|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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|From: E_K_S||12/10/2019 9:47:29 AM|
|PGTI To acquire NewSouth Window Solutions|
Dec. 10, 2019 9:45 AM ET|About: PGT Innovations, Inc. (PGTI)|By: Jignesh Mehta, SA News Editor
PGT Innovations ( PGTI +0.7%) has signed a definitive agreement to acquire NewSouth Window Solutions for a purchase price of $92M in cash, subject to adjustments.
NewSouth is a manufacturer and installer of factory-direct, energy-efficient windows and doors, including both impact-resistant and non-impact residential products.
Sherri Baker, Senior Vice President and CFO of PGT Innovations: “NewSouth has a strong track record of sales growth and is forecasted to achieve net sales for 2019 in the range of ~$82M to $85M and EBITDA margin in the mid-teens, inclusive of acquisition synergies, with retail margins similar to PGTI’s legacy business, including solid margins in NewSouth’s non-impact product line”.
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|To: richardred who wrote (5714)||12/11/2019 1:42:23 PM|
|Added ENZ in quantity > 2.63. ENZ Management has made a move to create shareholder value by possibly monetizing the Therapeutics unit. The stock made a blip up late yesterday. IMO with thoughts the company might sell itself. This wasn't the case and the stock pull back today, and then some. I doubt this monetizing effort of the Therapeutics unit would have happened without Harbert Discovery Fund pushing. Given the court awards this company has previously received. IMO the unit might attract interest, or an outright bid for the whole company? If no hypothetical bid comes. I can hold till improvement comes. Either through a lucrative venture with a big partner, or new model conditions leading the way to profitability .|
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|From: E_K_S||12/12/2019 8:35:25 AM|
|Nestle unloads U.S. ice cream business|
Dec. 11, 2019 1:52 PM ET|About: Nestlé S.A. (NSRGY)|By: Clark Schultz, SA News Editor
Nestle ( OTCPK:NSRGY) says it plans to sell its U.S. ice cream business to its joint venture with PAI Partners.
The sale of the business to Froneri is being completed at a transaction value of $4B.
"The creation of Froneri has been a phenomenal success. We are now making this business our global strategic partner in ice cream and are convinced that Froneri’s successful business model can be extended to the U.S. market. With this transaction, we are taking a decisive step towards our goal of achieving global leadership in ice cream," says Nestle CEO Mark Scheider.
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|To: E_K_S who wrote (5719)||12/12/2019 10:17:10 AM|
|I always wondered if Nestles would go after the J.M. Smucker Company? This After the Starbucks purchase.|
|To: richardred who wrote (4560)||5/5/2018 11:27:14 AM|
|From: richardred||1 Recommendation Read Replies (3) of 5720|
|JVA- Speculation |
Nestles making a move on Coffee. JVA makes a small niche acquisition for themselves. The Steep N Brew Coffee Company which they say is profitable.
Nestle close to deal for Starbucks bagged coffee, drinks business: report
LONDON (Reuters) - Nestle ( NESN.S), the world’s largest coffee company, is close to a deal with Starbucks Corp ( SBUX.O) for the part of its business that sells bagged coffee and drinks in supermarkets, according to media reports on Friday.
Any deal between the coffee giants would not involve any of the Seattle-based chain’s more than 28,000 cafes, according to Bloomberg, which reported the news after Swiss financial blog Inside Paradeplatz.
The deal could net Starbucks $3.8 billion after tax, according to Cowen analysts, based on Starbucks’ operating earnings excluding its K-Cups and the multiple recently paid for Keurig Green Mountain. They predicted Starbucks would use that to buy back shares.
An agreement will probably be announced on Monday, Bloomberg said.
