AMAG - Earnings call transcript Q1 2020 | Amag Pharmaceuticals, Inc.

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Operator

Good morning. My name is Michele, and I will be your conference operator today. At this time, I would like to welcome everyone to the AMAG Pharmaceuticals First Quarter 2020 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

pleasure President call Investor my Linda to turn Vice Lennox, Relations. to now over today’s Ms. Its

You may begin your conference.

Linda Lennox

XXXX discuss Thank welcome you, first to to and quarter our the AMAG Michele. Pharmaceuticals conference Good financial results. morning, call

this press we a Earlier morning, release. issued

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

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

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

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

in have arise. any you a with issues should technical do any We there place that if handle bear are So ask please to we team and process issues. us

Casciano, appointed CEO; some Scott the Chief remarks, Chief With our call off Myers, Myles, financial are Tony with results and commercial Commercial Financial we'll Chief our and Q&A. call our me conclude will then and Officer, status environment. Scott, the Officer. kick President our open and on will will will and guidance. the newly provide goals Operating and call introductory Ted today's for Ted COVID-XX the cover a in XXXX a with Scott, up Tony, update executing our of call including

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

Scott Myers

Good and I us. Linda. joined for morning very company engaged weeks executive I'm you about team thank to two and a and Thanks as everyone be ago, joining AMAG with just the pleased the whole. fully

the assets. have CEO the and I've and pharma, I been in stage Chairman through with companies their and commercial decades. leading last development space biotech as in for or three a medtech a my roles nearly three served

HERX positive Most Previously, also AB, oncology recently, for CEO FDA. TUKYSA Therapeutics. cancer Cascadian's assets the and I in Seattle served brain I the served in Genetics at treatment be patients XXXX. recently company metastatic Genetics, a as a metastatic stage Therapeutics, by lead Stockholm, of all Chairman which Rainier I based bladder of in without focused medtech Cascadian is cancer. breast in with approved to Director and Swedish at and mets, Aerocrine acquired opportunity CEO for the Seattle had was of CEO combination tucatinib, as of now Cascadian asset company clinical

bear experiences all, senior DOV at years, and portion Sweden. worked so look for on Johnson, consulting, Pharma. overseas perspectives to & with I forward bringing before approximately taking moving to development Johnson and management management my as industry I in career nine and lived such and some AMAG. of spent the of companies here increased those UCB into In I responsibilities,

believe and and companies Many be changes? AMAG's of their that spanning as had given asked enterprise lead solutions. a the The people you impacts helped would broader of several I've announced myriad me I last the case well. entire joined have why also with challenges, now, will that COVID previously here we AMAG found

meet This products unmet in the company marketplace. needs that critical high has value

medical the operations integrated patients We healthcare sales to really point. affairs fully at our support marketing, and this market need and backdrop sales, us providers have their and of with COVID, the

become forward as I'm even with and few that nimble, improved spoken provide already for shareholders. AMAG. engage to the have more effort looking helping on decision-making communication as discussions after this to will coverage analysts AMAG we the actively this and a and shareholders, with I've more call, continue well

team capital our guiding important principles core In is continue tenure, on brought theme, to I've the to and focus the manage be grow for expenses can added medical to my short utilize development sheet to on business, executive and balance our evolve business promotional headcount be to this and prepared to will teams efforts. that field products few what a our that non-dilutive company, our strengthen is focus look bring underlying in education also

to products and is serve that unlocking if our pipeline, potential goal needs and through value then unmet efficiently marketed can ultimate the the developing begin. The patients we do shareholder providers for of the and

