AMAG Pharmaceuticals Inc. Q4 2008 Earnings Call Transcript

Feb.27.09 | About: AMAG Pharmaceuticals, (AMAG)

AMAG Pharmaceuticals Inc. (NASDAQ:AMAG)

Q4 2008 Earnings Call

February 27, 2009; 8.30 am ET

Executives

Brian Pereira - President & Chief Executive Officer

David Arkowitz - Executive Vice President, Chief Financial Officer & Chief Business Officer

Kristen Galfetti - Senior Director, Corporate Communications / Investor Relations

Analysts

Gwen Deckwidth - Needham & Company

Adam Cutler - Canaccord Adams

Matt Roden - JP Morgan

Carol Werther - Summer Street Research Partners

Eric Varma - Leerink Swann

Eun Yang - Jefferies

Veronica Dubajova [Ph] - Goldman Sachs

Juan Sanchez - Ladenburg

Operator

Good morning. My name is Rebecca and I will be your conference operator today. At this time I would like to welcome everyone to the AMAG’s fourth quarter and year end 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. Galfetti, you may begin your conference.

Kristen Galfetti

Thank you, Rebecca. Good morning. I’d like to welcome you all to our fourth quarter and year end 2008 financial results conference call. Today we’ll be discussing our financial results, business highlights and development program. Our call today will reference the press release we issued this morning 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 expenses for the remainder of 2009, both before and after the approval of Feraheme, the claims and US launch of the commercialization of Feraheme, our belief that we will not need to conduct any additional clinical trials prior to approval of Feraheme, the structure and time lines associated with our planned Feraheme clinical development programs in AUB, oncology NIDA, plan size and design of our Phase II Feraheme imaging study and the impact of current turmoil in the financial markets on our ability to fund our operations and execute our business plans. 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, provide the information requested and satisfactorily address the manufacturing deficiencies referenced by the FDA in the October and December 2008 Feraheme complete response letters and obtain the necessary regulatory approvals in order to manufacture, market and sell Feraheme.

The possibilities that we may not be able to address such issues, provide such information, address such deficiencies, and obtain such approvals 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 complete 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 the 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 and Chief Financial Officer and Chief Business Officer, David Arkowitz.

David Arkowitz

Thank you, Kristin and good morning everyone. Today we reported unaudited and consolidated financial results for the fourth quarter and year ended December 31, 2008.

Revenues for the quarter ended December 31, 2008 were $0.6 million as compared to $0.4 million for the same period in 2007. Total operating costs and expenses for the quarter ended December 31, 2008 were $23.8 million as compared to $13.9 million for the same period in 2007, an increase of $9.9 million.

The increase in operating costs and expenses, was primarily due to increased selling, general and administrative expenses to prepare for the planned commercialization of Feraheme. Included in the fourth quarter operating costs and expenses is the reversal of $4.9 million in stock based compensation expense related to certain performance based stock options, where the performance condition was not met or considered improbable.

This reversal includes amounts recorded in 2007 and in the first three quarters of 2008 and is the reason why the stock-based compensation expense for the fourth quarter of 2008 is a negative $1.7 million.

Going forward, we expect that until approval of Feraheme in the U.S., our total operating costs and expenses, excluding stock based compensation expense will generally be at or around the level of the fourth quarter 2008 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 December 31, 2008 of $21.8 million or $1.28 per basic and diluted share as compared to a net loss of $9.7 million or $0.57 per basic and diluted share for the same period in 2007.

For the 12 month period ended December 31, 2008, revenues were $1.9 million as compared to revenues of $2.6 million for the same period in 2007. Total operating costs and expenses for the 12 months ended December 31, 2008 were $81.5 million as compared to $45 million for the same period in 2007, an increase of $36.5 million or over 80%.

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

The net loss for the 12 months ended December 31, 2008 was $71.6 million or $4.22 per basic and diluted share as compared to a net loss of $33.9 million or $2.15 per basic and diluted share for the same period in 2007.

