|To: richardred who wrote (5704)||12/5/2019 1:36:21 PM|
|Picked up some more CYAN. Reasoning-The supplement market seems gaga over CBD. From what I've recently seen. There' are many questions looming with consistency, content, and medicinal claims. More questions if it needs to be regulated? astaxanthin & spirulina the supplements CYAN sells have been in the market much longer, and seem a safer route. IMO CYAN is risky company, but more reasonably priced currently. Earnings have been erratic and inconsistent however. Meridian was an activist at one point and has been quite for far to long. IMO the founder needs to sell to a bigger parent. |
|To: richardred who wrote (4295)||2/6/2018 1:30:12 PM|
|From: richardred|| Read Replies (1) of 5704|
|RE- CYAN speculation Nice earnings today.|
Added to CYAN today. Signs of a turnaround. Net sales increase 16% to a record $9.9 million and in the black. Costco problems on the mend? >Growth in our packaged products was primarily due to our Costco expansion. During this quarter, BioAstin expanded into an additional 64 warehouse stores in Costco's Northwest region and now is available in 252 Costco warehouses, or roughly 52% of their domestic total.
Added to struggling CYAN today. I think Meridian partner has backed themselves into a corner. IMO perfect size for TerraVia. RENAISSANCE TECHNOLOGIES LLC has been slowly adding over time to their small bet. They have over 90,000 shares now.
Atrium Innovations to be Acquired by #Nestlé for $2.3 Billion. Looking to divest some candy and sell healthy. $CYAN IMO a Natural fit for #DSM. Federal NOL carryforward was $11.8 million and our NOL carryforward for Hawaii was $6.3 mil. #astaxanthin #spirulina Nat. #microalgae
— Richard - richardred (@rreding1) January 12, 2018
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|To: richardred who wrote (5377)||12/6/2019 10:35:30 AM|
Cambridge Bancorp and Wellesley Bancorp, Inc. to Merge
Expanding Commercial Banking, Private Banking and Wealth Management Presence in Greater Boston
December 05, 2019 04:15 PM Eastern Standard Time
CAMBRIDGE, Mass. & WELLESLEY, Mass.--( BUSINESS WIRE)--Cambridge Bancorp (Nasdaq: CATC) (the “Company” or “Cambridge”), the holding company for Cambridge Trust Company (“Cambridge Trust”), and Wellesley Massachusetts-based Wellesley Bancorp, Inc. (“Wellesley”), the holding company for Wellesley Bank, are pleased to jointly announce entry into a definitive agreement pursuant to which Wellesley will merge with and into Cambridge in an all-stock transaction. Under the terms of the agreement, each share of Wellesley common stock will be exchanged for 0.580 shares of Cambridge common stock. The transaction is presently valued at $45.54 per Wellesley common share, or approximately $122 million in the aggregate, based upon Cambridge Bancorp’s 10 day average closing price of $78.53 as of December 4, 2019. On a pro forma basis the transaction is expected to be approximately 4.4% accretive to Cambridge’s 2021 earnings per share and approximately 1.6% dilutive to tangible book value per share with an expected earnback period of approximately 2.2 years.
“We are excited about the opportunity to partner with Cambridge Trust” This strategically compelling merger is expected to enhance and expand Cambridge’s Greater Boston presence with the addition of Wellesley’s six full service banking offices in Norfolk, Middlesex, and Suffolk Counties. Cambridge and Wellesley share similar service-oriented business models and each provide their clients with banking and wealth management services. The combined company will benefit from enhanced scale and an expanded client base, and be well-positioned to capitalize on future growth opportunities. Thomas Fontaine, Chairman, President and CEO of Wellesley, will join the combined company in the role of Chief Banking Officer and Director.
As of September 30, 2019 Wellesley had approximately $986 million of total assets, $833 million of gross loans, $759 million of deposits, and $363 million of wealth management assets. Based on financial metrics as of September 30, 2019, the combined company is expected to have over $3.8 billion in assets, $3.0 billion in gross loans, $3.2 billion in deposits, and $3.6 billion of wealth management assets upon completion of the transaction.
