1. CAMBRIDGE, Mass., Sept. 08, 2021 (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 participate in a virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Monday, September 13, 2021, at 4:15p.m. Eastern Time.

    A 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…

    CAMBRIDGE, Mass., Sept. 08, 2021 (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 participate in a virtual fireside chat at the Morgan Stanley 19th Annual Global Healthcare Conference on Monday, September 13, 2021, at 4:15p.m. Eastern Time.

    A 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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Eric Burns

    ir@vcel.com

    +1 734-418-4411



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  2. CAMBRIDGE, Mass., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, announced the appointment of Patrick J. Fowler as Senior Vice President, Corporate Development and Strategy, effective today.

    Mr. Fowler joins Vericel with over 15 years of business development, strategy and commercial operations experience in the biotech and medical technology industries. Most recently, Mr. Fowler served as Head, North America Strategy, Operations & New Product Development for Sanofi, formerly Genzyme Corporation. During his tenure at Sanofi, he also served as Head, North America Business Development, Specialty Care, as well as Head of Biosurgery Business…

    CAMBRIDGE, Mass., Sept. 07, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, announced the appointment of Patrick J. Fowler as Senior Vice President, Corporate Development and Strategy, effective today.

    Mr. Fowler joins Vericel with over 15 years of business development, strategy and commercial operations experience in the biotech and medical technology industries. Most recently, Mr. Fowler served as Head, North America Strategy, Operations & New Product Development for Sanofi, formerly Genzyme Corporation. During his tenure at Sanofi, he also served as Head, North America Business Development, Specialty Care, as well as Head of Biosurgery Business Development & Portfolio Strategy. Previously, Mr. Fowler served in a number of corporate development roles at Genzyme. Mr. Fowler earned a Bachelor of Science in Molecular Genetics and Cell Biology from the University of Minnesota and an M.B.A. from the University of Toronto.

    "Patrick is a proven corporate development leader with a strong track record of success in executing strategic transactions, as well as developing and implementing corporate and business unit strategies across a variety of therapeutic area franchises," said Nick Colangelo, President and Chief Executive Officer of Vericel. "I am delighted that Patrick is joining the Vericel executive leadership team at a time when his extensive transactional and commercial experience will help drive continued strong growth for the Company in the years ahead."

    "Vericel's innovative and high-growth product portfolio, coupled with its unique profitability profile, provides significant strategic flexibility for the Company to continue to enhance its portfolio through both lifecycle management initiatives and potential business development opportunities," said Mr. Fowler. "I am excited to join Vericel and look forward to working with the team to generate value for patients and shareholders through the continued growth of the Company's current franchises as well as through potential new external opportunities."

    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 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. © 2021 Vericel Corporation. All rights reserved.

    Forward Looking Statements

    This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Vericel's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

    Investor Contacts:

    Eric Burns

    ir@vcel.com

    +1 (734) 418-4411



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  3. Second Quarter Total Net Revenue Increased 97% to $39.5 Million

    Full-Year 2021 Revenue Guidance Raised to $168-$171 Million

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., Aug. 04, 2021 (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 second quarter ended June 30, 2021.

    Second Quarter 2021 Financial Highlights

    • Total net revenue of $39.5 million, an increase of 97% compared to the second quarter of 2020 and 51% compared to the second quarter of 2019
    • MACI® net revenue of $26.5 million, Epicel® net revenue of $12.2 million, and NexoBrid® revenue of $0.8 million related…

    Second Quarter Total Net Revenue Increased 97% to $39.5 Million

    Full-Year 2021 Revenue Guidance Raised to $168-$171 Million

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., Aug. 04, 2021 (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 second quarter ended June 30, 2021.

    Second Quarter 2021 Financial Highlights

    • Total net revenue of $39.5 million, an increase of 97% compared to the second quarter of 2020 and 51% compared to the second quarter of 2019
    • MACI® net revenue of $26.5 million, Epicel® net revenue of $12.2 million, and NexoBrid® revenue of $0.8 million related to the U.S. Biomedical Advanced Research and Development Authority (BARDA) procurement for emergency response preparedness
    • Gross margin of 68%, compared to 57% in the second quarter of 2020
    • Net loss of $3.8 million, or $0.08 per share, compared to $8.3 million, or $0.18 per share, in the second quarter of 2020
    • Non-GAAP adjusted EBITDA of $7.8 million, or 20% of net revenue, compared to adjusted EBITDA loss of $3.5 million in the second quarter of 2020
    • Operating cash flow of $4.8 million
    • As of June 30, 2021, the Company had $116 million in cash and investments, compared to $100 million as of December 31, 2020, and no debt

    Business Highlights and Updates

    • MACI net revenue growth of 76% compared to the second quarter of 2020 and 27% compared to the second quarter of 2019
    • MACI biopsy growth of more than 50% in the first half of 2021 compared to the same period in 2020, with a record quarterly high in the number of biopsies and the number of surgeons taking biopsies in the second quarter
    • Record quarterly Epicel revenue, with growth of 148% compared to the second quarter of 2020 and 128% compared to the second quarter of 2019
    • Record quarterly high in the number of Epicel biopsies and grafting burn centers

    "The Company continued to execute extremely well in the second quarter as we delivered another quarter of strong financial and commercial results," said Nick Colangelo, President and CEO of Vericel. "Based on the strength of the underlying growth drivers for MACI and Epicel, we believe that the Company is well-positioned to continue driving sustainable penetration into the addressable markets for both products in the years ahead."

    Full-Year 2021 Financial Guidance

    • Total net revenue now expected to be in the range of $168-$171 million, compared to previous guidance of approximately $165-$168 million
    • Adjusted EBITDA margin now expected to be in the range of 23% to 25%, compared to previous guidance of 21.5% to 23.5%
    • Maintaining gross margin guidance of 70% to 71% and estimated operating expenses of approximately $115 million

    Second Quarter 2021 Results

    Total net revenue for the quarter ended June 30, 2021 increased 97% to $39.5 million, compared to $20.0 million in the second quarter of 2020. Total net product revenue for the quarter included $26.5 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $12.2 million of Epicel (cultured epidermal autografts) net revenue, compared to $15.1 million of MACI net revenue and $4.9 million of Epicel net revenue, respectively, in the second quarter of 2020. Total net revenue for the quarter also included $0.8 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by BARDA for emergency response preparedness.

    Gross profit for the quarter ended June 30, 2021 was $26.9 million, or 68% of net revenue, compared to $11.4 million, or 57% of net revenue, for the second quarter of 2020.

    Total operating expenses for the quarter ended June 30, 2021 were $30.6 million, compared to $19.7 million for the same period in 2020. The increase in operating expenses was primarily due to an increase in stock-based compensation expense driven by share price appreciation over the past year and lower spend in the prior year due to COVID-19-related factors.

    Net loss for the quarter ended June 30, 2021 was $3.8 million, or $0.08 per share, compared to $8.3 million, or $0.18 per share, for the second quarter of 2020.

    Non-GAAP adjusted EBITDA for the quarter ended June 30, 2021 was $7.8 million, or 20% of net revenue, compared to an adjusted EBITDA loss of $3.5 million in the second quarter of 2020. A table reconciling non-GAAP measures is included in this press release for reference.

    As of June 30, 2021, the Company had $116 million in cash and investments, compared to $100 million as of December 31, 2020, 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 second quarter 2021 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 August 4, 2022. A replay of the call will also be available until 11:30am (EDT) on August 11, 2021 by calling (855) 859-2056, or from outside the U.S. by calling (404) 537-3406. The conference ID is 2969646.

    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 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, 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 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. (MediWound) and is used under license to Vericel Corporation. © 2021 Vericel Corporation. All rights reserved.

    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 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 our expectations regarding future revenue, growth in revenue, market penetration for MACI and Epicel, growth in profit, gross margins and operating margins, the ability to achieve or sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of operations over the course of the year, timing and conduct of clinical trial and product development activities, timing or likelihood of approval by the U.S. Food & Drug Administration (FDA) of a Biologics License Application (BLA) for NexoBrid for treatment of severe burns in the United States following MediWound's receipt of a complete response for NexoBrid on June 28, 2021, the estimate of the commercial growth potential of our products and product candidates, availability of funding from BARDA under its agreement with MediWound for use in connection with NexoBrid development activities, competitive developments, changes in third-party coverage and reimbursement, our ability to supply or meet customer demand for our products, and the wide-ranging impacts of the COVID-19 pandemic on our business or the economy generally.

    With respect to COVID-19, we are currently unable to predict whether a resurgence of COVID-19 infections or the spread of COVID-19 variants that may limit the effectiveness of approved vaccines will result in future restrictions on the performance of elective surgical procedures or affect the availability of physicians and/or their treatment prioritizations, the willingness or ability of patients to seek treatment, or heighten the impact of the outbreak on the overall healthcare infrastructure. 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 product development efforts, and additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts or initiatives 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. With respect to NexoBrid, the COVID-19 pandemic may impact the FDA's response times to future regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections of manufacturing facilities involved in the production of NexoBrid, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid. 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, 2020, filed with the Securities and Exchange Commission (SEC) on February 24, 2021, Vericel's Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, filed with the SEC on August 4, 2021, 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 Contact:

    Eric Burns

    ir@vcel.com

    +1 (734) 418-4411



    VERICEL CORPORATION

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited, amounts in thousands)

     June 30, December 31,
     2021 2020
    ASSETS   
    Current assets:   
    Cash and cash equivalents$51,761  $33,620 
    Short-term investments39,214  42,187 
    Accounts receivable (net of allowance for doubtful accounts of $3 and $143, respectively)31,732  34,504 
    Inventory12,959  9,356 
    Other current assets2,854  3,893 
    Total current assets138,520  123,560 
    Property and equipment, net10,590  7,633 
    Restricted cash211  211 
    Right-of-use assets47,798  50,105 
    Long-term investments24,826  24,099 
    Total assets$221,945  $205,608 
    LIABILITIES AND SHAREHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable$8,134  $6,755 
    Accrued expenses11,077  11,293 
    Current portion of operating lease liabilities4,611  4,394 
    Other liabilities41  41 
    Total current liabilities23,863  22,483 
    Operating lease liabilities46,928  48,789 
    Other long-term liabilities62  76 
    Total liabilities$70,853  $71,348 
    COMMITMENTS AND CONTINGENCIES   
    Shareholders' equity:   
    Common stock, no par value; shares authorized — 75,000; shares issued and outstanding 46,579 and 45,804, respectively534,005  510,061 
    Accumulated other comprehensive income (loss)(23) 14 
    Accumulated deficit(382,890) (375,815)
    Total shareholders' equity151,092  134,260 
    Total liabilities and shareholders' equity$221,945  $205,608 





    VERICEL CORPORATION

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited, amounts in thousands, except per share amounts)

     Three Months Ended June 30, Six Months Ended June 30,
     2021 2020 2021 2020
    Product sales, net$38,680  $20,014  $72,307  $46,692 
    Other revenue839    1,780   
    Total revenue39,519  20,014  74,087  46,692 
    Cost of product sales12,609  8,660  24,192  18,582 
    Gross profit26,910  11,354  49,895  28,110 
    Research and development4,449  3,226  8,079  6,989 
    Selling, general and administrative26,190  16,486  48,850  34,555 
    Total operating expenses30,639  19,712  56,929  41,544 
    Loss from operations(3,729) (8,358) (7,034) (13,434)
    Other income (expense):       
    Interest income43  147  119  453 
    Interest expense(1) (1) (2) (3)
    Other income (expense)(27) (57) 57  10 
    Total other income15  89  174  460 
    Net loss before tax provision(3,714) (8,269) (6,860) (12,974)
    Tax provision(72)   (215)  
    Net loss$(3,786) $(8,269) $(7,075) $(12,974)
    Net loss per share attributable to common shareholders (Basic and diluted)$(0.08) $(0.18) $(0.15) $(0.29)
    Weighted average number of common shares outstanding (Basic and diluted)46,403  45,137  46,195  45,031 





    RECONCILIATION OF REPORTED NET LOSS (GAAP)
    TO ADJUSTED EBITDA (NON-GAAP MEASURE) - UNAUDITED
            
     Three Months Ended June 30, Six Months Ended June 30,
    (In thousands)2021 2020 2021 2020
    Net loss$(3,786) $(8,269) $(7,075) $(12,974)
    Stock compensation expense10,866  4,376  17,885  8,144 
    Depreciation and amortization695  546  1,506  1,079 
    Net interest income(42) (146) (117) (450)
    Income tax provision72    215   
    Adjusted EBITDA (Non-GAAP)$7,805  $(3,493) $12,414  $(4,201)


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  4. CAMBRIDGE, Mass., July 21, 2021 (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 second-quarter 2021 financial results and business highlights.

    What:Vericel Corporation Second-Quarter 2021 Earnings Call
      
    When:Wednesday, August 4, 2021 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., July 21, 2021 (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 second-quarter 2021 financial results and business highlights.

    What:Vericel Corporation Second-Quarter 2021 Earnings Call
      
    When:Wednesday, August 4, 2021 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 second-quarter 2021 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 August, 2022. A replay of the call will also be available until 11:30am (EDT) on August 11, 2021 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 5824035.

    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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Eric Burns

    ir@vcel.com

    +1 (734) 418-4411

     



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  5. CAMBRIDGE, Mass., July 07, 2021 (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 Ladenburg Thalmann Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Tuesday, July 13, 2021, at 9:00 a.m. 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., July 07, 2021 (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 Ladenburg Thalmann Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Tuesday, July 13, 2021, at 9:00 a.m. 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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Eric Burns

    ir@vcel.com

    +1 734-418-4411



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  6. YAVNE, Israel, June 29, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.

    The FDA communicated that it had completed its review of the BLA, as amended, and has determined that the application cannot be approved in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls…

    YAVNE, Israel, June 29, 2021 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD), a fully-integrated biopharmaceutical company focused on next-generation bio-therapeutics solutions for tissue repair and regeneration, today announced it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) seeking approval of NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.

    The FDA communicated that it had completed its review of the BLA, as amended, and has determined that the application cannot be approved in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls ("CMC") section of the BLA and requested additional CMC information. The FDA acknowledged receipt of several CMC amendments, submitted in response the CMC information requests, which were not reviewed for this action.

    The FDA also stated that an inspection of NexoBrid's manufacturing facilities in Israel and Taiwan, are required before the FDA can approve the BLA, but it was unable to conduct the required inspections during the current review cycle due to COVID-related travel restrictions. The FDA stated that it will continue to monitor the public health situation as well as travel restrictions and is actively working to define an approach for scheduling outstanding inspections. In addition, the CRL cited certain observations identified during good clinical practice (GCP) inspections related to the U.S. Phase 3 study (DETECT), and requested the company to provide its perspective on the potential impact, if any, of these observations on the efficacy findings in the study. The FDA also requested to provide a safety update as part of its BLA resubmission, although there were no safety issues raised in the CRL.

