(VVUS): I hope an investor stands up in the breakout session and demands CEO Leland Wilson strike a marketing deal with Big Pharma immediately, or put the entire company up for sale. Qsymia's horrible sales numbers so far don't exactly put Vivus in the strongest negotiating position, but the current "go it alone" commercial strategy for the weight-loss pill is a total failure. Vivus is desperate for help. (Amaroids, take note -- Vivus could be your fate, too.)
(BIIB): The FDA approval decision date for the multiple sclerosis pill BG-12 is March 28. The current sell-side consensus estimate for 2013 sales of BG-12 is approximately $346 million. The on-time approval and strong commercial launch of BG-12 is the biggest, most important storyline for Biogen in 2013, particularly true after the failure of dexpramipexole in ALS on announced Thursday. Current consensus 2013 earnings estimate is $7.27 per share on total revenue of $5.98 billion.
(GILD - Get Report): Investors love Gilead, and who can blame them given the stock's 80% return in 2012. The story for 2013 is more of the same: Data from several phase III studies of the company's GS-7977 in hepatitis C are due in the current quarter, leading to regulatory submission in the second quarter and approval in early 2014 (or perhaps late this year.) Gilead is also moving forward with late-stage studies of the more important, all-oral combination of GS-7977 and GS-5885.
On the commercial front, the recent approval and launch of Stribild promises to bolster growth in the company's core HIV franchise. Gilead is super-awesome! What could possibly go wrong?
: Remember when investors cared? Dendreon is running out of time to reach the break-even point of $400 million in annual Provenge sales -- a task made more difficult with new competition from J&J's Zytiga and Medivation's Xtandi.
: The Xtandi launch. The Xtandi launch. The Xtandi launch.
: The Iclusig launch. The Iclusig launch. The Iclusig launch.
Anyone interested in
and its Duchenne muscular dystrophy drug eteplirsen needs to keep pay close attention to the closest competitor. Hopefully, Prosensa will be empowered by its partner GlaxoSmithKline to provide an update on the release of data from ongoing studies of PRO051.
Tuesday, Jan. 8
: I remember when Genentech was a must-see presentation at J.P. Morgan, in part because everyone wanted to hear from CEO Art Levinson -- always the smartest, wisest guy in any room. Collectively, Roche-Genentech is bigger and arguably more important but definitely less exciting. Still, investors should pick up some good tidbits from Roche's presentation and breakout given the company's dominant presence in the cancer market. The company's take on global deal-making and drug development are typically enlightening.
: The company is holding an investor/analyst meeting on Feb. 7 so I don't expect much news at the conference next week. Amgen ended 2012 up 36% because of its dividend and share buybacks, less so from growth in the company's drug franchises. The Street is only looking for about 3% revenue growth from Amgen this year, which means investors will look more to the company's pipeline (and additional share repurchases) for increased value. On the pipeline front, we should get top-line results from phase III trials of T-Vec (melanoma) and AMG386 (ovarian cancer) sometime this year. A phase II study of the fracture-healing drug AMG785 is also one to watch.
: The under-the-radar obesity pill stock, but for how much longer? The big event for Orexigen will be the interim analysis of its Contrave cardiovascular outcomes study, expected in the second half of the year. If Contrave doesn't cause in increase in cardiovascular adverse events, Orexigen could (pending FDA agreement) re-file the weight loss drug with the agency before the study's final results are known.
: Recent insider buying appears to have stopped the stock's slide. Still, questions remain about the future of AVEO's kidney cancer drug tivozanib that won't likely be answered until FDA convenes an advisory panel to review the drug's efficacy and safety.
: The launch of Juxtapid for the treatment of patients with homozygous familial hypercholesterolemia (HoFH) attracts even more attention given the debate over super-premium pricing for orphan and ultra-orphan drugs.
: This will be the first, major public presentation of the company's outlook since its spin off from Abbott.
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