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Commercial launch of Nexobrid was expected for Q1 2021. Do you know if that date remains the same. Thank you.
MDWD is running, get on board
And look at it run!!!
Down of course.
Obviously we need another round of insider selling so it magically and oh so briefly jumps over 15 for a nanosecond so they get theirs... then just as quickly back down for all us peons.
What a piece of crap this stock has become
Vericel Announces Submission of Biologics License Application to the FDA for NexoBrid for the Treatment of Severe Thermal Bur...
June 30 2020 - 07:00AM
GlobeNewswire Inc.
Print
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.”
13G - 3,751,168 BROWN CAPITAL MANAGEMEN
PERCENT OF CLASS REPRESENTED BY AMOUNT IN ROW
8.34%
Eddie C. Brown
https://en.wikipedia.org/wiki/Eddie_C._Brown
Looks like a new position.
Needham analyst Chad Messer assigned a Hold rating to Vericel (VCEL) today.
He hasn't budged
Ryan Zimmerman from BTIG reiterated a Buy rating on Vericel (VCEL), with a price target of $21.00.
Vericel Reports First Quarter 2020 Financial Results
8:00 am ET May 5, 2020 (Globe Newswire) Print
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
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.
Institutional ownership 86%
https://fintel.io/so/us/vcel
Blocks >=10K
04/30/20 16:00:00 14.50 14.49 14.53 40,400
04/30/20 15:44:44 14.61 14.58 14.61 30,000
04/30/20 14:53:48 14.45 14.43 14.46 26,200
04/30/20 13:55:23 14.40 14.38 14.43 20,000
04/30/20 13:28:57 14.49 14.51 14.54 11,600
04/30/20 12:57:09 14.53 14.52 14.54 11,400
04/30/20 10:44:31 14.21 14.22 14.25 10,000
04/29/20 16:00:00 14.56 14.52 14.56 39,000
04/29/20 13:42:50 14.62 14.62 14.67 10,000
04/28/20 16:00:00 14.48 14.47 14.48 31,200
04/28/20 13:24:42 14.81 14.80 14.81 12,500
04/28/20 13:24:42 14.81 14.80 14.81 23,100
04/27/20 16:00:00 13.93 13.94 13.97 58,300
04/27/20 13:59:06 13.955 13.94 13.97 15,400
04/27/20 13:51:51 13.92 13.91 13.93 48,900
04/27/20 13:48:40 13.945 13.92 13.97 40,200
04/27/20 11:50:31 14.00 13.99 14.02 13,500
04/27/20 10:32:07 13.895 13.88 13.91 25,000
04/27/20 10:30:36 13.935 13.93 13.94 48,200
04/27/20 10:22:46 13.97 13.96 13.98 20,100
04/27/20 09:52:45 14.055 14.04 14.07 40,000
04/27/20 09:48:44 13.96 13.94 13.98 24,700
04/27/20 09:44:40 13.76 13.73 13.79 25,000
04/27/20 09:40:04 13.92 13.89 13.95 49,900
04/27/20 09:37:44 13.83 13.80 13.86 20,000
04/24/20 16:00:00 13.50 13.49 13.50 33,700
04/24/20 13:12:33 13.345 13.33 13.36 25,000
04/24/20 12:53:10 13.25 13.23 13.27 50,000
04/24/20 12:53:04 13.25 13.23 13.27 25,000
04/24/20 12:11:58 13.25 13.27 13.30 25,000
04/24/20 11:27:32 13.255 13.23 13.28 75,000
04/24/20 11:26:23 13.255 13.23 13.28 19,900
04/24/20 11:26:23 13.255 13.23 13.28 10,100
04/24/20 11:26:23 13.255 13.23 13.28 24,800
04/24/20 11:26:23 13.255 13.23 13.28 25,000
04/24/20 11:26:23 13.255 13.23 13.28 15,000
04/23/20 16:00:00 13.18 13.14 13.18 30,700
04/23/20 11:53:24 13.20 13.22 13.25 24,600
04/23/20 11:30:33 13.18 13.18 13.21 15,000
04/23/20 11:28:22 13.18 13.18 13.21 21,800
04/23/20 09:58:30 13.10 13.10 13.16 36,200
04/22/20 16:00:00 12.75 12.71 12.76 161,000
04/22/20 15:41:57 12.80 12.79 12.81 92,800
04/22/20 09:30:01 13.12 12.60 13.49 11,000
04/21/20 16:00:00 12.50 12.47 12.51 114,700
04/21/20 11:50:19 12.815 12.81 12.82 10,000
04/20/20 16:00:00 12.75 12.74 12.76 30,900
04/20/20 13:33:37 12.93 12.92 12.93 13,500
04/20/20 13:28:54 12.925 12.92 12.93 36,500
04/20/20 12:39:52 13.00 12.99 13.01 25,000
04/20/20 10:47:00 13.04 13.03 13.05 10,000
04/17/20 16:00:06 12.69 9.00 13.19 122,700
04/17/20 16:00:00 12.69 12.68 12.69 183,700
04/17/20 13:49:22 12.24 12.24 12.25 10,800
04/17/20 13:21:12 12.00 12.01 12.02 16,000
04/17/20 09:30:00 11.82 9.37 12.30 27,000
04/16/20 16:00:00 11.02 11.03 11.04 34,300
04/14/20 17:33:01 11.43 10.25 13.06 173,000
04/13/20 16:54:13 10.53 10.07 12.50 28,300
interview on TDA
https://tdameritradenetwork.com/video/rB4AoXFnHp6BcX8ErXoH4Q
Press Release: Vericel Provides Business and Financial Updates
9:00 am ET April 2, 2020 (Dow Jones) Print
