, the global incidence of fractures is anticipated to increase by 240% in women and 310% in men by 2050. This is likely to increase the number of bone graft surgery procedures, consequently propelling the global bone grafts and substitutes market. Based on product, the global bone grafts and substitutes market has been categorized into allografts, synthetic bone grafts, and xenografts. The allograft segment has been further divided into demineralized bone matrix (DBM) and others.

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Ceramic-based Bone Grafts and Substitutes to be a Highly Lucrative Segment

In terms of material, ceramic-based is an emerging segment of the bone grafts and substitutes market. The segment is likely to hold a major market share, due to a rise in the adoption of technologically advanced products by surgeons. The cell-based segment is likely to expand at a significant CAGR. This is because cell-based assays are relatively easy to use, reproducible, inexpensive, and do not involve the suffering of animals. Moreover, cell-based bone graft substitutes are easily adopted by body and have shown potential results.

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Hospitals to be a Promising Segment

In terms of end-user, the global bone grafts and substitutes market has been categorized into hospitals, orthopedic clinics, and others. The hospitals segment held a major share of the global market in 2017. Expansion of the segment can be attributed to the availability of multiple service options and devices and tie-ups with health care companies in order to enhance health care products and service offerings. Moreover, hospitals are the preferred choice for patients due to the availability of advanced technology and better health care services. The orthopedic clinics segment is expanding at a high growth rate, especially in developed economies, due to a rise in the geriatric population and the development of health care infrastructure and support. A rise in demand for bone grafts and substitutes in orthopedic clinics during medical emergencies is projected to drive the segment.

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North America Expected to Dominate the Global Market

In terms of region, the global bone grafts and substitutes market has been segmented into North America, Europe, Asia Pacific, Latin America, and Middle East & Africa. North America dominated the global bone grafts and substitutes market in 2017. In terms of revenue, the market in North America was valued at US$ 1.6 Bn in 2017.This is due to a highly developed health care sector, increase in awareness among health care providers about bone grafts and substitutes, and continuous evolution of bone grafts and substitutes. This region offers significant opportunity to the bone grafts and substitutes market. The market in Asia Pacific is anticipated to expand at a CAGR of 5.0% during the forecast period. The market in Asia Pacific is likely to be driven by factors such as a rise in the ability of patients to pay for treatment, increase in medical tourism due to low cost of synthetic bone grafts in the region, and a rapidly increasing geriatric population. Moreover, expansion of the health care sector in countries such as China, Japan, and India offers significant potential to the market in the region. Additionally, technological advancements and increase in the rate of adoption of bone grafts and substitutes products are expected to propel the market in the region during the forecast period.

Browse Press Release – https://www.transparencymarketresearch.com/pressrelease/bone-grafts-substitutes-market.htm

GE Healthcare and Koninklijke Philips N.V. Anticipated to Lead the Global Market

The global bone grafts and substitutes market is highly fragmented. A number of players provide different products. Key players in the global bone grafts and substitutes market include AlloSource, DePuy Synthes, Integra LifeSciences, NuVasive, Inc., Stryker, Wright Medical Group N.V., XTANT MEDICAL, Zimmer Biomet, Baxter Healthcare Corporation, and Medtronic. Expansion of the product portfolio through mergers and acquisitions is a key strategy followed by several global players.

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About TMR

Transparency Market Research (TMR) is a global market intelligence company providing business information reports and services. The company’s exclusive blend of quantitative forecasting and trend analysis provides forward-looking insight for thousands of decision makers. TMR’s experienced team of analysts, researchers, and consultants use proprietary data sources and various tools and techniques to gather and analyze information.

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NuVasive Reports Third Quarter 2018 Financial Results

SAN DIEGOOct. 30, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA), the leader in spine technology innovation, focused on transforming spine surgery with minimally disruptive, procedurally-integrated solutions, today announced financial results for the quarter ended September 30, 2018.

Third Quarter 2018 Highlights

  • Revenue increased 9.8% to $271.3 million, or 10.2% on a constant currency basis;
  • GAAP operating profit margin of 6.6%; Non-GAAP operating profit margin of 15.6%;
  • GAAP diluted earnings per share of $0.30; Non-GAAP diluted earnings per share of $0.56; and
  • Company updates full-year 2018 guidance.

“Our third quarter results reflect accelerated year-over-year revenue growth of nearly 10%, supported by strong performances in both spinal hardware and surgical support business lines with overall U.S. case volumes up more than 7%,” said Gregory T. Lucier, chairman and chief executive officer of NuVasive. “With the sense the overall U.S. spine market is trending healthier, we made strategic investments this quarter on the heels of this momentum in key R&D initiatives, additions to our commercial sales force and infrastructure upgrades to improve set fulfillment—all to support a strong start to 2019 and beyond.” 

The Company’s financial results reflect continued improvement of its in-sourcing efforts at the West Carrollton, Ohiomanufacturing facility, and the Company reiterated expectations that the facility will drive an additional 130 to 150 basis points in operating margins in 2019.

Lucier commented, “We made solid progress with our in-source manufacturing initiatives by bringing in additional SKUs during the third quarter with throughput ramping to higher volumes. This strategic investment is on track and will become a business advantage, both to drive a competitive cost position and to control the quality required to produce evermore complex implants.”

NuVasive also recently made several key technology introductions and partnership announcements, including the unveiling of the NuVasive Pulse™ surgical automation platform, Spine Precision Partnership with Siemens Healthineers and signing of a strategic partnership with Biedermann Technologies to further enhance NuVasive’s best-in-class complex spine deformity technologies. The Company also launched several new products to further reinvigorate its Biologics business line, which continues to recover at a faster-than-expected pace. The Company now anticipates its Biologic business will return to growth in the fourth quarter 2018.

A full reconciliation of GAAP to non-GAAP measures can be found in the tables of this news release.

