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Bill HeidenThank you, Amy. I'd also like to welcome all of you to the call here today. I joined AMAG in May and I've now had a couple of months to dig into the business. As you hear this morning, our core business is solid and growing and we are ready to continue to build. This slide depicts our business strategy to develop a multi-product specialty pharmaceutical company will build up our strong base in dark blue, a strong commercial footprint in two very attractive segments, hematology and hospital, in green, a very strong balance sheet and an experienced management team that knows how to execute. As we build, there are four key drivers of growth of Feraheme, shown here in light blue. First, continue to gain share in the US CKD IDA market. Second, to expand the label to include IDA regardless of underlying cause doubling the market opportunity for Feraheme. Three, international expansion of Feraheme. We've already had success here with recent approvals in Canada and the EU where Takeda is our partner and plans to launch by year-end 2012. And fourth, market expansion. Taking share from the oral iron market which is an enormous opportunity for future growth of Feraheme. And in orange, you can see that we plan to add additional marketed products to leverage our strong base. We'll be adding products to our portfolio that are commercial staged leverage our current call points and have sales upside. So, let's talk about the quarter. In terms of quarterly highlights, we had many successes this quarter. First is continued growth of Feraheme in the US with record provider demand more than 28,000 grams and growth in all segments. In terms of international, we had European approval which triggered a $15 million milestone and Takeda's launch in the EU by year-end will trigger an additional $15 milestone and provide future royalty revenues for AMAG.
In terms of label expansion, in July we reported positive data from the IDA 301 study, the second of the two Phase III studies evaluating Feraheme with the treatment of IDA in the broad patient population who have failed oral iron. And we plan to submit that SNDA by the end of the year.If you just step aside and mention that this morning there was good news on the competitive front, Luitpold announced that they've received a third negative response from the FDA. A non-approval regarding some manufacturing issues. The press release also alludes to some clinical questions and so while we are prepared for and all competitors, it looks like this particular competitor has been delayed at a minimum. Returning to the quarterly highlights. In terms of our base business, our base business is growing and we will expand the portfolio through an aggressive business development initiative which is underway at AMAG. And finally, speaking about the numbers and the focus of today's call, I'm pleased to announce that based upon the Feraheme sales trends of the first and second quarter, we are refining and modestly increasing our topline financial guidance for Feraheme product revenue to arrange a $55 to $58 million which would represent more than 10% increase over 2011. Frank will dive into the details of our financial performance in a bit, but at a very high level, our revenues and expense trajectories are both heading in the right direction. Read the rest of this transcript for free on seekingalpha.com