Vericel Provides Business and Financial Updates
First Quarter Preliminary Unaudited Product Revenues Increased Approximately 21% Over First Quarter 2019
Full Year 2020 Financial Guidance Withdrawn Due to Uncertainty Regarding Impact of COVID-19
CAMBRIDGE, Mass., April 02, 2020 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, today announced preliminary unaudited product revenue growth for the quarter ended March 31, 2020, and provided business and financial updates related to the COVID-19 pandemic.
Over the past several weeks, Vericel has implemented several measures to safeguard the health and well-being of its employees, their families, and healthcare providers, while continuing to supply its autologous cell therapy products MACI(R) (autologous cultured chondrocytes on porcine collagen membrane) and Epicel(R) (cultured epidermal autografts) to patients with knee cartilage and severe burn injuries. At this time, all Vericel employees not directly involved in the production and delivery of MACI or Epicel are working from home. For production-related teams, the Company has implemented additional measures to protect the health and safety of its workforce. Vericel representatives will also continue to provide field-based support for surgical cases, as needed, in compliance with applicable government mandated business activity restrictions and facility access rules.
"First and foremost, our thoughts are with those affected by the virus and we are especially thankful to all healthcare workers for their critical efforts to support patients during this challenging time," said Nick Colangelo, President and Chief Executive Officer of Vericel. "While our MACI business has been impacted by the restrictions on elective surgical procedures, the fundamentals of our business remain strong. Prior to cancellations that occurred in the last two weeks of the quarter, MACI was on track to exceed revenue growth guidance and we believe that most patients will reschedule cases to the extent possible following this crisis. In addition, we believe that Epicel may be less directly impacted by the pandemic given the critical nature of severe burn injuries. We are implementing a number of initiatives to maintain our near-term and future growth opportunities while supporting patients and reducing non-essential discretionary spending. Given the strength of our financial position and the underlying fundamentals of our business, we believe that the Company is well-positioned to maintain its leadership position in the sports medicine and severe burn care markets."
Preliminary Unaudited First Quarter Results and 2020 Financial Guidance
Preliminary unaudited total revenues for the quarter ended March 31, 2020 increased approximately 21% compared to the first quarter of 2019, with MACI revenue increasing approximately 21% and Epicel revenue increasing approximately 22%. As a result of various national, state and local restrictions on elective surgical procedures related to the COVID-19 pandemic, beginning in the middle of March there was a significant increase in cancellations of scheduled MACI procedures as well as a slowdown in new MACI orders. The number of MACI procedures scheduled to occur in the first quarter that were cancelled between March 15, 2020 and the end of the quarter reduced the volume of MACI implants for the quarter by approximately 9%.
Due to the significant uncertainty regarding the duration and impact of restrictions on elective procedures related to the COVID-19 pandemic, and the fact that the U.S. Biomedical Advanced Research and Development Authority (BARDA) may adjust the emergency stockpile delivery plan for NexoBrid(R) due to shifting priorities related to the pandemic, the Company is withdrawing its previously announced 2020 financial guidance, which was issued on February 25, 2020. At this time, the Company cannot predict the extent or duration of the impact of the COVID-19 outbreak on its financial and operating results. The Company plans to provide additional information, to the extent practicable, during its first quarter earnings call in May.
