CAESAREA, Israel, May 14, 2018 /PRNewswire/ — Mazor Robotics Ltd. (TASE: MZOR) (NASDAQ-GM: MZOR), a pioneer and a leader in the field of robotic guidance systems, reported record first quarter revenue of $15.5 million compared to $11.7 million in the first quarter of 2017.

“Our record first quarter revenue reflects clinical adoption, as we surpassed 33,000 cases performed, and the continued global demand for the Mazor X and Renaissance systems,” commented Ori Hadomi, Chief Executive Officer. “Commercially, we successfully expanded into a new international market with the Mazor X and making progress penetrating into the Ambulatory Surgery Center (“ASC”) market in the U.S. with the Renaissance.  Our performance, coupled with the growing number of peer-reviewed papers, presentations and the interim data from our prospective studies, is transforming spine surgery in markets around the world.  Finally, we are also advancing and expanding our technology development efforts with Medtronic, and I am pleased to share that commercialization of the Mazor X platform, which integrates Medtronic’s Stealth navigation and offers a unique robot-guided implant solution that eliminates the need for guidewires, is expected at the end of 2018.”

FIRST QUARTER 2018 FINANCIAL RESULTS ON IFRS BASIS (“GAAP”)

Revenue for the three months ended March 31, 2018 increased 32% to $15.5 million compared to $11.7 million in the year-ago first quarter, mainly due to increased recurring revenue from kit sales, services and other.  U.S. revenue increased 27% to $14.2 million compared to $11.2 million in the year-ago first quarter. International revenue increased 160% to $1.3 million compared to $0.5 million in the year-ago first quarter.

The Company’s gross margin for the three months ended March 31, 2018 was 58.3% compared to 64.6% in the year-ago first quarter.  This expected decrease is attributed mainly to the pricing terms with Medtronic. Total operating expenses were $10.5 million compared to $13.3 million in the year-ago first quarter, mainly due to lower selling and marketing expenses, following the transition to the global distribution phase of the Medtronic partnership.  Operating loss was $1.4 million compared to an operating loss of $5.7 million in the year-ago first quarter. Net loss for the first quarter of 2018 was $1.3 million, or $0.02 per share, compared to a net loss of $5.2 million, or $0.11 per share, for the year-ago first quarter.

Cash provided by operating activities was $2.7 million compared to cash provided by operating activities of $0.7 millionin last year’s first quarter as a result of high collection efforts from customers. As of March 31, 2018, cash, cash equivalents and investments totaled $114.5 million.

FIRST QUARTER 2018 FINANCIAL RESULTS ON NON-GAAP BASIS

The tables below include reconciliations of the Company’s GAAP results to non-GAAP results. The reconciliations relate to non-cash expenses in the amount of $1.6 million with respect to share-based payments and amortization of intangible assets recorded in the first quarter of 2018. On a non-GAAP basis, the net income in the first quarter of 2018 was $0.3 million, or $0.01 per share, compared to net loss of $3.9 million, or $0.08 per share, for the year-ago first quarter.

CONFERENCE CALL INFORMATION

The company will host a conference call to discuss these results on Monday, May 14, 2018, at 8:30 AM EDT (3:30 PM IDT).  Investors within the United States interested in participating are invited to call 800-239-9838.   Participants in Israel can use the toll-free dial-in number 1809 212 883. All other international participants can use the dial-in number +1 323-794-2551.

A replay of the event will be available for two weeks following the conclusion of the call. To access the replay, callers in the United States can call 1-888-203-1112 and reference the Replay Access Code: 3873868. All international callers can dial +1 719-457-0820, using the same Replay Access Code. To access the webcast, please visit www.mazorrobotics.comand select ‘Investor Relations.’

Use of Non-GAAP Measures

In addition to disclosing financial results calculated in accordance with generally accepted accounting principles in conformity with International Financial Reporting Standards (GAAP), this press release contains Non-GAAP financial measures for gross profit, operating expenses, operating profit (loss), net income (loss) and basic and diluted earnings (loss) per share that exclude the effects of non-cash expense of amortization of intangible assets and share-based payments. Management believes that these non-GAAP financial measures provide meaningful supplemental information regarding the Company’s performance that enhances management’s and investors’ ability to evaluate the Company’s net income (loss) and earnings (loss) per share and to compare them to historical net income (loss) and earnings (loss) per share.

