Amag Pharmaceuticals (AMAG) 1 Nov 192019 Q3 Earnings call transcript

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 Third Quarter 2019 Earnings Call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question-and-answer session. Instructions] [Operator

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

You may begin your conference.

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

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

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

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

sec.gov at obtained the section maybe Copies in our Investors of and website.

continued progression AMAG's and certain products a maximizing product new product in auto-injector. commercialized our a the the timeframe assumptions, and the for fund including on AMAG's approval expectations forward-looking of about of multiyear of estimates including trajectory subcutaneous with commercial of on products, and Makena based adjusted candidates We investments assumptions viability various outlook. long-term to growth AMAG's have opportunities are EBITDA strategy

these to factors. please So additional refer risk

Medical Officer; me our Dr. Ted Heiden, our on Officer. our Chief Commercial Executive Officer; Chief and President our Chief Julie Officer; Bill With Tony are Krop, Myles, and Financial today's Casciano, Chief call

for briefly through will call. Makena our Bill quarter run provide will closing provide then discuss Ted guidance. launch third financial some results programs. quickly Meeting. then will third cover the morning's our XXXX will development this quarter the Bill Committee of an me Vyleesi. overview for Advisory financial recent the provide will And our open back updated on Let Tony and Q&A. come FDA agenda our remarks of an Julie highlights. the Julie update call up and to recent will review

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

Thank you, quarter, call. first the record continued average revenue market grew out quarter, Feraheme, a over XX.X% X% in shown revenues here XX%. press million posted to left third the which the teams. quarter. subcutaneous even Revenue auto-injector Linda. saw and more XXXX the is products: three of three and Good third commercial update impressive has for Feraheme, each The the we on quarter. in basis We're the on is thanks us performance Intrarosa. of Feraheme Year-over-year of a execution from In laid our quarterly consistent all of quarters as in for with morning, pleased growth strong of on our Feraheme's the year-over-year share release. commercial joining increased which our Makena prior strong $XX.X in grew our increase

of generics market, all products. in caproate pleased revenues Makena stabilized quarter, have the in hydroxyprogesterone per $XX nearly center four predicted we've and been intramuscular be. FDA-approved they the million where is roughly of subcutaneous able Shown we're would With auto-injector around the maintain that slide to which we capture two-thirds

remember a may the the eligible Makena week's market in the revenues grew Julie quarter women. market advisory on that to important right, share cover and this net committee on finally, And meeting this growing quarter. Makena Intrarosa's third $X.X going million have and TRx all in available X.X% to the average remains for about franchise will I to pregnant and But following the know you questions forward it's moment. the to

going turn the over to can an who Meeting. Advisory Tuesday's Julie, provide FDA on now I'm call to Committee update

of the ahead recommended Committee committee as better top publication study. Bill. that call, appropriate well from to you, results the Advisory been identify preparing interpret been we the with our PROLONG line QX accelerate and time, forward. that ongoing understand Thank Since Since the to earlier publications discussions the for the of data as we of we've PROLONG Meeting with first in the you this path an announced closely study results our Advisory Meeting On the the year, we've FDA working to with meeting. shared FDA Committee

Gynecology the Sciences in on on behind XX a Just results. author of on October publication. was at of lays Journal perspective reasons Dr. week Reproductive Perinatology. publication were a author's Medical ago PROLONG American Chair study results the and published lead the the School Friday, of UTHealth the potential out the Department Blackwell, McGovern Houston, in and And PROLONG's Obstetrics the the Sean

Advisory of the the study College results updated this high-risk of met better Earlier Maternal-Fetal population. use studies. this of Bone Reproductive the and for Obstetrics American interpret the understand publication, Gynecologists Medicine prior Drugs Society context Urologic their to guidelines reviewing the their Committee support and patient Makena and in the reiterating After and week, for in PROLONG

of in for was of balance a of lot the use conduct In additional successfully with meeting, that and the need questions data face U.S. how to to how the widespread regarding there XXP. the study

only data from drug market. to was felt the get Some members the additional remove way to even the

Makena members and additional the of the in confirmatory from two members voted market. favor pursue trial. of six on five with FDA Importantly, new keeping voted market that a recommend the OB/GYNs to the withdrawal Nine

but the publicly, it their to FDA binding, we not we've remember will mixed consider the making vote. decisions. that, it's have vote As with committee's to But advisory disappointed is shared the are in important

options working eligible Makena. that be gather that FDA to committed patients data will the continue how additional are to informative ensure to the on most access physicians have to to to We same and at and exploring time

now turn Tony on it an launch update I'll provide to to Vyleesi. of over the

and month women those the indicates you, on research digital morning, women's bring force a Julie, driving first team of our through are everyone. Since of option. And early outreach, our market approximately has sales launching proud six generalized start there our been which reminder a wanted about to Vyleesi. and awareness Vyleesi, premenopausal I with important on-demand treatment with the nationally health ago focused to HSDD. team good quick is Thank acquired million women

prioritized co-pay patients. which co-pay the secure patients commercial Vyleesi, makes packs and access four our is coverage of eligible women program, on through market of to team Vyleesi available We've co-pay maximum first subsequent early while to our helping This program a access $XX for works fills. also for $X access

the we're probably month into launch, know a to to indications about we early eager While see some only progress you're date. of

qualitative the on we're social side side, in women illustrated the presence to providing On is our posts chance of engage with on of left-hand media slide. discussions the shown a seeing the HSDD by some about

with sales force the discussions right. from to in offices. in physicians is call In consistent Vyleesi. had in different addition, four engage are "I And access the detail to These about our out the on can eager this slides requests just by came see Those employee to viewing providers quote you you're the come requesting Vyleesi." no case not quote have me says finding

the For those representatives allow not familiar these the offices, office. that with not into access offices are term sales no will historically