Financial Position and Business Continuity
The Company started the year in a strong position across multiple dimensions and is taking prudent measures to ensure a rapid return to normal operations when conditions allow. As of March 31, 2020, the Company had approximately $83 million in cash and investments and carries no debt. Moreover, appropriate expense reduction measures have been implemented.
The Company continues to manufacture MACI and Epicel and maintains a significant safety stock of all key raw materials. At this time there is no indication that supply chain interruptions will impact the Company's ongoing manufacturing operations. The Company also continues to plan for a mid-2020 submission of the NexoBrid Biologics License Application to the FDA. To drive current and future demand, the Company's 71 MACI and 10 Epicel sales representatives and clinical support specialists are adapting their practices to support physician education initiatives using virtual tools in regions where executive orders or hospital restrictions preclude their physical presence.
Vericel continuity of business statement regarding COVID-19
Updated March 23, 2020
On Monday, March 23rd, the Governor of Massachusetts issued an Order requiring businesses in the Commonwealth that do not provide essential services to close their physical workplaces and facilities to workers, customers and the public until noon on April 7th. Vericel, as a manufacturer of medical and pharmaceutical products, is considered an essential business under the Governor’s Order. Accordingly, Vericel will continue to manufacture and provide patient access to both Epicel® (cultured epidermal autografts) and MACI® (autologous cultured chondrocytes on porcine membrane) moving forward. Customer Care as well as MyCartilageCare® services will remain operational in accordance with normal business practices. Point-of-care clinical case support from Vericel personnel will be subject to local, state or regional movement and business activity restrictions as well as facility vendor access rules. We ask you to contact your local Vericel representative if you have any questions or concerns.
on their website, not a press release
https://www.vcel.com/covid-19/
I would sell any rally.
Best place to get sick is the hospital. Elective surgery will take a back seat.
Yup- another blood letting
Looks like AT LEAST 5 buck Drop from Monday am.
But earnings were so goooooood.
??
And now even more blood....
Looks like a full bown "Island Reversal". Big dogs drove it down, and hopefully get the price they want to pick it back up with massive share count. That would be called "Churning". What puzzels me is volume isn't there. That's why I suspect "Manipulation". Maybe Tim Sykes bunch?!
and boom--- just like that
15 held firm for like, uh, 90 seconds
now there's a fleet race to see how low into the 14's this will go.
never seen such a flood for the door after earnings that logically should have cemented VCEL as a legitimate company (to invest in).
shades of the penny stock days of Aastrom
is that where this is really heading?
hard to fathom, but so has a 20%+ drop and declining fast in less that a day and a half.
It´s raining hail. Something we don´t know, A previlege to know, I know nothing.
Edit PART TWO:
from 6 to 8 and now basically 10%
that's 20 percent in less than two days...
on 'stellar' earnings?
a miss by a frog hair?
WTF
and another 6+% down already-
with no bottom in sight.
hard to spin this in anyway but the company failed investors.
they've got some 'splainin to do....
edit: like 30 seconds later
down over EIGHT percent
freakin garbage
back toward 14's
It is maddening. A good friend of who invests made a comment to me “ it is just not sexy “. Whatever the hell that means .
the same thing happened in 2019 - Feb 26th
the day before earnings it closed at $20
They beat, it opened at 20.87 then went down hill from there
the low of the day of earnings was 16.20, closed at 18.92
The difference is that the whole market wasn't tanking like this year.
The next day 2/27, it went lower and closed at 18.52
March 4th the high was 20.50
closed with the 20 handle 4 days in march
They gave the same guidance. 25% increase in MACI.
However they exceeded in total revenue for the year, at 30%
fact
stock is down nearly 3bucks and nearly 16% AFTER the 'beat/meet ER..."
virus fears?
yesterday it wasn't a factor.
so why, after 'beat/meet ER....' is this thing down as if it missed by a gazillion percent?
so define reasonable... is it because VCEL really is as high as it's gonna be for who knows how long?
apparently it's just one of those securities that defies logic-
down on bad news
down on good news
You trying to tel me this is a reasonable response to a beat/meet ER with continued high rev growth and profitability?
bullish sign?
stock is down 16%....
15% drop and back into the 15's
manipulation?
is that what has been going on for the past year??
high expectations not met-
doubters reaping the benefits.
this stock needs to beat by like 3x in order to rise.
or show a pulse.
pathetic.
Fricking Stock manipultion. No reason for this stock to drop on these earnings numbers. God, I hate greedy wallstreet. Looks to be a great Company, and a shady bunch of jerks shorting and high fiving each other...Sad.
