Scotts Miracle-Gro dragged down by Bayer woes

Bayer drags Scotts Miracle-Gro down after Monsanto weed killer ruling

Scotts Miracle-Gro dragged down by Bayer woes, Stockwinners
Scotts Miracle-Gro dragged down by Bayer woes, Stockwinners

Shares of Bayer (BAYRY) trading in New York are sliding after the recently acquired Monsanto was ordered to pay $289M by a California court, who found it liable in a lawsuit alleging that the company’s Roundup caused cancer.

Commenting on the news, JPMorgan analyst Richard Vosser told investors that the selloff in the shares is “significantly overdone” as he sees the potential for the verdict to be overturned on appeal and for the damage amount to be greatly reduced.

Meanwhile, his peer at Bank of America Merrill Lynch argued that the ruling adds cloud over an important product for Scotts Miracle-Gro (SMG).

ROUNDUP RULING

Last week, a jury found Monsanto, which was recently acquired by Bayer for $63B, liable in a lawsuit alleging that the company’s glyphosate-based weedkillers, including its Roundup brand, caused cancer.

The case against Monsanto is the first of more than 5,000 similar lawsuits across the U.S.

The jury at San Francisco’s Superior Court of California found that Monsanto had failed to warn school groundskeeper Dewayne Johnson and other consumers of the cancer risks posed by its weed killers, and awarded Johnson $250M in punitive damages and about $39M in compensatory damages.

Monsanto, which plans to appeal the verdict, has denied that glyphosate causes cancer and has contended that decades of scientific studies have shown the chemical to be safe for human use.

SELLOFF ‘SIGNIFICANTLY OVERDONE’

In a research note to investors, JPMorgan’s Vosser said he views the selloff in shares of Bayer after a California jury ordered the company’s Monsanto unit to pay $289M for not warning of cancer risks posed by its weed killer, Roundup, as “significantly overdone.”

The analyst added that he sees the potential for the verdict to be overturned on appeal and for the damage amount to be greatly reduced. Overall, Vosser believes current share levels of Bayer provide a good long-term buying opportunity and reiterated an Overweight rating on the name.

RULING ‘ADDS CLOUD’ OVER IMPORTANT PRODUCT

Also commenting on the California court’s ruling, BofA/Merrill analyst Christopher Carey pointed out in a research note of his own that while the product is owned by Monsanto, Scotts Miracle-Gro is the exclusive distributor/marketer of consumer Roundup in the U.S. and Canada, with the brand on track to be about 15% to FY18 profit, but less in FY19 as a 3-year term for $20M annual payments from Monsanto ends in FY18.

Carey noted that he does not expect a ban of glyphosate, but argued that the court decision nevertheless “adds a cloud” over a product which is important for Scotts Miracle-Gro.

While any additional impact from Roundup is unclear, this adds another layer to risks, he contended, highlighting that the company already must overcome a number of headwinds in 2019.

The analyst reiterated an Underperform rating and $74 price target on Scotts Miracle-Gro’s shares. Meanwhile, his peer at SunTrust told investors that there is likely no legal risk to Scotts Miracle-Gro from Friday’s jury verdict in California.

As part of the master agreement between Scotts and Monsanto signed three years ago, Scotts is indemnified from any litigation relating to the Roundup/glyphosate issue, analyst William Chappell pointed out.

Further, the analyst noted that the company is not listed as a defendant in any of the cases filed against Monsanto.

Nevertheless, Chappell estimates that Roundup represents roughly 10% of Scotts’ EBITDA, and believes sales could be impacted over the long-term from these trials.

The analyst reiterated a Buy rating and $100 price target on Scotts Miracle-Gro’s shares.

PRICE ACTION

In Monday morning trading, shares of Bayer in New York have dropped over 10% to $23.75, while Scotts Miracle-Gro’s stock has slipped 2.25% to $73.65.


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 EU ruling against Google seen as win for Amazon, Apple

EU antitrust ruling against Google seen as win for Amazon, Apple

 

 EU ruling against Google seen as win for Amazon, Apple, Stockwinners
EU ruling against Google seen as win for Amazon, Apple, Stockwinners

The EU has hit Alphabet-owned Google (GOOG; GOOGL) with a record antitrust fine for abusing the dominance of its Android mobile operating system.

Commenting on the decision, Baird analyst Colin Sebastian said he believes it to be a “pro-Amazon” (AMZN) ruling, benefiting the e-commerce giant and potentially Apple (AAPL) as well.

ANTITRUST FINE

The European Commission has fined Google EUR4.34B for breaching EU antitrust rules.

“Since 2011, Google has imposed illegal restrictions on Android device manufacturers and mobile network operators to cement its dominant position in general internet search. Google must now bring the conduct effectively to an end within 90 days or face penalty payments of up to 5% of the average daily worldwide turnover of Alphabet, Google’s parent company,” the Commission stated.

