Logo of jester cap with thought bubble.

Image source: The Motley Fool.

AMAG Pharmaceuticals Inc (NASDAQ:AMAG)
Q4 2019 Earnings Call
Mar 4, 2020, 8:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good morning. My name is Maria, and I'll be your conference operator today. At this time, I would like to welcome everyone to the AMAG Pharmaceuticals' Fourth Quarter and Full Year 2019 Earnings Conference Call. [Operator Instructions]

It is now my pleasure to turn the call over to Ms. Linda Lennox, Vice President, Investor Relations. You may begin your conference.

Linda Lennox -- Vice President of Investor Relations and Corporate Communications

Thank you, Maria. Good morning, and welcome to the AMAG Pharmaceuticals' conference call to discuss our financial results for 2019. Earlier this morning, we issued a press release. For those of you who don't have a copy, you can access it in the Investors section of our website at amagpharma.com.

Please be reminded that remarks made during this call may include forward-looking statements 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 2018 Form 10-K and our 2019 Form 10-Qs as well as those included in our presentation materials for a full review of risks and uncertainties associated with our business. You should also carefully read those risks that will be included in our upcoming 2019 Form 10-K, which we expect to file later this week.

On today's call, we will discuss certain non-GAAP financial measures with respect to our performance. We use these non-GAAP measures for financial and operational decision-making and as a means to evaluate our performance, because we believe they better represent the ongoing economics of our business. The definitions of our non-GAAP measures are set forth in our earnings release which was filed with the SEC today. Copies may be obtained at sec.gov and in the Investors section of our website.

This morning, we will keep our prepared remarks brief. So, we have ample time for Q&A. With me on today's call are Bill Heiden, our President and Chief Executive Officer; and Ted Myles, our Chief Operating and Chief Financial Officer. Bill and Ted will cover 2019 and review our 2019 financials, core value drivers for 2020 and beyond, and our 2020 financial guidance and goals. We will then open the call for Q&A.

With that, it's my pleasure to now turn the call over to Bill.

William K. Heiden -- President and Chief Executive Officer

Thank you, Linda. Good morning and thanks for joining us on our quarterly update call. Before we get started on our financial review, I wanted to mention that we announced this morning that our Chief Medical Officer, Julie Krop will be leaving AMAG at the end of the month. While we search for a permanent or interim replacement, AMAG's medical development leaders will report directly to me. Over the last several years, we have built out our development organization and today have a strong tenured leadership team across development and regulatory. This is the team that achieved three important regulatory approvals in the last couple of years and it's the same team that will continue to drive our key development and regulatory priorities forward. And with that let's turn to today's topic of AMAG's 2019 results.

I'll start with a recap of 2019. Outlined here on slide 4 are some corporate milestones, and I'd like to call out a few of these. We continue to make progress on our strategic evolution to expand the portfolio and progress valuable development stage products that can meet significant unmet medical needs. In 2019, we acquired Perosphere Pharmaceuticals, adding a potential next generation anticoagulant reversal agent, ciraparantag to our development portfolio. We continue to advance enrollment in the Phase 2b/3a trial for AMAG-423, an orphan drug candidate in development for the treatment of severe preeclampsia.

The AMAG team also submitted an NDA and received FDA approval for Vyleesi, making our third regulatory approval in two years. On the commercial side of our portfolio, we launched Vyleesi in September and also continue to grow Intrarosa revenue and market share. We had another strong year for Feraheme, achieving record revenue of $168 million, which was an increase of 24% over 2018.

Despite these accomplishments, we had a mixed year for Makena, due to sustained supply disruptions and increased generic competition that resulted in loss of share, the Company made the decision to exit the intramuscular market and through mutual agreement, terminated the arrangement with Prasco, who was our authorized generic partner. Almost a year ago, we announced the results of the PROLONG study, which was followed in October by an FDA advisory committee meeting. Following the advisory committee meeting, we did some -- see some market contraction and additional net price pressure in the fourth quarter. Despite these challenges, the Makena subcutaneous auto-injector maintained strong market share of 63% in Q4. Going forward, we remain committed to working with the FDA to find a path that could allow at-risk women to have continued access to Makena. We believe there is an urgent public health crisis in America as preterm birth rates continue to rise and hydroxyprogesterone caproate or 17P remains the only FDA-approved therapy for this vulnerable patient population.

And with that, let me turn it over to Ted to walk you through our fourth quarter and full year 2019 financial results.

