AMAG - Earnings call transcript Q2 2019 | Amag Pharmaceuticals, Inc.

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Operator

Good morning. My name is Carmen, and I will be your conference operator today. At this time, I would like to welcome everyone to the AMAG Pharmaceuticals Second 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. Instructions] [Operator

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

You may begin your conference.

Linda Lennox

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

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

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

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

multiyear new adjusted maximizing opportunities long-term AMAG's a time various approval trajectory progression on assumptions fund be commercial EBITDA XXXX. product about adjusted including certain of with on growth are of the estimates investments and will to strategy based our for neutral expectations forward-looking outlook, in assumptions, product including AMAG’s frame of have we products candidates. that a We and by EBITDA

factors. these So additional please risk to refer

with our our Tony Financial On Heiden, Executive Officer; Officer; on today's Myles, Chief Casciano, portion our Medical Chief question-and-answer Dr. Officer our for Julie call. Bill and Krop, Commercial also Ted the Chief Chief call us be are today's Officer. and President will

our me will second Let will call. Ted overview through second briefly some provide of developments. agenda morning's this for the guidance. financial quarter quickly Vyleesi, will an of Bill call up and revision to highlights close results recent our review run Tony quarter and of will an our out the the for open overview we'll financial then XXXX provide and launch Bill and Q&A. upcoming it

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

Bill Heiden

joining this call. for on lot We've let's Thanks, to update get a Linda. thanks morning, our quarterly Good got us cover and morning, so started.

at and versus impressive on revenue we commercial see press Makena consistent Feraheme saw quarter the the our also release As can market our on you the to our team. ago promoted and from year led same that of versus tables The Intrarosa. XXXX. and also grew a quarter with growth. products sequential look This auto-injector, slide, quarter of share first sequentially And show this each execution strong and growth we quarter, subcutaneous year-over-year

market quarter auto-injector QX. XX% XX% saw versus Feraheme revenues share. X Makena the and market quarter the were the X.X% for up than quarter, the and to we X% last revenues first share Net our higher versus were first over up year second points percentage grow of

than addition, in XX% market second we record In more the achieved quarter. share of

X.X% exiting QX a were QX. this highest at significantly up ago Intrarosa over quarter share our since grew grew through share, year the versus finally, share net XX% quarter, prescription revenues market achievement market And Total and launch.

in wanted other the front. on Returning items quarter that to a There I to a right are of for moment. touch Makena to report couple up

competition, And for share. pursue issues we issues sustained lose mentioned remedies stemming against market contract manufacturer. Prasco Makena intramuscular the few in market. detail had caused we've generic impact are cover product, intend expectations supply of in Ted with face ongoing all that minutes, Prasco the to a the And These a As exit supplier. more for And we year. increased to will including to supply in our made mutual impact the previously, disruption available with the the on generic original financial IM we that decision

the auto-injector based we're and Makena to that on than mentioned, that But this less means already XX%, market I've grew actually share is now has been achievement. XX% proud the total shrinking of that As market. market generic really intramuscular growth, and share of

advisory us study the results. regulatory many plan of where here inform the the have with in year necessary study, that also the a the PROLONG they trial Today, Makena. meeting recent and results an advisory to informed we this months, study facilitate committee you discussions go of PROLONG agency fourth the in committee us stakeholders important allow about from FDA transparent announced members, we decision-making from of few hold last PROLONG meeting to to the FDA to those the regarding quarter input from asked obtain Over with that and

can't demonstrate to a run population treatment in reinforce won't Institutes the the AMAG birth I preterm preterm Meis original the I patient And placebo. in for lead at to of do, reduction other the than birth compared the lower preterm outcomes speak to newborn. that The to Health risk Women other to U.S. utility a options want continues Makena. risk by While of in of births XX% what can of no trial Makena. a healthcare preterm FDA have or devastating of their birth clinical FDA-approved to firmly rate will believe National

for United and the birth the experts, opportunity directly that the data think of personal clinical as in clinical patients need representatives hear vulnerable are populations. rising patient is society scientific the step addition, agency to will medical We and some their the Makena. from an and the in most preterm and advisory on have company, States the experiences supporting next medical importance are the committee In rates highest logical

