VCEL Vericel Corporation

15.11
+0.24  (+2%)
Previous Close 14.87
Open 15.65
52 Week Low 6.78
52 Week High 19.95
Market Cap $681,621,695
Shares 45,110,635
Float 43,280,220
Enterprise Value $616,479,142
Volume 829,240
Av. Daily Volume 716,432
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Drug Pipeline

Drug Stage Notes
NexoBrid
Severe burns
BLA Filing
BLA Filing
BLA filing announced June 30, 2020.
ixmyelocel-T
Stem cells - Dilated Cardiomyopathy
Phase 2b
Phase 2b
Phase 2b topline data released March 2016. Full data released April 2016
MACI
Focal chondral cartilage defects in the knee.
Approved
Approved
FDA Approval announced December 13, 2016 ahead of PDUFA date of January 3 2017.

Latest News

  1. YAVNE, Israel, June 30, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet medical needs in severe burn and wound management, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. 

    The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and full-thickness thermal burns up to 30% of total body…

    YAVNE, Israel, June 30, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet medical needs in severe burn and wound management, today announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. 

    The BLA submission includes a comprehensive set of manufacturing data, multiple preclinical and clinical studies including the pivotal U.S. Phase 3 (DETECT) study of NexoBrid in adult patients with deep partial and full-thickness thermal burns up to 30% of total body surface area. The DETECT study successfully met its primary endpoint and all secondary endpoints, with a comparable safety profile. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union and other international markets. Vericel Corporation (NASDAQ:VCEL) holds an exclusive license for North American commercial rights to NexoBrid.

    Funding and technical support for the development of NexoBrid is being provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA), including the ongoing expanded access protocol (NEXT) in the U.S., which allows for the continued clinical use of NexoBrid during FDA's review of the NexoBrid BLA. In addition, BARDA has made a $16.5 million commitment to procure NexoBrid for emergency stockpile as part of its mission to build national preparedness for public health medical emergencies.

    "The NexoBrid BLA submission is a major milestone in our unique long-term partnership with BARDA, and we believe that upon approval, NexoBrid will benefit severe burn victims in routine care and serve as a critical medical countermeasure in case of a U.S. mass casualty incident," said Sharon Malka, CEO of MediWound. "Submitting the BLA has been a collaborative effort of many dedicated parties and we thank all of our investigators and their teams, studies participants, our employees and our partners, especially BARDA and Vericel, for their commitment to the program."

    "The BLA submission for NexoBrid marks an important milestone in our partnership with MediWound, bringing us one step closer to providing NexoBrid as a treatment option for the tens of thousands of patients each year who suffer deep-partial and full-thickness burns that require debridement," said Nick Colangelo, President and CEO of Vericel.  "We look forward, together with MediWound, to working with the FDA during the BLA filing and review process as we seek marketing approval for NexoBrid in the United States."

    The FDA has a 60-day filing review period to determine whether the BLA is complete and acceptable for filing. MediWound is eligible to receive a milestone payment from Vericel upon BLA approval.

    About NexoBrid

    NexoBrid (concentrate of proteolytic enzymes enriched in Bromelain) is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue. NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union, and other international markets. Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal. Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved. In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed.

    MediWound and Vericel participated in a pre-BLA meeting in July 2019 with the FDA and received concurrence that the existing safety and efficacy data, including the two Phase 3 clinical studies and the twelve-month safety follow up data from DETECT are adequate to allow for BLA submission and review of NexoBrid. Additional twenty-four-month long term safety follow up data will be submitted as a safety labeling update as part of a post-approval commitment. NexoBrid is currently an investigational product in the United States.

    About MediWound Ltd.

    MediWound is a fully-integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, chronic and other hard-to-heal wounds. MediWound's first innovative biopharmaceutical product, NexoBrid, non-surgically and rapidly removes burn eschar without harming viable tissue. The product has received marketing authorization from the European Medicines Agency as well as the Israeli, Argentinian, South Korean, Russian and Peruvian Ministries of Health. MediWound's second innovative product, EscharEx® is a topical biological drug candidate for the debridement of chronic and other hard-to-heal wounds using the same proteolytic enzyme technology as NexoBrid. In two Phase 2 studies, EscharEx has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, within a few daily applications. For more information, please visit www.mediwound.com.

