AMAG - Earnings call transcript Q4 2019 | Amag Pharmaceuticals, Inc.

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Operator

Good morning. My name is Maria, and I will 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. All lines have been placed on mute to prevent any background noise. After the speakers’ remarks, there will be a question-and-answer session. Instructions] [Operator

my Vice the President now Ms. over to Lennox, Linda Investor pleasure is call turn to It Relations.

You may begin your conference.

Linda Lennox

Good to results Maria. Pharmaceuticals you, morning, to welcome Thank the conference call XXXX. discuss for financial our and AMAG

Earlier this morning, a release. issued we press

you of a have in don't access website at copy of Investors section who our can amagpharma.com. it those For you the

XXXX. in results provisions to that Please We presentation full a risks Reform pursuant to discussed statements may include of be forward-looking our Litigation to that emphasize in materials reminded XXXX our that risks to actual those XX-K review refer and Securities and safe Form included Please our want and remarks of harbor statements. these made well our Act differ XXXX as involve Private during of could this from call statements the Form business. for such associated the forward-looking materially with cause uncertainties XX-Q forward-looking those as uncertainties

also carefully XX-K, which You Form will week. later to file in expect XXXX read this included that should upcoming we our those risks be

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

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

then will for call open Q&A. the We

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

Bill Heiden

and update joining morning, Good Linda. quarterly thanks you, on our us for Thank call.

financial the mention this started Before at Krop Medical leaving our be of AMAG Chief month. morning we will the Officer, on I we get end that Julie wanted that announced review, our to

search we medical report directly leaders for a replacement, interim While development AMAG’s me. permanent or to will

built the Over the will we across forward. leadership last in continue team key of strong is development three that and to approvals regulatory and regulatory couple This several achieved a same regulatory. years, today team our and have have the organization out team last and drive it's development our that important years, priorities the tenured development

a results. With out today's topic start of turn call XXXX AMAG's and Outlined recap to slide I'd on milestones like that, of I'll to four are the of XXXX. corporate some let's with these. here few

progress our development products expand make medical to can meet to that and on needs. strategic evolution stage unmet continued the portfolio We progress valuable significant

In portfolio. acquired XXXX, ciraparantag next anticoagulant Perosphere development agent Pharmaceuticals, to our generation a potential having reversal we

the the NDA third treatment submitted approval We trial severe The in regulatory orphan years. in also for of Phase FDA candidate an advance AMAG-XXX, received continue an two for Xb/Xa drug to preeclampsia. development in team our making approval AMAG Vyleesi, for enrollment and

mixed of for year the share. mutual $XXX FDA our ago, year generic to intramuscular who in September an an Almost decision results the revenue million, and On continued Makena advisory market Intrarosa study, committee partner. We of meeting. Feraheme, had increase launched was The market a was sustained our disruptions the to record portfolio, by the over commercial increased Despite which we these which generic grow another authorized October of of accomplishments, revenue loss achieving had for for the competition was side due and the followed Prasco, arrangement XX% prolonged in in Vyleesi share. and resulted to terminated a supply made of agreement, and we that with year XXXX. we exit also announced Company strong

committee and in additional contraction we advisory meeting, price quarter. see did some fourth the the Following market pressure net

Despite these subcutaneous challenges, XX% of maintained Makena strong market the share in auto-injector QX.

rates we rise working health remains Makena. remain the allow hydroxyprogesterone Going We have only forward, urgent caproate and public there's find preterm for or with approved committed vulnerable women the access crisis that patient to population. America FDA as path to this believe to at-risk an could continue to birth to the FDA therapy XXP in continued

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

Ted Myles

Bill. Thanks,

of I'll quarter from column the the slide. the XXXX, fourth start side left first of with the

Revenue came preannounced we January. range in within that the

As This their the we indicated approximately in recall to Daiichi which payment of for settlement at collaboration due million in settlement Company previously received us. they XXXX, recognition fourth recorded recorded revenue with accounts to of the determinate deferred relationship revenue a our the revenue $XX in $XX Sankyo. with wanted had a previously and we with you’ll reached quarter. with $XX million million that million of They included to end along the $X.X cash the