draws experts medication important we meeting forward any the later a information that this we look year. we'll to this closer, FDA the productive about and provide with conversation can, As and

now, and few checker, have We're weeks, or with have In HSDD guide currently national a and might vyleesi.com CNN, X,XXXs including and a some country, such NBC of sales we'll drive for taking Reuters, as the of L.A. if that awareness in and the amount by visitors upcoming early for little And cover And of about having news. also launch Tony a covered we'll on approximately be website, announcement, patients medical coverage, in More visitors see out questions will helped as details incredible this approval launching our branded call. Times to that Vyleesi up action, downloading with helped be than FDA the the know, digital with the the we've they just This gauge Vyleesi availability. discussion watching potential our since pickup answering professionals. half gearing direct-to-consumer XXs our later which product symptom June. news the raise across to we'll with was their on metrics of media has had media force those campaign. has approved an our outlets launch XXX you of our field physician. have of a success

financial quarterly And through to turn our to full financials opening year Ted? let remarks, update guidance. me with the over and call Ted those the to go

Ted Myles

second We've continued been $XX the for revenue by the to generic same shows in quarter of Thanks, period competitors. period The Bill. success first auto-injector year, $XX second last Makena XXXX compared on Slide multiple of revenue X pleased compared of of product the very significant our million performance with the the was strong intramuscular the quarter the in in as same with the gained auto-injector share to XXXX. auto-injector's quarter every subcu its the which full in we've launch, even face market. since quarter million

IM past Medicaid million reported overall after from Makena invoice incorporated estimated mix, liability market. our includes Next new caused rebate $XX ship line The arrive negative supply and were the assumptions a any information in commercial revenue for channel Medicaid-oriented invoices heavily supplier, during to IM to Makena product received current It in liability the based disruptions for second product. sale of primary periods. the item is and recently and in the in cases, the common initial many by quarters reporting very product. particularly quarter. remaining change and some our of to is estimated exposure, This In lag invoices our Due illustrates revised unable obligations we IM expectations. quarter on the the future

market. quarter, revenue did again, only in was did performance volume. market Feraheme grow Feraheme's the the of driven the during iron IV over million. demonstrated Once so quarter that Not by growth of strong share but This all with $XX

cash deliver to to and a will be flow. continues team of source Heme/Onc Our results, Feraheme believe steady we continue strong

same quarter year. last $X.X of from million, period were the up sales Second Intrarosa million $X.X in

a you year to As of that first made in and quarter have recall, this believe of the the patient we program. co-pay we savings couple changes optimized program

and showed, trajectory. on NRx a As back TRx steady growth Bill are we

XXXX. operating illustrate and assets. the of sales second period operating the results for down, compared intangible amortization product of period. next results the our items out slide trends a basis of and to to expenses XXXX line in GAAP the of We better the Moving quarter P&L same on presents on couple driving a the broke non-GAAP for Cost includes

of million to expense, During XXXX, all of related amortization was Makena of recognized $XX substantially product. approximately the the second IM this quarter we

we we product. During IM any Makena didn't because Makena the sell did of second amortization quarter recognize IM any XXXX, not

million a The item sales liability. with inventory. QX comparison by and a SG&A line Makena the XXXX XXXX product includes our $XX of of intramuscular million down cost reversal contingent of direct bit complicated approximately the write The expectations. $X.X SG&A were R&D is of of aligned

During negative it shareholders payment therefore, would Lumara we achieve former was recorded that milestone will that we sales that liability and to unlikely expense. period, determined have reversed that a and a the the we triggered

was revised of Makena in full for charge we of to intangible X. that supply probable a the Prasco the second XXXX would forecast of a revenue was This quarter $XX IM product in second our XXXX, of therefore, longer noncash determined resulted no we it intramuscular and quarter that Late asset, impairment the in million.

