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Wednesday, October 16, 2019

Bayer expects significant surge in number of U.S. glyphosate cases

Bayer expects the number of claims in the United States related to Roundup herbicide to have surged in the third quarter, as the German drugs and pesticides maker tries to reach a settlement after earlier court rulings against it.

“With the substantial increase in plaintiff advertising this year, we expect to see a significant surge in the number of plaintiff filings over the third quarter,” the company said in a written statement.
Bayer, which acquired Roundup and other glyphosate-based weed killers as part of its $63 billion takeover of Monsanto last year, faces potentially heavy litigation costs as plaintiffs claim Roundup causes cancer, something Bayer disputes. [nL8N25520Y]
Bayer’s shares have lost about 30% of their value since last August when a California jury in the first such lawsuit found Monsanto should have warned of the alleged cancer risks.
The drugmaker said in July that the number of U.S. plaintiffs in the litigation had risen to 18,400 and it is due to provide an update on Oct. 30, along with quarterly earnings.
Analysts at JP Morgan, citing an analysis of Missouri court data, said in an Oct. 9 research note that the total number of glyphosate cases could rise to more than 45,000.
However, several lawsuits have been delayed recently as mediator Ken Feinberg tries to negotiate a settlement.[nL5N26R0MN]
The increase “may reflect a campaign by plaintiffs’ lawyers and lead generators to increase the volume of plaintiffs as quickly as possible in connection with that process,” Bayer said, adding that the number of plaintiffs was not an indication of the merits of these cases.
Bayer has previously said that cases where lawyers expect to win the highest damages tend to be filed first.
The head of Bayer’s Crop Science unit, Liam Condon, already flagged a likely increase in the number of cases in a newspaper interview earlier this month, citing the prospect of a settlement and lawyers’ efforts to recruit new plaintiffs via media campaigns.
Bayer, which says regulators and extensive research have found glyphosate to be safe, has previously said it was banking on U.S. appeals courts to reverse or tone down three initial court rulings that have so far awarded tens of millions of dollars to each plaintiff.

https://www.marketscreener.com/BAYER-AG-436063/news/Bayer-expects-significant-surge-in-number-of-U-S-glyphosate-cases-29383519/

Citron Calls Bausch Health — Formerly Valeant — The ‘Textbook Turnaround’

Three years after Citron Research called Valeant the “pharmaceutical Enron,” the firm said Tuesday that it’s time to give Valeant successor Bausch Health Companies Inc BHC the credit it is due for its rebranding and turnaround efforts.

Turnaround Story

On Tuesday, Citron Research’s Andrew Left said CEO Joe Papa has done a spectacular job since taking over less than four years ago.

In the past three years alone, management has paid down about $8 billion in debt, vastly improving the company’s balance sheet and putting them in a position of financial flexibility.
“In 2019, the debt has become manageable and the company is gaining momentum with recent, successful launches of new drugs, consistent with its ‘pivot to offense,’” Left said.

‘Bausch Is Not Valeant’

Bausch has now reported six consecutive quarters of organic revenue growth, and Left said the company is likely positioned to significantly exceed consensus 2020 revenue and earnings expectations.
Wall Street also doesn’t seem to be appreciating just how much of a blockbuster Doubrii will be, he said.
“While initially criticized as just another ‘combination drug’ with no widespread appeal or reimbursements, in just the past six months, Duobrii has become the most successful dermatology drug launch in the last 10 years for ANY dermatology product in the U.S.”
After several years of skeptical observation, Left is is convinced Bausch deserves credit for its turnaround.
“The new Bausch Health is not Valeant, and investors have an opportunity to buy a well-diversified pharmaceutical company with durable products and a healthy pipeline under a world-class management team that has proven their honesty and dedication,” he said.
Citron set a $40 price target for Bausch stock, suggesting nearly 100% upside from recent levels.

Benzinga’s Take

Once a company like Valeant/Bausch is hit by accounting/financial scandals, its actions and balance sheet will be analyzed by the market with a fine-toothed comb.
Citron’s confidence that Bausch is now walking the straight-and-narrow path is reassuring to investors. The only question mark will be whether the sour taste of the Valeant fiasco will linger in investor’s minds and continue to suppress the stock’s valuation over time.
https://www.benzinga.com/analyst-ratings/analyst-color/19/10/14597045/citron-calls-bausch-health-formerly-valeant-the-textbook-turnaround

Axsome started at Buy by Guggenheim

Target $48
https://www.benzinga.com/stock/AXSM/ratings

Assembly Biosciences started at Buy by Mizuho

Target $20
https://www.benzinga.com/stock/ASMB/ratings

Ipsen in-licenses Blueprint Medicines BLU-782

Ipsen (OTCPK:IPSEY) subsidiary Clementia Pharmaceuticals and Blueprint Medicines (NASDAQ:BPMC) have entered into an exclusive, worldwide license agreement for the development and commercialization of BLU-782, an oral, highly selective investigational ALK2 inhibitor being developed for the treatment of fibrodysplasia ossificans progressiva (FOP).
Subject to the terms of the license agreement, Blueprint Medicines will be eligible to receive up to $535M in upfront, milestone and other payments, including an upfront cash payment of $25M and up to $510M in milestone payments, plus tiered percentage royalties ranging from the low- to mid-teens.
https://seekingalpha.com/news/3506031-ipsen-licenses-blueprint-medicines-bluminus-782-treatment-fop

ViiV Healthcare files U.S. application for expanded use of HIV med Dovato

ViiV Healthcare has submitted a supplemental marketing application to the FDA seeking approval to use Dovato (dolutegravir and lamivudine) as a switch treatment for HIV-1 infection in virologically suppressed adults on a stable antiretroviral regimen with no treatment failure.
The FDA approved the drug in April for the treatment of HIV-1 infection in adults with no antiretroviral treatment history and with no known resistance to either DTG or 3TC.
ViiV Healthcare is the HIV-focused joint venture between GlaxoSmithKline (NYSE:GSK), Pfizer (NYSE:PFE) and Shionogi (OTCPK:SGIOY).
https://seekingalpha.com/news/3506056-viiv-healthcare-files-u-s-application-expanded-use-hiv-med-dovato

Incyte’s Jakafi successful in late-stage Graft v Host Disease study

Incyte (NASDAQ:INCY) announces a successful outcome from a Phase 3 clinical trial, REACH2, conducted by licensee Novartis (NYSE:NVS), evaluating Jakafi (ruxolitinib) in patients with steroid-refractory acute graft-versus-host disease (GvHD).
The study met the primary endpoint of overall response rate (ORR) at day 28 compared to best available therapy.
Data analyses are ongoing. The results will be submitted for presentation at a future medical conference. Novartis plans to initiate discussions with ex-U.S. regulatory authorities in 2020 regarding marketing applications.
The FDA approved Jakafi for GvHD in May.
Incyte markets Jakafi in the U.S. while Novartis owns marketing rights ex-U.S.
https://seekingalpha.com/news/3506061-incytes-jakafi-successful-late-stage-gvhd-study