AMAG - Earnings call transcript Q1 2019 | Amag Pharmaceuticals, Inc.

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Operator

Good morning. My name is Regina and I will be your conference operator today. At this time, I would like to welcome everyone to the AMAG Pharmaceuticals First Quarter 2019 Earnings 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. now to is over today’s It Ms. to Instructions] my turn pleasure call [Operator President, Investor Vice Lennox, Linda Relations.

begin may You your conference.

Linda Lennox

financial discuss Thank welcome you, release. first to a to and this quarter our the AMAG we Regina. Pharmaceuticals conference press Good issued results. Earlier morning, morning, call

Chief Dr. the our Investors Executive are Chief our Officer. Medical with our represent We of business. to our it the at measures our during Julie which of Officer; to of are Bill in measures forward-looking those pursuant means these Chief President our amagpharma.com. SEC Form Securities The today. press full of a Myles, because forward-looking obtained reminded filed of and remarks made section from our that access of discuss cause Ted Chief in Casciano, evaluate Please earnings for discussed they call today’s provisions don’t XX-K Investors may section actual the and Officer; statements copy, and you to and as and have of performance. review Copies be uncertainties financial Safe associated will operational may For we the risks With statements Krop, a release, On economics emphasize certain was of respect to this the use include uncertainties business. our our Officer; a sec.gov to those measures that non-GAAP these Reform performance believe today’s statements. Heiden, could who Litigation to can Financial me with XXXX XXXX. you involve our risks non-GAAP be Harbor in the we financial the our website with call, Commercial forward-looking ongoing and our that website. better in for non-GAAP materially decision-making Tony differ on such call and want definitions at We Private results our Act refer set forth Please

an for review through open will with call. provide run and developments. then and pipeline. on quarter to quickly now our will year Tony turn up over With quarter provide morning’s an financial then our this highlights Bill. close the Ted Bill? Bill and of of pleasure my guidance. we’ll provide that, me for full development will call update overview update first XXXX call first products Let results commercial the an agenda And our will priorities our it’s Bill Julie and some will recent Q&A. the to the

Bill Heiden

Thanks, Linda and to good and for everyone you us. morning thank joining

Officer. started Commercial first let's responsible and get label with joined the well company as commercial review Chief some very the start of quarter recent injector, highlights Feraheme for year. auto Tony our list expanded successful efforts three promotion highlights Casciano ago as developments. a successful to launch years the launches with of this subcutaneous the to of I’ll was quarter’s last Makena past So, and our Tony our

commercial Vyleesi. the well Intrarosa, overseeing efforts for In as now addition, he on launch is preparations also as

minutes. under from in and well, spent The Before strong first last commercial subcutaneous injector, XX% digit quarter for market the growth XXXX of very has over XX to team million volume few achieving and quarter a XX% Tony years start of with a the market record of in the strong in the areas strong double joining Sanofi, over hear auto to where Tony continues share Feraheme record execute a last and great achieving The of the quarter, growth success. drove quarter. quarterly number over year, AMAG, he fourth therapeutic growth worked of team most a across revenues share $XX a Makena first team recent year. you'll had and directly at Tony they him

about few hear supply Makena However, quarter. disappointing in on revenues issues a a more impact minutes, in as muscular the some the financial to you'll product Makena caused intra

expect IM bounced a two with Makena year's our quarter walk to $X.X replace through revenue inventory the of double Tony primary QX previous is supplier quarter. highlights minute. the in from of revenue, we first suppliers will the the in However, which quarter in of from million, quarter second totaled Intrarosa XXXX. first new and last slightly

that upward trajectory. market and share both on back volume growth are Importantly, see an you'll

Pharmaceuticals, quarter, excited During closed and for very including prospects on this the the we we're also product. to Perosphere about ciraparantag pair acquire transaction the

Lastly, Ted which morning. this reaffirming in today, of this on touch financial guidance, are we will presentation our the XXXX section financial

over it Tony everyone our review platforms turn anchor wanted I two commercial a strong building performance, I of commercial Before we're to our on for on. that to