of During $XX higher expected, than by largely we the is revenue intramuscular a million. and products. negative approximately loss of adjusted driven This sales lost quarter, EBITDA second recorded the in

the intramuscular for decided expectations development So our ciraparantag our us product year, of revenue as for lower they from the our full and to terminate due the review XXXX loss we guidance partner to to informing financial we our agreement. intend have Makena

we for revenue the they from have our milestone believe termination, removed XXXX we've expectations. no While grounds

ended million $XXX million. and the approximately revenue see adjusted side slide June can of loss XX, the XXXX, approximately six months for the of EBITDA You $XX left that we reported of on

million $XXX assumes of revised adjusted of revenue Our revenue the of and far milestone the the guidance and respective right of at no previously midpoints, expected million million EBITDA approximately on $XX IM revenue. removal loss slide, $XX of the

plan for continued in investments funded and the and back of on Our year launch continued commercial is based auto-injector Vyleesi. a fully includes Intrarosa and performance half Makena of the AMAG-XXX also subcu the and for of continued operating of Feraheme in development ciraparantag the growth plan strong

early to believe balance to a debt, needs us these We products go portfolio opportunities sheet position these past XXXX. years, and transform medical $X address balance unmet make of our patients sheet. billion retirement in even to temporary have the for in to than Moving and done The work our into worthy of loss more near-term and several investments investments. positioned has we over the are are important

look of quarter We year, XXXX, payment million XXXX. thereby we setting EBITDA ended first half to as to cash. a the period made EBITDA the $XX up second the In adjusted with milestone of half narrowing of adjusted neutral back Palatin. versus $XXX of million our the the we As loss July,

now Tony? upcoming is provide Vyleesi. of to our an Tony going of overview launch

Tony Casciano

September. our Vyleesi, Ted, good of launch take and like morning, for just everyone. a early elements and a to minutes few scheduled I'd national updates to of provide couple including Thanks, on signals market

premenopausal that approximately are The excited to very We of from do in market. XX market experiencing know realize women Yet, these product HSDD. one most team a experience research this medical condition. symptoms of treatable AMAG not bring to women is they

undeserved that We providing Vyleesi to also treatment population to awareness acquired, raise an new safe patient effective option own and by HSDD. generalized believe research with market potential the from has a our

with way we've unbranded of sites. early we on date, patient checker XX,XXX This suggest we're over time unbranded and into HSDD only or would more the website, symptom to post Our staying and see is unblush.com, translating seen XXX,XXX or HSDD excited date. our longer assessment approval actions the treated. changing viewing content completed visitors very visited over than typically have the not one discussed market visitors is by to To

about early experience rolled In market. to mid-July, us This designed help program out is a we our program. more the learn targeted

today, sales messaging. our our XX healthcare refine the assumptions Their small reps a We'll and challenge treatment to is have feedback We providers in across of HSDD, our subset the calling use from further and of validate the feedback and launch. helping which on of is and insights research targeting improve field country. these ahead on informing plans us

sexual also mentioned, of trained approximately approximately sales care These sales healthcare auto-injector. and our our professionals following Intrarosa consisting at currently with specialists national XX,XXX and sales promoting professionals include primary launch force select be September who will will As will of the XXX are place activation in Makena on launch, of high-performing offices. fully mostly This but take are medicine OB/GYNs, and team representatives. the the

before, HSDD shared women to we generalized Vyleesi. to have helping acquired, ensure we're premenopausal access As with committed

our couple electronic We hard team will Vyleesi our to national system been now recently the payer processing ordering systems. Over to submitted the pharmacy past listing and of access market has payers months, put compendia, of profile which Vyleesi. the working clinical the in on educate

the We commercial indicate of research the eventually that to same health sexual commercial plans. would believe is range all XX% in other reach XX% Vyleesi approved currently as which products, coverage seen our insurance with will broad

will Vyleesi our $X anticipate, take insurance. most for refills her the a expect price subsequent patients you meantime, first of we prescription probably $XX the pack access the approved of on to four of vary for by we on In like payer available As products, a making the time. Vyleesi patient's maximum will four And we're pack. newly first expect co-pay and

delivery experience pharmacies. discrete through with well ensure by we services two patient for nature coupled help received the be our specialty by will patients, be home will this type demographic. believe launching To that positive We model provided target Vyleesi of of

So on important an I treating I'll generalized of AMAG first as-needed is at by moment acquired, we treatment for as the to to started how premenopausal HSDD the option are team millions This them. women close the with emphasizing physicians the and Vyleesi. bring FDA-approved excitement who

an driving an marketplace. and ultimately faster We is starts in and Vyleesi awareness of innovative with provide HSDD, helping to to women and the between healthcare This conversations product. Vyleesi by experience want physicians patients providers match. differentiating

work Our deliver to successful is a commercial in organization hard September. at launch already

back with that, And Bill I'll to turn it over for Bill? closing remarks.