    About BARDA

    The Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies. For more information, refer to www.phe.gov/about/BARDA. Funding and technical support for development of NexoBrid to obtain marketing approval in the U.S. including the expanded access treatment protocol (NEXT), the pivotal U.S. Phase 3 clinical study (DETECT) and the marketing approval registration process for NexoBrid in the U.S. is provided by BARDA, under the Assistant Secretary for Preparedness and Response (ASPR), within the U.S. Department of Health and Human Services (HHS), under ongoing USG Contract No. HHSO100201500035C. Additional projects for evaluation of NexoBrid funded under the BARDA contract include randomized, controlled pivotal clinical trial for use in pediatric population, establishment of a pre-emergency use data package and development of the health economic model to evaluate the cost savings impact to enable market adoption in the United States.

    Cautionary Note Regarding Forward-Looking Statements

    MediWound caution you that all statements other than statements of historical fact included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations and commercial potential of NexoBrid. Among the factors that may  cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; expected payments under the license agreement with Vericel; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of NEXT Study; the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions. Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of NexoBrid in the future.

    These and other significant factors are discussed in greater detail in MediWound's annual report on Form 20-F for the year ended December 31, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 6-K and other filings with the SEC from time-to-time.  These forward-looking statements reflect MediWound's current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law. 

      
    MediWound Contacts:      
    Boaz Gur-Lavie Jeremy Feffer
    Chief Financial OfficerManaging Director, LifeSci Advisors 
    MediWound Ltd. 212-915-2568
      

     

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  2. CAMBRIDGE, Mass., June 30, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic in the United States, European Union and other international markets.  Vericel holds an exclusive license for North American commercial rights to NexoBrid.  Funding and technical support to MediWound Ltd. for development…

    CAMBRIDGE, Mass., June 30, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking the approval of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic in the United States, European Union and other international markets.  Vericel holds an exclusive license for North American commercial rights to NexoBrid.  Funding and technical support to MediWound Ltd. for development of NexoBrid is provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    The BLA submission for NexoBrid is based on multiple preclinical and clinical studies including the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-thickness and full-thickness thermal burns up to 30% of total body surface area.  The study met its primary endpoint of complete eschar removal as well as all secondary endpoints, including shorter time to eschar removal, a lower incidence of surgical eschar removal, and lower blood loss during eschar removal compared to standard of care (SOC), including both surgical and non-surgical debridement methods.  A key safety endpoint, non-inferiority in time to complete wound closure compared with patients treated with SOC, was also achieved.  Long-term follow-up data to assess cosmesis, function, and quality of life, including 12-month results from the DETECT study, were also included in the submission.

    "The BLA submission for NexoBrid marks an important milestone in our partnership with MediWound, bringing us one step closer to providing NexoBrid as an innovative treatment for the thousands of patients admitted to burn units each year with deep partial-thickness and full-thickness burns who would benefit from rapid and selective eschar removal," said Nick Colangelo, President and CEO of Vericel.  "We look forward, together with MediWound, to working with the FDA during the BLA filing and review process as we seek marketing approval for NexoBrid in the United States."

    Sharon Malka, CEO of MediWound added, "Submitting the NexoBrid BLA has been a team effort and we thank all of the investigators, their teams, our employees and all our partners, especially BARDA and Vericel, for their commitment to the program.  This is a major milestone for MediWound and it is gratifying to know NexoBrid is one step closer to being available to help burn victims in the U.S."

    About NexoBrid

    NexoBrid is a topically administered biological product that enzymatically removes nonviable burn tissue, or eschar, in patients with deep partial and full-thickness thermal burns within four hours of application without harming viable tissue.  NexoBrid is approved in the European Union and other international markets and has been designated as an orphan biologic drug in the United States, European Union and other international markets.  Vericel holds an exclusive license for North American commercial rights to NexoBrid. In January 2019, MediWound announced positive top-line results from the acute phase of the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with deep partial-and full-thickness thermal burns up to 30 percent of total body surface area. The study met its primary endpoint of complete eschar removal compared to gel vehicle as well as all secondary endpoints compared to standard of care (SOC), including shorter time to eschar removal, a lower incidence of surgical eschar removal and lower blood loss during eschar removal.  Safety endpoints, including the key safety endpoint of non-inferiority in time to complete wound closure compared with patients treated with SOC, were also achieved.  In addition, the twelve-month follow-up safety data of cosmesis and function were found to be comparable between the treatment and SOC arms, and no new safety signals were observed.  Additional twenty-four-month long term safety follow up data will be submitted as a safety labeling update as part of a post-approval commitment. NexoBrid is currently an investigational product in the United States.