Edward Myles -- Executive Vice President, Chief Financial Officer and Chief Operating Officer

Thanks, Bill. I'll start with the fourth quarter of 2019, the first column from the left side of the slide. Revenue came within the range that we pre-announced in January. As you'll recall, we recorded approximately $16 million in revenue due to our settlement with Daiichi Sankyo. They had previously indicated they wanted to terminate their relationship with the Company, and we reached a settlement with, at the end of 2019, which included a $10 million payment to us. This $10 million in cash received along with the recognition of previously deferred revenue of $6.3 million accounts for the collaboration revenue recorded in the fourth quarter.

As we mentioned, when we pre-announced our financial results in January, the operating loss we reported at that time did not include the impact of any impairment charges or associated acceleration of amortization that we expected to record in connection with the strategic decisions announced at the same time.

During the fourth quarter of 2019, we identified indicators of impairment for our Makena, Intrarosa and Vyleesi assets related to the unfavorable FDA AdCom recommendation for Makena on October 29th, and the completion of our strategic review and decisions to divest Intrarosa and Vyleesi. As a result, in the fourth quarter, we recorded non-cash impairment charges of $155 million on our intangible assets, which are shown in a separate operating expense line. As a result of these impairment charges, our fourth quarter operating loss was approximately $194 million. We reported a $5.8 million adjusted EBITDA loss in the fourth quarter, which was in line with our expectations and represented a sequential decline in the loss from the third quarter of 2019.

Moving to the third column from the left of the slide, you can see that revenue for the full year of 2019 was approximately $328 million, which was within our guidance range. Feraheme had a record year growing 24% over 2018, driven exclusively by volume growth. Makena subcutaneous auto-injector was off to a good start, averaging approximately $40 million per quarter for the first three quarters of the year. Unfortunately, media coverage of the AdCom meeting caused some confusion in the physician community. Some physicians even thought the product had been pulled from the market. During the fourth quarter, we observed a decline in Makena Care Connection enrollments, which unfavorably impacted revenues, because Makena Care connection enrollments are a leading indicator of revenue, we anticipate that the fourth quarter decline will also impact Makena revenue results in the first half of 2020. Our commercial team has been in the field working to clarify that Makena continues to be available to at-risk pregnant moms.

Further down the P&L, our spending was in line with our expectations. You'll note, the impairment of assets line totaling approximately $230 million in addition to the fourth quarter charges I previously discussed, the full year number includes a second quarter impairment charge of approximately $77 million associated with the Makena intramuscular product, when the Company made the decision to exit the intramuscular market and reached a mutual agreement with our authorized generic partner Prasco to terminate their distribution and supply agreement.

On a non-GAAP basis, our full year loss of approximately $65 million was the mid-point of the preliminary results we published early in January, and at the favorable end of our guidance range for the year. We are diligently managing our expenses as we look to become an adjusted EBITDA positive Company in 2020.

I'll now turn it back to Bill.

William K. Heiden -- President and Chief Executive Officer

Thanks, Ted. So, you recall that in January, we announced the results of the Company's strategic review and our decision to focus on our four highest value product opportunities, shown on the left, and the decision to divest Vyleesi and Intrarosa. Since we made the announcement in early January, we've continued to progress our plans to implement these decisions and expect to be in a position to provide further details on the divestiture in the second quarter. In early January, we also announced that I will be stepping down as President and Chief Executive Officer. It's been an honor to lead AMAG for nearly eight years as we've transformed from a single product company to one with strong commercial and development capabilities that position us to bring new treatment options to patients with unmet medical needs. Immediately following the announcement in January, the Board initiated a search for my successor with the Company expects to name by mid-year. All of us at AMAG remain committed to making this a smooth transition, so that the Company remains on track to achieve its key priorities in 2020 and beyond.

Our decision to divest Vyleesi and Intrarosa will allow AMAG to focus on its core value drivers, continuing to grow Feraheme, working collaboratively with the FDA on a path forward that would allow at-risk pregnant women to continue to have access to Makena and developing ciraparantag and AMAG-423.

Feraheme has shown steady growth since it was approved for the broader IDA label two years ago. The IV iron market has grown in recent years, which we believe is due to the increasing prevalence of underlying conditions of anemia. Our teams have done a great job understanding the IV iron market, identifying opportunities for growth and executing against our plans. This helped us achieve record revenues of $168 million in 2019, as well as growing market share to 17.7% in the fourth quarter.