HSDD of earned signs early see to amplify happy Vyleesi and to continue will media, to also drive are efforts We we believe awareness. which our

On slide of side, the launch. quantitative XX the you we're see can to more on tracking the of month first some metrics

XX.X women XXX,XXX us symptom and we've digital reach completed more Our has seen checkers than million focus than on helped to-date. more

health to professionals From prescriptions launch. prescription our that received perspective, with than have it's more X,XXX a prescribing to partners early we're more in X,XXX Again, happy specialty pharmacy Vyleesi the share care date. than

with we on So providing launch. plan calls sharing moving we'll the can the work the And we progress on subsequent on of informed slide, subset bottom of you on the keep metrics, be these are just you you. metrics additional to a forward of the as see the

so progress days, further the but good, far we more launch. Vyleesi and So, through come to with as so early

I'll to and Ted financials over the walk it turn guidance. that through to now With

Maternal compared Tony. XXXX, quarter second Slide a Health with sequential with the foothold believe quarter in in We this Team. the the Thanks, shows pleased in number that Makena by of for performance, XX auto-injector continued the We're the results. steady On of XXXX. execution our third with our second revenue the of the competitors of a established intramuscular product subcu revenues for consistent market generic Health QX by subcu can demonstrates with Women's you the see market. were our great importance been very auto-injector considering quarter has Commercial basis, a

that intramuscular This revenue from negative the shows revenue second these past item in IM we and received. estimated new compared initial any commercial on line of is invoices product. the quarter. new invoices next as the that declined rebate third to after from the revisions has to liability the periods. are information, primarily It the cases, of obligations the many sale from common revise quarter negative to as our result Medicaid The recorded estimated In the Makena based is arrive months liability

driven record quarter volume steady of very will million. Feraheme to our by continues growth cash deliver flow. Hem/Onc well, continues all and continue to We source perform strong another $XX to a team was be posting Feraheme believe results. of This

our key last of revenues the $XX $XXX Total revenues. shows third quarter The period the for the declined third takeaway of million quarter the XX year. compared XXXX. in revenue to quarter XXXX third of is Slide in the to intramuscular decline in million by same Makena product XXXX from

that that the termination exiting our including of August, market, Prasco, our earnings authorized partner. quarter contract generic mutual we on recall second the announced call we with in IM our You'll were

continued decision of significant IM share this disruptions of the supply generic increased intramuscular as a our due in resulted authorized well competition for which supplier by third-party made our and to both loss product, market brand We as generic.

max partially quarters, IM price was out-of-pocket go-to-market in script unencumbered auto-injector. $XX and In with for revenue statements. revenue by Vyleesi commercial subsequent noting in increase. offset subcu co-pay suffering financial the realized HSDD, a Consistent coverage will Intrarosa the access for ensuring and scripts. of Makena women net the launched scripts refill also future that our growth grow strategy worth are from in doesn't as number increases, who first Vyleesi we the of $X with for decline Makena It's Feraheme, and This appear for

Overall, compared same of couple total a cost trends, period line represents Moving down period. driving XXXX third down, to the quarter operating results to nearly P&L. for third to broke expenses Slide $XX items in the expenses illustrate were out the and million quarter We for for XX the of our XXXX. the better year-over-year.

product. During this the Substantially recognized quarter expense. of of to we IM $XX of was related year, approximately Makena last third million amortization all

During our primarily related AMAG-XXX, in quarter program site of IM approximately we recognize the the including our $X Europe. third with million plan, additional initiations any expenses didn't consistent increased third quarter R&D XXXX, clinical amortization. Makena for in to development

by Also XXXX. women's was direct-to-consumer February the our third This expenses to health plans, offset the spend marketing in was maternal of decrease health increased combination primarily by of SG&A This in launch Vyleesi. partially $X nearly to forces of of and consistent support our quarter year-over-year with our related XXXX decrease million. sales decreased

of $X.X EBITDA EBITDA million, During period million we compared in $XX with the the third of positive quarter, year. same negative last recorded

to still in investing our programs. our expenses, products and continue carefully development We while manage

the financial our As year of XXXX, full adjusting are approach end we guidance. we

$XXX midpoint previously. million, revenue our by the expected and negative lowered million lowered revenue Intrarosa driven of the from range I to discussed have IM expectations We primarily that of $XXX

$XX We carefully of expenses enables a year. $XX EBITDA million midpoint for continue to this our to of to from a and revise million full revised loss expected manage the our very us midpoint

It's out important point trend. to the

in million, to XXXX. loss half EBITDA year adjusted the dropping approximately of $XX was for the million first Our approximately $XX second the half of

consideration. on committed Tuesday to for As the our we an planning are FDA. Advisory working important corporate outcome We is and believe we the with in Makena XXXX, Committee consider

revenue In the Committee and our Makena the corporate planning. of Advisory heightens meantime, the the that this uncertainty vote we informs recognize around durability

look the of are shareholder to a value. We ways portfolio for maximize to our scenarios of prepared continue and optimize potential value to variety for

more formal get we forward position a earnings regarding guidance path on Makena, As be better in provide and we'll XXXX. clarity to the revenue for

investment several to Over we the will Advisory forward months, the impact community be the of guidance financial that expect next clear. more to providing We January. Committee full in look the

