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AMAG Pharmaceuticals, Inc. (NASDAQ:AMAG)

Q1 2009 Earnings Call

April 30, 2009 4:30 pm ET

Executives

Kristen Galfetti - IR

David Arkowitz - EVP, CFO and CBO

Brian Pereira - President and CEO

Analysts

Yaron Werber - Citi

Matt Roden - JPMorgan

Peter Hellman - Robert Baird

Mark Monane - Needham

Adam Cutler - Canaccord Adams

Marshall Urist - Morgan Stanley

Carol Werther - Summer Street

Eric Varma - Leerink Swann

Eun Yang - Jeffries

Josh Schimmer - FTN

Operator

At this time, I would like to welcome everyone to the AMAG Pharmaceuticals First Quarter Financial Results Conference Call. (Operator Instructions).

Ms. Galfetti you may start your conference.

Kristen Galfetti

I'd like to welcome you all to our first quarter 2009 financial results conference call. Today we will be discussing our financial results, business highlights and status of our Feraheme development program. Our call today will be referenced to the press release we issued this afternoon which is posted on our website, at www.amagpharma.com, in the Investor section.

The agenda for our call today will begin with our Executive Vice President, Chief Financial Officer and Chief Business Officer, David Arkowitz, who will discuss our financial results for the quarter. Next, our President and Chief Executive Officer, Dr. Brian Pereira will follow with a brief discussion of the company's accomplishments, our corporate update and steps that we are taking to become a commercial, biopharmaceutical company. This will be followed by a question-and-answer period.

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, including statements regarding our financial condition, our expected cost and expenses for the remainder of 2009, both before and after the approval of Feraheme, the planned US launch and commercialization of Feraheme and the timing thereof, the structure and timelines associated with our planned broad-based Feraheme clinical development programs in IDA, the impact of current turmoil in the financial markets on our ability to fund our operations and execute our business plans and our expectations regarding the adequacy of our Feraheme product supply for launch. Our forward-looking statements are 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. Such risks and uncertainties include the possibility that we may not be able to adequately address the issues raised and provide the information requested in Feraheme complete response letters in a timely manner, if at all, uncertainties regarding our ability to manufacture Feraheme, the fact that we have limited sales and marketing expertise, uncertainties regarding our ability to successfully compete in the intravenous iron replacement and imaging markets, uncertainties regarding our ability to obtain favorable coverage pricing and reimbursement for Feraheme if approved, uncertainties relating to our patents and proprietary rights and other risks identified in our Securities and Exchange Commission filings.

Any forward-looking statements that we make today must be considered in light of these factors. The assumptions on which we base any forward-looking statements and our perception of the factors influencing those assumptions are highly likely to change overtime. However, our company policy is to provide forward-looking statements only at certain points in the year, such as during calls like this one. We do not plan to otherwise update such statements. Actual results may differ materially.

I will now turn the call over to our Executive Vice President, Chief Financial Officer and Chief Business Officer, Mr. David Arkowitz.

David Arkowitz

Today, we reported unaudited consolidated financial results for the quarter ended March 31, 2009. Revenues for the quarter ended March 31, 2009 were approximately $1 million as compared to $0.6 million for the same period in 2008. Total operating costs and expenses for the quarter ended March 31, 2009 were $28.9 million as compared to $13.3 million for the same period in 2008, an increase of $15.6 million.

The increase in operating costs and expenses was due to increased research and development expenses to expand the company's clinical development and infrastructure, conduct clinical trials and scale up the company's manufacturing capabilities and increased selling, general and administrative expenses to prepare for the planned commercialization of Feraheme.

Our total operating costs and expenses, excluding stock-based compensation for the quarter March 31, 2009, were basically equal to those in the fourth quarter of 2008 and consistent with the direction that we provided on our yearend 2008 conference call.

The direction that we provided at that time continues to hold, which is we expect that until approval of Feraheme in the US, our total operating costs and expenses excluding stock-based compensation will generally be at or around the current run rate. If Feraheme is approved, then we would expect our expenses to increase from that level.

We reported a net loss for the quarter ended March 31, 2009 of $26.4 million or $1.55 per basic and diluted share as compared to a net loss of $9.3 million or $0.55 per basic and diluted share for the same period in 2008. At March 31, 2009, the company's cash, cash equivalents, investments, settlement rights associated with certain auction rate securities totaled $194.6 million, which is a decrease of approximately $20 million from our December 31, 2008 balance.