Bill Heiden

as heard, innovative build to important patients Only in-license Well, this Tony. regulatory company. just our to treatments just development you set expand And two done late-stage to we goal when for portfolio just to an streams. out set through additional patients, to have that. We we take to durable medicines and our acquire or them even ago, and revenue product ambitious products, commercial and the moment had bring more two years Thanks, is we approval.

capabilities We and subcutaneous Feraheme the Vyleesi goal executing And support recent quarter, just Makena strategy. and for to are broader of have on this that we successfully been this past label building regulatory additional approvals the show auto-injector. approval internal

no today, and development maternal in challenging a neonatal And and the currently of cause for to have and There two AMAG-XXX XXX preeclampsia clinical completion. we mortality. treatment leading it trials enrollment on is pregnant of programs: ciraparantag. antibody in difficult timing this severe predict condition for options polyclonal the of is other preeclampsia are in for and such, the Enrollment as is treatment FDA-approved severe exciting women. development

for additional IIa/IIIB We new this to trial enroll add are AMAG-XXX. continuing Phase in and patients sites

dose, effect reversal development anticoagulants heparin for with needed uncontrolled ready-to-use treated Ciraparantag or solution serious our surgery emergency development as low-molecular-weight anticoagulant other or is the in a oral when patients of novel program. single Ciraparantag is for bleeding. is

approval coagulometer. from for initiate partners FDA the an or Perosphere the investigational the We year. submission, submission for device met Based and this recently upcoming fourth to the automated of quarter a to in Xa exemption, on with IDE ciraparantag we of our Phase IDE, expect Technology that an program of discuss

for pursue But decided Ciraparantag on that from has apply our allow an for fast already which at to breakthrough a NDA We had review ciraparantag. required based pursuing on breakthrough, us might will designation, application. achieve feedback track data the agency considered we've be that expedited to additional designation to not filing.

new in Investments and our AMAG shareholders. of chapter growth will for the launch allow to patients innovative Vyleesi build and development-stage durable bring their additional products to need in therapies of

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

Operator

is Tsao from line your Daniel[ph] Instructions] of comes line Wainwright. And [Operator question your open. H.C. first with Douglas, the

Douglas Tsao

taking for question. good Thanks morning. Hi, the

Just as terms their upcoming, the of in been any ACOG Comm on in have the and of what a starting from meeting? results with in societies that's you sort might medical conversations Ad of at to of engaged key discuss terms point, get perspective prolonged in FDA this – the of anticipation they

Bill Heiden

her Thanks, to is Medical Doug. for our that Julie I'm Officer, here going Krop, you. ask and to I'm answer to going ask Julie. Chief question

Julie Krop

Yes.

of them order we'll and the contact continue it's critical. is of stakeholders, with provide variety are asking course, them in whole Ad including course, in in in sort understanding medical the And data discussion with totality think constantly societies. at in be committee. Of this interested Comm for to information obviously are FDA yes, to And a this of different of to – the very in able advisory all they access from the the the I we need participants

Bill Heiden

definitely they advisory have so will committee. been and Yes. patients. stake that who They're Julie a her And is treat preterm of so closely, are play here. at team they at the Doug. birth, of patients role working for obviously this They the option have treatment are aware a only lot They an important these a stakeholder, risk

Douglas Tsao

– And that them the can you feedback maybe results of you've share PROLONG? gotten of terms from from the some early in just –

Julie Krop

data speak societies. really the used physicians. think in treatment I medical of this mean, I market of Bill negative is – recent U.S. XX and a prior risk a the And a with the I we're safety been as obviously, SMFM think has for Yes. in unique Obviously, a ACOG set treated on and AMAG outside the with birth. It's the by now had for data mean, on with and Strong a different situation system healthcare patients product I that. U.S. situation as positive the reinforce patients profile. just I in years, patients reiterated, different widely preterm I unique PROLONG trial factors guideline the can't U.S. we mean, in prior over for of

such so – can is will for And respond I for And to all be the just put the them. try totality speak as that we can't to societies think – of I this we data handled. how because together that can't said, will that speak I medical how understand

So...

