SAN FRANCISCO (
) -- I used to call the J.P. Morgan Healthcare Conference the "Super Bowl of biotech investing confabs." This year, I'm retiring that moniker for "Life Sciences Lollapalooza."
On the main stage, of course, will be the few hundred biotech, drug and healthcare companies presenting their 2013 stories to thousands of institutional investors, all running around like rats in the maze-like hallways of the Westin St. Francis Hotel.
Outside the J.P. Morgan hotel, on satellite stages scattered across downtown San Francisco, scores of hangers-on biotech conferences and meetings will be taking place. It's quite the scene.
Next week's J.P. Morgan conference will be my thirteenth. As always, I'll be on site to cover and analyze all the breaking news, rumors and goings-on inside and outside the Westin St. Francis. The fun starts Monday.
This year, my plan is to rely heavily on Twitter and live blogs to cover the conference in real time. When I hear something juicy from a biotech executive or investor, you'll read it too.
My daily live blogs, which you'll find easily on
home page, will capture all my tweets, just in case you're one of those people not hip to Twitter quite yet.
To help prep for next week, I've prepared capsule summaries of some (but not all) of the major story lines and questions for biotech and drug companies presenting at the conference.
Monday, Jan. 7
: If tradition hold, Celgene will pre-announce fourth-quarter earnings and offer 2013 financial guidance. Right now, 2013 consensus stands at $5.54 per share in earnings on total revenue of $6 billion. I don't have consensus pegged for 2013 Revlimid sales but J.P. Morgan analyst Geoff Meacham is at $4.31 billion (15% year-over-year growth), which he says is "marginally below consensus."
Remember, Celgene typically goes conservative with early guidance so it can "beat and raise" later in the year.
Celgene always garners a lot of attention at the conference but perhaps more so this year because of three very near-term catalysts: 1) Presentation of data from the Abraxane phase III study in pancreatic cancer at a cancer research meeting Jan. 24-26; 2) the FDA approval decision for pomalidomide in relapsed/refractory multiple myeloma on or before Feb. 10; and 3) top-line results from the "MM-020" study of Revlimid in front-line multiple myeloma (transplant ineligible patients) expected in the first quarter.
: The good: Sales of Onyx's multiple myeloma drug Kyprolis came out of the gate smoking hot. The not-so-bad: Investors now expect the strong launch to continue. There are definitely worse problems for a biotech company to have going into 2013, but Onyx does need to be mindful that investor expectations are growing (even if sell-side models may still be lagging.) Speaking of, the current sell-side 2013 sales consensus for Kyprolis is approximately $200 million.
Outside of Kyprolis, don't forget Onyx receives a 20% royalty on sales of the newly approved colon cancer drug Stivarga, marketed by Bayer. The company could also report data from a phase III study of Nexavar in breast cancer. A similar study in thyroid cancer met its primary endpoint successfully on Thursday.
: How much lingering hostility against (and mistrust of) Vertex management do investors carry into 2013 following the amateurish cystic fibrosis data debacle of last summer? Let's not also forget the "good news in the morning, bad news in the afternoon" investor-relations brain fart of Nov. 1.
Vertex will do well at J.P. Morgan if it can begin to repair a strained relationship with institutional investors following a rocky 2012. Sales of the hepatitis C drug Incivek are falling (consensus calls for an approximate 35% drop in year-over-year U.S. sales) but that's baked into the stock already.
What Vertex needs is for investors to buy into its long-term plan for the cystic fibrosis drug franchise. Kalydeco was the most important drug approved in 2012 but Vertex's valuation will grow only if the combination of Kalydeco and follow-on drugs can demonstrate benefit for a larger swath of cystic fibrosis patients. Vertex CEO Jeff Leiden lays out an ambitious and exciting long-term plan that could have Vertex dominating cystic fibrosis the way Gilead Sciences dominates HIV. In 2013, Vertex needs to execute on Leiden's vision -- and avoid the screw-ups that had investors cursing the company's name in 2012.
: Investors are in love with orphan drugs. BioMarin has lots of 'em. Two to watch: GALNS for Marquio syndrome (FDA approval filing expected in the first quarter with potential approval in the fourth quarter) and PEG-PAL for PKU entering phase III this year. GALNS is particularly important because once approved, the drug has the potential to double Biomarin's revenue.