Excluding stock option proceeds and the change in unrealized investment gains and losses, our cash burn for the quarter was approximately $23 million. The cash burn over the 12-month period ended March 31, 2009 has been approximately $76 million.

I'd now like to provide some additional information regarding our auction rate securities and other investments. Our auction rate securities balance as of March 31, 2009 using the par value of these securities was $66.5 million. Since there is still no primary market for auction rate securities, we continue to estimate the fair value of these securities using discounted cash flow analysis, incorporating assumptions that we believe market participants would use in their estimates of fair value.

Therefore, we have recorded a temporary impairment relating to our auction rate securities as of March 31, 2009 in the amount of $8.2 million, which is a decrease in the estimated temporary impairment to these securities of $2.3 million from the $10.5 million that we had recorded at the end of the fourth quarter.

In addition, we've recorded an impairment related to auction rate securities subject to our settlement with UBS of $0.7 million, a decrease in the estimated impairment of these securities is about a million from the amount we had recorded at the end of the fourth quarter. The net result of all of this is that the fair value of our auction rate reflected on our balance sheet as of May 31, 2009 is $57.6 million.

As I've stated in the past, we have a high quality cash and investments portfolio, and our primary objective is to preserve capital while maintaining liquidity. Of our $195 million of cash investments and settlement rights, approximately $92 million is highly liquid and is invested in cash, money market funds and US treasury and government agency debt.

The rest is held in auction rate securities and associated settlement rights and corporate debt. We continue to believe that the current turmoil in the financial markets will not materially impact our ability to fund our operations and execute our business plans.

I'll now turn the call over to Brian for his comments.

Brian Pereira

During the last several months, we have focused on two key issues. First, the resolution of the observations noted during the inspection of our manufacturing facility in the fall of 2008 to clear the path to approval; and second, the continued build-up of our corporate and commercial operations infrastructure to ensure a successful commercial launch of Feraheme.

We're happy to report that the FDA has informed us that we have satisfactorily addressed the observations noted during the inspection of our manufacturing facility. The resolution of these issues allows us to move on to bring the approval process to closure.

As a reminder, in October 2008 we received a complete response letter from the FDA with respect to our NDA for Feraheme. We submitted a response in October 2008 and were granted a Class 1 designation.

In December 2008, we received a second completed response letter from the FDA requesting data to clarify a specific CMC question, resolution of the observations noted during the FDA's inspection of our manufacturing facility and finalization of laboring discussions for Feraheme.

As previously stated, we have been pleased with our FDA interactions regarding the draft Feraheme label and its content. The final label is going to be approved when all other issues have been brought to closure. So today, we are one step closer to our goal of approval. We are pursuing a broad indication for Feraheme for the treatment of iron deficiency anemia for all stages of chronic kidney disease, whether or not on dialysis.

Our commercial team continues to prepare for launch, which we expect to occur shortly after approval. We have an experienced and motivated sales team that has been diligently preparing for the anticipated US commercial launch of Feraheme. Our [AD's] renal cell specialists and managers have been in the field meeting with physicians to interview AMAG, raising the awareness of the disease state, profiling accounts and seeking our decision makers in the different treatment settings. We are targeting over 5,000 nephrologists and hematologists in the US.

We expect to have sufficient products supply on hand for our existing manufacturing facility in Cambridge, Massachusetts for our anticipated US launch. At the same time, we continue to make progress towards bringing second source manufacturers for Feraheme online, which would augment our manufacturing capabilities to meet the future demand of the marketplace.

On the clinical development front, our Phase II study of Feraheme for vascular-enhanced magnetic resonance imaging, or VEMRI, in patients with peripheral arterial disease of PAD, continues to enroll patients. We plan to endorse just over 100 patients with PAD. We hope to address this unmet medical need and offer patients a safe imaging agent that facilitates the diagnosis of arterial abnormalities in patients with compromised kidney function. We're pleased that in August 2008, the FDA granted Fast Track designation to Feraheme for the development in this indication.

As previously stated, following discussions with the FDA, we have decided to pursue a broad Phase III clinical development program to treat iron deficiency anemia in a wide range of patient populations and in multiple disease states rather than pursue individual indications. Therefore, we will not commence enrollment in our previously planned Phase III clinical development program in abnormal uterine bleeding nor advanced plans for a separate Phase III program in patients with iron deficiency and cancer.