Julie to for turn I'll programs. quick that, a update development back Julie? With it on our

Ted. Thank you,

our molecule, know, require taking As who you Ciraparantag stage to patients anticoagulant we development an a serious have anticoagulation in or therapy. is in emergency while bleeds two reverse urgent will designed small portfolio. surgery assets have

currently blood clotting automated working clinical coagulometer gain are on of We trial. with in Perosphere study proposed of the The the measure to whole design FDA the alignment time by process developed will an Technologies. using next

or study clear will the be Perosphere initiation for Exemption Investigational study design then Device IDE IDE the Before Technology coagulometer submit through must once extra an finalized. The time will is and the to we plan of data, study have next the end we the to Phase successful will schedule help meeting, after us II spend which completion. now ensure that a allow generate, the we

preeclampsia need orphan forward is efficacy severe other AMAG-XXX, treat medical and safety Regarding when you being updating enrollment to Bill? is development IIb/IIIa ongoing Phase high with and women of we study enrollment to program is which with condition look the unmet our the developed complete. an pregnant

Okay.

on slide, look summary Here with ahead. to of want final wrap just our up of I as company we for a the focus areas

continuing path data forward to to and majority and auto-injector subcu Makena, follow-up FDA continue agree will generate that additional it's market a Makena. with also to the physicians the that capture of to the in patients access For have this with requisite and ensuring the

XXX out-licensing Exemption continuing As quarter-on-quarter We're is covered, progress clinical opportunity the submit enroll as possible. clinical continuing in as to maximize that patients working launch to by Vyleesi trial. Device and Tony portfolio shareholder on closely finally, to new with team report optimizing focused to encouraged example performance Technologies been the of And has exploring growth. with and the launch this product's strong Feraheme on for working on sites next focus early value for We're also in the Investigational to to look Ciraparantag. new preeclampsia and severe Perosphere healthy ex-U.S. opening automated metrics to trajectory. and continue forward the we're continuing Ciraparantag the initiate value study quickly coagulometer our volunteers an the

And me with and so that, for the our we'll let questions. prepared with call open stop Regina? remarks

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

of Thank morning. couple limit questions you. Good I to I'll but have a three. them

Firstly for is and you of registry if current do study that what RCT could a the also thinking, or of next and the a on efficacy could steps type study lines you sort sense from for Makena? provide some be FDA that a it to sort If substantial us of elaborate evidence of Julie, the think give you discussing of with what feasible study around could time the with cadence be? help provide us could

this Yes discuss mean good need I with question. the to we FDA. obviously

of committed far to studies. we're As -- design as we're variety of study a proposing different proposing types

you want to I evidence. we need as to think, able fulfill is the key we the substantial for that make are said sure

some a some also prospective to data studies is combination can has PK/PD to be is control we're randomized that with along FDA I if maybe studies. trial more prepared observational collected type what for obviously But with of be But decided. this in do a that combination think clinical done with

far as because haven't As answer the have with down for it's FDA. and steps hard me the discussion timing, yet the next sat question and to we

take to forever. to not I be it's think and going going not quick, it's

-- in of sometime a So a and better weeks frame, timing months be. say in think in would where the more few their have to the, we'll that it's will idea much the going -- be not I I time sometime but

some to elaborate shareholder alternative maximize of courses be may to of question the is Okay. in taken have value, the Bill. Makena options types scenario where the exploring Thank Can next you. you're you market? especially on off or for Maybe the

but Yeah. fully some is Thanks, us, working the some can we for scenario, -- is that to we programs. development actively exciting of a ways of are of which and variety Ami. different our are ex-U.S. going the scenarios. through on today, that We will be certainly number that, tell for a we you are approach don't things we We've I different thought of partnerships believe there prepared but

mentioned example partner to there I other where is and good AMAG-XXX ciraparantag U.S. interest the outside

to think value today. on portfolio in in the our opportunity I focused we the we're so maximize and so, have products that's And of that an that's that near-term something

consider you Would something or kind different regards more with exploring monetizing the of the to some partnership of maybe in U.S.? assets

options. Certainly, a we're different number open to of

Sachs. currently with may you are we have Goldman think I working seen that

And variety term, so, product on the patients who a that are the is important to ensure for Makena need certainly table. on focused is obviously the the of what about this market certainly with options thinking working FDA we it. remains on Near

question clarify on months us and you some you an over the My when made update the has about last the percent for then sort and will what the trial could what your And completed? just AMAG-XXX, for you. has what Analyst far? what's seems us keep progress on the Thank of of guess best there? pipeline. Okay. has it the on -- since reason be a been delay, it And And third if Day? is one, delay what there ciraparantag Julie, couple could enrolled of been to if on last been give be Maybe I'll has so on the

