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Saturday, December 8, 2018

Altria: Seeks Growth With Edgy Bets


Marlboro maker set to invest in vaping, cannabis
Altria Group Inc., faced with slumping cigarette sales and the threat of new federal regulations, is placing some big bets in search of growth beyond dominant its Marlboro brand.
On Friday, the biggest U.S. tobacco company said it would invest $1.8 billion in a Canadian marijuana grower, pushing into a nascent business that is illegal on the federal level in the U.S. but could unlock international markets.
Altria also said it would discontinue its e-cigarette alternatives to its familiar Marlboro, Virginia Slims and Parliament cigarettes. Altria has been developing and marketing e-cigarettes for years but failed to get traction with consumers.
The tobacco company isn’t giving up on the vaping business that threatens to undermine its roughly $20 billion in annual cigarette revenue. Altria is in talks to invest billions of dollars to take a significant stake in Juul Labs Inc., acontroversial but fast-growing San Francisco e-cigarette startup, according to people familiar with the matter.
Although Altria dominates U.S. cigarette sales with 46% of the market, the Richmond, Va., company is under pressure to shift strategies because of the decline in adult smokers and a proposed U.S. ban on menthol-flavored cigarettes. Its shares have declined more than 20% this year.
It has been “an exceedingly challenging year as growth from e-cigarettes, and Juul in particular, seem to finally be weighing on cigarette consumption,” Cowen analyst Vivien Azer said.
For years, Altria and its U.S. rivals have been able to boost profits, despite falling cigarette volumes, by raising prices . But the surge in e-cigarette sales over the past year threatens to further shrink the pool of adult smokers and undercut cigarette pricing.
For the year ended Nov. 17, Altria’s cigarette volumes fell 4.5%, and the rate steepened to 7.6% in the most recent four weeks, according to a Wells Fargo analysis of Nielsen data. Altria’s long-term cigarette volume forecast had been a decline of between 3% and 4%.
Altria CEO Howard Willard, in an October conference call, attributed the accelerated decline to higher gas prices, which reduce discretionary spending, and e-cigarettes’ growing popularity. “It’s hard to tell how long it’s going to persist,” he said of the slide. “I think we’re going to have to wait and see what happens with both gas prices…and whether or not the growth rate of e-vapor slows down.”
A significant investment in Juul, which has captured roughly three-quarters of the U.S. e-cigarette market, would be one way to counter the slide. It would come at a steep price: Juul, with roughly $2 billion in sales, was valued at $16 billion in a funding round over the summer.
Altria’s own e-cigarette brands, MarkTen and Green Smoke, had captured just a small slice of the market. On Friday, Altria said it would take a $200 million charge to discontinue that business and its Verve nicotine gum.
“We do not see a path to leadership with these particular products and believe that now is the time to refocus our resources,” Mr. Willard said in a news release. He said the company is still committed to e-cigarettes and other cigarette alternatives.
Altria is awaiting Food and Drug Administration approval of a heat-not-burn tobacco product called IQOS, which it hopes to market in the U.S. in a partnership with Philip Morris International. The companies say the device is less harmful than cigarettes.
Mr. Willard, a 26-year company veteran, took over as Altria’s chairman and CEO in May. He played a role in the company’s 2009 acquisition of smokeless tobacco company UST Inc. and its 2007 acquisition of cigar maker John Middleton.
Altria’s discussions with Juul have met resistance within the startup, which pitches itself as an alternative to big tobacco but has come under fire for the popularity of its fruit-flavored products with teens. In response to a surge in underage use, the FDA recently announced sharp restrictions on retail sales of such products.
At Juul, some employees are concerned about a partnership with a cigarette maker. At an all-hands meeting Wednesday, Juul’s CEO said the startup wouldn’t do a deal that didn’t align with its mission of helping adult cigarette smokers switch to less harmful products.
Meanwhile, Altria agreed Friday to pay $1.8 billion for a 45% stake in Toronto-based cannabis company Cronos Group Inc. It grows and sells medical and recreational marijuana products mainly in Canada, with smaller medical growing and distribution operations in such countries as Germany and Australia.
Altria and Cronos plan to work together to design vaporizers for cannabis use, according to Cronos CEO Michael Gorenstein. He said vaporizers are one of the fastest growing products in Colorado and California, where pot is legal, and a vaping device is a priority for both companies.
Canada legalized recreational pot sales in October, and a number of other countries have legalized medical marijuana sales.
In the U.S., recreational marijuana is legal in 10 states and medical marijuana is legal in more than 30.
Altria said the cannabis industry “is poised for rapid growth over the next decade” and called cannabis “an adjacent category” for its tobacco operations. Cronos had just US$7.5 million in revenue for the nine months ended Sept. 30.
Cronos is one of several Canadian marijuana growers to attract a big investment from established U.S. companies. In August, Corona brewer Constellation Brands Inc. invested $4 billion to expand its stake in Canopy Growth Inc., which is developing both medical and recreational products.
Altria is paying C$16.25 for each Cronos share, a 40% roughly premium to where the stock was trading last week. Altria has a warrant to buy more Cronos shares at C$19 a share that would give it control of the company with a total stake of 55%. Cronos’s board will be expanded from five directors to seven and Altria will get to nominate four directors.