Denis Sheahan, CEO of Cambridge Trust, commented, “We are pleased to announce the strategic combination of Cambridge Trust and Wellesley Bank, who are both dedicated to providing individuals, families, and businesses with exceptional personal attention and custom financial solutions.” Sheahan added, “Wellesley Bank is a well-managed, financially strong and growing company located in attractive markets. The combination strengthens the position of Cambridge Trust in Greater Boston and is a logical extension of our market. We look forward to welcoming the talented Wellesley Bank team to Cambridge Trust.”
“We are excited about the opportunity to partner with Cambridge Trust,” said Thomas J. Fontaine, President and CEO of Wellesley Bank. “Cambridge Trust, much like Wellesley Bank, has a genuine commitment to its clients and the community. Together, we’ll build a premier private banking and wealth management company in Greater Boston and Southern New Hampshire.”
The transaction has been approved by the Boards of Directors of both companies and is expected to be completed during the second quarter of 2020, subject to regulatory approval, approval by Cambridge and Wellesley shareholders, and other customary closing conditions. Upon closing, three Wellesley directors will join the Board of Directors of Cambridge, including Mr. Fontaine.
A presentation with additional information regarding the merger can be accessed by visiting the Cambridge Bancorp investor relations site at “ir.cambridgetrust.com”. Keefe, Bruyette & Woods, Inc. served as financial advisor and provided a fairness opinion to Cambridge Bancorp and Hogan Lovells US LLP served as its legal counsel. Sandler O'Neill + Partners, L.P. served as financial advisor and provided a fairness opinion to Wellesley and Kilpatrick Townsend & Stockton LLP served as its legal counsel.
About Cambridge Bancorp
Cambridge Bancorp, the parent company of Cambridge Trust Company, is based in Cambridge, Massachusetts. Cambridge Trust Company is a 129-year-old Massachusetts chartered commercial bank with approximately $2.8 billion in assets and a total of 16 banking offices in Massachusetts and New Hampshire. Cambridge Trust Company is one of New England’s leaders in private banking and wealth management with $3.3 billion in client assets under management and administration. The Wealth Management group maintains offices in Boston, Massachusetts; Concord, Manchester, and Portsmouth, New Hampshire.
For more details on Cambridge Bancorp visit: www.cambridgetrust.com
About Wellesley Bancorp, Inc.
Wellesley Bank and its wholly-owned wealth management company, Wellesley Investment Partners, LLC, are subsidiaries of Wellesley Bancorp, Inc. Wellesley Bank provides personal, customized, premier banking services to successful people, families, businesses and Non-profit organizations. The bank has six full-service banking offices in Wellesley, Newton, Needham, and Boston. Wellesley Investment Partners, a subsidiary of Wellesley Bank, provides wealth management services to individuals and families, private foundations and endowments. Wellesley Bank has been serving the Greater Boston Area for over 108 years.
For more details on Wellesley Bancorp, Inc., please visit: www.wellesleybank.com
This report contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements about Cambridge Bancorp (together with its bank subsidiary unless the context otherwise requires, “Cambridge”) and Wellesley Bancorp, Inc. (together with its bank subsidiary unless the context otherwise requires, “Wellesley”) and their industry involve substantial risks and uncertainties. Statements other than statements of current or historical fact, including statements regarding Cambridge’s or Wellesley’s future financial condition, results of operations, business plans, liquidity, cash flows, projected costs, and the impact of any laws or regulations applicable to Cambridge or Wellesley, are forward-looking statements. Words such as “anticipates,” “believes,” “estimates,” “expects,” “forecasts,” “intends,” “plans,” “projects,” “may,” “will,” “should,” and other similar expressions are intended to identify these forward-looking statements. Such statements are subject to factors that could cause actual results to differ materially from anticipated results. Such factors are described within Cambridge’s and Wellesley’s filings with the Securities & Exchange Commission. Among the risks and uncertainties that could cause actual results to differ from those described in the forward-looking statements include, but are not limited to the following: (1) the businesses of Cambridge and Wellesley may not be combined successfully, or such combination may take longer to accomplish than expected; (2) the cost savings from the merger may not be fully realized or may take longer to realize than expected; (3) operating costs, customer loss and business disruption following the merger, including adverse effects on relationships with employees, may be greater than expected; (4) governmental approvals of the merger may not be obtained, or adverse regulatory conditions may be imposed in connection with governmental approvals of the merger; (5) the stockholders of Cambridge or Wellesley may fail to approve the merger; (6) changes to interest rates, (7) the ability to control costs and expenses, (8) general economic conditions, (9) the success of Cambridge’s efforts to diversify its revenue base by developing additional sources of non-interest income while continuing to manage its existing fee-based business, and (10) risks associated with the quality of Cambridge’s assets and the ability of its borrowers to comply with repayment terms. Further information about these and other relevant risks and uncertainties may be found in Cambridge’s and Wellesley’s respective Annual Reports on Form 10-K for the fiscal year ended December 31, 2018 and in subsequent filings with the Securities and Exchange Commission. Cambridge and Wellesley do not undertake, and specifically disclaims any obligation, to publicly release the result of any revisions which may be made to any forward-looking statements to reflect the occurrence of anticipated or unanticipated events or circumstances after the date of such statements. You are cautioned not to place undue reliance on these forward-looking statements.