At December 31, 2008 the company’s cash, cash equivalents, investments and settlement rights associated with certain auction rate securities totaled $215 million, which is a decrease of approximately $26 million from our September 30, 2008 balance.

Excluding stock option proceeds and the change in unrealized investment gains and losses, our cash burn for the quarter was approximately $24 million. Our cash burn over the 12 month period ended December 31, 2008 has been approximately $63 million.

As I’ve done in previous quarters, I’d now like to provide some additional information regarding our auction rate securities, the related settlement rights and other investments. Our auction rate securities balance as of December 31, 2008 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 our auction rate securities using discounted cash flow analyses, incorporating assumptions that we believe market preciseness would use in their estimates of fair value. Therefore, we recorded a temporary impairment relating to our auction rate securities as of December 31, 2008 in the amount of $10.5 million, an increase of about $4.4 million over the amount that we had recorded at the end of the third quarter.

In addition, during the fourth quarter we entered into a settlement agreement with one of our brokers, UBS, related to approximately $9 million in par value of auction rate securities. This settlement provides us with a right to sell these auction rate securities to UBS, at par for a two year period beginning June 30, 2010.

As a result, we recorded a realized loss for the impairment related to the auction rate securities subject to the UBS settlement of $1.7 million in our income statement. In the fourth quarter, we also recognized a benefit for the fair value of the UBS settlement rights, which is $1.6 million in our income statement and on our balance sheet as a non-current asset.

The net result of all this is that the fair value of our auction rate securities, as reflected on our balance sheet as of December 31, 2008 is $54.3 million. As I’ve previously stated, we have a high quality cash and investments portfolio and our primary objective is to preserve capital while maintaining liquidity.

Of our $250 million of cash investments and settlement rights, approximately $101 million is highly liquid and is invested in cash, money market funds and U.S. Treasury and government agency debt. The rest is held in auction rate securities and settlement rights, corporate debt and commercial paper.

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 will now turn the call over to Brian for his comments.

Brian Pereira

Thank you, David and good morning. During the past year, we made steady progress throughout the entire organization, which we believe has positioned us for a successful year ahead. We realized numerous commercial, regulatory and medical development achievements over the past year.

During 2008, we advanced our NDA for Feraheme, our IV iron therapeutic agent, which we are developing to treat iron deficiency anemia in chronic kidney disease patients, whether or not on dialysis.

We initiated a Phase II imaging trial for Feraheme, completed the scale up of our commercial operations group including the hiring of our Feraheme sales force, made several strategic additions to the senior executive level and elsewhere throughout the organization, welcomed two new members to our Board of Directors and moved our corporate headquarters from Cambridge to Lexington to accommodate our growing employee base.

At the end of 2008 our headcount totaled more than 250 employees. All of this was accomplished while being thoughtful of our balance sheet and cash position as David has just summarized. More recently, during the fourth quarter, we continued our preparations to commercialize Feraheme.

In October 2008, we received a complete response letter from the FDA with respect to our NDA for Feraheme, requesting certain additional clinical information. Our response to certain observations noted during FDA inspection at one of our Phase III clinical sites and resolution of certain deficiencies noted during a recent FDA inspection of our Cambridge, Massachusetts manufacturing facility. We submitted a response in October 2008 and were granted a Class 1 designation.

In December 2008 we received a second complete response from the FDA, requesting data to clarify a specific CMC question, resolution of the deficiencies observed during the FDA’s inspection of our manufacturing facility and finalization of labor discussions for Feraheme. We have provided a response to the FDA regarding the CMC question and we are in active dialogue to resolve the outstanding manufacturing issues.

We have received numerous questions regarding the status of our labor discussions with the FDA. As previously stated, we have been pleased with our FDA interactions to-date regarding the draft Feraheme label and its content. However, the final label is approved only when the other issues have been brought to closure. So, this will be one of the last items to be locked down prior to approval.

We are pursuing a broad indication for all stages of chronic kidney disease, whether or not on dialysis and that has not changed. We continue to believe that we will be able to dissolve these issues without conducting any additional clinical trials prior to the approval of Feraheme. We are working with the FDA district office and central compliance to resolve the manufacturing observations. When we have additional information to share, we’ll do so at the appropriate time.

