AMAG Pharmaceuticals' CEO Discusses PDUFA Date Extension Conference Call (Transcript)

| About: AMAG Pharmaceuticals, (AMAG)

AMAG Pharmaceuticals (NASDAQ:AMAG)

PDUFA Date Extension Conference Call

October 17, 2013, 8:00 AM ET


Bill Heiden – President and CEO

Frank Thomas – COO

Amy Sullivan – VP, IR

Steve Caffe – SVP, Chief Development and Regulatory Officer

Greg Madison – EVP and Chief Commercial Officer


Mike Ulz – JPMorgan

Joseph Schwartz – Leerink Swann


Good morning everyone. My name is Stephanie and I will be your conference operator today. At this time I would like to welcome everyone to the AMAG conference call. (Operator Instructions) Thank you and I would now like to turn the call over to Amy Sullivan, Vice President of Investor Relations. You may begin your conference.

Amy Sullivan

Thank you, Stephanie. Good morning and welcome to the AMAG Pharmaceuticals conference call. We issued a press release last night announcing a three-month extension of the PDUFA date of the supplemental new drug application for Feraheme. For those of you who don’t have a copy of the release, you can access it on the Investors section of our website at Additionally I want to let you all know that we will issue another release shortly after this call announcing a date for our third quarter financial results call, which is scheduled for October 23 before market. So please mark your calendars.

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 FCC for a full review of the risks and uncertainties associated with our business.

Let me quickly run through the agenda for this brief update call this morning. Bill Heiden, our President and CEO, will provide opening remarks. Dr. Steve Caffe, our Chief Development and Regulatory Officer, will comment on the FDA review of our SNDA. Greg Madison, our Chief Commercial Officer, will talk about the commercial plan for the upcoming month. Bill will provide some closing remarks and then we will open the call for Q&A. Frank Thomas, our Chief Operating Officer, is also with us this morning and will be available during Q&A.

I will now turn the call over to Bill.

Bill Heiden

Thanks Amy and thank all of you for joining us here this morning with fairly short notice. Last night we announced that we have been informed by the FDA that they have extended the review clock by three months for the Feraheme SNDA. While we will not be providing a lot of detail on the content of our regulatory interactions on this call, we did think it would be helpful to provide a little more color and give everybody the opportunity to hear from our Chief Regulatory Officer, Dr. Steve Caffe about how we have been working with the agency and then also from Greg Madison, our Chief Commercial Officer, regarding how we are factoring this news into our commercial plans.

We look forward to working with the FDA over the next three months and their review of the SNDA. We continue to believe that approval of the Feraheme SNDA would provide physicians an important treatment option for their patients.

Before I turn the call over to Steve, let me tell you a little about his background, since many of you have not had the opportunity to meet him. Steve has more than 20 years of industry experience in the U.S. in companies ranging from Merck to most recently MedImmune. Prior to that he trained in medicine and was a practicing physician. Steve joined us in June and has a wealth of U.S. regulatory and development experience having achieved more than 25 new product approvals and successful label expansions. He has been leading the team here at AMAG, working with the FDA, on the Feraheme SNDA over the last few months.

And with that I will turn the call over to Steve to provide some additional information on our interactions with the FDA. Steve?

Steve Caffe

Yes, thank you, Bill. I would like to provide some background for those who perhaps have not followed the Feraheme SNDA since our filing late last year. Feraheme is currently approved in the U.S. for the treatment of iron deficiency anemia in adult patients with chronic kidney disease. The supplemental new drug application was filed with the FDA in December 2012 to extend the label of Feraheme to include the treatment of patients with all-cause IDA who have failed or are intolerant to all IN therapy.

The filing acceptance letter from the agency set a PDUFA date of October 21, and informed us that September 23 would be the target date to enter labeling discussions. On September 23, however, we received a letter from the agency informing us that they were not at a point in their review where they could enter into label discussions. We are fortunate to be working with the same FDA review team that approved Feraheme in 2009 and our interactions with the agency have been very collaborative and productive.

We have worked closely with the agency over the past few weeks, actively engaged in dialogue and have provided them with additional information in support of the SNDA. So this morning we announced that the agency has extended our PDUFA date by three months to January 21, 2014, based on the additional information that we provided. In the notice informing us of the extension, the agency also informed us that they have set December 23 as a new target date to initiate label negotiations.

Now let me turn it over to Greg.

Greg Madison

Thank you, Steve. From a commercial planning perspective, for the next three months, we will remain focused on continuing to grow the CKD business so that we are best positioned for the potential approval and launch in the broader IDA population. I have been pleased with the performance of the commercial organization this year and will continue to push the team to gain share and grow the brand in the CKD segment.

Over the next three months we will not only focus on the key strategies that will drive strong growth for Feraheme, but we now have a nice window to step up our promotional efforts on MuGuard. We have just started to integrate MuGuard in to our commercial portfolio and will be presenting the MuGuard product benefits to all of our Feraheme customers over the coming weeks. And with all of the Feraheme IDA launch planning work that we have done to date, we are fully prepared for the potential approval of the Feraheme label expansion.

