HSS Ranked No. 1 in Orthopedics by U.S. News & World Report for Ninth Consecutive Year

NEW YORKAug. 14, 2018 /PRNewswire/ — For the ninth consecutive year, Hospital for Special Surgery (HSS) has been ranked the No. 1 hospital in the nation for orthopedics by U.S.News & World Report “Best Hospitals 2018-2019” survey. HSS was also recognized as a leader in the field of rheumatology, maintaining the No. 3 ranking in the country. This is the 27th consecutive year HSS has been among the top rated hospitals.

“We are fully committed to our singular focus on musculoskeletal health which allows us to not only provide the highest quality of care and value but also to be a leader in the field through innovation,” said Louis A. Shapiro, president and CEO of HSS. “We are invested in helping people move better so they can live better.”

For the 2018-19 rankings, U.S. News evaluated more than 4,500 medical centers nationwide in 25 specialties, procedures and conditions. In the 16 specialty areas, 158 hospitals were ranked in at least one specialty.

“Whether it’s a routine or complex case, our patients benefit from highly specialized physicians with the shared goal of delivering an unmatched level of personalized care to each patient,” said Todd J. Albert, MD, surgeon-in-chief and medical director of HSS. “It is truly an honor to be a part of such a dedicated, patient-centric medical staff.”

In 2017, HSS cared for over 135,000 pediatric and adult patients surgically and non-surgically for conditions including joint pain, trauma and sports injuries, osteoarthritis, rheumatoid arthritis, back pain and spinal disorders, and conditions of the hand and upper extremity, and foot and ankle.

“Rheumatic and autoimmune diseases often present as diagnostic puzzles, and medical management can be challenging,” said Mary K. Crow, MD, physician-in-chief and chief of the Division of Rheumatology. “The chronic nature of these disorders requires sustained attention and a personal approach to care. I am regularly impressed at the level of specialized expertise that our outstanding rheumatologists provide for these complex patients and the coordinated teamwork and commitment of our HSS staff that optimizes patient outcomes and quality of life.”

HSS also provides care to elite, professional and collegiate athletes and organizations around the world, including USABasketball, Fédération Internationale de Football Association (FIFA), UFC, the Brooklyn Nets, New York Giants, New York Knicks, New York Mets and New York Red Bulls, among others.

About HSS | Hospital for Special Surgery

HSS is the world’s leading academic medical center focused on musculoskeletal health. At its core is Hospital for Special Surgery, nationally ranked No. 1 in orthopedics (for the ninth consecutive year) and No. 3 in rheumatology by U.S. News & World Report (2018-2019). Founded in 1863, the Hospital has one of the lowest infection rates in the country and was the first in New York State to receive Magnet Recognition for Excellence in Nursing Service from the American Nurses Credentialing Center four consecutive times. The global standard total knee replacement was developed at HSS in 1969. An affiliate of Weill Cornell Medical College, HSS has a main campus in New York City and facilities in New JerseyConnecticut and in the Long Island and Westchester County regions of New York State. In 2017 HSS provided care to 135,000 patients and performed more than 32,000 surgical procedures. People from all 50 U.S. states and 80 countries travelled to receive care at HSS. In addition to patient care, HSS leads the field in research, innovation and education. The HSS Research Institute comprises 20 laboratories and 300 staff members focused on leading the advancement of musculoskeletal health through prevention of degeneration, tissue repair and tissue regeneration. The HSS Global Innovation Institute was formed in 2016 to realize the potential of new drugs, therapeutics and devices. The culture of innovation is accelerating at HSS as 130 new idea submissions were made to the Global Innovation Institute in 2017 (almost 3x the submissions in 2015). The HSS Education Institute is the world’s leading provider of education on the topic on musculoskeletal health, with its online learning platform offering more than 600 courses to more than 21,000 medical professional members worldwide. Through HSS Global Ventures, the institution is collaborating with medical centers and other organizations to advance the quality and value of musculoskeletal care and to make world-class HSS care more widely accessible nationally and internationally.

SOURCE Hospital for Special Surgery

Artificial Discs Market 2018: Study on Eminent Players | Medtronic, Globus Medical, Depuy Spine, NuVasive, Zimmer-Biomet, Stryker Corporation and Aesculap Implant System

(EMAILWIRE.COM, August 11, 2018 ) Artificial Disc Market  to exceed USD 4.5 billion by 2024 as per a new research report. Steadily growing number of osteoarthritis and rheumatoid arthritis procedures around the world is a primary factor responsible for artificial disc market growth. Increasing incidences of degenerative disc diseases and adult patient’s willingness to opt for artificial disc are predominant factors boosting the global artificial disc market growth.

Moreover, promoting factors such as improving medical literacy, medical tourism and growing practice of advanced medical interventions are some of the high impact rendering forces.

From patient’s side, growing ability of patients to afford cost intensive artificial disc procedures also happens to be a major factor for market growth. Furthermore, low probability of re-operation with artificial disc also plays a key role in patient’s decision to undergo procedure. Rising per capita income in emerging economies should further add on to the market demand and therefore spur the market growth during the forecast period.

Request sample copy of this report @ https://www.gminsights.com/request-sample/detail/1183

However, risks associated during and after the procedure such as development of infections, dislocation of disc, stenosis etc. mind-blocks patient from undergoing the surgery, especially seen in young patient population. Moreover, inadequate insurance coverage on artificial disc procedures in many countries happens to be a major constraint in market growth.

Cervical artificial disc market commanded over 60% of total artificial disc market in 2016 in years to come, rising number of cervical artificial discs surgeries and accessibility of more number of products will add to growth of artificial cervical disc market. Recent approvals of distinctive types of cervical disc in U.S. should prove to be a growth promoter in near future. Metal on biopolymer material should continue to be the most commonly used during the forecast timeframe, because of its high biocompatibility, shock absorbing capability and ease of insertion these advantages have resulted to higher demand of metal on biopolymer than metal on metal in recent past. In coming years, improvements in metal on biopolymer material should drive its market growth.

 

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Wright Medical Group N.V. Reports 2018 Second Quarter Financial Results

AMSTERDAM, The Netherlands, Aug. 08, 2018 (GLOBE NEWSWIRE) — Wright Medical Group N.V. (NASDAQ:WMGI) today reported financial results for its second quarter ended July 1, 2018 and increased its 2018 annual guidance.  Unless otherwise noted, all net sales growth rates in this release are stated on a constant currency basis.

Net sales totaled $205.4 million during the second quarter ended July 1, 2018, representing 14.3% as reported and 12.9% constant currency growth, an estimated 370 basis point improvement versus the first quarter of 2018.  Gross margins were 77.8% during the quarter ended July 1, 2018 and were 78.5% on a non-GAAP adjusted basis.  Reconciliations of all historical non-GAAP financial measures used in this release to the most comparable GAAP measures can be found in the attached financial tables.

Robert Palmisano, president and chief executive officer, commented, “We produced outstanding results across the board in the second quarter, including 13% constant currency net sales growth, an estimated 370 basis point increase versus the first quarter of 2018, and we exited the quarter on a strong, positive trajectory, which we expect to continue throughout the remainder of 2018.  These results represent another strong performance in our U.S. upper extremities business, which grew 22% in the second quarter, driven by 24% growth in our U.S. shoulder business.  We anticipate that continued penetration of our SIMPLICITI shoulder system, our ongoing PERFORM Reversed launch and accelerating adoption of our BLUEPRINT enabling technology will continue to drive market-leading shoulder sales growth in 2018.”

