Celgene Corporation Q3 2009 Earnings Call Transcript

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2009-10-22 11:43:10.0

Tags: Japan, Call Transcript, Celgene Corp., Earnings, Therapy, Strategy, Management, Seeking Alpha

Question-and-Answer Session

Operator

Thank you. (Operator instructions) And we will take our first question from Maged Shenouda with UBS.

Maged ShenoudaUBS

Hi. Thanks for taking my question. Can you outline your plans for top line growth over the next few years as we wait for execution on your frontline multiple myeloma strategy.

Sol Barer

Okay. Bob, could you take that please?

Bob Hugin

Sure. Well, I mean the growth strategy I think is consistent with the strategy that we've had for the last few years. Clearly, there are three major areas. We'll continue to benefit for the next couple of years for expansion geographically, both in terms of regulatory approval and, importantly, reimbursement approvals.

As we mentioned, Japan is the second largest individual oncology market. We filed, in accordance with our plans, on time at the end of the second quarter of this year in myeloma. We expect to file an MDS late this year. And we're expecting about 12 months review, and look to commercialize in Japan late next year. And that's a very attractive market. It's one that clearly has a focus on oral therapies, with important side – ability to manage side effects is very important in that marketplace. But we have reimbursement approvals staggered, fortunately or unfortunately, over the next couple of years in different markets and in some of the Eastern European markets, and some of the Asian markets, and Japan.

So global expansion, both from regulatory and reimbursement market access approvals will be a driver for the next couple of years. And importantly, we will continue to also see market share gains, we believe, in all the markets that we've launched. In Europe, we are making good progress in second and third line. But we're not anywhere near where we think the potential is of fully capitalizing on the existing data and the approvals that we have from both regulatory and reimbursement authorities in Europe.

And the United States, frankly, the success that we've had over the past year to continue to grow market share and improve the profile of the drug and its position in the marketplace has – in fact, our internal target as to where we think ultimately will play out in the US is higher than we would have thought for five years ago.

So geographic expansion, important market share gains in all of our markets we think we'll be able to achieve over the next couple of years, and importantly, the theme that we're seeing more and more, and hopefully you can sense it from today's call, is that when you look at the profile of REVLIMID as an oral therapy, with extended duration of response, with tolerability that allows – there are patients that we're aware of that have been on the drug now for seven, eight years, continuous treatment offers an upside for patients and for us also to extend the duration of therapy.

 

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