    "While we are disappointed that the FDA has issued a CRL for NexoBrid, we remain confident in the strength of our clinical data and in the depth of our development program," said Sharon Malka, Chief Executive Officer of MediWound. "We remain committed to working collaboratively with the Agency, as well as BARDA, to identify the most expeditious pathway toward a potential approval for this important therapy. 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."

    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 procured NexoBrid for the U.S. emergency stockpile as part of its mission to build national preparedness for public health emergencies.

    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 and twenty four-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. NexoBrid is currently an investigational product in the United States.

    About MediWound Ltd.

    MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy leverages our enzymatic technology platform, focused on next-generation bioactive therapies for burn, wound care and tissue repair.

    NexoBrid, our commercial orphan biological product for non-surgical eschar removal of deep, partial and full-thickness thermal burns, is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union and other international markets and is at registration-stage in the U.S. NexoBrid is supported by the U.S. Biomedical Advanced Research and Development Authority (BARDA).

    EscharEx, our next-generation bioactive therapy for debridement of chronic and hard-to-heal wounds, is a product candidate in advanced stages of development. In two Phase 2 studies, EscharEx was well-tolerated and has demonstrated safety and efficacy in the debridement of various chronic and other hard-to-heal wounds, with only a few daily applications.

    MW005, our topical biological drug for the treatment of non-melanoma skin cancers, is a clinical-stage product candidate under development.

    Committed to innovation, we are dedicated to improving quality of care and patient lives. 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 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, study design, objectives anticipated timelines, expectations and commercial potential of our products and product candidates, including NexoBrid. Among the factors that may cause results to be materially different from those stated herein are the inherent uncertainties associated with the uncertain, lengthy and expensive nature of the product development process; the timing and conduct of our studies of our products and product candidates, including the timing, progress and results of current and future clinical studies, and our research and development programs; our ability to obtain marketing approval of our products and product candidates in the U.S. or other markets; the clinical utility, potential advantages and timing or likelihood of regulatory filings and approvals of our products and products; our expectations regarding future growth, including our ability to develop new products; risks related to our contracts with BARDA; market acceptance of our products and product candidates; our ability to maintain adequate protection of our intellectual property; competition risks; the need for additional financing; the impact of government laws and regulations and 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 ability to recruit patients, the ability to conduct the studies in medical sites and 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 our products and product candidates 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, 2020, filed with the Securities and Exchange Commission ("SEC") on February 25, 2021, 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.

    Contacts:Jeremy Feffer
    Boaz Gur-LavieManaging Director
    Chief Financial OfficerLifeSci Advisors
    MediWound Ltd.212-915-2568
    ir@mediwound.comjeremy@lifesciadvisors.com


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  7. CAMBRIDGE, Mass., June 29, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that its development partner, MediWound Ltd., received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for NexoBrid, a potential treatment for eschar removal in adults with deep partial-thickness and/or full-thickness burns.

    The FDA communicated to MediWound that it had completed its review of the BLA, as amended, and has determined that it cannot approve the BLA in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls (CMC) section…

    CAMBRIDGE, Mass., June 29, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that its development partner, MediWound Ltd., received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the Biologics License Application (BLA) for NexoBrid, a potential treatment for eschar removal in adults with deep partial-thickness and/or full-thickness burns.

    The FDA communicated to MediWound that it had completed its review of the BLA, as amended, and has determined that it cannot approve the BLA in its present form. The FDA identified issues related to the Chemistry, Manufacturing and Controls (CMC) section of the BLA and requested that MediWound provide additional CMC information. The FDA stated that it has not reviewed several amendments submitted by MediWound in response to the CMC information requests for this action. The FDA also stated that inspections of manufacturing facilities in Israel and Taiwan are required before the BLA can be approved, but that it was unable to conduct the required inspections during the current review cycle due to COVID-related travel restrictions. In addition, the CRL referenced observations that were made during good clinical practice (GCP) inspections related to the DETECT study and requested that MediWound address questions regarding the impact of the observations on the study's efficacy findings. The FDA also requested that MediWound provide a safety update as part of its BLA resubmission.

    "We are committed to working with MediWound and the FDA on next steps to address the issues identified in the complete response letter in order to obtain the potential approval of NexoBrid and bring this important product to patients as expeditiously as possible," said Nick Colangelo, President and CEO of Vericel. "Importantly, we will continue to support the NexoBrid expanded access treatment (NEXT) protocol during the resubmission and FDA review process."

    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 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. © 2021 Vericel Corporation. All rights reserved.

    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 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 timing or likelihood of approval by the U.S. Food & Drug Administration of the NexoBrid BLA for treatment of severe burns in the United States or other North American markets, availability of funding from BARDA under its agreement with MediWound Ltd. for use in connection with NexoBrid development activities, and the wide-ranging impacts of the COVID-19 pandemic on our business or the economy generally.

    With respect to FDA's review of the pending NexoBrid BLA, the COVID-19 pandemic may impact the FDA's response times to future regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections of manufacturing facilities involved in the production of NexoBrid, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid. 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, 2020, filed with the Securities and Exchange Commission (SEC) on February 24, 2021, Vericel's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 5, 2021, 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:

    Eric Burns

    ir@vcel.com

    +1 734-418-4411



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  8. CAMBRIDGE, Mass., June 09, 2021 (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 Goldman Sachs 42nd Annual Global Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, June 10, 2021, at 4:40 p.m. 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…

    CAMBRIDGE, Mass., June 09, 2021 (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 Goldman Sachs 42nd Annual Global Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, June 10, 2021, at 4:40 p.m. 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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Eric Burns

    ir@vcel.com

    +1 734-418-4411



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  9. CAMBRIDGE, Mass., June 02, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the appointment of Lisa Wright to its Board of Directors, effective immediately. Ms. Wright will serve as a member of the Governance and Nominating Committee of the Board. With the appointment of Ms. Wright, Vericel's Board is now comprised of eight directors, seven of whom are independent.

    Ms. Wright is President and Chief Executive Officer of Community Health Choice, Inc., a managed care organization with approximately 430,000 members and a provider community consisting of over 10,000 physicians and 100 hospitals in the greater Houston, Texas area. Previously…

    CAMBRIDGE, Mass., June 02, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced the appointment of Lisa Wright to its Board of Directors, effective immediately. Ms. Wright will serve as a member of the Governance and Nominating Committee of the Board. With the appointment of Ms. Wright, Vericel's Board is now comprised of eight directors, seven of whom are independent.

    Ms. Wright is President and Chief Executive Officer of Community Health Choice, Inc., a managed care organization with approximately 430,000 members and a provider community consisting of over 10,000 physicians and 100 hospitals in the greater Houston, Texas area. Previously, Ms. Wright served as a Regional President, Medicare, at WellCare Health Plans, Inc., President of Dual Special Needs Plan, Medicare-Medicaid Plan and Nursing Facilities at UnitedHealth Group, Inc., and in marketing programs management at Anthem, Inc. Ms. Wright currently serves on the boards of directors of several non-profit organizations. She received a Bachelor of Arts degree in Communication from the University of Kentucky and a Master of Business Administration from the University of Maryland, University College system.

    "We are delighted to welcome Lisa to the Vericel Board of Directors," said Nick Colangelo, President and Chief Executive Officer of Vericel. "Lisa is a highly-experienced executive with a track record of strong strategic, operational and financial performance across a number of leading healthcare organizations. Her extensive experience and deep expertise in the payer and provider aspects of the healthcare system will be tremendously valuable as we continue on our strong growth trajectory in the years ahead."

    "Lisa's appointment reflects Vericel's commitment to ensuring that we have a broad set of skills and perspectives on the Board," said Robert L. Zerbe, M.D., Chairman of the Vericel Board of Directors. "We look forward to benefitting from her healthcare industry experience and expertise as we continue to advance our Company's strategic and operational objectives and increase shareholder value."

    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 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. © 2021 Vericel Corporation. All rights reserved.

    Forward Looking Statements

    This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Vericel's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

    Investor Contacts:

    Eric Burns

    ir@vcel.com

    +1 734-418-4411



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  10. CAMBRIDGE, Mass., May 13, 2021 (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 Canaccord Genuity Virtual Musculoskeletal Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, May 20, 2021, at 9:30 a.m. 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…

    CAMBRIDGE, Mass., May 13, 2021 (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 Canaccord Genuity Virtual Musculoskeletal Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, May 20, 2021, at 9:30 a.m. 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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Eric Burns

    ir@vcel.com

    +1 734-418-4411



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  11. First Quarter Total Net Revenue Increased 30% to $34.6 Million

    Full-Year 2021 Revenue Guidance Raised to $165-$168 Million

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., May 05, 2021 (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, 2021.

    First Quarter 2021 Financial Highlights

    • Total net revenue increased 30% to $34.6 million, compared to $26.7 million in the first quarter of 2020
    • MACI® net revenue of $23.8 million, Epicel® net revenue of $9.8 million and NexoBrid® revenue of $0.9 million related to the U.S. Biomedical Advanced Research…

    First Quarter Total Net Revenue Increased 30% to $34.6 Million

    Full-Year 2021 Revenue Guidance Raised to $165-$168 Million

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., May 05, 2021 (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, 2021.

    First Quarter 2021 Financial Highlights

    • Total net revenue increased 30% to $34.6 million, compared to $26.7 million in the first quarter of 2020
    • MACI® net revenue of $23.8 million, Epicel® net revenue of $9.8 million and NexoBrid® revenue of $0.9 million related to the U.S. Biomedical Advanced Research and Development Authority (BARDA) procurement for emergency response preparedness
    • Gross margin of 66%, compared to 63% in the first quarter of 2020
    • Net loss of $3.3 million, or $0.07 per share, compared to $4.7 million, or $0.10 per share, in the first quarter of 2020
    • Non-GAAP adjusted EBITDA of $4.6 million, or 13% of net revenue, compared to adjusted EBITDA loss of $0.7 million in the first quarter of 2020
    • Operating cash flow of $10.1 million
    • As of March 31, 2021, the Company had $110 million in cash and investments, compared to $100 million as of December 31, 2020, and no debt

    Business Highlights and Updates

    • MACI implant and biopsy growth of more than 20% compared to the first quarter of 2020
    • Epicel net revenue growth of 54% compared to the first quarter of 2020, with record monthly volume in February and the second highest quarterly Epicel revenue in history
    • Expansion of UnitedHealthcare's MACI medical policy to include patella and multiple cartilage defects in the knee
    • Joined the S&P SmallCap 600®

    "We entered 2021 with a great deal of momentum and delivered another quarter of strong results across both our sports medicine and burn care franchises," said Nick Colangelo, President and CEO of Vericel. "Our first quarter results demonstrate the strength of the Company's financial profile as we continue to generate strong revenue growth and increase profitability and cash flow.   Based on these results and our strong underlying business fundamentals, we remain on track for significant growth across both of our franchises and have raised our full-year 2021 revenue and adjusted EBITDA guidance."

    Full-Year 2021 Financial Guidance

    • Total net revenue now expected to be in the range of $165-$168 million, compared to previous guidance of approximately $161-$164 million
    • Adjusted EBITDA margin now expected to be in the range of 21.5% to 23.5%, compared to previous guidance of 21 to 23%
    • Gross margin guidance of 70% to 71% and estimated operating expenses of approximately $115 million maintained

    First Quarter 2021 Results

    Total net revenue for the quarter ended March 31, 2021 increased 30% to $34.6 million, compared to $26.7 million in the first quarter of 2020. Total net product revenue for the quarter included $23.8 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $9.8 million of Epicel (cultured epidermal autografts) net revenue, compared to $20.3 million of MACI net revenue and $6.4 million of Epicel net revenue, respectively, in the first quarter of 2020. Total net revenue for the quarter also included $0.9 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by BARDA for emergency response preparedness.

    Gross profit for the quarter ended March 31, 2021 was $23.0 million, or 66% of net revenue, compared to $16.8 million, or 63% of net revenue, for the first quarter of 2020.

    Total operating expenses for the quarter ended March 31, 2021 were $26.3 million, compared to $21.8 million for the same period in 2020. The increase in operating expenses was primarily due to an increase in stock-based compensation expense driven by share price appreciation over the past year.

    Net loss for the quarter ended March 31, 2021 was $3.3 million, or $0.07 per share, compared to $4.7 million, or $0.10 per share, for the first quarter of 2020.

    Non-GAAP adjusted EBITDA for the quarter ended March 31, 2021 was $4.6 million, or 13% of net revenue, compared to an adjusted EBITDA loss of $0.7 million in the first quarter of 2020. A table reconciling non-GAAP measures is included in this press release for reference.

    As of March 31, 2021, the Company had $110 million in cash and investments, compared to $100 million as of December 31, 2020, 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 2021 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, 2022. A replay of the call will also be available until 11:30am (EDT) on May 12, 2021 by calling (855) 859-2056, or from outside the U.S. by calling (404) 537-3406. The conference ID is 9036676.

    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 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, 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 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. © 2021 Vericel Corporation. All rights reserved.

    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 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 our expectations regarding future revenue, growth in revenue, market penetration for MACI and Epicel, growth in profit, gross margins and operating margins, the ability to achieve or sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of operations over the course of the year, timing and conduct of clinical trial and product development activities, timing or likelihood of approval by the U.S. Food & Drug Administration of the NexoBrid Biologics License Application (BLA) for treatment of severe burns in the United States or other North American markets, the estimate of the commercial growth potential of our products and product candidates, availability of funding from BARDA under its agreement with MediWound Ltd. for use in connection with NexoBrid development activities, competitive developments, changes in third-party coverage and reimbursement, our ability to supply or meet customer demand for our products, and the wide-ranging impacts of the COVID-19 pandemic on our business or the economy generally.