Palmisano further commented, “Our U.S. lower extremities growth rate accelerated to 9% in the second quarter, driven by approximately 15% growth in total ankle and improved growth in our core lower extremities business.  The lower extremities business returned to market rates of growth well ahead of schedule, driven primarily by increased contributions from our expanded sales organization.  We are on a good trajectory headed into the second half of the year when we expect the third quarter launch of our PROstep Minimally Invasive Surgery System to provide further momentum for this business.  We also received PMA approval for AUGMENT Injectable Bone Graft and initiated launch activities in the U.S.  We believe the superior handling characteristics and ease of use of AUGMENT Injectable, combined with the proven clinical benefits of AUGMENT, will accelerate the growth in our biologics business in the back half of this year.”

Net loss from continuing operations for the second quarter of 2018 totaled $90.6 million, or $(0.85) per diluted share.

The company’s net loss from continuing operations for the second quarter of 2018 included the after-tax impacts of a $39.9 million non-cash loss on extinguishment of debt to write-off unamortized debt discount and deferred financing fees associated with the partial settlement of its 2020 convertible notes, a loss of $32.9 million related to mark-to-market adjustments on derivatives, non-cash interest expense of $12.3 million related to its convertible notes, non-cash foreign currency translation charges of $1.9 million, and $1.3 million of transaction and transition costs associated with non-cash inventory provisions.  These charges were offset by an unrealized gain of $2.5 million related to mark-to-market adjustments on contingent value rights (CVRs) issued in connection with the BioMimetic acquisition and a $6.2 million U.S. tax benefit within continuing operations recorded as a result of the pre-tax gain recognized within discontinued operations due to the previously announced $30.75 million insurance settlement.

The company’s second quarter 2018 non-GAAP net loss from continuing operations, as adjusted for the above items, was $9.6 million.  The company’s second quarter 2018 non-GAAP adjusted EBITDA from continuing operations, as defined in the non-GAAP to GAAP reconciliation provided later in this release, was $25.6 million. The attached financial tables include reconciliations of all historical non-GAAP measures to the most comparable GAAP measures.

Cash and cash equivalents totaled $313.2 million as of the end of the second quarter of 2018.

Palmisano concluded, “Overall, second quarter net sales growth improved significantly, with Upper Extremities, Lower Extremities, Biologics and International all accelerating their constant currency growth rates.  Based on the strength of the underlying business and the approval of AUGMENT Injectable, we are increasing our guidance, which now calls for annual constant currency net sales growth of 10% to 12%, excluding the impact of the four fewer selling days in the fourth quarter of 2018.  I believe we are set up well for the remainder of 2018.  Our end markets remain healthy and fast growing, our gross margins are outstanding, and our new product pipeline is full of innovative and commercially impactful products and surgical solutions across all parts of our business.”

Outlook

As a result of the approval of AUGMENT Injectable and the performance of the business, the company is increasing its net sales guidance for full-year 2018 to approximately $808 million to $820 million from its previous guidance of approximately $800 million to $812 million.  This guidance range has approximately 0.5% cushion from foreign currency exchange rates as compared to current rates.  In addition, this range implies full-year 2018 constant currency net sales growth of 10% to 12%, excluding the estimated $9 million impact of the four fewer selling days in fourth quarter of 2018.

The company is raising its full-year 2018 non-GAAP adjusted EBITDA from continuing operations, as described in the non-GAAP reconciliation provided later in this release, to a range of $106 million to $113 million.

The company expects its non-GAAP adjusted earnings per share from continuing operations, including share-based compensation, as described in the non-GAAP to GAAP reconciliation provided later in this release, for full-year 2018 to be a loss of $0.14 to $0.21 per diluted share.

The company estimates approximately 106.4 million diluted weighted average ordinary shares outstanding for fiscal year 2018.

The company’s non-GAAP adjusted EBITDA from continuing operations target is measured by adding back to net loss from continuing operations charges for interest, income taxes, depreciation and amortization expenses, non-cash share-based compensation expense and non-operating income and expense.  Additionally, the company’s adjusted EBITDA from continuing operations target excludes possible future acquisitions; other material future business developments; and due diligence, transaction and transition costs associated with acquisitions and divestitures.

The company’s non-GAAP adjusted earnings per share from continuing operations target is measured by adding back to net loss from continuing operations non-cash interest expense associated with the convertible notes; due diligence, transaction and transition costs associated with acquisitions and divestitures; mark-to-market adjustments to CVRs; non-cash mark-to-market derivative adjustments; non-cash gains and losses associated with foreign currency translation of balances denominated in foreign currencies; and charges for non-cash amortization expenses, net of taxes. Note that as a result of the company’s relatively low effective tax rate due to the valuation allowance impacting a substantial portion of the company’s income/loss, the company is currently estimating the tax effect on amortization expense at 0%. Further, this non-GAAP adjusted earnings per share from continuing operations target excludes possible future acquisitions and other material future business developments.

All the historical non-GAAP financial measures used in this release are reconciled to the most directly comparable GAAP measures. With respect to the company’s 2018 financial guidance regarding non-GAAP adjusted EBITDA from continuing operations and non-GAAP adjusted earnings per share from continuing operations, however, the company cannot provide a quantitative reconciliation to the most directly comparable GAAP measures without unreasonable effort due to its inability to make accurate projections and estimates related to certain information needed to calculate some of the adjustments as described above, including the foreign currency fluctuations and market driven fair value adjustments to CVRs and derivatives. The anticipated differences between these non-GAAP financial measures and the most directly comparable GAAP measure are described above qualitatively.

The company’s anticipated ranges for net sales from continuing operations, non-GAAP adjusted EBITDA from continuing operations, and non-GAAP adjusted earnings per share from continuing operations are forward-looking statements, as are any other statements that anticipate or aspire to future events or performance.  They are subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets.  The anticipated targets are not predictions of the company’s actual performance.  See the cautionary information about forward-looking statements in the “Cautionary Note Regarding Forward-Looking Statements” section of this release.

Supplemental Financial Information

To view the second quarter of 2018 supplemental financial information, visit ir.wright.com.  For historical information on Wright Medical Group N.V. segment reporting changes and non-GAAP combined pro forma financial information, please refer to the presentation posted on Wright’s website at ir.wright.com in the “Financial Information” section.

Internet Posting of Information

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

Conference Call and Webcast

As previously announced, Wright will host a conference call starting at 3:30 p.m. Central Time today.  The live dial-in number for the call is (844) 295-9436 (U.S.) / (574) 990-1040 (Outside U.S.).  The participant passcode for the call is “Wright.”  A simultaneous webcast of the call will be available via Wright’s corporate website at www.wright.com.

A replay of the call will be available beginning at 5:30 p.m. Central Time on August 8, 2018 through August 15, 2018.  To hear this replay, dial (855) 859-2056 (U.S.) / (404) 537-3406 (Outside U.S.) and enter code 9379128.  A replay of the conference call will also be available via the internet starting today and continuing for at least 12 months.  To access a replay of the conference call via the internet, go to the “Investor Relations – Presentations/Calendar” section of the company’s corporate website located at www.wright.com.