    About Vericel Corporation

    Vericel is a leader in advanced 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.  The company also holds an exclusive license for North American commercial rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns.  For more information, please visit the company's website at www.vcel.com.

    Epicel® and MACI® are registered trademarks of Vericel Corporation. NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2019 Vericel Corporation. All rights reserved.

    Cautionary Note Regarding Forward-Looking Statements

    Vericel cautions you that all statements other than statements of historical fact included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors, all of which are difficult to predict and many of which are beyond our control.  Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Specifically, this press release contains forward-looking statements concerning the anticipated progress, development, objectives, expectations and commercial potential of NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the timing and conduct of clinical trial and product development activities; the timing or likelihood of regulatory approvals; the ability to successfully develop and commercialize NexoBrid, including its commercial growth potential and the market demand for the product; the availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities; competitive developments; whether FDA will accept all or part of the BLA and provide marketing approval for NexoBrid in the United States; the risks related to the timing and conduct of our NEXT Study; the impact of applicable laws and regulations; and the uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic.  For example, we are unable to predict how the pandemic will affect the overall healthcare infrastructure, including the pace with which governmental agencies, such as the FDA, will review and approve regulatory submissions.  Additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts also may impact our ability to source supplies for our operations or our ability to sell and support the use of NexoBrid in the future.

    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, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, Quarterly Reports on Form 10-Q and other documents filed by the Company with the SEC from time-to-time.  These forward-looking statements reflect management's current views as of the date hereof and Vericel does not undertake, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in our views or events or circumstances that occur after the date of this release except as required by law. 

    Investor Contact:

    Lee Stern

    Solebury Trout



    +1 (646) 378-2922

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  3. CAMBRIDGE, Mass., May 13, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, president and CEO, will present the latest company overview at the UBS Virtual Global Healthcare Conference.  The conference is being conducted with a virtual format and the presentation will take place on Wednesday, May 20, 2020 at 12:30pm Eastern Time.

    A live webcast of the presentation will be available on the Investor Relations section of the Vericel Corporation website at: http://investors.vcel.com

    About Vericel Corporation
    Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets.  The company…

    CAMBRIDGE, Mass., May 13, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Nick Colangelo, president and CEO, will present the latest company overview at the UBS Virtual Global Healthcare Conference.  The conference is being conducted with a virtual format and the presentation will take place on Wednesday, May 20, 2020 at 12:30pm Eastern Time.

    A live webcast of the presentation will be available on the Investor Relations section of the Vericel Corporation website at: http://investors.vcel.com

    About Vericel Corporation
    Vericel is a leader in advanced 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.  The company also holds an exclusive license for North American commercial rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns.  For more information, please visit the company's website at www.vcel.com.

    Epicel® and MACI® are registered trademarks of Vericel Corporation.  NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation.  © 2019 Vericel Corporation.  All rights reserved.

    Investor Contacts:
    Lee Stern
    Solebury Trout

    +1 646-378-2922

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  4. Product Revenues of $26.7 Million Increase 22% Over First Quarter 2019

    Positive Cash Flow for the Quarter

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., May 05, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today reported financial results and business highlights for the first quarter ended March 31, 2020.

    First Quarter 2020 Financial Highlights

    • Total net product revenues increased 22% to $26.7 million, compared to $21.8 million in the first quarter of 2019, marking the twelfth consecutive quarter with record revenues for the reported quarter;
    • MACI® net revenue of $20.3 million and Epicel® net revenue of $6.4 million; the cancellation…

    Product Revenues of $26.7 Million Increase 22% Over First Quarter 2019

    Positive Cash Flow for the Quarter

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., May 05, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today reported financial results and business highlights for the first quarter ended March 31, 2020.