We anticipate that the IV iron market will continue to grow. We believe this coupled with our ability to understand market dynamics and execute accordingly will position Feraheme for continued growth. We also acknowledge that new competitors may enter the market. For example, Monoferric was approved in January for sale in the United States, although now appears to be facing a patent challenge, and we have indications to Sandoz, continues to pursue a generic version of Feraheme and their ANDA which was submitted over four years ago. Which as you know, could be launched as early as July 2021 under the terms of our settlement agreement, if they are able to secure FDA approval by a certain undisclosed date.

However, we continue to believe that there are significant barriers to bring a generic IV iron to the market. If Sandoz is unable to secure approval by that certain date, they can launch an authorized generic version of Feraheme in July 2022 for up to 12 months. Sandoz's right to distribute and AMAG's obligation to supply the authorized generic product has been set up with standard commercial terms and profit splits.

Over the course of 2019, we started to share that we're exploring new opportunities to grow Feraheme. These opportunities will take time to progress and none of these are baked into our current revenue guidance for 2020. But this work is a priority for the Company. Next, I'll touch on the Makena subcutaneous auto-injector.

Makena was approved nine years ago by the FDA, based on the landmark MEIS clinical trial, which was run by the NIH and published in the New England Journal of Medicine, and that study demonstrated a 30% risk reduction of treating at-risk women with weekly administrations of Makena. With high rates of preterm birth in United States, especially in underserved patient populations, the approval of Makena was encouraging news for pregnant women who had experience to prior preterm birth and their physicians.

As part of the original Subpart H accelerated approval, there was an agreement to conduct a placebo-controlled confirmatory trial, which was called the PROLONG study. This study was ongoing and enrolling patients outside the United States, when we purchased Makena in 2014. The PROLONG study results which were published in the American Journal of Perinatology in October of last year, did not show a reduction in preterm birth rates with the use of Makena, but did confirm Makena's strong safety profile. The preterm birth rates in the PROLONG placebo arm were appreciably lower than in the MEIS study, indicating a lower-risk patient population in PROLONG.

The PROLONG study results highlight the challenges of many medical conditions and their treatments where it's not well understood which patients are at highest risk of developing a condition or which patients would most benefit from treatment. Importantly, on October 25th after the PROLONG study results have been published, ACOG and SMFM updated their guidelines reiterating their recommendations for use of Makena in the appropriate patient population.

As you know, the FDA convened an advisory committee on October 29th and we're now hard at work and follow-up to that meeting. We are very committed to working with the FDA to agree on how best together additional data that will be most informative to physicians in the FDA finding a path forward that would allow eligible patients to continue to have access to Makena.

AMAG-423 is in development for severe preeclampsia. This is a high risk, potentially high reward program. Preeclampsia affects approximately 140,000 women a year in the United States and about 50,000 of those women are estimated to have a severe form of preeclampsia. Preeclampsia threatens the health of pregnant women and their unborn babies and the condition typically results in a preterm birth and all of the attendant negative health consequences. There are currently no therapies to treat preeclampsia. So, it's an enormous serious unmet medical need, both here in the US and internationally. We have global rights to this asset to treat preeclampsia and you can see that it obviously hold significant commercial potential.

Enrollment in our ongoing clinical trial continues, both at US and international sites, and while these are difficult trials to recruit, the unmet medical need demands that we continue to work hard on this project. Our other development assets, ciraparantag is an important future core value driver with a large market potential. There are an estimated 6 million patients taking these novel oral anticoagulants or low molecular weight happened in the US alone. A subset of these patients, approximately 150,000 a year require a reversal agent. These patients will be treated at approximately 3,000 target hospitals across the US, either in the ER or as an inpatient, and our Feraheme sales force is already in those hospitals today.

Ciraparantag has a differentiated profile with potential advantages over existing reversal agents. We believe what is most important to a clinician taking care of a patient who has a serious bleed or is in need of urgent surgery while on a NOAC is to have the ability to rapidly reverse its anticoagulant effect. Limiting the time from arrival in the hospital to administration of the reversal agent is a paramount importance in an emergency situation, so, a drug like ciraparantag that does not require any preparation is, and is ready for use is ideal.

Importantly in clinical studies, ciraparantag has demonstrated a rapid and sustained reversal effect that persist up to 24 hours, which is important for patients who are bleeding or must undergo emergency surgical procedure that requires maintenance of normal clotting capacity throughout the duration of that procedure.

