Amag Pharmaceuticals (AMAG) 9 Aug 202020 Q2 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 Second Quarter 2020 Earnings Call. [Operator Instructions]. It is now my pleasure to turn today's call over to Ms. of and President Relations. Vice Nofsinger, Corporate Investor Affairs Rushmie

conference. You your may begin

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

materials, to these which with the our website. release, financial as The sec.gov and our our at our certain evaluate you included reminded of emphasize a forward-looking have of earnings provisions June such during uncertainties our operational XX, and include of upcoming Act well call as and X-Ks, materially today's that that in the risks Copies Investors represent filed from non-GAAP remarks want forth ended the We performance our performance. statements. don't risks access website means may at Form forward-looking copy, to with differ our a of cause Form section our because XX-Qs may SEC to we harbor definitions associated Investors made for today. of XX-Q review section of business. who in Securities obtained in discussed full are to these XX-K, for our can better economics forward-looking and the statements could uncertainties Form of our www.amagpharma.com. with it business. that believe Litigation measures respect those XXXX. financial in For ongoing of be quarter we those they to measures in the you set was XXXX to the Private Please including safe will a pursuant non-GAAP Please call, be non-GAAP On discuss involve the this the Reform and measures our results use for actual as refer statements our statements and presentation We XXXX decision-making

in participants COVID-XX earnings call We conducting different with pandemic. the locations are today's given

we do making there are with please that issues evolution progress in us our issues. technical remarks focusing We a against ask become we have focused and arise to biotech handle prepared a you are company. our process if the So on Today, they to we bear strategic team should are any place

to comments the Chief Chief We I will Financial upfront have CEO, Myers, Piekos, will looking President from Brian we're line our call Scott their With Q&A. our After Casciano, Officer; for that, and over to Officer. Scott. turn comments, opening Tony forward and Operating our brief the

to key the through call while a today. Thanks, of all for Good XX, COVID-XX morning. deal progress we've pandemic. our us milestones, thanks everyone Since joining last managing the the making And Rushmie. on on May great been business

about morning's slide. talk can You on we've made these the of call. some see this recently accomplishments We'll throughout this here headway

us changes our to April, late management products. driving further people are Our Board holistic culture we and our needs executive the Since our We time in and and shape exciting fully we a organizational have to and to multifaceted company to be meet team this evolution. The the building of products, of view an are potential the AMAG changes requires June at people, I unmet in committed CEO our patients. to take future joined our Directors of are our unlock It's our the team as to our our medical in of in help to some made and and continue evolution. been company. capabilities drive company's help

our as that I'm and role been that Some and morning, AMAG's greatly team Chief Operating business him leadership of contribute drive promoted CFO our appreciative and Brian on Brian thrilled has evolution. further brings to appointing changes This team, the our to partnership these the as Chief to I'm serve of Financial management have we shared Tony Casciano Officer. our included as of our Officer. we Piekos

up Our agent. includes It's advancing could exciting exploring company highest and ciraparantag, is ciraparantag focused also to the is on commercialize which the developing oral the development emerging weight reverse to could value of out-of-pocket assets licensing that's AMAG-XXX. license Norgine that our clinical Phase cost excited across that low $XXX million an total of of and as We Europe, referred agreement we for molecular also an reflects development or of in with exclusive about also entered program probability develop X/X we with consideration, broad how heparin. anticoagulants -- million for direct a and potential the royalties. receive new Australia and double-digit New option USD this ciraparantag upfront in because together attractive effect success, spectrum a announced escalating agreement to development will searching commercial Norgine ciraparantag Zealand. we provide a XX committed to very for We're program. with we contribute believe treatment offer believe into agreement for milestones, physicians and our July, us This pipeline. up reversal with In III it exists

continue we of expenses we assets us Health and our unlock assets. Women's will as ex help to explore further U.S. pipeline. completed on operating This business Last We marketed to to the divestment also value opportunities this allows month, focus of our development pipeline. our us reduce the

pandemic our activities. forced The the pause We an trial AMAG-XXX this all the this this IIb/IIIa also we of Then a on morning, have began difficult recommendation the patient Phase were population board. to announced earlier trial-related to another review based change made stopped trial independent small when year, we portfolio COVID-XX to enroll.