The Board leadership AMAG some the along open you excellent in a progress have me of I'd the challenging rest welcomed share associates, and arms, our environment. team, very with of with so Directors executive with like to

announced, AMAG we turn with Vyleesi. progressing and plans Intrarosa going to as let's So page through to an are evolution, divest five; is and our previously

second look and to are end the updating by of We negotiations quarter. forward in everyone now

focus mark The to of priorities and value, out to important will Feraheme's value ciraparantag. efficiently patient retaining our women's develop access sharpen our maximizing shareholder and health therapies, increase consumer-driven products on on Makena an continuing innovative milestone our and to path transition including

country, decline not not adversely COVID-XX and as this AMAG's results, the across in pandemic has Despite have led period. patient should during declined the the be solid by This to impacted for COVID-XX. visits first surprising being related as conditions pandemic, to visits quarter medical are products illnesses

reduced and we our of total, of the about implement impact headcount the about has our in by workforce. company-wide positions. AMAG Given a divestiture planned to Intrarosa COVID-XX made of decision XXX the of Vyleesi, In restructuring XX%

moment of our contributions the This was are to colleagues take a leaving recognize like who well. them and very wish to difficult decision, AMAG, a I'd

our to As organization. believe we towards look size taken we future, the have we right steps

and focused maximizing maternal on oncology existing developing our pipeline and hematology, laser therapies. reviewing are We innovative health,

We exploring lifecycle hematology, the front, are business, on in as oncology business process grow as both well of to development our additional the management. currently opportunities

now going it turn am I a Tony? to over provide to update. Tony to commercial

Tony Casciano

both And COVID performance Scott. impact seeing slide you, provide six, our update best good everyone. the a like Makena. we Feraheme my some an you just on On are quarter take to and Thank morning, few color to with I'll on to then the provide minutes do in for today. I'd

another Onc of revenues Hem, in $XX.X was XX% team with quarter, strong an year. which same Starting of the with the by period our Feraheme, record last over million yet first performance increase

year patient hematology, full label And that nearly of a IDA business QX share early This time, following, the in quarter been XXXX, than has our our in in expansion doubling XXXX, the team in in has the marks more what XXXX. XX% results, second in oncology launch. strong Feraheme to consistently the truly XX.X% delivered of segment QX remarkable

Makena; million below below to and $XX.X quarter finished [ph] QX million last million $X revenue, which was XXXX. in Turning [ph] with same year the $X.X we quarter the

quarter full As following a our first meeting last this was October. Advisory the reminder, Committee FDA

down job a quarter-over-quarter, the monthly to that enrollments was patient nice stabilizing pandemic. prior seems revenue While

have reported, and related As business been and Scott that to mentioned, especially widely Feraheme, immune products, declines have impact. illnesses been conditions our not not in COVID-XX where medical to

will already As Feraheme dynamic has and in We declines access infusions, this administered a you sales negatively the believe challenged. the is second with volume those to of observed as clinic in settings, might we've hospital patient's be April. month Feraheme in aware, become two or quarter, ability typically the treatment impact

increasing For patients seen their More to alternative as period, recently, patient injections we time enrollments for these have seeing outflow have for and levels. returned Makena. with weeks Feraheme high-risk consecutive indicators pre-COVID we've customers smaller same are of yet during the the be not Makena, finding get But to we begun impacts over recovery, clear, leading ways to our pandemic. of

the And patient patient believe need. speed for the to we need remains normalization recovery speed the on administer on extent those and and underlying providers extent visit ability healthcare for in both the largely of treatment products and while depends high,

our do in and we centers and begin treatments pandemic policymakers their impact has receive to to the orders people We normal While COVID they remove the as stay-at-home medications. patients will we they will begin routines, access the business, of to in to ensure to participate infusion the full offices don't on head there doctor's need. be yet we there to believe know that believe again passed, patients back our have once will the be and

it financial now Ted I'll over pass the for update. to

Ted Myles

with start to Tony Since revenue operating Makena, after slide covered Feraheme, on QX the and here Thanks, appears meeting, strong just which AdCom I'll Tony. were have stabilized expenses seven. which for

expenses Health We had we strategic acquisition see Women's year-over-year charge couple pandemic. our managing can related the combination. from and XXXX quarter evolution the of related our you carefully navigated to salesforce as a trends, As of been Pharmaceuticals in COVID-XX and Perosphere we've expenses to restructuring the have and the one-time first of a Health Maternal