Third Quarter 2018 Results

NuVasive reported third quarter 2018 total revenue of $271.3 million, a 9.8% increase compared to $247.1 million for the third quarter 2017. On a constant currency basis, third quarter 2018 total revenue increased 10.2% compared to the same period last year.

For the third quarter 2018, GAAP and non-GAAP gross profit was $197.1 million and $197.4 million, respectively, while GAAP and non-GAAP gross margin was 72.7% and 72.8%, respectively. These results compared to GAAP and non-GAAP gross profit of $181.5 million and $181.7 million, respectively, and both GAAP and non-GAAP gross margin of 73.5% for the third quarter 2017. Total GAAP and non-GAAP operating expenses were $179.2 million and $155.1 million, respectively, for the third quarter of 2018. These results compared to GAAP and non-GAAP operating expenses of $151.1 million and $138.4 million, respectively, for the third quarter 2017.

NuVasive reported GAAP net income of $15.9 million, or $0.30 per diluted share, for the third quarter 2018 compared to GAAP net income of $33.5 million, or $0.64 per diluted share, for the third quarter 2017. On a non-GAAP basis, NuVasive reported net income of $29.5 million, or $0.56 per diluted share, for the third quarter 2018 compared to net income of $26.6 million, or $0.51 per diluted share, for the third quarter 2017.

Annual Financial Guidance for 2018

The Company updated its full-year 2018 financial guidance by increasing its revenue guidance by $5 million to reflect a new range of $1,100 million to $1,110 million and reducing its non-GAAP operating margin guidance range to 15.0% – 15.5% as a result of accelerated investments in infrastructure and commercial sales force in anticipation of the overall spine market growth trending up to more historical averages.

2018 Guidance Range 1, 2

Prior

Current

(in million’s; except %’s and EPS)

GAAP

Non-GAAP

GAAP

Non-GAAP

Revenue

$1,095 – $1,105

$1,095 – $1,105

$1,105 – $1,110

$1,105 – $1,110

   % Growth – Reported

6.7% – 7.6%

6.7% – 7.6%

7.6% – 8.1%

7.6% – 8.1%

% Growth – Constant Currency 3

6.3% – 7.3%

7.4% – 7.9%

Operating margin

8.0% – 8.1%

16.7%

5.4% – 5.9%

15.0% – 15.5%

Earnings per share

$0.45 – $0.48

$2.37 – $2.40

$0.22 – $0.31

$2.15 – $2.23

EBITDA

18.3%

25.9%

16.1% – 16.6%

24.4% – 24.9%

Tax Rate

~33%

~21%

~18%

~21%

1

Prior guidance reflects the range provided July 31, 2018. Current guidance reflects the range provided October 30, 2018.

2

Amounts for 2017 have been recasted and presented based on our full retrospective method of adoption of ASC 606. Commencing with the fourth quarter of 2017, amounts also reflect expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Companys intellectual property.

3

Constant currency is a measure that adjusts US GAAP revenue for the impact of currency over the same period in the prior year.

  • Full-year 2018 revenue in the range of $1,105 million to $1,110 million reflecting reported growth of 7.6% to 8.1%, and growth in the range of 5.7% to 6.2%, exclusive of the SafePassage acquisition;
  • Non-GAAP diluted earnings per share in a range of $2.15 to $2.23 compared with the prior expectation of $2.37 to $2.40;
  • Non-GAAP operating profit margin in the range of 15.0% to 15.5%, compared with the prior expectation of 16.7%;
  • Adjusted EBITDA margin in the range of 24.4% to 24.9%, compared with the prior expectation of 25.9%;
  • Non-GAAP effective tax expense rate of approximately 21%;
  • The Company expects currency to have a positive impact on revenue in 2018 of approximately $2 million compared with the prior expectation of $3 million; and
  • The Company expects to drive an adjusted EBITDA of approximately $269 million to $276 million, compared with the prior expectation of approximately $283 million to $293 million.

The above guidance assumes a full-year benefit of U.S. tax reform, suspension of the medical device tax and the SafePassage acquisition.

Supplementary Financial Information

For additional financial detail, please visit the Investor Relations section of the Company’s website at www.nuvasive.comto access Supplementary Financial Information.

Reconciliation of Full Year EPS Guidance

2017 
Actuals 
1, 2

2018 Guidance Range 1, 3

Prior 4

Current  5

GAAP net income per share

$

1.48

$0.45 – $0.48

$0.22 – $0.31

Impact of change to diluted share count

0.08

GAAP net income per share, adjusted to diluted Non-GAAP share count

$

1.56

$0.45 – $0.48

$0.22 – $0.31

Business transition costs 6

0.08

0.13

0.15

Non-cash purchase accounting adjustments on acquisitions 7

0.01

0.02

0.02

Non-cash interest expense on convertible notes

0.33

0.32

0.32

Litigation related expenses and settlements 8

0.09

0.60

0.63

Non-recurring consulting fees 9

0.13

0.12

Net loss on strategic investments

0.17

0.07

Amortization of intangible assets 10

0.89

0.95

0.95

Purchase of in-process research and development 11

0.17

Tax effect of adjustments 12

(1.08)

(0.40)

(0.50)

Non-GAAP earnings per share

$

1.89

$2.37 – $2.40

$2.15 – $2.23

GAAP Weighted shares outstanding – basic

50,874

51,397

51,396

GAAP Weighted shares outstanding – diluted

55,193

52,131

52,853

Non-GAAP Weighted shares outstanding – diluted 13

52,345

52,131

52,295

1

Items may not foot due to rounding.

2

Amounts for 2017 have been recasted and presented based on our full retrospective method of adoption of ASC 606.   Commencing with the fourth quarter of 2017, amounts also reflect expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Companys intellectual property.

3

Prior guidance reflects the range provided July 31, 2018. Current guidance reflects the range provided October 30, 2018.

4

Effective tax expense rate of ~33% applied to GAAP earnings and ~21% applied to Non-GAAP earnings.

5

Effective tax expense rate of ~18% applied to GAAP earnings and ~21% applied to Non-GAAP earnings.