Friday, December 7, 2018

First Alzheimer`s drug from Eisai/UCL alliance to enter clinical trials


The first drug candidate from Eisai and University College London (UCL)s drug discovery collaboration is to enter Phase I clinical trials for Alzheimers disease (AD) early next year.
The candidate drug, known as E2814, is an anti-tau monoclonal antibody set to be tested in human trials for the first time to assess its ability to slow the progression of AD.
The research partnership between Eisai and UCL was agreed in 2012 for an initial period of six years, but has been extended for a further five years to 2023.
E2814 is one outcome out of a portfolio of projects established during the first phase of the collaboration, designed to prevent the spreading of tau protein seeds spread between different areas of the brain as the disease advances within affected individuals.
This prevents further build-up of neurofibrillary tangles, and as a result may slow the course of the disease.
Andy Takle, executive director and head, Eisai Hatfield Research Laboratories said: The discovery is the result of a truly open partnership with UCL. We are proud that our collaboration has led to the discovery of E2814, which will progress into clinical trials early next year.
This achievement would not have been possible without the unique collaboration model we have built based on a continued exchange of ideas, and sharing of expertise and resources.
There is currently no cure for dementia, a disease that 850,000 people live with in the UK, with numbers set to rise to over one million by 2025. It is believed AD accounts for up to 70% of all dementia cases.

Quidel: Comments on California Court Ruling


Quidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that the San Diego Superior Court (the “Court”) stated that it intends to enter an order granting Beckman’s motion for summary adjudication relating to the agreement for the supply of antibodies and other inputs related to, and distribution of, the Triage® BNP Test for the Beckman Coulter Access Family of Immunoassay Systems, between Quidel and Beckman (the “Beckman Agreement”). Specifically, the Court stated that it intends to rule that a provision of the Beckman Agreement restricting Beckman from manufacturing or selling another BNP or NT-proBNP assay is void as a matter of law. The remainder of the Beckman Agreement remains in effect. Beckman will continue to supply Quidel, and Quidel will continue to sell, the underlying BNP assay.
“The ruling does not end the litigation, as it concerns only one aspect of the case. Quidel intends to promptly request that the Court stay its order, and it intends to request that the Fourth District Court of Appeal immediately review the decision,” said Douglas Bryant, president and chief executive officer of Quidel Corporation. “Our overall view of the litigation remains unchanged, and we continue to believe that Beckman’s position is meritless, in opposition to Beckman’s long-standing strategy over the last 15 years of honoring the Beckman Agreement with its previous partners – Alere and Biosite. The Court’s ruling today does not change our view that Quidel will ultimately prevail in the litigation on the merits through motion, or at trial, which is currently scheduled for August 30, 2019.”
Conference Call Information
Quidel management will host a conference call to discuss the matter on Monday morning, December 10, 2018 beginning at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time). During the conference call, management may answer questions regarding the intended ruling. Quidel’s responses to these questions, as well as other matters discussed during the conference call, may contain or constitute material information that has not been previously disclosed.

San Antonio Breast Cancer to hold a symposium


San Antonio Breast Cancer Symposium 2018 will be held in San Antonio, TX on December 3-8.

Piper remains buyers of Alnylam following recent weakness


Alnylam Pharmaceuticals’ R&D day highlighted the the transition into a commercial stage company with multiple late stage programs, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. Alnylam is expanding RNAi drug discovery outside of the liver into central nervous system and cardiovascular disease, adds the analyst. He says Piper remains buyers of Alnylam on recent weakness ahead of new RNAi drug approvals and data read-outs. Tenthoff reiterates an Overweight rating on the stock with a $160 price target.

Corbus Pharmaceuticals initiated at RBC Capital


Corbus Pharmaceuticals initiated with an Outperform at RBC Capital. RBC Capital analyst Brian Abrahams initiated Corbus Pharmaceuticals with an Outperform rating and a price target of $23. The analyst believes that the current valuation on its stock “substantially underappreciates the broad potential of lead drug lenabasum across multiple high unmet need autoimmune/inflammatory conditions”. Abrahams also sees potential for share appreciation ahead of the company’s late-stage readouts, with “significant upside” coming in late 2019 and early 2020 if Corbus’ Phase 2 trial data show benefits in systemic sclerosis and dermatomyositis studies.

Regeneron price target raised to $483 from $473 at Leerink


Leerink analyst Geoffrey Porges maintained an Outperform rating on Regeneron and raised his price target to $483 from $473. In a research note to investors, Porges says that he believes it is “appropriate” to include some revenue for the Libtayo indication in NSCLC in his forecast and valuation. Including this revenue, which commences in 2022, Porges is raising his long-term revenue forecast for Regeneron by $313M. Based on the strong data that has led to the recent FDA approval in cutaneous squamous cell carcinoma, or CSCC, and the promising early data in other tumor types, the analyst says he is increasingly confident that Libtayo is a potent PD-1 blocking agent with comparable activity to the approved anti-PD-1s, Keytruda and Opdivo. He says that Even though Regeneron is likely to be a late entrant to the lung cancer market compared to the established players, even a relatively small minority market share will generate significant value for the company and its partner.