Google CEO Sundar Pichai, in response to the European Commission competition decision, stated that “rapid innovation, wide choice, and falling prices are classic hallmarks of robust competition and Android has enabled all of them.

Today’s decision rejects the business model that supports Android, which has created more choice for everyone, not less. We intend to appeal.”

‘PRO-AMAZON’ RULING:

In a research note to investors, Baird’s Sebastian argued that the European Commission’s ruling against Google is “a bit misguided,” but likely a “relatively minor inconvenience” in the short and medium terms.

Longer-term, the analyst said he sees modest but not unexpected added risk from requirements to support forked versions of Android, and from the direct and/or indirect benefits of this ruling for Apple and Amazon. In practical terms, the EC is saying that Android users need to download the Google apps they want rather than have them pre-installed and implicitly instructs Google to make its apps available on forked-version of Android, even if those apps won’t work as well or as intended on modified operating systems, he contended.

Sebastian believes this ruling should have a limited direct impact on Google since it ostensibly does not force a change to the Google search algorithm and seems relatively straight-forward for Google to comply. However, the bigger issue may be the obvious benefits to Amazon and potentially Apple, he argued.

The analyst pointed out that while Amazon already generates about 50% of commerce and product-related searches, the EC will require Android users to take another step before they can access an alternative product search engine. Additionally, to force Google to support distribution of forked-versions of Android could directly benefit Amazon’s Fire devices, he highlighted.

Nonetheless, the analyst noted that the decision does not change his positive view on Alphabet and reiterated an Outperform rating and $1,300 price target on shares of Google’s parent company.

PRICE ACTION

In morning trading, Class A shares of Alphabet and Amazon are each fractionally lower. Meanwhile, Apple’s stock has dropped almost 1% to $190.12.


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Arconic higher following report of private equity interest

Arconic higher following report of private equity interest

Arconic higher following report of private equity interest, Stockwinners
Arconic higher following report of private equity interest, Stockwinners

Shares of Arconic (ARNC) are rising following a report that the aluminum producer has received interest from private equity firms including Apollo Global Management (APO).

PE  INTEREST

Arconic has received takeover interest from private-equity firms, including Apollo Global, The Wall Street Journal reported Friday.

A deal for the aerospace parts maker, which currently has a market value of $8.3B, could be worth over $10B, but no buyout agreement is imminent, the report said.

The company, which also holds $6.4B in debt, has a tumultuous recent history, facing an activist investor campaign from Elliott Management after being separated from the aluminum business now known as Alcoa (AA) in 2016.

The campaign led to the resignation of former Arconic Chief Executive Officer Klaus Kleinfeld and an overhaul of the company’s board.

In addition, the company came under scrutiny after investigators discovered its aluminum composite panels contributed to the spread of a fire last year at London’s Grenfell Tower that killed 80 people.

At the time, Arconic said it had no control over how its products were used in the building.

‘PLAUSIBLE LBO CANDIDATE’

Following the WSJ report, Morgan Stanley analyst Rajeev Lalwani said two things stand out to make Arconic a “plausible” leveraged buyout candidate: Its low EV/EBITDA multiple, which creates potentially favorable entry and exit points, and its cash flow profile, which has room for improvement.

The analyst stated that a more lean and efficient approach could support considerably better cash generation.

While the reported private equity interest “adds a level of intrigue,” Lalwani still believes headwinds within it rings and disks business, working capital and CapEx issues and volatility associated with aluminum prices will be the key driver of shares in the near-term.

Given the aforementioned execution concerns, Lalwani kept an Equal Weight rating and $20 price target on Arconic shares.

‘VERY VIABLE LBO CANDIDATE’

Credit Suisse analyst Curt Woodworth said he views Arconic as a “very viable” leveraged buyout candidate given its “highly depressed” multiples, operational and financial mismanagement, and “very strong” positions in automotive and aerospace end markets.

The analyst believes the issues at Firth Rixson are “very fixable” as the company is a new entrant into the disks market and said Arconic could be worth $24-$26 per share in a buyout. Woodworth has an Outperform rating on the shares with a $28 price target.

WHAT’S NOTABLE

On Monday, Arconic announced it had signed a new long-term contract with Boeing (BA) to supply aluminum sheet and plate for all models produced by Boeing Commercial Airplanes.

The multiyear contract, which extends and adds to the companies’ 2014 contract, is the largest to date and captures growth in the build rate increases of the Boeing 737 program.

PRICE ACTION

Arconic rose about 10%, or $1.73, to $19.12 in morning.


