Key questions and answers from the second quarter fiscal 2008 earnings call conducted by Schering Plough Corp. (SGP: chart) on July 22, 2008.
Tim Anderson (Sanford Bernstein):
What's your confidence level on your asenapine PDUFA? You just mentioned introducing sugammadex later this year, PDUFA date is next month. You are very close to launching, but your comments seem to suggest it might be a little farther off?
Carrie S. Cox: I think the potential for asenapine is very interesting. We've had experience in this marketplace for many years, and during that time we've seen that this may be considered as one of the most conservative divisions of FDA and it is unusual for them to provide any first cycle approvals. We are with active review with asenapine right now and don't have anything further to report. Hopefully, we will be bringing that one to the market soon. Looking at sugammadex, we actually do have a positive opinion from EMEA for Europe. So that's part of why we are hoping to be able to bring it to the market later this year. And with FDA, the product is under active review.
Catherine Arnold (Credit Suisse):
I just wanted to touch on your integration success so far in expense control. You are obviously far ahead of your target for the year. Was that because you gave us a conservative base case or that you are pleasantly surprised as you've moved through early days of the integration?
Fred Hassan: We tend to be careful with our targets because we don't like to do things that might hurt the long-term success of the business. We have made very strong progress in a very systematic manner on our PTP project. We did what we said we would do in April. We went first to the senior management groups, and then we are now looking at the broader picture and we are reducing costs. We are reducing cost across the company. Everybody is making their contribution. These were targets that we believed were very doable, and we are ahead of plan at this stage.
Chris Schott (JPMorgan):
I know you are still digesting results of SEAS. But just how do you intend to handle questions on cancer risk associated with VYTORIN?
Robert J. Bertolini: I really think doctors know about certain trails that have occurred out there. We have read about them for the last several years. As you know BioScience is very unpredictable. It's not as predictable as physical science is, and when you do a lot of trials and you heard that during the conference call, you do get the deviant observations. And you did hear very clearly from Sir Richard Peto, who is a world renowned cancer epidemiologist. In fact the science of meta-analysis in the use of medical - in the practice of medicine in some ways has been strongly associated with him as a pioneer. And he said that this does not provide credible evidence of any adverse effect on cancer. So, we do hope as the science keeps going forward, things will keep coming forward.
Steve Scala (Cowen & Co):
Is the $60 million from Merck in or out of the $0.45? Do you know the results of the sands' subset analysis, and can you reassure us that it's not going to generate concern for ZETIA?
Robert J. Bertolini: The $64 million is not in the $0.45.
Fred Hassan: And the Sands analysis was intriguing because the LDL levels went down quite a bit. It's hard to get the LDL levels down with just titrating the statins up because then you get other issues. But at this point we do not know what the situation is with the publication or anymore sub-analysis. We don't know anything further about sands. But we hope that it will be published soon.
David Moskowitz (Caris & Company):
Could you quantify the specific synergies that were gained in the second quarter and also quantify how much of that was related to ZETIA and VYTORIN, the cholesterol JV cost reductions? Can you talk about what you'd expect in terms of R&D expenses in the next two quarters?
Robert J. Bertolini: So, the total savings year-to-date was about $100 million. And the savings from PTP and synergies, $70 million roughly came in this quarter. And then with respect to R&D, generally as our pipeline matures, we would expect R&D to increase in the back half versus the front half.
Anthony Butler (Lehman Brothers):
I've been impressed with the diversity that Organon brings, with respect to its animal health franchise. I seem to recall that under the Akzo Nobel umbrella, part of the operating margin opportunity that they were trying to shoulder was something in excess of 20% out of that business. What’s your target for the animal health business at your organization?
Robert J. Bertolini: We are very pleased with the animal health business. We have seen good growth. The vaccine business is very diverse and from a profit standpoint, I think we would like to see operating targets north of 20% in that business.
Fred Hassan: We do care about margins and we also care about growth in this case, because we are R&D intensive with animal health. We actually do enjoy a strong opportunity here to keep going with very good margins.
Roopesh Patel (UBS):
First, on the SEAS trial, has the FDA seen these results that were presented today, and have they given you any initial feedback? Then separately on TRA, is the initiative to partner the drugs still on the table?
Fred Hassan: We are still looking at the opportunity to partner our drug at the same time. We are also feeling very good about our own situation. So, if we don't get the right partner, we will definitely go on our own. The SEAS results are with the FDA, there might be more submissions and we are making a normal progress you heard in the call this afternoon, directly from the independent investigators as they have directly filed their reports also with the authorities. And, we also have done the same in the EU and in other countries. And the ENHANCE situation is also under review at the FDA and there does not seem to be any particular accelerated schedule.
Jim Tumbering (BMO Capital Markets):
There has also been some discussion lately about a fill Lipitor CIMT study. What’s your comment?
Carrie S. Cox: The Cashmere study was interesting in the sense that it also demonstrated the complexity of these trials and we believe that it is another way to understand how long it can take to be able to provide the data to the public. It's interesting to see that it's another failed trial and it may raise the question as to whether or not these unproven surrogate endpoint is in fact a viable option for studies going forward. We also think in the case of statin depleted population or statin treated populations that you find that pre-treatment and aggressive treatment of LDL should be done, may again affect these populations for future study. Our focus continues to be on the many patients out there who do need aggressive LDL lowering and will really benefit from the products that we bring to the market, since they are the best in providing options for lowering LDL cholesterol.