The study designs and timeline for the initiation of this larger clinical development program for Feraheme are currently subject to the completion of protocol discussions with the FDA. We hope to share the additional details about our program in the months ahead

The company presented two posters with positive clinical results in March at the National Kidney Foundation's Spring Clinical Meetings, the details of which were provided in today's press release. We also continue to seek to publish our Phase III safety and efficacy results in leading medical journals, and we'll share those as they become available.

Although AMAG's immediate focus is on USA approval and the commercial launch of Feraheme in the US, our business development team continues to evaluate business opportunities and markets for Feraheme, since iron deficiency anemia is a widely prevalent global problem and is inadequately treated with the options available today.

In summary, the company has made good progress during the last quarter towards approval of Feraheme, preparations for the launch in commercialization and initiation of new clinical development programs. We believe that when approved Feraheme will bring an important new therapy to millions of patients with iron deficiency anemia. We are positioning ourselves to realize the potential of this opportunity and look forward to updating you on key developments over the next few months and look forward to seeing you at upcoming investor conferences.

This completes my prepared comments. We will now turn the call back to the operator to conduct the question-and-answer session of this call. Operator?

Question-and-Answer Session

Operator

(Operator Instructions). Your first question comes from Yaron Werber from Citi.

Yaron Werber - Citi

I was a little confused on the labeling. Did you say that the final label is done or are you still in final labeling discussions? The obvious question is, can you explain to us the timing from now on or if you actually filed with the FDA, what's the process to actually getting the official approval?

Brian Pereira

As you well know, the final label is only on the day you get approved. Until then, everything is labeling discussions. As I said earlier, we'll update you when we have information to share with you. We do not intend to provide the details with respect to when we submit and so on. The key issue here is approval of Feraheme.

This is the same pattern we have followed in the past. We tend not to give the logistical details to investors. It's not material at this point in time.

Operator

Our next question comes from Matt Roden from JPMorgan.

Matt Roden - JPMorgan

I understand that Feraheme is going to be sold through a normal supply channel. Can you comment on how much inventory would be pushed into the channel at launch and are you contracting a normal band of day sales?

Brian Pereira

The answer is that the dialysis and the non-dialysis segments are catered to by a wide range of both specialty and non-specialty distributors. Our intent is to use all of them to make sure that we have maximum penetration of both these segments, and each of these segments have sub segments and specific affiliations. As we get closer to launch and in the post launch period, we will share with you the appropriate information.

Matt Roden - JPMorgan

My follow-up is on the Phase III program to be. Now that you're changing the clinical trial plans with no longer doing trials in AUB, does that change the total number of patients you'll need to expose to the drug to gain regulatory approval? Does it impact the timelines or cost for running trials?

Brian Pereira

As I said in my prepared comments, we completed discussions with the FDA regarding the Phase III program for the treatment of IDA and AUB. Actually, by now, we would have enrolled the first few patients in this program. We were in discussions with the agency with respect to the Phase III oncology program.

In the course of these discussions with the agency, they suggested that beyond CKD, which is relatively unique because of the amount of iron that these patients need and the frequency of use of ESA in this population, they believe that the general pathophysiology and approach to treatment of IDA is not unique for conditions such as AUB, cancer, inflammatory bowel disease and so on.

So the FDA expressed a willingness to work with us to pursue a broad Phase III clinical program for Feraheme for the treatment of IDA in all patients regardless of the underlying disease. Given this more attractive approach in terms of the construct of the clinical trials, the potential broad ultimate labels, we are in discussions with the agency to pursue a single large clinical development program to obtain a broad based label.

As you would expect, there are economies of scale in doing a large clinical program both in terms of cost and logistics. At this time, its early days for us to give you a very clear picture of the number of patients and the time and cost, but we'll share with you more information as we bring this discussion with the review division to closure.

Operator

Mr. Yaron Werber from Citi is ready for his follow-up.

Yaron Werber - Citi

If you were to get a PDUFA date, I assume you would communicate that, is that correct?

Brian Pereira

As I said, all pertinent information will be shared with you at the appropriate time.

Operator

Your next question comes from Peter Hellman from Robert Baird.

Peter Hellman - Robert Baird

Given the multiple delays, how have you fared with employee retention and could you specifically talk any attrition you've had?

Brian Pereira

The answer to that, Peter, is we had originally planned to launch in January. So we don't see this as an inordinate delay. The good news is that both our field and non-field employees have from day one been convinced and excited about the potential for approval and commercial success of Feraheme. We have been fortunate that we have had literally no turnover.