: 2012 ended brilliantly and profitably for Amarin... bears. The stock lost 50% of its value, plunging from $15 in July following FDA approval of Vascepa (and insiders dumping tons of stock) to $7 at the end of December due to the "Three Nos" -- No NCE status, No Vascepa launch partner, no takeout.
As we enter 2013, the Amarin bear story is, admittedly, less compelling. There's probably another $2 or so in downside from here if the Vascepa launch is delayed (my prediction) or otherwise fails to meet expectations. If Amarin manages not to screw up the Vascepa launch, the stock could find firmer footing at its current valuation. Harder to envision is a scenario under which Amarin shares claw back to $15 or higher any time soon -- not until the company can prove to skeptical investors that Vascepa is a blockbuster drug.
: 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.)
: 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.
: 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.
: The prostate cancer radio-pharmaceutical Alpharadin was submitted to FDA in December so Algeta is still waiting to hear on filing acceptance and priority review. Even though Alpharadin is much easier to use than previous radio-pharmaceutical disappointments like Bexxar and Zevalin and despite stellar survival data, Wall Street investors remain generally suspect about Algeta's commercial prospects. The company needs a speedy FDA approval and a strong launch (hopefully in the back half of 2013) to reverse the skepticism.
: I'm finally going to dig into Opko, to figure out if there's anything more substantive to the company beyond the celebrity status of Chairman and CEO Phil Frost.
Wednesday, Jan. 9 (Feeling really tired by now)
: What, if anything, can CEO Raj Shrotriya say to scare the shorts, who have nested comfortably in this stock for a year? For starters, Shrotriya should offer more details from the phase III study of belinostat in peripheral T-cell lymphoma. Disclosure to date has been woefully inadequate. Shrotriya will also surely be peppered with questions about the future growth of Fusilev in the face of leucovorin supply slowly coming back on line.
: Like many investors, I'm still waiting for Nektar and its partner AstraZeneca to tell us what really happened with the phase III study of opioid constipation drug naloxogel. How much bio-statistical jujitsu was necessary to turn a failed study into one with "positive" results?
: You're really going to price Gattex at $295,000 per year?
: When European regulators rejected Isis' HoFH drug Kynamro, supporters defended, claiming the company's real value lies in its deep antisense drug pipeline. Okay, show us what you got.
: The only thing that matters are data from the phase III study of palifosfamide in soft-tissue sarcoma. Results expected before the end of the first quarter.
: What caused the failure of the Amigal study in Fabry disease? We may not get the answer until data are presented at a medical meeting in February, but Amicus management will be needled with questions during the breakout session.
: The commercial launch of its weight-loss pill Belviq is imminent, making Arena the best short of 2013 or a soon-to-be blockbuster.
: 2012 started off bright for Idenix with shares soaring on optimism about its hepatitis C drug portfolio and speculation about a takeout. That all went to crap in August when FDA placed two Idenix drugs on clinical hold -- casualties of the cardiovascular toxicities that killed Bristol-Myers Squibb's BMS-094.
Those two Idenix drugs, IDX-184 and IDX-368, remain on FDA clinical hold, although the company hopes to hear good news from the agency in the first quarter. After that, Idenix needs to play a serious game of catch-up drug development if it wants to remain a viable Hep C player.
: Top-line results from the pivotal validation study of Cologuard, the company's non-invasive colon cancer screening test, will be released in March.
: Expect incremental updates from CEO Chris Garabedian about timelines for eteplirsen in 2013.
Thursday, Jan. 10 (I'll be on a plane flying home but in case you're still paying attention...)
: Round two of Afrezza phase III data coming. Al Mann still can't find a partner or enough investors to care about inhalable insulin.
: Is there anything Questcor management can do to stem the criticisms about its Acthar pricing and marketing practices?
: Investors are still waiting for results from the long-term safety study of the phosphate binder Zerenex. Even if approved, Keryx needs to figure out how to sell a premium-priced drug in a generic and highly competitive dialysis market.
: Waiting to hear if Allovectin melanoma data will be pushed back again -- this time to 2016.
-- Reported by Adam Feuerstein in Boston.
Adam Feuerstein writes regularly for TheStreet. In keeping with company editorial policy, he doesn't own or short individual stocks, although he owns stock in TheStreet. He also doesn't invest in hedge funds or other private investment partnerships. Feuerstein appreciates your feedback;
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