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

our for completion Makena, and the quarter fourth identified indicators October of and we and FDA of divest strategic for decisions to related Intrarosa Vyleesi. assets Adcom unfavorable XXXX, and review on our the Vyleesi recommendation Makena to impairment the Intrarosa of During XX

on we charges separate assets, a noncash result, our intangible shown the are recorded in impairment quarter, which of fourth expense a $XXX operating line. As in million

million. these a loss quarter impairment of $XXX As fourth result charges, operating was approximately our

of the in $X.X We our with loss adjusted quarter XXXX. expectations was a EBITDA represented decline which third fourth the in sequential quarter, the reported a million in and loss line from

slide, XXXX volume was XXXX, which the range. driven exclusively Feraheme of record year, year guidance million, the third $XXX within revenue growth. the our approximately column you the to for see was by Moving growing over left a full XX% of that had from can

subcutaneous auto-injector good quarters year. Adcom confusion a the million approximately some media the quarter per community. three of $XX meeting for Unfortunately, was caused physician of to the in Makena start, the coverage off first averaging

physicians Some had even from the market. thought the product been pulled

we During enrollments the care first of care of Makena which that decline enrollments, impact a half leading revenues. Because observed indicator are fourth fourth we quarter, next Makena will quarter in connection unfavorably in decline revenue, Makena the the connection XXXX. impacted anticipate also results revenue a

that pregnant moms. the be available at-risk been has team to Makena commercial to to Our in field continues clarify working

P&L, line our in the was spending expectations. down Further our with

You'll note $XXX million. assets of impairment the line approximately totaling

a reach charges In addition the decision to their agreement generic second our supply and exit fourth full to market quarter to $XX Makena quarter the with and previously impairment agreement. approximately associated year of charge intramuscular intramuscular product. company with number distribution the discussed, includes the million authorized terminate the And made I Prasco the mutual partner

basis, favorable range published a million the $XX the non-GAAP our a early preliminary our for results approximately of and loss full of as guidance the we January year end year. On was in of midpoint

EBITDA our expenses as become positive managing we diligently adjusted are company an to in XXXX. We look

back Bill. now I'll turn to it

Bill Heiden

Ted. Thanks,

quarter. left, four results announced to on shown the January highest in on Company's made product the the second continued and and that divest decision and opportunities to in review divestiture our strategic of value decisions the we our expect implement Since a to progress Vyleesi on the we to to recall early plans details decision Intrarosa. announcement these you’ll the our in in the So, January, further position and to be focus we've provide

medical in early eight transformed the commercial with also In needs. options that announced company a expects to years is following that announcement successor an as we’ve AMAG mid-year. and January, to been for the from one patients search development Board strong President single down capabilities my bring by It's Executive product to nearly new treatment Immediately I a will Company as Chief be January, initiated Officer. lead to with the for name that and position to honor unmet we stepping

priorities making a the committed remains AMAG smooth remain so at key us transition track XXXX beyond. of on to its in All company to achieve this that and

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

recent has underlying conditions ago. has approved increasing two with Feraheme was for we to iron grown steady which growth believe market anemia. years, it the shown is label since of in The prevalence IDA the broader IV years due

as XXXX the helped revenues identifying us Our iron great opportunities quarter. understanding to of XX.X% teams job done have well in plans. share against for as IV our the record achieve This million market, $XXX growing market growth in and executing fourth a

that ability to the continue dynamics growth. Feraheme iron our to market understand grow. IV continued position with We accordingly market will for and will this execute anticipate We coupled believe

enter that We competitors also acknowledge market. the new may

four FDA be terms certain the agreement, date. which if was be that a Feraheme patent indications to our know, pursue approval you States, early of we able a to Sandoz ANDA launched of facing Monoferric as as over their a by and in example, for appears to January could approved years ago, secure under in For now sale the which although July they're was XXXX submitted settlement undisclosed in generic have United challenge, continues version as

to XXXX certain version to Sandoz we are unable authorized continue up can a the that in IV generic is generic for approval If believe to there by bringing date, secure July they However, XX to to barriers months. an launch significant Feraheme market. of iron that

set standard and obligation distribute to authorized has with commercial generic right product Sandoz’s splits. been supply profit terms to and AMAG's the up

exploring none guidance grow Company. into XXXX. take a started is the progress our to these current time priority for to new for to But opportunities will of this that course revenue Over share XXXX, work of and the we're opportunities Feraheme. are These we baked

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

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

preterm a which birth arm of which in highest well PROLONG would the The many PROLONG. most risk conditions than patient patients the in lower lower patients medical is treatment. a understood which risk of highlight Meis treatments, The study, benefit in study and rates challenges results a condition placebo PROLONG were are developing their appreciably not population or from indicating