The conference call may include a discussion of non-GAAP financial measures.  Reference is made to the most directly comparable GAAP financial measures, the reconciliation of the differences between the two financial measures, and the other information included in this release, the Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission (SEC) today, or otherwise available in the “Investor Relations – Supplemental Financial Information” section of the company’s corporate website located at www.wright.com.

The conference call may include forward-looking statements.  See the cautionary information about forward-looking statements in the “Cautionary Note Regarding Forward-Looking Statements” section of this release.

About Wright Medical Group N.V.

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

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

Non-GAAP Financial Measures  

To supplement the company’s consolidated financial statements prepared in accordance with U.S. generally accepted accounting principles, the company uses certain non-GAAP financial measures in this release. Reconciliations of the historical non-GAAP financial measures used in this release to the most comparable GAAP measures for the respective periods can be found in tables later in this release. Wright’s non-GAAP financial measures include net sales, excluding the impact of foreign currency; net income, as adjusted; EBITDA, as adjusted; gross margin, as adjusted; earnings, as adjusted; and earnings, as adjusted, per diluted share, in each case, from continuing operations. The company’s management believes that the presentation of these measures provides useful information to investors.  These measures may assist investors in evaluating the company’s operations, period over period. Wright’s non-GAAP financial measures exclude such items as non-cash interest expense related to the company’s convertible notes, non-cash loss on extinguishment of debt, transaction and transition costs, net gains and losses on mark-to-market adjustments on CVRs and derivative assets and liabilities, net non-cash gains and losses on foreign currency translation all of which may be highly variable, difficult to predict and of a size that could have substantial impact on the company’s reported results of operations for a period.  It is for this reason that the company cannot provide without unreasonable effort a quantitative reconciliation to the most directly comparable GAAP measures for its 2018 financial guidance regarding non-GAAP adjusted EBITDA from continuing operations and non-GAAP adjusted earnings per share from continuing operations. Management uses the non-GAAP measures in this release internally for evaluation of the performance of the business, including the allocation of resources and the evaluation of results relative to employee performance compensation targets.  Investors should consider non-GAAP financial measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS 

This release includes forward-looking statements under the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “could,” “may,” “will,” “believe,” “estimate,” “continue,” “guidance,” “future,” other words of similar meaning and the use of future dates. Forward-looking statements in this release include, but are not limited to, statements about the company’s anticipated financial results for 2018, including net sales from continuing operations, adjusted EBITDA from continuing operations and adjusted earnings per share from continuing operations, anticipated continued strong shoulder sales growth, at or above market growth for our U.S. lower extremities business, accelerated growth in our biologics business in the second half of 2018, and the success of our new products, including our PROstep Minimally Invasive Surgery System. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Each forward-looking statement contained in this release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement. Applicable risks and uncertainties include, among others, the failure of the company’s 2017 U.S. sales force additions to achieve expected results, delay or failure to drive U.S. lower extremities or biologics sales to anticipated levels; continued supply constraints; failure to integrate the legacy Wright and Tornier businesses and realize net sales synergies and cost savings from the merger with Tornier or delay in realization thereof; operating costs and business disruption as a result of the merger, including adverse effects on employee retention and sales force productivity and on business relationships with third parties; integration costs; actual or contingent liabilities; adverse effects of diverting resources and attention to providing transition services to the purchaser of the large joints business; the adequacy of the company’s capital resources and need for additional financing; the timing of regulatory approvals and introduction of new products; physician acceptance, endorsement, and use of new products; failure to achieve the anticipated commercial sales of our AUGMENT® Bone Graft and other new products; the effect of regulatory actions, changes in and adoption of reimbursement rates; product liability claims and product recalls; pending and threatened litigation; risks associated with the metal-on-metal master settlement agreement and the settlement agreement with the three settling insurers; risks associated with the subsequent metal-on-metal settlement agreements and ability to obtain the additional new insurance proceeds contingent thereon; risks associated with international operations and expansion; fluctuations in foreign currency exchange rates; other business effects, including the effects of industry, economic or political conditions outside of the company’s control; reliance on independent distributors and sales agencies; competitor activities; changes in tax and other legislation; and the risks identified under the heading “Risk Factors” in Wright’s Annual Report on Form 10-K for the year ended December 31, 2017 filed by Wright with the SEC on February 27, 2018 and subsequent SEC filings by Wright, including without limitation its Quarterly Reports on Form 10-Q for the quarters ended April 1, 2018 and July 1, 2018. Investors should not place considerable reliance on the forward-looking statements contained in this release. Investors are encouraged to read Wright’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this release speak only as of the date of this release, and Wright undertakes no obligation to update or revise any of these statements. Wright’s business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

Investors & Media:

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

–Tables Follow–

Wright Medical Group N.V.
Condensed Consolidated Statements of Operations
 (dollars in thousands, except per share data–unaudited)
Three months ended Six months ended
July 1, 2018 June 25, 2017 July 1, 2018 June 25, 2017
Net sales $ 205,400 $ 179,693 $ 403,937 $ 356,884
Cost of sales 45,558 38,122 86,697 75,248
Gross profit 159,842 141,571 317,240 281,636
Operating expenses:
Selling, general and administrative 140,826 130,818 278,074 260,652
Research and development 14,665 12,547 28,564 24,979
Amortization of intangible assets 6,009 6,999 13,150 14,396
Total operating expenses 161,500 150,364 319,788 300,027
Operating loss (1,658 ) (8,793 ) (2,548 ) (18,391 )
Interest expense, net 20,678 18,339 40,490 36,534
Other expense (income), net 72,747 (6,557 ) 71,747 1,418
Loss from continuing operations before income taxes (95,083 ) (20,575 ) (114,785 ) (56,343 )
(Benefit) provision for income taxes (4,462 ) 385 (4,257 ) 1,324
Net loss from continuing operations $ (90,621 ) $ (20,960 ) $ (110,528 ) $ (57,667 )
Income (loss) from discontinued operations, net of tax 22,923 (20,202 ) 17,316 (42,194 )
Net loss $ (67,698 ) $ (41,162 ) $ (93,212 ) $ (99,861 )
Net loss from continuing operations per share, basic and diluted $ (0.85 ) $ (0.20 ) $ (1.04 ) $ (0.55 )
Net income (loss) from discontinued operations per share, basic and diluted $ 0.21 $ (0.19 ) $ 0.16 $ (0.41 )
Net loss per share, basic and diluted $ (0.64 ) $ (0.39 ) $ (0.88 ) $ (0.96 )
Weighted-average number of shares outstanding-basic and diluted 106,095 104,377 106,000 104,020
Wright Medical Group N.V.
Consolidated Net Sales Analysis
(dollars in thousands–unaudited)
Three months ended Six months ended
July 1, 2018 June 25, 2017 %
change
July 1, 2018 June 25, 2017 %
change
U.S.
Lower extremities $ 59,464 $ 54,348 9.4 % $ 116,287 $ 109,809 5.9 %
Upper extremities 70,171 57,535 22.0 % 137,829 113,493 21.4 %
Biologics 20,234 19,273 5.0 % 38,399 37,907 1.3 %
Sports med & other 1,706 1,780 (4.2 )% 3,853 3,881 (0.7 )%
Total U.S. $ 151,575 $ 132,936 14.0 % $ 296,368 $ 265,090 11.8 %
International
Lower extremities $ 15,680 $ 14,767 6.2 % $ 31,007 $ 28,409 9.1 %
Upper extremities 29,137 22,987 26.8 % 58,731 45,409 29.3 %
Biologics 6,582 5,129 28.3 % 11,839 10,300 14.9 %
Sports med & other 2,426 3,874 (37.4 )% 5,992 7,676 (21.9 )%
Total International $ 53,825 $ 46,757 15.1 % $ 107,569 $ 91,794 17.2 %
Global
Lower extremities $ 75,144 $ 69,115 8.7 % $ 147,294 $ 138,218 6.6 %
Upper extremities 99,308 80,522 23.3 % 196,560 158,902 23.7 %
Biologics 26,816 24,402 9.9 % 50,238 48,207 4.2 %
Sports med & other 4,132 5,654 (26.9 )% 9,845 11,557 (14.8 )%
Total net sales $ 205,400 $ 179,693 14.3 % $ 403,937 $ 356,884 13.2 %
Wright Medical Group N.V.
Supplemental Net Sales Information
(unaudited)
Three months ended July 1, 2018 net sales growth/(decline)
U.S.
as
reported
Int’l
constant
currency
Int’l
as
reported
Global
constant
currency
Global
as
reported
Product line
Lower extremities 9 % 1 % 6 % 8 % 9 %
Upper extremities 22 % 20 % 27 % 21 % 23 %
Biologics 5 % 26 % 28 % 9 % 10 %
Sports med & other (4 %) (41 %) (37 %) (30 %) (27 %)
Total net sales 14 % 10 % 15 % 13 % 14 %
Six months ended July 1, 2018 net sales growth/(decline)
U.S.
as
reported
Int’l
constant
currency
Int’l
as
reported
Global
constant
currency
Global
as
reported
Product line
Lower extremities 6 % 2 % 9 % 5 % 7 %
Upper extremities 21 % 19 % 29 % 21 % 24 %
Biologics 1 % 12 % 15 % 4 % 4 %
Sports med & other (1 %) (29 %) (22 %) (20 %) (15 %)
Total net sales 12 % 9 % 17 % 11 % 13 %

 

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Histogenics Corporation Announces Second Quarter 2018 Financial and Operating Results

WALTHAM, Mass., Aug. 09, 2018 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq: HSGX), a leader in the development of restorative cell therapies (RCTs) that may offer rapid-onset pain relief and restored function, announced its financial and operating results for the quarter ended June 30, 2018.

“Our focus in the second quarter of 2018 was on the NeoCart Biologics License Application submission and we remain on track to announce top-line data in the third quarter of 2018.  In preparation for this exciting milestone, we enhanced our management team with the addition of Lynne Kelley as Chief Medical Officer.  Lynne’s experience and capabilities in medical and regulatory affairs and product development will be instrumental as we advance the preparation of the upcoming BLA for NeoCart,” said Adam Gridley, President and Chief Executive Officer of Histogenics.  “We also made important progress on the international expansion of the NeoCart platform alongside MEDINET, our NeoCart development and commercialization partner in Japan, as they prepare for the initiation of the Phase 3 trial in Japan in the second half of the year.”

Second Quarter 2018 and Recent Highlights

  • NeoCart top-line Phase 3 Data Release on Track for Third Quarter of 2018:  Histogenics expects to report top-line data from its 249-patient Phase 3 randomized, controlled clinical trial of NeoCart in the third quarter of 2018.  The trial is designed to show superiority of NeoCart at one year after treatment as compared to microfracture, the current standard of care, and will follow patients for three years.
  • Expansion and Enhancement of Executive Team:  In July 2018, Histogenics appointed Lynne Kelley as its Chief Medical Officer.  In this role, Dr. Kelley will leverage her 20 plus years of executive management and surgical experience in medical affairs, clinical operations, regulatory affairs and product development to establish Histogenics’ medical affairs strategy and build a medical affairs team to support the potential launch of NeoCart.  Dr. Kelley will also work with the executive team on the preparation of the upcoming Biologics License Application (BLA) for NeoCart and any related discussions with the United States Food and Drug Administration (FDA).
  • Held Inaugural Investor Day:  In June 2018, Histogenics hosted its first investor day in New York City.  Members of Histogenics’ management team discussed the commercialization plan for NeoCart and provided an overview of its Restorative Cell Technology platform.  The team was joined by leading orthopedic surgeons who shared their overall experiences with and provided their clinical perspectives on NeoCart, as well as a NeoCart patient from the Phase 3 clinical trial who provided his thoughts on his recovery, specifically the impact NeoCart has had on his ability to return to work and sports activities.  The event also included a discussion on the NeoCart mechanism of action based on work conducted as part of Histogenics’ collaboration with Cornell University.  A full replay of the webcast is available via the “Investor Relations” page of Histogenics’ website, www.histogenics.com, or by clicking here.

Financial Results for the Second Quarter of 2018

Loss from operations was $(7.3) million in the second quarter of 2018, compared to $(6.4) million in the second quarter of 2017.  The increase in operating expenses was due to an increase in both research and development expenses and general and administrative expenses.

Research and development expenses were $4.5 million in the second quarter of 2018, compared to $4.2 million in the second quarter of 2017.  The increase was primarily due to increases in consulting, salaries and materials in connection with the potential submission of a BLA for NeoCart with the FDA and was partially offset by a reduction in patient costs related to the NeoCart Phase 3 clinical trial, for which enrollment was completed in June 2017.  General and administrative expenses were $2.8 million in the second quarter of 2018, compared to $2.2 million in the second quarter of 2017.  The increase was primarily due to higher salaries and consulting expenses related to increased activities to support the potential commercialization of NeoCart.

Net loss attributable to common stockholders was $(3.7) million in the second quarter of 2018, or $(0.13) per share, compared to $(5.5) million, or $(0.25) per share, in the second quarter of 2017.  The decrease in net loss attributable to common stockholders is primarily due to the conversion of convertible preferred stock issued in connection with the 2016 private placement into common stock and a change in the fair value of the warrant liability which generated a gain in the second quarter of 2018, both of which were partially offset by an increase in operating expenses.

As of June 30, 2018, Histogenics had cash, cash equivalents and marketable securities of $8.8 million, compared to $8.0 million at December 31, 2017.  Histogenics believes its current cash position will be sufficient to fund its operations into the fourth quarter of 2018.

Conference Call and Webcast Information

Histogenics management will host a conference call on Thursday, August 9, 2018 at 8:30 a.m. EDT.  A question-and-answer session will follow Histogenics’ remarks.  To participate on the live call, please dial (877) 930-8064 (domestic) or (253) 336-8040 (international) and provide the conference ID “6679509” five to ten minutes before the start of the call.

To access a live audio webcast of the presentation on the “Investor Relations” page of the Histogenics website, please click here. A replay of the webcast will be archived on Histogenics’ website for approximately 45 days following the presentation.