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Pfizer shares lower after talk with President prompts rollback

Pfizer under pressure after talk with President prompts rollback

Pfizer shares lower after talk with President prompts rollback, Stockwinners
Pfizer shares lower after talk with President prompts rollback, Stockwinners

After speaking with President Donald Trump, Pfizer (PFE) stated that it will roll back its July 1 price increases “to give the president an opportunity to work on his blueprint to strengthen the healthcare system and provide more access for patients.”

Additionally this morning, the company announced that it will reorganize into three units, separating its consumer health-care business, which the drugmaker has been trying to sell since last year, from its groups focused on “innovative” medicines” and “established” medicines.

PRICE ROLLBACK

In a statement provided to CNBC’s Meg Tirrell yesterday, Pfizer said it will roll back its July 1 price increases “to give the president an opportunity to work on his blueprint to strengthen the healthcare system and provide more access for patients.”

The company released the statement following an “extensive discussion” with President Trump. Pfizer said it will return such prices to their pre-July 1 levels as soon as technically possible, and the prices will remain in effect until the earlier of when the president’s blueprint goes into effect or the end of the year. In addition, the drug giant said that the price declines the company took as of July 1 will remain in effect.

This comes after President Trump called out the company and other drugmakers for raising prices.

In a tweet, Trump previously said Pfizer and peers “should be ashamed that they have raised drug prices for no reason,” accusing the company and industry of “merely taking advantage of the poor and others unable to defend themselves, while at the same time giving bargain basement prices to other countries in Europe and elsewhere.”

BUSINESS REORGANIZATION

This morning, Pfizer also announced it will organize the company into three businesses, namely a science-based Innovative Medicines business that will now include biosimilars and a new hospital business unit for anti-infectives and sterile injectables; an off-patent branded and generic Established Medicines business operating with substantial autonomy within Pfizer; and a Consumer Healthcare business.

These changes will be effective at the beginning of the company’s 2019 fiscal year, and are not expected to impact current capital allocation priorities or full-year 2018 financial guidance.

READ-THROUGH TO OTHERS IN THE SECTOR

Commenting on the events, Wells Fargo analyst David Maris told investors that drug stocks will not react favorably to this news, given the chilling effect this will likely have on others looking to take price increases.

Nonetheless, the analyst pointed out that the price increases taken in July are only small compared to other increases taken over the past year or several years, so the impact of the rollback to the healthcare system is insignificant in the big picture.

Maris also added that he believes the administration’s and other key legislators’ focus is not only on drug pricing, but on the overall supply chain and delivery system, including drug rebating, co-pay coupons, etc.

WHAT’S NOTABLE

According to Bloomberg, Gilead (GILD), Roche (RHHBY), Novo Nordisk (NVO) and Novartis (NVS) have all sent notices to California health plans rescinding or reducing previously announced price hikes in the wake of a new drug pricing transparency law that was enacted in the state.

The California measure, which is among the most aggressive efforts by states to rein in drug costs, is being challenged in court by the drug industry’s lobbying group, the report noted.

Other large cap pharmaceutical companies include AstraZeneca (AZN), Bristol-Myers (BMY), Eli Lilly (LLY), GlaxoSmithKline (GSK), Johnson & Johnson (JNJ), Merck (MRK), and Sanofi (SNY).

PRICE ACTION

In morning trading, shares of Pfizer have dropped about 0.5% to $37.28.


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21st Century Fox boosts it’s offer for Sky

21st Century Fox boosts offer for Sky to GBP 14 or $32.5B 

21st Century Fox boosts it's offer for Sky , Stockwinners
21st Century Fox boosts it’s offer for Sky , Stockwinners

21st Century Fox (FOXA) and the Independent Committee of Sky PLC (SKYAY) announced that they have reached agreement on an increased recommended pre-conditional cash offer for the fully diluted share capital of Sky which Fox and its affiliates do not already own at a price of GBP 14.00 for each Sky share.

The price of GBP 14.00 per Sky share represents an increase of approximately 12% to the Comcast (CMCSA) offer price of GBP 12.50 per Sky share announced on April 25, Fox says in a statement.

Under the terms of the increased offer, Sky shareholders will be entitled to receive for each Sky share GBP 14.00 in cash.

The increased price includes an amount in lieu of a final dividend in respect of the financial year ended June 30, 2018.

It is intended that the acquisition will be implemented by means of a scheme of arrangement under applicable U.K. law.

The Sky Independent Committee announced that it intends to unanimously recommend that the Sky shareholders unaffiliated with 21st Century Fox vote in favor of the scheme and take no action in relation to the Comcast offer.

Fox currently anticipates that the acquisition will complete in Q3 of 2018.

Fox added that the Sky acquisition is not a condition to completion of the Disney (DIS) transaction.

