AMAG Pharmaceuticals' CEO Discusses Q2 2012 Results - Earnings Call Transcript
July 26, 2012 11:46 AM ET
AMAG Pharmaceuticals, Inc. (AMAG)
Q2 2012 Earnings Call
July 26, 2012 8:00 AM ET
Amy Sullivan – VP, IR
Bill Heiden – President and CEO
Frank Thomas – COO
Matt McKinsey – Robert W. Baird
Eun Yang – Jefferies
Carol Werther – Summer Street Research
David Friedman – Morgan Stanley
Joseph Schwartz – Leerink Swannshort
Good afternoon my name is Tiffney and I will be your conference operator today. At this time I would like to welcome everyone to the AMAG Pharmaceuticals second quarter financial results call. All lines have been placed on mute to prevent any background noise. After the speakers' remarks there will be a question-and-answer session. (Operator Instructions). Thank you. Amy Sullivan, Vice President of Investor Relations, you may begin your conference.
Thank you Tiffney. Good morning. I would like to welcome you to the AMAG Pharmaceuticals second quarter 2012 financial results conference call. Before proceeding with this call, please be reminded that any statements we make during the course of this conference call that are other than historical facts are forward-looking statements made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. We want to emphasize that these forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Please refer to our recent filings with the SEC for a full review of the risks and uncertainties associated with our business.
Let me quickly run through the agenda for this call. Bill Heiden, our President and CEO will review our strategy including our expansion initiative, discuss the business highlights for the quarter and provide an update on our commercial progress with Feraheme. Frank Thomas, our Chief Operating Officer will review our financial performance for the quarter and update the financial guidance for 2012. Bill will provide some closing remarks and then we'll open the call for Q&A. Scott Holmes; our Chief Accounting Officer is also with us this morning and will be available during Q&A. I'll now turn the call over to Bill.
Thank 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.
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