XXX look and and We of development OB-GYNS. hematologists hospitals on a Krop future, consolidated these and subcutaneous call. calling Intrarosa, on have a excellence auto nicely as XX pipeline the Julie And later calling person bit on health, the those will person are the an maternal and are give fits a those injector. on on focusing across to US. Makena on promoting have salesforce, how progressing key salesforce we women's update our programs newly centers commercial teams in right, we US Today, the And Feraheme,

me to Tony? turn update. provide to it Tony commercial let So a now, over

Tony Casciano

Thanks, today talented patients’ Bill. now a I'm excited in has make commercial be difference organization. that some really lives. products to great this AMAG leading

product of anemia, for me start Feraheme. deficiency our with iron the Let treatment

continues over million a expanded As growth and share market an Feraheme Bill These with to has sales accelerated an through increase record by XX.X%, team quarter. of XX%. achieved has share higher year-over-year label, to continues mentioned, oncology differentiating enable data last a in first strong will over Feraheme were first more in of a Feraheme expanded as X% To size show with In and modestly results market positive trend also force this quarter. first first segments, achieving X% efforts in even grow primarily Feraheme’s segment, support growth. XX% of expanded year's to quarter, than growth, over the last the clinical share which continue sales $XX increase in market label. in IVIM drive the sales year's the recently GI. volume driven hematology quarter, expanded the selling our increased more help we of the The additional

we a steam full as in for So, Feraheme growing ahead share by the market. performance continued team, expect growing strong

couple slide abandon in resulted Turning patient program, drop prescriptions million, listed quarter, in did The QX. other the but impacting which improve the to the modified to in copay first quarter can in year. per patients tend first of X, that down see but first reset quarter, more which last were market in double from do insurance our sales or were than items the first There deductibles left some sales, X.X script the Intrarosa of year's as Intrarosa, the the first volume you a quarter Intrarosa loss. savings on realized slide by on We right revenue this delay overall the side and volumes in few months also slide. of XX%, is

tune about the the fine to more continue year, of learn we will market. this elasticity throughout as adjustments those We

total of about health quarter, this recent we women's excited lines to It's year. the did also disruption covering the nice to what can salesforces script we're the solid quarter we share do. and February. We anticipated that quarter a team maternal changes trend in couple dotted and last result in growth know the And weekly and bit red trained In and combined the center through Those health nicely share trend new blue the weeks, cross have the few market team returned we realigned the see see of most We you share the that the grew the Makena experienced total chart, through dotted prescription the of script share is script and market from mid that start prescription in we in new red last we're can right and on dip, in which from total Intrarosa. weeks. as growth line. market weekly both in share

direct year. consumer focused positive we to as ahead, with expect through and from revenues share program, would market our grow, to progress we promotion a the and Looking impacts salesforce

and to subcutaneous injector, Ted? the to financial of in auto performance the strong headwinds I of Turning some the Makena that affected share quarter. through before about volume going walk Makena, team the tell on incredibly is revenues Ted our you market total

Ted Myles

Thanks, performance growth some volume first XXXX Makena’s needs and share of subcu auto Tony. the the delivered during team quarter unpacking. incredible for injector. gains The

our the want injector. reported can bullish net pink gross net right Makena impacted the However, fundamentals, to more bar there revenues that disappointed with the of the bar for the underlying a state by the on represented of that our of so There franchise. net gross the financial few that of $XX.X to number explaining story. million, results to light understand far we spend were we're chart. charges the a auto subcu minutes charges particularly investors And view our business is to I'll

in start $XX the hatched products approximately pink XXXX. $XX the of muscular reported revenue comprised million the bar in gray chart, the period and total, million of bar. million $XX represented bar chart, intra far sections by in of revenue left nearly and In us QX we shown injector of Let that auto of the in

through. out increase our for directly price revenue constraints. in of price during manufacturers’ gross penalties worth is sales for revenues supply fourth item quarter best average that Medicaid the chart in the to in believe and was million have presented lag quarter injector The final Due net would of incurred estimate still many $X as revenue in importantly for stacked sales relates This noting the The represents to the looked this to labeled increase period the and in can quarters by in period, the times often pro pink booked liability the this derived QX arrears, an XXXX. Medicaid bar stock liability pro we bar nature, gap recorded total rebates absent right, quarter column our million gross bar, would quarter, that estimate next therefore that XXXX. the authorized IM estimates to between change I'm forma quarter of unfavorable AMP this generic in liability compared charge, of an injector represented information million arrives. Medicaid more these estimate the we calculations IM government as million on million case, injector This the been IM revenue, was auto the by to it and next prior in The estimated is a you injector to increase failure QX result shown multiplying walk related generic to actual liability plus in for price. relates This to increase Due period. recorded. an auto auto XX.X by routine $XX.X of the of charge auto for not we the net in higher product we was revenue going million temporary you rebates. a is the gray. and sales. charges XXXX And Medicaid in our the of $XX.X million the estimated branded in recorded, a injector We an given change the current as it in labeled auto net see volume It to the Moving in revenue is forma. $X.X unfavorable. authorized XX.X if new the of to or estimated In includes favorable. of like, to supply liability price have $X some the best what quarters, update offset

quarter. that QX. we to this IM resolved the new IM a supplier, will issues be for supply approval significant sale We Pending stock expect available be of FDA have in

currently QX. Additionally, ramping supplier for been working with we've is that production another up

we we IM get supply will revenues have from believe track. to formulation ample back on the So

underlying that to Specifically, dynamics in wanted of partner provide detail our to level the to understand we will can business. QX. We this generic so this you resupply avoid and occurred plan issues the of authorized the allow us