Completion of the Sky acquisition will not affect the amount or form of consideration that stockholders of 21st Century Fox receive in the Disney deal, it said.

“We strongly believe that a combined 21CF and Sky will be a powerful driver for the continued growth and vibrancy of the UK and broader global creative industries.

The enhanced scale and capabilities of the combination will enrich Sky’s ability to continue on its mission for years to come, especially at a time of dynamic change in our industry.

This transformative transaction will position Sky so that it can continue to compete within an environment that now includes some of the largest companies in the world, but none of whom have demonstrated the same local depth of investment and commitment to the UK and to Europe,” added Fox.


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Bristol-Myers treatment for colorectal cancer approved

Bristol-Myers’ Opdivo approved for MSI-H/dMMR metastatic colorectal cancer

Bristol-Myers treatment for colorectal cancer approved, Stockwinners
Bristol-Myers treatment for colorectal cancer approved, Stockwinners

Bristol-Myers (BMY) announced Opdivo – nivolumab – 3 mg/kg plus low-dose Yervoy – ipilimumab – 1 mg/kg injections for intravenous use received approval from the FDA for the treatment of adult and pediatric patients 12 years and older with microsatellite instability high or mismatch repair deficient metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin and irinotecan.

Approval for this indication has been granted under accelerated approval.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

The application was granted Priority Review and Breakthrough Therapy Designation by the FDA.

Among the 82 patients who received prior treatment with a fluoropyrimidine, oxaliplatin and irinotecan, 46% responded to treatment with Opdivo + Yervoy.

The percentage of these patients with a complete response was 3.7%, and the percentage of patients with a partial response was 43%.

Among these 38 responders, the median DOR was not reached; 89% of those patients had responses of six months or longer, and 21% had responses of 12 months or longer.

This trial is ongoing. Among all enrolled patients, 49% responded to treatment with Opdivo + Yervoy; 4.2% experienced a complete response, while 45% experienced a partial response.

Opdivo was discontinued in 13% of patients and delayed in 45% of patients due to an adverse reaction.

Serious adverse reactions occurred in 47% of patients.

The Opdivo + Yervoy combination is also approved in two other tumor types, advanced renal cell carcinoma and unresectable or metastatic melanoma.

Continued approval for these accelerated approval indications may be contingent upon verification and description of clinical benefit in the confirmatory trials.

BMY closed at $56.18.


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Biogen sharply higher on data

Eisai and Biogen announce positive results of the final analysis for BAN2401

Biogen sharply higher on data, Stockwinners
Biogen sharply higher on data, Stockwinners

Eisai (ESALY) and Biogen (BIIB) announced positive topline results from the Phase II study with BAN2401, an anti-amyloid beta protofibril antibody, in 856 patients with early Alzheimer’s disease.

The study achieved statistical significance on key predefined endpoints evaluating efficacy at 18 months on slowing progression in Alzheimer’s Disease Composite Score and on reduction of amyloid accumulated in the brain as measured using amyloid-PET. Topline results of the final analysis of the study demonstrated a statistically significant slowing of disease progression on the key clinical endpoint after 18 months of treatment in patients receiving the highest treatment dose as compared to placebo.

Results of amyloid PET analyses at 18 months, including reduction in amyloid PET standardized uptake value ratio and amyloid PET image visual read of subjects converting from positive to negative for amyloid in the brain, were also statistically significant at this dose. Dose-dependent changes from baseline were observed across the PET results and the clinical endpoints.

Further, the highest treatment dose of BAN2401 began to show statistically significant clinical benefit as measured by ADCOMS as early as 6 months including at 12 months. BAN2401 demonstrated an acceptable tolerability profile through 18 months of study drug administration.

The most common treatment emergent adverse events were infusion-related reactions and Amyloid Related Imaging Abnormalities. Infusion related reactions were mostly mild to moderate in severity. Incidence of ARIA-E was not more than 10% in any of the treatment arms, and less than 15% in patients with APOE4 at the highest dose per the study protocol safety and reporting procedures.

BIIB closed at $298.81, it last traded at $338. ESALY closed at $71.10.


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Juniper Pharmaceuticals sold for $139.6 Million

Catalent agrees to acquire Juniper Pharmaceuticals for $11.50 per share 

Juniper Pharmaceuticals sold for $139.6 Million, Stockwinners
Juniper Pharmaceuticals sold for $139.6 Million, Stockwinners

Catalent (CTLT) announced that it has agreed to acquire Juniper Pharmaceuticals (JNP), including its Nottingham, U.K.-based Juniper Pharma Services division.