Additional Information and Where to Find it
In connection with the proposed transaction, Cambridge expects to file with the SEC a registration statement on Form S-4 that will include a joint proxy statement of Cambridge and Wellesley that also constitutes a prospectus of Cambridge. Cambridge and Wellesley also plan to file other relevant documents with the SEC regarding the proposed transaction. INVESTORS ARE URGED TO READ THE JOINT PROXY STATEMENT/PROSPECTUS AND OTHER RELEVANT DOCUMENTS FILED WITH THE SEC IF AND WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. You may obtain a free copy of the joint proxy statement/prospectus (if and when it becomes available) and other relevant documents filed by Cambridge and Wellesley with the SEC at the SEC’s website at www.sec.gov. Copies of the documents filed by Cambridge with the SEC will be available free of charge on Cambridge's website at ir.cambridge.com or by directing a request to Cambridge Bancorp, 1336 Massachusetts Avenue, Cambridge, MA 02138, attention: Corporate Secretary (617) 876-5500. Copies of the documents filed by Wellesley with the SEC will be available free of charge on Wellesley's website at www.wellesleybank.com or by directing a request to Wellesley Bancorp, Inc., 100 Worcester Street, Suite 300, Wellesley, MA 02481, attention: Corporate Secretary (781) 235-2550.
Participants in Solicitation
Cambridge and Wellesley and their respective directors and executive officers and other members of management and employees may be deemed to be participants in the solicitation of proxies in respect of the proposed transaction. You can find information about Cambridge's executive officers and directors in Cambridge's definitive proxy statement filed with the SEC on March 19, 2019. You can find information about Wellesley's executive officers and directors in Wellesley’s definitive proxy statement filed with the SEC on April 10, 2019. Additional information regarding the interests of such potential participants will be included in the joint proxy statement/prospectus and other relevant documents filed with the SEC if and when they become available. You may obtain free copies of these documents from Cambridge or Wellesley using the sources indicated above.
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|From: E_K_S||12/6/2019 2:51:35 PM|
|Encana cut at Barclays but shares rise on OPEC+ production deal|
Dec. 6, 2019 2:23 PM ET
Encana ( ECA +2.9%) is downgraded to Equal Weight from Overweight with a $5 price target, slashed from $11, at Barclays, citing the company's leverage and "below average" total return yield.
While ECA has enjoyed positive operational momentum in the STACK with lower costs and six-month oil production exceeding its type curve, the play is a "show-me" story that will take time to prove out, Barclays analyst Janine Wai says.
ECA and other oil and gas names are broadly higher today following OPEC's agreement on additional production cuts.
-------------------------------------------------I think analyst may have over adjusted. SMA (200) is now around $5.50/share but chart dhows first level of suport at/above $7.50/share. If so, even my high cost shares will show a 36% return. Still low downside risk IMO
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|From: E_K_S||12/9/2019 8:42:16 AM|
|IFF vies with Kerry for DuPont nutrition business - Bloomberg|
Dec. 9, 2019 8:32 AM ET|About: DuPont de Nemours, Inc. (DD)|By: Carl Surran, SA News Editor
DuPont's (NYSE: DD) nutrition division has attracted strong interest from International Flavors & Fragrances (NYSE: IFF) and Ireland's Kerry Group ( OTCPK:KRYAY), and the winner could reach a deal to purchase the ~$25B asset by year's end, Bloomberg reports.