6

Costs related to acquisition, integration and business transition activities which include severance, relocation, consulting, leasehold exit costs, third party merger and acquisitions costs, contingent consideration fair value adjustments, and other costs directly associated with such activities.

7

Represents costs associated with non-cash purchase accounting adjustments, such as acquired inventory fair market value adjustments, which are amortized over the period in which underlying products are sold.

8

For 2017, amounts relate primarily to the Medtronic litigation matter.  For 2018, amounts relate primarily to the loss recorded in connection with the settlement of the Madsen Medical, Inc. litigation matter.  Commencing with the fourth quarter of 2017, amounts also reflect expenses associated with ongoing litigation with a former Board member and his current employer related to various matters, including infringement of the Companys intellectual property.

9

Non-recurring consulting fees associated with the implementation of our state tax-planning strategy.

10

For 2017, amortization excludes the amortization attributable to non-controlling interest.  In January 2018, the Company completed the acquisition of the non-controlling interest.

11

Purchase of an in-process research and development asset which had no future alternative use.

12

The impact on results from taxes include tax effecting the adjustments above at the statutory rate as well as taking into account discrete items and including those discrete items in the annual effective tax rate calculation. The Company also includes those adjustments that would have benefited the tax rate in lieu of the above adjustments as part of the Companys tax filings. The impact of the changes to the tax rate results in an annual estimated rate of ~18% on a GAAP basis and ~21% on a non-GAAP basis.

13

Adjusted non-GAAP diluted WASO excludes the impact of dilutive convertible notes and warrants for which the Company is economically hedged through its anti-dilutive bond hedge arrangements.

EOS imaging Announces Installations of First EOS® Systems in Spain and Portugal

October 30, 2018

PARIS–(BUSINESS WIRE)–Regulatory News:

EOS imaging (Paris:EOSI) (Euronext, FR0011191766 – EOSI – Eligible PEA – SME), a pioneer in 2D/3D orthopedic medical imaging, today announced the first two installations in Barcelona at Clavel’s Instituto, a spine center of Hospital Quiron, and the HM Delfos Hospital. In addition, the first installation in Portugal is planned in Lisbon by the end of the year. All three facilities are part of private hospital groups.

“We are delighted with these first installations in two of the best private spine surgery centers in Spain as well as the upcoming installation in Portugal. Our solutions, already widely adopted within academic hospitals in Europe and around the world, are increasingly becoming valued by private orthopedic centers and private hospitals. We are happy and proud to see our technology accessible to more patients, as a large traction of osteoarticular care and orthopedic surgeries are taking place outside of academic hospital settings,” concluded Marie Meynadier, Chief Executive Officer of EOS imaging.

ABOUT EOS IMAGING

EOS imaging is listed on Compartment C of Euronext Paris

ISIN: FR0011191766 – Ticker: EOSI

EOS imaging designs, develops and markets EOS®, a major innovative medical imaging solution dedicated to osteoarticular pathologies and orthopedics combining equipment and services and targeting a $2B per year market opportunity. EOS imaging is currently present in 33 countries, including the United States under FDA agreement, Japan, China and the European Union under CE labelling, through the over 280 installed EOS® platforms representing more than one million patient exams every year. Revenues were €37.1M in 2017, e.g. a +32% CAGR over 2012-2017. For more information, please visit www.eos-imaging.com.

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.

Contacts

EOS imaging
Marie Meynadier
CEO
Ph: +33 (0)1 55 25 60 60
investors@eos-imaging.com
or
Investor Relations (US)
Matt Picciano / Emma Poalillo
The Ruth Group
Ph: 646-536-7008 / 7024
EOS-imagingIR@theruthgroup.com
or
Press Relations (US)
Kirsten Thomas
The Ruth Group Ph: 508-280-6592
kthomas@theruthgroup.com

BoneSmart and Maxx Orthopedics Announce Collaboration on Initiatives to Educate Joint Replacement Patients

SAN DIEGOOct. 30, 2018 /PRNewswire/ — BoneSmart and Maxx Orthopedics are pleased to announce an exciting partnership to develop educational content for patients undergoing knee replacement surgery.

BoneSmart® is the largest joint replacement community in the world. More than 2.5 million unique users come to BoneSmart.org each year looking for information about joint replacement, in addition to searching for the orthopaedic surgeons that perform them.

The site offers joint replacement candidates and patients:

  • Information about hip, knee, and shoulder replacement surgery options, implants, and technologies as well as pre- and post-operative planning.
  • Access to the world’s largest online joint replacement patient support forum, staffed with over a dozen dedicated moderators.
  • Ability to find orthopaedic surgeons.

The collaboration between BoneSmart® and Maxx Orthopedic brings together an independent, educational platform for patients and a rapidly growing orthopaedic implant manufacturer in the world.

“BoneSmart is excited about this collaboration which brings Maxx Orthopedics’ Freedom Knee® implants and surgeons to our patient community,” said Mark Sacaris, CEO, BoneSmart, LLC.

The opportunities for Maxx Orthopedics are to provide awareness and education on its Freedom Knee® System to BoneSmart patients, as well as, connect BoneSmart patients to orthopaedic surgeons that use these implants.

“Maxx Orthopedics is excited about this collaboration, which brings together our Freedom Knee® System and surgeons to BoneSmart’s robust patient community,” said Ashesh Shah, CEO, Maxx Orthopedics.

ABOUT BONESMART
BoneSmart.org is the award-winning website for a public-awareness and patient advocacy organization for joint replacement patients. BoneSmart is part of The Foundation for the Advancement in Research in Medicine, Inc. is a 501(c)(3) non-profit public benefit organization, supported by donations and underwriting from corporate partners.

BoneSmart® is dedicated to raising awareness about the latest joint replacement options, fostering a supportive community through the world’s largest joint replacement forum where members can share experiences, knowledge, and stories.  BoneSmart produces the annual Joint Replacement Awareness Day® program to bring together the global joint replacement community through the JointAwareDay.org website.