Excluding decreased approximately expenses those year-over-year. by two items, operating XX%

spend comparison of SG&A expenses DTC support decreased of the favorable by first during second trend that the in campaign was in Intrarosa. XXXX. reduced half driver to the in QX key you quarter the the driving We year, product XXXX investment our our the A SG&A XX% year-over-year. see to

approved was June spend expenses second of of R&D in Year-over-year Vyleesi year. product last XXXX, on XX%, half so decreased that R&D by decreased significantly in the the approximately

an expense offset Intrarosa fourth intangible driven life operating Vyleesi. in an of sales, the decreases useful the by to estimated revision non-cash of approximately due related by of These Makena, in cost expenses to assets million were in $X increase the amortization and of quarter partially product increase

significantly decreased last first to Our to quarter. operating million million in year's year-over-year $XX.X compared loss $XXX

return million quarter in to of decreased loss our million As first quarter $X.X the our of to the year. a adjusted part to first in significantly over $XX EBITDA stated of last strategy to profitability, loss compared

left the eight. our to becoming guidance, the adjusted Moving our slide the of slide. assets of XXXX side of into here account January, divestiture financial positive. provided took and goal Health That on we EBITDA In Women's issued

global a navigated on it of as While our a that impact business. for year through its outcomes a wide business, captured for potential and uncertainty, pandemic we guidance not range did account our of

it We this is to is speed predict take withdraw at to the uncertain, to pre-pandemic duration the status. Because the for will guidance form impossible will XXXX reasonably any severity long return decision this how how of it of the time. our recovery look made patient recovery financial pandemic and some therefore and subsequent so and visits of to

the may year. we in saw we of the just remainder April have As are Tony decline mentioned have some of earlier, suggest the of don't to leading indicators or that representative if indicators the we stabilized, the the quarter know remainder

note reduction It's for XXXX, we in company morning important the while achieving and the to profitability. risk of line, to compared step that to the operating remain by expenses we returning to our as XXXX, is new stated This important is these the top $XXX announced committed total an that previously objectives rightsizing more and there goal workforce in in future. this million reducing organization than

continue guidance reinstitute financial business will as We the to of provide and can in and impact our COVID-XX to reasonable we monitor as range. financials soon a closely plan

patients, Please committed to partners. turn our and slide business employees, very providers we At safety and healthcare nine. the are AMAG, to of health

actions numerous continuity. have business ensure taken We to-date to

private been payers. to call customers, our are continuing These steps very well and with working interact and upon have government we

to their our essential continue focus or these sure, help access to maintain healthcare We activities important regain products. to providers on patients, make can

term. with supply After will do we ability time, not the market COVID-XX that our manufacturing to this our in partners, materially impact near the at review anticipate

suppliers work maintain as our continue diligently to continuous the situation to We COVID-XX with evolves. supply,

our site while to Phase Again, development continue to and severity planned these clinical initiations recovery, enrollment the On estimate these trial we patient of due trials. in trial delays have delays ongoing and ciraparantag and speed IIb experienced the Phase cannot subsequent front, we to clinical and IIb-IIIa duration trial impact we our of AMAG-XXX for pandemic the expect COVID-XX. do

reduce to this spend We these period. trials are during working on CROs our with

updating the growth of the to leg our of While that the development time. we we company, you developing remain timing could committed forward next appropriate create at We to progress. products do cannot for confirm look

goals call. I'll up back now wrap hand our remind Scott it of you today's to Scott? to and

Scott Myers

our ask review I'd turn status page goals we everyone Ted. Thanks, the where now. and and to stand XX to

outlined as in continue critical and our We making execute at juncture on are am to those. great towards which this now I goals, and its evolution. XXXX pleased the have CEO lead to are joined we new company the strides AMAG