We plan to launch Feraheme promptly after approval. Progress continues in our commercial group. Our sales force of approximately 80 renal sales specialists and managers has been hired and has been out in the field, interacting with physicians on disease state awareness, profiling of accounts and similar activities.

Our team is targeting over 5,000 nephrologists and hematologists in the U.S. We’ve hired a talented and experienced professional team, who are excited to be part of our launch plans. We are also pleased that the FDA informed us that our trade name, Feraheme, is acceptable.

On the clinical development front our Phase II study for Feraheme for vascular enhanced Magnetic Resonance Imaging or VE-MRI in patients with peripheral arterial disease is ongoing. Our plan is that the study will enroll just over 100 patients with PAD.

As a reminder in August 2008, the FDA granted fast track designation to Feraheme for the development in this indication. We hope to address this unmet medical need and offer patient a space imaging agent that facilitates the diagnosis of arterial abnormalities in patients with compromised kidney function.

We continue to advance our clinical development program for additional indications beyond CKD and currently intend to initiate two Phase III studies of Feraheme in women with iron deficiency anemia and abnormal uterine bleeding in the first half of 2009. We expect that these studies will enroll a total of approximately 1200 patients combined.

We also intend to initiate a Phase III program later this year in patients with iron deficiency anemia and cancer, whether or not receiving chemotherapy. The study design and timelines for the initiation of our clinical programs for Feraheme in abnormal uterine bleeding and cancer patients are currently subject to the completion of protocol discussions with the FDA and may ultimately serve as the basis for a broad Phase III clinical development program of Feraheme, for the treatment of iron deficiency anemia in a wide range of patient populations and disease states. We hope to share additional details about our programs in the months ahead.

Efforts to educate physicians and publish our clinical data continue. Positive clinical results continue to be published in leading scientific journals, supporting the efficacy and safety profile of Feraheme. In February this year, the clinical journal of the American Society of Nephrology, CJASN published results of our Phase III safety and efficacy study in dialysis patients. This study enrolled 230 dialysis patients with iron deficiency anemia. Three of our four Phase III clinical studies have now been published in leading medical journals.

In November, we had a strong presence at the American Society of Nephrology annual meeting in Philadelphia. We presented eight posters on Feraheme, and sponsored several symposia and lectures at the meeting.

We are looking forward to our participations in the National Kidney Foundation meetings in Nashville, Tennessee next month as well. While our focus is currently on obtaining U.S. approval for Feraheme, we have an active business development team that continues to evaluate business opportunities and markets.

We continue our manufacturing scale-up efforts in our Cambridge Massachusetts facility, where we have built a Feraheme inventory. We are continuing to make progress towards bringing a second manufacturing source online, which would augment our manufacturing capabilities for Feraheme, to meet the future demands of the marketplace.

In November 2008, we decided to discontinue the manufacturing of Feridex I.V., one of our legacy contrast agents used for liver and screen imaging. The decision to stop manufacturing Feridex was a business decision that we believe is in the best interest of AMAG and its shareholders.

We believe our progress and accomplishments in 2008 position us for an exciting year ahead as we prepare for the launch and commercialization of Feraheme and the initiation of new development programs.

We believe that if approved by the FDA, Feraheme could represent a significant opportunity to improve therapy of thousands of patients with iron deficiency anemia and we are positioning ourselves to realize the potential of this opportunity. We look forward to updating you on developments over the next several months and look forward to seeing you at our upcoming investor conferences.

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

Question-and-Answer Session

Operator

(Operator Instructions) Your first question comes from the line of Gwen Deckwidth [Ph] with Needham & Company. You have the floor, sir.

Gwen Deckwidth - Needham & Company

Hi, good morning. My first question is I just wanted a clarification on the two new trials. It’s going to be uterine bleeding and also in cancer. Is there any plans for multiple indications in general iron deficiency anemia?