Specifically volume strong, in revenue. performance also to but be are the subcu about share that IM supply quarter reported clear auto how the and the they and issues injector impacted

these nature. non-recurring to of failure many that penalty, supply the in prove is belief higher government will the to particularly and rebates be items, Our

Now, back Tony. over I'll it turn to

Tony Casciano

physician strong qX. support. availability that of an Thank the we XX% grew auto in driven continue over grow growth by generics. Not XX% volume you, was subcu his Bill but seven opening injector, this seeing excellent points perspective, to Ted. to gains quarter remarks a percentage and the IM that From QX, in mentioned favorable which market volume payer support, for despite demand was are multiple only continued share of also already

We mechanic the XX% demonstrating injector being best-in-class the the skilled the launch attributed continued care In decreasing IM. our growth successful services, received by arriving auto generic sales or the believe and a force patient greatly dispense of support hub prescriptions patient product’s with prescription, script subcu preference on be and of to differentiation, patients written by care for addition, mechanic further injector, the physician highly sustained and for switched injector. and auto connection nurse our indicated of strong a the execution offered to on subcu connection subcu as are auto potential growing can

of and in execution franchise. durability the by So, team, the the quarter confidence great growth to some maternal of health leading demand continued the commercial

trial. also salesforce line I'd top physicians, Julie? we Julie results. update been quarter, There from released ask PROLONG an hasn't from prescribing on first the like nor but those Krop results to much cover the noise from During to the

Julie Krop

Thanks, like the field sounds further PROLONG commitment practice Tony. with to Makena to related any their statements of recent the wait ACOG published reinforce use news the and It major societies, which intention issued to current medical from SMS, before our is and by conclusion. consistent guidelines making is data until the

PROLONG not profile. was note the of it favorable As served original data birth. PROLONG comprised trial, population Meis. but FDA It rate Caucasian rate the patient study consisted to replicate that a did confirm background a in of in Europe with Meis primarily Makena’s approval, background which significantly compared of population as lower the birth, racially efficacy results different reminder, preterm Eastern a to did seen important needs the a with that patient preterm safety trial from Makena’s It's the the evaluated in a US higher a more patient of of patients diverse population the basis

we've the perspective will US So our of what additional subset FDA data we the to completed the for to with are study on primary the context recently patient analyses and be steps, the next submitting population. which how into data, the along this put correct results

in results. In We publication steps. to for group don't opinion expect parallel, safety with stakeholders meet key it’s the of the going FDA discuss want the a as are is sit committee evaluate also this this to of previous of plan of the quickly leaders next our any to medical light move trials and we publications the to carefully clear to keynote’s the on that positive data with to planning new favorable need working study I begin all profile. in US, large unmet the

meeting recent since detail weeks. and Now, of at activities. in three in our in American let's presence my of strong Nashville. stage reveal we to Obstetricians development Analyst will College upcoming going annual development our comments more this had brief, Gynecologists all much a covering keep I'm at our of couple year's assets be a Day We

The taking related bremelanotide type women regardless phase women contraceptives with activities In as poster presentation presentation a Intrarosa, of bremelanotide and had pivotal sexual oral the two we X podium traded desire addition as analysis demonstrated on to to meeting. analysis of used. Makena from stress The and the the well and in the compared improved an many oral subset presentations contraceptive focused commercial of to of placebo study.

with in of in the a focused patients of disease. data for months six consistent ferumoxytol. other bleeding in their and to demonstrated supporting One after study BMT poster anemia abnormal uterus up with of patients presentation data of poster And presentations single that from course on duration efficacy the fatigue of summarized ir-respectable a the treatment improvements HSDD,

June a date. lot desire of with data the and So, under with trade presented of FDA premenopausal the and women ACOG of Bremelanotide its a related at near potential enthusiasm term disstress. a is name sexual approval in of by interesting treatment bremelanotide interest the PDUFA lot and or currently low review Vyleesi XX for