Intrarosa resulting the We by our second COVID-XX, progressing affairs driving medical previously quarter. of remain Vyleesi the challenges provide we mentioned, end about and steadfast we teams As update despite will support, and sales, are we an divestitures engaged. are keeping Feraheme growth and the we sales from the fully

We dialog to FDA access are working continue for our the eligible maintain with women. pregnant to to Makena

As this the discuss this we FDA responded to morning, it was shared and of indicated meeting future the in Makena at to press request release to the a our hold premature time.

continue the marketplace. Makena We support in and actively market to

committed collaboratively We to are to support patients. Makena to FDA and the work continued its with availability

and Phase the As to had trials patient hospital-based has sites and have sites paused pause expected, delays IIIa the enrollment. significantly ciraparantag The impacting and thus COVID-XX development clinical recruitment to to all new IIb is the resulted of initiation due AMAG-XXX pandemic, in has and company trial new AMAG-XXX enrollment a programs and

work initiate trial the to the volunteers also forced close IIb but COVID-XX trial has conduct ciraparantag to pandemic the with to expected where the the trial the in the clinical pandemic. FDA US, healthy to Phase continues AMAG company the in sites, during

continue our established explore and We opportunities for ex-US our brands to partnering portfolio pipeline.

look our to managing of to business we towards XXXX. remain achieving future, goal in our profitability committed As we the further

that no with had doubt headwinds unforeseen COVID-XX. There some we've is

control However, we in to manage will our our do portfolio. expenses our and maximize everything closely

situation, all ask up questions challenge this the I I open member concludes are now remarks This questions in the remote for and of operator that to the operator team. or either our a direct the questions. the the of answer Given executive after formal line call having my us the opens will

Operator

from The first Ami Fadia Instructions] from [Operator Leerink. comes SVB question

line Your is open.

Ami Fadia

in on morning. in I And its the on been the and company? value you of company, - company the my question. of shareholder taking view some how the in new light about what for trajectory of driving good wanted Hi, the weeks the and for are company, that at couple you've stated going Thanks Scott, might congratulations kind the sort at, of thinking role. the your of priorities

and Portola talk And ciraparantag, of visibility into to take the acquisition asset you ciraparantag and just forward? we to AndexXa. kind Can regards get Thank you. ciraparantag then with you about specifically saw plan might certainly recently do when competitive, that some features of relative we to are the approvability how the of

Scott Myers

Thanks Yeah, for the Ami. Nice albeit you, question. to virtually. meet

team, in, coming by some arms a welcome with said, did simple couple points. So and start I open really we I've things, focal very off been of as with the executive

this base First stabilize to keeping continues and foremost, access with and growing obviously to our business Feraheme and Makena, which and day. Makena,

future. The second focus positions, expenses, reduction the XXX in of both that's company the rightsize and for on OpEx the and headcount, today, was to growth announced to we

class of that The nice drug. we of Want Portola on is your third think do. the to which And focused obviously the really assets, that's value very to this area given acquisition, highest a a good. look question, down the ciraparantag believe validation very, I is at pipeline, to

on And free we're some reduce either fully other buy we sheet integrated have had have, say affairs also improve improve very doing for a companies and those but with I'd sales I sell up these a can ways balance it's with then resources the our And we sales medical finally, sheet. the team the finally those of flow to a people attracting that partner down our versus to of some - who even then don't out, think support, people. side, companies, also - using and anything impacted lot then then has attractive to sales balance or yet, great and our excuse the the people, to team, business side and cash COVID-XX development, me, and both

the to our shared and balance the turn make cash to current other So expenses look is my efficient company, efficient, and team, focus vision sheet. more much on I've our with improve and that stabilize in then products, the assets future towards us really for bring watching and

why the company, focal move all do I've are those here, but brought the that. that's really I together So ship the to we're hard just want right points came And and going get the to it's ship, that's say really foundation the love I to to don't to very-very forward. about. I ready few clear work

that your hopefully So answered question.