And down 10% in pre
I’d get it if there was a big run into earnings-
Last year, near 21$ without this additional revenue
If there was a bit of a miss or even a perceived miss, then I’d not be surprised.
But this has stumbled for close to a year-
Shows good biz numbers- and we’re potentially back to where we were months ago. At best.
What the hell is it gonna take?
In line on earnings. Sales beat 39.4 vs $38.99
Epicel lighter than last year. 2020 guidance 1m lower than estimates.
Not looking good premarket
Hopes dashed?
Vericel Reports Fourth Quarter and Full-Year 2019 Financial Results and Provides Full-Year 2020 Financial Guidance
February 25, 2020 at 8:00 AM EST
PDF Version
Full Year 2019 Product Revenues of $117.9 Million Increased 30% Over 2018
Record Quarterly Revenue and Profit in the Fourth Quarter
Conference Call Today at 8:30am Eastern Standard Time
CAMBRIDGE, Mass., Feb. 25, 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 fourth quarter and year ended December 31, 2019, and provided full-year 2020 financial guidance.
Fourth Quarter 2019 Financial Highlights
Total net product revenues increased 26% to $39.4 million, compared to $31.3 million in the fourth quarter of 2018, marking the eleventh consecutive quarter with record revenues for the reported quarter;
MACI® net revenue of $33.6 million and Epicel® net revenue of $5.8 million;
Gross margin of 73%, compared to gross margin of 72% in the fourth quarter of 2018;
Net income of $9.5 million, or $0.20 per share, compared to $5.2 million, or $0.11 per share, in the fourth quarter of 2018; and
Non-GAAP adjusted EBITDA of $12.8 million, compared to $7.7 million in the fourth quarter of 2018.
Full-Year 2019 Financial Highlights
Total net product revenues increased 30% to $117.9 million, compared to $90.9 million in 2018;
MACI net revenue of $91.6 million and Epicel net revenue of $26.2 million;
Gross margin of 68%, compared to gross margin of 65% in 2018;
Net loss of $9.7 million, or $0.22 per share, which includes the $17.5 million upfront license payment to MediWound Ltd. for North American rights to NexoBrid®;
Non-GAAP adjusted net income, excluding the $17.5 million upfront license payment to MediWound, of $7.8 million, or $0.18 per share, compared to a net loss of $8.1 million, or $0.20 per share, in 2018;
Non-GAAP adjusted EBITDA of $21.2 million, compared to $4.7 million in 2018; and
As of December 31, 2019, the company had $79.0 million in cash and investments, compared to $82.9 million as of December 31, 2018; excluding the $17.5 million license payment to MediWound, the company’s cash balance increased by $13.6 million in 2019.
Business Highlights and Updates
Initiated the MACI sales force expansion from 49 to 76 sales territories and from six to nine sales regions, which remains on track to be implemented on April 1, 2020;
Announced initiation of the NexoBrid Expanded Access Treatment Protocol (NEXT) to treat patients with deep partial- and full-thickness burns in the United States during the preparation and review of the NexoBrid Biologics License Application;
Announced that that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has begun procuring NexoBrid for emergency stockpile as part of the U.S. Department of Health and Human Services’ mission to build national preparedness for public health medical emergencies; and
Planning a mid-2020 submission of the NexoBrid Biologics License Application to the FDA.
“Our fourth-quarter and full-year results reflect a landmark year for the company in which we not only continued to deliver significant revenue growth, but also achieved strong profit growth and added an exciting new product to our portfolio,” said Nick Colangelo, President and CEO of Vericel. “With expected sustained strong double-digit growth ahead for MACI, together with continued growth for Epicel and the anticipated launch of NexoBrid, we believe that Vericel is well-positioned to deliver substantial revenue, profit, and cash flow growth in the years ahead.”
2020 Financial Guidance
The company expects total net revenues for 2020 to be in the range of $141 million to $146 million, including full-year revenue of approximately $3.0 million from BARDA’s emergency stockpile purchases of NexoBrid.
Fourth Quarter 2019 Results
Total net product revenues for the quarter ended December 31, 2019 increased 26% to $39.4 million, compared to $31.3 million in the fourth quarter of 2018. Total net product revenues for the quarter included $33.6 million of MACI® (autologous cultured chondrocytes on porcine collagen membrane) net revenue and $5.8 million of Epicel® (cultured epidermal autografts) net revenue, compared to $25.1 million of MACI net revenue and $6.2 million of Epicel net revenue, respectively, in the fourth quarter of 2018.