    With respect to COVID-19, we are currently unable to reasonably estimate the specific extent, or duration of the impact of the COVID-19 pandemic on our business, financial and operating results. We are also unable to predict whether a resurgence of COVID-19 infections or the spread of COVID-19 variants, which may limit the effectiveness of approved vaccines, will result in future restrictions on the performance of elective surgical procedures or affect the availability of physicians and/or their treatment prioritizations, the willingness or ability of patients to seek treatment, or heighten the impact of the outbreak on the overall healthcare infrastructure. 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 product development efforts, and additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts or initiatives 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. With respect to FDA's review of the pending NexoBrid BLA, the COVID-19 pandemic may impact the FDA's response times to regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections of manufacturing facilities involved in the production of NexoBrid, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid. 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, 2020, filed with the Securities and Exchange Commission (SEC) on February 24, 2021, Vericel's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, filed with the SEC on May 5, 2021, 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 Contact:

    Eric Burns

    ir@vcel.com

    +1 (734) 418-4411



    VERICEL CORPORATION

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited, amounts in thousands)

     March 31, December 31,
     2021 2020
    ASSETS   
    Current assets:   
    Cash and cash equivalents$58,154  $33,620 
    Short-term investments25,402  42,187 
    Accounts receivable (net of allowance for doubtful accounts of $121 and $143, respectively)29,122  34,504 
    Inventory10,322  9,356 
    Other current assets4,213  3,893 
    Total current assets127,213  123,560 
    Property and equipment, net9,076  7,633 
    Restricted cash211  211 
    Right-of-use assets48,943  50,105 
    Long-term investments26,021  24,099 
    Total assets$211,464  $205,608 
    LIABILITIES AND SHAREHOLDERS' EQUITY   
    Current liabilities:   
    Accounts payable$8,826  $6,755 
    Accrued expenses9,965  11,293 
    Current portion of operating lease liabilities4,398  4,394 
    Other liabilities41  41 
    Total current liabilities23,230  22,483 
    Operating lease liabilities47,968  48,789 
    Other long-term liabilities57  76 
    Total liabilities$71,255  $71,348 
    COMMITMENTS AND CONTINGENCIES   
    Shareholders' equity:   
    Common stock, no par value; shares authorized — 75,000; shares issued and outstanding 46,225 and 45,804, respectively$519,360  $510,061 
    Accumulated other comprehensive income (loss)(47) 14 
    Accumulated deficit(379,104) (375,815)
    Total shareholders' equity140,209  134,260 
    Total liabilities and shareholders' equity$211,464  $205,608 



    VERICEL CORPORATION

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited, amounts in thousands, except per share amounts)

     Three Months Ended March 31,
     2021 2020
    Product sales, net$33,627  $26,678 
    Other revenue941   
    Total revenue34,568  26,678 
    Cost of product sales11,583  9,922 
    Gross profit22,985  16,756 
    Research and development3,630  3,763 
    Selling, general and administrative22,660  18,069 
    Total operating expenses26,290  21,832 
    Loss from operations(3,305) (5,076)
    Other income (expense):   
    Interest income76  306 
    Interest expense(1) (2)
    Other income84  67 
    Total other income159  371 
    Net loss before tax provision$(3,146) $(4,705)
    Tax provision(143)  
    Net loss$(3,289) $(4,705)
    Net loss per share attributable to common shareholders (Basic and diluted)$(0.07) $(0.10)
    Weighted average number of common shares outstanding (Basic and diluted)45,984  44,924 





    RECONCILIATION OF REPORTED NET LOSS (GAAP)
    TO ADJUSTED EBITDA (NON-GAAP MEASURE) - UNAUDITED
        
     Three Months Ended March 31,
    (In thousands)2021 2020
    Net loss$(3,289) $(4,705)
    Stock compensation expense7,019  3,768 
    Depreciation and amortization811  533 
    Net interest income(75) (304)
    Income tax provision143   
    Adjusted EBITDA (Non-GAAP)$4,609  $(708)


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  12. CAMBRIDGE, Mass., April 21, 2021 (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 2021 financial results and business highlights.

    What: Vericel Corporation First-Quarter 2021 Earnings Call
    When: Wednesday, May 5, 2021 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 21, 2021 (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 2021 financial results and business highlights.

    What: Vericel Corporation First-Quarter 2021 Earnings Call
    When: Wednesday, May 5, 2021 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 2021 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, 2022. A replay of the call will also be available until 11:30am (EDT) on May 12, 2021 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 9036676.

    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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Eric Burns

    ir@vcel.com

    +1 (734) 418-4411



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  13. CAMBRIDGE, Mass., April 09, 2021 (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 20th Annual Needham Virtual Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, April 15, 2021, at 4:30 p.m. 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…

    CAMBRIDGE, Mass., April 09, 2021 (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 20th Annual Needham Virtual Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, April 15, 2021, at 4:30 p.m. 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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Eric Burns

    ir@vcel.com

    +1 734-418-4411



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  14. NEW YORK, March 17, 2021 /PRNewswire/ -- Vericel Corp. (NASD:VCEL) will replace QEP Resources Inc. (NYSE:QEP) in the S&P SmallCap 600 effective prior to the opening of trading on Monday, March 22. S&P 500 constituent Diamondback Energy Inc. (NASD:FANG) has acquired QEP Resources in a transaction that closed today.

    Following is a summary of the changes that will take place prior to the open of trading on the effective date:

    Effective Date

    Index Name      

    Action

    Company Name

    Ticker

    GICS Sector

    March 22, 2021

    S&P SmallCap 600

    Addition

    Vericel

    VCEL

    Health Care


    S&P SmallCap 600

    Deletion

    QEP Resources

    QEP

    Energy

    For more information about S&P Dow Jones Indices, please visit www.spdji.com

    ABOUT S&P DOW JONES INDICES

    S&P Dow Jones Indices is the…

    NEW YORK, March 17, 2021 /PRNewswire/ -- Vericel Corp. (NASD:VCEL) will replace QEP Resources Inc. (NYSE:QEP) in the S&P SmallCap 600 effective prior to the opening of trading on Monday, March 22. S&P 500 constituent Diamondback Energy Inc. (NASD:FANG) has acquired QEP Resources in a transaction that closed today.

    Following is a summary of the changes that will take place prior to the open of trading on the effective date:

    Effective Date

    Index Name      

    Action

    Company Name

    Ticker

    GICS Sector

    March 22, 2021

    S&P SmallCap 600

    Addition

    Vericel

    VCEL

    Health Care



    S&P SmallCap 600

    Deletion

    QEP Resources

    QEP

    Energy

    For more information about S&P Dow Jones Indices, please visit www.spdji.com

    ABOUT S&P DOW JONES INDICES

    S&P Dow Jones Indices is the largest global resource for essential index-based concepts, data and research, and home to iconic financial market indicators, such as the S&P 500® and the Dow Jones Industrial Average®. More assets are invested in products based on our indices than products based on indices from any other provider in the world. Since Charles Dow invented the first index in 1884, S&P DJI has been innovating and developing indices across the spectrum of asset classes helping to define the way investors measure and trade the markets.

    S&P Dow Jones Indices is a division of S&P Global (NYSE:SPGI), which provides essential intelligence for individuals, companies, and governments to make decisions with confidence. For more information, visit www.spdji.com.

    FOR MORE INFORMATION:

    S&P Dow Jones Indices 

    index_services@spglobal.com

    Media Inquiries 

    spdji.comms@spglobal.com

     

    Cision View original content:http://www.prnewswire.com/news-releases/vericel-set-to-join-sp-smallcap-600-301249704.html

    SOURCE S&P Dow Jones Indices

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  15. CAMBRIDGE, Mass., March 10, 2021 (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 Oppenheimer 31st Annual Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Wednesday, March 17, 2021, at 10:00 a.m. 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…

    CAMBRIDGE, Mass., March 10, 2021 (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 Oppenheimer 31st Annual Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Wednesday, March 17, 2021, at 10:00 a.m. 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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Eric Burns

    ir@vcel.com

    +1 734-418-4411



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  16. CAMBRIDGE, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Joe Mara, Chief Financial Officer, will present the latest company overview at the H.C. Wainwright Virtual Global Life Sciences Conference. The conference is being conducted in a virtual format and a webcast of the presentation will become available on Tuesday, March 9, 2021, at 7:00 a.m. Eastern Time.

    A 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…

    CAMBRIDGE, Mass., March 02, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that Joe Mara, Chief Financial Officer, will present the latest company overview at the H.C. Wainwright Virtual Global Life Sciences Conference. The conference is being conducted in a virtual format and a webcast of the presentation will become available on Tuesday, March 9, 2021, at 7:00 a.m. Eastern Time.

    A 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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contact:

    Eric Burns

    ir@vcel.com

    +1 617-588-5666



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  17. Record Fourth Quarter Total Revenue, Gross Margin, Net Income and Operating Cash Flow

    Full-Year 2021 Total Revenue Expected to Grow 30%-32% to Approximately $161 to $164 Million

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., Feb. 24, 2021 (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 fourth quarter and year ended December 31, 2020, and provided full-year 2021 financial guidance.

    Fourth Quarter 2020 Financial Highlights

    • Total net revenue increased 15% to $45.2 million, compared to $39.4 million in the fourth quarter of 2019
    • MACI® net revenue of $34.7 million, Epicel…

    Record Fourth Quarter Total Revenue, Gross Margin, Net Income and Operating Cash Flow

    Full-Year 2021 Total Revenue Expected to Grow 30%-32% to Approximately $161 to $164 Million

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., Feb. 24, 2021 (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 fourth quarter and year ended December 31, 2020, and provided full-year 2021 financial guidance.

    Fourth Quarter 2020 Financial Highlights

    • Total net revenue increased 15% to $45.2 million, compared to $39.4 million in the fourth quarter of 2019
    • MACI® net revenue of $34.7 million, Epicel® net revenue of $9.6 million and NexoBrid® revenue of $1.0 million related to the U.S. Biomedical Advanced Research and Development Authority (BARDA) procurement for national response preparedness
    • Gross margin of 74%, compared to gross margin of 73% in the fourth quarter of 2019
    • Net income of $12.2 million, or $0.25 per share, compared to $9.5 million, or $0.20 per share, in the fourth quarter of 2019
    • Non-GAAP adjusted EBITDA of $16.0 million, or 35% of net revenue, compared to $12.8 million, or 33% of net revenue, in the fourth quarter of 2019
    • Operating cash flow of $11.3 million

    Full-Year 2020 Financial Highlights

    • Total net revenue increased 5% to $124.2 million, compared to $117.9 million in 2019
    • MACI net revenue of $94.4 million, Epicel net revenue of $27.5 million and NexoBrid revenue of $2.2 million related to the BARDA procurement for national response preparedness
    • Gross margin of 68%, compared to gross margin of 68% in 2019
    • Net income of $2.9 million, or $0.06 per share, compared to a net loss of $9.7 million, or $0.22 per share, in 2019
    • Non-GAAP adjusted EBITDA of $18.6 million, or 15% of net revenue, compared to $21.2 million, or 18% of net revenue, in 2019
    • Operating cash flow of $17.6 million
    • As of December 31, 2020, the company had $100 million in cash and investments, compared to $79 million as of December 31, 2019, and no debt

    Business Highlights and Updates

    • Record fourth-quarter and full-year total net revenue
    • Record quarterly gross margin, net income and operating cash flow
    • Record quarterly and full-year MACI implants and net revenue
    • Record fourth-quarter and full-year Epicel grafts and net revenue, and the second highest quarterly Epicel grafts and revenue in history
    • Received MACI biopsies from approximately 1,500 surgeons in 2020, an increase from approximately 1,400 surgeons in 2019
    • Record quarterly high in the number of surgeons taking MACI biopsies in the fourth quarter
    • Double-digit growth in MACI biopsies in the fourth quarter, achieving a record quarterly high and a record monthly high in December
    • Announced expansion of MACI coverage by UnitedHealthcare to include patella and multiple cartilage defects in the knee
    • Appointed Joe Mara as Chief Financial Officer

    "We delivered a record fourth quarter across multiple financial and operational metrics and ended the year in a very strong financial position," said Nick Colangelo, President and CEO of Vericel. "With revenue growth for both products in 2020, we demonstrated the resiliency of the Company's growth profile and are on track for significant growth in the years ahead. Our guidance for 2021 reflects a return to MACI's pre-COVID growth trajectory, continued momentum for Epicel, and significant adjusted EBITDA growth."

    2021 Financial Guidance

    • Total net revenue for 2021 expected to grow 30%-32% to approximately $161 million to $164 million
    • Gross margin expected to be 70% to 71%
    • Adjusted EBITDA margin expected to be 21% to 23%

    Fourth Quarter 2020 Results

    Total net revenue for the quarter ended December 31, 2020 increased 15% to $45.2 million, compared to $39.4 million in the fourth quarter of 2019. Total net product revenue for the quarter included $34.7 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $9.6 million of Epicel (cultured epidermal autografts) net revenue compared to $33.6 million of MACI net revenue and $5.8 million of Epicel net revenue, respectively, in the fourth quarter of 2019. Total net revenue for the quarter also included $1.0 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by BARDA for emergency response preparedness.

    Gross profit for the quarter ended December 31, 2020 was $33.6 million, or 74% of net revenue, compared to $28.8 million, or 73% of net revenue, for the fourth quarter of 2019.

    Total operating expenses for the quarter ended December 31, 2020 were $21.4 million, compared to $19.6 million for the same period in 2019. The increase in operating expenses was primarily due to incremental employee expenses related to the MACI sales force expansion.

    Net income for the quarter ended December 31, 2020 was $12.2 million, or $0.25 per share, compared to $9.5 million, or $0.20 per share, for the fourth quarter of 2019.

    Non-GAAP adjusted EBITDA for the quarter ended December 31, 2020 was $16.0 million, or 35% of net revenue, compared to $12.8 million, or 33% of net revenue, in the fourth quarter of 2019. A table reconciling non-GAAP measures is included in this press release for reference.

    Full-Year 2020 Results

    Total net revenue for the year ended December 31, 2020 increased 5% to $124.2 million, compared to $117.9 million in 2019. Total net product revenue for the year included $94.4 million of MACI net revenue and $27.5 million of Epicel net revenue compared to $91.6 million of MACI net revenue and $26.2 million of Epicel net revenue, respectively, in 2019. Total net revenue in 2020 also included $2.2 million of revenue related to the procurement of NexoBrid by BARDA for emergency response preparedness.

    Gross profit for the year ended December 31, 2020 was $84.2 million, or 68% of net revenue, compared to $80.3 million, or 68% of net revenue, in 2019.

    Total operating expenses for the year ended December 31, 2020 were $81.9 million, compared to $91.5 million for the same period in 2019. Operating expenses in 2019 included the $17.5 million upfront license payment to MediWound Ltd. for North American rights to NexoBrid.

    Net income for the year ended December 31, 2020 was $2.9 million, or $0.06 per share, compared to a net loss of $9.7 million, or $0.22 per share, in 2019.

    Non-GAAP adjusted EBITDA for the year ended December 31, 2020 was $18.6 million, or 15% of net revenue, compared to $21.2 million, or 18% of net revenue, in 2019. A table reconciling non-GAAP measures is included in this press release for reference.