ABOUT MAXX ORTHOPEDICS
Maxx Medical Pvt. Ltd. (“Maxx Medical”) develops and markets innovative orthopedic medical devices on an international scale. The company is focused on providing state-of-the-art implants and related solutions that best restore patient mobility while accommodating lifestyle, anatomical and economic needs. Maxx Medical is the parent company of Maxx Orthopedics, Inc., the manufacturer of the Freedom Knee® System.

Media Contact:
Mark Sacaris
Mark@bonesmart.org
(760) 815-6474

SOURCE BoneSmart, LLC

Related Links

http://www.bonesmart.org

Life Spine Announces First Clinical Cases of PROLIFT® Post Pack Expandable TLIF/PLIF Spacer System

October 30, 2018

HUNTLEY, Ill.–(BUSINESS WIRE)–Life Spine, a medical device company that designs, develops, manufactures and markets products for the surgical treatment of spinal disorders today announced the first clinical cases of PROLIFT Post Pack Expandable Interbody System with Dr. Richard Weiner of Dallas, Texas and Dr. Bryan Barnes of Athens, Georgia.

PROLIFT Post Pack allows for in-situ disc height restoration, for minimally invasive PLIF, TLIF and oblique approaches, as well as a systematic method for the introduction of additional graft material in-situ within the device. PROLIFT Post Pack, which incorporates the proprietary surface technology OSSEO-LOC, provides the surgeon the ability to restore normal spinal pelvic parameters with the multiple lordotic options, while continuing to build upon the patented expandable technologies at Life Spine.

“Expandable technology, such as PROLIFT Post Pack, continues the innovation process for challenges associated with complex spine procedures, as well as providing the means to enhance patient outcomes. Restoration of normal spinal alignment, as well as lowering iatrogenic impact to the patient’s anatomy can all be achieved with the technology developed by Life Spine,” noted Richard L. Weiner M.D. of Dallas Neurosurgical and Spine at Texas Institute for Surgery.

Minimally Invasive Surgery (MIS) is one of the fastest growing segments in the spinal implant market. Trends and market research have noted that in 2011 MIS surgical solutions made up 20% of all surgical procedures, and that by the year 2021, this paradigm with have expanded to almost 80%1. Development of MIS technologies such as the ProLift, and complementary fixation systems such as the AVATAR® Percutaneous Screw System and CENTERLINE® Cortical Bone Fixation Systems allow Life Spine to provide surgeons the tools to support these important surgical procedure advancements and trends. In addition, the advancement of MIS access products like CENTRIC®-T Pedicle-Based Retractor System and CALYPSO® Midline Retractor System, enhance Life Spine’s goal of offering full MIS procedural solutions.

“One of the cornerstones for successful spinal fusion surgery is providing an environment to enhance the fusion process. Facilitating in-situ delivery of bone grafting material after placement increases the volume within and around the device required for a successful fusion,” noted Bryan B. Barnes, MD of the Georgia Neurological Surgery & Georgia Comprehensive Spine in Athens, Georgia.

About Life Spine

Life Spine is dedicated to improving the quality of life for spinal patients by increasing procedural efficiency and efficacy through innovative design, uncompromising quality standards, and the most technologically advanced manufacturing platforms. Life Spine, which is privately held, is based in Huntley, Illinois. For more information, please visit: http://www.lifespine.com.

1: 2015 iData Reports

Life Spine is a registered trademark

Contacts

Life Spine
Mr. Omar Faruqi
Chief Financial Officer
ofaruqi@lifespine.com
847-884-6117

South Denver Surgery Center First to Deploy 7D Surgical’s Machine-Vision Image Guided Surgery (MvIGS) Platform in Colorado

TORONTOOct. 29, 2018 /PRNewswire/ — As providers around the world look for new and innovative ways to improve surgical outcomes and patient safety, the South Denver Surgery Center has taken a leap into the future with the installation of the 7D Surgical System for spinal procedures.  This system virtually replaces standard fluoroscopy, providing the surgical team with a fast, accurate and radiation-free tool for the placement of spinal implants.

“7D Surgical’s technology makes perfect sense in the ASC setting where speed, safety, ease of use and cost are critical factors,” said Beau Standish, Chief Executive Officer of 7D Surgical.  “We will expand our presence in the ASC market while continuing to build on our hospital based installations.”

The 7D Surgical System is the first and only Machine-Vision Image Guided Surgery (MvIGS) platform. For the first-time, spine surgeons can guide their tools to the critical anatomy using sophisticated camera technology linked to a computer in the operating theater.  The underlying technology is similar to what is used in the latest self-driving automobiles.  Unlike time-consuming, conventional image guided surgery (IGS) systems that depend on intraoperative radiation, this new MvIGS platform can achieve an incredibly fast surgical workflow for spine procedures, reducing operative time for patients.

“We’re excited to be the first to have the new 7D Surgical navigation system in the western United States.  We feel this technology offers groundbreaking workflow efficiency to optimize patient outcomes and patient safety,” said Dr. David Vansickle, neurosurgeon with Neurosurgery One.

Dr. J. Adair Prall, also with Neurosurgery One, agrees. “This system puts us right where we want to be in the outpatient environment – fast, accurate, safe and cost-effective.  This technology is the future of spine surgery.”

If you are a surgeon or facility administrator and interested in learning more about 7D Surgical, please visit www.7Dsurgical.com or contact our team at 203933@email4pr.com.

About 7D Surgical

7D Surgical is a privately-owned Toronto based company that develops advanced optical technologies and machine vision-based registration algorithms to improve surgical workflow and patient care. 7D Surgical’s flagship FDA 510(k)-cleared and Health Canada approved MvIGS system delivers profound improvement to surgical workflows in spine and cranial surgery.  The underlying technology provides the promise of similar future advancements for other surgical specialties.