Douglas Tsao

this just Jumping future Okay. ciraparantag, means in the And AMAG? the one. time just terms just so missed program terms on in then for it. that I of of quick development just the one what lines and But even collaboration agreement might the between have termination morning, calls and of the of

Bill Heiden

Yes.

is – termination, did a a think mean, end So anticoagulant having co-development to This market. the U.S. I agreement. in was that the U.S. partner the this up stake not actually significant I a background the

the contractual to is ability believe background And understandable. don't we terminate. standpoint, so partner actually a certainly, the From has that

is think, ultimately, development was will plan thought we prevail, but remove from we course it the guidance. The most So financial conservative unchanged. really our to

plans. for product development anticoagulants use comments? but heparin, this low-molecular-weight developing it with not are combination in any the and We Julie, further does the change various

Julie Krop

doesn't – also Yes. it time line. No. our it doesn't change And

not the lines on dependent time were agreement. Our

Douglas Tsao

you, much. Thank very

Bill Heiden

Doug. Okay, thanks

Operator

Jessica is your And the Fye Morgan. with of question JP next line from

Jessica Fye

for Hey, guys, questions. thanks and good taking morning my

expense you're reiterating the lower of help think When the First million about guidance about will about million XXXX revenue on your cuts, close. to us can on to year-over-year, come for neutral how be need guidance, the year-over-year rest I would from come think suggesting has adjusted projecting, appreciate you EBITDA I roughly basis. XXXX improvement you $XX because much an assuming consensus OpEx? revenue versus ask higher that $XX is consensus from up we

Ted Myles

here. Jess, it's Ted

specifically XXXX Feraheme. the So and we but end stability will Intrarosa a in our Makena great little year Obviously, bucket in continued with expectations, of portfolio. about a EBITDA neutral next clearly early talk will cash the it's of Makena year lot assumes the by execution subcu, Feraheme. to flow be see positive on with

as R&D – of was two-product bit you a a – launch and year there's launch year. a then two XXXX know, And big

less in costs of get on of driving launch believe launch, Intrarosa in because mode incurred into that the the we're still lot will As Vyleesi XXXX, And may being so we're we but aren't R&D out we a there. begin XXXX. XXXX

Jessica Fye

rate sticking with with milestone guidance, XXXX come subcu million Got to to with this in, Okay. you standing in the the from coming that $XX And explained million from it. just are year, rest fully I run not was $XX the quarterly revenue Makena by And ciraparantag IM? solely think the by guidance million Makena product? the supposed $XX is

Ted Myles

Yes.

So drivers big were as IM. said, the guidance you of the Makena clearly, lowering

As were we There negative $XX – some revenue you know, QX. in million QX. in so headwinds of had

who actually on particularly are So authorizing but Makena we that recounting our product, we're the the generic for incurred IM revenue not revenue. with partnership, only positive negative

hole. So a of that's bit a

what So the removal the that's guidance of driver, million revision. conservative drove we'll – Those development of revenue. key the then milestone $XX ciraparantag call a the and two

million the we've and delivered of $XX QX. that largely million of subcu. The of $XX to subcu big $XX picture proud And about We're revenue. really results your other sort million about in question by talked of the Makena, driven

is team subcu the physicians. with continually that So progress adoption and by range, the by the commercial we're we're in making and encouraged the

Bill Heiden

Yes.

been very, the full last this the auto-injector we've think share now, quarter, performing Obviously, the forward quarters. – for for that achieved market over XX%, If Jess, several has you shrinking intramuscular go the is Bill. about is nicely. very the the The

– we to market market going eventually but sort will, that intramuscular players look as way came forward. out we drive revenues of into as of of Makena so you get were and really to of the auto-injector sort to the is interesting, any success multiple going less what's became future, going the if likely And the

Jessica Fye

ciraparantag. Daiichi be one was the on the prior to question Okay. to remind last you Xa Got up understand Can you following product? help it. could able asserting you the And results us that agreement? Phase terminate what just me like when believe report on for And

Bill Heiden

Sure.