to remains the XXXX. advice forced to an made this on actual to unanimous note the Monitoring AMAG data. safety by important they and that and conduct there stop from raised interim was is an to concerns and came trial. conducted pause It group validate by of recommendation or DSMB decision completed blinded physicians to we the analysis. analysis help In were assumptions their provide statisticians no to analysis original the Board, this which July, COVID-XX, The back this with trial, analysis. Safety study, interim and the the Given Data independent convened DSMB, in

However, It low severe would the likelihood trial. the indicate there this AMAG-XXX to with enrollment of was preeclampsia. a that in to future women a demonstrate did stop data data is that recommendation benefit that their led

contracts We trial trial. down have the and accepted the and with contractual of process associated obligations the and have stopped in winding DSMB's recommendation We're ancillary the trial. the addressing

key the and made their role the the choice played who who trial, the in we closely with As our to trial, especially enroll. to families to slide patients please. work gratitude out stakeholders everyone a the share close to Slide, want I AMAG-XXX

pandemic. in we short time, As have done the we of reached a many during it period accomplishments have COVID-XX

pandemic the by key following a navigated have principles. few We COVID-XX

First, our of the protect employees. health

Next, providers customers our to by patient direct the of to do them part and to on focus care. and support stop spread allowing our COVID-XX

All we've in of this environment. rapidly of us ability are changing taken proud evolve pandemic and the during execute approach team's and a to our

based comfortable states to institutions to field health at as data number doing public are return engagements reopen, and be and offices. if providers they returns are steps we our with municipalities to and to the standards force principles Now we from take accordance a on so. These and keeping limited will prepare allow of as in-person the in same forefront guiding the

participate safety help the all mandatory We in whom safety training and with health requiring our those workforce field-based to to ensure they are personnel of interact. also and

voluntary make We to for the utilize to flexible virtual our to continue engagements. and remain or technology health with and as engagements will teams in-person return choice safety their prioritize they continue to

been remotely corporate In addition to since working today. our have remain teams, field virtual and March functions our

Our not continue believe supply materially intact throughout our impact the supply COVID-XX chains will for foreseeable entire have we pandemic, in and our ability remained shared call, May market that the the we future. to as to

remain ensure continue We with also our our suppliers available We've to our products work our pandemic. to able patients providers. the diligently been continue that and regulatory interactions to our to during to continue

on completed need please. to indicated shared it the had call a FDA premature their to patient In Now product, call, time FDA that our an FDA, the to recent review review yet to and information update pertinent our they Slide agency the with be QX we to working a we I'd are not how the On X, retain like would access meeting. Makena. Makena. to that more hold of with share

the that for plan which ongoing we Given and they are X the the any decision affects priorities, their It's and availability issue for competing a discussions. They the on also not generics remember that surprised Makena regarding the time of that market. the need FDA-approved haven't yet review. complexity they currently of to additional everyone are additional time on indicated in commercial continuing important

Makena, promote efficacy to the our to continue team with through educate we We generate discussions In commercial FDA data continues the of on supporting future anticipation plan MSL our the on market and regarding to team label. the product. of Makena

to proposed a these most benefit preterm have secondary collection prospective sources to retrospective data studies history study support study and a with to of We with the in conduct The primary use populations a XXP. further using that would of effectiveness the the would Both pregnancy spontaneous aim evaluate data from study. a birth. XXP patient predictors defining data benefit of singleton real-world women of retrospective in

patients important this way the the clinical initiate are decided the we of believe We While part and with further characteristics to is confirm timely will feasible, benefit. which treatment untreated. in we evaluating have being those overall optimal, and in status treated by be to baseline FDA, first discussions awaiting the study, retrospective versus informative