The presentation of this non-GAAP financial information is not intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. Management uses both GAAP and non-GAAP measures when operating and evaluating the Company’s business internally and therefore decided to make these non-GAAP adjustments available to investors.

About Mazor

Mazor Robotics (TASE: MZOR; NASDAQGM: MZOR) believes in healing through innovation by developing and introducing revolutionary technologies and products aimed at redefining the gold standard of quality care. Mazor Robotics Guidance System enables surgeons to conduct spine and brain procedures in an accurate and secure manner. For more information, please visit www.MazorRobotics.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other securities laws. Any statements in this release about future expectations, plans or prospects for the Company, including without limitation, statements regarding interim data from prospective studies, advancing and expanding technology development efforts, timing of integration of Stealth navigation, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions are forward-looking statements. These statements are only predictions based on Mazor’s current expectations and projections about future events. There are important factors that could cause Mazor’s actual results, level of activity, performance or achievements to differ materially from the results, level of activity, performance or achievements expressed or implied by the forward-looking statements. Those factors include, but are not limited to, the impact of general economic conditions, competitive products, product demand and market acceptance risks, reliance on key strategic alliances, fluctuations in operating results, and other factors indicated in Mazor’s filings with the Securities and Exchange Commission (SEC) including those discussed under the heading “Risk Factors” in Mazor’s annual report on Form 20-F filed with the SEC on April 30, 2018 and in subsequent filings with the SEC. For more details, refer to Mazor’s SEC filings. Mazor undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in our expectations, except as may be required by law.

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DUBLIN – May 10, 2018 – Medtronic plc (NYSE: MDT) announced today that it will report financial results for its fourth quarter and fiscal year 2018 on Thursday, May 24, 2018. A news release will be issued at approximately 5:45 a.m. Central Daylight Time (CDT) and will be available at http://newsroom.medtronic.com. The news release will include summary financial information for the company’s fourth quarter and fiscal year 2018, which ended on Friday, April 27, 2018.

Medtronic will host a webcast at 7:00 a.m. CDT to discuss financial results for its fourth quarter and full fiscal year 2018. The webcast can be accessed at http://investorrelations.medtronic.com on May 24, 2018.

Within 24 hours of the webcast, a replay and transcript of the prepared remarks will be available by clicking on the Investor Events link at http://investorrelations.medtronic.com.

Looking ahead, Medtronic plans to report its fiscal year 2019 first, second and third quarter financial results on Tuesday, August 21, 2018, Tuesday, November 20, 2018, and Tuesday, February 19, 2019, respectively. Medtronic also plans on hosting its biennial Institutional Investor & Analyst Day on Tuesday, June 5, 2018. Confirmation and additional details will be provided closer to the specific event.

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

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

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

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

CAMBRIDGE, Mass., May 08, 2018 (GLOBE NEWSWIRE) — Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today reported financial results and business highlights for the first quarter ended March 31, 2018.

First Quarter 2018 Financial Highlights

• Total net revenues of $18.0 million compared to $9.4 million in the first quarter of 2017; first quarter 2017 revenues included a $2.8 million revenue reserve for Carticel^® and MACI^® related to a contractual dispute between one of the Company’s pharmacy providers and a third-party payer;
• Gross margins of 57% compared to gross margins of 24% in the first quarter of 2017;
• Net loss of $7.7 million, or $0.21 loss per share, which included warrant-related expense of $2.9 million, compared to net loss of $9.8 million, or $0.31 per share, in the first quarter of 2017, which included $0.1 million of warrant income;
• Non-GAAP adjusted EBITDA loss of $2.6 million compared to a loss of $5.9 million in the first quarter of 2017; and
• As of March 31, 2018, the company had $29.8 million in cash compared to $26.9 million in cash at December 31, 2017.

Recent Business Highlights
During and since the first quarter of 2018, the company:

• Achieved record first quarter revenues and the fourth straight quarter of 30% or greater revenue growth versus the same quarter of the prior year;
• Achieved the Company’s first quarter of positive operating cash flow;
• Deployed the expanded MACI (autologous cultured chondrocytes on porcine collagen membrane) sales force, which increased from 28 to 40 sales representatives;
• Launched the MACI ‘It’s Your Move’ campaign in partnership with world champion swimmer, five-time Olympian, and best-selling author Dara Torres; and
• Announced the publication of results from the Phase 3 SUMMIT Extension Study in the American Journal of Sports Medicine demonstrating sustained clinical benefit of MACI out to five years.