Such a deal would be the biggest ever for IFF, whose last big acquisition was in the food-flavoring industry last year when it bought Israel's Frutarom Industries for $7.1B including debt.
Kerry has long wanted to expand in healthy bacteria strains and nutritional products that claim to have some sort of role in assisting in disease treatment or prevention.
|RecommendKeepReplyMark as Last ReadRead Replies (1)|
|From: E_K_S||12/9/2019 8:48:43 AM|
|Just Eat mulls over new offer|
Dec. 9, 2019 8:45 AM ET|About: Just Eat plc (JSTLF)|By: Clark Schultz, SA News Editor
Just Eat ( OTC:JSTLF, OTCPK:JSTTY) says it's considering the higher cash offer doled out by Prosus earlier today, according to The Times.
The company's board has previously backed an offer from Takeaway.com ( OTCPK:TKAYF).
Takeaway.com maintains that the new Prosus is "derisory as a cash exit price."
Shares of Just Eat are up 0.55% in London trading amid the M&A drama.
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|To: richardred who wrote (5709)||12/9/2019 8:51:53 AM|
|NorthState Enters into Definitive Agreement to be Acquired by Segra |
Email Print Friendly Share
December 09, 2019 07:59 ET | Source: NorthState
Segra to pay $80.00 per share in all-cash transaction
Merger will enhance Segra’s growing fiber footprint in the Mid-Atlantic U.S.
HIGH POINT, N.C. and CHARLOTTE, N.C., Dec. 09, 2019 (GLOBE NEWSWIRE) -- North State Telecommunications Corporation (“NorthState” or the “Company”), a fiber optic network, cloud and IT services and cybersecurity provider, today announced a definitive agreement to merge with a subsidiary of MTN Infrastructure TopCo, Inc., which, together with its other subsidiaries, does business as “Segra”. Segra will pay $80.00 in cash per share for both Class A and Class B of NorthState’s common stock, which, inclusive of indebtedness, represents an enterprise value of approximately $240 million. The Merger Consideration represents a premium of 31.1% and 34.5% to the December 6, 2019 closing prices of $61.00 and $59.50, respectively, for the Company’s Class A and B common shares.
Royster Tucker III, president and chief executive officer of NorthState, said, “We are excited to announce this transaction with Segra. We believe the combination of our businesses will deliver immediate and compelling value for NorthState’s shareholders and customers. Segra is an outstanding company that will continue to grow our network footprint in the Piedmont Triad Region of North Carolina and provides a great fit for our growing IT services business.
“I would like to extend my sincere appreciation to all of the NorthState employees whose dedication, support and hard work have made our success possible. I would also like to thank our customers and shareholders for their support and loyalty over our long history.”
Segra Chief Executive Officer Tim Biltz said, “Both NorthState and Segra have great histories of infrastructure, innovation and service. Customers and businesses throughout our service area will benefit from an expanded network, enhanced products and a superior customer experience as a result of this transaction.”
The merger agreement was unanimously approved by NorthState’s Board of Directors. It restricts NorthState’s ability to pay dividends on its common shares beyond those declared for the fiscal quarter ending December 31, 2019 payable in March of 2020. Separately, acting in their capacity as shareholders, each of the members of the Board entered into a separate voting agreement with respect to all shares of NorthState Class A common stock beneficially or directly owned by such Board member, representing approximately 37% of NorthState’s voting shares outstanding. A proxy statement will be distributed to shareholders during the first quarter of 2020. The transaction is anticipated to close in the second or third quarter of 2020 and is subject to customary regulatory approvals and other closing conditions.
Wells Fargo Securities, LLC served as exclusive financial advisor, and GC Solutions and Nelson Mullins Riley & Scarborough LLP served as legal advisors to NorthState in connection with this transaction. TD Securities acted as exclusive financial advisor and Simpson Thacher & Bartlett LLP, Morgan, Lewis & Bockius LLP and Womble Bond Dickinson (US) LLP served as legal advisors to Segra.