When combined with Catalent’s existing industry-leading drug development and manufacturing capabilities in the U.S. and Europe, the acquisition of Juniper will expand and strengthen Catalent’s offerings in formulation development, bioavailability solutions and clinical-scale oral dose manufacturing, and will complement its integrated global clinical and commercial supply network. Juniper’s nearly 150 employees have deep scientific expertise in formulation development, and supply, and will augment Catalent’s current portfolio of solid-state screening, preformulation, formulation, analytical, and bioavailability enhancement solutions, including development of spray-dried dispersions, with integrated development, analytical, and clinical manufacturing co-located in its Nottingham facility.

Catalent will continue to support Juniper’s CRINONE franchise marketed by Merck KGaA outside of the U.S.

Juniper’s Intravaginal Ring development pipeline was previously licensed to Dare Bioscience, and Catalent will not be involved in the further development of this program.

The acquisition of Juniper is subject to certain customary closing conditions, including that a majority of Juniper’s shares are tendered into the offer, and is expected to close in the first quarter of Catalent’s 2019 fiscal year, which began on July 1, 2018.

Like Catalent, Juniper has expertise in solid-state and preclinical formulation screening for lead-candidate selection, phase-appropriate dose-form development, and superior technologies for challenging molecules, which will strengthen and expand on Catalent’s OptiForm Solution Suite platform.

Juniper provides bioavailability enhancement solutions for the development of poorly soluble compounds, including nano-milling, spray drying, hot-melt extrusion, lipid-based drug delivery, and cGMP clinical manufacturing, including specialized facilities and controls for potent and controlled substances. Under its acquisition agreement with Juniper, a subsidiary of Catalent will promptly commence a tender offer to purchase all of Juniper’s shares for a price of $11.50, net to the seller in cash.

Following the conclusion of the tender offer, Catalent intends to complete the transaction by acquiring the remainder of the Juniper shares at the same price through a merger with a newly formed wholly owned subsidiary of Catalent.

JNP closed at $8.70. CTLT closed at $41.82.


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Compugen Higher as FDA lifts clinical hold on its cancer treatment 

Compugen Higher as FDA lifts clinical hold on its cancer treatment 

Compugen Higher as FDA lifts clinical hold on its cancer treatment , Stockwinners
Compugen Higher as FDA lifts clinical hold on its cancer treatment , Stockwinners

Shares of Compugen (CGEN) surged in pre-market trading after the Israeli biotech company said that the clinical hold on its investigational new drug application for COM701 was lifted by the U.S. Food and Drug Administration.

Separately, Compugen said the FDA cleared Bayer’s (BAYRY) IND application for BAY 1905254.

CLINICAL HOLD LIFTED

Compugen said this morning that the FDA has lifted the clinical hold on its IND for COM701, an immuno-oncology therapeutic antibody targeting PVRIG in patients with advanced solid tumors.

The FDA said the company may now begin a clinical study of the antibody. PVRIG is an investigational monoclonal antibody, a molecule that has the ability to bind with high specificity to a given target, being developed by Compugen to treat various types of cancer.

“We believe the COM701 preclinical data suggest that targeting PVRIG may effectively stimulate an anti-tumor immune response in certain cancers such as breast, endometrial, ovarian and lung, and specifically in patient populations that are unresponsive to current checkpoint inhibitors,” Compugen President and Chief Executive Officer Anat Cohen-Dayag stated.

Looking ahead, Compugen said it plans to initiate a first-in-human Phase 1 study in the U.S. in patients with advanced solid tumors and for whom standard of care therapies are currently ineffective.

In April, Compugen said the FDA requested additional CMC information from the company in support of the COM701 IND application.

At the time, the FDA recommended a lower starting dose of COM701 for the trial.

BAYER IND APPLICATION CLEARANCE

Additionally this morning, Computgen said that the FDA approved Bayer’s (BAYRY) IND application for BAY 1905254, a a first-in-class immuno-oncology therapeutic antibody targeting the ILDR2 protein in patients with advanced solid tumors.

Compugen is entitled to receive a milestone payment upon the first patient dosing with BAY 1905254 in the Phase 1 clinical trial expected in 2018.

PRICE ACTION

In pre-market trading, Compugen is up 45c, or 13.6% to $3.75 per share.


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Novartis receives positive CHMP opinion for Kymriah

Novartis receives positive CHMP opinion for Kymriah

Novartis receives positive CHMP opinion for Kymriah, Stockwinners
Novartis receives positive CHMP opinion for Kymriah, Stockwinners

Novartis (NVS) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion recommending approval of Kymriah – a novel one-time treatment that uses a patient’s own T cells to fight cancer.

The positive opinion includes two B-cell malignancies: B-cell acute lymphoblastic leukemia that is refractory, in relapse post-transplant or in second or later relapse in patients up to 25 years of age; and diffuse large B-cell lymphoma that is relapsed or refractory after two or more lines of systemic therapy in adults.