ACOG. campaigns, the to campaign we've As number And study and that duration care about already the a FDA broad health this completed since called, times study pressure previously at volunteers. a the I We've today, it March, but that in data six we it's weeks. in the million providers short with a conduct to are also X.X to of approval, campaign be we launched for able past are discussions one the preparation that small we kicked for any at submitted to which about FDA XX. looking aimed viewed reintroduced ambulatory In a and provider agency's into healthcare previously has directed disease report go FDA state to review. won't two happy [indiscernible] awareness and at healthcare monitoring campaign. blood consumer currently in been we healthy new disclosed, week professionals, detail I'm as disclosed, have recently already the forward a and other not decision direct requested at we awareness over off sex In digital March launched labeling

their can partnering our consumer to HSDD to off further and to women the educate We're I'm this month, last the highlighting some really increasing to seek questions, month. forward community who to HSDD and increase it And treatable, is experts also to with them approval prior premenopausal HSDD start. is So of campaign treatment. direct we condition, just and a answers provide to launched appropriate women. diagnosis looking potential awareness about the awareness encouraging [indiscernible] campaign to consumer next intended that with among great

the with program. update on end quick I'll a Finally, ciraparantag

blood blood more effective to required most clot laboratory the precisely anticoagulation On an developed allow of form our of blood is will us of healthy important of Xa select effects of the to clotting and dose the Perosphere a slide in automated rapidly the it a study. side Whole time. time this picture phase is the to reverse whole measure measure Technologies and takes clotting time by to volunteer ciraparantag NOACs right coagulometer portable

Before measure an use whole blood need clearance to we initiate FDA clotting IDE. through we X from device the to or a get to the phase the exemption, investigational coagulometer called time studies, process

takes phase meeting data and the included FDA any application. to device with what on the we the on to be needs submit approval, initiate a process IDE applications studies. Xa for the breakthrough phase the parallel, in will feedback, to to Based soon receive The as which we have typically apply that additional are the both Xa if as mid-year. In we review soon discuss and We XX plan about scheduled designations, that days, and we orphan protocol us the on us alignment and allow end financial will first FDA patient closely the X will of take phase of place FDA will financial guidance. development agency with review the with to second We will year, to meeting you enable the through partner in walk the XXXX now anticipate to Ted? of granted Xb if with the design and quarter that the overall gain more expedite a study. the our program. Ted this results of phase half preparing

Ted Myles

Thanks, Julie.

numbers results As was been morning for CBR. separate a of income consolidated discontinued have as that through of already the I the and financial statements. operating appear That quick operations since section accounted those divestiture this historical presenting financial all excludes reminder, walk revenue won't information the in our our covered. those we're results

is our is due year-over-year, ciraparantag expenses million the acquisition a expenses, operating accurate still as company's asset. asset period. our to specifically charge by a $X.X to almost million This in the forces sales, million the a expenses to $X.X amortization QX an to Because The accounting increase positive result Makena lower was amount and by intangible higher as process clinical women's intangible development expectations sales revenues a one-time Also IPR&D current Perosphere. million of was a in expenses of reduction acquisition XXXX operating our acquired of expense, combining expense $XX $XX the negative acquisition accounting Perosphere to research stated qualifies and related higher for loss and the in to restructuring asset was the the appropriate purposes. offset million increase operating programs. health increased lower Therefore, related from operating The to were These combination $XX EBITDA ongoing the costs in was of with exclusively our costs in $XX increased clinical in the ITR&D described product partially increases acquired health plan. of of EBITDA they maternal and driven development, contributing above. acquisition reported the concentrated and XXXX related in charge to shift development R&D is in asset. in to primarily in of The or due value Moving consistent QX to by million.

are have assets We the temporary a exciting and to support for Julie the shifted product investing and EBITDA launches, of new therefore loss into clinical the future development discussed earlier.

$XX the Fortunately, of support during sheet also million included and common balance convertible XXXX this we past notes. years of the acquisition uses million cash. the quarter company cash over stock The X.X open of ended repurchase of the We in our $XX several evolution. to for shares remaining settle with transformed quarter. approximately our million $XXX the The the market million to utilized Perosphere, to $XX.X million

our an have convertible $XX we stock of million program, debt, buyback directors $XX XXXX authorized buyback approved now XXXX, March notes. additional was of board $XXX remaining. the Our such million million existing of stock of as to Total XX, approximately that

our reaffirming guidance are We XXXX. for financial

acquisition excluded to note growth When the for business, revenue of we includes million ciraparantag a that transaction. $XX approximately underlying not we XXXX confidence fundamentals the GAAP the milestone strong in the insight partner, Feraheme. guidance we guidance increasing our of high continued Perosphere, as provide of the include bit impact that to to a January, a have yet global that want into payments To subcu the We Perosphere acquisition. we indicated guidance, whole franchise program. of more our loss of operating degree Makena our is accounting guidance in of from I expect the issued our had the a and closed basis, so On receive accounting the impact pharmaceutical of our

Now, it to our objectives for Bill to turn Bill? I'll key back present XXXX.

