TXMD - Earnings call transcript Q4 2017

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Operator

Good morning, ladies and gentlemen, thank you for joining us for the TherapeuticsMD Fourth Quarter and Full-Year 2017 Financial Results Conference Call.

Following prepared remarks from the Company, we will open the call for questions. I would now like to turn the call over to Therapeutics’ Director of Investor Relations, David DeLucia. David?

David DeLucia

Good afternoon, everyone. today and our business joining full-year quarter for financial XXXX results. you to fourth discuss and Thank This afternoon, TherapeuticsMD quarter and issued a press XXXX results. release financial full-year announcing fourth in on The is the the Investors Company's press & available website, release section. Media therapeuticsmd.com, Chief TherapeuticsMD; Financial Cartwright; Officer, call Clinical Robert Daniel Officer, our today's Finizio; Executive On Chief Dr. from Chief Officer, Bernick; Chief Medical and Officer, Brian Dr. Sebastian Mirkin. certain statements. I would be this forward-looking conference during like to statements remind call made everyone that may that there forward-looking results statements upon based these be will contemplated the Such assurance statements current expectations in could no and are be realized. from may differ which statements results press number the quarterly Actual a in reports of identified and materially release of such some other due annual, our with and risks, to and our factors filed are SEC. on the today based update to forward-looking to obligation statements Company no as information and circumstances statements change. are TherapeuticsMD available assumes These replay call Media Investors recording today's the audio also An of the section for webcast in available & be and online website. conference will Company's

be replay I'll Finizio. turn of over and XX, that, those With For call webcast, TherapeuticsMD's CEO, XXXX. to recorded on to held or listening who the the was this archived February benefit may Rob the call

Robert Finizio

afternoon, Thanks, Dave. everyone. Good

at I’d XX work the First, thank team Company the entire hard to all for months. their and here over like dedication relentless our past

Although with our for first XXXX after the TXMD, resubmitted was agreement new a drug application product challenging discussions FDA we and year for TX-XXXHR. our in November, candidate

XXXX. PDUFA Our is date XX, May target action

including filing candidate, which to upon launch application submitted early the our arrive results III we currently drug expect plan of letter TX-XXXHR. March, in date the expected is it action be our as we PDUFA NDA. pivotal REPLENISH positive and product assuming as is data clinical our of October, acceptance day the contain complete the Phase will to to in from target in trial, our XX approval, Assuming December, year second Based for program, of third In our TX-XXXHR the quarter July. this new

continue for quarter and sales of infrastructure commercial prepare the appropriately We this third to of launch to potential in the year. expand our TX-XXXHR

hired as specific launching regional women’s drugs, represents therapeutic for the reps we of total of category. our This across XXX believe right the either managers which have experience experience U.S. management team XX has in the and of of when direct, or retail hiring been well team order TXMD of established pharmacy chains national largest mail headwinds a pharmaceutical today America. late. given the the the focused retail in also We've one this Commercial for complete. facing – our the focused our as strength with our XXXX, Chief We made the We non-branded team progress Dawn as campaign OB/GYN and sales launch awareness of believe and sales, our launch in focused important leading talk staffing a progress of towards infrastructure with laser in quarters charge. have approved. staffed the that like Beginning our established Halkuff, goal, management In disease sales now to few VVA. if team been on the for with past will our significant Officer, channel relationships drive fully We’ve strategy has industry with large very relationships is the We health place process This mix successful new that TX-XXX about. talent over is and have on launch on I’d sales as our partnerships made TX-XXXHR. as sales well top

the nationwide. is that retail the shelves co-pay that mail whether steps the and affordable TX-XXX the launches. necessary We avoid the to relationships and postmenopausal will typically on help available to us believe these for try U.S. in assistance pharmacies ensure of taken plague both all stocking We have issues through or women

represents retail our we believe to launches can this growing is with This under further the approved. both are we and of dedicated with that addition, for TX-XXX pharmacies the unique compounding that effective multi-threaded in pharmaceutical of critical program. goal utilizing TX-XXXHR. for products retail by been This unrecognized our under a place our relationships in In now channel approach, excited significant and Company. is has establishing network We ensure and further a By and TXMD believe a them. opportunity a relationships opportunity if team approach the is successful believe relationship contains we our differentiated of current appreciated compounding vertical we pharmacy significant to BioIgnite utilized industry our build

significant Lastly, the a had past quarters. few we've progress on these payer side

in getting major is dose are new lower parity of after major and competitive the a a held that discussions These have they that The payers to strong introduction with covering continue launch are feedback barriers of dialogue no TX-XXXHR. to pricing. for We – recent there preparation are estrogen multiple we or Estrace generics the branded product assuming to the Vagifem market. were that

a and Estrace have generics dose lower its if Vagifem than X.Xx XXx than reminder, dose its a lower a As and estrogen and TX-XXX would estrogen generics. approved

then the remarks call financial for today, of the open our review developments these review On Q&A. our we clinical both programs. Dan? results Dr. regulatory then Dan for provide up and Mirkin it will in will update Sebastian will prepared a start with