    As of December 31, 2020, the company had $100 million in cash and investments, compared to $79 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 third-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 February 24, 2022. A replay of the call will also be available until 11:30am (EDT) on March 3, 2021 by calling (855) 859-2056, or from outside the U.S. by calling (404) 537-3406. The conference ID is 4364298.

    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 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, 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 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. © 2021 Vericel Corporation. All rights reserved.

    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 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 our expectations regarding future revenue, growth in revenue, market penetration for MACI and Epicel, growth in profit, gross margins and operating margins, the ability to achieve or sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of operations over the course of the year, timing and conduct of clinical trial and product development activities, timing or likelihood of approval by the U.S. Food & Drug Administration of the NexoBrid Biologics License Application (BLA) for treatment of severe burns in the United States or other North American markets, the estimate of the commercial growth potential of our products and product candidates, availability of funding from BARDA under its agreement with MediWound Ltd. for use in connection with NexoBrid development activities, competitive developments, changes in third-party coverage and reimbursement, our ability to supply or meet customer demand for our products, and the wide-ranging impacts of the COVID-19 pandemic on our business or the economy generally.

    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 or whether additional such restrictions may be imposed by states in the future, the availability of physicians and/or their treatment prioritizations, the willingness or ability of patients to seek treatment or the impact of the outbreak on the overall healthcare infrastructure. 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 product development efforts, and additional government-imposed quarantines and requirements to "shelter at home" or other incremental mitigation efforts or initiatives 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. With respect to FDA's review of the pending NexoBrid BLA, the COVID-19 pandemic may impact the FDA's response times to regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections of manufacturing facilities involved in the production of NexoBrid, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid. 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, 2020, filed with the Securities and Exchange Commission (SEC) on February 24, 2021, 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:

    Chad Rubin

    Solebury Trout

    crubin@troutgroup.com

    +1 (646) 378-2947

    VERICEL CORPORATION

    CONSOLIDATED BALANCE SHEETS

    (Unaudited, amounts in thousands)

      December 31,
      2020 2019
    ASSETS    
    Current assets:    
    Cash and cash equivalents $33,620    $26,889   
    Short-term investments 42,187    42,829   
    Accounts receivable (net of allowance for doubtful accounts of $143 and $306, respectively) 34,504    32,168   
    Inventory 9,356    6,816   
    Other current assets 3,893    2,953   
    Total current assets 123,560    111,655   
    Property and equipment, net 7,633    7,144   
    Restricted cash 211    89   
    Right-of-use assets 50,105    25,103   
    Long-term investments 24,099    9,247   
    Total assets $205,608    $153,238   
    LIABILITIES AND SHAREHOLDERS' EQUITY    
    Current liabilities:    
    Accounts payable $6,755    $6,345   
    Accrued expenses 11,293    7,948   
    Current portion of operating lease liabilities 4,394    5,461   
    Other liabilities 41    41   
    Total current liabilities 22,483    19,795   
    Operating lease liabilities 48,789    22,242   
    Other long-term liabilities 76    110   
    Total liabilities 71,348    42,147   
    COMMITMENTS AND CONTINGENCIES    
    Shareholders' equity:    
    Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 45,804 and 44,864, respectively 510,061    489,749   
    Accumulated other comprehensive income 14    21   
    Accumulated deficit (375,815)  (378,679) 
    Total shareholders' equity 134,260    111,091   
    Total liabilities and shareholders' equity $205,608    $153,238   

    VERICEL CORPORATION

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited, amounts in thousands, except per share amounts)

      Three Months Ended December 31, Year Ended December 31,
      2020 2019 2020 2019
    Product sales, net $44,256    $39,390    $121,968    $117,850   
    Other revenue 973    —    2,211    —   
    Total revenue 45,229    39,390    124,179    117,850   
    Cost of product sales 11,582    10,585    39,951    37,571   
    Gross profit 33,647    28,805    84,228    80,279   
    Research and development 3,118    3,217    13,020    30,391   
    Selling, general and administrative 18,240    16,378    68,836    61,139   
    Total operating expenses 21,358    19,595    81,856    91,530   
    Income (loss) from operations 12,289    9,210    2,372    (11,251) 
    Other income (expense):        
    Interest income 117    321    691    1,614   
    Interest expense (1)  (2)  (6)  (8) 
    Other expense (5)  (28)  (13)  (20) 
    Total other income 111    291    672    1,586   
    Net income (loss) before tax provision $12,400    $9,501    $3,044    $(9,665) 
    Tax provision 180    —    180    —   
    Net income (loss) $12,220    $9,501    $2,864    $(9,665) 
             
    Net income (loss) per share attributable to common shareholders (Basic) $0.27    $0.21    $0.06    $(0.22) 
    Net income (loss) per share attributable to common shareholders (Diluted) $0.25    $0.20    $0.06    $(0.22) 
    Weighted average number of common shares outstanding (Basic) 45,545    44,775    45,221    44,180   
    Weighted average number of common shares outstanding (Diluted) 48,101    46,803    47,282    44,180   



    RECONCILIATION OF REPORTED NET INCOME (LOSS) (GAAP) TO ADJUSTED EBITDA (NON-GAAP MEASURE) - UNAUDITED
             
      Three Months Ended December 31, Year Ended December 31,
    (In thousands) 2020 2019 2020 2019
    Net income (loss) $12,220    $9,501    $2,864    $(9,665) 
    Upfront license agreement payment —    —    —    17,500   
    Stock compensation expense 3,024    3,083    13,843    13,179   
    Depreciation and amortization 734    573    2,383    1,744   
    Net interest income (116)  (319)  (685)  (1,606) 
    Income tax expense 180    —    180    —   
    Adjusted EBITDA (Non-GAAP) $16,042    $12,838    $18,585    $21,152   


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  18. CAMBRIDGE, Mass., Feb. 22, 2021 (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 SVB Leerink 10th Annual Global Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, February 25, 2021, at 10:00 a.m. 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…

    CAMBRIDGE, Mass., Feb. 22, 2021 (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 SVB Leerink 10th Annual Global Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, February 25, 2021, at 10:00 a.m. 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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Chad Rubin

    Solebury Trout

    crubin@troutgroup.com 

    +1 646-378-2947



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  19. CAMBRIDGE, Mass., Feb. 16, 2021 (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, and Joe Mara, CFO, will participate in a fireside chat at the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Thursday, February 18, 2021, at 3:00p.m. Eastern Time.

    A live webcast of the event 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…

    CAMBRIDGE, Mass., Feb. 16, 2021 (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, and Joe Mara, CFO, will participate in a fireside chat at the BTIG Virtual MedTech, Digital Health, Life Science & Diagnostic Tools Conference on Thursday, February 18, 2021, at 3:00p.m. Eastern Time.

    A live webcast of the event 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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Chad Rubin

    Solebury Trout

    crubin@troutgroup.com

    +1 646-378-2947



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  20. CAMBRIDGE, Mass., Feb. 12, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that its Board of Directors unanimously approved the termination of the Company's shareholder rights agreement, commonly referred to as a "poison pill", which was originally scheduled to expire on August 15, 2021. The shareholder rights agreement was amended to accelerate the expiration date to February 11, 2021, effectively terminating the plan as of that date.

    "Vericel is committed to enhancing its governance policies for the benefit of shareholders," said Nick Colangelo, President and Chief Executive Officer of Vericel. "The termination of the shareholder…

    CAMBRIDGE, Mass., Feb. 12, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that its Board of Directors unanimously approved the termination of the Company's shareholder rights agreement, commonly referred to as a "poison pill", which was originally scheduled to expire on August 15, 2021. The shareholder rights agreement was amended to accelerate the expiration date to February 11, 2021, effectively terminating the plan as of that date.

    "Vericel is committed to enhancing its governance policies for the benefit of shareholders," said Nick Colangelo, President and Chief Executive Officer of Vericel. "The termination of the shareholder rights plan advances that objective."

    Shareholders are not required, nor do they need to take any action because of the termination of this shareholder rights agreement.

    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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Chad Rubin

    Solebury Trout

    crubin@troutgroup.com

    +1 646-378-2947



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  21. CAMBRIDGE, Mass., Feb. 10, 2021 (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 fourth-quarter 2020 financial results and business highlights.

    What:Vericel Corporation Fourth-Quarter 2020 Earnings Call
    When: Wednesday, February 24, 2021 at 8:30am (EST)
    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., Feb. 10, 2021 (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 fourth-quarter 2020 financial results and business highlights.

    What:Vericel Corporation Fourth-Quarter 2020 Earnings Call
    When: Wednesday, February 24, 2021 at 8:30am (EST)
    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 fourth-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 February 24, 2022. A replay of the call will also be available until 11:30am (EST) on March 3, 2021 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 4364298.

    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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contact:

    Chad Rubin

    Solebury Trout

    crubin@troutgroup.com 

    +1 646-378-2947



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  22. CAMBRIDGE, Mass., Jan. 25, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, announced the appointment of Joe Mara as Chief Financial Officer of the Company, effective today.

    Mr. Mara joins Vericel with over 20 years of financial, strategic and operational experience, including more than 14 years of experience in the biotech industry. Most recently, Mr. Mara served as Vice President, Finance and Head of Investor Relations at Biogen Inc. During his tenure at Biogen, Mr. Mara held several finance leadership roles, including Vice President, Global Financial Planning and Analysis and Strategic Corporate Finance and Vice President, U.S. Finance and Operations…

    CAMBRIDGE, Mass., Jan. 25, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, announced the appointment of Joe Mara as Chief Financial Officer of the Company, effective today.

    Mr. Mara joins Vericel with over 20 years of financial, strategic and operational experience, including more than 14 years of experience in the biotech industry. Most recently, Mr. Mara served as Vice President, Finance and Head of Investor Relations at Biogen Inc. During his tenure at Biogen, Mr. Mara held several finance leadership roles, including Vice President, Global Financial Planning and Analysis and Strategic Corporate Finance and Vice President, U.S. Finance and Operations. Prior to joining Biogen, Mr. Mara held finance and strategy roles in the financial services and technology industries, including at Thomson Reuters Corporation and Fidelity Investments. Mr. Mara earned a B.A. degree in Economics and International Studies from Northwestern University and an M.B.A. from the Sloan School of Management at M.I.T.      

    "Joe is a proven finance and business leader with a track record of success in operational and strategic finance roles across U.S. and global organizations," said Nick Colangelo, President and Chief Executive Officer of Vericel. "I am very pleased that Joe is joining the Vericel executive team at a time when his extensive experience will help drive continued strong growth and financial results for the Company in the years ahead."

    "I am very excited to join Vericel given its leadership position in cell therapy and the sports medicine and severe burn care markets, its innovative product portfolio, and the Company's significant growth potential," said Mr. Mara. "I look forward to working with the Vericel team to continue to provide important products to patients, execute on the Company's long-term growth strategy, and drive continued value for our shareholders."

    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 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. © 2021 Vericel Corporation. All rights reserved.

    Forward Looking Statements

    This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Vericel's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

    Investor Contacts:

    Chad Rubin

    Solebury Trout

    crubin@troutgroup.com

    +1 646-378-2947



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  23. Record Quarterly and Full-Year Total Revenues

    Fourth Quarter Revenue Growth of Approximately 15%

    CAMBRIDGE, Mass., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced preliminary unaudited financial results for the fourth quarter and year ended December 31, 2020, and provided business updates.

    Preliminary Unaudited Fourth-Quarter and Full-Year 2020 Financial Results
    Preliminary total net revenues for the fourth-quarter 2020 are expected to be in the range of $44.9-$45.4 million, with MACI® (autologous cultured chondrocytes on porcine collagen membrane) net revenue in the range of $34.4-$34.9 million, Epicel® (cultured epidermal…

    Record Quarterly and Full-Year Total Revenues

    Fourth Quarter Revenue Growth of Approximately 15%

    CAMBRIDGE, Mass., Jan. 11, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced preliminary unaudited financial results for the fourth quarter and year ended December 31, 2020, and provided business updates.

    Preliminary Unaudited Fourth-Quarter and Full-Year 2020 Financial Results

    Preliminary total net revenues for the fourth-quarter 2020 are expected to be in the range of $44.9-$45.4 million, with MACI® (autologous cultured chondrocytes on porcine collagen membrane) net revenue in the range of $34.4-$34.9 million, Epicel® (cultured epidermal autografts) net revenue of approximately $9.6 million, and NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain) revenue of approximately $1 million related to the U.S. Biomedical Advanced Research and Development Authority's (BARDA) procurement of NexoBrid for emergency response preparedness.  

    Preliminary total net product revenues for the full-year 2020 are expected to be in the range of $123.9-$124.4 million, with MACI net revenue in the range of $94.1-$94.6 million, Epicel net revenue of approximately $27.5 million, and NexoBrid revenue of approximately $2.2 million related to the BARDA procurement.

    Cash and investments increased by approximately $14.5 million in the fourth quarter. As of December 31, 2020, the company had approximately $100 million in cash and investments and no debt, compared to $79.0 million as of December 31, 2019.

    Business Highlights and Updates

    • Record fourth-quarter and full-year total net revenues;
    • Record quarterly and full-year MACI implants and net revenue;
    • Record fourth-quarter and full-year Epicel grafts and net revenue, and the second highest quarterly Epicel grafts and revenue in history;
    • Received MACI biopsies from approximately 1,500 surgeons in 2020, up from approximately 1,400 surgeons in 2019;
    • Record quarterly high in the number of surgeons taking MACI biopsies in the fourth quarter; and
    • Double-digit growth in MACI biopsies in the fourth quarter, achieving a record quarterly high and a record monthly high in December.

    "We delivered strong financial and operational results in the fourth quarter and for the full year, including record product volumes and revenue for both MACI and Epicel for the year," said Nick Colangelo, President and CEO of Vericel.   "Epicel performance was very strong in the fourth quarter, with revenue growing over 60% for the quarter. MACI performance was in line with our expectations through mid-December. However, due to the recent surge in COVID-19 cases in the United States, the scheduling of MACI pipeline cases for the last two weeks of December slowed compared to historical trends and there was an increase in case cancellations during that period. We expect, based on our experience earlier this year, that the majority of those MACI cases, which represent approximately $2 million in revenue, will move forward in 2021.   Moreover, the underlying growth drivers for MACI were in line with our expectations, which we believe will drive strong revenue and profitability growth in 2021."

    The company will host a webcast and conference call to discuss its fourth quarter 2020 financial results and business highlights on February 24, 2020, at 8:30am Eastern Time. Webcast information can be found on the events and presentation section of the Investor Relations website at https://investors.vcel.com/events-presentations.

    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. © 2021 Vericel Corporation. All rights reserved.

