Monday, August 18, 2008

July 2008 IMS Data -- Vytorin®/Zetia® market share continues to melt -- month over month. . . .

Schering just released its July 2008 US cholesterol management market IMS data. The data includes only about five selling days after the SEAS Trial disappointment/announcement, so this month's data cannot be relied upon as representative of how August will turn out.

That said, the overall US cholesterol management market grew slightly, July over June -- and again, Vytorin®/Zetia® actually lost share, July over June -- despite being up a fraction of a percent in raw scrips. [This "losing share" trend was also seen in the June 2008, over May 2008, IMS data.]

More precisely, Vytorin/Zetia represented about 11.72 percent of the US cholesterol management presecription market in July, down from about 12.1 percent in June 2008.

That is bad news. Graphics -- with more trendline detail -- coming shortly, right here. Stay tuned. See above. And below.

UPDATED -- 08.19.08 @ 8 AM EDT

Overnight, The Insider, at PharmaGossip linked this post, and featured an earlier draft version of the above graphic! Cool!

Next, Ed over at Pharmalot, has a nice analysis of the melting Schering market share issue, this Tuesday morning -- and so, I thought I'd amplify one point of his, from yesterday -- and sythesize it with this -- all of it probably being lost on the casual reader of that fine site:

Yesterday, Pharmalot noted that a consulting firm has labeled Schering's pipeline the "deepest" in the business -- it has the most potential to be self-replenishing by 2012. For the moment, let's assume that is true.

To bring the number -- and variety -- of drug candidates to approval by 2012 -- that these consultants (and Schering, itself) forecast, Schering will need massive cash-flow generation mechanisms -- perhaps $2 to $3 billion per year, every year -- over and above the cash-flow needed for ordinary operations.

That "machine" was to be Vytorin. No more. As US market share melts, like an ice cream sandwich, in the August heat on the beaches of Fire Island. . .

I wonder, honestly, which of those "fan-tabu-licious" new drug candidates are going to have to be shelved -- or scrapped -- for lack of cash flow to bring them forward, fast enough -- all by 2012.

Schering's own recent SEC filings (see page 27 of the most recent Form 10-Q, at the end of the fourth full paragraph) plainly warn that Schering is "substantially dependent" upon Vyotrin -- to fund its future pipeline delivery strategy.

That may be the meta-narrative, here.


Anonymous said...

I've saw an article where it mentioned that Fred was involved in both Phen-Fen and Bextra/Vioxx cardiopulmonary toxicity. Both of those toxicities involved thickening of the intima of the pulmonary artery. It seems to me that Vytorin if it had worked in Aortic stenosis would have been useful as a treatment.

Does Fred know something about other drugs already on the market that the rest of us should?


Anonymous said...

Condor, it’s true that if SGP is to replenish revenue lost from Vytorin, Clarinex and it’s Hep-C franchise, much hinges on the approval of golimumab, SCH-503034, and SCH-5034308. Our analysis only considered new products on their own merits, and didn’t go into the company’s ability to develop and commercialize them. (Maybe SGP could take a page from BMS and cut some creative out-licensing deals?) Keep in mind that SGP has pretty much passed through its loss-of-exclusivity crisis, and is starting at a lower base than other companies in its peer group. Its remaining big products will maintain exclusivity until 2014. That’s why it’s replacement ratio looks so good.

Mike Goodman
VP Research Products,
AVOS Life Sciences, LLP

Condor said...

Hey Mike --

One man's "creative out-licensing deals" may be another man's "forever lost profits", right?

That said — I think you are right — Schering has passed through its “loss of exclusivity” crisis — I would now be concerned about its coming “cash flow” constrictions. Those could prove daunting.

Steadily-losing share on Vytorin — in addition to impacting perhaps 55 percent of Schering’s 2008-2009 profitability — will seriously hamper Schering’s ability to generate free cash flow.

It will truly be “cold comfort” if Schering has the “best-in-class” pipeline — but will (perhaps) be unable to fund all the activities associated with acheiving approval (capacity expansions, Phase IIb and Phase III trials, and marketing juggernauts), for all those candidates.

That is, Schering may end up “selling off” a chunk of its vaunted pipeline, to raise cash for the rest of it. . . .

That was my central point. Cheers — And, Well met!