Bill Heiden

Ted. you, Thank

and programs here, planning commercial Vyleesi. on receive a that to under shown So are just we another phase continue Tony's AMAGXXX in approval, continued year few the for as for with progress success to where are well busy our where program on away, enrollment potentially initiate weeks expect stage we X development program ciraparantag, focus leadership preeclampsia and our and launch then

As we invest and we've will previously, use products development XXXX of picture, from flows shown AMAG. products big will at the future commercial value cash a the is year our in that drive to launch new

coming of our In lineup live of of or on these impact and and their deeper we standards our for join to And people Analyst bit weeks, medical products products. products. who patient in with the going you'll where of I sharing enthusiasm we've the of key opinion hope us about will expert to of our the each that plenty of be of these couple Q&A in able potential current through the to value leaders got role And webcast. we've on potential time care, new allocated Day dig fact, allowing development new have these conditions. opinion goal we're conditions, relevant great up a a a give

questions. for we'll So the Operator? our that, open and with we conclude remarks call prepared will

Operator

SVB will line Fadia from the Leerink. Our of first question Ami Instructions] [Operator come with

Ami Fadia

questions. of Couple

the you expecting initial recent to guidance, impact you And you are a with have may also generic with are genetics Makena. the your be you to impact you've question. entry Can I'll to just and regard second what expecting then enter? as and revised additional talk thought about seeing additional Firstly,

Bill Heiden

I don’t Why take Bill. ask Tony to first question? is This that

Tony Casciano

Sure. Yeah.

good morning. So

we're continue remarkable those auto that despite injector, the the coming see in. of growth One the generics is generics with to things enter we seeing as marketplace

of these But available some I increasing straight approvals are injector, them I have there, it's what seeing yet. to have with seen just that patients haven't we in CI are that important pursuing perfect perfect. CI CI nature. It's From pleased we a the as science, it's actively. of be those know, others important year additional and what that far despite so availability, and would estimates that in our XXXX. don't think realize out approvals, we're couple the auto are, continue number there'd few general, CI an indicate to generic been of for I we for generics perspective, you we've generic there It's we're been listed as remember Again, as that year in least are that competitive the not convert full to seeing. and assume but we're that throughout think accurate a at there's of with think pretty a not that our is to would been intelligence, I think

Ted Myles

in. jump this Ted. just I'll is And,

mentioned revised You guidance.

guidance. not revising We are

is – want that. So just Guidance to I clarify

Ami Fadia

[indiscernible]

Bill Heiden

sure. Sure,

The $XX.X contracting. we've in Ted we've the aggressively it really earlier includes quarter playing million exactly to be out clear strong we and way that have volume, is growth, the I volume been had pro nice strong that which want other that thing but because forma spoke about forecasted,

is pricing was it lower so in XXXX. And than little a

basis, subcu again, And product that to continue we is we’ll nicely. see to go think on think, that of comfortable very But forward continue auto we're so share I going I perform bit price a may we'll is for net-net, go gain trade what have injector, a to to forward. the as we the

stop yes, question. So second your And I'll there.

Ami Fadia

of as see to and flexibility to, we do where If your you the what’s not what that Intrarosa, in had you dynamics, a with made some changes you Thank those copay you of program regards the have your some latest as to thinking regards do change year hoped with earlier at P&L? point the would on the will we pick Just year? you. have are And, progresses? in volumes up

Tony Casciano

sure. Yeah,

a make we So, and to can learning what flexibility becomes copay revenue made the think this the can In I last time. response as is, changes from And trying of but balance we we're learning to of idea Obviously, strike. program. about have you perspective, couple it cost is we're to there's improve a a a to month. over that we're grow right, volume. that marketplace as what recent And changes GTMs,

you you If lose volume, result. not but GTMs, increase a too that's much possible

have I GTMs of more this competition little see some We're it's marketplace, low learning we sacrificing to which some that that from priced one close reflecting changes the the I bit competitors so volume. other signs it, made difficult improve those does remarks. to a lot, as in So, opening said, things to generic monitor a far since is without we've in quarter a been think positive volume we'll have continue But seen the in perspective.

Bill Heiden

also add nicely. we think that terms close you I'd net. the And to presented, saw are chart TRXs the where to I want that program of be copay as gross in in back Tony just bouncing and to our we're

ask we're here into expenses. the So head and we the year. I in think talk to on right the remainder comes trajectory, it to maybe Ted QX, of And as the flexibility when about P&L

Ted Myles

QX. mean, merged forces in sales you the Yeah, Sure. that I we saw

the mix are It bit promoting more down obviously progresses. heavy one, Vyleesi, salesforce, and a expenses Intrarosa, changed adjustable, to class, spend P&L and best a as up to our soon be of So us of sort year or those gives the weighted that also Makena in hopefully of total flexibility. external and lot more little

business, of strength we're the is the hold the Intrarosa. subcu, Feraheme of to guidance the things conviction seeing and of a us trends that on the our gives lot underlying One