RWD both expansions. evidence indications medical as known a increasingly that indicates to range effectiveness, as the led to that across FDA assessing with safety relying their when decisions or data research is regulatory real-world the of as and original products as and approvals well upon Our label known RWE, real-world supplemental on inform

benefit the Makena its to team XXP While data other key approaches In Makena design by conclusion, COVID-XX clinical by willingness decisions where be the things generation. to We're be remained the continue of times. at stand we as first confirm any a utilization a will our next a steps the the to pandemic. to discussion alternative this accelerated consider their durability placebo-controlled to and it moment. not support has so FDA regulatory trial do as The therapies. steady for pleased to rushing additional agency is shown of while decision-making to remain AMAG prescribe patients utilized is unprecedented soon with following providers are and wait there the has few demonstrating randomized during reasons ready to FDA traditionally the with commitment initiating agency, to these point. the collaborate with at approval, We during is encouraged in ready for of

pandemic. COVID-XX turn to the the of Tony, call over Tony? going progress more to I'm of share Now the portfolio our will who during

Thank everybody. Scott, and you, good morning,

of couple next I'll which not our the full level underlying thought how calls, revenue and brands. products I'll Over share the insights in the different on of impacted quarter ways, provide information our of the help you Due in We for might year provided this share the on of the updated the Makena pandemic timing we both intend Feraheme. help half some illustrate future we're health viewing performance back quarter, as of the slides, think year sharing to data guidance do today. to it additional the some in about and but has

X. with on Slide let's start Makena So

volume relatively following slide, decreases committee. to the as grew have immediately to on slide. and last the in the fact, revenue in was share this of On monthly side to noting, have in of And health of illustrated left-hand the below providers see quarter year, the care ensure QX pandemic, the access in XX%, are the XXXX stabilized. the that advisory therapy. These volumes quarter stable Worth quarter Makena as continue since QX due primarily volumes we despite the we observed auto-injector important the you'll to market right-hand side patients

grew enrollments volume While quarter. stable market relatively some softening in patient and ex-factory Makena the quarter, see share during was the of we did

guidance. year restructuring expectations and have incorporated in QX field trends our our and following our Specifically these full May into

Turning X, Feraheme. on to Slide

in due COVID-related to quarter this QX see primarily the and was You'll was revenue that XXXX, below impacts.

indicators on of early signaled indicators as disproportionate in a on strong We're a we As into we these report, QX recovery that early happy right-hand the earnings the impact of to some as leading share illustrated exited at call, translated slide volume driven ex-factory April, recovery in over the our to saw a an we Feraheme growth, of sequential with This and ex-factory in quarter with gains the combination highs monthly the normalization the strong market the of June. inventory some share by in iron a recovery, market and all-time wholesalers. IV June performance market month month. was

as to for the the QX to half turn we're enter the how And So results back an over return financial some Brian? that, of we announced positioned it morning. that Feraheme I'll on with year. positive and we with momentum this update to guidance Brian

I'm everyone Thanks, on glad to today's Tony. join call.

As evolution. against highlighted, progress we're XXXX and our both making Tony Scott and strategic goals

X, period performance, periods. color Slide you results compared last the year. through and see and quarter I'll on expenses of walked the same provide to the on in impacting accounting error Here revenue second financial revenue some for can XXXX an prior Makena Tony

our The of financials relates financial adjustments As controls potential release and been the our error mid-May XXXX revenue further statements error rebates. financials adjusted immaterial were recognition this governmental recurring, XX-Q. referenced on in historical controls. rebates. discussed the gross by have are total prior XXXX, We identified impact the to prior quarter, the preliminary periods. errors recognition the timely Between understated updated during our a we in certain and enhanced and of to be governmental our reviewing Therefore, million. in timely us the press period prevent morning to from in this still in of release, second internal Makena's net auditors the by To the and may $X.X are correct around Makena today's