    First Quarter 2020 Financial Highlights

    • Total net product revenues increased 22% to $26.7 million, compared to $21.8 million in the first quarter of 2019, marking the twelfth consecutive quarter with record revenues for the reported quarter;
    • MACI® net revenue of $20.3 million and Epicel® net revenue of $6.4 million; the cancellation of scheduled MACI procedures late in the first quarter due to restrictions on elective surgical procedures reduced the volume of MACI implants for the quarter by approximately 9%;
    • Gross margin of 63%, compared to gross margin of 60% in the first quarter of 2019;
    • Net loss of $4.7 million, or $0.10 per share, compared to $2.8 million, or $0.07 per share, in the first quarter of 2019;
    • Non-GAAP adjusted EBITDA loss of $0.7 million, compared to $0.4 million in the first quarter of 2019;
    • Operating cash flow of $4.7 million; and
    • As of March 31, 2020, the company had $83.3 million in cash and investments, compared to $79.0 million as of December 31, 2019, and no debt.             

    Business Highlights and Updates

    • Implemented multiple measures in response to the COVID-19 pandemic to safeguard the health and well-being of employees, their families, business partners and healthcare providers, while continuing to supply MACI and Epicel to patients with knee cartilage and severe burn injuries;
    • Continued to provide field-based support for MACI and Epicel surgical cases, as needed, in compliance with applicable governmental orders and surgical facility policies and procedures;
    • Implemented the MACI sales force expansion from 49 to 76 sales territories and from six to nine sales regions;
    • Expanded utilization of virtual tools to support physician education initiatives in regions where executive orders or hospital policies restricted access;
    • Continued to actively work with surgeon offices and patients to move cases through the pipeline and reschedule or prepare to reschedule cancelled and postponed cases;
    • Implemented appropriate expense reduction measures, while maintaining workforce and operational readiness to rapidly return to normal operations when conditions allow; and
    • Continue to plan for a mid-2020 submission of the NexoBrid® Biologics License Application to the FDA.

    "The entire Vericel team would like to thank healthcare workers across the nation for their selfless efforts in the treatment and care of COVID-19 patients, and I would also like to thank all of our employees for their dedication and commitment to ensure that our customers and patients continue to have access to our products and clinical case support," said Nick Colangelo, President and CEO of Vericel.  "I remain highly confident in the fundamental prospects for our business given the significant clinical need for both MACI and Epicel and, while uncertainties remain, we expect a robust return of MACI orders in regions where elective surgery restrictions are being lifted."

    2020 Financial Guidance
    As previously reported on April 2, 2020, due to the continued uncertainties resulting from the impact of the COVID-19 pandemic, the company has withdrawn its previously announced 2020 financial guidance.

    First Quarter 2020 Results
    Total net product revenues for the quarter ended March 31, 2020 increased 22% to $26.7 million, compared to $21.8 million in the first quarter of 2019.  Total net product revenues for the quarter included $20.3 million of MACI® (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $6.4 million of Epicel® (cultured epidermal autografts) net revenue, compared to $16.6 million of MACI net revenue and $5.2 million of Epicel net revenue, respectively, in the first quarter of 2019.

    Gross profit for the quarter ended March 31, 2020 was 16.8 million, or 63% of net revenues, compared to $13.2 million, or 60% of net revenues, for the first quarter of 2019.

    Total operating expenses for the quarter ended March 31, 2020 were $21.8 million, compared to $16.5 million for the same period in 2019.  The increase in operating expenses was primarily due to a $1.3 million increase in MACI sales force expenses driven by the expansions in the first quarter of 2019 and 2020, a $0.9 million increase in stock based compensation expense, a $0.6 million increase in patient reimbursement support services, a $0.6 million increase in non-sales force related salaries and a $0.6 million increase in Epicel sales force expenses compared to the same period a year ago.

    Vericel's net loss for the quarter ended March 31, 2020 was $4.7 million, or $0.10 per share, compared to $2.8 million, or $0.07 per share, for the first quarter of 2019.

    Non-GAAP adjusted EBITDA loss was $0.7 million for the quarter ended March 31, 2020, compared to $0.4 million in the first quarter of 2019.  A table reconciling non-GAAP measures is included in this press release for reference.