“We had a strong start to 2018 with significant revenue growth for both MACI and Epicel, and delivered the fourth straight quarter of 30% or higher revenue growth compared to the same quarter of the prior year,” said Nick Colangelo, president and CEO of Vericel.  “We also reported significant margin improvements and generated the Company’s first quarter of positive operating cash flow as we continue to move our current business towards sustained profitability.”

First Quarter 2018 Results
Total net revenues for the quarter ended March 31, 2018 were $18.0 million, which included $12.1 million of MACI net revenue and $6.0 million of Epicel^® (cultured epidermal autografts) net revenue, compared to $5.0 million of Carticel (autologous cultured chondrocytes) and MACI net revenue and $4.4 million of Epicel net revenue, respectively, in the first quarter of 2017.  Total net revenues for the quarter ended March 31, 2017 included a $2.8 million revenue reserve for Carticel and MACI related to a contractual dispute between one of the Company’s pharmacy providers and a third-party payer.  Total net revenues increased 93% compared to the first quarter of 2017, with MACI revenue increasing 141% and Epicel revenue increasing 37%, respectively, compared to the same period in 2017.  Excluding the revenue reserve in the first quarter of 2017, non-GAAP net revenues increased 49%, with MACI revenue increasing 55% compared to first quarter of 2017.

Gross profit for the quarter ended March 31, 2018 was $10.4 million, or 57% of net revenues, compared to $2.3 million, or 24% of net revenues, for the first quarter of 2017.

Total operating expenses for the quarter ended March 31, 2018 were $14.7 million compared to $11.9 million for the same period in 2017.

Loss from operations for the quarter ended March 31, 2018 was $4.3 million, compared to a loss of $9.6 million for the first quarter of 2017.  Material non-cash items impacting the operating loss for the quarter included $1.3 million of stock-based compensation expense and $0.4 million in depreciation expense.

Other expense for the quarter ended March 31, 2018 was $3.3 million compared to $0.2 million for the same period in 2017.  The change in other expense for the quarter is primarily due to a $2.9 million change in the fair value of warrants.

Non-GAAP adjusted EBITDA loss was $2.6 million for the quarter ended March 31, 2018 compared to a loss of $5.9 millionin the same period in 2017.  See table reconciling non-GAAP measures for more details.

Vericel’s net loss for the quarter ended March 31, 2018 was $7.7 million, or $0.21 per share, compared to a net loss of $9.8 million, or $0.31 per share, for the same period in 2017.

As of March 31, 2018, the company had $29.8 million in cash compared to $26.9 million in cash at December 31, 2017.

“Our first quarter results demonstrated continued momentum moving into our second year with MACI on the market and that investments made in Epicel are continuing to drive additional utilization,” added Mr. Colangelo.  “We believe that an expanded MACI sales force in 2018, together with patient-focused marketing initiatives, will further strengthen our position in the market and build the foundation for strong revenue growth in the years ahead.”

Conference Call Information
Today’s conference call will be available live at 8:30am Eastern time in the Investor Relations section of the Vericel website at http://investors.vcel.com/events.cfm. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary.  To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation’s first-quarter 2018 investor conference call. If calling from outside the U.S., please use the international phone number (253) 237-1173.

If you are unable to participate in the live call, the webcast will be available at http://investors.vcel.com/events.cfm until May 8, 2019.  A replay of the call will also be available until 11:30am (EST) on May 13, 2018 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 1564056.

About Vericel Corporation
Vericel is a leader in advanced cell therapies for the sports medicine and severe burn care markets.  The company markets two cell therapy products in the United States.  MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults.  Epicel (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area.  For more information, please visit the company’s website at www.vcel.com.

GAAP v. Non‑GAAP Measures
Vericel’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission.  Vericel has provided in this release financial information that has not been prepared in accordance with GAAP.  Vericel’s management believes that adjusted EBITDA loss described in the release, or EBITDA loss adjusted for specific items that are generally not indicative of our core operations, provides additional information that is useful to investors in understanding Vericel’s underlying performance, business and performance trends, and helps facilitate period to period comparisons and compare its financial measures with other companies in Vericel’s industry.  However, non-GAAP financial measures that Vericel uses may differ from measures that other companies may use.  Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.

Epicel^®, MACI^® and Carticel^® are registered trademarks of Vericel Corporation. © 2018 Vericel Corporation. All rights reserved.