Finally, from a safety perspective, ciraparantag has not demonstrated any pro-coagulant signals to date. And like AMAG-423, we have global rights to this asset and we are already exploring potential ex-US partnering opportunities.

Let me turn it over to Ted now, who can walk you through our 2020 guidance and goals.

Edward Myles -- Executive Vice President, Chief Financial Officer and Chief Operating Officer

Thanks, Bill. Slide 11 presents the 2020 financial guidance that we published in advance of the J.P. Morgan Conference in January. We believe this guidance captures a range of potential outcomes for our business as we navigate through some key uncertainties. It's important to note that the guidance has presented on a continuing operations basis, meaning reflects our intention to divest Intrarosa and Vyleesi, therefore revenue and expenses associated with those products are excluded. Our financial -- our actual financial statements will be presented in such a way, when we qualify for discontinued operations treatment in accordance with the accounting rules. Importantly, the strategic decisions to divest Intrarosa and Vyleesi allows us to remove more than $100 million of operating expenses as compared to 2019. This opportunity for cost cutting is a key driver in our return to profitability, which is an important goal for 2020.

Listed here on slide 12 is our full set of 2020 goals. They include successful completion of the CEO transition, divestiture of Intrarosa and Vyleesi, working with the FDA to drive the best outcome for patients who may benefit from Makena, continuing to advance both of our development programs, as it relates to AMAG-423, continue to enroll the Phase 2b/3a study in both the US and ex-US sites and open new sites. For ciraparantag, submit the investigational device exemption and initiate the Phase 2b study in healthy volunteers, mid-year, and pursue ex-US portfolio partnering opportunities. Achieving our financial objectives, which includes revenue of between $230 million and $280 million and adjusted EBITDA of between $20 million and $50 million.

And now, let's open the call for your questions. Operator?

Questions and Answers:

Operator

Thank you. The floor is now open for questions. [Operator Instructions] Our first question comes from the line of Douglas Tsao of H.C. Wainwright.

Douglas Tsao -- H.C. Wainwright -- Analyst

Hi, good morning. Thanks for taking the questions. Just maybe starting with Makena, obviously, we're now a couple of months into the new year. Have you started to see some stabilization in terms of the volume decline that we really saw in the fourth quarter? And second, in terms of the restructuring and the cost savings, Ted, you indicated, those are going to be tied to Vyleesi and Intrarosa. Obviously, you haven't divested the asset yet, so at what point should we expect to see the associated SG&A start to come down?

William K. Heiden -- President and Chief Executive Officer

Hey, Doug, it's Bill. Why don't I start with Makena. As we mentioned, we have some go-forward visibility through the Makena Care Connection. And so, as we mentioned, due to some of that at the press in the fourth quarter around the advisory committee we saw Makena Care enrollment got a little soft in the fourth quarter, and we knew that would affect then sort of first half revenues for Makena. There has been some stabilization, and our field force has been able to get out and clarify to doctors that Makena continues to be available and that we're working hard to ensure that that continues.

So our sales force is out in force. I think clearly, for a lot of reasons, we want to remove this cloud of uncertainty. And I think that will help physicians and patients. And so, that's job one right now, is to work with the agency, so to craft the path forward so that patients can continue to have access and we can assure positions that their patients can continue to have access to Makena going forward.

Edward Myles -- Executive Vice President, Chief Financial Officer and Chief Operating Officer

It's also important to note that the softness we saw in Q4 informed our 2020 guidance. So, as part of the wide range on the guidance revenue, the revenue guidance. In terms of managing expenses, we're always managing expenses carefully as we talked about throughout 2019, we were pulling the direct to consumer spend away from Intrarosa to make room to support the launch of Vyleesi that continues Intrarosa as a cash flow positive product from a direct product cost basis. Vyleesi obviously is not, we're continuing to invest in the launch, but we're doing so very mindfully. Importantly, the divestiture process is moving along nicely and we're optimistic that we'll be able to deliver something announceable to the market as we indicated previously some time in Q2.

Douglas Tsao -- H.C. Wainwright -- Analyst

Okay, great. Thank you. And then one quick follow-up on Makena. Has there been any change from a reimbursement standpoint? And then just also, in terms of physician feedback, in terms of the slower scripts that we saw, obviously in the fourth quarter. I mean was that really just driven by confusion around availability of the product or were there some physicians who just sort of became aware of the PROLONG data and just decided that it wasn't worthwhile? Thank you.