Operator

Your next question comes from Mark Monane from Needham.

Mark Monane - Needham

I'm calling from Manhattan, the concrete jungle, so I'm going to start with a concrete question, and that is the three points you brought up on the response letter. The label you talked about, the FDA and the lack of need for inspection, and the last one I believe was the data around the CMC question. Did you talk about that, Brian? Is there any follow-up there?

Brian Pereira

I didn't talk about this because that we turned around almost immediately and we had spoken to that at a call and at investor conferences in the January, February timeframe. That's probably the reason why I didn't provide an update on that.

Mark Monane - Needham

Who do you see is the target audience for Ferumoxytol? It's much less clear that I think it is several other diseases. First you have the kidney doctor presented at these conferences and the hematologist which makes sense with the diagnosis of anemia, but if you're going for post op indication, maybe the surgeon is the target audience. How do you think about that?

Brian Pereira

You have rightly pointed to the complexity of audiences. Right now we are focusing on the audience for the first indication, that's CKD both dialysis and non-dialysis. For that, the key audience in terms of prescribers is nephrologists and the key audience in terms of purchases are nephrologists and dialysis chains, large, medium, small, independents.

In addition a fair number of pre-dialysis patients are treated by hematologists. So they are going to be in the inner circle of our first round of targets. Now, as we move to additional indications, oncology is fairly straightforward. It's oncologists.

When you look at abnormal uterine bleeding, postpartum anemia, those get a little more complicated. They're treated by gynecologists, obstetricians, primary care doctors, adolescent medicine pediatricians and so on and so forth. Given our limited resources at this point in time, we are focusing on the launch of the CKD market because our key is to do a good job of that.

The others ought to bridge which are a couple of years in the future, and as we get to that bridge, we think that we will be better equipped to attack those markets aggressively.

Operator

Your next question comes from the Adam Cutler from Canaccord Adams.

Adam Cutler - Canaccord Adams

Thanks for taking the question. I'm wondering if you could just remind us about how this process has worked with the FDA so far. I believe that at the time of your last complete response letter, you told us that you had essentially addressed all of the issues in the previous complete response letter, but the division was still waiting for a verdict, if you will, from the manufacturing division on whether you had addressed their observations.

Now, obviously, you've told us that you have addressed those, which is great, but I'm wondering if you can remind us how that process works, and if possible, let us know when you heard that you had adequately addressed those observations?

Brian Pereira

When we received our first complete response letter in October of 2008, the agency had identified three major pockets of issues. One was a couple of clinical question. One was GCP issue in terms of one of our clinical sites and then the GMP issues around our manufacturing facilities.

We turned around provided a comprehensive response to all three and the agency gave us a plus one response letter, designated as the plus one response with December 30 PDUFA date. During that period of time, we brought the clinical questions and the GCP issues to closure. We made very good progress with the label and we shared that information to you.

Unfortunately, the CMC issues were not dealt with by the appropriate focus, both at the district and the central compliance folks to allow the agency to make a decision by the time of our PDUFA date. Hence, we got a second complete response letter and that letter highlighted the fact that we had to resolve the manufacturing issues prior to approval. Of course, the perfunctory language that labeling discussions have to be finalized was in the letter. There was one minor CMC question which we addressed right away.

So with the January, February timeframe, we worked with both central compliance as well as the district office in a fairly regular back and forth to bring the manufacturing issues to closure and we had in March at the Cowen Meeting, we made a statement that we had had a regulatory meeting with the agency to this effect.

Since then, we brought this back and forth to closure. In general, keeping with the past tradition, we don't provide color as to when exactly the agency issue does a letter stating that the manufacturing issues have been brought to closure.

Adam Cutler - Canaccord Adams

So in terms of the mechanics of how this works going forward, I know you don't want to get into specifics about predicting decision dates, now the division has all the information that they need from your responses to the various issues brought up in the two complete response letters and they have a thumbs up, if you will, from the manufacturing group at the FDA, and now the ball is in their court. Is that fair to say?

Brian Pereira

That's an accurate characterization.

Operator

Your next question comes from Marshall Urist from Morgan Stanley. Your line is now open.

Marshall Urist - Morgan Stanley

Following up on that question, is it fair to assume then that the issue of next steps and whether a formal resubmission will be required is still something to be worked out, and so that's just part of the open logistics question, or should we be assuming that a formal resubmission and then a new PDUFA is the base case from here?