I want so we into the you they market. of can a asserting Daiichi don't then a into what from certainly I is get U.S. don't don't commercial specifics because Again, So to want get into legal and that. contractual the language get perspective, presence understand, to in have

could there I you so out And understand of the might contractually, they understand to where they some don't we want actually but do ability have so. to and think be get may agreement, why try this certainly background

timing, In to terms let of me turn Julie. over it

Julie Krop

Yes.

Xa to next in So first be data that half I of – year probably the today, sometime Phase able don't but we'll timing definitely have the the study. report for exact

Bill Heiden

these are fast... pretty fortunately, And trails

Julie Krop

Yes. They're pretty volunteer fast. I mean, as remember, healthy studies. you

So pretty quick. yes, it's

So...

Jessica Fye

great. Okay, you. Thank

Bill Heiden

Thank you, Jessica.

Operator

go Your Ami Leerink. with line next comes of SVB from question Fadia Please the ahead.

Eason Lee

is Maybe good sort first, for Bill, this, I wanted of on taking you to our touched Eason Hi, Ami. morning. This think just confirm. but you questions. on for Thank

has XXXX your negligible pretty XXXX you view like – despite change So sort in the preliminary of the sounds guidance, the XXXX. basically fact contribution you it of didn't IM didn't that lowering of that assume

to the that sort if confirm that's case. wanted Just of

Bill Heiden

well And better Eason. expected. is as subcu the right, performing or than auto-injector we again, That's Yes. had

our a or versus And ago, so shrinking. is intramuscular the forecast year interesting two from market

market. that other as that are have get And to There market so to as as was is it becoming continues forecasted less generics be interesting the smaller. entered uninteresting even

with generic complicated had to with auto-injector. with authorized And another decided intramuscular, great and contributor the the the the that we've was success we player being had and challenges so subcutaneous as going to rather market supply continued in than best execution we've on that be the forward focus course our a by

Eason Lee

third been on the broadly of share just of just generic seem more the like terms you maybe guess of that maybe year, give recently. us sort of there then, – the Maybe that's be then scripts, pretty supply I Prasco generics the on And financial be AG terms quarter. Thank contribution, work Will of also maybe impact just year? the obviously, in from through the I there. just still in one any penalty think some we numbers third of focusing to number us in of your you. sort up of could sort sort in of of of has rest sort And quarter? – that Maybe flowing there Okay. failure for to – sort expectations your more rest see IMs, into picking help kicks-in,

Bill Heiden

Okay.

let So a which comment, a community buying is analyst big of than some just with start the me actually we different dataset think is I buy.

So the we have very accurate data on market.

And so as I mentioned, the intramuscular shrinking. market is

mind getting trading that but to important is actually smaller. the folks market, share there market some that are keep in Now within

you Ted, In mention... terms impact, want of the financial maybe to

Ted Myles

Yes.

hold shipments out in are inventory that based that their some are QX So that ship we market for We still or matter. any demand. QX seeing on currently didn't still some in putting – sense. product may hold to Prasco and they Prasco own the make They

Bill Heiden

We've in those already revenues booked QX.

Ted Myles

Yes.

is exposure. So there's small to minimal inventory a us. exposure financial amount of and There minimal

Bill Heiden

Yes. expectation further? the The they anything that is will inventory hand. ultimately deplete bleed to on out they have inventory and continue Tony, that

Tony Casciano

No.

was asked of a a question generics. Just a on maybe, number comment

So of today. we them see a number

amount the way. horse supplied. FDA. couple a We two subcutaneous out would see sitting there's markets fully from simply discrete think which on starting to in is But total moving branded least we versus number, because I expect file perspective right uptake more There's going on. of the market the is we today, big that’s some think out generic We a auto-injector, generic generics are the know though more focus trading kind so there's at with there there. believe here, with we're enough what we of

Eason Lee

very you much. thank Okay,

Bill Heiden

Thanks, Eason.