William K. Heiden -- President and Chief Executive Officer

Sure. Thanks, Doug. So on reimbursement, we continue to have virtually universal reimbursement. So, there has been no real challenges on reimbursement. There has been some additional discounting, and you see that, the net pricing on Makena, that's something that we've mentioned, but we continue to have very, very broad reimbursement.

In terms of the physician community, you can imagine there is a spectrum, Doug, there was some confusion on some -- part of some physicians in terms of availability. So we simply had to clarify that. I imagine there are some physicians who now, maybe they treated 100 patients and have patients who might have had a late preterm birth and might ask themselves of that patient at significant risk, and they may feel differently about treating those patients. So I think some of the softness comes back. I think some of -- some physicians may have altered their prescribing pattern, but I think all of that could be righted [Phonetic] through some clarification and confirmation with the agency that there is a path forward and that Makena will remain on the market.

Douglas Tsao -- H.C. Wainwright -- Analyst

Okay, great. Thank you so much.

William K. Heiden -- President and Chief Executive Officer

All right. Thank you, Doug.

Operator

Our next question comes from the line of Jessica Fye of J.P. Morgan.

Jessica Fye -- J.P. Morgan -- Analyst

Hey guys, good morning. Thanks for taking my questions. I appreciate you providing the adjusted operating profit and EBITDA guidance on a continuing ops basis. But given that for now, you're still spending on Intrarosa and Vyleesi. Can you talk about whether you expect AMAG's cash flow from operations to be positive or negative in 2020 prior to accounting for any proceeds from the divestitures?

Edward Myles -- Executive Vice President, Chief Financial Officer and Chief Operating Officer

Hey, Jess, it's Ted. It's a good question. Certainly, depends on when we transact, but our estimate is I think a good place to assume is that cash flow for 2020 will be about neutral. So the EBITDA, let's focus on the mid-point EBITDA of $35 million. There is about $10 million of cash interest on the converts and $25 million, $20 million to $30 million on cash spend for the period of time that we own the assets.

William K. Heiden -- President and Chief Executive Officer

And as just pointed that's not including any upfront that we might receive in the divestiture.

Edward Myles -- Executive Vice President, Chief Financial Officer and Chief Operating Officer

Right, right.

Jessica Fye -- J.P. Morgan -- Analyst

Okay. And can you set some expectations about how much investors can or should expect you to bring into the Company when you divest Intrarosa and Vyleesi? And maybe related to that, can you summarize what the terms would be if you were to return those products to [Indecipherable]?

William K. Heiden -- President and Chief Executive Officer

So on, in terms of the deal structure, I don't want to go into too much detail, because obviously, there is a balance as you might imagine with upfront money is downstream monies that might be based on milestones and royalties. And so, we're still in process on that and so, I wouldn't want to give any, necessarily any direction on that. And in terms of, yeah, just giving the products back that's not, that's not the current plan, I don't know what details contractually they would, we would have there. I don't think it would have, there is not much economics, if you will, economic impact that I recall from the contracts. But again, currently that's not the intention.

Jessica Fye -- J.P. Morgan -- Analyst

Okay. And just thinking about the revenue guidance, can you just speak to the low end of the range versus high end of the range. We think of the low end is being conservative or based on what you're seeing with Makena so far this year. Is that still kind of a realistic part of the guidance range?

Edward Myles -- Executive Vice President, Chief Financial Officer and Chief Operating Officer

Well, look, there's a lot of uncertainty. We feel good about our Feraheme business and the projections for 2020. Feel like there is a little less of, there is a more narrow bound on our internal estimates of Feraheme. So, as you can infer the majority of that uncertainty is around Makena. It's hard to handicap what the FDA is going to do. It's hard to under -- it's hard to estimate exactly how we're going to be able to return, undue some of that confusion in the prescriber market and get docs back to writing Makena more regularly. We were encouraged by the, about $40 million per quarter that we had back in the first few quarters of 2019. But it's going to be very hard to get back to that level. So we wanted to provide a nice wide range to account for as you say, hopefully in hindsight, a conservative number, but give yourselves room to navigate through a lot of uncertainty.

Jessica Fye -- J.P. Morgan -- Analyst

Okay. I'm just, I'm not sure I totally understand the response to Doug's question earlier, when I think you said Makena was stabilizing. Like we're two months of the quarter now, is there anything you can say about just directionally how 1Q is tracking relative to 4Q for Makena?