performance. Turning to quarter quarter's back 'XX. expenses the to $XX second million compared of second Operating declined

not divest reduce activities recur. in Our the of declined and NDA expenses Health lower by by to Vyleesi-related organization quarter decisions did driven were Women's our for business clinical development size spend research spend the and trial approximately XX%, to SG&A due COVID-related X/X. XXXX the almost delays the and the by

we during our operate shared, have pandemic. adapted to COVID-XX As the business Scott

the are Our access Providers treatments indicate trends and working have second our the second that quarter are and to we're million On for we business pandemic. exiting negative seeing total expect leading of to come between basis, patients year important guidance. the adjusted and remains to $XXX patients business, Makena of the and quarter and $XXX we $X treatments strength range results to that recognize million. reassuring on positive million EBITDA million during intact. are XXXX an full the ensure consolidated Feraheme a the year to Based in revenue $XX these core

guidance The and the the spend the the that the balances reflects range additional risks COVID the delayed that ongoing to restructuring associated of to and our with quarter. EBITDA we of positive due second May to performance half R&D organizational adjusted guidance we'll revenue restructuring confirmation year related and in with COVID second Women's EBITDA Health for full Our half return strong produced divestiture year. the completed,

over Scott back our call we update on goals the turn I'll to Now objectives it turn provide to before and Q&A. for an

Thanks, Brian.

part here recent it's the XXXX of XX, and XXX Slide we've my this been see, as about progress you here. to the agreement I'll direction. at to pandemic. We continues patients. strong assets remain align divested amidst Norgine ciraparantag, our company's available Feraheme for the recovery saw Makena these exclusive We for strategic our making goals. against see a on accomplishments We as spoke first of morning, quickly busy Here completed drive many days can days, and you new continued team. XXX Health with can we the our been very Women's And management licensing with growth to an recap

a the for AMAG-XXX for to as initiating Phase the the retrospective generate stopped months, efficacy of following to In the as additional on ciraparantag healthy product. teams IIb in analysis continue amidst to commitment we've our made company. DSMB, we educate data the and trial part volunteers. preparations are on We field data promote the this steps and our COVID-XX pandemic, from recent advance studies have is priority the recommendation key And

be these confirm the the III will reminder, to use dose studies program, a will in Phase and proposed As ciraparantag of coagulometer. we the used

IIb in study. progressed the company's the our coagulometer clinical Phase have We training operations use team to for

in of FDA investigational These the into Successful to enable support or Additionally, Perosphere their set study on a second Technologies be the that in review. our in final device IDE recent validation for IDE. exemption, later completion for submit EBITDA key the initiated milestones to the are to Perosphere includes more III of the study multi-site achievements study and return guidance, projection sharing detailed half journey us of have which we'll the assets Phase These to up progress we'll positive year. reissue this year. this will

of the operator the -- With that, in XXXX our half beyond biotech We carry open are which I'll to us light will we the and Q&A. back as a momentum, line evolve forward continue now building company. ask carry into to focused for company

Instructions]. [Operator

first Our with Fadia come Leerink. from line of Ami question the will

made Congratulations on questions. the that's being all got X at progress the company. I've

you the we will complete ciraparantag. Firstly, on we might could update. plan rough approved the and for how the the can you Thank being think Secondly, update? do IDE on, completion? you time when if to that do we FDA, do to And be on agreement get your just Phase -- the lay of some lines you when do be as And and able on to address we able study us company, the to you on the from when FDA. IIb you by XXXX When out have by generic there Feraheme, restructure mix, on the the by with convert, the likelihood remind a convert? thirdly, Sandoz a application

This Thanks, is great. Ami, the questions. for all

on would after would review, be the the as based and should IDE that and should clinical time of start fourth to we the IIb in we've submitted end to back to set year, plan so or that. third -- Phase So quarter out That directly that on development with hear late early quarter, be frame should track, in ciraparantag, regard our the -- we the we for are by plan.