Operator

Your next line of question with comes Needham. from the Serge Belanger

Serge Belanger

have Thanks any good supply whether talk auto-injector you that Makena. on just are first affecting issues question. my carryover product going morning. Hi, I taking can the the guess for Can the forward? to intramuscular

Bill Heiden

don't. There do two form. caused have whole this our was nothing the No, and in really with subcu primary again, Yes. issue they one supply And to separate by suppliers they the intramuscular supplier, intramuscular are auto-injector. supplier

Serge Belanger

Okay. And it's you was of now just us then in whether terminated, seek place. on ciraparantag, And development? an will being that structure collaboration kind additional partner what for remind

Bill Heiden

was of development based the particular funding agent So development reversal combination with oral really the partnership in anticoagulant. a on our

or And or change whether said, plan not in that's does so, frankly, development program as I our at out, all.

consummated structured. the in In terms not of around development that's don't of there some Serge? is the partnering ex-U.S. be certainly ex-U.S., and was but see current same that's answer structured program ciraparantag program Daiichi this with There Does this partner, question, way so that way is structured type program Sankyo. eventually ciraparantag additional development a development partnership I your may interest replacement

Serge Belanger

Yes. guess I Vyleesi. how progression on about of coverage should you expect And year commercial pricing And September? or what at in this then one that last year? kind think in launch next one we lack

Tony Casciano

Yes. Sure.

for question. the thanks So

We're payers. for say price coverage that today with high the now of anticipate other XX% just kind get eventually therapies got how be early and seeing for listed. putting you product. there out go as takes when Vyleesi go the of know and a but to think. just discussions in they to targets it's coverage And you early lack start forward. forward of is comments, XX%, we'll I let as time, one-of-a-kind back with over going we'll expectations super to but in kind forms. So did the to do out the marketplace level having We've now We've roughly We

Bill Heiden

Yes.

Just patient access program... the want to restate, Tony,

Tony Casciano

folks I jumping are of just know for so midway on the apologize. in benefit the maybe folks Yes, and later the restate late, absolutely. some And maybe call I'll the I that call. joining

we for launching of will so pack with be co-pay refills max a for four even four do time. it's So product access the of to though going like anticipate to we type launch, fill the patients at $XX critical we anticipate do coverage, that then I believe take some first pack. the – interim, is said, In $X out-of-pocket and subsequent of the we for

Bill Heiden

think not what you'll see, launch. Serge, the I right uncommon So product is into

will at up high time You'll on start that coverage. just go relatively net over and time based see the down will and a price then come growth over

Serge Belanger

thank Great, you.

Bill Heiden

Thank you, Serge.

Operator

from of comes next question Tyler Your line with Knisley the SunTrust.

Tyler Knisley

questions. on Tyler Hi, you Makena one the just could have that market? recent one Greg. the for quick for Makena. the taking Thanks court vasopressin ruling Do implications this for any is on think have on compounding I the

Bill Heiden

think generics And option. low-priced think we're version, – a don't think a to versus is versions I Pandora's obviously exposing the lower-priced so I there of of but you because – to reopen availability that I you – will, patients today subcutaneous don't so. form hydroxyprogesterone generic. which that the lesser No. intramuscular got going box we've in Because if are of of auto-injector, think when caproate compounded

has don't impact. no, any think that So I

Tyler Knisley

Okay, thank you.

Bill Heiden

thanks Okay, Tyler.

Operator

other There at call closing questions for are no Heiden over any will this now Bill remarks. the I turn time. to back

Bill Heiden

call today. you, Thank Carmen, us everybody on to the Great. and want for joining I thank

us, you just of weeks really front few on busy of a is away. continued a busy we which and Vyleesi, the includes our progress QX in look updating forward got QX to launch have that We

very more enthusiastic all help to we're that get out even marketplace and So the into patients.

thank you to forward your update we continuing So to and time, look on for again, progress. our you,

Operator

you. again, for today's joining conference. you, Thank Thank

now disconnect. may You

Amag Pharmaceuticals (AMAG) 7 Aug 192019 Q2 Earnings call transcript