Ami Fadia

Thank you.

Operator

Tsao next Wainwright. Douglas HC question from comes from Your

open. Your line is

Douglas Tsao

good questions. business taking about do Hi, think of maybe you morning. when pivoting on development start, the given of for Scott, Thanks a your bit focus background, see little sort to oncology? opportunities, a more you

to of sort a not of have the do continue you in Feraheme with that's you certainly - sector exclusive the obviously or asset, to space of business? women's a mean I anchor see lot health oncology, promise strong

Scott Myers

to been, discussions of Actually to think the move going meet right in a direct-to-consumer have in unmet Nice undertaking do and question. have that But the businesses, I the need. a But a Thanks actually negotiations with we Doug. pivot. out divestiture think completely serves the is progress the I you. Yeah, before can obviously we you're announced right make for advertising direction. the an - we're product Makena now heavy lot to

not we're certainly. that giving So on up

a bag, and And that and so more teams looking that some again those us. field medical help on could companies commercial yes, can that very there's go great, and Craig the our at great in the assets But need we far. add Onc met then Onc I'd as of be have because attractive I look for force I've Tony affairs out built Hem, Flanagan to like to mentioned, side. And there

but type to and Onc going a we things we, time, have lot some to can of think Onc support Hem, Doug, and take we and our I other do. that's more of play,

cleaning in Board I in hopefully some and we've sheet. us in have up support for recently success and goal strong a other certainly and the Yes that like we companies had is with the the shareholders. Onc play. feel positive EBITDA But from to balance Returning

I I foundation spec - with versus see there's make But don't the because lot we say successful a I can think of that want I over think very pharm, time. to pivot spec pharm. very, here,

Douglas Tsao

Okay, by of just in XQ, quickly, based of was been it really in most or Makena everybody impacted have Makena, geographies curious that was And - broad-based. great. a pressure terms you. sort in then terms obviously just seeing is Thank of in COVID if

COVID can I'm to what be trying just the trying of And folk just out the on pressure -- you. figure reason as additional question Thank the franchise? is, we might to versus the parse be just some sort understand asking related

Scott Myers

Yeah, Tony that Tony. Tony, is actually turn add actually you can I to question? indicators, any would the in sticky, proving more it to some over at think color we as mentioned looking But leading going be brand to to I'm say rather jargon. Doug's

Tony Casciano

Good Yeah, Doug. sure. question,

clear So to was of quarter, on first it be a AdCom really quarter the the saw post right. just in what impacts, full we

and So and were that's of in quarterize we saw kind if just what quarter. our stabilizing look work stabilizing business you enrollments in the quarter. indicators patient the in December lead November of in what we at to good Due during and that, seeing terms that essentially some

we believe important that risk. why Makena the and and we I we its the interesting of a our than saw that, during mentioned, anecdotally impact from as COVID more the Scott quarter, been it Not time, part bit would And see, we in one to the is have I we is view hear anticipated an think high-risk a these as all which durable patients pandemic, managing as patients exited believe quarter. physicians is

ensure the So patients, sites, to operate are around get the we've their changing they so alternate seen things offices injections. like they way

access years. and a have model they built we've access around what at was insurance out so AllCare can and can moms of Connection in certainly Makena help kind that. through work companies, home and Care the can for thirdly, really patients navigate their over injection, to strong patients nursing we've And team these We also built, high-touch need

in of care. - So this a patient for of model market bit was essentially built interruptions kind impact

with we've for products you impact, COVID. and Feraheme what wouldn't seeing, an definitely seen and really much the impact both been at look I during because those how a impacted marginal, is a we're lighter - all much, other reasons, as call across So industry, but it it they've than

Douglas Tsao

And in far last versus there been shift Medicaid terms has in or the more so Makena, quarter, during commercial XQ? of - a towards