About Histogenics Corporation

Histogenics (Nasdaq:  HSGX) is a leader in the development of restorative cell therapies that may offer rapid-onset pain relief and restored function.  Histogenics’ lead investigational product, NeoCart, is designed to rebuild a patient’s own knee cartilage to treat pain at the source and potentially prevent a patient’s progression to osteoarthritis.  NeoCart is one of the most rigorously studied restorative cell therapies for orthopedic use.  Histogenics completed enrollment of its NeoCart Phase 3 clinical trial in June 2017 and expects to report top-line, one-year superiority data in the third quarter of 2018.  NeoCart is designed to perform like articular hyaline cartilage at the time of treatment, and as a result, may provide patients with more rapid pain relief and accelerated recovery as compared to the current standard of care. Histogenics’ technology platform has the potential to be used for a broad range of additional restorative cell therapy indications. For more information on Histogenics and NeoCart, please visit www.histogenics.com.

Forward-Looking Statements

Various statements in this release are “forward-looking statements” under the securities laws.  Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.

Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others:  the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in generating the data from the clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; MEDINET’s ability to initiate NeoCart clinical development in Japan in a timely manner; NeoCart’s regulation as a Regenerative Medical Product in Japan; the market size and potential patient population in Japan; the scope, progress, timing, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended December 31, 2017 and Quarterly Report on Form 10-Q for the quarter ended March 31, 2018, which are on file with the SEC and available on the SEC’s website at www.sec.gov.  Additional factors may be set forth in those sections of Histogenics Quarterly Report on Form 10-Q for the quarter ended June 30, 2018, to be filed with the SEC in the third quarter of 2018.  In addition to the risks described above and in Histogenics’ Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, other unknown or unpredictable factors also could affect Histogenics’ results.

There can be no assurance that the actual results or developments anticipated by Histogenics will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Histogenics.  Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

All written and verbal forward-looking statements attributable to Histogenics or any person acting on its behalf are expressly qualified in their entirety by the cautionary statements contained or referred to herein.  Histogenics cautions investors not to rely too heavily on the forward-looking statements Histogenics makes or that are made on its behalf.  The information in this release is provided only as of the date of this release, and Histogenics undertakes no obligation, and specifically declines any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
 (Unaudited)
(in thousands, except share and per share data)

Three Months Ended June 30, Six Months Ended June 30,
2018 2017 2018 2017
Revenue $   ‒ $   ‒ $   ‒ $   ‒
Operating expenses:
Research and development   4,458   4,208   7,744   8,712
General and administrative   2,826   2,166    5,633    4,492
Total operating expenses   7,284   6,374   13,377   13,204
Loss from operations   (7,284 )   (6,374 )   (13,377 )   (13,204 )
Other income (expense):
Interest income (expense), net   32   40    69    75
Other expense, net    (26 )    (73 )    (50 )    (90 )
Change in fair value of warrant liability    3,501    (135 )    (5,252 )    (404 )
Total other income (expense), net   3,507   (168 )    (5,233 )    (419 )
Net loss $ (3,777 ) $ (6,542 ) $ (18,610 ) $ (13,623 )
Other comprehensive loss:
Unrealized gain (loss) from available for sale securities   ‒   4   ‒   (2 )
Comprehensive loss $   (3,777 ) $   (6,538 ) $   (18,610 ) $   (13,625 )
Net loss attributable to common stockholders – basic and diluted $ (3,697 ) $ (5,454 ) $ (18,124 ) $ (11,285 )
Net loss per common share – basic and diluted: $ (0.13 ) $ (0.25 ) $ (0.64 ) $ (0.51 )
Weighted-average shares used to compute loss per common share – basic and diluted:   28,740,030   22,183,804   28,208,030   22,050,572

HISTOGENICS CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS 
(Unaudited)
(in thousands)

  June 30,   December 31,
  2018   2017
Cash and cash equivalents and marketable securities $    8,772 $     7,981
Prepaid expenses and other current assets     881     194
Property and equipment, net    5,173   2,723
Other assets, net    325     137
  Total assets $   15,151 $   11,035
Current liabilities $   11,657 $     3,805
Warrant and other non-current liabilities   26,932   18,498
Total stockholders’ equity (deficit)   (23,438 )   (11,268 )
  Total liabilities and stockholders’ equity (deficit) $   15,151 $   11,035

SOURCE: Histogenics Corporation

Orthopedics & Joint Replacement at Mercy Offers Patients Robotic-Arm Assisted Total Knee Replacement with MAKOplasty System

Orthopedics & Joint Replacement at Mercy Medical Center now offers a new advanced minimally invasive surgical option for patients needing total knee replacement: MAKOplasty Total Knee Replacement Surgery using robotic technology.

According to Dr. Marc Hungerford, Chief of the Division of Orthopedics at Mercy, this knee replacement treatment option is designed to relieve the pain caused by joint degeneration due to osteoarthritis. With the new MAKOplasty system, Mercy can offer patients a personalized surgical experience tailored to their specific diagnosis and anatomy.

The process begins with a CT scan of the patient’s knee joint which is used to generate a 3D virtual model of the patient’s anatomy. This model is then uploaded on to the MAKOplasty system software and is used to create a pre-operative plan, specific to that patient.

Robotic technology improves accuracy, allows the surgeon to make adjustments for muscular and soft tissue alignment, and yields better outcomes for patients, Dr. Hungerford explained.

“This advanced technology transforms the way joint replacement surgery is performed, enabling surgeons to more accurately position a patient’s joint replacement. The result is a better, and longer-performing joint, as well as a faster recovery after surgery,” Dr. Hungerford said. “In addition, this state-of-the-art implant gives patients natural range of motion.”

The MAKOplasty robotic-arm is guided by the surgeon to remove diseased bone and cartilage and then inserts the knee replacement. During the procedure, the surgeon can make any necessary adjustments while guiding the robotic-arm.

Recent research indicates there will be at least 3.5 million total knee replacements in the United States by 2030, with the demand for knee replacements growing even faster than the demand for hip replacements.

Named a “Best National Hospital in Orthopedics” by U.S. News and World Report, the surgeons of Orthopedics & Joint Replacement at Mercy are trained in the use of the MAKOplasty system, and can perform both total and partial knee replacement surgery.

“Our physician team includes top rated orthopedic surgeons, offering innovative hip replacement and knee preservation, replacement and treatment options as well as other treatments for a wide variety of orthopedic and sports medicine related issues,” Dr. Hungerford said.

Founded in 1874 by the Sisters of Mercy, Mercy Medical Center is a university-affiliated Catholic hospital with a national reputation in orthopedics and women’s health. For more information, visit Mercy online at http://www.mdmercy.com, MDMercyMedia on Facebook and Twitter, or call 1-800-M.D.-Mercy.

NuVasive and Siemens Healthineers partner to transform spine surgery

SAN DIEGO and ERLANGEN, GermanyAug. 9, 2018 /PRNewswire/ — NuVasive, Inc. (NASDAQ: NUVA) and Siemens Healthineers today announced a strategic partnership focused on technology development, marketing and commercial activities to advance clinical outcomes in minimally invasive spine surgery. NuVasive is an innovation leader in spine health technology, focused on transforming spine surgery with minimally disruptive, predictable and clinically reproducible procedurally-integrated solutions, while Siemens Healthineers offers surgeons a broad portfolio of imaging systems including 3D imaging for complex spine cases.