    Preliminary and Unaudited Nature of Reported Results

    Our revenue expectations for the fourth quarter and full year ended 2020, as well as our estimates concerning cash and investments are preliminary, unaudited and are subject to adjustment based on the completion of our ongoing internal control, review, and audit procedures.

    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 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 may result in differences are the inherent uncertainties associated with our expectations concerning expected revenue results for the fourth quarter and full year ended 2020 and estimates of our cash and investments as of December 31, 2020. Vericel's revenue expectations for the fourth quarter and full year ended 2020, as well as its estimates concerning cash and investments are preliminary, unaudited and are subject to adjustment during our ongoing internal review. Additional 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 our expectations regarding future revenues, growth in revenues, market penetration for MACI and Epicel, growth in profit, gross margins and operating margins, the ability to achieve or sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of operations over the course of the year, competitive developments, changes in third party coverage and reimbursement, our ability to supply or meet customer demand for our products, and the wide-ranging impacts of the COVID-19 pandemic on our business or the economy generally.

    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 or whether additional such restrictions may be imposed by states in the future, the availability of physicians and/or their treatment prioritizations or the impact of the outbreak on the overall healthcare infrastructure. 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 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. With respect to FDA's review of the pending NexoBrid Biologics License Application, the COVID-19 pandemic may impact the FDA's response time to regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid. 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, Vericel's Quarterly Report on Form 10-Q for the quarter ended September 30, 2020, filed with the SEC on November 5, 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:

    Chad Rubin

    Solebury Trout

    crubin@troutgroup.com

    +1 (646) 378-2947



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  24. CAMBRIDGE, Mass., Jan. 08, 2021 (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 23rd Annual Needham Growth Conference. The conference is being conducted in a virtual format and the presentation will take place on Friday, January 15, 2021, at 1:15 p.m. 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., Jan. 08, 2021 (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 23rd Annual Needham Growth Conference. The conference is being conducted in a virtual format and the presentation will take place on Friday, January 15, 2021, at 1:15 p.m. 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 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. © 2021 Vericel Corporation. All rights reserved.

    Investor Contacts:

    Chad Rubin

    Solebury Trout

    crubin@troutgroup.com

    +1 646-378-2947



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  25. CAMBRIDGE, Mass., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that UnitedHealthcare has expanded its medical policy for MACI® (autologous cultured chondrocytes on porcine collagen membrane) to include coverage for patients with symptomatic full-thickness cartilage defects in the patella and multiple cartilage defects in the knee. UnitedHealthcare is the largest commercial payer in the United States, covering more than 26 million lives, and more patients treated with MACI are covered by UnitedHealthcare than any other plan in the United States. The revised policy is effective February 1, 2021.

    "We are very pleased that…

    CAMBRIDGE, Mass., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced that UnitedHealthcare has expanded its medical policy for MACI® (autologous cultured chondrocytes on porcine collagen membrane) to include coverage for patients with symptomatic full-thickness cartilage defects in the patella and multiple cartilage defects in the knee. UnitedHealthcare is the largest commercial payer in the United States, covering more than 26 million lives, and more patients treated with MACI are covered by UnitedHealthcare than any other plan in the United States. The revised policy is effective February 1, 2021.

    "We are very pleased that United Healthcare has expanded MACI coverage to include patients with patella and multiple cartilage defects in the knee, which is consistent with the MACI label and current clinical practice," said Nick Colangelo, President and CEO of Vericel. "Since its launch, MACI has become a preferred treatment option, particularly for patients with cartilage defects on the patella, and this updated policy will increase patient access and support continued MACI growth in the years ahead."

    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 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.

    Forward Looking Statements

    This press release contains forward-looking statements. Forward-looking statements are subject to risks and uncertainties such as those described in Vericel's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.

    Investor Contacts:

    Chad Rubin

    Solebury Trout

    crubin@troutgroup.com

    +1 646-378-2947



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  26. CAMBRIDGE, Mass., Dec. 18, 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 39th Annual J.P. Morgan Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, January 14, 2021 at 11:40 a.m. 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…

    CAMBRIDGE, Mass., Dec. 18, 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 39th Annual J.P. Morgan Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, January 14, 2021 at 11:40 a.m. 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 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.

    Investor Contacts:

    Chad Rubin

    Solebury Trout

    crubin@troutgroup.com

    +1 646-378-2947



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  27. Total Net Revenues of $32.3 Million and Net Income of $3.6 Million

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., Nov. 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 third quarter ended September 30, 2020.

    Third Quarter 2020 Financial Highlights

    • Total net revenues of $32.3 million, compared to $30.5 million in the third quarter of 2019;
    • MACI® net revenue of $24.4 million, Epicel® net revenue of $6.7 million and NexoBrid® revenue of $1.2 million related to the U.S. Biomedical Advanced Research and Development Authority (BARDA) procurement for national response…

    Total Net Revenues of $32.3 Million and Net Income of $3.6 Million

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., Nov. 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 third quarter ended September 30, 2020.

    Third Quarter 2020 Financial Highlights

    • Total net revenues of $32.3 million, compared to $30.5 million in the third quarter of 2019;
    • MACI® net revenue of $24.4 million, Epicel® net revenue of $6.7 million and NexoBrid® revenue of $1.2 million related to the U.S. Biomedical Advanced Research and Development Authority (BARDA) procurement for national response preparedness;
    • Gross margin of 70%, compared to gross margin of 69% in the third quarter of 2019;
    • Net income of $3.6 million, or $0.08 per share, compared to $3.5 million, or $0.07 per share, in the third quarter of 2019;
    • Non-GAAP adjusted EBITDA of $6.7 million, compared to $6.8 million in the third quarter of 2019;
    • Operating cash flow of $4.6 million; and
    • Cash and investments of $85.5 million as of September 30, 2020, compared to $79.0 million as of December 31, 2019, and no debt.    

    Business Highlights and Updates

    • Reported record third quarter MACI revenue and total revenues, and the second highest quarterly Epicel revenue in history;
    • Achieved double-digit growth in MACI revenue, implants and biopsies in the third quarter, including a record monthly high for biopsies in September;
    • Announced the first delivery of NexoBrid to BARDA for emergency response preparedness; and
    • Announced that the FDA accepted for review the Biologics License Application for NexoBrid for the treatment of severe thermal burns, with a PDUFA goal date of June 29, 2021.

    "Our company executed exceedingly well during the third quarter as we generated stronger than expected financial results, drove strong commercial performance for MACI and Epicel, and achieved important milestones towards our goal of obtaining marketing approval of NexoBrid in the United States," said Nick Colangelo, President and CEO of Vericel.  "Our third quarter results demonstrated the strength of our business across several measures and, while uncertainties related to COVID-19 remain, we are highly confident in the underlying fundamentals of our business and we remain on track to deliver strong revenue and profit growth in the years ahead."

    Third Quarter 2020 Results

    Total net revenues for the quarter ended September 30, 2020 increased 6% to $32.3 million, compared to $30.5 million in the third quarter of 2019.  Total net product revenues for the quarter included $24.4 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $6.7 million of Epicel (cultured epidermal autografts) net revenue compared to $20.6 million of MACI net revenue and $9.9 million of Epicel net revenue, respectively, in the third quarter of 2019, and $1.2 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by BARDA for emergency response preparedness.

    Gross profit for the quarter ended September 30, 2020 was $22.5 million, or 70% of net revenues, compared to $21.2 million, or 69% of net revenues, for the third quarter of 2019.

    Total operating expenses for the quarter ended September 30, 2020 were $19.0 million, compared to $18.1 million for the same period in 2019.  The increase was primarily driven by incremental employee expenses related to the MACI sales force expansion.

    Vericel's net income for the quarter ended September 30, 2020 was $3.6 million, or $0.08 per share, compared to $3.5 million, or $0.07 per share, for the third quarter of 2019.

    Non-GAAP adjusted EBITDA was $6.7 million for the quarter ended September 30, 2020, compared to $6.8 million in the third quarter of 2019.  A table reconciling non-GAAP measures is included in this press release for reference.

    As of September 30, 2020, the company had $85.5 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 third-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 November 5, 2021.  A replay of the call will also be available until 11:00am (EDT) on November 12, 2020 by calling (855) 859-2056, or from outside the U.S. by calling (404) 537-3406.  The conference ID is 5426489.

    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 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, 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 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.  © 2020 Vericel Corporation.  All rights reserved.

    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 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 our expectations regarding future revenues, growth in revenues, market penetration for MACI and Epicel, growth in profit, gross margins and operating margins, the ability to achieve or sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of operations over the course of the year, timing and conduct of clinical trial and product development activities, timing or likelihood of regulatory approvals, the estimate of the commercial growth potential of our products and product candidates, availability of funding from the U.S. Biomedical Research and Development Authority under its agreement with MediWound Ltd. for use in connection with NexoBrid development activities, competitive developments, changes in third party coverage and reimbursement, our ability to supply or meet customer demand for our products, and the wide-ranging impacts of the COVID-19 pandemic on our business or the economy generally.

    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 whether the outbreak will cause state and local governments to impose future restrictions on the performance of elective surgical procedures or the pace with which such restrictions may be lifted should they be imposed, the willingness or ability of patients to seek treatment, the availability of physicians and/or their treatment prioritizations or the impact of the outbreak on the overall healthcare infrastructure.  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 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.  With respect to FDA's review of the pending NexoBrid Biologics License Application, the COVID-19 pandemic may impact the FDA's response times to regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid.  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, Vericel's Quarterly Report on Form 10-Q for the quarter ended September, 30, 2020, filed with the SEC on November 5, 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

    lstern@troutgroup.com

    +1 (646) 378-2922

    VERICEL CORPORATION

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited, amounts in thousands)

      September 30, December 31,
      2020 2019
    ASSETS    
    Current assets:    
    Cash and cash equivalents $43,507  $26,889 
    Short-term investments 42,035  42,829 
    Accounts receivable (net of allowance for doubtful accounts of $187 and $306, respectively) 26,174  32,168 
    Inventory 10,080  6,816 
    Other current assets 3,586  2,953 
    Total current assets 125,382  111,655 
    Property and equipment, net 7,115  7,144 
    Restricted cash 211  89 
    Right-of-use leased assets 24,796  25,103 
    Long-term investments   9,247 
    Total assets $157,504  $153,238 
    LIABILITIES AND SHAREHOLDERS' EQUITY    
    Current liabilities:    
    Accounts payable $6,475  $6,345 
    Accrued expenses 8,695  7,948 
    Current portion of operating lease liabilities 6,102  5,461 
    Other liabilities 41  41 
    Total current liabilities 21,313  19,795 
    Operating lease liabilities 21,487  22,242 
    Other long-term liabilities 74  110 
    Total liabilities $42,874  $42,147 
    COMMITMENTS AND CONTINGENCIES    
    Shareholders' equity:    
    Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 45,315 and 44,864, respectively $502,587  $489,749 
    Other comprehensive gain 78  21 
    Accumulated deficit (388,035) (378,679)
    Total shareholders' equity 114,630  111,091 
    Total liabilities and shareholders' equity $157,504  $153,238 

    VERICEL CORPORATION

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited, amounts in thousands, except per share amounts)

      Three Months Ended September 30, Nine Months Ended September 30,
      2020 2019 2020 2019
    Product sales, net $31,020  $30,499  $77,712  $78,460 
    Other revenue 1,238    1,238   
    Total revenue 32,258  30,499  78,950  78,460 
    Cost of product sales 9,787  9,324  28,369  26,986 
    Gross profit 22,471  21,175  50,581  51,474 
    Research and development 2,913  3,096  9,902  27,174 
    Selling, general and administrative 16,041  14,982  50,596  44,761 
    Total operating expenses 18,954  18,078  60,498  71,935 
    Income (loss) from operations 3,517  3,097  (9,917) (20,461)
    Other income (expense):        
    Interest income 121  385  574  1,293 
    Interest expense (2) (2) (5) (6)
    Other income (expense) (18) (10) (8) 8 
    Total other income 101  373  561  1,295 
    Net income (loss) $3,618  $3,470  $(9,356) $(19,166)
    Net income (loss) per share attributable to common shareholders (Basic) $0.08  $0.08  $(0.21) $(0.44)
    Weighted average number of common shares outstanding (Basic) 45,272  44,251  45,112  43,979 
    Net income (loss) per share attributable to common shareholders (Diluted) $0.08  $0.07  $(0.21) $(0.44)
    Weighted average number of common shares outstanding (Diluted) 47,314  46,667  45,112  43,979 



    RECONCILIATION OF REPORTED NET INCOME (LOSS) (GAAP)

    TO ADJUSTED EBITDA (NON-GAAP MEASURE) – UNAUDITED

      Three Months Ended September 30, Nine Months Ended September 30,
    (In thousands) 2020 2019 2020 2019
    Net income (loss) $3,618  $3,470  $(9,356) $(19,166)
    Non-recurring license agreement purchase       17,500 
    Stock compensation expense 2,675  3,285  10,819  10,095 
    Depreciation and amortization 570  475  1,649  1,174 
    Net interest income (119) (383) (569) (1,287)
    Adjusted EBITDA (Non-GAAP) $6,744  $6,847  $2,543  $8,316 

     

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  28. CAMBRIDGE, Mass., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced presentations at the following upcoming investor conferences.

    • The Credit Suisse 29th Annual Healthcare Conference on Monday, November 9th at 2:45pm EST
    • The Stifel 2020 Virtual Healthcare Conference on Monday, November 16th at 2:40pm EST

    A live webcast of the presentations 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…

    CAMBRIDGE, Mass., Nov. 02, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced presentations at the following upcoming investor conferences.

    • The Credit Suisse 29th Annual Healthcare Conference on Monday, November 9th at 2:45pm EST
    • The Stifel 2020 Virtual Healthcare Conference on Monday, November 16th at 2:40pm EST

    A live webcast of the presentations 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 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.

    Investor Contacts:

    Lee Stern

    Solebury Trout

    lstern@troutgroup.com 

    +1 646-378-2922

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  29. CAMBRIDGE, Mass., Oct. 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 third-quarter 2020 financial results and business highlights.

    What:Vericel Corporation Third-Quarter 2020 Earnings Call
    When:Thursday, November 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., Oct. 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 third-quarter 2020 financial results and business highlights.

    What:Vericel Corporation Third-Quarter 2020 Earnings Call
    When:Thursday, November 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 second-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 November 5, 2021. A replay of the call will also be available until 11:00am (EDT) on November 12, 2020 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406. The conference ID is 5426489.

    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.