Gross profit for the quarter ended December 31, 2019 was $28.8 million, or 73% of net revenues, compared to $22.7 million, or 72% of net revenues, for the fourth quarter of 2018.
Total operating expenses for the quarter ended December 31, 2019 were $19.6 million, compared to $16.7 million for the same period in 2018. The increase in operating expenses was primarily due to a $1.3 million increase in stock-based compensation expense, a $0.7 million increase in MACI sales force expenses driven by the expansion in the second quarter of 2019, and a $0.7 million increase in patient reimbursement support services.
Vericel’s net income for the quarter ended December 31, 2019 was $9.5 million, or $0.20 per share, compared to $5.2 million, or $0.11 per share, for the fourth quarter of 2018.
Non-GAAP adjusted EBITDA was $12.8 million for the quarter ended December 31, 2019, compared to $7.7 million in the fourth quarter of 2018. A table reconciling non-GAAP measures is included in this press release for reference.
Full-Year 2019 Results
Total net product revenues for the year ended December 31, 2019 increased 30% to $117.9 million, compared to $90.9 million in 2018. Total net product revenues included $91.6 million of MACI net revenue and $26.2 million of Epicel net revenue, compared to $67.7 million of MACI net revenue and $23.1 million of Epicel net revenue, respectively, in 2018.
Gross profit for the year ended December 31, 2019 was $80.3 million, or 68% of net revenues, compared to $58.7 million, or 65% of net revenues, in 2018.
Total operating expenses for the year ended December 31, 2019 were $91.5 million, including the $17.5 million upfront license payment to MediWound for North American rights to NexoBrid®. Excluding the $17.5 million license payment, operating expenses were $74.0 million, compared to $62.6 million in 2018. Other increases in operating expenses include a $5.0 million increase in stock-based compensation expenses, an incremental $2.6 million in MACI sales force expenses driven by the expansion in the second quarter of 2019, a $2.4 million increase in marketing expenses, and a $1.8 million increase in patient reimbursement support services.
Vericel’s net loss for the year ended December 31, 2019 was $9.7 million, or $0.22 per share, which includes the $17.5 million upfront license payment to MediWound for North American rights to NexoBrid. Non-GAAP adjusted net income, excluding the $17.5 million upfront license payment to MediWound, was $7.8 million, or $0.18 per share, compared to a net loss of $8.1 million, or $0.20 per share, in 2018. A table reconciling non-GAAP measures is included in this press release for reference.
Non-GAAP adjusted EBITDA was $21.2 million for the year ended December 31, 2019, compared to $4.7 million in 2018. A table reconciling non-GAAP measures is included in this press release for reference.
As of December 31, 2019, the company had $79.0 million in cash and investments, compared to $82.9 million as of December 31, 2018. Excluding the $17.5 million license payment to MediWound, the company’s cash balance increased by $13.6 million in 2019.
Conference Call Information
Today’s conference call will be available live at 8:30am Eastern Standard 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 2019 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 25, 2021. A replay of the call will also be available until 11:00am (EDT) on March 1, 2020 by calling (855) 859-2056, or from outside the U.S. at (404) 537-3406. The conference ID is 1269587.
About Vericel Corporation
Vericel is a leader in advanced therapies for the sports medicine and severe burn care markets. The company markets two cell therapy products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full-thickness burns greater than or equal to 30% of total body surface area. The company also holds an exclusive license for North American commercial rights to NexoBrid®, a registration-stage biological orphan product for debridement of severe thermal burns. For more information, please visit the company’s website at www.vcel.com.
GAAP v. Non-GAAP Measures
Vericel’s reported earnings are prepared in accordance with generally accepted accounting principles in the United States, or GAAP, and represent earnings as reported to the Securities and Exchange Commission. Vericel has provided in this release certain financial information that has not been prepared in accordance with GAAP. Vericel’s management believes that the non-GAAP adjusted EBITDA described in the release, which includes adjustments for specific items that are generally not indicative of our core operations, provide additional information that is useful to investors in understanding Vericel’s underlying performance, business and performance trends, and help facilitate period to period comparisons and comparisons of its financial measures with other companies in Vericel’s industry. However, the non-GAAP financial measures that Vericel uses may differ from measures that other companies may use. Non-GAAP financial measures are not required to be uniformly applied, are not audited and should not be considered in isolation or as substitutes for results prepared in accordance with GAAP.
Charts don't matter with earnings this next Tuesday and the biggest revenue quarter of the year.
Hello,first timer here. Question for someone. Is VCEL forming a head-and-shoulders bottom formation on the one year chart?