SMFM Importantly, study the reiterating PROLONG been XXth, results in for guidelines, updated their recommendations October their after on patient population. and of Makena the appropriate have published, use ACOG

convened we're that As at XXth, meeting. October work to follow-up you the an hard FDA advisory now on know, committee and and

physicians a very and allow the on that to Makena. agree to are patients continue with access data We gather on will to additional to to that have how FDA would eligible to best to forward most be the path FDA committed informative working

about AMAG-XXX a affects form women women of negative and a are attendant XXX,XXX preeclampsia. to of of no of in high-reward have This a typically all They're treat XX,XXX severe health Preeclampsia health preeclampsia. estimated their United year severe is those program. potentially high-risk, preterm is in babies. development Preeclampsia in the and approximately birth for States, And currently threatens consequences. pregnant unborn therapies results to condition and women the preeclampsia. the a

medical U.S. serious and need, in enormous here the internationally. it's So, unmet both an

obviously it asset global rights and to commercial significant holds can see you have treat this potential. preeclampsia, You that to

on ongoing our sites. U.S. hard trials international trial in And these the recruit, project. while both medical need difficult Enrollment demands work to we and unmet that clinical continue continues, at this are to

those an Feraheme subset target and require with market existing Our already patients a future novel molecular hospitals value year, our a patients, the be a agent. today. treated reversal weight sales differentiated development U.S. reversal anticoagulants oral in U.S., approximately in-patient as advantages low X an large these the agent. asset either ciraparantag or These these will estimated There driver ER approximately Ciraparantag a is patients other at or profile million hospitals is are X,XXX A in force important in potential the alone. heparin taking with potential. over across core XXX,XXX of has

most taking hospital to is clinician from rapidly or the anticoagulant agent have in of a to of importance has NOAC, is patient the a need situation. We in to is a its is the surgery believe bleed effect. urgent serious of an Limiting paramount the a administration arrival reversal reverse what important care in to ability of while time who emergency on

So a like ciraparantag ready is drag preparation require ideal. not that use any does is and for

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

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

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

Ted Myles

Thanks, Bill.

presents that as uncertainties. operations expenses XX and Intrarosa the range outcomes Slide intention with some is business through advance of our note It's our divest of navigate Therefore, We and captures guidance associated we important in Morgan XXXX meaning conference products revenue the reflects continuing to January. guidance potential it in financial on that this a the we believe published JP are key presented those excluded. for to guidance Vyleesi. basis,

operations be we treatment for accordance presented way accounting when such qualify Our a the with discontinued actual financial in rules. will statements in

Importantly, key for our as return the and a operating is goal more to than expenses Intrarosa profitability, $XXX to This us an million driver XXXX. XXXX. remove to decisions divest allows opportunity for strategic to of important cutting Vyleesi which compared in is cost

revenue divestiture XXXX best outcome Intrarosa of here relates it goals. Vyleesi; completion XX for and the is Phase patients of enroll with may the who initiate of to million healthy for include the and successful the $XX and new portfolio exemption set opportunities; advance AMAG-XXX, our from both on U.S. open transition; development achieving between financial midyear $XX sites ex-U.S. and and and the investigational adjusted EBITDA submit pursue which the full FDA device in as our of to $XXX of Xb in partnering the million, to ciraparantag, working study ex-U.S. slide volunteers million Makena; to Phase $XXX continuing and million. sites; Listed between our study includes benefit objectives, They CEO and drive both programs; Xb/Xa continue of

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

Operator

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

Douglas Tsao

we the Makena. the started with that to you months the a some now see we're decline volume of starting in into Have Maybe Year. couple terms of Obviously, stabilization saw in the those restructuring haven't fourth divested yet. assets quarter? were terms you you Vyleesi indicated and and Ted, And Intrarosa. second, going the in cost of be the tied to to Obviously, savings, New

to point down? what should see we expect start the associated SG&A to come at So,

Bill Heiden

Bill. with start I Why don’t Doug, Makena. it’s

we go mentioned, through we have connection. the As Makena visibility forward some care

out and available. force to have working been clarify we some of of continues. quarter around get been to mentioned, and affect to able knew fourth as saw the enrollment’s we Makena first half And little There advisory gotten in press so, soft doctors in ensure fourth a due Makena. some field we're committee, stabilization, would be sort has revenues And then that the continues the our to for quarter. And that that hard to we Makena that the