Operator

Stacy question with the from Ku Cowen. of comes line next Your

Stacy Ku

have few. a I

asked but likely you how clarify, could follow issues are issues have might I up. future and the First, Makena’s can with And additives supply we no view this well. been pie pie us you Just going experiencing as supply help other a forward? have generics before, consider to these understand resolved

Bill Heiden

Sure.

supply So I on year. the really unique supply primary of We from side, us. the our think suppliers was for issue to moving to now original remainder two supplier the the were

will two that in significant and be we second the suppliers those and why quarter confidence second We there terms in -- that's teed IM from have to because two supply such have resolved. up quarter volumes this issue suppliers coming got in confidence the we've are supply in

have than I been So know we don't that generics there but are the supply I side not Tony, yes, have on believe approved, generic other still two have confidence. launched. about

Tony Casciano

Yes.

issues can no we speculate, supply competition. from reports we generic only of have So

Maybe that we Bill don't end on know about there is that received they are don't have not As that true mentioned, yet that that reason know to today. of supply. We approvals a their a commercialized. for But have couple know nothing as definitively. be

Stacy Ku

phase the year? And we X end that a take provide ciraparantag of begin might meeting? might on this crystal more the clarity pipeline we results to details. understand But on question. long any when measure And anticipate a have you there after how quantitative might get getting by clear is the FDA could timing specific it potentially still results? Could not the trial I on

Julie Krop

Yeah.

study definitely the as So do getting I Xa dependent, to term. the we’ll that able which again, will approval, we're confident mentioned, the be we’re idea on fairly near in

Xa hoping trial. to So quarter, the start third we're

I of confident up, pretty it that. the when I about still we exactly able we're we're think think that complete year, should we’ll finish saying end by as to the study, far be As

was I and -- – think that So

Bill Heiden

Yeah.

the healthy these, trial, These Xa phase Stacy, you're are So, this. of aware probably volunteers.

so are the over is and agent in lined them hours. a up actually of results fairly that reversal fairly XX run And kind And studied that site that has so the that you quickly. with work also can you you quick get

you're what alluding is, we think I quickly. results should get those So to pretty

probably excuse to early of Julie Xa have would me completed As XX. year, be by results ’XX, mentioned, targeting we're end means the available which early

Operator

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

Jessica Fye

just could you you -- beyond kind detail general. realize confidence of your business in line and more maintaining us EBITDA top hoping understand in a your in was guidance the help the are adjusted little how I

event? questions on a Makena that development guaranteed couple million specific some mentioned So Are XX And year? for that range for ciraparantag XX Is revenue. of the quarterly rate $XX milestone million run also in you rest you reiterating of the to or million pending expected payments.

Ted Myles

volumes the us timers the we would been got particularly subcu, time. rate of impact that generic the we million quarter really run questions. the still Makena are have for we XX quarterly in Thanks are sum But and Yeah, there – this these to and franchise to for is due some one Ted. this competition. $XX the of It’s based price on million confident

confidence demand beyond. the and these prove it is and So net resolved, one get underlying the have just will thing gross us the issues of lot that charges of gives to with lot that we as strong through we’ll us supply that a a IM behind QX be conviction to one-time out time one and

from or is it. our set guaranteed, plan. with of our got our the on other $XX XX about pharmaceutical it's your sights question global that receiving not aligned The development million we've partner, Achieving clinical component million

it that. have a degree we of the we in we’ll guidance, break transaction confidence So receive yet. we didn't originally hadn't our was because out baked high closed It

Bill Heiden

not there's a risk, really perspective, tremendous amount execution. our scientific it’s From

So the as that's, volunteers. we trial a in And just and mentioned running. to healthy we trial, believe is we up which just get, Xa again, got getting the trial

it's so execution. just And

Jessica Fye

spend and this, And little can with I X. just a and things the the meeting, you of ID on what phase know itself, feedback points at you pre the guys like you'll progress the recap ciraparantag end just on on coagulometer submission touched submission communicate time time more

Julie Krop

for Krop. Julie is This Thanks question. the

device, you So meeting pre-submission FDA, with the of as get as in on has the coming analytics be know, is to as a a to up an IDE there's that order lot far submitted.

as as plan we the analytics submit application. after data. we're to will And the our of well sharing the quickly all then with So the analytic those be completing able studies, that on be hopefully FDA, some

we when As updating this we obviously, be progress trigger start application. don't meeting, you the phase be will announcing updating but -- I study with the submit approval. get. And takes as be that will IDE as the we said, meeting, of typically IDE pre-submission the Xa it then, the likely on we the days we We, probably XX of about completed that on to far won't

primarily meeting you about with the that's are of speaking are end phase think far those with And as where the X, FDA? I as then timelines. So we X end the of phase

Jessica Fye

Yes.