    Investor Contact:

    Lee Stern

    Solebury Trout

    lstern@troutgroup.com

    +1 646-378-2922

    Primary Logo

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  30. Double-Digit Revenue, Implant and Biopsy Growth for MACI in the Quarter and Record Monthly Biopsies in September

    Approximately $4.6 Million of Operating Cash Flow for the Quarter

    CAMBRIDGE, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced preliminary financial results for the quarter ended September 30, 2020.

    Preliminary total net revenues for the third quarter are expected to be approximately $32 million, including approximately $24.2 million of MACI® (autologous cultured chondrocytes on porcine collagen membrane) net revenue, approximately $6.7 million of Epicel® (cultured epidermal autografts…

    Double-Digit Revenue, Implant and Biopsy Growth for MACI in the Quarter and Record Monthly Biopsies in September

    Approximately $4.6 Million of Operating Cash Flow for the Quarter

    CAMBRIDGE, Mass., Oct. 14, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced preliminary financial results for the quarter ended September 30, 2020.

    Preliminary total net revenues for the third quarter are expected to be approximately $32 million, including approximately $24.2 million of MACI® (autologous cultured chondrocytes on porcine collagen membrane) net revenue, approximately $6.7 million of Epicel® (cultured epidermal autografts) net revenue, and approximately $1.2 million of revenue related to the procurement of NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain) by the U.S. Biomedical Advanced Research and Development Authority (BARDA) for emergency response preparedness.

    The company generated approximately $4.6 million of operating cash flow in the third quarter. As of September 30, 2020, the company had approximately $85.5 million in cash and investments and no debt, compared to $79.0 million as of December 31, 2019.

    "We are very pleased with our third quarter results as we generated consistent double-digit growth in revenue, implants and biopsies for MACI and achieved a record monthly high for biopsies in September," said Nick Colangelo, President and CEO of Vericel. "Moreover, the robustness of our business model was demonstrated as we generated positive operating cash flow for the quarter. While considerable uncertainties related to COVID-19 remain, given the strength of our patient pipeline, we expect to maintain strong MACI growth in the fourth quarter. We look forward to providing further updates to investors during our upcoming virtual Analyst and Investor Day webcast and our third quarter earnings call."

    As previously announced, the company will host a virtual Analyst and Investor Day on October 16, 2020, at 9:00am Eastern Time. The company also will host a webcast and conference call to discuss its third quarter 2020 financial results and business highlights on November 5, 2020, at 8:30am Eastern Time. Webcast information can be found on the events and presentation section of the Investor Relations website at https://investors.vcel.com/events-presentations.

    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.

    Preliminary and Unaudited Nature of Reported Results

    Our revenue expectations for the third quarter, as well as our estimates concerning operating cash flow and cash and investments are preliminary, unaudited and are subject to adjustment in the course of our ongoing internal control and review procedures.

    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 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 may result in differences are the inherent uncertainties associated with our expectations concerning expected revenue results for the third quarter of 2020 and estimates of operating cash flow and our cash and investments as of September 30, 2020. Vericel's revenue expectations and operating cash flow for the third quarter, as well as its estimates concerning cash and investments are preliminary, unaudited and are subject to adjustment during our ongoing internal review. Additional 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 our expectations regarding future revenues, growth in revenues, market penetration for MACI and Epicel, growth in profit, gross margins and operating margins, the ability to achieve or sustain profitability, contributions to adjusted EBITDA, the expected target surgeon audience, potential fluctuations in sales and volumes and our results of operations over the course of the year, competitive developments, changes in third party coverage and reimbursement, our ability to supply or meet customer demand for our products, and the wide-ranging impacts of the COVID-19 pandemic on our business or the economy generally.

    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 or whether additional such restrictions may be imposed by states in the future, the availability of physicians and/or their treatment prioritizations or the impact of the outbreak on the overall healthcare infrastructure. 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 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. With respect to FDA's review of the pending NexoBrid Biologics License Application, the COVID-19 pandemic may impact the FDA's response time to regulatory submissions, its ability to monitor our clinical trials, and/or conduct necessary reviews or inspections, any or all of which may result in timelines being materially delayed, which could affect the development and ultimate commercialization of NexoBrid. 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, Vericel's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 5, 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

    lstern@troutgroup.com

    +1 (646) 378-2922

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  31. CAMBRIDGE, Mass., Oct. 09, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, will host a virtual Analyst and Investor Day on Friday, October 16, 2020, from 9:00 a.m. - 11:00 a.m. ET. During the event, Vericel executives will provide a general business update as well as current U.S. commercialization plans for NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain). Additionally, burn surgeon thought leaders will discuss current burn debridement practices and how NexoBrid, upon approval by the U.S. Food and Drug Administration (FDA), could change the current treatment paradigm for debridement of severe thermal burns.

    The presentation…

    CAMBRIDGE, Mass., Oct. 09, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, will host a virtual Analyst and Investor Day on Friday, October 16, 2020, from 9:00 a.m. - 11:00 a.m. ET. During the event, Vericel executives will provide a general business update as well as current U.S. commercialization plans for NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain). Additionally, burn surgeon thought leaders will discuss current burn debridement practices and how NexoBrid, upon approval by the U.S. Food and Drug Administration (FDA), could change the current treatment paradigm for debridement of severe thermal burns.

    The presentation will be live webcast at http://investors.vcel.com/events-presentations. For those not available to listen to the live broadcast, a replay will be archived and available at http://investors.vcel.com/events-presentations.

    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. On September 16, 2020, Vericel announced that the FDA has accepted a Biologics License Application (BLA) seeking approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.   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.

    Investor Contacts:

    Lee Stern

    Solebury Trout

    lstern@troutgroup.com

    +1 (646) 378-2922

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  32. CAMBRIDGE, Mass., Sept. 16, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the recently submitted Biologics License Application (BLA) for NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain) for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application. 

    "The FDA's acceptance of the NexoBrid BLA for review represents another important milestone toward our goal of…

    CAMBRIDGE, Mass., Sept. 16, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL) today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing the recently submitted Biologics License Application (BLA) for NexoBrid® (concentrate of proteolytic enzymes enriched in bromelain) for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021. In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application. 

    "The FDA's acceptance of the NexoBrid BLA for review represents another important milestone toward our goal of providing a new standard of care for eschar removal in patients with severe burns," said Nick Colangelo, President and CEO of Vericel. "We look forward, together with MediWound, to working with the FDA during the BLA review process as we seek marketing approval for NexoBrid in the United States."

    Sharon Malka, CEO of MediWound added, "The acceptance of the NexoBrid BLA 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 United States. We thank all of the investigators, their teams, our employees and all our partners, especially BARDA and Vericel, for their commitment to the program."

    Vericel will host a virtual Analyst and Investor Day on Friday, October 16, 2020, from 9:00 a.m. - 11:00 a.m. EST which will focus on NexoBrid. In addition to a general corporate update, Vericel executives will facilitate discussions with burn surgeon thought leaders on current burn debridement practices and how NexoBrid, upon approval, could change the current treatment paradigm for debridement of severe thermal burns.

    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 from MediWound Ltd. for North American rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns. Funding and technical support to MediWound Ltd. for development of NexoBrid is provided by the U.S. Biomedical Advanced Research and Development Authority (BARDA). 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.

    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 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 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, Vericel's Quarterly Report on Form 10-Q for the quarter ended June 30, 2020, filed with the SEC on August 5, 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 Contact:

    Lee Stern

    Solebury Trout

    lstern@troutgroup.com

    +1 (646) 378-2922

    Primary Logo

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  33. YAVNE, Israel, Sept. 16, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "MediWound"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.  In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

    "The FDA's acceptance…

    YAVNE, Israel, Sept. 16, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "MediWound"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its recently submitted Biologics License Application (BLA) for NexoBrid® for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns.  The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of June 29, 2021.  In addition, the FDA communicated that it is not currently planning to hold an advisory committee meeting to discuss the application.

    "The FDA's acceptance of the NexoBrid BLA submission for review 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 United States," said Sharon Malka, CEO of MediWound. "We thank all our partners for their commitment to this important program, and we look forward, together with BARDA and Vericel, to working with the FDA during the regulatory review process as we seek marketing approval for NexoBrid in the United States."

    Nick Colangelo, President and CEO of Vericel, added, "The FDA's acceptance of the NexoBrid BLA for review represents another important milestone toward our goal of providing a new standard of care for eschar removal in patients with severe burns and brings us one step closer to providing NexoBrid as a treatment option for the thousands of patients each year who suffer deep-partial and full-thickness burns that require debridement."

    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/or 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. NexoBrid is currently an investigational product in the United States. 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).

    Vericel, our U.S. commercial partner, will host a virtual Analyst and Investor Day on Friday, October 16, 2020, from 9:00 a.m. - 11:00 a.m. EST which will focus on NexoBrid, which will include discussions with burn surgeon thought leaders on current burn debridement practices and how NexoBrid, upon approval, could change the current treatment paradigm for debridement of severe thermal burns.

    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. On June 29, 2020, a BLA was submitted to the U.S. FDA seeking the approval for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. 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.

    About MediWound

    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 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 the Biomedical Advanced Research and Development Authority (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 and EscharEx. 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; the timing of the NexoBrid delivery to BARDA, 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 ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, 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.

    Contacts:

    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com

                           

    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com
       

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  34. CAMBRIDGE, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced presentations at multiple upcoming investor conferences.

    • The H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15th at 10am EST
    • The 2020 Cantor Global Healthcare Conference on Wednesday, September 16th at 4:00pm EST
    • The Oppenheimer Fall Healthcare Summit on Monday, September 21st at 3:20pm EST

    A live webcast of the presentations 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…

    CAMBRIDGE, Mass., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced presentations at multiple upcoming investor conferences.

    • The H.C. Wainwright 22nd Annual Global Investment Conference on Tuesday, September 15th at 10am EST
    • The 2020 Cantor Global Healthcare Conference on Wednesday, September 16th at 4:00pm EST
    • The Oppenheimer Fall Healthcare Summit on Monday, September 21st at 3:20pm EST

    A live webcast of the presentations 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 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.

    Investor Contacts:

    Lee Stern

    Solebury Trout

    lstern@soleburytrout.com

    +1 646-378-2922

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  35. CAMBRIDGE, Mass., Sept. 04, 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 18th Annual Morgan Stanley Global Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, September 17, 2020 at 2:45 p.m. 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…

    CAMBRIDGE, Mass., Sept. 04, 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 18th Annual Morgan Stanley Global Healthcare Conference. The conference is being conducted in a virtual format and the presentation will take place on Thursday, September 17, 2020 at 2:45 p.m. 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 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.

    Investor Contacts:

    Lee Stern

    Solebury Trout

    lstern@troutgroup.com

    +1 646-378-2922

    Primary Logo

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  36. YAVNE, Israel and CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ:VCEL) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has accepted the first shipment of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds…

    YAVNE, Israel and CAMBRIDGE, Mass., Aug. 25, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ:VCEL) today announced that the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, has accepted the first shipment of NexoBrid® (concentrate of proteolytic enzymes enriched in Bromelain) as part of its mission to build national preparedness for public health emergencies. The initial BARDA procurement of NexoBrid is valued at $16.5 million, which includes additional quarterly deliveries planned through the end of 2021. In addition, BARDA holds an option to procure additional quantities of NexoBrid through funding of up to $50 million. 

    "This first shipment of NexoBrid is another major milestone in our longstanding partnership with BARDA, and we look forward to delivering the full procurement by the end of 2021," said MediWound Chief Executive Officer Sharon Malka. "The acceptance of the first delivery by BARDA during the ongoing COVID-19 pandemic underscores the importance of NexoBrid to U.S. national preparedness for the potential emergency treatment of large numbers of patients with severe thermal burns injuries."

    "The procurement of NexoBrid for our nation's response preparedness is one of many key NexoBrid activities occurring in 2020," said Nick Colangelo, President and Chief Executive Officer of Vericel. "This shipment, combined with the recent BLA submission and growing number of burn centers enrolled in the NexoBrid expanded access treatment protocol, bring us a step closer to ensuring that healthcare providers have both the supply and training needed to enzymatically debride burn patients, whether the need is due to individual accidents or a burn mass casualty event."

    On June 30, 2020, a Biologics License Application (BLA) was submitted 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. While the BLA is being reviewed by the FDA, burn centers across the U.S. are treating burn patients under the NexoBrid expanded access (NEXT) protocol.

    The procurement is a key milestone of the Project BioShield (PBS) contract between MediWound and BARDA which was signed in September 2015 with procurement initiated in January 2020. Under the PBS contract, BARDA provides funds and support for the advancement of the development and manufacturing of NexoBrid, as well as the procurement of NexoBrid as a medical countermeasure for mass casualty emergencies involving thermal burns. In May 2019, Vericel entered into exclusive license and supply agreements with MediWound to commercialize NexoBrid in North America. As part of the license agreement, Vericel and MediWound will equally split gross profits generated by BARDA's initial $16.5 million procurement.

    In October 2019, MediWound initiated the NEXT protocol, which is supported and funded by BARDA and enables the continued clinical use of NexoBrid for U.S. patients during the preparation and review of the NexoBrid BLA. NEXT is an open-label, single-arm treatment protocol which allows for the treatment of up to 150 burn patients with deep partial- and full-thickness thermal burns up to 30 percent of total body surface area. NEXT has been designed to be consistent with current real-life burn treatment practices in the U.S. and up to 30 U.S. burn centers are anticipated to participate. MediWound received FDA concurrence that patients can be treated under the NEXT protocol in a burn mass casualty incident that is not a declared national emergency.  Therefore, this provides a mechanism for U.S. burn centers to treat patients and gain valuable experience using Nexobrid prior to FDA approval as well as making the product readily available for response to mass burn emergencies.

    BARDA submitted a Pre-Emergency Use Authorization (PEUA) to FDA for the intended use of NexoBrid under an Emergency Use Authorization (EUA) during a declared emergency involving burn injuries. The availability of medical countermeasures (MCMs), such as Nexobrid, which mitigate preparedness gaps (like debridement and excision steps of burn care) will add to the United States Government's armamentarium for treatment of mass burn casualties. The EUA is a mechanism by which the FDA can allow an unapproved medical product that qualifies as a mass casualty medical countermeasure to be used in a public health emergency.

    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.  On June 29, 2020, a BLA was submitted to the U.S. FDA seeking the approval for eschar removal (debridement) in adults with deep partial-thickness and/or full-thickness thermal burns. 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.

