The Most Ominous Line — for Schering — in Merck’s Q2 Press Release, tonight?

UPDATED — 11 AM EDT: Though clearly not fully-intending to do so, the generally very-pro-Schering-Plough web site “In the Pipeline” (Derek is an ex-Schering science guy) — seems to be throwing in the towel on the Cholesterol Joint Venture. He adds detailed credence to the thesis that the Joint Venture is coming to an end — albeit not directly.

He writes of SEAS “. . . .put out press releases that your compound, even though it failed to work again, isn’t actually a cancer risk. You really couldn’t do worse; a gang of saboteurs couldn’t have done worse. Of course, there’s no such gang: the companies themselves authorized these trials, thinking that there were home runs to be hit. But all these sidelines — familial hypercholesteremia, aortic stenosis — have only sown fear, confusion, and doubt. . . . .“

[Emphasis supplied.]

~~~~~~~~~~~~~~~~~

From CEO Dick Clark’s first full paragraph after the first two tables [emphasis supplied; link to the full release]:

“. . . .Earlier today, data for the SEAS study was presented by the primary investigator,” he said. “We are moving quickly to fully assess the potential implications of the data for our cholesterol joint venture. . . .”

The bolded bit could be read to suggest one possible “implication” for the Joint Venture. . . . would be its end.

Am I reading too much into his statement, here? Let me know.

Revised — Schering-Plough: A Greek Tragedy, in Three Acts.

An update, to this one, proclaiming it all a “comical farce“, also in three acts — I sincerely apologize. That was entirely premature:

Act I

March 31 — April 1, 2008: ACC ENHANCE Panel Discussion in Chicago — Schering stock goes from $19.87, to $14.41 per share [Meanwhile earlier, off-stage, left, SEAS study launches -- to compare Vytorin to a placebo (i.e., stack the deck-chairs)].

Act II

Slowly recover — to around $22 — by late last week. . . . Then, delay Schering and Merck Q2 earnings conference calls — to after market-close, on July 21, 2008 — for “an important update” on SEAS: Vytorin to a placebo results^*.

Act III

Fail the primary endpoint on a Vytorin study — [Again!]

But flog an (underpowered) secondary SEAS endpoint, while ignoring some data on cancer incidence-spikes. Point to your successes in rearranging those pesky deckchairs — dutifully ignore that icberg. Vytorin/Zetia is still more than 50 percent of all of Schering’s 2008 full-year profitability – at least before this evening, it was. . . .

Tune in tomorrow, for all [the rest] of the carnage. James Cameron is now under contract – to direct. Shorter Condor [channeling PharmaGossip's excellent turn of phrase!]: Heavy SEAS, ahead!

~~~~~~~~~~~

^* A more detailed plot synopsis, then: I just walked off my plane from the West Coast, and I am still digesting how this topsy-turvy Schering-Plough trading day ended. . . .

Over 108 million shares changing hands — off another 3 percent in the NASDAQ after-hours session — on about a million shares changing hands after hours.

Yep. I think it safe to say — “Look out below.”

Add to this that Merck refused to update its full-year 2008 guidance, tonight — CEO Clark is still studying the SEAS fallout. So, will Schering close below $18 tomorrow?

$17?

$16?

$15?

I honestly need to do some math — but all of these are at least possibilities “in play“, at the moment. [Had the analysts really taken all of the 2008 Vytorin profits out of their models, before last Friday? I doubt it.]

I am genuinely saddened — for the Schering rank and file — to have been so terribly right, over the last few weeks. That $22 was truly a suckers’ rally.

So, it would seem SEAS missed the primary end-point (bad enough), but wait! There’s more! The big “C” — However, since no similar cancer incidence results have been seen in IMPROVE-IT (thus far, apparently) — this should “only” mean that Vytorin is largely ineffective at improving cardiac outcomes — not “inherently a dangerous drug“, per se.

And, while it is also true that the secondary result (flogged by CEO Hassan, tonight) was a “positive“, that positive is underpowered. That is, it should have been significantly better than it was, if it was NOT (quite likely) an artifact.

So, tomorrow we will know — by the close of the market — whether Wall Street’s analysts had really factored Vytorin sales to be near zero by mid-2009. If so, Schering should be flat, to slightly rising, tomorrow. I. don’t. think. so.

I expect it will be off sharply, and on very heavy volume, again. I cannot see how there is a significant market for a combo pill that costs at least triple what a plain statin does — but can’t beat a placebo. Sell me that one, please.

Where is the [revised] business model for this drug? I say this fully-aware that I am simply ignoring the cancer-incidence data. (Will your family doctor do the same?) And — still, I genuinely ask — what is the “value proposition” this drug now offers? At any price. What?

I don’t see it. I don’t think Wall Street will, either.

The Most Ominous Line — for Schering — in Merck’s Q2 Press Release, tonight?