MiMedx Receives Regulatory Approval to Commercialize Product Portfolio in Australia

Augmedics Begins First-in-Human Clinical Trial of xvision-spine (XVS) Augmented-Reality Surgical Navigation System

August 08, 2018

YOKNEAM, Israel–(BUSINESS WIRE)–Augmedics has begun a first-in-human clinical trial of its xvision-spine (XVS) augmented-reality surgical navigation system at Sheba Tel Hashomer Medical Center and Asaf Harofeh Medical Center, in Israel. Led by Co-Principal Investigators Dr. Ran Harel and Prof. Yigal Mirovsky, the open label, prospective, single arm, multi-center study will evaluate the safety, performance, accuracy and usability of XVS during spine fusion procedures involving pedicle screw placement. The number of subjects will range from eight to 22, depending on the number of screws placed in each subject, with a minimum of 85 total screws placed in the study. The first human case was completed August 5, with cases expected to continue for approximately three months. Pedicle screw placement accuracy will be assessed by two independent, experienced radiologists using the Gertzbein score (GS). Usability will be evaluated using a User Experience Questionnaire (UEQ), which wil be completed by the surgeons at the end of each procedure.

Augmedics’ xvision-spine system (XVS) is an augmented-reality surgical navigation system designed to give surgeons “X-ray vision” during complex procedures. With XVS, surgeons can see and navigate inside a patient’s body through skin and tissue, which may lead to easier, faster and safer surgeries. The XVS system comprises a transparent near-eye-display headset and has all elements of traditional navigation systems. It accurately determines the position of surgical tools, in real-time, and superimposes them on patient’s CT data. The navigation data is then projected onto the surgeon’s retina using the transparent near-eye-display headset, allowing surgeons to simultaneously look at their patient and see the navigation data without averting their eyes to a remote screen.

XVS has the potential for use in many procedures, with its first intended use in minimally invasive or open spine surgeries. XVS uses patented see-through optics to project a 3D image of a patient’s spine, as well as axial and sagittal planes, onto a surgeon’s retina, in real-time, with surgical precision and outstanding depth perception.

“This first-in-human study is a critical step towards providing surgeons a more intuitive way to navigate in surgery that allows them to always keep their eyes on the patient,” said Nissan Elimelech, CEO of Augmedics. “We believe that XVS has the potential to deliver precise results and easier, faster and safer surgeries.”

The first-in-human clinical trial follows Augmedics’ successful second cadaver study, which was completed in November 2017 by four surgeons in Baltimore, Maryland.

About Augmedics

Founded in 2014, Augmedics seeks to improve healthcare by developing cutting-edge technologies that will revolutionize surgical treatment. The company’s first product, the xvision-spine (XVS) system, is an augmented-reality surgical navigation system designed to allow surgeons to see and navigate inside a patient’s body during complex procedures. The XVS system, with XVS Software, has the intended use to precisely locate anatomical structures in either open or percutaneous neurosurgical and orthopedic procedures. Their use is indicated for any medical condition in which the use of stereotactic surgery may be appropriate, and where reference to a rigid anatomical structure, such as the spine or pelvis, can be identified relative to images of the anatomy. This can include spinal implant procedures such as pedicle screw placement, Iliosacral screw placement or interbody device placement.

Augmedics is funded by various investors, led by AO-Invest, an investment arm of the AO-Foundation, and has received numerous honors, including Technion’s BizTEC 2014, MedTech Innovator 2016 and MEDinISRAEL 2017. It was a finalist at TechCrunch Disrupt San Francisco 2017 Startup Battlefield and recognized as a leading HealthTech Innovator in the 2017 Global Digital Health 100 by the Journal of mHealth.

Contacts

MEDIA CONTACT:
Nobles Global Communications
Diana Soltesz, 818-618-5634
diana@noblesgc.com

OrthoPediatrics Corp. Reports Second Quarter 2018 Financial Results

WARSAW, Ind., Aug. 08, 2018 (GLOBE NEWSWIRE) — OrthoPediatrics Corp. (NASDAQ:KIDS), a company exclusively focused on advancing the field of pediatric orthopedics, announced today its financial results for the second quarter ended June 30, 2018.

Second Quarter & Recent Highlights

  • Increased total revenue to $15.1 million for second quarter 2018, up 27.7% from $11.8 million in second quarter 2017
  • Deployed $2.8 million of consignment sets during the second quarter 2018
  • Added four incremental U.S. sales representatives in the second quarter 2018 for a total of 88 reps
  • Launched 25th surgical system, Pediatric Nailing Platform | FEMUR
  • Increased revenue guidance to a range of 23% to 24% year-over-year growth and investment in consignment sets to $11.0 million for full year 2018

Mark Throdahl, Chief Executive Officer of OrthoPediatrics, commented, “We are extremely pleased to report record quarterly revenues of $15.1 million, which demonstrates strong and consistent execution across the business. As we continue to invest in consignment sets, R&D, and the expansion of our sales reps, we are strengthening our competitive position for sustainable future growth. We have supplemented our domestic sales force with 13 reps year-to-date to help support the $8.3 million of consigned sets deployed in the first half of the year, enabling us to broaden utilization of our pediatric systems. Furthermore, our investments in R&D drove recent FDA clearance of our 25th surgical system and keep us on track to launch four additional systems by year end. We look forward to continued strong momentum as we continue to advance these initiatives. Our confidence grows due to greater than anticipated performance in the first half of the year, and so we anticipate our full year 2018 revenue growth will increase to a range of 23% to 24% with consigned set investments increasing to $11.0 million.”

Second Quarter 2018 Financial Results
Total revenue for the second quarter of 2018 was $15.1 million, a 27.7% increase compared to $11.8 million for the same period last year. U.S. revenue for the second quarter of 2018 was $11.5 million, a 24.6% increase compared to $9.2 million for the same period last year, representing 76% of total revenue. International revenue was $3.6 million, a 38.7% increase compared to $2.6 million for the same period last year, representing 24% of total revenue.

Trauma and Deformity revenue for the second quarter of 2018 was $9.9 million, a 25.3% increase compared to $7.9 million for the same period last year. Scoliosis revenue was $4.9 million, a 42.7% increase compared to $3.4 million for the second quarter 2017. Sports Medicine/Other revenue for the second quarter of 2018 was $0.3 million, a 36.3% decrease compared to $0.5 million for the same period last year.

Gross profit for the second quarter of 2018 was $11.3 million, a 29.4% increase compared to $8.7 million for the same period last year. Gross profit margin for the second quarter of 2018 was 74.7%, compared to 73.8% for the same period last year, reflecting the benefit of our four direct country conversions and partially offset by continued international set sales.

Total operating expenses for the second quarter of 2018 were $13.4 million, a 42.6% increase compared to $9.4 million for the same period last year. The increase in operating expenses was driven by a 66.9% increase in R&D, a 27.9% increase in sales and marketing, including higher commissions, and unusually higher, non-recurring professional fees associated with legal expense. Operating loss for the quarter increased to ($2.1) million from ($0.7) million for the same period last year.

Net interest expense for the second quarter of 2018 was $0.6 million, a 13.5% decrease compared to $0.7 million for the same period last year.