Daniel Cartwright

Both press are quarter Rob. the issued results included the release in and fourth Thanks, today. XXXX full-year

$XX.X for quarter prenatal the Net compared of full-year decline during million, million for in related for R&D fourth a were points. full-year $XX Company's full-year million $XX.X million with a XXXX decreases during The XXXX XXXX. of vitamin summarize reflect as prescription $XX.X the $XX.X we to This due were year’s compared to $X.X clinical increase support R&D during sales, approximately $XX.X approximately million, XXXX. quarter. XXXX. the the were approximately to million, fourth expenditure with revenue million costs million in Company's approximately Phase III for $XX.X XXXX trial full-year approximately the fees commercialization. the Net the regulatory million $X.X quarter million approximately during expenses $XX.X quarter. trial. quarter prenatal the fourth the NDA prior-year's was personnel during XXXX were quarter fourth our are approximately from uptick the SG&A the was million reflects in approximately approximately with for for expenses in future approximately the SG&A prescription business quarter The the and $XX.X business SG&A fourth the full-year the XXXX, XXXX million full-year primarily approximately the in the increases compared of compared submission the compared in NDA XXXX. XXXX approximately submission prior expenses TX-XXXHR. of compared R&D completed with full-year to the $XX.X for to during costs of key few expenses full-year for for an vitamin Let marketing, revenue me XXXX, the

We support activities are to XXXX. the third the health force continuing our launch expand to of in TX-XXX, quarter invest in women's sales potential pre-commercialization and of

expect to rate We of throughout growth factors increase these expenses the our SG&A XXXX.

bottom share $X.XX the fourth and our was per to XXXX per or for fourth loss of approximately million $X.XX approximately share, XXXX. million line, diluted quarter basic the quarter for of basic $XX.X the or $XX.X net compared diluted Turning with and

$XX.X $X.XX per with Our basic diluted XXXX per loss for approximately million and the million basic and or $XX.X for net share, share diluted XXXX. $X.XX approximately full-year or was compared full-year

at million cash, XX, December approximately $XXX.X compared Finally, million we approximately $XXX.X finished in with XXXX. with XXXX

financing third approximately an of September, the $XXX.X commercialization in cash As plans which a a of fourth approximately cash XXXX to was reminder, at the Company's the our million of In two end balance phase product equity in raised million the $XX.X of equates late-stage candidates. our we million, the approximately support to quarter utilization $XX.X representing first offering, quarter. of

late-stage million loan deal Company's financing. enables of intend debt currently the for discussions term a that phase We $XXX plans. Company in of the are debt draw upon product candidates. in structure of the approval to We tranches second our financing

products the both the best strong We of of our are and the to support candidates our to in access launches that the We of the launches so. capital our of do to support commercialization sufficient secure our position non-dilutive allows and will candidates. a before May. continue to in shareholders for position we of Company financing both PDUFA to this believe working date advance sheet are our products. balance believe towards us TX-XXX to of both Company has to of and product Confirmation late-stage We late-stage strong deal financial deal finalize our

and turn me clinical Let the call to for development Sebastian our update. over

Sebastian Mirkin

scientific Thank, in presence and programs, Dan. meetings our throughout medical for I key our update will well now provide XXXX. as as TX-XXX TX-XXX regulatory clinical

resubmission we efficacy, effects a from in Menopausal TX-XXX received on submitted to X significance Society and with resubmitted data and productive that We response clinically I presented Turing the trial by TX-XXX the XXXX, numerous year X, Letter a treatment and the and the After December, accepted improvement FDA is TX-XXX, clinical meaningful analysis November we and X, for to microgram In our XXXX. of this would on American are abstracts endpoints flashes now May learn XXXX, II In is that December tool regard class teams we with successfully TX-XXX, a dose Impression work. major for presented closed and their the with NDA secondary robust XX. show to and in like meeting discuss for Clinical our as primary TX-XXX that indicated TX-XXX, target Response PDUFA all NDA to year. a on of to hard the With therapies. complete North expect five March PDUFA XX, the Global XX, Complete we On the of satisfaction measures which the acknowledged FDA with we includes action a REPLENISH statistical The regulatory the for NDA oral date which thank a for our meeting. accomplishment. XXXX. November October excited XX progress date and May hot our

low secondary presented incidence of quality in sleep of show very and also with that in endpoints improvement somnolence improvement life. significant We parameters,

of data vaginal In and amenorrhea. TX-XXX, bleeding on rights safety we presented addition, including of the the

not unexpected than higher rates on reported therapies. incidence is existing with the may that bleeding This FDA bleeding Although in hormone amenorrhea of contrast data, have to compounded is comparison vaginal and hormone of TX-XXX head-to-head replacement rates rates approved lower based occur therapy. historical to synthetic of high also

of presentations XXXX numerous year the We in very upcoming ahead us have of busy meetings. medical with a