Contact:
Beau Standish, CEO
7D Surgical
+1 647 484-0078
203933@email4pr.com

SOURCE 7D Surgical

Related Links

http://www.7Dsurgical.com

Orthofix Reports Third Quarter 2018 Financial Results

October 29, 2018

LEWISVILLE, Texas–(BUSINESS WIRE)–Orthofix Medical Inc. (previously Orthofix International N.V.) (NASDAQ:OFIX) today reported its financial results for the third quarter ended September 30, 2018. Net sales were $111.7 million, net loss per share from continuing operations was $0.07 and adjusted earnings per share from continuing operations was $0.43.

“In addition to solid financial performance on both the top line and adjusted EBITDA in the third quarter, we made significant operational progress in the alignment of our Bone Growth Therapy, Spinal Implants and Biologics segments into Orthofix Spine,” said Brad Mason, Orthofix President and Chief Executive Officer. “We believe that our market-leading technologies in osteogenesis stimulation and stem cell allografts, together with the M6 cervical disc, once it is approved by the U.S. Food and Drug Administration, will uniquely position us in the spine market overall and particularly in the cervical spine segment. We also believe this combination of spine products in conjunction with our historical strength in Orthofix Extremities provides the platforms for us to drive accelerating growth as we move into 2019 and for the foreseeable future.”

Financial Results Overview

The following table provides net sales by reporting segments:

Three Months Ended September 30,
(Unaudited, U.S. Dollars, in thousands) 2018 2017 Change Constant

Currency

Change

Bone Growth Therapies1 $ 48,059 $ 44,427 8.2 % 8.2 %
Spinal Implants2 22,102 20,155 9.7 %

4

10.0 %

4

Biologics 14,636 15,218 (3.8 %)

5

(3.8 %)

5

Orthofix Extremities3 26,911 25,447 5.8 % 7.5 %
Net sales $ 111,708 $ 105,247 6.1 %

6

6.6 %

6

1 Formerly referred to as BioStim
2 Formerly referred to as Spine Fixation
3 Formerly referred to as Extremity Fixation
4 Excluding Spinal Kinetics, net sales decreased 4.5% on a reported basis and 4.3% on a constant currency basis
5 Excluding the contractual reduction in fee for marketing services, the growth year over year was 3.7% on a reported and constant currency basis
6 Excluding Spinal Kinetics and the contractual reduction in fee for marketing services, the increase was 4.5% on a reported basis and 5.0% on a constant currency basis

 

Gross margin increased 100 basis points compared to the prior year period primarily driven by costs savings from our 2017 U.S. restructuring initiative and continued improvement related to inventory management initiatives. Non-GAAP net margin, an internal metric that the Company defines as gross profit less sales and marketing expenses, was $37.8 million compared to $34.0 million in the prior year period. As a percentage of net sales, non-GAAP net margin increased to 33.8% as compared to 32.3% in the prior year period, primarily due to the improvement in gross margin and improvements in commission rates.

GAAP net loss from continuing operations was ($1.2) million, or ($0.07) per share, compared to net income of $3.3 million, or $0.18 per share in the prior year period. This decrease was primarily driven by changes in the fair value of contingent consideration associated with the acquisition of Spinal Kinetics and an unrealized loss on investment securities recognized during the third quarter of 2018. Adjusted net income from continuing operations was $8.2 million, or $0.43 per share, compared to adjusted net income of $7.7 million, or $0.42 per share in the prior year period. Excluding the impact of the Spinal Kinetics operating loss in the period, adjusted net income was $9.5 million, or $0.50 per share, a 19.0% increase over prior year.

EBITDA was $3.6 million, compared to $14.5 million in the prior year period. Adjusted EBITDA was $21.4 million, or 19.2% of net sales, for the third quarter, compared to $21.1 million, or 20.1% of net sales, in the prior year period.

Liquidity

As of September 30, 2018, cash, cash equivalents, and restricted cash totaled $56.2 million compared to $81.2 million as of December 31, 2017. As of September 30, 2018, the Company had no outstanding indebtedness and borrowing capacity of $125 million under its existing credit facility. Cash flow from operations was $28.8 million, an increase of $19.7 million, and free cash flow was $18.1 million, an increase of $22.3 million when compared to the same prior year period.

2018 Updated Outlook

For the year ending December 31, 2018, the Company expects the following results, assuming exchange rates are the same as those currently prevailing.

Previous 2018 Outlook Current 2018 Outlook
(Unaudited, U.S. Dollars, in millions, except per share data) Low High Low High
Net sales $ 450.0 $ 456.0 $ 451.0 1 $ 455.0 1
Net income from continuing operations $ 18.3 $ 19.7 $

11.4

$

12.7

Adjusted EBITDA $ 85.0 $ 87.0 $ 85.5 $ 87.0
EPS from continuing operations $ 0.97 $ 1.04 $

0.60

$

0.67

Adjusted EPS from continuing operations $ 1.66 $ 1.72 $ 1.70 $ 1.75
1

Represents a year-over-year increase of 4.0% to 4.9% on a reported basis

Conference Call

Orthofix will host a conference call today at 4:30 PM Eastern time to discuss the Company’s financial results for the third quarter of 2018. Interested parties may access the conference call by dialing (844) 809-1992 in the U.S. and (612) 979-9886 outside the U.S., and referencing the conference ID 6295495. A replay of the call will be available for two weeks by dialing (855) 859-2056 in the U.S. and (404) 537-3406 outside the U.S., and entering the conference ID 6295495. A webcast of the conference call may be accessed by going to the Company’s website at www.orthofix.com, by clicking on the Investors link and then the Events and Presentations page.

About Orthofix

Orthofix Medical Inc. is a global medical device company focused on musculoskeletal products and therapies. The Company’s mission is to improve patients’ lives by providing superior reconstruction and regenerative musculoskeletal solutions to physicians worldwide. Headquartered in Lewisville, Texas, Orthofix’s spine and orthopedic extremities products are distributed in over seventy countries via the Company’s sales representatives and distributors. For more information, please visit www.orthofix.com.