In terms of competition, based on our field intelligence and IMS data, we have not seen much trial usage for Injectafer to date. While it was relatively early in their launch, we continue to believe that the clinical profile of Feraheme is what’s driving continued adoption by clinicians. We like to say that Feraheme is as easy as 123; 1 gram, 2 short IV administrations, separated by as little as 3 days. And no other iron could provide these same attributes to physicians, nurses and patients. So stay tuned.

As Amy mentioned, we will report full third quarter results next week. Our plan is to continue to drive growth in the CKD segment, generating revenue growth and building shareholder value in the near term and putting ourselves in the best possible position of the potential approval and launch in the broader IDA patient population.

I will now turn the call back over to Bill for closing remarks.

Bill Heiden

Thanks Greg. I think that Steve and Greg have done a nice job, summing up our view of the news today. We are optimistic that this extension will allow the agency adequate time to complete their review. We will do everything we can to support the review towards a positive outcome.

As promised that’s our brief update call and we’d now like to open the call up to Q&A with the caveat that we will not be providing detail regarding our various regulatory interactions. And also as Amy mentioned, we will be announcing our third quarter results next week and so I ask that you hold any questions related to Q3 results to that time.

And with that, Stephanie, if you would open the line for any questions.

Question-and-Answer Session


(Operator Instructions) Your first question comes from the line of Geoff Meacham of JPMorgan.

Mike Ulz - JPMorgan

Hi guys, it is actually Mike in for Jeff, thanks for taking the question. I am going to give a shot at this. I am just curious if you could maybe comment to the extent you can, on what type of additional information you provided the FDA and if you still have to provide additional information from this point, or is it just kind of waiting for them to kind of take a review of what you have already provided? Thanks.

Bill Heiden

So I appreciate the attempt. I am not going to go into great detail. I will say that we’ve got another 60 days before we initiate labeling discussions and another 90 days to a decision. And so we don’t have any visibility but it’s certainly possible that the agency could ask for additional information. That’s obviously a possibility but Steve, let me ask you if you have any additional comments.

Steve Caffe

No Bill, I was just going to say – we had a number of discussions with the agency on a broad range of topics and also that as you just said – they will be reviewing the additional information we submitted and that may bring them to us more questions. So it’s a possibility – we don’t know.

Mike Ulz - JPMorgan

Okay and then maybe if I can ask a follow up. I know your partners sort of filed in Europe some time in 2Q this year. I am just curious if you anticipate whatever the issue was to sort of pop up in that filing and can you address it ahead of time or might that play out? Thanks.

Steve Heiden

So this indication is also under review in Europe. We are awaiting the official list of questions from the agency through the rapporteur [ph]. So I don’t know that I can comment at this point on this interaction.

Mike Ulz - JPMorgan


Bill Heiden

Thank you, Mike.


(Operator Instructions) Your next question comes from Joseph Schwartz of Leerink Swann.

Joseph Schwartz – Leerink Swann

Thanks very much. In the last press release you provided a long list of potential issues and then you were going to meet with the FDA to determine what the first phase issue or issues were. Is it safe to say that you have narrowed down your understanding of what it is they want at this point?

Steve Caffe

Yes. So I think it’s fair to say, based on the good dialogue that we have had, that we have narrowed down the list of issues as far as that was provided in the former press release – in the prior press release and as the agency goes over the additional information that we submitted. I don’t think that we are in a position to say that any of these are completely off the table. So we have an understanding of the issues, I think a very good understanding of the issues. The possibilities remain open as to what the agency will want to discuss further with us.

Joseph Schwartz – Leerink Swann

Okay and are they more related to the clinical program or the filing itself? In other words, do you think that the program is sufficient and you have the data on hand to answer the questions and it was just the filing – you know that left some questions open or do you think that there could be the need to generate more data to answer the questions?

Steve Caffe

So I think that it is fair to say that the agency needed additional time to review the information we submitted. I really – it’s a number of complex issues. I don’t think I should speculate on, again, what they might come back with respect to additional questions or data requirements. We view this at this time as having presented all the data we thought were in support of the SNDA and the agency is simply needing the time to review the additional information and that’s really not uncommon.

Joseph Schwartz – Leerink Swann

So it sounds like you are still continuing with your commercial planning. So it sounds like you are encouraged enough that you are not pulling back on those plans. Is that the right characterization?

Greg Madison

This is Greg. That is correct. We simply see this as a simple delay – that showed [ph] our commercial plan that we had for the broader label by about three months to time it to the new PDUFA date. But we remain optimistic and we will continue to push forward with our plans for that January 21 date.

Joseph Schwartz – Leerink Swann

Okay, thanks for taking all of my questions.

Bill Heiden

Thanks Joe.


(Operator Instructions) Okay and we have no further questions. Thank you. I will turn the call back over to Mr. Heiden.

Bill Heiden

Great. Thank you very much, Stephanie. I want to thank again all of you for joining the call on such short notice. I appreciate you all joining the call and hope that you will be able to join us next week when we release the Q3 earnings. I look forward to speaking to you all then. Thank you.


And this does conclude today’s conference call. You may now disconnect.

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