So, out force is our sales force. in

physicians uncertainty want and this for of think cloud clearly I will of patients. reasons, a that remove think and we to lot help I

so, the patients job right forward, work And physicians Makena now agency can craft assure to continue have to continue is that so to patients to with going their can path we one And to the access. that's can access that forward. have

Ted Myles

XXXX It’s informed the guidance. that our softness important also to we QX saw in note

wide revenue the guidance it's -- range So, revenue of on part the guidance. the

expenses, managing of always managing expenses terms we're carefully. In

launch talked from obviously, cost to we're support the away Intrarosa Intrarosa Vyleesi. but As not. make were cash we product a flow in from positive we consumer That to the XXXX, the throughout about direct is Vyleesi, of direct to We're so to launch, continuing product is room pulling doing very spend invest a continues. basis; mindfully.

is process And previously, along deliver divestiture that the we're as nicely. in market, the moving be optimistic Importantly, to as able announcable we to QX. indicated sometime we'll something we

Douglas Tsao

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

Bill Heiden

Doug. Thanks, Sure.

to on have So, the reimbursement, continue we virtually reimbursements. universal

challenges been real to that’s you we've net reimbursement. see continue that on discounting additional that mentioned. has and the there's have and pricing But something broad been no Makena, reimbursement. So, some from very on There very, we

In terms that. terms of community, part can had Doug. you to in imagine some was a confusion of so There of and feel risk and who I XXX who there might imagine simply themselves and treated spectrum, patients physician some we physicians patients. physicians that have some are maybe ask those late had -- there's patients clarify treating about had availability, a the might they patient they preterm differently that now have may birth significant on

the So, softness some I of think comes back.

path a forward Makena pattern. their think clarification of I market. that on may the confirmation I through remain some have all that the and prescribing righted be and could there's will physicians But think some agency altered with that

Operator

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

Jessica Fye

and that flow still given to EBITDA be But and a prior operating about on continuing now expect operations can to you basis. from accounting Vyleesi, XXXX I appreciate ops for divestitures? Intrarosa profit negative positive talk the or providing proceeds cash you whether spending on guidance the for adjusted from any AMAG’s you're you in

Ted Myles

But, we Ted. flow neutral. assume that be question. a it’s to depends when It’s about -- think transact. our XXXX good will for I is Jess, on cash place Hey, good is Certainly a estimate

cash period So, million to the about million, EBITDA the spend converts, on we the midpoint there's for own and $XX the million focus the $XX on EBITDA, -- million XX of that of interest on cash $XX assets. let's of time $XX

Bill Heiden

any that might our we as in that's just including not upfronts pointed, receive And divestiture.

Jessica Fye

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

Ted Myles

that So, in I deal with milestones detail, monies, downstream because structure, go might there's monies don't too you the into as terms might be want to of based a imagine, obviously much balance, or royalties. on upfront

that. process still And so, we're in on

that's we would recall any wouldn't any there. And don't contractually economic I so, give products I currently, have just know impact on terms contracts. would economics, you I -- not the I But of details -- that. back, again, will, the to giving there from that's want not don't what just the plan. it And the And current -- in intention. if not direction have think much that necessarily

Jessica Fye

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

Ted Myles

-- lot internal little business bound feel there's our a feel our I of of for Feraheme like a narrower on is We projections of about and there the Feraheme. look, more estimate less there's Well, a uncertainty. good XXXX.

to about Makena. exactly that in the $XX regularly. prescriber the to can level. able XXXX. to But, to get writing to around to as confusion that docs hard first Makena few how back of infer, you the going hard that that going So, we hard to -- very were of to be It's million what estimate in majority of encouraged we're per undo hard handicap and uncertainty it's going had quarter quarters it’s back FDA It's by back is is some get be to return, the We market to do. more

a give say, in So, hopefully, we of wide a room hindsight, lot number, to uncertainty. for, range to but you a nice navigate wanted provide account conservative ourselves to through as

Jessica Fye

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

Bill Heiden

we the -- normally don't quarter. I inside don’t comment No,

stabilization. seen, think, into think stabilization? I have question due was, We've press to outcome we of out seen we field, we've able certainly, about of been to who advisory qualitatively, generally misunderstood the the again, the the we've clarify the is the And as were simply again, committee. some I answer yes, physicians seen some

simply So, -- that those those who we able clarify just with have physicians confirm we able were physicians. been for to physicians misunderstood, that just to and