Additional Information about the Proposed Transaction
In connection with the proposed merger, NorthState will hold a special meeting to obtain shareholder approval and will mail a definitive proxy statement/information statement to its shareholders. The definitive proxy statement/information statement will contain important information about the proposed merger and related matters. In addition, investors and security holders may obtain free copies of the documents mailed to NorthState’s shareholders by contacting NorthState investor relations at firstname.lastname@example.org and by viewing the documents on or through NorthState’s website at www.northstate.net/investor-relations/. INVESTORS AND SECURITY HOLDERS OF NORTHSTATE ARE URGED TO READ THE PROXY STATEMENT/INFORMATION STATEMENT WHEN THEY BECOME AVAILABLE BEFORE MAKING ANY VOTING OR INVESTMENT DECISION WITH RESPECT TO THE PROPOSED TRANSACTION BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION.
NorthState is a technology company focused on inspiring the Internet-driven lifestyle through high-touch experiences. Its fiber-delivered, ultrafast Internet and Internet-driven applications enable residential customers and businesses to efficiently and securely take advantage of the Internet. Through its Technology Solutions business unit, NorthState provides data center colocation, customized cloud and IT solutions, managed disaster recovery services, cybersecurity, managed security and unified communications. For more information, visit northstate.net.
Segra is one of the largest independent fiber bandwidth companies in the eastern U.S. It owns and operates an advanced fiber infrastructure network of more than 23,000 miles that connects more than 9,000 on-net locations and six data centers throughout nine Mid-Atlantic and Southeastern states. Segra provides Ethernet, MPLS, dark fiber, advanced data center services, IP and managed services, voice and cloud solutions, all backed by its industry-leading service and reliability. Customers include carriers, enterprises, governments, and healthcare organizations. In addition, Segra delivers high-speed, fiber-based integrated telecommunications services to residential and business customers in rural Virginia under the Lumos Networks brand name. For more information about Segra’s technology and commitment to customer care, visit segra.com.
Special Note from NorthState Regarding Forward-Looking Statements
Any statements contained in this press release that are not statements of historical fact, including statements about our beliefs and expectations, are forward-looking statements and should be evaluated as such. Such forward-looking statements reflect, among other things, our current expectations about the transaction and its timing, all of which are subject to known and unknown risks, uncertainties and factors that may cause actual results to differ materially from those expressed or implied by these forward-looking statements. Many of these risks are beyond our ability to control or predict. Because of these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. Furthermore, forward-looking statements speak only as of the date they are made. We do not undertake any obligation to update or review any forward-looking information, whether as a result of new information, future events or otherwise. Important factors with respect to any such forward-looking statements, including certain risks and uncertainties that could cause actual results to differ from those contained in the forward-looking statements, include: the successful closing of the announced transaction with Segra, including obtaining the requisite regulatory, governmental and shareholder approvals and satisfying other closing conditions; the risk that required governmental and regulatory approvals may delay the transaction or result in the imposition of conditions that could cause the parties to abandon the transaction; the timing to consummate the proposed transaction; any disruption from the proposed transaction making it more difficult to maintain relationships with our customers, employees or suppliers; the diversion of management time on transaction-related issues; the transaction may involve unexpected costs, liabilities or delays; the outcome of any legal proceedings related to the transaction; the failure by Segra to obtain the necessary financing arrangement set forth in the debt commitment letters received in connection with the transaction; and other unforeseen difficulties that may occur. These risks and uncertainties are not intended to represent a complete list of all risks and uncertainties inherent in our business.
For NorthState: Harriet Fried, LHA, 212.838.3777 email@example.com
For Segra: Media John Nee Chief Marketing Officer 503.789.4986 firstname.lastname@example.org
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|To: richardred who wrote (4817)||12/9/2019 10:47:35 AM|
|Re-Entry of MDWD-MEDIWOUND >3.00 I didn't like the deal MDWD signed with VCEL-VERICEL CORPORATION on it's NexoBrid burn product. I however like the VCEL product line and feel VCEL took advantage of cash weak MDWD. This needing a partner to help fund the approval process for NexoBrid. That being said. I made made a new buy of VCEL also. Based on a earlier MDWD merger approach. Just guessing Integra Lifesciences could be interested in a stock deal. IMO Hypothetically someone like J&J or other complimenting big Pharma could also be interested?|
Message #4817 from richardred at 3/19/2018 11:12:20 AM
New buy today MDWD -MEDIWOUND
The company said it has been approached. Basically this is still a R &D company in wound care. I'm going to make a small bet. This based upon a big Past wound care winner I had in Derma Science.