Brian Pereira

While I understand investors and analysts interest in knowing the detailed logistics, we believe that that's not relevant at this point in time. The key issue is how soon can we get approval. That's our endeavor at this point in time. If there is material information that we should share with you, we will do so at the appropriate time.

Marshall Urist - Morgan Stanley

Maybe I'm beating a dead horse here, can we assume that there are still range of possibilities and scenarios that could occur and that we will out how it ends up when you tell us?

Brian Pereira

We don't know what the range of possibilities are because based on the last complete response letter, the three issues identified by the agency were a CMC question, finalizing the label and resolution of the manufacturing issues.

The CMC issue, we turned it around within a week and the key outstanding issue was the resolution of manufacturing, which at this point is done. So we see the next step being the agency, I would say, starting its engines to move ahead with the approval process.

Marshall Urist - Morgan Stanley

So you will hear from them in terms of what next steps are?

Brian Pereira

We know what the next steps are. It's just we haven't shared that with investors. We have taken the required next steps.

Operator

Your next question comes from Carol Werther from Summer Street.

Carol Werther - Summer Street

I just wanted to ask you since we've missed March 31 for the J-code, could you explain to me how it works with the Q-code and how long it takes to get reimbursed especially when doctors treating patients out in their offices instead of in dialysis centers?

Brian Pereira

It's fairly standard to use a miscellaneous reinvestment code until specific J-code is established. We have a very experienced governmental and private payer team out there who have been working with governmental agencies as well as private payers. We are very confident that upon approval and launch, we'll be able to get the drugs reimbursed.

Carol Werther - Summer Street

How quickly was it reimbursed like say if you are a doctor? Do they have to buy the drug outright and then wait for the reimbursement? Can you help me with any timeline there?

Brian Pereira

There are many permutations and combinations which are probably beyond the scope of this call. I'd be happy to walk through those combinations with you at the appropriate forum.

Operator

Your next question comes from Eric Varma from Leerink Swann.

Eric Varma - Leerink Swann

My first question is on pricing. Given that you could potentially have a label that [has broad as] IDA of any cause, where should we think about where you might price Feraheme, because the dialysis market is kind of limiting there?

Brian Pereira

The issue is that we expect a broad label because our clinical program was for all stages of kidney disease, both dialysis and non-dialysis, including native and transplanting kidneys. The price, given the clinical profile and the utility of the drug, given that Feraheme is a new iron therapy that simplifies anemia management by making treatment more efficient, we intend to premium price it.

We haven't disclosed that to you or to the purchasing public at this point in time. That will be made available at launch.

Eric Varma - Leerink Swann

So you will be targeting non-dialysis setting with the pricing?

Brian Pereira

No, for both dialysis and non-dialysis.

Eric Varma - Leerink Swann

The follow-on question was down the road question for partnerships. Could you potentially see yourself partnering in the other indications that you might be see less familiar at marketing in, for example, Crohn's disease or very broad indication on your label, as well as how your partnership discussions are going forward.

Brian Pereira

Clearly, as we move to broad markets such as primary care, we will be evaluating who the right partner would be in those markets. With respect to EU markets, our VD team has been involved in active discussions with a wide range of potential EU partners, as well as regulatory team has been in close contact with uh, European regulatory agencies. I think the approval of Ferumoxytol will allow us to take these discussions to legitimate conclusions.

Operator

Your next question comes from the Eun Yang from Jeffries.

Eun Yang - Jeffries

In your communications with the FDA, did they say that (inaudible)?

Brian Pereira

As you know, the risk evaluation and management strategies are required in general for new drugs which don't have antecedents, or drugs that have shown less than optimum safety profile. Intravenous irons have been around for a long time, for 40 years. We haven't done head-to-head trials with other intravenous irons has a very attractive safety profile. So we don't believe that that will be required at this point in time.

Operator

Your next question comes in Josh Schimmer from FTN.

Josh Schimmer - FTN

I hope it's not redundant, but I don't think I've heard this addressed specifically, so I'll go ahead and ask. What issues do remain to be addressed prior to approval?.

Brian Pereira

At this point in time, it's an issue of signing off the final label and signing off on the post-approval commitments.