Brian Pereira

Good question Gwen. We are planning to initiate two clinical trials in women with abnormal uterine bleeding. Concurrently, we have an ongoing discussion with the agency, regarding a Phase III program in patients with cancer, irrespective of whether they’re on chemotherapy or not and we are also in discussions with the agency as to what would be required to get a broad iron deficiency label, irrespective of the cause of iron deficiency. All of this is work-in-progress and we’ll be able to provide you much more clarity in the months ahead.

Gwen Deckwidth - Needham & Company

Thank you and I have a question on commercialization ex-U.S. in Europe and Japan. Do you have an update on filings and an update on potential partnerships?

Brian Pereira

At this point we don’t have an update on partnerships and filing. As I’ve said in my prepared remarks, the business development team is working with several potential partners in different parts of the world. Our regulatory and clinical development team, have had interactions with agencies outside the U.S. Our ex-U.S. filing strategy will in some ways be linked to potential partnership, but not necessarily so.

Gwen Deckwidth - Needham & Company

Thank you for the handed information.

Brian Pereira

My pleasure.

Operator

Your next question comes from the line of Adam Cutler with Canaccord Adams; you have the floor, sir.

Adam Cutler - Canaccord Adams

Hi, thanks for taking the question. I am wondering, you mentioned that you’re in active dialogue with the FDA around trying to resolve any questions around manufacturing. Can you tell us, have you been interacting with the central office or the district office?

Brian Pereira

Sure Adam, that’s a good question. Just to provide clarity as to how this works; the primary source of contact for manufacturing issues is always the district office. This district office works with the central office in bringing issues to closure. We have been working with both the district and the central compliance office to bring our manufacturing observations to closure.

Adam Cutler - Canaccord Adams

Okay and then I’m wondering if you can just remind us of what your disclosure guidance is around, any of these discussions. So for instances if there was a request for a re-inspection, is that the kind of thing you would tell us about or would you wait until you have either a decision or an action date, before you would tell investors?

Brian Pereira

That’s a good question, Adam. As we have in the past, we don’t provide an update on our interactions with the agency and we consider a re-inspection if required as just a continuum of interactions at the appropriate time. When we have material information to share with investors; we will do so. Meanwhile, we are having a healthy and active dialogue with both the central compliance and the district office in our efforts to bring this to closure as soon as possible.

Adam Cutler - Canaccord Adams

Okay, thanks a lot.

Brian Pereira

Thank you.

Operator

Your next question comes from the line of Matt Roden with JP Morgan. You have the floor, sir.

Matt Roden - JP Morgan

Hi, good morning and thanks for taking my questions. Have you received any feedback from the FDA on whether or not you need to resubmit your NDA and establish a new PDUFA or whether or not they could just approve the NDA outright following the resolution of manufacturing issues; can you tell us where you are with that process?

Brian Pereira

Good question, Matt. The reality is that we need to bring the manufacturing issue to closure. It doesn’t make sense at this point to engage the review division with whom we’ve had a collaborative dialogue, in a discussion regarding re-submission until the manufacturing issues have been locked on. As you recall, at the last time around, we were granted a Class 1 response and although the review division made good progress, the inability of the manufacturing compliance folks to bring it to closure led to that date come and go.

So, at this point in time we are keeping our options open, but we have an open line of communication with the review division. We are keeping them posted as to where things stand with respect to our interactions with the manufacturing folks.

Matt Roden - JP Morgan

Is that to say that re-submission or not has not been discussed directly?

Brian Pereira

As I said Matt, we are not going to go through the details of our interactions with the review division. At the appropriate time, we will share that information with you.

Matt Roden - JP Morgan

Okay. Thanks and then just one last follow-up. Brian, do you have any thoughts on what’s coming out of Washington these days? Obviously, you have come out with the budget proposal yesterday or comments on the budget. Do you have any thoughts on what you’re hearing out of the Washington from the policy side and what impacts that could have on your business?

Brian Pereira

Great question Matt. We’ve been very closely monitoring Obama’s budget. We have seen the body language and the hand waving in Washington with respect to the implications for federal entitlements including Medicare, Medicaid. We did see how the markets reacted with respect to pharma stocks yesterday, but I think its early days at this point in time. A lot of water will flow down the charts before this proposal ultimately gets translated into a real budget.

