Replies to post #107865 on Biotech Values

[HattieTheWitch]

...Later in the Teva call they are asked if Lovenox approval is built in to their guidance for the year. He hems and haws and then says they won't comment on what specifically is in the guidance, but he would be "very disappointed" if it wasn't approved during the year. (I was listening at double speed and reporting from memory, so it's possible I misrepresented what was said a little)...

The part you are referring to (by Marth) is at 1 hour, 7 minutes.

http://www.vcall.com/CustomEvent/EU005995/index.asp?ID=162118

And yes, lots of hems and haws.

[DewDiligence]

Peter et al: Lovenox is certainly not in Teva’s 2010 guidance for revenue and EPS. This is obvious from the numbers themselves and also from Teva’s written statements about its financial guidance.

[Praveen]

Hi Peter, I agree with you abt the teva's optimistic tone. But from the fda's point of view, what's the hurry? There is a generic and they will be closely watching for any immunogenicity issues for at least some time like 6months to an yr. I feel they won't take addn risk by approving teva's now.

do u follow IRWD? Any thoughts on their results today?

[DewDiligence]

Teva’s corporate culture has been shaped by the CEO, Shlomo Yanai. From the capsule bio of Yanai on Teva’s own website:

Mr. Yanai served for 32 years in the Israel Defense Forces, reaching the rank of Major General, and holding some of the most senior positions in the IDF, including that of Commanding Officer of the Southern Command, and head of the Division of Strategic Planning.

Yanai runs Teva in a military manner, and this carries over to the members of Yanai’s inner circle. These executives view an assault on Teva’s lucrative Copaxone franchise as tantamount to a Declaration of War, and they are determined to respond with all due force right up to the border of legality.

I’m being completely serious.

[turtlepower]

I thought they sounded pretty confident on "sameness" - whether that is their version of sameness or the FDA version remains to be seen. But personally I'm a little more cautious after their call.

Craig wheeler was somewhat confident as well with the following statement during his prepared remarks

We believe our competitors will need to do substantial work to meet the FDA's criteria for approval.

So the question remains whether Teva has already completed the "substantial" work required or whether it has some ways to go. Evidence appears to point to the latter but as you wrote Teva's bullishness can't be taken lightly IMO.

edit: changed former to latter