Operator

We have a follow-up question from Yaron Werber from Citi

Yaron Werber - Citi

The next stage of discussions with investors is going to be the market opportunity presumably assuming you guys get approval sooner than later. So the questions that we get a lot have to do with potential contracting with some of the major clinics out there, [Dallas] has chains out there.

Specifically, Fresenius has Venofer under its belt where then can provide that to their clinics with attractive terms, whereas the Venofer is very popular within the Vita clinic, and to a certain degree some could argue that it's to a certain degree harder to get on the formulary in the Vita.

So I wanted to get to the extent you can discuss this, share your thoughts on what could make Feraheme attractive to a Fresenius clinic, and ultimately how does one manage to entice the Vita to give you a contract as well?

Brian Pereira

There are several reasons why given a dialysis chain or given a dialysis unit would want to choose Feraheme over the existing intravenous iron. First is the very attractive clinical profile of Feraheme, both from the safety and efficacy point of view, which makes Feraheme a very efficient vehicle for treating iron deficiency anemia. Second is the logistics. Although you don't lop off a nurse by switching from existing iron to Feraheme, the reality is Feraheme simplifies the workflow logistics in a dialysis unit.

Third is the Feraheme contract will be very attractive both to individual units as well as to dialysis chains. And consequently, we expect to have our fair share of both the large dialysis organizations as well as the small dialysis organizations.

At the end of the day, I think it's going to be hard to turn down a Feraheme contract. Once a Feraheme contract is established, it's hard to turn down docs from prescribing Feraheme, which will be the first truly new product in the nephrology space in the last seven or eight years.

Yaron Werber - Citi

What are you thoughts about the dialysis bundling that's going to go into effect January 1, 2011 in terms of pricing?

Brian Pereira

We have our strategies for Feraheme to retain its market share in the bundle. It's inappropriate for me to discuss these contracting strategies at this point in time as well as spell out the value proposition that we will advocate in the bundle for competitive and strategic reasons. It's important that we hold our cards close to our chest.

Operator

(Operator Instructions). Our next question comes from Eric Varma from Leerink Swann.

Eric Varma - Leerink Swann

I had two more quick questions. One was for the all encompassing Phase III trial. Would that be one or two trials? Is there any clarity around that?

Brian Pereira

That's an issue of ongoing discussion with the agency, whether it's one large trial, two half-size trials, what the proportion of patients with different disease states is going to be. All of that is subject that our clinical development team is in ongoing discussions with the agency as we speak.

Eric Varma - Leerink Swann

My understanding of a Class 1 response is that means that the FDA thinks they only need two months in order to review all data out that's being submitted. Given that you have given your Class 1 response, would that mean if you have resubmitted your information, given sometimes soon that we can expect approval within two months. Is that the right mindset?

Brian Pereira

As I said earlier, we have not provided a detailed description as to when we have or plan to resubmit, but when there is relevant information that we need to share with you, we will. On the resubmission front, I've said this in the past, there is basically nothing to resubmit because the only outstanding issue that we had was the resolution of the manufacturing issue.

Operator

Your next question comes from Mark Monane from Needham. Your line is now open.

Mark Monane - Needham

Can you talk about the data that exists in pregnant women and children? You mentioned adolescent medicine. What data do we have right now concerning the safety and efficacy of this population?

Brian Pereira

That's an interesting point. Today, in the US, the only drug that could be used in these populations is INFeD, because INFeD or the dextran iron, these were approved 20, 30 years ago. At that time there were no specific indications. So they were just approved for iron deficiency anemia.

The two current drugs, Venofer and Ferrlecit, have very limited labels, Ferrlecit only for dialysis and Venofer for dialysis and a very restricted label for pre-dialysis. So, today what these populations get is [Oruline] which is not effective, not well tolerated, and tend to continue with fairly severe anemia for long periods of time.

There's an occasional enterprising doctor who will say, okay, let's try dextran and bring them in and give them a gram of dextran, and the results are very good. These patient populations tend to be younger, tend to have no other disease conditions. So the response to intravenous iron is just remarkable. We think that this is a very attractive population for Feraheme to get into.

Operator

We have no further questions in queue. I'd like to turn it back to you fork closing remarks.

Brian Pereira

We have no additional comments. Thank you very much for traveling this road with us. We look forward to seeing you at upcoming investor meetings. Have a wonderful evening. Bye, bye.

Operator

This concludes today's conference call. You may now disconnect.

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Source: AMAG Pharmaceuticals, Inc. Q1 2009 Earnings Call Transcript
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