Matt Roden - JP Morgan

Thanks a lot.

Operator

Your next question comes from the line of Carol Werther with Summer Street Research Partners; you have the floor, ma’am.

Carol Werther - Summer Street Research Partners

Alright, can you tell us if you have any plans to stop producing GastroMARK also?

Brian Pereira

At this point we will continue to manufacture GastroMARK, but we’ll evaluate what role this product plays in our business strategy going forward. As you know Carol, Feridex and GastroMARK were great drugs when they were developed, but Magnetic Resonance Imaging technology has progressed at an extraordinarily rapid pace, making the clinical demand for many of these legacy products decline at a fairly rapid pace.

So, we are balancing the needs of the last few patients and our last few partners and vis-à-vis the profitability and the distraction to our core opportunity, that’s Feraheme. I hope that gives you an answer.

Carol Werther - Summer Street Research

Okay, yes and then could you help us with how much the cost of the launch might be, once you get approval?

Brian Pereira

David has given you a fairly robust analysis as to how much we’ve been spending in the last couple of quarters. As you see, a large part of this spending has been related to the launch preparation. As you also know that most of our employee base and almost our entire commercial employee basis already in place.

So that gives you a rough estimate of what we’ve been spending in the last quarter when we were almost fully staffed. Beyond that, it’s been our consistent policy not to give guidance as to how much either clinical programs or commercial initiatives will cost.

David Arkowitz

If I could just add to that I maybe stating the obvious, I’m sure I am here, but associated with the launch there’ll clearly be some onetime expenditures around that and then there will be a commercial spending at a higher level as we’re out in the field, actively promoting Feraheme.

Carol Werther - Summer Street Research

Okay, great. Thank you.

Operator

Your next question comes from the line of Eric Varma with Leerink Swann. You have the floor, sir.

Eric Varma - Leerink Swann

Good morning, Brian and thanks for taking my question. I was wondering, would you still launch the Phase III trial in abnormal uterine bleeding if you hadn’t received Feraheme approval in CKD?

Brian Pereira

We think, go ahead, Eric.

Eric Varma - Leerink Swann

That was my first question.

Brian Pereira

Okay. Yes, I did. Our clinical development program is not contingent on Feraheme approval. We have a strong level of comfort with the quality of our clinical data in chronic kidney disease and as said several times today, we are working hard to bring all of the manufacturing issues to closure.

Our plans for abnormal uterine bleeding as well as cancer are going ahead and these are the future value of the company and so we think that this is a large market. We believe that it is a large unmet need and so that’s progressing at a pace that we have consistently pushed along.

Eric Varma - Leerink Swann

Okay, perfect and then have you had any sales force attrition to-date since there have kind of been a delay in the launch so far for Feraheme, just a slight delay and do you have something in place to keep them kind of interested?

Brian Pereira

Sure, that’s a great question. The answer is our sales force is very motivated and excited. They’ve had a large number of in-house training sessions. They know about the potential of the product and they’re out in the field, profiling practices, building relationships with nephrologists and hematologists and embarking on disease state education.

Attrition; there is the normal attrition of folks coming in and out. There is a normal attrition that occurs when you’ll bring a large contingent of sales force on board, maybe one or two may not be the right fit, but I don’t believe that we have had any significant attrition. In fact we have a very motivated and loyal, I would say, sales force.

Eric Varma - Leerink Swann

Okay, that makes a lot of sense and one last question. So, you mentioned in the past that before any sort of re-inspection if needed, you’d have a mock inspection. Can you just kind of walk us through what a mock inspection would and what personnel you hired to make this go smoothly?

Brian Pereira

Well, even before we had our 483 observations, we have embarked on a system-wide quality improvement process. We have probably the best consulting firms in the business working with us at our manufacturing facility to make sure that we leave no stone unturned with respect to manufacturing quality assurance and quality control. These folks are in-house; they are assisting us and will run us through a fine toothcomb several times over, if re-inspection is required.