Net loss for the second quarter of 2018 was ($2.7) million, compared to ($1.3) million for the same period last year. Net loss per share attributable to common stockholders for the second quarter of 2018 was ($0.21) per basic and diluted share, compared to ($1.56) per basic and diluted share for the same period last year.

Adjusted EBITDA for the second quarter of 2018 was $0.7 million as compared to $0.3 million for the second quarter of 2017. The change was primarily driven by the significant increase in revenue and associated gross margin. See below for additional information and a reconciliation of non-GAAP financial information.

The weighted average number of diluted shares outstanding as of June 30, 2018 was 12,549,226 shares.

As of the second quarter of 2018 our independent sales agencies in the United States employed 88 full-time equivalent sales representatives specifically focused on pediatrics, up four from the 84 employed in the first quarter of 2018. This increase keeps us on track for 18 additional reps for the full year 2018.

Purchases of property and equipment during the second quarter of 2018 were $1.4 million, a 7.7% decrease compared to $1.5 million for the same period last year. This investment reflects the deployment of consigned sets, which includes product specific instruments and cases and trays. Including the implants, $2.8 million of consigned sets were deployed during the second quarter of 2018 compared to $3.0 million during the second quarter of 2017. Set deployment during the second quarter of 2017 was higher than normal because of the conversion of the U.K. and Ireland stocking distributor to an agency model.

As of June 30, 2018, cash and cash equivalents were $26.5 million, compared to $34.6 million as of March 31, 2018, and the Company had approximately $25.4 million in total outstanding indebtedness, including $3.9 million outstanding under the revolving credit facility.

Full Year 2018 Financial Guidance
OrthoPediatrics is providing financial guidance for the full year 2018, as follows:

  • Revenue growth in a range of 23% to 24% year-over-year, up from prior guidance of 22%.
  • Consigned set investments of approximately $11.0 million, up from prior guidance of $10.0 million.

Conference Call
OrthoPediatrics will host a conference call on Thursday, August 9, 2018 at 8:00 a.m. ET to discuss its financial results. The dial-in numbers are (855) 289-4603 for domestic callers and (614) 999-9389 for international callers. The conference ID number is 4835859. A live webcast of the conference call will be available online at OrthoPediatrics’ investor relations website, ir.orthopediatrics.com.

A replay of the webcast will remain available online at OrthoPediatrics’ investor relations website, ir.orthopediatrics.com, until OrthoPediatrics releases its third quarter 2018 financial results. In addition, a telephonic replay of the conference call will be available until August 16, 2018. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. The replay conference ID number is 4835859.

Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of U.S. federal securities laws. You can identify forward-looking statements by the use of words such as “may,” “might,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “believe,” “estimate,” “project,” “target,” “predict,” “intend,” “future,” “goals,” “potential,” “objective,” “would” and other similar expressions. Forward-looking statements involve risks and uncertainties, many of which are beyond OrthoPediatrics’ control. Important factors could cause actual results to differ materially from those in the forward-looking statements, including, among others, the risks, uncertainties and factors set forth under “Risk Factors” in OrthoPediatrics’ Annual Report on Form 10-K filed with the SEC on March 15, 2018. Forward-looking statements speak only as of the date they are made. OrthoPediatrics assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable securities laws.

Use of Non-GAAP Financial Measures
This press release includes the non-GAAP financial measure of Adjusted EBITDA, which differs from financial measures calculated in accordance with U.S. generally accepted accounting principles (“GAAP”). Adjusted EBITDA in this release represents net loss, plus interest expense (income), net plus other expense (income), depreciation and amortization, stock-based compensation expense, accelerated vesting of restricted stock upon our IPO, public company costs and initial public offering costs. Adjusted EBITDA is presented because the Company believes it is a useful indicator of its operating performance. Management uses the metric as a measure of the Company’s operating performance and for planning purposes, including financial projections. The Company believes this measure is useful to investors as supplemental information because it is frequently used by analysts, investors and other interested parties to evaluate companies in its industry. The Company believes Adjusted EBITDA is useful to its management and investors as a measure of comparative operating performance from period to period. Adjusted EBITDA is a non-GAAP financial measure and should not be considered as an alternative to, or superior to, net income or loss as a measure of financial performance or cash flows from operations as a measure of liquidity, or any other performance measure derived in accordance with GAAP, and it should not be construed to imply that the Company’s future results will be unaffected by unusual or non-recurring items. In addition, the measure is not intended to be a measure of free cash flow for management’s discretionary use, as it does not reflect certain cash requirements such as debt service requirements, capital expenditures and other cash costs that may recur in the future. Adjusted EBITDA contains certain other limitations, including the failure to reflect our cash expenditures, cash requirements for working capital needs and other potential cash requirements. In evaluating Adjusted EBITDA, you should be aware that in the future the Company may incur expenses that are the same or similar to some of the adjustments in this presentation. The Company’s presentation of Adjusted EBITDA should not be construed to imply that its future results will be unaffected by any such adjustments. Management compensates for these limitations by primarily relying on the Company’s GAAP results in addition to using Adjusted EBITDA on a supplemental basis. The Company’s definition of this measure is not necessarily comparable to other similarly titled captions of other companies due to different methods of calculation. The schedules below contain a reconciliation of Net Income to non-GAAP Adjusted EBITDA.

About OrthoPediatrics Corp.
Founded in 2006, OrthoPediatrics is an orthopedic company focused exclusively on providing a comprehensive product offering to the pediatric orthopedic market to improve the lives of children with orthopedic conditions. OrthoPediatrics currently markets 25 surgical systems that serve three of the largest categories within the pediatric orthopedic market. This offering spans trauma & deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and 38 countries outside the United States.

Investor Contacts
The Ruth Group
Tram Bui / Emma Poalillo
(646) 536-7035 / 7024
tbui@theruthgroup.com / epoalillo@theruthgroup.com

ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED BALANCE SHEETS
(In Thousands, Except Share Data)
June 30, December 31,
  2018   2017
  (unaudited)  
ASSETS
Current assets:
Cash $ 26,506 $ 42,582
Accounts receivable – trade, less allowance for doubtful accounts of
$131 and $143, respectively 9,755 5,603
Inventories, net 24,816 19,498
Inventories held by international distributors, net 595 1,047
Prepaid expenses and other current assets 1,063 831
Total current assets 62,735 69,561
Property and equipment, net 12,770 10,391
Other assets:
Amortizable intangible assets, net 2,080 2,089
Other intangible assets 260 260
Total other assets 2,340 2,349
Total assets $ 77,845 $ 82,301
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable – trade $ 5,455 $ 5,495
Accrued compensation and benefits 3,237 2,905
Current portion of long-term debt with affiliate 115 113
Other current liabilities 1,683 954
Total current liabilities 10,490 9,467
Long-term liabilities:
Long-term debt with affiliate, net of current portion 21,360 21,418
Revolving credit facility with affiliate 3,938 3,921
Total long-term liabilities 25,298 25,339
Total liabilities 35,788 34,806
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.00025 par value; 50,000,000 shares authorized;
12,789,039 shares and 12,621,781 shares issued and outstanding as
of June 30, 2018 (unaudited) and December 31, 2017 2 2
Additional paid-in capital 153,055 150,424
Accumulated deficit (110,758) (103,066)
Accumulated other comprehensive income (242) 135
Total stockholders’ equity 42,057 47,495
Total liabilities and stockholders’ equity $ 77,845 $ 82,301
ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In Thousands, Except Share and Per Share Data)
Three Months Ended June 30, Six Months Ended June 30,
2018 2017 2018 2017
Net revenue $ 15,077 $ 11,802 $ 27,171 $ 21,564
Cost of revenue 3,807 3,090 6,982 5,437
Gross profit 11,270 8,712 20,189 16,127
Operating expenses:
Sales and marketing 6,776 5,299 12,855 9,491
General and administrative 5,499 3,422 11,516 6,795
Research and development 1,115 668 2,333 1,355
Total operating expenses 13,390 9,389 26,704 17,641
Operating loss (2,120) (677) (6,515) (1,514)
Other expenses:
Interest expense 562 650 1,114 1,095
Other expense (income) 10 (61) 63 (58)
Total other expenses 572 589 1,177 1,037
Net loss $ (2,692) $ (1,266) $ (7,692) $ (2,551)
Net loss attributable to common stockholders $ (2,692) $ (2,720) $ (7,692) $ (5,431)
Weighted average common shares – basic and diluted 12,549,226 1,746,787 12,312,814 1,745,390
Net loss per share attributable to common stockholders – basic and diluted $ (0.21) $ (1.56) $ (0.62) $ (3.11)
ORTHOPEDIATRICS CORP.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(In Thousands)
For the Six Months Ended June 30,
2018 2017
OPERATING ACTIVITIES
Net loss $ (7,692) $ (2,551)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization 1,400 1,092
Stock-based compensation 2,631 727
Changes in certain current assets and liabilities:
Accounts receivable – trade (4,152) (2,428)
Inventories (4,724) (3,551)
Inventories held by international distributors 452 104
Prepaid expenses and other current assets (232) (727)
Accounts payable – trade (40) 2,569
Accrued expenses and other liabilities 1,061 531
Other (377)
Net cash used in operating activities (11,673) (4,234)
INVESTING ACTIVITIES
Purchases of licenses (180) (300)
Purchases of property and equipment (4,167) (2,844)
Net cash used in investing activities (4,347) (3,144)
FINANCING ACTIVITIES
Proceeds from issuance of debt with affiliate 8,055
Payments on mortgage notes (56) (52)
Net cash provided by financing activities (56) 8,003
Effect of exchange rate changes on cash 72
NET INCREASE (DECREASE) IN CASH (16,076) 697
Cash, beginning of year 42,582 1,609
Cash, end of period $ 26,506 $ 2,306
SUPPLEMENTAL DISCLOSURES
Cash paid for interest $ 1,114 $ 1,095
Accretion of redeemable convertible preferred stock $ $ 2,880
Transfer of instruments from property and equipment to inventory $ 594 $ 770
ORTHOPEDIATRICS CORP.
NET REVENUE BY GEOGRAPHY AND PRODUCT CATEGORY
(Unaudited)
(In Thousands)
Three Months Ended June 30, Six Months Ended June 30,
Product sales by geographic location: 2018 2017 2018 2017
U.S. $ 11,458 $ 9,193 $ 20,111 $ 16,529
International 3,619 2,609 7,060 5,035
Total $ 15,077 $ 11,802 $ 27,171 $ 21,564
Three Months Ended June 30, Six Months Ended June 30,
Product sales by category: 2018 2017 2018 2017
Trauma and deformity $ 9,860 $ 7,869 $ 18,983 $ 15,609
Scoliosis 4,897 3,431 7,582 5,353
Sports medicine/other 320 502 606 602
Total $ 15,077 $ 11,802 $ 27,171 $ 21,564

ORTHOPEDIATRICS CORP.
RECONCILIATION OF NET LOSS TO NON-GAAP ADJUSTED EBITDA
(Unaudited)
(In Thousands)
Three Months Ended June 30, Six Months Ended June 30,
2018 2017 2018 2017
Net Loss $  (2,692) $   (1,266) $  (7,692) $   (2,551)
Interest expense, net 562 650 1,114 1,095
Other expense   10   (61)   63  (58)
Depreciation and amortization 728 594 1,400 1,092
Stock-based compensation 225 388 645 727
Accelerated vesting of restricted stock upon our IPO 229 1,986
Public company costs 337 674
Non-recurring professional services fees 1,314 1,768
Adjusted EBITDA $   713 $   305 $   (42) $   305

Brigham Redd, M.D. is first surgeon in Idaho to offer OMNIBotics® Robotic-assisted Total Knee Replacement

RAYNHAM, Mass.Aug. 8, 2018 /PRNewswire/ — OMNIlife science, Inc. (“OMNI”), a privately-held, established medical technology company targeting the $15 billion global hip and knee replacement device market, announced today that Brigham Redd, M.D., of Liljenquist & Redd Orthopedic Surgery, is the first surgeon in Idaho to offer OMNIBotics, an advanced robotic-assisted treatment option for total knee replacement. This innovative total knee replacement solution is designed to relieve the pain caused by joint degeneration due to osteoarthritis. OMNIBotics is the global leader in robotic-assisted total knee replacement, with over 7 years of clinical use worldwide. This treatment option will be available for Dr. Redd’s patients at both Mountain View Hospital and Eastern Idaho Regional Medical Center in Idaho Falls, ID.

The OMNIBotics procedure utilizes advanced software and instrumentation to tailor each procedure to the patient’s unique anatomy in order to optimize implant fit and alignment. Patented OMNIBotics Bone Morphing™ technology eliminates the need for costly CT scans or MRIs and allows the surgeon to perform “virtual surgery” on a digital model before any bone is cut. A robotic cutting guide is then used by the surgeon when making the planned bone resections to ensure accuracy. The surgeon maintains control and decision-making regarding the total knee replacement while providing a customized, patient-specific surgery. OMNIBotics also allows for a less invasive surgical technique, compared to traditional knee replacement surgery, which may promote a quicker recovery.

“It’s been great to be able to check the accuracy of the surgery and make adjustments to perfect the angles and alignment of each step of surgery. This is so much more personalized and accurate than the traditional knee replacements done elsewhere,” said Dr. Redd. “It’s exciting to offer the most advanced technology to my patients and see them come back feeling even better than they do after a traditional knee replacement, and to be confident that their knee replacement will last even longer because of the precise and individualized alignment.”

ABOUT OMNIlife science™, Inc. (OMNI™)

OMNI is a privately held company with a proprietary robotic platform, OMNIBotics®, which allows surgeons to conduct patient-specific total knee surgery designed to enhance patient satisfaction and reduce hospital costs. In addition, OMNI designs, engineers, manufactures and distributes a wide range of proprietary hip and knee implants and is focused on providing cutting edge technologies to transform outcomes in joint replacement surgery and enhance a surgeon’s ability to help patients live active and pain-free lives. For more information about OMNI, please visit www.omnils.com.

CONTACT 

Cindy Holloway, Director of Marketing Communications 

Phone: (508) 824-2444  

cholloway@omnils.com

SOURCE OMNIlife science, Inc.

Related Links

http://www.omnils.com