You're not going to acknowledge the CEO exercising and acquiring shares today? Extremely bullish sign. You're always very quick to point out when they cash them in, even when they're pre-arranged.
would love to see the momentum continue
been languishing too long.
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 2019 financial results and business highlights.
What: Vericel Corporation Fourth-Quarter 2019 Earnings Call
When: Tuesday, February 25, 2020 at 8:30am (EDT)
Where: http://investors.vcel.com/events-presentations
EIRMC first in Idaho to use new skin grafting method
https://www.postregister.com/news/local/eirmc-first-in-idaho-to-use-new-skin-grafting-method/article_81e5240b-e595-5ba8-9a17-14119437820a.html
The Eastern Idaho Regional Medical Center burn care center recently conducted Idaho’s first Epicel skin graft treatment. Epicel is a cultured epidermal autograft that is grafted onto the patient.
EIRMC’s inaugural Epicel procedure began in November when a patient between the age of 35 and 45 came in with more than 54 percent of his body covered in burns from a scalding incident, mainly on his upper and lower extremities.
A piece of skin, around the size of a postage stamp, was taken from the patient and sent to a Vericel laboratory, a company with headquarters in Cambridge, Mass. The skin cells were then divided into multiple Petri dishes where they were grown into larger quantities of skin. In these kinds of procedures, the final amount of skin is often 10,000 times larger than the postage-stamp amount sent. The company then shipped the skin pieces back to EIRMC where doctors were able to graft them together on the patient.
This patient spent approximately 100 days at EIRMC for burn treatments. Dr. Tait Olaveson, trauma, burn and general surgeon at EIRMC, estimated without the new Epicel procedure, the patient would have spent six months at the hospital.
“He’s doing great now. He’s back home. He’s recovering and still going through some physical therapy,” Olaveson said.
In the past, there have been two traditional methods of skin grafting. The first, known as either traditional or autologous skin grafting, involves removing sections of healthy skin from the patient’s body and transplanting the healthy skin to cover the burn area. That method’s downsides are that the healthy skin that can be taken is limited, and the process can be painful and scarring.
The second method involves taking skin from a cadaver to treat a patient. The downsides of this method are high risks of donor rejection, infection, scarring and pain.
While more expensive, the Epicel procedure significantly increases a patient’s likeliness to survive a burn incident. At the same time, it reduces a patient’s pain, scarring, inflammation and average time in the hospital compared to other grafting methods.
“Having the skin on hand means we don’t have to harvest as much (skin) from them, and it allows us to do it in a shorter time frame,” Olaveson said. “That cuts off sometimes at least two-thirds of their hospital stay.”
Doctors from the Burn and Reconstructive Centers of America in Georgia flew to Idaho Falls to train EIRMC burn care staff on how to conduct this procedure and how to care for patient’s undergoing it. The Burn and Reconstructive Centers of America is a partner of EIRMC’s.
According to Olaveson, with more traditional procedures, around 75 percent of transplanted skin successfully grafts, meaning it needs no further therapy or treatment. With this first patient, 99 percent of skin successfully grafted.
As for downsides, those are relatively small. The procedure is costly, but Olaveson felt the price to be worth it when considering survival rates and pain reduction.
“It significantly helps patients. Being able to offer this here locally, allows it so patients don’t have to travel. They don’t have to dislodge their family,” Olaveson said.
The EIRMC burn care center opened in April. The $5 million center is the primary provider of burn care between Salt Lake City and Seattle, meaning it services all burn patients in Idaho, Montana, Wyoming and North Dakota. Before its opening, patients with acute burns would often move their family to Denver, Salt Lake City or Seattle while undergoing treatments that can take up to six months.
As of the end of December, the EIRMC burn center has treated 97 in-patients and 786 out-patients.
2/3/2020 HC Wainwright Reiterated Rating Buy $21.00 ? $22.00
BARDA order was discussed on the MDWD Q3 earnings, here is the important parts on the last page of Q&A
https://seekingalpha.com/article/4306787-mediwound-ltd-mdwd-ceo-sharon-malka-on-q3-2019-results-earnings-call-transcript?page=5
Regardless this clinical supply for the NEXT, BARDA is committed to procure $16.5 million of NexoBrid for stockpiling which we believe, based on discussion that we have with BARDA, that they can or will trigger throughout the end of this year, enable us to start recognizing revenues upon deliveries from the first quarter of next year.
....