Ami. Thanks

-- into to the to -- just II final go for And of be been that patient are up end studies we Phase far for design Technology had soon pre-submission to As announced, with the and of coagulometer. there to continuing analytic ciraparantag some FDA there's were were ourselves study. had I set discussions Subsequent Perosphere that that a pipeline the think going alongside as as the meeting subsequent were us all meeting conduct. allow have on really there we we successful resolved that, will to to we the hopefully additional

then unfortunately, enrollment. are as not updating I'd -- And really we far say as the timing

we've said rare this terms population a of condition. when into study. before, in orphan As is will they highly the a It's come unpredictable

know think when predict. we difficult. easy its because not update than So, this -- is I prediction that is This to hard rather better to you we try a guess, it's

we'll enrollment things the the Europe sites out modeled sites. get recently one Ami, those this this we've European some that some do morning significant is, we in of new we and of we've believe as site, in opened enrollment from some mentioned

that the aperture going coming And so in are additional XXX to we're of trial. terms the sites open those patients into optimistic

to on And the then trial, is reiterate just actually trial we believe the before go into last ciraparantag this that patients. we

the to we give what so as Phase initiate meeting that want to And the they need go Phase of trial into important really will II agency III program. ensure this exactly that end we

Thank Got it. you.

comes of the Your from next Douglas Tsao question Wainwright. H.C. line with

Hi, question. good morning. for Thanks the taking

bit little Ted, we've trend. maybe seen and could from Just a guidance. the the some just the half first in you the EBITDA improvement about reflection we've if of Obviously, start already, seen some year

some see fourth to we the improvement or expect from line Just forward going And expectations we in expect the some expect growth curious, -- what around further going the of should rationalization you quarter? revenues further more to portfolio? be do in the is that from expense

Yeah.

first half. the or really quarter. in And in want give mentioned million the a first for $XX room. of $XX I guidance, If a the we EBITDA, remarks, speaking literal for being to little our as million revised quarter, combined So were now bit fourth would for of at ourselves third imply with the year we aggregate to the half that the for of but second implying half million in -- my negative $XX the

fourth to we the third going the indicative trend about. that the up saw in think of be quarter where end is I you quarter So in

The we're And in you that big pick that and IM. wildcard at all up. negative is of quarter, million the that's finished million expect $X the $X with third look from we revenue fourth if quarter make

very seen. -- be are capital. we But to allocating remains we've diligent it expense been of how in So, terms we're about management,

We metrics. we're XXXX to looking XXXX. in that. we good accounts shifted launch for early to emphasize And budget launch through to have keep We that. at want support continue Vyleesi supporting in obviously a that The how

that the And the into you to Ted as spend product of terms in Vyleesi, the terms the up trend a commercialization, little R&D moves spend, other activity. something a there? in the on a of we for spending mean saw Or follow-up on bit Is now? ongoing as given step-up rate sort that then I a And some just is continue that see at of bit? will could that. stages of of increase little

start of cast the end we the sort is to of we and start the what cast closer year. I'll launch So, metrics. based die on through die see the of we'll for to Vyleesi, end Vyleesi. And with year, as in the the get QX QX the

the mentioned, are got dashboard Tony here. As metrics very We've favorable. a launch interactive

trend So very we're spend lines carefully. managing the and to revenue

In of will aggressively that's -- as enroll is outcome. R&D, this is priority. be completed. ciraparantag expensive, trial be but terms of we in for that's pursuing new pretty be there patients what to Europe big enrollment a and might this spend XXXX Makena, I get sites, the additional in help a good would which of mentioned, obviously Part And very to continues

we have sort see time of the in a on be that I a when a decision do should you then following terms mean line sense on And of of note, Okay. this? final just we might that

respect With Makena? to

Yeah.

news of team her is engaged, but are and -- We're mentioned, three to so and no focused team where her Julie it's predict are her days and news to this This line. hard As active that hard predict. kind the at time old. point, on Julie actively

out plays of It's There'll a But Doug out Bill. with discussions the not months. said, as number ongoing be agency. think weeks. Julie this this is plays over This -- I

the meet be on is interacting begin agency in studies that a Julie or As could to order said, study to our with data. desire additional pursued their goal for

for committed at team who Makena remains preterm to all to going access patients available birth is to So, time. I in our some meantime, subcu a ensuring to is risk and have the take are the and Makena auto-injector. especially this continue And that think

Thank you. Okay. Great.

Thank you, Doug.

you. Thank

comes Barclays. Your of line Balaji the next from question Prasad with

taking everyone, questions. Good thanks for Hi. morning, and

you the the I if market, do anything belabor there So, that can remove in potential you sorry offset the -- point, to process or from to a addressed now, the it? request is know do to outcomes case, Makena but in delay you and to but to products the get

So, if as FDA to basically something would mentioned, were initially pursue request be you to company. the like the a probably

committed to the Makena. a We would then the there FDA and We efficacy believe of to in a are If safety guidance be the would the hearing. -- as States. pursue to majority in the path public United

And so in that. -- preparing involved there's some there's for time

if went way because And trial out not the over question safety period no then, been like, of decision because, like nothing second issue time lengthy raised was that's the a safety is here. again the ultimately, plays about would raised. fairly, there's This a we the confirmatory

confirm the of for how really on, it's Makena efficacy the in we do, so, FDA. And honing

enough. Fair

understand I So, nuance. do and that appreciate

of XXXX. to on to way So think to asked had if some you're two on it if we you trials. broad either, market or see confirmatory comes will go goes Is it the that if up the to product product, your Then, it need we it's now. being the cost do scenarios? And happily would the additional think how about

work I that's Again And they think on do rapid. likely Makena. Yeah. additional not

about Makena on took I know clinical recent years think enrol. XX you to most trial the

be PK Those inexpensive. lengthy could relatively a like things are relatively study process. quickly. it's So, done Smaller a

I which some utilization data, subcu terms and generating of the could interesting helpful where which talked And helpful also could track in auto-injector could type of then, registry the initiative we've think subcutaneous, about of of be the in auto-injector. terms supporting we be be

side, question cost I in final this could last cost on is it professional quarter. it? pick What your I out the I'm up consulting believe, that XX%. went sure not one around Understood, quarter by

Professional professional consulting. and Balaji is and increased. consulting asking about

falls bucket that bucket in the in terms of or in So spend external marketing. is, that

Sure.