William K. Heiden -- President and Chief Executive Officer

No, I don't, we normally don't comment inside the quarter. I think the question was again, have we seen stabilization and I think the answer is generally, yes, we've seen stabilization, we've seen, again qualitatively, certainly as we've been out into the field. We were able to clarify some physicians who simply misunderstood due to some of the press about the outcome of the advisory committee. So, we have been able to just confirm that with physicians and those physicians who just simply were just misunderstood, we were able to clarify that. But for those physicians, so yes, there's been stabilization. We're not going to get into numbers mid-quarter though.

Jessica Fye -- J.P. Morgan -- Analyst

Okay. Thanks for taking all my questions.

William K. Heiden -- President and Chief Executive Officer

Okay, thanks, Jess.

Operator

Our next question comes from the line of Ami Fadia of SVB Leerink.

Ami Fadia -- SVB Leerink -- Analyst

Hi, good morning. Thanks for taking my questions. Maybe just a follow-up on Makena to begin with. Your guidance range, if you could sort of just think about a stable Feraheme performance into 2020, suggest a significant decline in Makena as the quarter has progressed this year? Maybe that's some level of conservatism on your side. But if you can give us a lower and upper bound of how Makena could perform? That would be helpful. Maybe a scenario where it does get pulled off the market, how quickly would that happen? And then on the other side, if you come to an agreement with the FDA to conduct some additional study and it stays in the market, how long before it can come back to its prior quarterly run rate? And then I have a follow, some questions on the pipeline.

William K. Heiden -- President and Chief Executive Officer

Right. So the -- look, as you you're alluding to, you can probably relatively accurately or then within spitting distance, think about the range around Feraheme and so the, and we've guided that the range around our revenues really does try and capture some level of uncertainty around Makena. And as Ted just mentioned you could view the low end of the range, as conservative. That's right. Capturing, yeah, very conservative view on how things might play out. I think from our point of view, given that level of uncertainty, we thought it was best to provide a -- again a more conservative level of guidance with a relative range around those revenue numbers. And obviously, our goal always when we give guidance is to, could be numbers that we think we can meet or beat.

And so, I think that's really my commentary around our guidance and the numbers. And then going forward, as you mentioned, our goal is of course to confirm with the agency, their view on Makena and that will remain on the market. And I do think that will be a positive piece of information in the prescribing community to the medical societies that they don't have to worry about not having treatment options for women who are at risk of a preterm birth that they would still have access to this product. And I think that would be a positive, which would be reflected eventually in our go-forward numbers around Makena. Ted, any additional comments?

Edward Myles -- Executive Vice President, Chief Financial Officer and Chief Operating Officer

I guess the only thing is that reminding everyone the course of therapy as 14 to 18 weeks. So, as you're physician, you see a patient, do you want to start that patient on this course with some uncertainty of whether or not the product is going to be pulled.

William K. Heiden -- President and Chief Executive Officer

Right.

Edward Myles -- Executive Vice President, Chief Financial Officer and Chief Operating Officer

And then we think that that may have been part of the calculus out there and we can't give perfect assurance that, the course of therapy won't be disrupted. So, we can balance our way through this.

William K. Heiden -- President and Chief Executive Officer

And because we guide physicians that in terms of process that's not how it works, you would continue to have access, but physicians are very focused on patient care, want to ensure and want to guarantee if you will, that they'll be able to start and complete therapy with Makena. And so, we want to give them that assurance as quickly as possible.

Ami Fadia -- SVB Leerink -- Analyst

Okay. Just on the pipeline. I wanted to sort of understand some of the timelines, especially with Julie's departure. And can you remind us, what we should be expecting in terms of some of the milestones around ciraparantag and when would you be able to provide us with some type of an update around enrollment or at least a rough timeline around AMAG-423's completion of enrollment? Thank you.

William K. Heiden -- President and Chief Executive Officer

Yeah, sure. Thanks. Well, let me start with your -- the last part, which is 423, because it's harder to predict. Right. We continue to enroll patients. We continue to open sites both in the US and outside the US. And I think when we get to a number that that we think is somewhat of a milestone, I think that would be a good time for us to talk publicly about where we are in enrollment. On ciraparantag, we are currently working with Perosphere Technologies for the submission of the investigational device exemption. And so, there is a submission. There is a 30 day waiting period. And then the Phase 2b clinical trial can be initiated. We anticipate that, that trial would be initiated sometime mid-year and based on our expectations for running that trial that we should have the trial enrolled and data by end of year or early next. On 2b, that then would lead into an end of Phase 2 meeting, which we anticipate would be in 2021 with the agency to confirm the design of the Phase 3 program. And obviously, once we have confirmation of that trial that will be initiated next year as well.