XXXX this setting, end of that time the early to in is XXXX, trial the So IIb. next of year, kind response of end the dosing year, And on early short. trial very Phase from

So clinical other say role trials that next we to by fulsome would a I'm you've mid year. data companies, I that. in plays seen would that to have anything COVID coverage related your sure expect in

regard right holding IDE. on we seems But on plan have now, So the more at feasible. our plan back the you to that are update the reasonable With year of Feraheme, half we'll we and as further no we generic. know to information and the

might right been working know. on it, on communication don't now, agency. we they we but assume and As from be heard we that, the of There's no anything haven't

So we plowing as ahead business are usual.

XXXX convert?

Brian, Yes. one? want handle do you to this

Scott. sure, Yes,

discussions So have and last holders over few months, continued convert the refinancing approaches. to with the we've shareholders on

I with discussing try really and financial flow reshape advisers the us. ahead the to of forecast, change are a optimal to financing of positive As Health find tasks and organizational the is profile kind alternatives been cash our and important With getting maturity. of we Women's the us behind on lines focused said time The approach available before, XXXX refinancing the we've divestiture behind company. those

the just to quick when With able do follow-up. Q? And a restatements, Brian, to to file regards you expect be the

filed these to expeditiously are control side The auditors. but Yes. through the and things are Certainly Q time, on aiming and quickly difficult we're We're get working that. complex working difficult. the with is

[Operator Instructions].

Your Douglas question Tsao will come line HCW. from with next the of

it curious the terms rest and during saw of just year. of think should Just in you for terms Makena, we trends of quarter the about the in what maybe on how

resilience. Just really it -- good sounds quarter the showed like obviously, some

rest and -- of Just there think continuation was enrollments of in How how early affect of how impact go was the the an And we terms the lot through April May enrollments of that as therapy. trajectory should of year? sounds during we sort maybe about new the of July? the And are part like in of early a revenue part there going June? does

going Yes. pick address Doug, that question. question. to up? Tony, thanks I'm Tony the that for you'll have

question. Good sure. Yes,

let's think, maybe firstly, I just clarify. So

was we shared that volumes. had ex-factory graphic the So

or month-to-month And So but of is. in inventory to or there. a from day perspective, a two here a there there, can sometimes as there wasn't clear, obviously, be movement movement, be just lot

So see both we slight May slight a we March, build build in then a did April. slight And givebacks in saw and in June.

So you in primarily pretty to What call the signaled enrollments we our that that a little -- on was month-to-month. out a we in was quarter, the fact actually as did underlying as in went the comments we exited stable demand early after the see we bit forward softening restructuring had demand the rolled of mid-May.

about point the super to because at third not out XXX%, enrollments Now we're quarter shift we think year. second saw tool, you do not wanted in that and the into but forecasting in did in dispenses May, as I particular actual sophisticated highlight third just half it's And it quarter. how that the in we is out so you're we product factor looking patient want plays that to dip of for the a thinking

then you answers that probably premature is stabilize we tell the in your July. hard question. the there of about patient to hopefully, So It's rebound bit have further. a And I talk team can was to a there. enrollments. did that that And July working in June,

call And now turn to any closing will remarks. back over for Scott I the

I of still been have work time. to everyone during want We we interesting know this a of supportive being AMAG. so involved pandemic lot a do. It's to -- very for again and thank

in We deeper made the a engage focused I company. look by the continuing to today's look to on to our progress accordingly. do are value and forward key the we've concludes executing that recently, of investors We progress upon committed months. exists This Thank to and this our we'll investors believe coming forward building staying priorities you. gain share to the we call. over understanding with helping

joining. for thank Ladies and gentlemen, you all

disconnect. now may You