QX? was $XX number it What last quarter. believe I So, in the million was

referring to number you're Balaji? what So

The professional and consulting charges.

number press. the that's right, in that's was assuming So detailed All a in I that's which kind Q. our of at very that's end Q. the a the broken number file we'll was of Yeah, out day. it so in the Yes

Okay.

Why get filed it. we to discuss we a Q shortly. have we'll don't -- And can call the

It sounds good. you. Thank

Thanks, Balaji.

Your next question Gregg SunTrust. with comes of Gilbert from the line

Good Thanks. have I morning. a few.

Or FDA dynamics? is should your suspended the prior we update pending consider First XXXX of still table? and Ted other some for that outlook the the for on

No. still It's referring if the table, -- you on neutral? to are you EBITDA

Yes.

EBITDA that yeah plan before getting the our Tuesday, in look, you us financials so, XXXX trend and internally the were is Is we developing -- see can operating that neutral. to

about a of talked we As we see XXXX. don't rapid disappearance Makena in

Right.

So expect profile in Makena. base substantial case, risk Tuesday impact Obviously because in all durability for revenues the from we the cases, of of still some And the heightened prepared be we're the revenues. that XXXX. could

all for prepared these cases. we're So

absolutely But comments is bit path This to to still specific that with the We EBITDA on learn out table. why here looked what neutral as team is the really her preserve when as more, scenarios. Julie figure today little for engage want we guidance I sit all a on. we the FDA at and we're

Okay.

very and do have really sharing relative Vyleesi, Is much to for go your metrics favorable? that these we to internal the don't specific thanks you is on favorable, you because say And When that are what expectations to? Moving metrics? mean on, it those, what by

that them revenue Really metrics you you later for to you is those for are -- to collect? metrics looking sure tie to saying actually how net that in those are compared favorable generation going Are benchmarking well, early other how as confident launches? things to

we weeks assumptions four where Tony to all we internal but of we with that those have long-term. our so share Yeah. at to based projections Casciano, absolutely, hope to in yes is one. be going would So point. line is to things, we be product not at this take expect today, Certainly, I'll those This on are right? this where what

stack and Again more Externally, mile four aren't marker, can That's weeks you as based want recent we it's we're does that launches on argue math. up launch. a to I them not we quite at where But challenging. But analogs. good it's look four be. stack where well internally. through would make a do this up of you weeks ton at and There

long-term one look this there's if multiples are would four is Again externally, it's than analog all if reason it's again to that. not adding. Specifically And marks one and were on we kind we're of mile at they HSDD aspire marker internally higher at the different and based a a encouraged. in where I we're by most But we off say weeks, for projection. great you where but

to you. Okay. to I it that they seems of heard, is to and access want panel general product If with back opposite. that, having think, caregivers listen to works And start maybe company's dialogue question, it. the study the Julie, is one go were just to keep like assertion the a Thank the feasibility the just or would believe another to have

These to we highly concern it whether some And if to There what seems will be panelists do? What remove by be agreement some members being works be it. were that that There drug or seems panel will not. questioning the around safe. safe? people

what that where and efficacy any agreement some occur, it be the good would there to every that clearly to questioning such seem if know obvious labeling there actually around of But were works, we the aren't subgroups even pretty benefit. subset

I that right it at many clinicians front? believe believe the want have I before So question. that on But works do product my just specific ask not a level does panel the believe it works? high more to do efficacy I understand you that, the

Yeah.

trial very And not it nuanced because Meis larger I -- population that agree trial was think people I think, different was positive. last most And studied I it's would this that and population. a the very patient women efficacy. of think that of definitely being really while demonstrated was high-risk and the U.S. representative trial complicated substantially also

It was -- the was event as patient it very, were many said and panel healthy a very low the of rates population.

statisticians. In is of product, was the that think of general I lot a voice I So, there the think the very community supportive. of

you the negative. As clearly numbers, was at study the PROLONG look

to talk think, States. they'd and I here relevant it's to study. the all trial OB/GYNs do their you in like like that how are most interpret patients you Meis But the than people's the United in more today they what's are PROLONG say And patience if

it's ACOG reiteration I in as well the SMFM. still that So -- in think the of both guidance's they're saw as -- you

that I Makena it strong a think, an in they remain market there's as those and efficacy endorsements for on there's patients. are and want the safety still to strong belief that option

overpopulated Gregg, of Committee Julie with was this this Advisory that was panel as at is clinicians. Bill. the we're statistics. supportive statisticians impression of were my the looking I who the just kind the on are would purely said, that also OB/GYNs Makena. efficacy clinicians of And not of Advisory Committee very And add

I And point across as bit And you out, out struggled these look in as statistically benefited that's most drugs. common little say there course, can't can't XXX% who clinicians figure we patients fact, saying -- still And that studies. know with drugs we I therapies to benefit. patients a are are because don't benefit but use of patients these which well the of

had supportive. the impression my very think OB/GYNs there time on other care. was Committee harder I So Advisory health really clinicians Committee understanding Advisory specifically a on some nuances constituents the were that of maternal the were that But the

And speak enough supportive, I think up didn't the the unfortunately was clinicians very were during who other meeting. the problem

heard was too that end the they at after rendered the support You vote the late. probably which

made the those FDA are taking obviously these the record that very they comments after the of who people those patients. considers vote all and But especially since are care those even the seriously are in

meeting during out loudly though, are that's is So record all even think, they they that that the voice I supportive. in didn't the

Okay.

no -- a I separate on several issue. guess separate voted But I that's of a that's efficacy. think, them

votes You're But the were characterizing overall right? support. sort their votes the of

supported on of remaining OB/GYNs the market. the of again, out five Makena Clinicians, six

to was for hard it study, positive negative the vote it's PROLONG And a because study.