Ami Fadia -- SVB Leerink -- Analyst

It seems that there has been a delay in submission of the investigational device submission. Can you throw some light around what has taken this long and if there is any sort of rework that's been happening with regards to the device or the application that would be helpful?

William K. Heiden -- President and Chief Executive Officer

Sure. So, no rework, it's simply been again just to back up, the investigational device exemption request is submitted by Perosphere Technologies. So, that's -- that's a request that goes in, from our Company that we don't really have any control over. We're working very closely with them. The investigational device exemption will include the protocol that we've designed for ciraparantag. So, that's our job. And I would say some of the time that's passed has been Perosphere Technologies doing all of the validation work that that they have agreed with the drug device division.

And that's important because we want to ensure that the FDA gets exactly what they need, so that this, when this is submitted, there is a 30-day review and we can initiate the Phase 2b clinical trial. And so, Perosphere Technologies has been doing the work that was requested, the devices unchanged. It's simply the validation work that was requested by the agency. And so again, that will be submitted and we're targeting based on our timeline that we would be able to initiate the 2b mid-2020.

Ami Fadia -- SVB Leerink -- Analyst

Got it. Thank you very much.

William K. Heiden -- President and Chief Executive Officer

Thank you, Ami.

Operator

Our next question comes from the line of Chris Raymond of Piper Sandler.

Christopher Raymond -- Piper Sandler -- Analyst

Hey, thanks. Just one question, on Feraheme, so, I don't know if you guys have talked about this too much, but I wonder if you could maybe describe, how you're preparing for the potential market entrants of HIFs in the renal space. Obviously, they've had some, there's been some data showing potential IV iron sparing from these compounds. And I know you guys have volume outside of renal. But I think there, there is still some renal presence and for that franchise. And I'm just kind of curious if you could maybe articulate how you're potentially preparing for that entrants? Should we be sort of thinking about that as a major impact or if not, why? Thanks.

William K. Heiden -- President and Chief Executive Officer

Yeah. So, Chris, it's Bill. I don't have a complete answer today for you and I'll get that, I know the, our medical team has been looking at this, and there is actually, there is a lot of work being done on this. As you pointed out, most of our, actually all of our business is certainly outside of Dallas. So we don't have any business in the late-stage renal disease area and over the last couple of years, our growth has come, primarily from outside of CKD. And so that's been the lion's share of our growth. But I want to answer your question more completely. There are certainly still some level of uncertainty around the HIF products and specifically around the long-term safety. But let me get you a more complete answer, Chris. I just don't have that in front of me.

Christopher Raymond -- Piper Sandler -- Analyst

Thank you.

Operator

Our next question comes from the line of Serge Belanger of Needham & Company.

Serge Belanger -- Needham & Company -- Analyst

Hi, good morning. Also couple of questions on Feraheme. Can you just talk about some of the growth drivers for 2020. I think in 2019, the market growth -- the growth of the IV iron market was a significant factor, is that expected to continue in 2020. And then you've talked about growth opportunities for the future for Feraheme. Did you just go through a label expansion or maybe a change in formulation that extends the IP. Just wanted to get some additional color on how you're looking at these opportunities for the future.

William K. Heiden -- President and Chief Executive Officer

Okay, great. Thanks for asking the question, Serge. In terms of market growth, as you mentioned, we've seen significant growth and we've actually seen significant market growth every year for the past few years. So the market continues to grow. I think there is really two factors here. We've got the growth in some of the underlying indications, patients who suffer from anemia, there's also been a concerted effort on the part of AMAG as well as some of our competitors to talk more broadly about some of the patients who may benefit from intravenous iron.

Gastroenterology is an interesting segment, where there are many patients who suffer from for example inflammatory bowel disease. Those patients have difficulty absorbing iron in the gut. And so, one of the most efficient ways to treat those patients as with intravenous iron, and so, that's been a nice growth opportunity for us. And so, I think that growth in the market should continue going forward. That certainly our expectation. I think we still have the ability to continue to grow share. As we mentioned, our market share in the fourth quarter was 17.7%. So, there's still a lot of market share for us to grow into.