Sharon Malka
So, BARDA - the rate work at BARDA will provide us with a purchase order for all the 16,000 units which is a 16.5 million unit. In terms of revenue recognitions in our financial, it will be based on deliveries of actual products to BARDA’s warehouses in the U.S.
And in accordance with the delivery schedule, I agree with BARDA which is based on our capacity and manufacturing plan. It will be recognized upon six quarter starting from the quarter after we trigger this procurement, and will be recognized throughout those - this period.
Takeaway
"As part of the license agreement, Vericel and MediWound will equally split gross profits generated by BARDA’s initial $16.5 million procurement."
Pure profit
BARDA Initiates the Procurement of NexoBrid for Emergency Response
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January 06, 2020 06:30 ET | Source: Vericel Corporation
YAVNE, Israel and CAMBRIDGE, Mass., Jan. 06, 2020 (GLOBE NEWSWIRE) -- MediWound Ltd. (NASDAQ: MDWD) and its U.S. commercial partner Vericel Corporation (NASDAQ: VCEL) today announced that the U.S. Biomedical Advanced Research and Development Authority (BARDA) within the Assistant Secretary for Preparedness and Response (ASPR), a part of the U.S. Department of Health and Human Services (HHS), has begun procuring NexoBrid® for emergency stockpile as part of the HHS mission to build national preparedness for public health medical emergencies. BARDA purchased inventory will be managed by MediWound under vendor managed inventory. The initial BARDA procurement is valued at $16.5 million, with the first delivery of NexoBrid expected by the end of the first quarter of 2020 and additional deliveries occurring over the subsequent five quarters. In addition, BARDA holds an option to procure additional quantities of NexoBrid through funding of up to $50 million. The submission of the Biologics License Application (BLA) for NexoBrid to the U.S. Food & Drug Administration (FDA) is planned for the second quarter of 2020.
“The initiation of the NexoBrid procurement by BARDA is a significant milestone in our partnership with BARDA,” said MediWound Chief Executive Officer Sharon Malka. “We have been working with BARDA since 2015 on multiple development and training initiatives with the mutual goal of adding NexoBrid to ASPR’s portfolio of medical countermeasures for mass casualty emergencies. The initiation of the procurement while NexoBrid is at the pre-BLA stage underscores the importance of NexoBrid to U.S. national preparedness for treatment of large number of severe thermal burns injuries.”
“Our country faces a multitude of evolving threats that could result in an overwhelming number of people suffering from burn injuries,” explained BARDA Director Rick Bright, Ph.D. “Today’s purchase is part of our ongoing efforts to provide first responders and other medical professionals with fast access to the products they will need to save as many lives as possible. The progress of NexoBrid to date is a testament to how much can be accomplished in a relatively short time through public-private partnership.”
“We believe that availability of NexoBrid for emergency response will significantly increase U.S. readiness for burn mass casualty incidents,” said Nick Colangelo, President and Chief Executive Officer of Vericel. “The increasing number of burn centers enrolling in the NexoBrid expanded access treatment protocol will help ensure that major burn centers across the country are trained and experienced in the use of NexoBrid should such an event take place.”
The procurement is a key milestone of the Project BioShield (PBS) contract signed in September 2015 between MediWound and BARDA. 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.
Recently, MediWound initiated the NexoBrid expanded access treatment protocol (NEXT), 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. MediWound has submitted documents for consideration by the FDA supporting the use of NexoBrid in a declared national medical emergency contingent upon the FDA issuance of an Emergency Use Authorization (EUA). 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.
At the end of July 2019, MediWound and Vericel participated in a pre-BLA meeting 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. The companies anticipate filling the BLA during the second quarter of 2020.
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 percent 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
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.
Vericel Corporation
@VericelCorp
“As a leader in the sports medicine and burn care markets, we look forward to helping more patients with our advanced #celltherapies while working to deliver additional innovative treatments." – Vericel CEO, Nick Colangelo on #2020
11:39 AM · Jan 3, 2020·Twitter Web App
Talbott
@talbottzink
·
3h
Very excited..I'm posting investment ideas and commentary at The Good Business Repository aka Hindsight Capital:
http://hindsight-capital.com
My first post is about Vericel Corporation, an emerging producer of autologous cell therapies with 2 one-of-a-kind products $VCEL
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Vericel Corporation. (VCEL)
http://epicel.com/healthcare-professionals/what-is-epicel/epicel-is-fda-approved/
https://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/ucm543860.htm
Click on Yellow to REVIEW FDA WEBSITE APPROVING MACI
http://www.maci.com/
Interesting FDA Transcript discussions on MACI going forward for widened age bracket and other body joints.