    As of March 31, 2020, the company had $83.3 million in cash and investments, compared to $79.0 million as of December 31, 2019, and no debt.

    Conference Call Information
    Today's conference call will be available live at 8:30am Eastern Time and can be accessed through the Investor Relations section of the Vericel website at http://investors.vcel.com/events-presentations.  A slide presentation with highlights from today's conference call will be available on the webcast and in the Investor Relations section of the Vericel website.  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 2020 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-presentations until May 5, 2021.  A replay of the call will also be available until 11:00am (EDT) on May 10, 2020 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406.  The conference ID is 5906069.

    About Vericel Corporation
    Vericel is a leader in advanced 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.  The company also holds an exclusive license for North American commercial rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns.  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 certain financial information that has not been prepared in accordance with GAAP.  Vericel's management believes that the non-GAAP adjusted EBITDA described in the release, which includes adjustments for specific items that are generally not indicative of our core operations, provide additional information that is useful to investors in understanding Vericel's underlying performance, business and performance trends, and help facilitate period-to-period comparisons and comparisons of its financial measures with other companies in Vericel's industry.  However, the 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® and MACI® are registered trademarks of Vericel Corporation. NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2019 Vericel Corporation. All rights reserved.

    Vericel cautions you that all statements other than statements of historical fact included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements.  Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control.  Our actual results may differ materially from those expressed or implied by the forward-looking statements in this press release.  These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "continues," "believe," "guidance," "outlook," "target," "future," "potential," "goals" and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "could," "may," or similar expressions.

    Among the factors that could cause actual results to differ materially from those set forth in the forward-looking statements include, but are not limited to uncertainties associated with the scope, scale and duration of the impact of the COVID-19 pandemic, growth in revenues for MACI and Epicel, the expected target surgeon audience, the estimate of the commercial growth potential of our products and product candidates, availability of funding from the Biomedical Research and Development Authority under its agreement with MediWound Ltd. for use in connection with NexoBrid development activities, potential fluctuations in sales and volumes and our results of operations over the course of the year, competitive developments, timing and conduct of clinical trial and product development activities, timing or likelihood of regulatory submissions or approvals, market demand for our products, changes in third party coverage and reimbursement, our ability to maintain and expand our network of direct sales employees, and our ability to supply or meet customer demand for our products.

    With respect to COVID-19, we are currently unable to reasonably estimate the specific extent, or duration, of the impact of the COVID-19 outbreak on our business, financial and operating results.  We are also unable to predict how the outbreak will affect the pace with which state and local governments lift restrictions on the performance of elective surgical procedures, the availability of physicians and/or their treatment prioritizations or the impact of the outbreak on the overall healthcare infrastructure.  In addition to impacts on procedure and surgery volumes, we are experiencing and may experience other disruptions as a result of the COVID-19 outbreak.  For example, enrollment in our clinical trials may be adversely affected.  In addition, patients who have cancelled or postponed surgeries may not reschedule cases in a timely fashion, or at all.  Other disruptions or potential disruptions include restrictions on the ability of Company personnel to travel and access customers for training, promotion and case support, delays in approvals by regulatory bodies, delays in product development efforts, and additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts that may impact our ability to source supplies for our operations or our ability or capacity to manufacture, sell and support the use of our products.  The total impact of these disruptions could have a material impact on the Company's financial condition, cash flows and results of operations.

    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, 2019, filed with the Securities and Exchange Commission ("SEC") on February 25, 2020, and in other filings with the SEC. These forward-looking statements reflect our views as of the date hereof and Vericel does not assume and specifically disclaims any obligation 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. 

