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▲ MERCK call: Jami Rubin, of Goldman Sachs asks about overall performance of equity income. She notices that Merck-Schering-Plough equity income was relatively flat, despite down sales, and wonders what’s happening with cost-reduction programs there?
▲ Answer: Peter N. Kellogg CFO, says related to the Merck-Schering-Plough joint venture that the second quarter of last year included a $43 million expense related to termination of the respiratory joint venture. When that's excluded on a year-over-year basis, the Merck-Schering-Plough joint venture equity income reflects the continuation of the trends seen in second half of last year and is pretty much in line with what Merck expected to see.
▲ Tim Anderson, of Sanford Bernstein: A few questions, can you frame out ARBITER 6 in terms of potential outcomes and what that might mean commercially to the franchise? Your cholesterol partner had surprisingly little to say on the subject.
And then Vytorin growth beyond 2009 outside the U.S., it seems like you're on a trajectory to turn negative which would imply an impact from Enhance, which I think is something you said previously would not likely impact ex-U.S. markets. . . .
▲ Answer: Kenneth C. Frazier says Vytorin sales outside the U.S. have been slowing in recent quarters, but he sees sales improving, a little now, Ex-U.S., and he expects to see international growth for the rest of the year (on an excurrencies basis). ARBITER 6 . . . was not sponsored by Merck or Schering-Plough. We don't know the results of ARBITER 6 or the reason why it was stopped.
We've seen several people's speculations about multiple reasons that could explain that. But we have really essentially no new light to shed on that. I do want to say that because we don't know those results, all we really can say is that we don't see any impact of ARBITER 6 on sales as we currently look at the product.
But again, all we really know is what the Web site said which is that the trial was not stopped for safety reasons. [Both per Call transcripts kindly made available by Seeking Alpha.]
▲ Global sales of Zetia, were $514 million in the second quarter, a decrease of 8 percent compared with the second quarter of 2008. Second-quarter 2009 global sales of Vytorin, were $520 million, a decrease of 12 percent compared with the same period in 2008. The company records the results from its interest in the Merck/Schering-Plough partnership, which totaled $362 million in the second quarter, in equity income from affiliates. [That's very close to the number I guessed, last week.] Merck said it expects the rate of US decline in cholesterol franchise sales to "moderate" in the second half. But that is very different than Schering-Plough CEO Hassan's "generally stabilizing" puffery.
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▲ Merck is the call up next -- I'll probably only drop in for portions of it.
▲ IMPROVE-IT mid-point has not yet been reached -- thus the blinded look will not occur for "some time, yet" according to Dr. Tom Koestler. That may mean the IMPROVE-IT final results won't be available until 2013, or 2014.
▲ Seamus Fernandez, Leerick Swann, just asked re TRA trial enrollment increase -- when will it be complete? Q4 2009? No real answer, but Schering still expects a 2011 FDA filing.
▲ Schering-Plough expects that FDA will focus, on July 30, 2009, on safety v. effectiveness -- in its meeting to review asenapine, or Saphris. [Per Salmon: Erh, that's stultifying.]
▲ Jami Rubin, of Goldman Sachs Morgan Stanley, just asked about Arbiter-6 HALTS -- Carrie Cox has "no idea" when it will be published in a peer-reviewed journal, and no other comment. Dr. Tom Koestler said "not our trial" -- so we have "no idea".
▲ Tim Anderson of Sanford Berstein just said he wonders how Schering-Plough can make "best in class" claims/statements about Boceprevir -- given how others (plainly meaning Vertex's Teleprevir, here!) have out performed it. OUCH! CSO Dr. Tom Koestler simply said he "still believes" the compound is a strong compound. Weak answer -- but probably accurate.
▲ According to Bob Bertolini, CFO, the Cholesterol Franchise, overall was off 8 percent in the quarter, worldwide -- compared to Q2 2008. A little better than I expected, but considerably worse than Cowen & Co.'s guess-timate.
▲ Dr. Tom Koestler just said the company has heard nothing new, about the study changes it proposed to FDA in February, 2009 -- on Bridion, or sugammadex. That likely means 2010, or later, for US FDA approval now.
▲ It is certain, now that Cowen & Co. was too optimistic on July 18, with this: ". . . .According to Cowen and Co., sales of Zetia will probably come in 5% lower at $550 million, while Vytorin sales will be 4% lower at $565 million. . . ." -- the actual numbers were Zetia: $555 million; Vytorin: $519 million -- together, sales were off 10 percent, operationally, just as I suggested.
▲ From the press release: GAAP net sales for the 2009 second quarter totaled $4.6 billion, down 6 percent as compared to the second quarter of 2008, reflecting operational growth of 4 percent and an unfavorable impact from foreign exchange of 10 percent during the quarter. Ten percent was exactly what I predicted, on July 18, 2009.
▲ 7:38 am -- Schering-Plough is reporting Q2 worldwide Cholesterol Franchise Equity Income of $370 million, from its half of the Cholesterol Joint Venture Franchise, that figure includes milestone "and other" payments, according to the press release -- so we will have to wait for the Form 10-Q to file in a few weeks, to see how much of the $111 million in "receivables" Schering-Plough was owed, at the close of the Q1 2009, were reversed out, to reach the $370 million figure. In any event -- that figure is actually $15 million worse than the number I suggested on July 18, 2009.
▲ Okay -- The live stream begins at about 7:40 am EDT. . . .
Schering-Plough's Stream
2 comments:
Schering-Plough expects that FDA will focus, on July 30, 2009, on safety v. effectiveness -- in its meeting to review asenapine, or Saphris.
Of course what else would the PDAC focus on except manufacturing issues which they typically don't as they aren't qualified and it's taken care of in house.
As ever this should be interesting. As pointed out previously similar drugs seem to produce pulmonary arterial hypertension like phen-fen which is a long term complicaiton.
(See http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/PsychopharmacologicDrugsAdvisoryCommittee/UCM164423.pdf)
So the question becomes what long term comparative information allows you to assess if it's worse and have adequate studies been down to mitigate it.
The other problem seems to be hepatotoxicity.
(See http://www.businessweek.com/investor/content/mar2007/pi20070312_868572.htm?campaign_id=tbw%22).
Add on top of this that one of the two studies claimed to support efficacy in schizophrenia is a failed study (active control did not work) and there are other problems such that it's clear that it's not adequet or well controlled.
http://www.glgroup.com/News/Does-The-FDA-Acceptance-of-The-NDA-for-Asenapine-Signal-A-Good-Outlook-for-Schering-Plough-(NYSE--SGP)--19717.html
This gives us a high risk and lack of efficacy in schizophrenia.
As for bipolar even less risk should be tolerated as the lethality and severity of the illness is much less than for schizophrenia.
Regardless of what FDA has published in the past, the law is absolutely clear that assessment of safety has to include expected off label use and with a sublingual formulation that will be used long term and especially in kids and the elderly regardless of what the label says means that it's likely asenapine can't meet the legal standard for approval. But of course that's not stopped FDA from approving drugs before.
Salmon
Yours is now a new post!
Thanks, my friend. . . .
Namaste
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