UPDATED — 11 AM EDT: Though clearly not fully-intending to do so, the generally very-pro-Schering-Plough web site “In the Pipeline” (Derek is an ex-Schering science guy) — seems to be throwing in the towel on the Cholesterol Joint Venture. He adds detailed credence to the thesis that the Joint Venture is coming to an end — albeit not directly.

He writes of SEAS “. . . .put out press releases that your compound, even though it failed to work again, isn’t actually a cancer risk. You really couldn’t do worse; a gang of saboteurs couldn’t have done worse. Of course, there’s no such gang: the companies themselves authorized these trials, thinking that there were home runs to be hit. But all these sidelines — familial hypercholesteremia, aortic stenosis — have only sown fear, confusion, and doubt. . . . .“

[Emphasis supplied.]

~~~~~~~~~~~~~~~~~

From CEO Dick Clark’s first full paragraph after the first two tables [emphasis supplied; link to the full release]:

“. . . .Earlier today, data for the SEAS study was presented by the primary investigator,” he said. “We are moving quickly to fully assess the potential implications of the data for our cholesterol joint venture. . . .”

The bolded bit could be read to suggest one possible “implication” for the Joint Venture. . . . would be its end.

Am I reading too much into his statement, here? Let me know.

Revised — Schering-Plough: A Greek Tragedy, in Three Acts.

An update, to this one, proclaiming it all a “comical farce“, also in three acts — I sincerely apologize. That was entirely premature:

Act I

March 31 — April 1, 2008: ACC ENHANCE Panel Discussion in Chicago — Schering stock goes from $19.87, to $14.41 per share [Meanwhile earlier, off-stage, left, SEAS study launches -- to compare Vytorin to a placebo (i.e., stack the deck-chairs)].

Act II

Slowly recover — to around $22 — by late last week. . . . Then, delay Schering and Merck Q2 earnings conference calls — to after market-close, on July 21, 2008 — for “an important update” on SEAS: Vytorin to a placebo results^*.

Act III

Fail the primary endpoint on a Vytorin study — [Again!]

But flog an (underpowered) secondary SEAS endpoint, while ignoring some data on cancer incidence-spikes. Point to your successes in rearranging those pesky deckchairs — dutifully ignore that icberg. Vytorin/Zetia is still more than 50 percent of all of Schering’s 2008 full-year profitability – at least before this evening, it was. . . .

Tune in tomorrow, for all [the rest] of the carnage. James Cameron is now under contract — to direct. Shorter Condor [channeling PharmaGossip's excellent turn of phrase!]: Heavy SEAS, ahead!

~~~~~~~~~~~

^* A more detailed plot synopsis, then: I just walked off my plane from the West Coast, and I am still digesting how this topsy-turvy Schering-Plough trading day ended. . . .

Over 108 million shares changing hands — off another 3 percent in the NASDAQ after-hours session — on about a million shares changing hands, after hours.

Yep. I think it safe to say — “Look out below.”

Add to this that Merck refused to update its full-year 2008 guidance, tonight — CEO Clark is still studying the SEAS fallout. So, will Schering close below $18 tomorrow?

$17?

$16?

$15?

I honestly need to do some math — but all of these are at least possibilities “in play“, at the moment. [Had the analysts really taken all of the 2008 Vytorin profits out of their models, before last Friday? I doubt it.]

I am genuinely saddened — for the Schering rank and file — to have been so terribly right, over the last few weeks. That $22 was truly a suckers’ rally.

So, it would seem SEAS missed the primary end-point (bad enough), but wait! There’s more! The big “C” — However, since no similar cancer incidence results have been seen in IMPROVE-IT (thus far, apparently) — this should “only” mean that Vytorin is largely ineffective at improving cardiac outcomes — not “inherently a dangerous drug“, per se.

And, while it is also true that the secondary result (flogged by CEO Hassan, tonight) was a “positive“, that positive is underpowered possibly the result of a confusing variable — the statin’s presence in the compound. [Edit: Thanks to the loyal fanbase, MM, for the edit -- I did misuse the term of art: "underpowered"!] That is, it should have been significantly better than it was, if it was NOT (quite likely) an artifact.

So, tomorrow we will know — by the close of the market — whether Wall Street’s analysts had really factored Vytorin sales to be near zero by mid-2009. If so, Schering should be flat, to slightly rising, tomorrow. I. don’t. think. so.

I expect it will be off sharply, and on very heavy volume, again. I cannot see how there is a significant market for a combo pill that costs at least triple what a plain statin does — but can’t beat a placebo. Sell me that one, please.

Where is the [revised] business model for this drug? I say this fully-aware that I am simply ignoring the cancer-incidence data. (Will your family doctor do the same?) And — still, I genuinely ask — what is the “value proposition” this drug now offers? At any price. What?

I don’t see it. I don’t think Wall Street will, either.