Tony Casciano

to yet. QX everybody So the would is mean I XX% that hard even we I April consistent remind haven't Medicaid, remind to in say because was first that and quarter. you closed Makena in close

shift I part And and of to did post think the believe highest in over earnings, as AdCom, slight and those was the in prior I this patients the we by story see physicians risk. categorized are don't mix a Medicaid,

that at are less you bit have less of risk if preterm for Makena, patients that a segmentation stickier looking birth and those as means around at preterm to So otherwise be availability, the birth, well. patients seemed a

in so shift transparent, the the closed we far quarter. big But no quarter yet. to XXX% haven't So be

we see that. wouldn't So

Douglas Tsao

Great. Thank you.

Tony Casciano

Yeah.

Operator

next your And Jessica from Fye to come will question JPMorgan.

open. Your line is

Jessica Fye

morning. Good Scott, my development. business as the a for capital you If question. relates guys. taking XXXX, off the or Thanks thinking to we pay the up are Hey, to how to need the of you structure refinance also cleaning but converts? years sheet, about couple potential balance about look it talked out

Scott Myers

I brings things sell like in out-licensing a Yeah, development, we and and or territories obviously that, non-dilutive we if one capital. do of the it's it side lot deals, when business deals about talk - of think,

would way we to one then like look towards pick the and XXXX? to ask I through how to at And plan that's Ted question up say So it. tactically move

Ted Myles

Yeah. Hi, Jess.

getting minds. has this back managing flow the profitability, cash long obviously of weeks over planning important now, internal our a and the that our an in which thinking morning profitability it important executing look, time, convert. part due us to and of It's of we convert generation obviously implemented is on in and been we're So months years, has is the an a the two on it is many and been little risk element for element

can we pay Suffice generate don't say, cash it we fully enough it think off. to to

of transaction typically, managing to point, occurring some about XX-month people going is range typically that to think is XX So in at a have form to maturities when convert. be to some there

all So straight or the be we're form debt equity stay to combination some tuned. could It linked of of of we're have but or going debt profitable to some We're above, mitigating or equity it. it. very this step on manage to and We're is on But some and going bring focused dilution focused then to first in convert. - managing capital. have undilutive get

Jessica Fye

just Okay, great. XXXX And on maybe the with how you just P&L. much of one And thinking linked that, about to the the Can was quarter another restructuring, understand and Vyleesi kind of Intrarosa? the related to are of first can you much the and are OpEx say Feraheme how associated to business help I'm Vyleesi? much how Intrarosa us Makena versus OpEx tied cuts and

Scott Myers

Yes.

QX trend the QX 'XX straightforward. is to So from 'XX pretty

you in 'XX the QX forces. recall merged we sales As

we merging had the a little bit forces. the of by QX. employees That workforce late So out XXX about sales in was

of was most spend. a XXXX sales So QX full force two effort and

shift was had on all investment plans we DTC as big from push push that to to the yet through our Vyleesi big Vyleesi XXXX, and support product's launch. with Intrarosa wasn't And approved, been, there, our step the Intrarosa

big of in as spending spend. that XXXX So Intrarosa is look ‘XX in in quarter, a the first the decrease the went you at away, chunk

were tell you is, much and between divestiture unfilled of this part deliberate was Women's how so a than that a of It's filled. softening We that associated mitigate eliminated In year, of the architected positions, line we Health the last I had non-hiring. can since have topline, RIF. associated to very a to so XXX there. easier about What - not that's terms how and much draw can't positions be of this RIF would of lot with we that I we that drawing one certainly position was an morning, was of eliminate able line to but QX impact hiring a with

quarter. So that to mindful throughout be the trying of we're

this And executed us But otherwise. heavily dig and more plans, certainly positions deeper our decisions more pandemic. in go have in - and make stronger, have COVID types crises, are substantial reduction than to we teams look, risk these that through would you the OpEx through get the made we companies of this they like make and think I as unforeseen management like

think where comfortable we a about and we're of we to hit all good with objectives remainder and the for key year So employees that's of landed, go-forward beyond. our XXX basis the just

Jessica Fye

Okay.