So there's we're stabilization, not into though. the to going this numbers get yes, been quarter

Operator

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

Ami Fadia

Maybe just with. Makena follow-up a to begin on

market, to market, quickly where the get a that quarters side. how rate? the come a long stays sort off agreement would conservatism Feraheme that’s Makena significant But, side then, Your on it us decline conduct prior as some a the if you can questions how the FDA could scenario and pipeline. study level to a And could lower if of upper give in be with suggests can have perform, you your other its about to some I back come run some then, on performance quality in pulled into it an additional and think progressed XXXX, just helpful. you the guidance before on year. happen? stable how does Maybe Maybe that Makena range, the it And is, bound of of this would

Bill Heiden

Right.

or distance alluding you accurately can the within Feraheme. around spitting to, about probably range are think So, relatively then you as

range of just And And the yeah, revenues Makena. around the on guided and view as why capturing of and try capture that might -- could out. around conservative very we've so, the things does view level range conservative. you how our end really mentioned, uncertainty some low -- play as That's Ted

of thought uncertainty, a I best given it numbers. to more that range of we view, we a of we guidance, obviously, was beat. guidance level or provide -- around to point can our And think we always revenue relative goal, is think from a level again, when our with those conservative convey numbers that meet

the And my I really that's and think commentary around so, guidance our numbers.

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

additional comments? any Ted,

Ted Myles

the XX the only reminding of the -- to course weeks. is guess, XX therapy I thing everyone, is

going out be assurance can't be think to we the do patient, so. of course with And physician, And uncertainty that then, patient that pulled. on the you So, perfect product’s you of this And, that been disrupted, part give start some our of the to a calculus we as that through whether there. balance we therapy or want see way a this. have not won't may course you're

Bill Heiden

it terms continue physicians care access. want to able works, patient that process we on And Makena. that's of and very-focused will physicians to a will guarantee, have guide ensure incomplete you if would to But are in with they start be not because therapy you how that and want

to So, them assurance quickly we as possible. want as give that

Ami Fadia

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

Bill Heiden

me Let patients. We XXX, right? to with your continue it's enroll because harder start which last -- is the to part, predict,

the when think We both think think number And and we of get to we I that'd U.S. the is U.S. continue to in outside that device good a to about of working us for Perosphere talk we the the where for with ciraparantag, a somewhat On Technologies in submission be publicly enrollment. open a time sites, currently are are we exemption. investigational I milestone,

of On running that the there's enrolled trial that data trial, have based sometime once next. and be we be agency of next end anticipate XXXX end lead so, would then that would into the We and will by the expectations that trial year Xb, a should initiated. waiting trial meeting, of early to submission. have which as of There's then that with a period be clinical for anticipate initiated XX-day or And trial Phase the Xb can initiated midyear. And, would confirm on obviously, program. confirmation design be we X an And well. that Phase we in year X that Phase the our

Ami Fadia

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

Bill Heiden

Sure.

been So it's rework, investigational simply device submitted up. to again Perosphere no Technologies. The just back -- exemption by request is

a in over. that that company don't we request goes So that's really any from a control have

device investigational with we've that ciraparantag. The exemption them. designed closely protocol very include for working We’re will the

with clinical validation important, that our the I we Perosphere device Technologies trial. that want initiate past or review has to there say, this -- time they because that's we the And a this the FDA job. been drug Xb agreed that's some ensure And the the all submitted, the doing so have what is is So, need, -- of that's can division. would that they Phase that gets XX-day when and exactly of

work been that Technologies unchanged. validation the that is agency. Perosphere The has So, work was the device simply requested by the was requested. doing It's

again, submitted. so, And to mid-XXXX. that based Xb able initiate timeline, we're targeting be will And we on would our be

Operator

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

Chris Raymond

Thanks.

on Just one Feraheme. question

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

Bill Heiden

Yes.

this. have work I at medical lot I'll get answer for it's and So, there's know, of done being looking that. and don't team on Bill. you, has this Chris, a a complete our I today been actually

is certainly all dialysis. out, pointed of you our most our -- outside business As of of actually

couple any have disease primarily last from late stage the CKD. come growth our area. of don't the And business we of over So, years, in renal outside has

of level answer complete give let hip around certainly I have completely. safety. But, been want of you the long-term that's of lion's in around don't some so a our still me more to that answer, uncertainty question specifically just growth. me. products share Chris. I your And There's more and front But a the