Okay. Right.

to did all negative were vote sort that set that of you They questions up I the a in would and no, way right? on think say be that -- had

Great.

be are and it permanent? alluded ACOG Medicine, Or do? they willing the updates to to real-time for those they so kind Maternal-Fetal sort to do Lastly the will those Society of wants you what the FDA updates as of you think flex

not They don't patient if are and the they're going will effective for that what based their their that I their to think data their necessarily make focused think typically data-driven for them. going decisions. says. affect what by FDA new their are is data. population. be I best FDA. comes committees on to decisions I based to out, They're going make decisions speak on patients are the just organizations can't on And

Okay.

Bill, maybe by of what's mentioned bank. looked some at, January? process? general little being have not or time more at for flavor in a longer-term frame? looked processes Should us sort the Or Lastly this a being we you you'd you more sort Can a of the process Thanks. guide and time by being is run what's investment update an give of

Sure, reviewing our is -- Gregg. we constantly strategic The Board options. – periodically,

a So process. special this isn't

review did in have to played we're options. We this with Goldman of that as the we past most public announce part thing And recent Sachs. working advisors external worked out, with that

with do this we but that, announce we we case we're So that did -- Sachs. normally Goldman don't in working don't that

will months, with over coming Board. is this working well seeking where external as weeks really because ourselves, can challenging process as is advisors maximize we're how advice not continual this work and obviously a with we those even We're value. our And again management the a shareholder the onetime Board best and process,

time So, no definitive this. on line

actively I are some And while As that no there's actively of on mentioned, things time we're partnerships in process. also line the are those ex-U.S. firm those, pursuing

to there. provide come be updates able those I So as anticipate fruition we'll to that

Thanks, guys.

Okay, Thanks, Gregg.

you, Thank Gregg.

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

Thanks questions. morning. for Good guys. so much Hey, my taking

morning. Good Hey,

Hey.

set scenario, of floor worst-case a be kind planning light for scenario in if about the Makena Makena it's I EBITDA any adjusted Can withdrawn? early. must talked You of you uncertainty. know

before be part And you would look? here do kind Would not about if can second how given clarity guide there months might that, then when could you kind there that you two you that? in give clarity framework a yet, get that of How scenarios? of is January to us you give

Jess, Hey, Ted. it's

early. it As I is mentioned, really

as in the million again have Analyst think, as portfolio. our internal as dependency That's products. Day, The our continue neutral May at our mentioned, in I million -- a $XX we to invest in commercial as our I we key mentioned are EBITDA in current August the committed to Obviously, be next but neutrality in $XX plan reveal they trend points loss months. the facts over second operating EBITDA next half year. of we couple incorporate the half base the and themselves to first case, to

that Obviously, I'll early. really can't the have at know your at moment handicap too to the know just give that it's what guidance best when I'll I is formal information we provide time we'll time. conference and

that One on mentioned, do of Ted formal we Jess provide that so the on basis some things providing we're of we'll the the provide is that can underlying guidance. guidance -- which guidance, as people understand we'll in also and assumptions

the of like X at of Okay. might point Got F, like past like in of it. have two kind Yeah, guidance. feel like different version some given an I you versions kind

of So of we I it heard yet. was call haven't kind like could kind wondering if look if final a similar

We there the of potential going we XXXX, It We might. didn't as were we were course. going It a was a know would days talking couple It outcomes. be and the generics of of past me, range to might. this approved. And I of into if over Bill were what think about do. auto-injector didn't know the reminded wide period also

provide This lot well. to to broke Things times of our ways, wide guidance. is forced in of increase of think a throughout guidance several outcomes. -- way were that range we I a navigated pretty And and we year. potential And that range able another we were

navigate we'll to it. well So, equipped be

I to concerns I out there don't because reiterate quickly. been no want have plays raised, anticipate But safety that that, this

period this time a plays it may little for which I a fairly think easier us lengthy over out guidance. navigate a of make to

OpEx in half marketing on finding talk about I clearly you Can year. reductions it you're where second Okay. a you're prior up spend? And the this savings? realizing following think of Is then the that on question, with

sounds And then anticipate to clearly it OpEx get further that order in some EBITDA year, neutral to next rationalization. you like

So, that come can you would help us from? where understand

I back question. to Yeah, the the and one answer to the the answer tie why earlier then don't first answer second

So, yielded that you sales know amount of the a of took consolidated force that -- in out we and XXXX January organization. cost the as of significant

external Intrarosa costs, shifted of cost lot in spend half. to pretty those a really second allocating we the aggressively supporting favor half were resources the that and Vyleesi of been Intrarosa we reduced in the in We've first and

apples-to-apples product launch. basis into only as supporting So really XXXX, you on one we're roll

So that's of lion's the share the savings.

clear, of on one last of just aspects you then elaborate the think Okay, Can -- it on the on volunteer great. question maybe And up first akin II? was healthy ciraparantag. you're IIIa to following with working the I this a very the you're some study you describing the very Phase FDA? make the described Phase that this trial it previously through Just to is new that is or

right talking an you after to those to an I'm earlier at think. patient's going IIIa. also now of about But you end this I Phase an happening trying after understand end in And Day meeting talked meeting then because response Phase you're about a the of into results question fall about II before were II talking Analyst this Phase trial.