Forward-Looking Statements

This communication contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (“the Exchange Act”), and Section 27A of the Securities Act of 1933, as amended, relating to our business and financial outlook, which are based on our current beliefs, assumptions, expectations, estimates, forecasts and projections. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “intends,” “predicts,” “potential,” or “continue” or other comparable terminology. These forward-looking statements are not guarantees of our future performance and involve risks, uncertainties, estimates and assumptions that are difficult to predict. Therefore, our actual outcomes and results may differ materially from those expressed in these forward-looking statements. You should not place undue reliance on any of these forward-looking statements. Further, any forward-looking statement speaks only as of the date hereof, unless it is specifically otherwise stated to be made as of a different date. We undertake no obligation to further update any such statement, or the risk factors described in Part I, Item 1A under the heading Risk Factors in our Form 10-K for the year ended December 31, 2017 and other SEC filings, to reflect new information, the occurrence of future events or circumstances or otherwise.

ORTHOFIX MEDICAL INC.
Condensed Consolidated Statements of Operations
Three Months Ended Nine Months Ended
September 30, September 30,
(Unaudited, U.S. Dollars, in thousands, except share and per share data) 2018 2017 2018 2017
Net sales $ 111,708 $ 105,247 $ 331,964 $ 316,927
Cost of sales 24,020 23,717 71,002 69,475
Gross profit 87,688 81,530 260,962 247,452
Sales and marketing 49,898 47,493 151,695 146,496
General and administrative 22,705 18,068 64,457 56,759
Research and development 9,598 6,935 24,426 21,246
Changes in fair value of contingent consideration 1,580 2,689
Operating income 3,907 9,034 17,695 22,951
Interest income (expense), net (181 ) (15 ) (615 ) 106
Other income (expense), net (5,054 ) 479 (5,785 ) (3,284 )
Income (loss) before income taxes (1,328 ) 9,498 11,295 19,773
Income tax benefit (expense) 115 (6,150 ) (6,346 ) (13,998 )
Net income (loss) from continuing operations (1,213 ) 3,348 4,949 5,775
Discontinued operations
Income (loss) from discontinued operations 65 (3 ) (1,762 )
Income tax benefit (expense) 2 43 (6 ) 642
Net income (loss) from discontinued operations 2 108 (9 ) (1,120 )
Net income (loss) $ (1,211 ) $ 3,456 $ 4,940 $ 4,655
Net income (loss) per common share—basic
Net income (loss) from continuing operations $ (0.07 ) $ 0.18 $ 0.26 $ 0.32
Net income (loss) from discontinued operations 0.01 (0.06 )
Net income (loss) per common share—basic $ (0.07 ) $ 0.19 $ 0.26 $ 0.26
Net income (loss) per common share—diluted
Net income (loss) from continuing operations $ (0.07 ) $ 0.18 $ 0.26 $ 0.31
Net income (loss) from discontinued operations 0.01 (0.06 )
Net income (loss) per common share—diluted $ (0.07 ) $ 0.19 $ 0.26 $ 0.25
Weighted average number of common shares:
Basic 18,562,204 18,180,845 18,460,848 18,071,093
Diluted 18,562,204 18,572,791 18,864,169 18,394,542

 

 

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Medical Device Makers Shut Out Of Value-Based Care Without Kickback Rule Change

Oct 26, 2018 / Bruce Japsen 

The medical device industry is pushing for a change in the federal anti-kickback law to allow companies to fully participate in the shift away from fee-for-service medicine to value-based care.

The device industry wants changes known as “safe harbors” designed to prevent medical device makers from running afoul of healthcare fraud laws that impose penalties if individuals knowingly pay for or induce a sale or referral. Such rules are applied to medical care providers, insurers and other companies that have their services, products and devices covered by government health insurance.

The value-based care form of payment rewards medical care providers by compensating doctors and hospitals that achieve the best health outcomes. That is in contrast to the traditional fee-for-service form of payment that is based on volume of medical care delivered and is known to increase healthcare costs in the form of unnecessary tests and procedures.

But device makers are limited despite the role of medical technology and devices in healthcare advancements. Thus, the industry Friday submitted suggestions to the U.S. Department of Health and Human Services’ Office of Inspector General, which is seeking input on rule changes related to value-based care payments.

“Device makers cannot currently enter into certain value-based partnerships because federal rules prevent them from providing any incentives unless they fall within safe harbor or a waiver,” said Scott Whitaker, chief executive officer of The Advanced Medical Technology Association (AdvaMed). The trade group represents some of the world’s biggest medical device makers including Johnson & Johnson, Abbott Laboratories, Medtronic, Stryker and Baxter International.

 The device industry wants clarity on how they can at least participate in a Medicare reimbursement structure that allows the company and the provider to share in savings should they create a system that led to a better outcome at a lower price,” Whitaker said. “The best way to accomplish this is through new value-based safe harbors for pricing arrangements, warranties, and risk-sharing arrangements.”

 

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Photo Credit: Getty Royalty Free / Forbes

 

Zimmer Biomet Announces Third Quarter 2018 Financial Results

WARSAW, Ind.Oct. 26, 2018 /PRNewswire/ — Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH) today reported financial results for the quarter ended September 30, 2018.  The Company reported third quarter net sales of $1.837 billion, an increase of 1.3% over the prior year period, and an increase of 2.3% on a constant currency basis.  Diluted earnings per share for the third quarter were $0.79, an increase of 65% over the prior year period.  Third quarter adjusted diluted earnings per share were $1.63, a decrease of 5% from the prior year period.

“We are pleased with our third quarter accomplishments, which reflect our sustained progress in a number of areas.  Although our sales results clearly benefited from less challenging sales comparisons, as well as the timing of certain tenders and capital sales, our organic growth continued to signal that we are turning the business around consistent with our expectations,” said Bryan Hanson, President and CEO of Zimmer Biomet.  “Looking to the balance of the year, we will continue to focus on priorities to improve the consistency of our results and drive sustained value creation.  These include important new innovations that are expanding our comprehensive portfolio, advancing standards of care and creating new opportunities for our salesforce to deliver growth.”