JVA speculation- Nestles picked up Blue Bottle. The pickings are getting slim on the coffee front. JVA just a drop and still working on branding and Comfort acquisition. Still wondering if it will be good till the last drop. However I've like the Coffee Holding's Sonofresco acquisition from the get go. The board has approved a share repurchase program of up to $2M on this low outstanding stock. IMO a value sign on a hypothetical family private bid. JAB went on a endless coffee and related coffee acquisition spree. I expect Nestles to do the same. JAB/Green Mountain’s Keurig has the lions share of the self brewing market. Nespresso has very little in the US. I can see them going after this market. Green Mountain was JVA's largest customer. They've almost weened them off. IMO Nestles can just buy JVA as a R&D experiment and expand Sonofresco and have JVA fill their high end Nespresso cups? FARM on my watch list. It's speculative fever has gone up considerably IMO. Nestles has a stake in L'Oreal who's founder just passed away. Just maybe they cash out to fund a US acquisition spree in complimenting growth and market share moves.
P.S. COTT just sold it beverage business for over a billion. PR snip>The company also will pursue small acquisitions in water, coffee, tea and filtration, as well as “larger-scale acquisitions if and when the right value-enhancing opportunities present themselves,” CEO Jerry Fowden said.
With Blue Bottle, Nestlé eyes high-end challenge to Starbucks
Established in 2002, Blue Bottle has built its reputation on hand-drip coffee, which costs more than US$10 a cup. It’s a favorite of Silicon Valley techies, who have dubbed it “the iPhone of the coffee industry”.
With less than 40 outlets, the boutique coffee chain has reportedly sold a controlling stake to Swiss food and beverage giant Nestlé for around US$500 million.
|To: richardred who wrote (4563)||9/30/2017 9:57:33 AM|
|From: richardred|| Respond to of 5719|
| What next for L’Oréal? Speculation builds over Nestle ownership following Bettencourt’s death September 25, 2017 Written by Georgina Caldwell |
Speculation is growing over the ownership of L’Oréal following the death of heiress Liliane Bettencourt, according to a report published by Reuters.
Bettencourt’s family owns 33 percent of the French cosmetics behemoth, while Nestle holds a 23 percent stake. An agreement between the two, which prevents either from increasing their stake and has been in place for 43 years, is due to expire within six months.
Several analysts are speculating that L’Oréal will buy in Nestle’s stake, with activist investor Third Point urging the company to dispose of its investment in L’Oréal. Others are predicting that Nestle may see an opportunity to up its shareholding. Both companies declined to comment, while Bettencourt’s daughter, Francoise Bettencourt-Meyers, has commented that the family remains committed to L’Oréal and its management.
Nestlé spares L’Oréal in $10 billion profit-boosting revamp September 27, 2017 Written by Louise Prance Miles
Nestlé has announced a $10 billion company revamp in a bid to boost profitability with the company said to be ‘actively managing’ its product line-up. However, its L’Oréal investment is said to be secure, for now.
Nestlé activist investor Dan Loeb from Third Point is said to have set out a strategy for the company to engage in a profit strategy over the scale of the business, with Nestlé Chief Executive Officer Mark Schneider thought to have agreed to plans.
However, Schneider stopped short of divesting the company’s 23 percent stake in L’Oréal, which he said was a ‘fabulous’ investment stating its approach to company is 'currently' not changing. The announcement follows speculation over the company’s share in the company following the death of Liliane Bettencourt last week.
The move heralds a shift from its known sales-focused strategy, with the company aiming for underlying trading operating profit margins between 17.5 and 18.5 percent by 2020, up 16 percent from 2016, according to the Financial Times. It will be the first time the company has a set a fixed profitability target.
Speaking at the Corinthia Hotel, London, Schneider stated that the company will focus on coffee, bottled water and pet care, with a move away from chocolate and sugary snacks, with selective investments and divestments said to affect around 10 percent of the business.
Speaking of the plan, Schneider stated, “We’ll need to trade out of some product areas and into others. We’ll act decisively, and the U.S. confectionery is a good example of that.”
The company’s skin-health business was another area the company was keen to develop, with the area being labelled a ‘strategic fit’, while the company will also cost-save in staffing with plans to reduce its seven sites in Paris down to just one, while also consolidating its Veyey operations.
It’s thought the adoption of a profit target by the US company is the start of a strong shift for large food companies as consumers continue to seek a greener angle to their mass-market buys. Meanwhile a strong push by investors to cut spends and develop into more lucrative areas is said to be on the up.
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