So just kind trying to happening what's here? understand of

Yeah.

is think one -- this I So Symantec. of the

really a is IIb the So IIIa.

the a the study. This going study is volunteer still patient -- into it a blood be manual dose confirmation III You healthy study. Phase definitive one. in right we're The with automated that the healthy to prior at study clotting we call This we would either looked that new full time. of patient IIb could more is on working a the study the have a coagulometer with

that that stronger the in data. forward confirming with that go so Phase if we have we we II of And moving be of meeting meeting end and then the data II Phase end after into feel will

the aspects that what about agency you're are trial? And of hammering that the with still Okay. kind out

this the already of some additional on some coagulometer. yeah, agency the asked mentioned the for and that had So, things Julie analytics

and So in the Perosphere ourselves so has we approved that Technologies it get IDE been pursuing we that ensure that rapidly. gets

use -- information part get imagine draws data when points on are that back And on healthy volunteer study. healthy into the then desired of data volunteer and study blood as we them can example that a in points you we for

so And this the the on of agency been some of there's with discussion the trial. exactly design details

Phase we II when so got into started get on end that with mentioned, important agency we Phase we program. as meeting to And that the this go get need of III we've this alignment really Julie it's everything

healthy when generate volunteer just And study? the the volunteer IDE study? on data coagulometer gating IDE healthy that you Or starting you some about that analytics do for talk is this Okay. in this support of

IDE is gating. So the

would that -- have the study. that the decision-making use for reason really make And any to all data is us decision-making the not a dosing. more that the because generated in have used So It's for is It's way you itself be that on to it we dangerous. is coagulometer to because it the in study. order data is in have coagulometer from

and be so the that's be to have of sort through to why -- prior study. all it put the up analytics of buttoned And to needs the start IDE the

you interesting, do coagulometer. data Jess. from healthy the IDE volunteers gather In preparing a It's using

it's So And in we approved, volunteers. once study the healthy are studying we into that Ciraparantag is where data and then go the submitted. NOACs

you put that looking mid-XXXX when like band Okay. study Got it. that volunteer Or the is off? study And could around healthy kick can start? the

the correct? XX-day I that Yes. think a too as There's soon is time we the that. line believe agreement as IDE I we're start to on agency review with prepared get

goes XX of that you go the with volunteer initiation days then assuming healthy So forward can study. well after

Thanks, Okay. Awesome. guys.

Thank Okay. you.

next with will of Your Needham come question the from line Serge Belanger Company. &

been have questions Most my answered Good of morning. here.

just a So couple.

iron talk Obviously, First going forward? continued or about additional there. Can in opportunities seen market Feraheme. from it we've to come the growth maybe Is contracting? you going growth strong additional on

this so Yes, is Tony.

that will So from is our growth continued two come anticipation things.

continues grow. the market to So

press So competitors. was our selling most mentioned gains release, Bill both over time and importantly differentiation against pick saw continue share And and the and IV iron as the through but that's as market you clinical contracting in we up growing. to itself

in turns there? promotion? Is focus DTC focus on mean And now promotion of does Vyleesi of that franchise, Okay. ongoing it health take what then Does obviously, a the Intrarosa? secondary terms the launch still to women's for kind

Yes, good question.

So today the there sales in the there as just is is as DTC product today marketplace professionals well. promoting

shift of we as year Vyleesi. think is this going the effort year, move into as back start the through to next mentioned half more to I Ted towards

are point out to think, it's important we I still However, actively promoting Intrarosa.

that a effort walk that our make force. sales shifting this not want a products be with clear all is that. away to of This scenario about of we're appropriately I to So is three sure promoting essentially

market and Makena, still as Intrarosa. which the is Vyleesi people So helping you in know

you. Thank Okay.

Thanks, Serge.

the comes of Your question from Raymond next Piper with line Chris Jaffray.

Hey, thanks taking questions. the for

during the a Bill, the the some but additional conduct heard drug times folks say Just the FDA to I this that studies studies know Adcom plan several have outlining, I you maybe in nearly conduct and be on touched on couple. Julie, think, the that to are with past on I impossible the it guys would market.

Makena the docs market And actually to the that. of even voted acknowledge keep on who some

studies, So guys I when talk hear in the I with guess, you additional about drug I hear think, market. the conducting I talking remaining you that doing about

scenario all, maybe do you What's that? square that that? able could the to of you're So first

on are Julie. several still where So There is this hi, Chris, the scenarios we the it market. study with drug -- can

could more do a there could places some go be that's the randomized things very not to also do registry rates are we some looking are we PK/PD exposure about we about we've the sure cautious trial, be we been place controlled of and by outside does talked done trial. that U.S. the a could of similar randomized we the to but going think that drug birth where making to at Obviously, and that go that. but need U.S. the certainly to placebo of a pre-term that I

have it's have ultimately make -- to hard getting and speculate. are sure of will working sit ideas, get ourselves. FDA we with is on And the but we think We FDA study matters ahead down we discussions aligned before what these it the with we design. that the really and to I need