This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of our products and growth in revenues, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “we believe,” “we intend,” “guidance,” ”outlook,” “future,” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “potential,” “could,” “may,” or similar expressions. Actual results may differ significantly from the expectations contained in the forward-looking statements. Among the factors that may result in differences are the inherent uncertainties associated with our expectations regarding 2018 revenues, our ability to achieve or sustain profitability, our need to generate significant sales to become profitable, potential fluctuations in sales volumes and our results of operations over the course of the year, competitive developments, estimating the commercial growth potential of our products and product candidates and growth in revenues and improvement in costs, market demand for our products, our ability to secure consistent reimbursement for our products, changes in third party coverage and reimbursement, any disruption or delays in operations at our facilities, our dependence on a limited number of third party suppliers, our ability to maintain and expand our network of direct sales employees, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission (“SEC”) on March 5, 2018, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management’s current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law. 

vcel-fin

Global Media Contacts:

David Schull
Russo Partners LLC
+1 212-845-4271 (office)
+1 858-717-2310 (mobile)
David.schull@russopartnersllc.com

Karen Chase
Russo Partners LLC
+1 646-942-5627 (office)
+1 917-547-0434 (mobile)
Karen.chase@russopartnersllc.com

Investor Contacts:
Chad Rubin
Solebury Trout
crubin@troutgroup.com
+1 (646) 378-2947

Lee Stern
Solebury Trout
lstern@troutgroup.com
+1 (646) 378-2922

VERICEL CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(unaudited, amounts in thousands)

May 10, 2018

SAN DIEGO–(BUSINESS WIRE)–DJO Global, Inc. (“DJO” or the “Company”), a leading global provider of medical technologies designed to get and keep people moving, today announced financial results for its public reporting subsidiary, DJO Finance LLC (“DJOFL”), for the first quarter ended March 31, 2018.

First Quarter Highlights

• Net sales were $292.6 million, up 1.5% compared to the first quarter of 2017.
• Operating income increased 501.9% to $33.5 million from $6.7 million in the prior year period.
• Net loss attributable to DJOFL was $17.6 million, compared to a net loss of $40.0 million in the prior year period.
• Adjusted EBITDA increased 13.2% over the prior year quarter to $64.8 million.

Business Transformation Outcomes

• Business Transformation continues to drive profitability expansion and remains on track to deliver 7% to 10% annual cost reductions by end of 2018.
• Transformation actions taken to date expected to contribute $21.8 million in savings over the next four quarters.

“After starting the quarter with slow revenue trends reflecting the overall market performance, we saw improvement later in the quarter, particularly in March. In line with our annual plan, we expect to build revenue momentum throughout the year as growth investments that began late in 2017 begin to materialize,” said Brady Shirley, DJO’s President and Chief Executive Officer. “Overall performance was highlighted by continued, strong earnings growth and significant margin expansion.”

“From a bottom-line perspective, we continue to demonstrate that our multi-year transformation is working, delivering 13% Adjusted EBITDA growth and over 200 basis point improvement in margin. The growth in Adjusted EBITDA is a product of improving gross margins and strong control of operating expenses, reflecting the hard work our team has put into our transformation initiatives,” commented Mike Eklund, DJO’s Chief Financial Officer and Chief Operating Officer. “Additional operations initiatives are already underway focused on enhancing customer satisfaction as well as financial metrics. We remain confident in our ability to continue the improvement we have seen since the start of this journey early last year.”

Sales Results

Net sales for DJOFL for the first quarter of 2018 were $292.6 million, an increase of 1.5% compared to the first quarter of 2017. On the basis of constant currency rates, sales declined 1.7%. The number of selling days in the first quarter of 2018 was unchanged from the prior year period in the US but there was one less selling day outside the US.

Net sales for DJO’s Surgical Implant segment grew 8.1% in the first quarter of 2018 to $53.6 million, reflecting greater than 20% growth in our large shoulder implant product line and single digit growth in our knee and hip implant product lines.

Net sales for DJO’s International segment grew 13.3% in the first quarter of 2018 to $88.6 million, or 1.5% on a constant currency basis with one less selling day. There was strong sales growth in France, Scandinavia and Australia, partially offset by slower sales in the UK, Spain and Benelux region.

Net sales for DJO’s Recovery Sciences segment were $35.9 million in the first quarter of 2018, down 6.8% compared to the first quarter of 2017, driven by softness in the segment’s Chattanooga product line.

Net sales for DJO’s Bracing and Vascular segment were $114.5 million in the first quarter of 2018, a decline of 6.2% compared to the first quarter of 2017, reflecting challenges in the segment’s Dr. Comfort product line and a decline in our US bracing business.