    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

    Funding and technical support for development of NexoBrid 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 the Biomedical Advanced Research and Development Authority (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

    This document contains forward-looking statements, including statements concerning the anticipated progress, development, objectives, expectations and commercial potential of NexoBrid. This release also includes forward-looking statements concerning the objectives and expectations regarding MediWound Ltd. and Vericel Corporation described herein, all of which involve certain risks and uncertainty. 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. 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: 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; 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; 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. 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, Quarterly Reports on Form 6-K and other filings with the Securities and Exchange Commission ("SEC"), as well as information contained in Vericel's Annual Report on Form 10-K for the year ended December 31, 2019, filed with the 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 Vericel's and MediWound's current views and neither Vericel nor MediWound undertakes 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.

    Vericel Contacts:  
    Lee Stern  
    Solebury Trout  
    lstern@troutgroup.com  
    +1 (646) 378-2922  
       
    MediWound Contacts:  
    Boaz Gur-Lavie Jeremy Feffer
    Chief Financial Officer Managing Director, LifeSci Advisors
    MediWound Ltd. 212-915-2568
    ir@mediwound.com                                                            jeremy@lifesciadvisors.com 

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  37. Submitted Biological License Application to the FDA for NexoBrid 
    EscharEx U.S. Phase 2 Study Resumed Patient Screening

    YAVNE, Israel, Aug. 06, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the second quarter ended June 30, 2020 and provided business and financial updates related to the COVID-19 pandemic. 

    Second Quarter Business and Financial Highlights:

    • Revenues for the second quarter of 2020 were $4.0 million, compared with $20.7 million for the second quarter of 2019, which included the upfront payment of $17.5 million…

    Submitted Biological License Application to the FDA for NexoBrid 

    EscharEx U.S. Phase 2 Study Resumed Patient Screening

    YAVNE, Israel, Aug. 06, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ:MDWD) (the "Company"), a fully-integrated biopharmaceutical company bringing innovative therapies to address unmet needs in severe burn and wound management, today announced financial results for the second quarter ended June 30, 2020 and provided business and financial updates related to the COVID-19 pandemic. 

    Second Quarter Business and Financial Highlights:

    • Revenues for the second quarter of 2020 were $4.0 million, compared with $20.7 million for the second quarter of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement

       
    • The Company had $24.4 million in cash and short-term investments as of June 30, 2020, compared with $29.5 million as of December 31, 2019

       
    • Resumed patient screening and randomization in U.S. EscharEx® phase 2 adaptive design study for the treatment of venous leg ulcers ("VLU's"); Interim assessment is anticipated in the first half of 2021

       
    • Submitted Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for NexoBrid® for the treatment of severe thermal burns in adults

       
    • Instituted a series of measures to address challenges associated with the COVID-19 pandemic, while maintaining workforce and operational capacity and flexibility

    "We are pleased to have submitted the BLA for NexoBrid on schedule despite the disruptions of the COVID-19 pandemic. This submission is a major milestone in our long-term partnership with BARDA, and we are actively preparing for the commercial launch with our partner, Vericel, upon approval," said Sharon Malka, Chief Executive Officer of MediWound. "In addition, we are actively recruiting and enrolling patients in our U.S. EscharEx phase 2 study, and we are encouraged to see progress in moving this trial forward."

    Mr. Malka concluded, "In recent months, humanity is facing tremendous challenges with a great deal of uncertainty. We are privileged to be among those tasked with improving patients' quality of care and impacting their lives. Our solid balance sheet continues to support our growth as we execute on our strategic plans, and we are optimistic that we will continue to successfully strengthen our Company."

    Corporate Update

    MediWound has implemented several measures to safeguard the health and well-being of its employees, their families, and healthcare providers. The Company has reduced expenses to minimize impact to operations while ensuring full compliance with all necessary regulations. Management continues to assess the impact of the pandemic, the potential implications to business continuity, and necessary remedies and will adjust accordingly to the challenges created by any directives from regulatory authorities.

    The Company continues to manufacture and supply NexoBrid to patients with severe burn injuries, including manufacturing NexoBrid and building an emergency stockpile for the U.S. Biomedical Advanced Research and Development Authority (BARDA), while the first delivery to BARDA is planned in the third quarter of 2020. The Company maintains a significant safety stock of all key raw materials and NexoBrid inventory to meet expected demand over the next several quarters. At this time, the Company does not expect any disruptions to its manufacturing operations and global supply chain.



    The Company submitted a BLA to the U.S. FDA seeking the approval of NexoBrid for eschar removal (debridement) in adults with deep partial-thickness and full-thickness thermal burns. The BLA submission is based on multiple preclinical and clinical studies including the pivotal Phase 3 U.S. clinical study (DETECT) of NexoBrid in adult patients with severe thermal burns. Vericel Corporation (NASDAQ:VCEL) holds an exclusive license for North American commercial rights of NexoBrid. MediWound is eligible to receive a $7.5 million milestone payment from Vericel upon BLA approval.



    On the clinical front, the Company has resumed new patients' screening and randomization in its U.S. EscharEx phase 2 adaptive design study for the treatment of VLU's and expects to achieve the pre-defined interim assessment in the first half of 2021. In addition, enrollment in the NexoBrid expanded access (NEXT) program continues with enhanced safety measures, such as remote visits and virtual tools.

    The Company had $24.4 million in cash and short-term investments as of June 30, 2020, compared with $29.5 million as of December 31, 2019, with no debt. The Company reiterates its expectations of cash use for operating activities in 2020 to be in the range of $8 to $10 million.  At this time, the Company cannot predict the extent or duration of the impact of the COVID-19 outbreak on its ongoing financial and operational results.

    Second Quarter Financial Results

    Revenues for the second quarter of 2020 were $4.0 million, compared with $20.7 million for the second quarter of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement. Revenues from product in the second quarter of 2020 were $1.1 million, reflecting an increase of 17% in comparison to the second quarter of 2019, excluding the one-time upfront payment.

    Gross profit for the second quarter of 2020 was $1.2 million, compared to a gross profit of $17.5 million for the second quarter of 2019, which included $16.8 million from the Vericel licensing agreement. 

    Research and development expenses for the second quarter of 2020, net of participations, were $1.6 million, compared with $0.4 million for the second quarter of 2019. The increase was primarily due to decrease of participation by BARDA and Israeli Innovation Authority (IIA).  

    Selling, general and administrative expenses for the second quarter of 2020 were $2.3 million, in line with the second quarter of 2019.

    Operating loss for the second quarter of 2020 was $2.7 million, compared with an operating profit of $13.9 million in the second quarter of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement, net of royalty payment of $0.7 million and $0.8 million of other expenses. 

    The Company posted a net loss of $3.1 million, or $0.11 per share, for the second quarter of 2020 compared with a net profit of $12.7 million, or $0.47 per share, for the second quarter of 2019, which included the $17.5 million upfront license payment, net of royalty payment of $0.7 million and $0.8 million of other expenses. Excluding the upfront license payment net of deal related costs, net loss for the second quarter of 2019 was $3.3 million, or $0.12 per share.

    Adjusted EBITDA, as defined below, for the second quarter of 2020 was a loss of $2.1 million, compared with a profit of $15.4 million for the second quarter of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement, net of royalty payment of $0.7 million.                                                  

    Year-to-Date 2020 Financial Results

    Revenues for the first half of 2020 were $8.5 million compared with $21.2 million in the first half of 2019, which included the $17.5 million upfront payment from the Vericel licensing agreement for NexoBrid.

    The Company's net loss for the first half of 2020 was $5.6 million or  $0.20 per share compared with net profit of $8.6 million or  $0.32 per share for the first half of 2019, which included the $17.5 million upfront license payment, net of royalty payment of $0.7 million and $0.9 million of other expenses. Excluding the upfront license payment net of deal related costs, net loss for the first half of 2019 was $7.3 million, or $0.27 per share.

    Adjusted EBITDA, for the first half of 2020, was a loss of $3.9 million, compared with a profit of $12.4 million for the first half of 2019, which included the upfront payment of $17.5 million from the Vericel licensing agreement, net of royalty payment of $0.7 million. 

    Conference Call

    MediWound management will host a conference call for investors today, Thursday, August 6, 2020 beginning at 8:30 a.m. Eastern Time to discuss these results and answer questions.  Shareholders and other interested parties may participate in the conference call by dialing 877-602-7189 (in the U.S.)  1809 315 362 (Israel), or 678-894-3057 (outside the U.S. & Israel) and entering passcode 3176168. The call also will be webcast live on the Company's website at http://ir.mediwound.com/events-and-presentations.

    A replay of the call will be accessible two hours after its completion through August 27, 2020 by dialing 855-859-2056 (in the U.S.) or 404-537-3406 (outside the U.S.) and entering passcode 3176168. The call will also be archived on the Company website for 90 days at www.mediwound.com.

    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 and EscharEx. 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; the timing of the NexoBrid delivery to BARDA, 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 ability to successfully develop and commercialize EscharEx, the design of the Phase 2 study, the timing of the interim assessment, 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. 

    Contacts: Investors:
    Boaz Gur-Lavie

    Chief Financial Officer

    MediWound Ltd.

    ir@mediwound.com 
    Jeremy Feffer

    Managing Director, LifeSci Advisors

    212-915-2568

    jeremy@lifesciadvisors.com 



    MediWound, Ltd.
     
    CONDENSED CONSOLIDATED BALANCE SHEETS

    U.S. dollars in thousands
     
      June 30, December 31,
      2020 2019 2019
           
      Un-audited Audited
    Cash, cash equivalents and short term deposits 24,382 38,712 29,458
    Accounts and other receivable 3,492 4,668 4,557
    Inventories 1,934 1,535 1,613
    Total current assets 29,808 44,915 35,628
           
    Property, plant and equipment, net 2,326 2,183 2,304
    Right of use assets, net 2,086 2,315 2,229
    Intangible assets, net 396 462 429
    Total long-term assets 4,808 4,960 4,962
           
    Total assets 34,616 49,875 40,590
           
    Current maturities of long-term liabilities 1,321 896 569
    Trade payables and accrued expenses 2,423 4,073 4,067
    Other payables 6,040 5,889 5,737
    Total current liabilities 9,784 10,858 10,373
           
    Deferred revenues 1,174 1,144 1,135
    Liability in respect of Israeli Innovation Authority grants net of current maturity 7,130 6,919 6,811
    Contingent consideration for the purchase of shares net of current maturity 4,249 4,412 4,853
    Liability in respect of discontinued operation - 6,003 -
    Lease liabilities, net of current maturity 1,866 2,022 2,006
    Severance pay liabilities, net 281 338 243
    Total long-term liabilities 14,700 20,838 15,048
           
    Shareholders' equity 10,132 18,179 15,169
    Total liabilities & shareholder equity 34,616 49,875 40,590



    MediWound, Ltd.
     
    CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE PROFIT (LOSS) (ANAUDITED)

    U.S. dollars in thousands
     
     Six months ended Three months ended
     June 30, June 30,
     2020 2019 2020 2019
            
    Revenues8,465 21,207 4,027 20,746
    Cost of revenues6,018 3,788 2,809 3,481
    Gross profit 2,447 17,419 1,217 17,265
            
    Operating expenses:       
    Research and development, gross3,312 6,075 1,593 1,893
    Participation by BARDA & IIA19 -4,624 19 -1,721
    Research and development, net3,331 1,451 1,612 172
    Selling, general & administrative4,028 4,708 2,311 2,343
    Other expenses- 901 - 812
    Operating profit (loss)(4,912) 10,359 (2,706) 13,938
    Financial expenses, net(645) (1,803) (390) (1,222)
    Profit (loss) from continuing operations(5,557) 8,556 (3,096) 12,716
    Profit from discontinued operation- 50 0 0
    Profit (loss) for the period(5,557) 8,606 (3,096) 12,716
    Foreign currency translation adjustments1 2 0 (2)
    Total comprehensive profit (loss)(5,556) 8,608 (3,096) 12,714
            
    Net Profit (loss) per share(0.20) 0.32 (0.11) 0.47
    Weighted average number of ordinary shares used in the computation

    of basic and diluted profit (loss) per share:
    27,207 27,179 27,211 27,179
            



    MediWound, Ltd.
     
    ADJUSTED EBITDA 

    U.S. dollars in thousands
        
     Six months ended Three months ended
     June 30, June 30,
     2020 2019 2020 2019
    Profit (loss) for the period(5,557) 8,606 (3,096) 12,716
            
    Adjustments:       
    Financial expenses, net(645) (1,803) (390) (1,222)
    Profit from discontinued operation- 50 - -
    Other expenses- (901) - (812)
    Depreciation and amortization(539) (552) (271) (278)
    Share-based compensation expenses(519) (599) (346) (324)
    Total adjustments(1,703) (3,805) (1,007) (2,636)
    Adjusted EBITDA (3,854) 12,411 (2,089) 15,352
            



    MediWound, Ltd.
     
    CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW

    (UNAUDITED)

    U.S. dollars in thousands
        
     Six months ended

    June 30, 
     Three months ended

    June 30,
     2020 2019 2020 2019
    Cash Flows from Operating Activities:     
    Net profit (loss)(5,557) 8,606 (3,096) 12,716
          
    Adjustments to reconcile net profit (loss) to net cash used in continuing operating activities:     
    Adjustments to profit and loss items:     
    Profit from discontinued operation- (50) - -
    Depreciation and amortization539 552 271 278
    Share-based compensation519 599 346 324
    Revaluation of liabilities in respect of IIA grants424 (392) 226 (466)
    Revaluation of contingent consideration for the purchase of shares348 1,322 196 1,081
    Revaluation of lease liabilities64 194 100 91
    Increase (decrease) in severance liability, net40 (10) 19 13
    Financing income(191) (149) (81) (87)
    Unrealized foreign currency (gain) loss28 (70) (51) 60
     1,771 1,996 1,026 1,294
    Changes in asset and liability items:     
    Decrease (increase) in trade receivables1,341 (9) 444 (318)
    Decrease (increase) in inventories(326) 146 65 (62)
    Decrease (increase) in other receivables(284) 2,744 (383) 2,482
    Increase (decrease) in trade payables(1,649) 1,357 (1,004) 1,076
    Increase in other payables & deferred revenues86 529 133 77
     (832) 4,767 (745) 3,255
    Net cash provided by (used in) continuing operating activities(4,618) 15,369 (2,815) 17,265
    Net cash provided by discontinued operating activities- 50  -
    Net cash provided by (used in)  operating activities(4,618) 15,419 (2,815) 17,265
          



    MediWound, Ltd.
     
    CONDENSED CONSOLIDATED STATEMENT OF CASH FLOW

    (UNAUDITED)-Cont.

