Key questions and answers from the second quarter earnings call conducted by Merck & Co. (MRK: chart) on July 21, 2008.
Chris Schott (J.P. Morgan):
On GARDASIL, the cuts of the guidance, what age group specifically was driving bulk of the clients here?
Kenneth C. Frazier: The cohort we have seen the most difficulty with is the 19 to 26-year old cohort. Trying to get actual the women even when you can drive high levels of awareness has proven more difficult than we anticipated.
In addition, these women primarily visit PCP then OBGYNs who are not typical routine vaccinators. And who in many cases have no established infrastructure for routine vaccination of this age group.
In addition, there is some lack of consistency around benefit design with the portion of these women which causes additional confusion with their physician, despite the fact that there are high levels of this individual have some coverage if they are privately insured.
Timothy Anderson (Sanford Bernstein):
Can you give an update on the ongoing SINGULAIR safety review by FDA in terms of when we might learn more?
Kenneth C. Frazier: We can not predict what the FDA will do. We are in the process of interacting with the FDA now, and providing that information to the FDA.
Roopesh Patel (UBS):
Given the challenges experienced with penetrating the 19 to 26 years olds, what do you believe the company will have to do differently when it gets approved for adult women 27 to 45 year olds?
Kenneth C. Frazier: As we deal with older population including adult women, we obviously will be dealing with very different populations than we did with adolescent girls.
What we found in the adolescent population was that our efforts to motivate the primary actors in that case, largely mothers of young girls as well as pediatrician, that's something that our early efforts were relatively successful and that created a very large uptake in the first year.
As we deal with older populations, we are going to have to find strategies and we are in fact defining and working on strategies that allow us to communicate what is clearly a valuable therapeutic offerings to those women as well as to their doctors and get people to begin acting on it, when they have that level of awareness. So that is the challenge.
Roopesh Patel (UBS):
On GARDASIL,when do you expect the drug to resume growth and what will the drivers be?
Kenneth C. Frazier: We have a number of programs in place to address some of the primary concerns and barriers that we have experienced in the market particularly from the 19 to 26-year old.
They include, financial issues that affect the physician as well as actions that are intended to drive more action among our young adult females including new consumer DTC campaigns that are end directly at young adult women.
We think those are the kinds of things that we will have to do in order for us to drive greater awareness during the course of the year. We have distributed a significant number of doses. The penetration has been 30 million worldwide and 18 million in the U.S.
David Risinger (Merrill Lynch):
Could you just run through the filed vaccine supplements?
Richard T. Clark: We have at least two supplements with the FDA concerning GARDASIL and they will move through the process now.
Catherine Arnold (Credit Suisse):
Comment on the ZOSTAVAX performance?
Kenneth C. Frazier: Due to the supply issues that had existed with varicella containing vaccine, we prioritize VARIVAX, particularly to ensure that we had a supply to support the second dose vaccination recommendations. As a result, we were not in the same way publicizing or promoting ZOSTAVAX.