Earnings Results

Operating income improved to $33.5 million from $6.7 million in the prior year quarter, primarily due to a significant reduction in selling, general and administrative expenses. Net loss attributable to DJOFL in the first quarter of 2018 was $17.6 million compared to a net loss of $40.0 million for the first quarter of 2017.

Adjusted EBITDA for the first quarter of 2018 grew 13.2% to $64.8 million from $57.2 million in the first quarter of 2017. Including projected future savings of $21.8 million from cost savings programs currently underway as permitted under our credit agreement and the indentures governing our outstanding notes, Adjusted EBITDA for the twelve months ended March 31, 2018 was $297.5 million.

The Company defines Adjusted EBITDA as net (loss) income attributable to DJOFL plus net interest expense, income tax provision (benefit), and depreciation and amortization, further adjusted for certain non-cash items, non-recurring items and other adjustment items as permitted in calculating covenant compliance under the Company’s secured term loan and revolving credit facilities (“Senior Secured Credit Facilities”) and the indentures governing its 8.125% second lien notes and its 10.75% third lien notes. A reconciliation between net loss attributable to DJOFL and Adjusted EBITDA is included in the attached financial tables.

Net cash provided by continuing operating activities for the first quarter of 2018 was $12.2 million compared to $38.6 million in the first quarter of 2017. The decline in cash flow was attributable to higher inventory balances to allow for the transition of suppliers and modernization of distribution facilities as part of the Company’s transformation initiative, and to the payment of one-time costs accrued in the prior year.

Conference Call Information

DJO has scheduled a conference call to discuss this announcement beginning at 4:30 pm, Eastern Time Thursday, May 10, 2018. Individuals interested in listening to the conference call may do so by dialing (866) 394-8509 (International callers please use (706) 643-6833), using the reservation code 22322226. A telephone replay will be available for 48 hours following the conclusion of the call by dialing (855) 859-2056 and using the above reservation code. The live conference call and replay will be available via the Internet at www.DJOglobal.com.

About DJO Global

DJO Global is a leading global provider of medical technologies designed to get and keep people moving. The Company’s products address the continuum of patient care from injury prevention to rehabilitation, enabling people to regain or maintain their natural motion. Its products are used by orthopaedic surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. In addition, many of the Company’s medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. The Company’s product lines include rigid and soft orthopaedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The Company’s surgical division offers a comprehensive suite of reconstructive joint products for the hip, knee and shoulder. DJO Global’s products are marketed under a portfolio of brands including Aircast®, Chattanooga, CMF™, Compex®, DonJoy®, ProCare®, DJO® Surgical, Dr. Comfort® and Exos^TM. For additional information on the Company, please visit www.DJOglobal.com.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements relate to, among other things, the Company’s expectations for improved liquidity, estimated cost reductions associated with the execution of its business transformation plans and improved efficiencies. The words “believe,” “will,” “should,” “expect,” “target,” “intend,” “estimate” and “anticipate,” variations of such words and similar expressions identify forward-looking statements, but their absence does not mean that a statement is not a forward-looking statement. These forward-looking statements are based on the Company’s current expectations and are subject to a number of risks, uncertainties and assumptions, many of which are beyond the Company’s ability to control or predict. The Company undertakes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise. The important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to the successful execution of the Company’s business transformation plans, including achievement of planned actions to improve liquidity, improvements in operational effectiveness, optimization of the Company’s procurement activities, improvements in manufacturing, distribution, sales and operations planning, and actions to improve the profitability of the mix of our product and customers. Other important factors that could cause actual operating results to differ significantly from those expressed or implied by such forward-looking statements include, but are not limited to: business strategies relative to our Bracing and Vascular, Recovery Sciences, International and Surgical Implant segments; the continued growth of the markets the Company addresses and any impact on these markets from changes in global economic conditions; the impact of potential reductions in reimbursement levels and coverage by Medicare and other governmental and commercial payers; the Company’s highly leveraged financial position; the Company’s ability to successfully develop, license or acquire, and timely introduce and market new products or product enhancements; risks relating to the Company’s international operations; resources needed and risks involved in complying with government regulations and government investigations; the availability and sufficiency of insurance coverage for pending and future product liability claims; and the effects of healthcare reform, Medicare competitive bidding, managed care and buying groups on the prices of the Company’s products. These and other risk factors related to DJO are detailed in the Company’s Annual Report on Form 10-K for the year ended December 31, 2017, filed with the Securities and Exchange Commission on March 16, 2018. Many of the factors that will determine the outcome of the subject matter of this press release are beyond the Company’s ability to control or predict.