In terms of broader growth opportunities going forward, I think there are certainly geographic potential opportunities. Those take a little bit longer, but those could be interesting as well. Feraheme opportunities outside the US, but as well as new indications and we are working on a couple of ideas and I haven't, we haven't publicly talked about those until we have a little bit more confirmation on the path forward for those opportunities, but that those could create additional growth opportunities, market expansion opportunities for the use of, specifically for Feraheme. So, a couple of nice growth opportunities going forward outside of anemia. But as you mentioned, we do expect that the market will continue to grow in 2020 and beyond.

Serge Belanger -- Needham & Company -- Analyst

Thank you.

William K. Heiden -- President and Chief Executive Officer

Okay. Thank you, Serge.

Operator

[Operator Instructions] Our next question comes from the line of Gregg Gilbert of SunTrust.

Gregg Gilbert -- SunTrust Robinson Humphrey -- Analyst

Thanks, good morning. I have a few. Bill, in light of Julie leaving, can you update us on how discussions with the agency are going on Makena? Would it be unfair to assume that one thing has to do with the other?

William K. Heiden -- President and Chief Executive Officer

Yeah, I would not assume that Gregg. The -- our interactions with the agency are really led by our Head of Regulatory Affairs and so, no, no change, no relation. We haven't commented on specific interactions with the agency around Makena and not going to do that today. But nothing changes in terms of our expectations. Our goals and our strategies for working with the agency to ensure that patients can retain access to Makena. So that plan continues and so no change.

Gregg Gilbert -- SunTrust Robinson Humphrey -- Analyst

Okay. Does the same go for sort of timelines on pipeline? I know some asked about that already, but more generally, are you confident and what's been laid out in terms of timelines? Oftentimes you see a new CMO come into a company and reset the bar in various ways. So can you maybe speak to the continuity on that team. And how confident you are and what's been communicated thus far broadly on the pipeline?

William K. Heiden -- President and Chief Executive Officer

Sure, sure. Look right now, the focus is execution. And so, if I go through both Makena, but also our development-stage assets, it's really about execution. We have the plans. We have the strategies laid out. And so, now it's all about aggressive execution. For 423, it's about enrolling patients, it's about expanding the number of sites in our clinical operations team is all over that, and that's job one. For ciraparantag, we have the plan, we're working with our partners at Perosphere Technologies. We anticipate filing the IDE, and initiating the Phase 2b clinical trial mid year. So, it's all about execution now, and I have every confidence that that our team will continue to execute well and we will meet our goals.

Gregg Gilbert -- SunTrust Robinson Humphrey -- Analyst

Thanks. And one last one, that you've been clear about the divestiture process being on track with news next quarter. I assume you're prepared to stay on as long as needed a bit. Has the Board communicated anything about how the CEO search is going and any timeline associated with that?

William K. Heiden -- President and Chief Executive Officer

So I'm aware of progress on the CEO search. I don't think they have communicated any specific timeline. I have indicated that I'll stay through my successor being named and be brought on board, which I think it gives the Board the ability to really do their work and find the ideal candidate for the job. We have roughly talked about a mid-year time point, I think that was really based on experience in CEO succession that a three to six-month timeframe is reasonable. And so, I think that's still a reasonable target for people to think about.

Gregg Gilbert -- SunTrust Robinson Humphrey -- Analyst

Okay. Thanks a lot for the questions.

William K. Heiden -- President and Chief Executive Officer

Okay. Thank you, Gregg.

Operator

I'm showing there are no further questions at this time. I would like to turn the floor back over to Bill Heiden for any additional or closing remarks.

William K. Heiden -- President and Chief Executive Officer

Great. Thank you, Maria. So I want to thank everybody for joining us on today's call and before we close, I also want to publicly thank all my colleagues for all their hard work over the last year and we look forward to continuing to update you on our progress at AMAG throughout the year. Thank you, again. This closes today's call.

Operator

[Operator Closing Remarks]

Duration: 46 minutes

Call participants:

Linda Lennox -- Vice President of Investor Relations and Corporate Communications

William K. Heiden -- President and Chief Executive Officer

Edward Myles -- Executive Vice President, Chief Financial Officer and Chief Operating Officer

Douglas Tsao -- H.C. Wainwright -- Analyst

Jessica Fye -- J.P. Morgan -- Analyst

Ami Fadia -- SVB Leerink -- Analyst

Christopher Raymond -- Piper Sandler -- Analyst

Serge Belanger -- Needham & Company -- Analyst

Gregg Gilbert -- SunTrust Robinson Humphrey -- Analyst

More AMAG analysis

All earnings call transcripts

AlphaStreet Logo