If approved by the European Commission, Kymriah will be the first CAR-T cell therapy available in the European Union for both DLBCL and B-cell ALL.

Both B-cell ALL and DLBCL are aggressive malignancies with significant treatment gaps for patients.

In Europe, ALL accounts for approximately 80% of leukemia cases among children, and for those patients who relapse, the outlook is poor. This low survival rate is in spite of patients having to undergo multiple treatments, including chemotherapy, radiation, targeted therapy or stem cell transplant, and further highlights the need for new treatment options.

DLBCL is the most common form of non-Hodgkin lymphoma, accounting for up to 40% of all cases globally.

For patients who relapse or don’t respond to initial therapy, there are limited treatment options that provide durable responses, and survival rates are low for the majority of patients due to ineligibility for autologous stem cell transplant or because salvage chemotherapy or ASCT have failed.

The positive CHMP opinion is based on two pivotal Novartis-sponsored global, multi-center, Phase II trials, ELIANA and JULIET, which included patients from Europe, the US, Australia, Canada and Japan. The collaboration of Novartis and the University of Pennsylvania has led to historic milestones in CAR-T cell therapy since 2012, including the initiation of the first global CAR-T trials, the PRIME designation granted by the EMA for Kymriah in pediatric patients with r/r B-cell ALL, and the approval of Kymriah in two distinct indications by the US Food and Drug Administration.

ELIANA is the first pediatric global CAR-T cell therapy registration trial, treating patients in 25 centers in the US, Canada, Australia, Japan and the EU, including: Austria, Belgium, France, Germany, Italy, Norway and Spain. JULIET is the first multi-center global registration study for Kymriah in adult patients with r/r DLBCL.

JULIET is also the largest global study evaluating a CAR-T cell therapy in patients with DLBCL, enrolling patients from 27 sites in 10 countries across the US, Canada, Australia, Japan and the EU, including: Austria, France, Germany, Italy, Norway and the Netherlands.

The Novartis CAR-T cell manufacturing platform includes cryopreservation, the process of freezing patients’ harvested cells in order to preserve them, which provides physicians with the flexibility to decide when to initiate both the harvesting of patients’ cells and the infusion of Kymriah, based on each patient’s condition, and allows for this individualized treatment approach on a global scale.

The European Commission will now review the CHMP recommendation to deliver its final decision, applicable to all 28 EU member states, plus Iceland, Liechtenstein and Norway.

NVS closed at $73.00, it last traded at $75.50.


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Tariffs kill jobs

European Union raises tariffs on Harley-Davidson to 31% from 6%

Harley-Davidson to move productions overseas to avoid tariffs

Harley-Davidson moves some productions out of U.S., Stockwinners
Harley-Davidson moves some productions out of U.S., Stockwinners

The European Union has enacted tariffs on various U.S.-manufactured products, including Harley-Davidson motorcycles (HOG).

These tariffs, which became effective June 22, 2018, were imposed in response to the tariffs the U.S. imposed on steel and aluminum exported from the EU to the U.S. Consequently, EU tariffs on Harley-Davidson motorcycles exported from the U.S. have increased from 6% to 31%.

Harley-Davidson expects these tariffs will result in an incremental cost of approximately $2,200 per average motorcycle exported from the U.S. to the EU.

Harley-Davidson believes the tremendous cost increase, if passed onto its dealers and retail customers, would have an immediate and lasting detrimental impact to its business in the region, reducing customer access to Harley-Davidson products and negatively impacting the sustainability of its dealers’ businesses.

Therefore, Harley-Davidson will not raise its manufacturer’s suggested retail prices or wholesale prices to its dealers to cover the costs of the retaliatory tariffs. In the near-term, the company will bear the significant impact resulting from these tariffs, and the company estimates the incremental cost for the remainder of 2018 to be approximately $30M-$45M.

On a full-year basis, the company estimates the aggregate annual impact due to the EU tariffs to be approximately $90M-$100M.

To address the substantial cost of this tariff burden long-term, Harley-Davidson will be implementing a plan to shift production of motorcycles for EU destinations from the U.S. to its international facilities to avoid the tariff burden. Harley-Davidson expects ramping-up production in international plants will require incremental investment and could take at least 9 to 18 months to be fully complete.

Harley-Davidson maintains a strong commitment to U.S.-based manufacturing which is valued by riders globally.

Increasing international production to alleviate the EU tariff burden is not the company’s preference, but represents the only sustainable option to make its motorcycles accessible to customers in the EU and maintain a viable business in Europe. Europe is a critical market for Harley-Davidson.

In 2017, nearly 40,000 riders bought new Harley-Davidson motorcycles in Europe, and the revenue generated from the EU countries is second only to the U.S.

