Amgen Earnings Call Nuggets: Generic Zometa, 785 Single Injection Process

On Tuesday, Amgen Inc (NASDAQ:AMGN) reported its third quarter earnings and discussed the following topics in its earnings conference call. Take a look.

Generic Zometa

Michael Yee – RBC Capital Markets: You made a comment about (your) Zometa going generic and we know that’s coming. What visibility or what discussions have you had with payors in regards to what you think the impact could be timing? Can you just be a little bit more specific in terms of modeling purposes and what we know?

Robert A. Bradway – President and COO: Tony why don’t you share your thoughts.

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Anthony Hooper – EVP, Global Commercial Operations: So while we are discussing with both payors and prescribers continue to be around clinical climate that XGEVA brings to patients. This is clearly the focus we have both in the short-term and in the long-term. Based on the reimbursement methodology under ASB, which takes into account the average last 12 months there could be a result situation where some physicians might make a decision based on short-term economics, but ASB catches up on a 12 months basis. It’s reported two quarters in (arrears), so between 12 to 18 months, there could be some discussion in the market place until we revert back to normality. We will continue to focus on the clinical benefit and ensuring that both physicians and their patients understand the value of this drug versus anything else.

785 Single Injection Process

Geoffrey Porges – Sanford C. Bernstein & Co., LLC: A couple of questions just to be sure on AMG 785 and 145, first on 785, you appear to be going ahead with the 210 milligram dose with three injections monthly, could you describe the process that would be required to get to a single injection formulation? Would that have to be an amendment after the approval or could you do it prior to approval? Then on AMG 145, Sean, could you give us some insight, there is a lot of FDA activity there in the homozygous FH category recently and what do you take away from that in terms of thinking about Phase 3 trial design for 145?

Robert A. Bradway – President and COO: Geoff, thanks for the questions, regarding 785, we do have a 210 milligram dose monthly there and well, I don’t want to get into the technical specifics. We frequently will use a different presentation format, different numbers of injections, formulations, and so on in clinical trials than what is actually used to support the market place. So, we won’t expect to be necessarily providing the number of injections to patients in the marketplace. With respect to 145, yes, I have seen the recent activity around that kind of genetically predisposed patient populations and certainly, we are going to be looking at both the heterozygous familial hypercholesterolemia and the homozygous patients with great interest with respect to PCSK9 inhibition. I think that the studies in the homozygous population are at a proof-of-concept kind of stage, so we’re pretty far away from thinking about Phase 3 design there, but I think the Phase 3 approach to the heterozygous patients is really not meaningfully different than that what we are using for rest of the patient population for whatever reason can’t reach their target by use of all available therapies.

A Closer Look: Amgen Earnings Cheat Sheet>>