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WALTHAM, Mass., May 10, 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 operational results for the quarter ended March 31, 2018.

“The preparation for top-line data and the NeoCart Biologics License Application for the U.S. Food and Drug Administration remained a key focus for Histogenics in the first quarter of 2018, and we are on track to achieve these important milestones in the third quarter,” said Adam Gridley, President and Chief Executive Officer of Histogenics.  “We are also actively supporting MEDINET, our NeoCart development and commercialization partner in Japan, as they prepare for the initiation of the planned confirmatory trial in Japan in the second half of 2018.  We also continue to work with our surgeon investigators on our commercialization plans in both the U.S. and Japanese markets, and are pursuing additional NeoCart licensing and partnership opportunities in other major international markets.  Our objective is to make NeoCart available to as many patients as possible with a goal of maximizing the clinical and commercial value of this innovative, restorative cell therapy that treats pain at the source,” continued Mr. Gridley.

First Quarter 2018 and Recent Highlights

• Release of NeoCart top-line Phase 3 Data and Submission of Biologics License Application on Track for Third Quarter 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.  The trial will follow patients for three years and is being conducted under a Special Protocol Assessment with the United States Food and Drug Administration.
• Development of Additional NeoCart Biomechanical Data to Support Potential Commercialization:  As part of their Sponsored Research Agreement, Histogenics and Cornell University (Cornell) continue to build upon the robust body of evidence related to the biomechanical properties of NeoCart, with additional data that were presented at the Orthopaedic Research Society Annual Meeting in March 2018.  The body of data is intended to provide additional mechanism of action and physical competence information to regulatory agencies and clinicians regarding the potential performance advantages of NeoCart when compared to other treatment alternatives.  Furthermore, Histogenics and Cornell are working together in related areas including the novel testing and three-dimensional printing of cartilage tissue.  Histogenics believes this work may have significant utility in identifying and supporting additional future product opportunities including the automation of certain aspects of the NeoCart manufacturing process.
• Expansion and Enhancement of Board of Directors:  In April 2018, Susan Washer, President and Chief Executive Officer of Applied Genetic Technologies (AGTC) joined Histogenics’ Board of Directors.  Ms. Washer has served as CEO of AGTC, a company developing genetic therapies to treat patients with rare inherited conditions, since 2002.  She also serves on the boards of Biotechnology Innovation Organization and the Alliance for Regenerative Medicine.
• Receipt of MEDINET Licensing Agreement Proceeds and Completion of Financing:  Histogenics received a $10 million up-front payment from MEDINET Co., Ltd. (MEDINET) pursuant to the terms of the license agreement with MEDINET for the development and commercialization of NeoCart in Japan.  In addition, Histogenics successfully completed a registered direct offering of common stock in January 2018 that raised proceeds of $5.7 million, after deducting underwriter’s discounts and commissions, and expenses related to the offering.

Financial Results for the First Quarter of 2018

Loss from operations was $(6.1) million in the first quarter of 2018, compared to $(6.8) million in the first quarter of 2017.  The decrease in operating expenses was driven by a reduction in research and development expenses which was partially offset by an increase in general and administrative expenses.

Research and development expenses were $3.3 million in the first quarter of 2018, compared to $4.5 million in the first quarter of 2017.  The decrease was primarily due to a reduction in 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 first quarter of 2018, compared to $2.3 million in the first quarter of 2017.  The increase was primarily due to increases in salaries and consulting expenses related to increased activities to support the potential commercialization of NeoCart.

Net loss attributable to common stockholders was $(14.4) million in the first quarter of 2018, or $(0.52) per share, compared to $(5.8) million, or $(0.27) per share, in the first quarter of 2017.  The increase in net loss attributable to common stockholders is primarily due to the conversion of convertible preferred stock into common stock and an increase in expense related to the fair value of the warrant liability which was partially offset by lower operating expenses.

As of March 31, 2018, Histogenics had cash, cash equivalents and marketable securities of $15.5 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, May 10, 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 “8376199” 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 recently completed enrollment of its NeoCart Phase 3 clinical trial 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, which is 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 March 31, 2018, to be filed with the SEC in the second quarter 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.

Contact:

Investor Relations
Tel: +1 (781) 547-7909