Harley didn’t specify which international plants will boost output for EU markets. The company operates manufacturing facilities in Brazil, India and Australia, and is beginning production in Thailand this year.

HOG closed at $44.21, it last traded at $42.50.


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Tesaro could be sold shortly

Analysts weigh in on Tesaro buyout value amid report of Roche interest 

 

Tesaro could be sold soon, Stockwinners
Tesaro could be sold soon, Stockwinners

According to a report by Intereconomia, Roche (RHHBY) is working with Citibank on a potential acquisition of Tesaro (TSRO).

While both companies are not commenting on the article, Citi analyst Robyn Karnauskas said Tesaro could be valued at $140-$213 per share in an M&A situation, while her peer at Suntrust sees a potential buyout value range of $109-$196.

INTERECONOMIA REPORT

Spanish media group Intereconomia reported that Roche, following its acquisition of Foundation Medicine (FMI) (see our blog here), is working with Citibank on a potential deal to buy Tesaro.

Earlier this month Tesaro entered into a clinical collaboration with Roche unit Genentech to evaluate the combination of the PD-L1 antibody atezolizumab.

Intereconomia, citing sources close to the situation, added that Roche could announce the acquisition of Tesaro in the coming days.

Tesaro said it does not “comment on market rumors,” while Roche gave a similar answer to Bloomberg.

TESARO TAKEOUT VALUE

In a research note to investors this morning, Citi’s Karnauskas said that her M&A analysis for Tesaro suggests the company could be valued at $140-$213 per share in a takeover scenario.

Karnauskas noted, however, that she does not assign any value to Zeluja expansion opportunities in platinum resistant ovarian cancer and metastatic castration resistant prostate cancer.

The analyst reiterated a Buy rating and $100 price target on Tesaro shares.

Meanwhile, SunTrust analyst Peter Lawson told investors that his takeover analysis suggests a potential buyout value of $153 per share for Tesaro, with a range of $109-$196.

The analyst argued that Intereconomia’s report could also be a potential positive for the biotechnology space, mainly Clovis Oncology (CLVS) and oncology peers.

Lawson reiterated a Buy rating and $150 price target on Tesaro’s shares.

PRICE ACTION

In Wednesday afternoon trading, shares of Tesaro have gained almost 15% to $45.92, while Roche’s stock has advanced over 2% to $27.11 and Clovis shares are up 5% to $48.10.


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Foundation Medicine sold for $2.4 billion

Roche acquires Foundation Medicine for $137 per share or $2.4B

Foundation Medicine sold or $2.4B, Stockwinners
Foundation Medicine sold or $2.4B

Roche (RHHBY) and Foundation Medicine (FMI) announced they have entered into a definitive merger agreement for Roche to acquire the outstanding shares of Foundation Medicine not already owned by Roche and its affiliates at a price of $137.00 per share in cash.

This corresponds to a total transaction value of $2.4B on a fully diluted basis, and a total company value of $5.3B on a fully diluted basis. This price represents a premium of 29% to FMI’s closing price on June 18.

The merger agreement has been unanimously approved by the board of Roche and a Special Committee of the independent directors of FMI and by its full board of directors with the Roche designated directors abstaining from the deliberations and vote.

All current members of the FMI board have indicated that they intend to tender their FMI shares in the tender offer. Under the terms of the merger agreement, Roche will promptly commence a tender offer to acquire all of the outstanding shares of FMI’s common stock not already owned.

The closing of the tender offer will be subject to a majority of FMI’s outstanding shares not already held by Roche being tendered in the tender offer, it noted.

In addition, the transaction is subject to other customary closing conditions. Following completion of the tender offer, Roche will acquire all remaining shares at the same price of $137 per share through a second step merger.

The closing of the transaction is expected to take place in the second half of 2018. Daniel O’Day, CEO Roche Pharmaceuticals, said, “This is important to our personalised healthcare strategy as we believe molecular insights and the broad availability of high quality comprehensive genomic profiling are key enablers for the development of, and access to, new cancer treatments.

We will preserve FMI’s autonomy while supporting them in accelerating their progress.”

FMI closed at $106.45. RHHBY closed at $26.39.


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Bluebird Bio reports data from Phase 1 HGB-206

Bluebird Bio reports interim data from Phase 1 HGB-206 study of LentiGlobin

https://stockwinners.com/
Bluebird Bio reports interim data from Phase 1 HGB-206 study of LentiGlobin

bluebird bio (BLUE) announced new interim data from the ongoing HGB-206 Phase 1 multicenter clinical study of LentiGlobin investigational gene therapy in patients with severe sickle cell disease will be presented in an oral presentation on Saturday, June 16 at the 23rd Congress of the European Hematology Association by Julie Kanter, M.D., Medical University of South Carolina, Charleston, South Carolina.