Operator

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

Serge Belanger

Can talk about of that looking just Do formulation drivers XXXX? the go about color you've on the these expansion, label you're growth the for Also or market in the future additional I for on talked in a for then opportunities change opportunities growth extends future? a how to wanted at through And market maybe significant the to morning. some for I Feraheme. these IVR expected in get IP? factor. of questions -- think, end just XXXX, Feraheme. the the a growth couple you was Good continue Is some that a XXXX? of

Bill Heiden

terms the we've growth growth, seen years. market market year actually seen as In significant growth, market and every mentioned, few of significant past you for we've

grow. the to continues market So,

talk inflammatory indications more there I of think been are from some growth as where suffer have difficulty as got concerted on broadly may We've Those of also about here. there's for gut. some of absorbing example, patients the benefit effort the in a patients patients iron. bowel who many disease. from, of suffer iron part an the the some anemia. Gastroenterology competitors our who underlying patients segment to really in is well who two interesting of intravenous There's AMAG, factors from

treat So, one those the most efficient to of is patients ways iron. with intravenous

so And a nice that's for us. growth opportunity

forward. certainly think market so, going expectation. our growth the I should continue And That's that in

we still I share. think, ability have the grow continue to to

the mentioned, quarter share our fourth we in market was As XX.X%.

still a lot for us to So, there's grow into. of market share

of terms opportunities In broader growth going forward.

but opportunity outside And for I And little as potential have is talked growth a there on bit on think, as could But, the opportunities, the little as confirmation we path Feraheme. working ideas. of the we market those be use well well, are U.S., Feraheme those of opportunities opportunities. -- indications. bit a those expansion certainly those until publicly forward opportunities, take for a haven't geographic couple we specifically for I are additional more about interesting those new could But longer. create haven't

the beyond. growth couple to we nice So, grow of forward outside going of continue mentioned, But a will you anemia. market and in do expect as opportunities that XXXX

Operator

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

Gregg Gilbert

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

Bill Heiden

Gregg. not that, would assume I Yes.

Affairs. are Our by really interactions of the our Head Regulatory led with agency

so, And change, no no relation.

Makena. We haven't changes our agency retain commented our the with on nothing strategies specific can goals terms of that do ensure to agency interactions our and with access expectations, not Makena, But for around patients today. to the to the the working and in going

so continues no plan change. that So and

Gregg Gilbert

Okay. generally, bar various of go in been confident but pipeline? same on new Oftentimes for see into are already, CMO Does a the some ways. and of company know, asked out a reset about more in laid I in what's sort we timelines? the come that you timelines terms

pipeline? you and maybe So, speak are communicated continuity how on on and the the thus what's can you theme confident that to been broadly far

Bill Heiden

Look, right is the execution. focus now,

it's Makena development go through both, also assets, about our but I if so, execution. And really stage

the plans; We strategies have have we out. the laid

execution. all And about it's now, progressive so,

enrolling For that. over patients, about XXX, one. and sites all it's it's the that’s job about number of it's expanding operations our clinical And team,

IDE our Xb the and For anticipate filing trial partners we the Perosphere clinical the We working midyear. at have ciraparantag, initiating Phase the with Technologies. We're plan.

confidence we I well, about to So, And goals. team now. execution all will and our every it's that execute meet our will continue have

Gregg Gilbert

one And one. last

stay communicated any being as You've on -- long search about has to the needed. anything I the news on with as quarter. how that? is going Board divestiture timeline been with about CEO and assume clear the you're next prepared process But, in associated track

Bill Heiden

successor the the have aware specific communicated through for work on indicated stay their I'm find don't job. gives do candidate of we think brought search. CEO the they any I the board, have So, being I and I really Board progress timeline. that my on think ideal which ability I'll to named and

roughly six have timeframe a that a CEO a was And three experience time succession months midyear based We really that in is point. think to I reasonable. and talked about on

reasonable about. And for think people think so I a still that's target to

Operator

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

Bill Heiden

Maria. you, Thank

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

Operator

call. conclude does today's This you. Thank conference

You may wonderful have day. now and disconnect a

Amag Pharmaceuticals (AMAG) 4 Mar 202019 Q4 Earnings call transcript