    U.S. dollars in thousands
        
     Six months ended

    June 30, 

     Three months ended

    June 30, 


     2020 2019 2020 2019
             
    Cash Flows from Investment Activities:       
    Purchase of property and equipment(244) (433) (100) (194)
    Interest received42 44 39 14
    Proceeds from short term bank  deposits, net of investments10,595 2,977 7,603 412
    Net cash provided by investing activities10,393 2,588 7,542 232
     



    Cash Flows from Financing Activities:
           
    Repayment of lease liabilities(313) (312) (153) (157)
    Proceeds from IIA grants, net of repayments(66) 193 - 248
    Net cash (used in) provided by financing activities(379) (119) (153) 91
            
    Exchange rate differences on cash and cash equivalent balances(26) 63 57 (55)
            
    Increase in cash and cash equivalents from continuing activities5,370 17,901 4,631 17,533
    Increase in cash and cash equivalents from discontinued activities- 50 - -
    Balance of cash and cash equivalents at the beginning of the period7,242 6,716 7,981 7,134
    Balance of cash and cash equivalents at the end of the period12,612 24,667 12,612 24,667

     

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  38. Product Revenues of $20.0 Million Reported for the Second Quarter

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., Aug. 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 second quarter ended June 30, 2020.

    Second Quarter 2020 Financial Highlights

    • Total net product revenues of $20.0 million, compared to $26.2 million in the second quarter of 2019;
    • MACI® net revenue of $15.1 million and Epicel® net revenue of $4.9 million;
    • Gross margin of 57%, compared to gross margin of 66% in the second quarter of 2019;
    • Net loss of $8.3 million, or $0.18 per share, compared to $19.8…

    Product Revenues of $20.0 Million Reported for the Second Quarter

    Conference Call Today at 8:30am Eastern Time

    CAMBRIDGE, Mass., Aug. 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 second quarter ended June 30, 2020.



    Second Quarter 2020 Financial Highlights

    • Total net product revenues of $20.0 million, compared to $26.2 million in the second quarter of 2019;
    • MACI® net revenue of $15.1 million and Epicel® net revenue of $4.9 million;
    • Gross margin of 57%, compared to gross margin of 66% in the second quarter of 2019;
    • Net loss of $8.3 million, or $0.18 per share, compared to $19.8 million, or $0.45 per share, in the second quarter of 2019, which included the $17.5 million upfront license payment to MediWound Ltd. for North American rights to NexoBrid®;
    • Non-GAAP adjusted EBITDA loss of $3.5 million, compared to positive adjusted EBITDA of $1.8 million in the second quarter of 2019; and
    • As of June 30, 2020, the company had $80.9 million in cash and investments, compared to $79.0 million as of December 31, 2019, and no debt.

    Business Highlights and Updates

    • Total net product revenues, which decreased approximately 23% for the quarter, declined approximately 78% in April and 32% in May compared to the same periods in 2019, and increased approximately 29% in June compared to June 2019; 
    • MACI implants, which declined approximately 84% in April and 37% in May compared to the same periods in 2019, increased approximately 21% in June compared June 2019;
    • MACI biopsies declined approximately 79% in April and 22% in May compared to the same periods in 2019, and increased approximately 23% in June compared June 2019;
    • Epicel graft volume, which declined 70% in April, increased approximately 20% in the May through June period compared to the same period in 2019;
    • Epicel biopsies increased approximately 6% in the second quarter compared to the second quarter of 2019; and
    • The company announced the submission of a Biologics License Application to the FDA for NexoBrid for the treatment of severe thermal burns.

    "In light of the ongoing pandemic, we are very pleased with our second quarter results as we saw a strong recovery as the quarter progressed and COVID-19 restrictions on elective surgeries were lifted across the country," said Nick Colangelo, President and CEO of Vericel.  "Looking ahead, while uncertainties remain, we are confident in the fundamental prospects of our business and for the third quarter we expect MACI revenue growth over the third quarter of 2019, Epicel revenue to increase sequentially over the second quarter of 2020 and return to recent historical levels, and to recognize revenue in connection with the first delivery of NexoBrid under the BARDA procurement contract, which is scheduled to take place later this quarter."



    Second Quarter 2020 Results

    Total net product revenues for the quarter ended June 30, 2020 decreased 23% to $20.0 million, compared to $26.2 million in the second quarter of 2019.  Total net product revenues for the quarter included $15.1 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $4.9 million of Epicel (cultured epidermal autografts) net revenue, compared to $20.8 million of MACI net revenue and $5.3 million of Epicel net revenue, respectively, in the second quarter of 2019.



    Gross profit for the quarter ended June 30, 2020 was $11.4 million, or 57% of net revenues, compared to $17.1 million, or 66% of net revenues, for the second quarter of 2019.



    Total operating expenses for the quarter ended June 30, 2020 were $19.7 million, compared to $37.3 million for the same period in 2019, which included the $17.5 million upfront license payment to MediWound Ltd. for North American rights to NexoBrid.  Excluding the $17.5 million license payment, operating expenses remained essentially flat as reductions to discretionary spend and variable cost reductions offset the cost increases associated with the expanded MACI sales force.



    Vericel's net loss for the quarter ended June 30, 2020 was $8.3 million, or $0.18 per share, compared to $19.8 million, or $0.45 per share, for the second quarter of 2019, which included the $17.5 million license payment for NexoBrid.



    Non-GAAP adjusted EBITDA loss was $3.5 million for the quarter ended June 30, 2020, compared to positive adjusted EBITDA of $1.8 million in the second quarter of 2019.  A table reconciling non-GAAP measures is included in this press release for reference.



    As of June 30, 2020, the company had $80.9 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 second-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 August 4, 2021.  A replay of the call will also be available until 11:00am (EDT) on August 12, 2020 by calling (855) 859-2056, or from outside the U.S. by calling (404) 537-3406.  The conference ID is 5851304.

    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 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, 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 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. © 2020 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 approvals, market demand for our products, changes in third party coverage and reimbursement, 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 or whether additional such restrictions may be imposed by states in the future, the availability of physicians and/or their treatment prioritizations or the impact of the outbreak on the overall healthcare infrastructure. 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, Vericel's Quarterly Report on Form 10-Q for the quarter ended June, 30, 2020, filed with the SEC on August 5, 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

    lstern@troutgroup.com

    +1 (646) 378-2922



    VERICEL CORPORATION

    CONDENSED CONSOLIDATED BALANCE SHEETS

    (Unaudited, amounts in thousands)




      June 30, December 31,
      2020 2019
    ASSETS    
    Current assets:    
    Cash and cash equivalents $55,704   $26,889  
    Short term investments 25,086   42,829  
    Accounts receivable (net of allowance for doubtful accounts of $207 and $306, respectively) 23,655   32,168  
    Inventory 8,417   6,816  
    Other current assets 2,900   2,953  
    Total current assets 115,762   111,655  
    Property and equipment, net 7,040   7,144  
    Restricted cash 89   89  
    Right-of-use leased assets 23,800   25,103  
    Long term investments    9,247  
    Total assets $146,691   $153,238  
    LIABILITIES AND SHAREHOLDERS' EQUITY    
    Current liabilities:    
    Accounts payable $4,535   $6,345  
    Accrued expenses 7,975   7,948  
    Current portion of operating lease liabilities 5,570   5,461  
    Other liabilities 41   41  
    Total current liabilities 18,121   19,795  
    Operating lease liabilities 20,881   22,242  
    Other long-term liabilities 93   110  
    Total liabilities $39,095   $42,147  
    COMMITMENTS AND CONTINGENCIES    
    Shareholders' equity:    
    Common stock, no par value; shares authorized — 75,000; shares issued and outstanding — 45,194 and 44,864, respectively $499,103   $489,749  
    Other comprehensive gain 146   21  
    Accumulated deficit (391,653)  (378,679) 
    Total shareholders' equity 107,596   111,091  
    Total liabilities and shareholders' equity $146,691   $153,238  
               





    VERICEL CORPORATION

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited, amounts in thousands, except per share amounts)



      Three Months Ended June 30, Six Months Ended June 30,
      2020 2019 2020 2019
    Product sales, net $20,014   $26,151   $46,692   $47,961  
    Cost of product sales 8,660   9,022   18,582   17,662  
    Gross profit 11,354   17,129   28,110   30,299  
    Research and development 3,226   21,070   6,989   24,078  
    Selling, general and administrative 16,486   16,259   34,555   29,779  
    Total operating expenses 19,712   37,329   41,544   53,857  
    Loss from operations (8,358)  (20,200)  (13,434)  (23,558) 
    Other income (expense):        
    Interest income 147   428   453   908  
    Interest expense (1)  (2)  (3)  (4) 
    Other income (expense) (57)  (18)  10   18  
    Total other income (expense) 89   408   460   922  
    Net loss $(8,269)  $(19,792)  $(12,974)  $(22,636) 
    Net loss per share attributable to common shareholders (Basic and Diluted) $(0.18)  $(0.45)  $(0.29)  $(0.52) 
    Weighted average number of common shares outstanding (Basic and Diluted) 45,137   43,956   45,031   43,841  
                     





    RECONCILIATION OF REPORTED NET LOSS (GAAP)
    TO ADJUSTED EBITDA (NON-GAAP MEASURE) – UNAUDITED 
     
             
      Three Months Ended June 30, Six Months Ended June 30,
    (In thousands) 2020 2019 2020 2019 
    Net loss $(8,269)  $(19,792)  $(12,974)  $(22,636)
    Non-recurring license agreement purchase    17,500      17,500 
    Stock compensation expense 4,376   4,182   8,144   6,810 
    Depreciation and amortization 546   376   1,079   700 
    Net interest income (146)  (426)  (450)  (904)
    Adjusted EBITDA (Non-GAAP) $(3,493)  $1,840   $(4,201)  $1,470 
                        

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  39. CAMBRIDGE, Mass., July 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 second-quarter 2020 financial results and business highlights.

       
    What: Vericel Corporation Second-Quarter 2020 Earnings Call 
    When: Wednesday, August 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., July 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 second-quarter 2020 financial results and business highlights.

       
    What: Vericel Corporation Second-Quarter 2020 Earnings Call 
    When: Wednesday, August 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 second-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 August 5, 2021.  A replay of the call will also be available until 11:00am (EDT) on August 12, 2020 by calling (855) 859-2056, or from outside the U.S. (404) 537-3406.  The conference ID is 5851304.

    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.

    Investor Contact:

    Lee Stern

    Solebury Trout

    lstern@troutgroup.com

    +1 646-378-2922

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  40. CAMBRIDGE, Mass., July 09, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced preliminary financial results for the quarter ended June 30, 2020, and provided business updates.

    Preliminary Second Quarter Financial Results

    • Preliminary total net product revenues for the second quarter are expected to be approximately $20 million, including approximately $15 million of MACI® (autologous cultured chondrocytes on porcine collagen membrane) net revenue and approximately $5 million of Epicel® (cultured epidermal autografts) net revenue;
    • Total net product revenues for the second quarter decreased approximately 23% compared to the second quarter…

    CAMBRIDGE, Mass., July 09, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced preliminary financial results for the quarter ended June 30, 2020, and provided business updates.

    Preliminary Second Quarter Financial Results

    • Preliminary total net product revenues for the second quarter are expected to be approximately $20 million, including approximately $15 million of MACI® (autologous cultured chondrocytes on porcine collagen membrane) net revenue and approximately $5 million of Epicel® (cultured epidermal autografts) net revenue;
    • Total net product revenues for the second quarter decreased approximately 23% compared to the second quarter of 2019, with MACI net revenue decreasing approximately 27% and Epicel net revenue decreasing approximately 8% compared to the second quarter of 2019;
    • Total net product revenues, which declined approximately 78% in April and 32% in May compared to the same periods in 2019, increased approximately 30% in June compared to June 2019; 
    • Total net product revenues for the first half of 2020 decreased approximately 2% compared to the first half of 2019, with MACI net revenue decreasing approximately 5% and Epicel net revenue increasing approximately 7% compared to the first half of 2019; and
    • As of June 30, 2020, the company had approximately $81 million in cash and investments and no debt.

    Second Quarter Business Updates

    • MACI implants, which declined approximately 84% in April and 37% in May compared to the same periods in 2019, increased approximately 21% in June compared June 2019;
    • MACI biopsies declined approximately 79% in April and 22% in May compared to the same periods in 2019, and increased approximately 23% in June compared June 2019;   
    • Approximately 70% of scheduled MACI cases that were cancelled in the first half of 2020 due to the COVID-19 pandemic have been rescheduled, with over 50% of the cancelled cases completed by the end of the second quarter;
    • Epicel graft volume, which declined 70% in April, increased approximately 20% in the May through June period compared to the same period in 2019; and
    • Epicel biopsies increased by approximately 6% in the second quarter compared to the second quarter of 2019.

    "We saw a very strong recovery for MACI during the second quarter as restrictions on elective surgeries were lifted across the country," said Nick Colangelo, President and CEO of Vericel.  "While considerable uncertainties related to COVID-19 remain, absent a significant resurgence in restrictions related to COVID-19 we expect growth for MACI in the third quarter, albeit at a more moderate rate compared to pre-COVID-19 levels given the decline in MACI biopsies in April and May.  We will continue to monitor the evolving landscape and we look forward to updating investors on our second quarter earnings call."

    The company will host a webcast and conference call to discuss its second quarter 2020 financial results and business highlights on August 5, 2020 at 8:30am Eastern Time.

    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.

    Preliminary and Unaudited Nature of Reported Results

    Our revenue expectations for the second quarter, as well as our estimates concerning cash and investments are preliminary, unaudited and are subject to adjustment in the course of our ongoing internal control and review procedures.

    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 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 may result in differences are the inherent uncertainties associated with our expectations concerning expected revenue results for the second quarter of 2020 and estimates of our cash and investments as of June 30, 2020.  Vericel's revenue expectations for the second quarter, as well as its estimates concerning cash and investments are preliminary, unaudited and are subject to adjustment in the course of our ongoing internal review.  Our internal control procedures over financial reporting have not yet been completed and, therefore, the change in revenue and cash and investments as described herein have not been evaluated under our internal control framework.  Additional 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, potential fluctuations in sales and volumes and our results of operations over the course of the year, competitive developments, market demand for our products, changes in third party coverage and reimbursement, 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 or whether additional such restrictions may be imposed by states in the future, the availability of physicians and/or their treatment prioritizations or the impact of the outbreak on the overall healthcare infrastructure.  In addition, some 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, 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, Vericel's Quarterly Report on Form 10-Q for the quarter ended March 31, 2020, filed with the SEC on May 11, 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

    lstern@troutgroup.com

    +1 (646) 378-2922

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  41. 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
    ir@mediwound.com jeremy@lifesciadvisors.com 

     

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  42. 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

    lstern@troutgroup.com

    +1 (646) 378-2922

    Primary Logo

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  43. 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
    lstern@troutgroup.com
    +1 646-378-2922

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  44. 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 spo