    Investor Contacts:
    Lee Stern
    Solebury Trout

    +1 (646) 378-2922


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

        March 31,   December 31,
        2020   2019
    ASSETS        
    Current assets:        
    Cash and cash equivalents   $ 45,623     $ 26,889  
    Short term investments   35,957     42,829  
    Accounts receivable (net of allowance for doubtful accounts of $223 and $306, respectively)   24,171     32,168  
    Inventory   7,282     6,816  
    Other current assets   6,129     2,953  
    Total current assets   119,162     111,655  
    Property and equipment, net   7,423     7,144  
    Restricted cash   89     89  
    Right-of-use assets   24,496     25,103  
    Long term investments   1,720     9,247  
    Total assets   $ 152,890     $ 153,238  
    LIABILITIES AND SHAREHOLDERS' EQUITY        
    Current liabilities:        
    Accounts payable   $ 6,400     $ 6,345  
    Accrued expenses   8,774     7,948  
    Current portion of operating lease liabilities   5,535     5,461  
    Other liabilities   41     41  
    Total current liabilities   20,750     19,795  
    Operating lease liabilities   21,597     22,242  
    Other long-term liabilities   91     110  
    Total liabilities   42,438     42,147  
    COMMITMENTS AND CONTINGENCIES        
    Shareholders' equity:        
    Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 44,963 and 44,864, respectively   493,774     489,749  
    Other comprehensive gain   62     21  
    Accumulated deficit   (383,384 )   (378,679 )
    Total shareholders' equity   110,452     111,091  
    Total liabilities and shareholders' equity   $ 152,890     $ 153,238  



    VERICEL CORPORATION
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (unaudited, amounts in thousands except per share amounts)

        Three Months Ended March 31,
        2020   2019
    Product sales, net   $ 26,678     $ 21,810  
    Cost of product sales   9,922     8,640  
    Gross profit   16,756     13,170  
    Research and development   3,763     3,008  
    Selling, general and administrative   18,069     13,520  
    Total operating expenses   21,832     16,528  
    Loss from operations   (5,076 )   (3,358 )
    Other income (expense):        
    Interest income   306     480  
    Interest expense   (2 )   (2 )
    Other income   67     36  
    Total other income (expense)   371     514  
    Net loss   $ (4,705 )   $ (2,844 )
    Net loss per share attributable to common shareholders (Basic and Diluted)   $ (0.10 )   $ (0.07 )
    Weighted average number of common shares outstanding (Basic and Diluted)   44,924     43,725  



    RECONCILIATION OF REPORTED NET LOSS (GAAP) 
    TO ADJUSTED EBITDA (NON-GAAP MEASURE) - UNAUDITED

             
        Three Months Ended March 31,
    (In thousands)   2020   2019
    Net loss   $ (4,705 )   $ (2,844 )
    Stock compensation expense   3,768     2,628  
    Depreciation and amortization   533     324  
    Net interest income   (304 )   (478 )
    Adjusted EBITDA (Non-GAAP)   $ (708 )   $ (370 )

     

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  5. CAMBRIDGE, Mass., April 22, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the following webcast and conference call to discuss its first-quarter 2020 financial results and business highlights.

    What: Vericel Corporation First-Quarter 2020 Earnings Call
    When: Tuesday, May 5, 2020 at 8:30am (EDT)
    Where: http://investors.vcel.com/events-presentations
    How: The conference call will be available live in the Investors section of the Vericel website at http://investors.vcel.com/events-presentations. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary.

    CAMBRIDGE, Mass., April 22, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the following webcast and conference call to discuss its first-quarter 2020 financial results and business highlights.

    What: Vericel Corporation First-Quarter 2020 Earnings Call
    When: Tuesday, May 5, 2020 at 8:30am (EDT)
    Where: http://investors.vcel.com/events-presentations
    How: The conference call will be available live in the Investors section of the Vericel website at http://investors.vcel.com/events-presentations. Please access the site at least 15 minutes prior to the scheduled start time in order to download the required audio software if necessary. Presentation slides for the conference call will be available on the webcast and in the Investor Relations section of the Vericel website. 

    To participate in the live call by telephone, please call (877) 312-5881 and reference Vericel Corporation first-quarter 2020 earnings 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-presentations until May 5, 2021. A replay of the call will also be available until 11:00am (EDT) on May 10, 2020 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 5906069.

    About Vericel Corporation
    Vericel is a leader in advanced 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. The company also holds an exclusive license for North American commercial rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns. For more information, please visit the company's website at www.vcel.com.

    Epicel® and MACI® are registered trademarks of Vericel Corporation. NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation. © 2020 Vericel Corporation. All rights reserved.

    Global Media Contacts:
    David Schull
    Russo Partners LLC

    +1 212-845-4271 (office)
    +1 858-717-2310 (mobile)

    Investor Contacts:
    Lee Stern
    Solebury Trout

    +1 646-378-2922

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