Net earnings for the third quarter were $162.2 million, and $334.6 million on an adjusted basis.  Operating cash flow for the third quarter was $484.1 million.  Free cash flow in the quarter was $345.0 million.

In the quarter, the Company paid $48.8 million in dividends and declared a third quarter dividend of $0.24 per share.

Guidance

The Company made minor updates to its full-year 2018 guidance.  The only factors changing are the expected impact of foreign currency and the expected adjusted effective tax rate.  All other prior guidance for 2018 remains unchanged.

  • The Company now expects the positive impact of foreign currency translation to be slightly below the low end of the previous range of 100 to 150 basis points, due to the strengthening of the dollar over the last several months.
  • The Company now expects the adjusted effective tax rate for the full year to be slightly below the low end of the previous range of 18.5% to 19.5%(1).

(1)  

This is a non-GAAP financial measure for which a reconciliation to the most directly comparable GAAP financial measure is not available without unreasonable efforts.  See “Forward-Looking Non-GAAP Financial Measures.”

Conference Call

The Company will conduct its third quarter 2018 investor conference call today, October 26, 2018, at 8:30 a.m. Eastern Time.  The audio webcast can be accessed via Zimmer Biomet’s Investor Relations website at http://investor.zimmerbiomet.com.  It will be archived for replay following the conference call.

Sales Tables
The following sales tables provide results by geography and product category, as well as the percentage change compared to the prior year quarter and nine months, on both a reported basis and a constant currency basis.

NET SALES – THREE MONTHS ENDED SEPTEMBER 30, 2018

(in millions, unaudited)

Constant

Net

Currency

Sales

% Change

% Change

Geographic Results

Americas

$

1,154

1.5

%

1.7

%

EMEA

372

(2.3)

Asia Pacific

311

5.4

7.6

Total

$

1,837

1.3

%

2.3

%

Product Categories

Knees

Americas

$

385

0.8

%

1.0

%

EMEA

134

(0.6)

2.6

Asia Pacific

109

2.5

5.4

Total

628

0.8

2.1

Hips

Americas

240

5.9

6.2

EMEA

108

(6.4)

(4.1)

Asia Pacific

97

6.7

8.6

Total

445

2.8

3.9

S.E.T *

415

2.4

3.1

Dental

92

(0.6)

(0.2)

Spine & CMF**

185

0.2

0.7

Other

72

(4.0)

(3.3)

Total

$

1,837

1.3

%

2.3

%

* Surgical, Sports Medicine, Foot and Ankle, Extremities and Trauma

** Craniomaxillofacial

NET SALES – NINE MONTHS ENDED SEPTEMBER 30, 2018

(in millions, unaudited)

Constant

Net

Currency

Sales

% Change

% Change

Geographic Results

Americas

$

3,578

0.2

%

0.1

%

EMEA

1,326

4.2

(1.7)

Asia Pacific

958

7.4

5.2

Total

$

5,862

2.2

%

0.5

%

Product Categories

Knees

Americas

$

1,210

(0.4)

%

(0.5)

%

EMEA

494

6.8

1.1

Asia Pacific

340

4.4

2.6

Total

2,044

2.0

0.4

Hips

Americas

$

738

3.3

3.1

EMEA

384

0.4

(5.2)

Asia Pacific

302

8.7

6.2

Total

1,424

3.6

1.4

S.E.T *

1,291

3.3

1.8

Dental

307

(1.4)

(3.7)

Spine & CMF**

566

0.4

(0.6)

Other

230

(0.8)

(2.1)

Total

$

5,862

2.2

%

0.5

%

* Surgical, Sports Medicine, Foot and Ankle, Extremities and Trauma

** Craniomaxillofacial

About the Company

Founded in 1927 and headquartered in Warsaw, Indiana, Zimmer Biomet is a global leader in musculoskeletal healthcare. We design, manufacture and market orthopaedic reconstructive products; sports medicine, biologics, extremities and trauma products; office based technologies; spine, craniomaxillofacial and thoracic products; dental implants; and related surgical products.

We collaborate with healthcare professionals around the globe to advance the pace of innovation. Our products and solutions help treat patients suffering from disorders of, or injuries to, bones, joints or supporting soft tissues. Together with healthcare professionals, we help millions of people live better lives.

We have operations in more than 25 countries around the world and sell products in more than 100 countries. For more information, visit www.zimmerbiomet.com or follow Zimmer Biomet on Twitter at www.twitter.com/zimmerbiomet.

Website Information

We routinely post important information for investors on our website, www.zimmerbiomet.com, in the “Investor Relations” section.  We use this website as a means of disclosing material, non-public information and for complying with our disclosure obligations under Regulation FD.  Accordingly, investors should monitor the Investor Relations section of our website, in addition to following our press releases, SEC filings, public conference calls, presentations and webcasts.  The information contained on, or that may be accessed through, our website is not incorporated by reference into, and is not a part of, this document.

Reclassifications

Beginning in the second quarter 2018, in our consolidated statements of earnings we have reclassified expenses that were previously recognized in a financial statement line item labeled, “Acquisition, quality remediation and other” to the financial statement line items of “Research and development”, “Selling, general and administrative”, “Goodwill and intangible asset impairment”, “Acquisition, integration and related”, and “Quality remediation”.  Prior periods have been reclassified to conform to the current year presentation.

Note on Non-GAAP Financial Measures

This press release includes non-GAAP financial measures that differ from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”).  These non-GAAP financial measures may not be comparable to similar measures reported by other companies and should be considered in addition to, and not as a substitute for, or superior to, other measures prepared in accordance with GAAP.

Sales change information for the three and nine-month periods ended September 30, 2018 are presented on a GAAP (reported) basis and on a constant currency basis.  Constant currency percentage changes exclude the effects of foreign currency exchange rates.  They are calculated by translating current and prior-period sales at the same predetermined exchange rate.  The translated results are then used to determine year-over-year percentage increases or decreases.