So to can about make reduction. year-over-year I talk understand sure I just follow-up on $XXX - that, just the you million OpEx when

had kind off the you to of make OpEx kind past understand, the Feraheme OpEx in off that or is overall base? alluded being But sure to the that minimum. in just of just I think Makena XXXX reduction I of want I of a base,

Ted Myles

heavy No. getting operating the company, women's we was we headline, associated removed from - the and expense very DTC than the million greater the of that $XXX the strategic That - as pivot kind of banner out really of spending. we what announced with very, products that's flew these health and these

spending XXXX total to associated than there'll That we DTC company, going were OpEx, going substantially. was million look OpEx knew was that to pre-COVID, decrease be total right a the we if with So more we were versus knew primarily you XXXX - $XXX at saying, comfortable just drop. also size we I was

stick deeper little COVID we But line to that. can We mitigate continue to help we're softness, dug a of in evolving that. we So course with seeing. whatever do top by QX,

Jessica Fye

Great, thank you.

Ted Myles

Okay. And congratulations.

Scott Myers

Thanks, Jess.

Operator

[Operator Instructions] & question Serge from Company. Belanger from Needham comes Your next

open. Your line is

Serge Belanger

Hi, morning. good

for a of Just couple questions me.

from the on when make decision? visibility on you I one, they Makena, for a any on timeline FDA, with can guess Scott, interactions a first your have do The

just can about that via shifting or the done be really marketing by expansion that additional expanding opportunity product, market just is label for you And clinical by talked then to focus, Feraheme, on the expanding or do that trials? secondly the way

Scott Myers

Makena, to review our meet the obviously follow-up in the touch agency Nice they and events our some first needed on is and with to that interpretation your Good time been to the question. the Thanks. from the folks regulatory situation. world more given AdCom had

signal We are really safety with here a dealing at all.

us told from label would hasn't which they hear So to wait obviously that changed. and them, our we

to product. So that continue promote actively we

we then with to to book suggestions send briefing in set post the the point and when what is. go about Our plans going some appropriate what to hear meeting in plan about with will do proactively plan AdCom. own to them We're and at is a up a back it's our

pretty feeling we're good So about that.

COVID I right COVID a that think it things very silence is drugs, lot a it's if of good other doing and on that of people great some from now, time. will they're thing hearing busy take and not other we're categories because related,

be a agency have when personally that. of proactively But they're that of very the not Affairs prepared weeks. Regulatory our to couple it, ready have will I whole working we to But the for and on since been spoken are team here only meeting it. Head I've

in regard to with One there and US say different business Feraheme, I that possibly is uses ideas for lifecycle development, of that's come through team is the settings, licensing that up the out to and looking expansion, have in Feraheme on so grow some type management, or that. opportunities different and about can With through two come all now. outside have from think investigators I territory so right angles

to just look past, what it's - forward. we're do It brand. and think I it But well the and trusted maximize see has a done that's very in we going going can to

Operator

back in call questions over the Myers I Okay. no Scott further queue. closing have for remarks. turn to I

Scott Myers

interesting our I we just as meeting hopefully. We're like in person really support our to Yes, here, an and well, us being. near meeting the ways different our the our I look all best you help for we the that in each the doing live do virtually a future and treating very need that continuing the feel AMAG now to are because patients time in want you virtually, forward and providers patients, organization. But thank time to we of can challenging in team all for them and other them. our really relationships

call future. But for thank enough and the soon. you caring safety and now to see in hopefully I for and for health you all good But, company. well and you wish bye today supporting the

Operator

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

You may now disconnect.

Amag Pharmaceuticals (AMAG) 11 May 202020 Q1 Earnings call transcript