AMAG Pharmaceuticals, Inc. (AMAG)
Q2 2010 Earnings Call
July 28, 2010 04:30 am ET
Brian Pereira - President and CEO
Gary Zieziula - EVP and CFO
David Arkowitz - EVP and CFO and CBO
Marshall Urist - Morgan Stanley
Geoff Meacham - JPMorgan Chase
Eun Yang - Jefferies
Chris Raymond - Robert Baird
Chris James - MLV
Yaron Werber - Citi
Carol Werther - Summer Street Research Partners
Brian Huang - Needham & Company
Joseph Schwartz - Leerink Swann
Adam Cutler - Canaccord
Juan Sanchez - Ladenburg
Subash Desai - Delaware Street Capital
Previous Statements by AMAG
» AMAG Pharmaceuticals Inc. Q1 2010 Earnings Call Transcript
» AMAG Pharmaceuticals, Inc. Q1 2009 Earnings Call Transcript
» AMAG Pharmaceuticals Inc. Q4 2008 Earnings Call Transcript
Good afternoon my name is Tracy and I will be your conference operator. At this time, I would like to welcome everyone to the Second Quarter Financial Results Conference 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 Ms. Sullivan, you may begin your conference.
Thank you, Tracy and thank you to those of you that have joined this afternoon. This is a reminder we will be using slides today to accompany our call. And you can access the webcast of the slide presentation at our website which is www.amagpharma.com.
Before presiding with the call please be reminded that the conference call will contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other Federal Security laws.
Any statements contained herein which do not describe historical facts and forward-looking statements which involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
For a full list of risks and uncertainties associated with our business, please refer to our filings with the SEC including our annual report on Form 10-K for the year ended December 31, 2009, and our quarterly report on Form 10-Q for the three months ended March 31, 2010.
On slide three, you will see the agenda for our call. Beginning with our President and Chief Executive Officer, Brian Pereira who will discus some of Amag's accomplishments today. Gary Zieziula, Chief Commercial Officer, will then share his perspective on the commercialization of Feraheme. David Arkowitz, our CFO and Chief Business Officer will follow with a review of our financial results for the quarter, and Brian will close the prepared remarks for the call before we open the floor to Q&A.
I’ll now turn the call over to Brian.
Thank you Amy,
and thank you to those of you who have joined us this afternoon. Before we dive into the slides, I’d like to provide a broad overview. Start business from two perspectives: Most of our SG&A efforts today are focused on ensuring the successful commercialization of Feraheme in the US CKD market and the Feraheme product revenues, we are reporting today reflects this effort.
Most of the R&D efforts today and in the near future are directed towards expanding the label and the global reach of Feraheme, we expect that these investments will create value over the long-term. As you can see on slide 5, we have made progress on both fronts.
For the second quarter, we reported $18.8 million in total revenue, $16 million of which were associated with Feraheme sales. Our recently announced partnership with Takeda contributed to our revenues this quarter with $1.5 million in amortization of the upfront license fees.
As well as $1 million in reimbursement for expense, associated with our marketing authorization application filing and certain other clinical and regulatory cost incurred by us in this quarter. David will discuss this in more detail when he reviews our financial results for the quarter.
In the second quarter of 2010, we continued the successful commercialization of Feraheme in the US CKD market. Today we report 23% increase in Feraheme net product revenues and a 34% increase in provided demand and utilization, as compared to the first quarter of 2010.
Early in 2010, we targeted hospital and hematology segment as significant areas of growth, for the treatment of CKD patients, and we have done very well in attracting new customers in each of these important segments.
I am pleased to report that as a result of these efforts the proportion of our business derived from the treatment of non-dialysis CKD patients has grown to approximately 70% which positions us nicely ahead of the implementation of the prospective payment systems for ESRD patients also known as the [BUN].
Gary will discuss our commercial progress in greater detail in a few moments.
Major objective for us in 2010 is to expand the global reach and the label Feraheme. During the quarter we made important strides towards this goal. We have filed our marketing authorization application with a European medicine agency for Feraheme for the treatment of iron deficiency anemia in adults CKD patients. And the initiative enrollment in the global registration program for Feraheme for the treatment of iron deficiency anemia, regardless of the underlying cost.
We expect to complete enrollment in these drug, by the end of 2011. Before I turn the call over to Gary I’d like to spend a few minutes just cutting the bundle that was released by CMS on July 26
From AMAG’s prospective there were no surprises in the final [room]. However from a dialysis provider’s perspective there are many new [ones] that will take some time to analyze so that they full understand the impact and to determine whether to opt in fully or transition into the bundle over four years.