P.S. - MediWound ( MDWD ): gets merger approach, Q4 loss beats views
|To: richardred who wrote (4308)||1/11/2017 8:18:17 AM|
|From: richardred|| Read Replies (2) of 5712|
|Eleven days into the new year and a Bullseye Today- DSCI|
BRIEF-Integra Lifesciences to buy Derma Sciences
* Derma Sciences to be acquired by Integra Lifesciences for $7.00 per share of common stock in cash
* Says will be acquired by Integra Lifesciences Holdings Corporation for $7.00 per share of common stock in cash
* Says deal for a total of approximately $204 million
* Says Integra will also assume contingent liabilities related to biod transaction
* Says q4 net sales of $26.9 million
* Says q4 awc net sales of $20.3 million representing growth of 95.6% Source text for Eikon: Further company coverage:
P.S. Message 30855045
Vericel Enters into Exclusive License Agreement with MediWound for North American Rights to NexoBrid, a Biological Orphan Product for Debridement of Severe Thermal Burns
May 7, 2019 at 1:59 AM EDT
Pivotal U.S. Phase 3 Clinical Study Met Primary and All Secondary Endpoints
Highly Synergistic with Existing Commercial Franchise and Significantly Expands Vericel’s Presence in the Severe Burn Care Market
CAMBRIDGE, Mass., May 07, 2019 (GLOBE NEWSWIRE) -- Vericel Corporation (NASDAQ:VCEL), a leader in advanced cell therapies for the sports medicine and severe burn care markets, today announced that it has entered into exclusive license and supply agreements with MediWound Ltd. to commercialize NexoBrid® in North America. 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 in the United States.
In January 2019, MediWound announced positive top-line results from 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% 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 compared to standard of care (SOC). A key safety endpoint, non-inferiority in time to complete wound closure compared with patients treated with SOC, was also achieved. Planned twelve-month and twenty-four month safety follow-ups are ongoing for cosmesis, function, quality of life and other safety measurements.
“We are delighted to expand our burn care franchise with the addition of NexoBrid, a highly innovative product with compelling clinical and pharmacoeconomic data that represents a paradigm shift in burn care for hospitalized patients,” said Nick Colangelo, president and CEO of Vericel. “NexoBrid is an excellent strategic fit with our advanced therapy portfolio and is highly synergistic with our existing commercial franchise. The addition of NexoBrid significantly expands our target addressable market and supports a broader commercial footprint to both drive NexoBrid uptake and increase Epicel penetration as we broaden our focus to a significantly larger segment of hospitalized burn patients. We look forward to working closely with the MediWound team to bring NexoBrid to the U.S. market.”
The U.S. Biomedical Advanced Research and Development Authority (BARDA) has awarded MediWound a contract valued at up to $132 million for the advancement of the development and manufacturing, as well as the procurement, of NexoBrid in the United States. Under the contract, BARDA provides technical assistance and $56 million in funding support towards NexoBrid development costs including the ongoing DETECT study and a Phase 3 pediatric (CIDS) study to obtain U.S. marketing approval from the Food and Drug Administration (FDA). The contract also includes a $16.5 million commitment for procurement of NexoBrid contingent upon FDA eligibility for use in an emergency or FDA marketing approval. The contract provides an option to fund up to $50 million for additional NexoBrid procurement. Independently, BARDA also awarded a different contract to MediWound for up to $43 million to support the development of NexoBrid as a debridement product to treat sulfur mustard injuries.
Under the terms of the license agreement, Vericel will make an upfront payment to MediWound of $17.5 million, with an additional $7.5 million payment contingent upon U.S. approval and up to $125 million contingent upon meeting certain annual sales milestones. The first sales milestone of $7.5 million would be triggered when NexoBrid annual net sales in North America exceed $75 million. Vericel also will pay MediWound tiered royalties on net sales ranging from single-digit to low double-digit percentages, and a percentage of gross profits on initial committed BARDA procurement orders and a royalty on any additional BARDA purchases of NexoBrid. Vericel also entered into a supply agreement with MediWound under which MediWound will manufacture NexoBrid for Vericel for a supply price of cost plus a fixed margin percentage.