Julie Krop

X Yes, and Xb upcoming third discuss terms of out in don't we're out in -- meetings, the range. that we’ll for that meeting time planning usually phase probably And will trial come come so for design somewhere meeting. plans on that quarter time comment of we will that some

a plan. like that's So

Bill Heiden

The is the get a Jess, actually thing coagulometer see to only at you'll I the other would chance say, to Analyst Day.

we'll So there in detail. more we're going -- you'll and it to discuss little a it see

currently validation have primitive pretty you know, blood a We probably a coagulation measure. lot as done of work the is whole and

on of of our fact part the results on relies coagulometer this are the so or – accurate, is lot the work, our reproducible. confidence more that And and based faster, validation

that agency. feedback in again confidence, I the degree think, to we the terms speak so want have a have that FDA confidently we can but on fairly meeting, high of of

Jessica Fye

that of here? net quarter? sure Okay, prior you've When for average to the growth from great. last specifically rest And dynamics, one is for And of we we net we or had following you improvement script talk stability in growth? relative just look revenue now revenue your that continued to expect the topic, to on the year, one about XXXX, maybe first should improvement price understand on last per this the price should net gross up in make just guidance, the was Intrarosa. What questions year-over-year in

Ted Myles

Ted. It's

between Tony half and we fill to the still grow net, we're $XX recall, balance $XX, dialing range. we in also patients approach gets one to this report to Pleased the market. back enables good their to XXX you in as try in So QX. gross of in were scripts, really right – us to mentioned, XXXX, And a really that but find to the fulfill healthy as

find. balance copay through as that's the continue we're to we program. so Stay to tuned And work trying the

Bill Heiden

year of our remainder That's stable volumes. increasing to gross think relatively I really So with goal. net for the the

Operator

next Needham & the question [Operator Serge Company. Belanger with comes of line Instructions] Your from

Serge Belanger

couple questions A on of Makena.

the have now quarter, we’re issues revenues? to impact offsetting should supply can if of these about So you quarter give five second we if and any expect into second addressed charges also Makena the indication weeks been any

Bill Heiden

Ted just ask I’ll excuse to me, So, let about Prasco to you talk has currently know, subcu, inventory.

Prasco have the of we're we shooting QX for, Makena. sure form suppliers then to that. to significant expectation. And of achieve should track currently that's we come are muscular significant And expect The give of to has the Prasco the remainder year. supply supply. we absolutely that's So intra for on this want And they our really inventory and online make in what QX two

In terms let I’ll subcu auto of injector volume, Ted.

Ted Myles

Sure.

demand is to underlying reiterate, the product drive physician we mentioned fundamentals. So subcu, of strong very so and is and the as very, continue demand, continuing differentiated, demand underlying to on this good, the call

us a confidence. it So gives of lot

that coming talked and and feel business. recur QX that in in penalties going we're mix IM will online on as we between million IM not the item, I higher rebates, the the the the any future. to about we expectation, overall With subcu And that get other past certainly supply on government that failure based to or feel $X item, that well

Serge Belanger

once And even payers of from like FDA yet. impact seen the do impact or an envision you results, trial haven't the PROLONG announcement the or it physicians? of then But following the sounds potential what study you is kind published,

Bill Heiden

field. in the you're KOLs Julie, then you're from to -- what ask Tony, So, maybe you the hearing and ask hearing terms I of from what

Julie Krop

obviously for the I to Physicians patients, Yeah, The options obviously, this product perspective, comment the medical but physician a that is lot many, unmet these this There's have of confirmed years. seen is from confidence a is no mean, other in with for market huge we've many don't profile it. need. has I strong. the Makena, -- trial safety PROLONG that been on a want FDA, used which for

population a those studied, any think was decisions for people really that making any to and drastic for gives I pause the practice. certainly very reasons, or all patient -- any then lot quick So their of obviously, different changes

then, you these do we're And on remaining comment that? results. Tony, confidence, despite to seeing So, want

Tony Casciano

Yeah.

it. comfortable have talk today, of and therapy to much physicians, have very these results, from with they're the sales on reps, long not say, been see results. we the I had they physicians to think they're encountering patients prescribing They lot using if a the time, product know the they a as what any, qualitatively, Julie it's So negative feedback,

more this we think continue encouraging the see that's super thing other I is quantitative and enrollments is grow. to

one a continue us bit. really written physician rates -- and for is that grow, strong waning branded see to to indicator We to isn't me dispensers Makena preference Makena which

Serge Belanger

Maybe there hematology one a Tony, just with sales in Obviously, commercial last was key And changes overview the one. Bill and organizations. the of for some or recent Okay. changes promotion give forces. an

Bill Heiden

responsible Yeah, the leading because job, so auto label. for injector, the the the with don't and Tony he did let launch I was incredibly outstanding Feraheme successful broader launch me he's of also Tony want. blushing of an start Look, and subcutaneous rapid

the was responsibility so some broader under him. got he’s pleased guy, and launch talented a And Tony include Intrarosa really of a Vyleesi. talented now team Tony's potential to upcoming give I to

the And business our so I sales on feel very the Tony, may to as the health that on good expansion women's salesforce, want about commercial comment the you well team. maternal platforms state of as Feraheme both of the realignment we the and have.