Eric Varma - Leerink Swann

Okay, great job guys in 2008 and best wishes in 2009.

Brian Pereira

Thank you very much.

Operator

Your next question comes from the line of with Eun Yang with Jefferies. You have the floor, sir.

Eun Yang - Jefferies

Thanks very much. Brian, in your earlier remark you said that one of the CMC issues, specific issues raised in the second letter, you guys have responded to it and provided the information to the FDA, should we consider that as a kind of continuum of active dialogue or is there something FDA would come back to and say your informational response is acceptable or things like that?

Brian Pereira

Well, that was in our opinion a fairly straightforward question. We responded to it right away and when the FDA does not come back, it means that they have no additional questions on that issue.

Eun Yang - Jefferies

Okay. So, could you actually tell us when you have provided the information to the agency?

Brian Pereira

No, we don’t give regular updates of our interactions with the agency. So we’ll let you know at the appropriate time when a material event occurs.

Eun Yang - Jefferies

Okay. Thanks.

Operator

(Operator Instructions) Your next question comes from the line of Adam Cutler with Canaccord Adams. You have the floor, sir.

Adam Cutler - Canaccord Adams

Hi, thanks for taking the follow-up. Just wondering, if you can remind us on about what impact the timing of approval might have on reimbursement and sort of any sort of important thresholds time wise around that issue?

Brian Pereira

Good question, Adam. On the reimbursement front, it’s good to have approval by March 31 each year, because that’s the filing deadline for a permanent J Code, but that’s really not a challenge in Nephrology, because both physician practices and dialysis chains have a fair amount of experience in using temporary J Codes and Q codes if required.

So, we have strong government affairs and managed care team, which is out in the field, working with payers. So, we believe that this is not going to hinder our launch in any significant way.

Adam Cutler - Canaccord Adams

Okay, thanks.

Operator

Your next question comes from the line of Veronica Dubajova [ph] – Goldman Sachs. You have the floor, ma’am.

Veronica Dubajova – Goldman Sachs

Yes, good morning. Thank you very much for taking my question. I was just wondering, how much do you think would a label that would be restricted simply to dialysis patients, limit your market opportunity for Feraheme?

Brian Pereira

As we have said in the past, that our NDA submission was for chronic kidney disease across the spectrum of chronic kidney disease including dialysis and not on dialysis; that’s been true for all our label discussions that have occurred thus far and we don’t see any reason why the agency would have restricted label in that respect.

Veronica Dubajova – Goldman Sachs

Thank you and if I may, as a follow-up, have you seen any change in the market now that you have the FMC agreement on Venofer have you seen pickup on Venofer and can you give any commentary that you can on that?

Brian Pereira

Well, the answer is that prescribing decisions are made by physicians and we believe that when we launch Feraheme, we will get our fair share of market in all our dialysis chains, including FMC.

Veronica Dubajova – Goldman Sachs

Great. Thank you very much.

Operator

Your next question comes from the line of Juan Sanchez with Ladenburg. You have the floor, sir.

Juan Sanchez – Ladenburg

Good morning guys and one quick question. When is the new manufacturing facility, coming functional; what’s the timing of that?

Brian Pereira

It’s not a new manufacturing facility it’s a contract manufacturing facility. We expect to bring that facility online in the second half of this year.

Juan Sanchez – Ladenburg

Yes, thank you very much. That was it.

Operator

Your next question comes from the line of Matt Roden with JP Morgan. You have the floor, sir.

Brian Pereira

Matt?

Operator

At this time, there is no response from Mr. Roden’s line. His question has been withdrawn. (Operator Instructions)

Ladies and gentlemen, we have reached the allotted time for questions. I will now turn the call over to Dr. Pereira for closing remarks.

Brian Pereira

Well, thank you all for joining the call. We appreciate your engagement with AMAG Pharmaceuticals. We’ll look forward to seeing you at upcoming investor conference and we’ll keep you posted at the appropriate time when we make progress on our Feraheme development plans. Thank you very much and see you soon.

Operator

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

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