So, the I that but outside primarily mean was just right? PROLONG changes. I curious conducted United States how I'm guess,

Yes.

it where when to time more and already as and there care enrolled of effort is a time lot XX% Europe of and So closer had Europe. would a consistent -- potentially Eastern was this America be Ukraine be drug would Russia. to when Ideally which Eastern inherited go to system the we you in there been so know probably than we the we Europe the care that standard health on the places more effort United South spend States in would was

a And obviously one-third as component understand to actually even stubbornly the was now. prepared this that also I'll may through the question mix. a and significant before payer Medicaid stayed so I to the guess non-XXP of, at has answer great. years about then market of But look published maybe guys ask sort Okay, be market PROLONG there's you I not you as

the talk Or your that us the allowed as remain stays scenario maybe about do think market the do under to you've the just dynamic So even done market drugs chance with same? see that believe that definitive on where the number research Just a how you you now grows? that is same? relatively number that that study of kind one-third stays a playing out. there one-third curious Or you

Sure.

So This maybe I'll that. good a is take Tony Casciano. It's question.

a lot I think question. in that

an start any the the on assumption changes to predicated is That's reimbursed XXX% cases in -- be me with Makena how payers that our today. absolute, not payer the guidelines. let but changes. most that's is follow will not and So question Again, is guideline

has And It PROLONG Adcom. out the out before again, it. been was with

in restated association were with guidelines PROLONG. in the reflection not but think association, I upon

So any I much of wouldn't changes. expect payer guideline outside action

first kind to the for us look be payer would for challenges forward. that moving So of Q

of in some has Again and of perspective Adcom. they some outside the it we're market overall there been information couple for an reaffirm time of element their this physician to-date days think, confidence product. From out the a feedback is I again,

but action positioning in been with premature to-date. watch. how seen we've And physician not payer they're would we'll PROLONG to how it response So say continue response far to have they're to or be so interpreting that encouraged and

watching So down are payer was in by again they'll carefully just guidelines data light new the we so perspective that to of it think from released. the comes and guidelines encouraged I the restate be far

on maybe Okay. question final one then And Vyleesi. and is this

XX% talked what completed of the around label was I be? women published like put to about -- you if appropriate some trying trials you know So details rates open-label in brackets actually drug look at it are to you guys the just the when discontinued trial. understand might could looks on who like the around maybe think before what the of on XX% study. completed patients stay -- of extension we actually the before label But actually completing the the refill

a about think we XX%? some number? rate? other should it good how So it Is Or is refill Thanks.

Yes.

So assumption model -- I not out you get. throw going there a I'm would to

its And of things certainly super think one early. have modeled. got modeled. We I a lot we've

the out XXXX probably than physicians it's SPs X,XXX throw think them. early have a I through that that bunch to to of written you number coming guys in prescriptions we're the seeing the other and

We by just it But because Certainly, whole, refills just what that's four that I statistic don't element of in. going not knowing already some seeing And if certainly is know small seeing four that's encouraged to already. are I report weeks. hope grows. retail level we're some of the weeks

it So at I'll probably leave that.

you. Yes. Thank

question of Yang Eun line final Jefferies. Your from come the will with

you. Thank

a little run sales annualized the So million. for market rate is $XX Intrarosa two into over about years

fair it's that been So disappointment. say to this a has

with now this I what's it's significantly expectations? better? So very Vyleesi, expect launch still in that Do the your be early cycle understand that you would

reaching question important is you. expectations breakeven is year? next Thank your how second in for And Vyleesi

Sure.

our let take maybe next first two handle year. expectations last Vyleesi for Ted about and So the the I'll fit expectations one how into

or the south obviously have to-date it our of have what launch, is sales generated been and Intrarosa expectations we think, So been. that I the

as not. successful to to we metrics more would keep Intrarosa in type against a best there would we right? sources. ways I And So right? easy through those So how again up-to-date put I if Vyleesi? it think products different, analog. that Yes launch. to on two differ relates a of because available not the product be lot you say other different be use to expect we'll patient But we you're lot out different do Obviously, we're they Different our that each understand upset the to and different, hesitate an it's was seeing Vyleesi a seeing

but weeks four pharmacies facts writing point a not everybody by physicians And we're seeing launch XXXX prescriptions those encouraged weeks, I does what four the just XXXX again received we're make at with and by remind specialty them. are that this through would

more weeks I again forward look think sharing good four call. so So and on the to next far at we'll so

theme breadth whole And for lot quarters of $XX about here Yes, net $X next we but drives price terms key sit for I product, obviously, XXXX have and and launch today couple the of the how the it before max. numbers. we pretty as in revenue. of be early I Eun expecting talked the commercial prescriptions mean, and access of coverage, of metric we're program probably low prescriptions. this is key number a will co-pay,

So what is other that not around the inform counting into investment, get strategies we're and metrics be you monitoring justify to tells a as we'll you the to revenue of on lot but product. to XXXX investment continue

Thank you.

Thank you.

any conference the over turn now to back will remarks. I for Heiden Bill closing

that progress we're look of our performance continuing I our want quarter all work want the provide across all last for a I to thank I going support of the which commercial our for close, AMAG to over and at continue on to work in We joining serve. for And one. forward their do to of Well, before of colleagues busy programs. products on hard call. hundreds development been today's us to thousands has here updates and to thank here you hard we And patients shareholders my the

call. we'll that today's with conclude And

Thank and call. Ladies you joining disconnect. and this for you gentlemen, all today's concludes now may