Net earnings and diluted earnings per share for the three and nine-month periods ended September 30, 2018 are presented on a GAAP (reported) basis and on an adjusted basis.  Adjusted earnings and adjusted diluted earnings per share exclude the effects of inventory step-up; certain inventory and manufacturing-related charges, including charges to discontinue certain product lines; intangible asset amortization; goodwill and intangible asset impairment; acquisition, integration and related expenses; quality remediation expenses; certain litigation gains and charges; other charges; any related effects on our income tax provision associated with these items; and other certain tax adjustments.

Free cash flow is an additional non-GAAP measure that is presented in this press release. Free cash flow is computed by deducting additions to instruments and other property, plant and equipment from net cash provided by operating activities.

Reconciliations of these non-GAAP financial measures to the most directly comparable GAAP financial measures are included in this press release. This press release also contains supplemental reconciliations of additional non-GAAP financial measures that the Company presents in other contexts. These additional non-GAAP financial measures are computed from the most directly comparable GAAP financial measure as indicated in the applicable reconciliation.

Management uses non-GAAP financial measures internally to evaluate the performance of the business.  Additionally, management believes these non-GAAP measures provide meaningful incremental information to investors to consider when evaluating the performance of the Company.  Management believes these measures offer the ability to make period-to-period comparisons that are not impacted by certain items that can cause dramatic changes in reported income but that do not impact the fundamentals of our operations.  The non-GAAP measures enable the evaluation of operating results and trend analysis by allowing a reader to better identify operating trends that may otherwise be masked or distorted by these types of items that are excluded from the non-GAAP measures.  In addition, constant currency sales changes, adjusted operating profit, adjusted diluted earnings per share and free cash flow are used as performance metrics in our incentive compensation programs.

Forward-Looking Non-GAAP Financial Measures

This press release also includes the forward-looking non-GAAP financial measure of adjusted effective tax rate for the year ending December 31, 2018.  We calculate forward-looking non-GAAP financial measures based on internal forecasts that omit certain amounts that would be included in GAAP financial measures.  For instance, we exclude the impact of certain potential charges or gains connected to quality remediation efforts and certain legal and tax matters.  We have not provided a quantitative reconciliation of this forward-looking non-GAAP financial measure to the most directly comparable forward-looking GAAP financial measure because the excluded items are not available on a prospective basis without unreasonable efforts.  It is probable that this forward-looking non-GAAP financial measure may be materially different from the corresponding GAAP financial measure.

Cautionary Statement Regarding Forward-Looking Statements

This release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including, among others, statements regarding sales and earnings guidance and any statements about our expectations, plans, strategies or prospects.   We generally use the words “may,” “will,” “expects,” “believes,” “anticipates,” “plans,” “estimates,” “projects,” “assumes,” “guides,” “targets,” “forecasts,” “sees,” “seeks,” “should,” “could,” “intends” and similar expressions to identify forward-looking statements.   All statements other than statements of historical or current fact are, or may be deemed to be, forward-looking statements.   Such statements are based upon the current beliefs and expectations of management and are subject to significant risks, uncertainties and changes in circumstances that could cause actual outcomes and results to differ materially.  These risks, uncertainties and changes in circumstances include, but are not limited to:  our chief executive officer transition, including disruptions and uncertainties related thereto, the potential impact on our business and future strategic direction resulting from our transition to a new chief executive officer, and our ability to recruit and retain other key members of senior management; the possibility that the anticipated synergies and other benefits from mergers and acquisitions will not be realized, or will not be realized within the expected time periods; the risks and uncertainties related to our ability to successfully integrate the operations, products, employees and distributors of acquired companies; the effect of the potential disruption of management’s attention from ongoing business operations due to integration matters related to mergers and acquisitions; the effect of mergers and acquisitions on our relationships with customers, vendors and lenders and on our operating results and businesses generally; compliance with the Deferred Prosecution Agreement entered into in January 2017; the success of our quality and operational excellence initiatives, including ongoing quality remediation efforts at our Warsaw North Campus facility; challenges relating to changes in and compliance with governmental laws and regulations affecting our U.S. and international businesses, including regulations of the U.S. Food and Drug Administration (FDA) and foreign government regulators, such as more stringent requirements for regulatory clearance of products; the ability to remediate matters identified in any inspectional observations or warning letters issued by the FDA, while continuing to satisfy the demand for our products; the outcome of government investigations; competition; pricing pressures; changes in customer demand for our products and services caused by demographic changes or other factors; the impact of healthcare reform measures; reductions in reimbursement levels by third-party payors and cost containment efforts of healthcare purchasing organizations; dependence on new product development, technological advances and innovation; shifts in the product category or regional sales mix of our products and services; supply and prices of raw materials and products; control of costs and expenses; the ability to obtain and maintain adequate intellectual property protection; the ability to form and implement alliances; changes in tax obligations arising from tax reform measures, including European Union rules on state aid, or examinations by tax authorities; product liability and intellectual property litigation losses; the ability to retain the independent agents and distributors who market our products; dependence on a limited number of suppliers for key raw materials and outsourced activities; changes in general industry and market conditions, including domestic and international growth rates; changes in general domestic and international economic conditions, including interest rate and currency exchange rate fluctuations; and the impact of the ongoing financial and political uncertainty on countries in the Euro zone on the ability to collect accounts receivable in affected countries.  For a further list and description of such risks and uncertainties, see our reports filed with the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 10-K for the year ended December 31, 2017.  Copies of these filings, as well as subsequent filings, are available online at www.sec.govwww.zimmerbiomet.com or on request from us.  Forward-looking statements speak only as of the date they are made, and we disclaim any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.  Readers of this release are cautioned not to rely on these forward-looking statements, since there can be no assurance that these forward-looking statements will prove to be accurate.  This cautionary statement is applicable to all forward-looking statements contained in this release.

 

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