“The consistent production of increased amounts of anti-sickling HbAT87Q in the Group C patients reflects the substantial positive impact of the changes introduced with the amended HGB-206 study protocol and refined manufacturing process.

All four Group C patients with greater than or equal to three months follow-up are making over 30 percent anti-sickling HbAT87Q.

The first patient treated, now with six months of follow-up, is producing over 60 percent anti-sickling HbAT87Q with a normal total hemoglobin level of 14.2 g/dL,” said David Davidson, M.D., chief medical officer, bluebird bio.

“The upward trajectory in Group C at these early time points suggests the potential for these patients to exceed the initially proposed therapeutic target of 30 percent anti-sickling HbAT87Q. We continue to define the development plan with regulatory authorities, and with further follow-up, we hope to see even higher levels of HbAT87Q, as well as sustained clinical benefit for patients.”

“The early data from Group C patients are very exciting and provide increasing confidence that LentiGlobin has the potential to deliver transformative benefit to patients. The longer-term data from patients treated earlier in the study show that levels of anti-sickling HbAT87Q in patients with SCD treated with LentiGlobin remain stable for at least two years,” said Dr. Kanter, a lead investigator of the HGB-206 study.

“Treatment options that can address the underlying cause of sickle cell disease are limited and LentiGlobin gene therapy has the potential to prevent or substantially reduce damaging symptoms associated with this debilitating disease.”

Separately, bluebird bio announced that new data from the completed Phase 1/2 Northstar (HGB-204) study in adolescents and adults with transfusion-dependent beta-thalassemia and any genotype, and its ongoing, Phase 3 Northstar-2 (HGB-207) multicenter clinical study of LentiGlobin investigational gene therapy in patients with TDT and non-beta0/beta0 genotypes, will be presented in an oral session on June 16 at the 23rd Annual Congress of the European Hematology Association by Franco Locatelli, M.D., Ph.D., of the IRCCS Ospedale Pediatrico Bambino Gesu of Rome, Italy.

“The maturing data from HGB-204 and HGB-207 suggest that one-time treatment with LentiGlobin may address the underlying genetic cause of TDT.

With our refined manufacturing process, the majority of patients with TDT and non-beta0/beta0 genotypes are transfusion-free and producing total hemoglobin at normal or near-normal levels,” said David Davidson, M.D., chief medical officer, bluebird bio.

“We are on track to submit a marketing authorization application in the European Union later this year, and we continue to work closely with clinical investigators and regulatory authorities to complete our ongoing clinical trials and bring this important treatment option to patients as soon as possible.”

“Consistently higher in vivo vector copy numbers and HbAT87Q hemoglobin levels in patients indicate that LentiGlobin manufacturing refinements have resulted in improved gene therapy characteristics and may enable sustained transfusion independence for a great majority of patients,” said Professor Locatelli, the lead investigator of the Northstar-2 study.

“Further, we are now seeing more than three years of data from the Northstar study indicating that LentiGlobin therapy may enable long-term transfusion independence in the majority of patients with non-beta0/beta0 genotypes.

These results hold the promise to change the natural history of many patients with this severe genetic disorder of hemoglobin production.”

BLUE closed at $197.00. It last traded at $204.65.


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BAE Systems receives contract for submarines

BAE Systems receives contract for payload tubes for Virginia-class submarines 

BAE Systems receives contract for submarines, Stockwinners
BAE Systems receives contract for submarines

BAE Systems (BAESY) has received a contract to produce payload tubes for two of the U.S. Navy’s new Virginia-class submarines to support increased firepower on the Block V version of the attack subs.

Under the contract with General Dynamics Electric Boat, a builder of the Virginia class, BAE Systems will deliver two sets, each consisting of four tubes, for the Virginia Payload Modules on the SSN 804 and SSN 805.

The Virginia Payload Module extends the length of the Block V submarines over previous versions of the Virginia-class by adding an additional mid-body section to create more payload space for greater firepower.

Each large-diameter payload tube can store and launch up to seven Tomahawk cruise missiles.

The VPM offers exceptional flexibility as well for the integration of future payload types, such as unmanned systems or next-generation weapons.

BAE Systems, which is also providing payload tubes for the SSN 803 under a previously awarded VPM contract, has a long history of supporting the Navy’s submarine fleet as the leading provider of propulsors and other submarine systems.

The company was selected to provide propulsors, spare hardware, and tailcones for Block IV Virginia-class vessels and stands ready to provide the same support for the Block V subs.

Under this most recent contract, BAE Systems will also develop the processes and tooling necessary for the Block V payload tube production.

Work will be performed at the company’s facility in Louisville, Kentucky, with deliveries scheduled to begin in 2020.

BAESY last traded at $35.39


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