Tony Casciano

Yeah, sure.

little bit. team My First is maybe just was maybe a overstated -- that amazing.

they're on injector. should And results of congratulated team. subcutaneous both We an and have they commercial the launch outstanding the really auto launch be -- really the the Feraheme for

individuals. yeah, And really of excited an OB-GYN, so perspective, of strong a been so got with combined leadership that They're cross sales they've oversees force everyone's XXX. up roughly be team. that we're really, a for alignment And to Vyleesi we about. blessed talented working launch getting trained. now we've a very gearing that team after From I'm with it a have So group

On the again, for Feraheme side, I Feraheme. profitable we're looking on think growth

responsible GIs. So primarily we a into at expanding took segments, additional approach

broader We that's XX. the modest reach But XX increase. We marketplace, about the say, going went also expansion have an away. some roughly roughly from was African primarily to getting into I’d not GI OB-GYN

are talented hospital doing almost groups, that have account space, out and then of to those contracting the with there managers oncology a also hematology some team in solely strategic We setting. very also dedicated

the with I'm this well. happy to team as work opportunity Commercial So Chief team. about again, as very blessed be on to working the executive Officer

Bill. thanks, So

Operator

Your next question the from comes Eun Jefferies. with Yang line of

Eun Yang

Intrarosa, has your to expectations. original regarding compared product So underperformed the obviously,

kind Vyleesi, you are that it’s I'm what you be preparing to launch confidence of when gives So time to wondering different.

expect and can revenue at the Secondly, with declining products time, but or for on cash a trying flow development that Thank be understand when growth, comment positive? you your I do you. same to you the future

Bill Heiden

Sure.

view, So, of flow term bit detail a we're going return positive. including to a to this, the a cash lot and at Day, more longer Analysts give try provide we’ll

So of some weeks. we'll Day at Analyst in of provide couple that a the

So hope there. folks to see

terms very marketplaces. In Intrarosa of and Vyleesi, two different are these

are obviously competing an a with market large competitors. in existing Intrarosa, For estrogen we number of

novel, existing I estrogen, think Intrarosa with dual about be But mechanism concerned there's there's that one market. has a differentiates very safety issues of the an which might action, really product.

tend our take longer And treatment good intensive entering where to a market for there no turn a so, markets those purposes, is little to are which versus options. Vyleesi,

be expectations And so slightly a for different is revenue, contributor. will in it's own Vyleesi a our to going I dynamic. modest terms you of tell XXXX, in that

is comment expectations. But of part Tony, what for different think, so I of modest trying expectations. beat maybe Vyleesi, are, beat obviously to you on. our to Vyleesi terms initially temper expectations. those expectations, goal want But then and in And we're will And those to doing be we

Tony Casciano

Sure. Yeah.

agree and thing I of think So I to sets I different just addition being in the Bill, add market one with competitive with different Vyleesi one the is would is, kind.

it's a think I unique to Absolutely. be going product fairly that's disruptive.

different So patient completely are patients very the are However, Right? these also types. different.

digitally. active have patients We younger engaged more side with HSDD, more on the the Vyleesi nature

those activating side have we time. And be our more on a there's different Right. time think will well. we this So as efficient also patients, that approach, so then potentially

Intrarosa, they while. at we've so speed. did had launched asset that the So breakneck I this commend for team a

industry beat of time, time, takes I the have right. how we analogs to it launch. of long most This think they

we So taking. have approach an that we're

Julie already commercial side. this a out from in we're some think both activities, to, from development a side alluded front with of market and medical I

I prudent this, think So in of more we have time kind over way, you doing if much will. a

it it is different. more that's say, it’s couldn't well. as would The I thing launching AMAG So similar be

Operator

further over will to conference the back remarks. we time, any for this Heiden At Bill turn

Bill Heiden

our throughout our update across on year. look on call with our on the providing you XX joining this panel thank portfolio today. as for details to here And that more all expert progress morning. We Great, forward continued the May as us development from our concludes well that, portfolio

Operator

and Thank this meeting. you for disconnect. does gentlemen, all you conclude Ladies today's and may now joining

Amag Pharmaceuticals (AMAG) 7 May 192019 Q1 Earnings call transcript