CLICK ON THE ABOVE LINK
CLICK ON THE ABOVE PICTURE TO GO INTO VCEL'S CAREER'S SITE
IXMYELOCEL-T
Our preapproval stage portfolio includes ixmyelocel-T, a unique patient-specific multicellular therapy derived from an adult patient’s own bone marrow which utilizes our proprietary, highly automated and scalable manufacturing system. Our proprietary cell manufacturing process significantly expands the mesenchymal stromal cells (MSCs) and M2-like anti-inflammatory macrophages in the patient’s bone marrow mononuclear cells while retaining many of the hematopoietic cells. These cell types are known to regulate the immune response and play a key role in tissue repair and regeneration by resolving pathologic inflammation, promoting angiogenesis, and remodeling ischemic tissue. The novelty and advantage of using ixmyelocel-T is the expansion of a unique combination of cell populations, including MSCs and M2-like macrophages, which secrete a distinct combination of angiogenic and regenerative factors, and possess the ability to remain anti-inflammatory in the face of inflammatory challenge.
Vericel develops, manufactures, and markets autologous cell-based therapies for patients with serious diseases and conditions. The company markets two cell therapy products in the United States. Carticel® (autologous cultured chondrocytes) is an autologous chondrocyte implant intended to treat cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure. 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. Vericel is also developing 2 additional cell products. MACI is a third generation autologous chondrocyte implant intended to treat cartilage defects in the knee. Ixmyelocel-T is a multicellular therapy intended to treat advanced heart failure due to ischemic dilated cardiomyopathy (DCM).
Developing autologous (patient’s own) cell therapies—with integrity
Vericel uses rigorous scientific methods to develop novel therapies for the treatment of patients with autologous (patient’s own) cells. In addition, personal integrity, team work, collaboration, and innovative technology are the foundations of our work. We seek to practice transparency in our clinical trials and research, and in our relationships with each other, our patients, and the investors who support us.
Management:
http://vcel.com/about-vericel/#Management
Clinical Research:
http://vcel.com/research-and-development/#cardioMyopathy
Recent News:
http://investors.aastrom.com/releases.cfm
http://www.4-traders.com/VERICEL-CORP-18635051/
http://finance.yahoo.com/q/h?s=VCEL+Headlines
Events and Presentations:
http://investors.aastrom.com/events.cfm
Analyst Coverage:
http://investors.aastrom.com/analysts.cfm
http://www.streetinsider.com/Analyst+Comments/Vericel+(VCEL)+MACI+Approval+Puts+Profitability+Within+Reach+-+Needham+%26+Company/12343070.html
https://www.thecerbatgem.com/2016/12/19/needham-company-llc-analysts-give-vericel-corp-vcel-a-9-00-price-target.html
https://sportsperspectives.com/2016/12/22/piper-jaffray-cos-begins-coverage-on-vericel-corp-vcel.html
http://www.4-traders.com/VERICEL-CORP-18635051/consensus/
http://seekingalpha.com/symbol/VCEL
http://seekingalpha.com/article/1228921-is-takeda-interested-in-aastrom-bio
Filings:
http://www.sec.gov/cgi-bin/browse-edgar?company=&match=&CIK=0000887359&filenum=&State=&Country=&SIC=&owner=exclude&Find=Find+Companies&action=getcompany
Share Structure:
See Filings
http://data.cnbc.com/quotes/vcel
http://finance.yahoo.com/quote/VCEL/?p=VCEL
YOU TUBE VIDEOS, and the fourth video down, you will NOW appreciate the meaning of less invasive on the new FDA approved MACI procedure and why MACI is anticipated to be 20x the procedures of Carticel
https://www.youtube.com/watch?v=y3S1kFfT0Qk
https://www.youtube.com/watch?v=dP5TgnS3Vr4
https://www.youtube.com/watch?v=gCbpFoY6ZUM
https://www.youtube.com/watch?v=3MFL10O-avE MUST WATCH
http://wnyt.com/health/maci-new-procedure-to-repair-damaged-knee-cartilage/4369510/
https://www.dvidshub.net/news/223965/wbamc-employs-state-art-knee-implant-first-time-dod
Conference Calls
September 27, 2016 Ladenburg Thalmann
October 24, 2016 Meeting on the Mesa
November 30th, 2016 The 28th Annual Piper Jaffray Healthcare Conference
December 14th, 2016 Vericel Corporation Investor Call
Investor Relations:
http://investors.aastrom.com/index.cfm
Yummy Land, click on Above Picture
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