“In addition to the clear strategic fit with our burn care franchise, this transaction is attractive from a financial perspective as well,” said Nick Colangelo. “The performance-based deal structure, together with BARDA funding support for development expenses to obtain U.S. marketing approval and medical countermeasure procurement, makes the transaction essentially neutral to adjusted EBITDA in the near-term and generates longer-term margins consistent with expected margins for our current portfolio.”
Approximately 40,000 burn patients are hospitalized in the U.S. each year1, most of whom require the debridement of burn eschar to facilitate healing and reduce the risk of infection.2 Surgical excision of eschar, or escharectomy, is currently standard of care and is performed through repeated use of a large surgical blade to remove necrotic tissue until bleeding, healthy tissue is reached.2 While effective, surgical debridement is not selective, results in the loss of both viable tissue and blood, and requires general anesthesia for the patient and operating facilities for the burn center or hospital.3 Currently available enzymatic debridement agents require a minimum of once daily application4 with dressing changes over a number of days. NexoBrid enables the rapid and early removal of eschar while reducing patients' surgical burden and the related loss of blood and healthy tissue associated with escharectomy.5
“MediWound is excited to partner with Vericel, a company that shares our commitment to bringing innovative therapies to the market to meet the needs of burn patients,” said Stephen T. Wills, Chairman of MediWound. “Vericel’s proven track record of commercializing novel products and changing standard of care, as well as their strong history with the burn community, gives us confidence that they are the ideal partner to realize the full potential of NexoBrid in North America.”
The U.S. Biologics License Application (BLA) currently is targeted for submission to the FDA in the fourth quarter of 2019 based on the acute primary, secondary and safety data, with the analysis of the twelve-month safety follow-up data submitted during the BLA review and the twenty-four month safety follow-up data submitted as a BLA supplement, subject to FDA concurrence at a pre-BLA meeting planned for the first half of 2019.
For more information on this transaction please refer to the Form 8-K filed today with the U.S Securities and Exchange Commission (SEC).
About Vericel Corporation
Vericel is a leader in advanced cell therapies for the sports medicine and severe burn care markets. The company markets two cell therapy products in the United States. MACI® (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellularized scaffold product indicated for the repair of symptomatic, single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. Epicel® (cultured epidermal autografts) is a permanent skin replacement for the treatment of patients with deep dermal or full thickness burns greater than or equal to 30% of total body surface area. For more information, please visit the company's website at www.vcel.com.
The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in 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. Funding and support for development of NexoBrid has been 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 and HHSO100201800023C.
Epicel® and MACI® are registered trademarks of Vericel Corporation. © 2019 Vericel Corporation. All rights reserved.
NexoBrid® is a registered trademark of MediWound Ltd. and is used under license to Vericel Corporation.
This document contains forward-looking statements, including, without limitation, statements concerning anticipated progress, objectives and expectations regarding the commercial potential of Vericel products, intended product development, clinical activity timing, regulatory process, and objectives and expectations regarding our company described herein, all of which involve certain risks and uncertainties. These statements are often, but are not always, made through the use of words or phrases such as "anticipates," "intends," "estimates," "plans," "expects," "we believe," “targeted” and similar words or phrases, or future or conditional verbs such as "will," "would," "should," "potential," "can continue," "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 timing and conduct of clinical trial and product development activities, timing or likelihood of regulatory submissions or approvals, availability of funding from BARDA, potential payments under the license and supply agreements, growth in revenue, profit and margins, impact to adjusted EBITDA, estimating the commercial potential of our products and product candidates, increasing market penetration for Epicel, competitive developments, market demand for our products and product candidates, product performance, and our ability to supply or meet customer demand for our products. These and other significant factors are discussed in greater detail in Vericel's Annual Report on Form 10-K for the year ended December 31, 2018, filed with the Securities and Exchange Commission ("SEC") on February 26, 2019, Quarterly Reports on Form 10-Q and other filings with the SEC. These forward-looking statements reflect management's current views and Vericel does not undertake to update any of these forward-looking statements to reflect a change in its views or events or circumstances that occur after the date of this release except as required by law.
American Burn Association - ameriburn.org.
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