Menopause. at and at and We category will push International Society strong. World health remains six of of at therapeutic our seven leader abstracts Gynecological women at Congress large is in forward abstracts the commitment the ACOG Society to the and a meeting, two Endocrine abstracts abstracts growing continues two as TherapeuticsMD Endocrinology, present

back to want I Rob. turn to call Now, the

Robert Finizio

Sebastian. Thanks

the XXXX. ahead, Looking catalyst to I would for like review

our the XX letter receive for NDA next day our to expect filing in of we month and First, acceptance potential TX-XXX March.

XXX million they approval a close May. in to TX-XXX term-loan financing working deal we're Second, before of

the late-stage support non-dilutive and Our launch the terms is as for will this to financings goal best we Company product the get of provide our to possible believe Company with our candidate. the shareholders

Our product a elegant Commercialization/Analyst and to next XX May a three post Day our catalyst, VVA. approval data that’s of new fourth number our TX-XXX for due dose lowest an of the PDUFA slotted for currently if catalysts effective moderate-to-severe becomes that approved TX-XXX were dyspareunia is planning of and host convenient June. treatment After for to

this Our in TX-XXXHR quarter launch fifth year of of the is catalysts a XXXX. third

NDA assuming the target launch date in quarter the XXXX. of if of PDUFA XXXX TX-XXX first and expect sixth, approved of our acceptance action for the October TX-XXX, of in Our we

execution. is By year, launched, underserved, innovative, our XXXX large, to see products the now operator. growing time to full and of to the for call and our year have We’ll products a estrogen can Q&A and bio-identical, delivering with promise women. late has critical potential TXMD approved of bring market you this next-generation, postmenopausal lower-dose a open of stage As next on

Operator

the Instructions] the with line will [Operator question And Samimy Annabel you. Stifel. first from come Thank of

Your line open. now is

Annabel Samimy

Thanks questions, taking congratulations. now. I guess and period I a my for Hi. we’re waiting in guess

you? trends stocking and And that the I then retail going be space, the little – lot have want broader more avoiding, first. one, issues you’re emphasis around second in that. population of larger mail is growth some women’s you women's non-hormonal to So are the question. you trend, Is accepted? towards How or how more housekeeping Are relationship couple wondering save moving some to the want your would women's guess, of you on just around can color of a us I've largest after of they co-pay about that the pharmaceutical those give what companies it that people typically still health and to non-hormonal We've any I there got thoughts Thanks. something has ask then been some this pharmacy order physician I the then, Maybe until might bit time. is market seen question. chains. just Or in I face a options? with And development you the affect talk trends that and still final launch? health could have a that's in pharmacies know entire about hormones? in readily this a I'll health there is if And at this

Robert Finizio

Annabel, Sure. Thanks. it’s Rob.

of as as the the it’s is for biggest medium piece product regardless and their the the through. channel one going the So industry the difficulty retail retail of getting far biggest in is one out of the most goes, stocked challenges headwinds and launches

value population for lack fronts been getting interest been multiple call products growing successfully have the the what – we've to So we'll innovation has lot in this able Analyst/Launch forward. what carrying approval. retailers, a very Day to we've be in give doing successful our post this and and given it on people But of population – an estrogen in to and color in more we able we're

of into all give Analyst on but number lot So plan right we our can color. Day, to more out lay and that’s I about here really a specific go strategies now, a

definitely tell postmenopausal emphasis health I turn the here Look, Brian given round over on the women’s As far and the women's the there's the I'll far clapping space, is in or non-hormonal I companies. there the Dr. should for a by and as Bernick, the side, as of commercial health, wonderful questions as say. would of emphasis lack you to competition.

hate and both the launch they’re go to lots of would spending you with approved. we assuming that you market be we guys when TX-XXX big not money have case to the So into a will TX-XXX, where compete

focus see lot women's hormones. do The specifically of other actually thing just space, is with a in postmenopausal we not health is the

the a health lot uterine and bone we If a a you like other at going it’s of endometriosis, there's areas, look space, the on, love. just in number research, which – not and fibroids, number of things the of that

successful, and question. approach. multiple I it So your successful here be that I can think if Brian in the turn non-hormonal fronts hope over we I'll on we’re to answers

Brian Bernick

it's that with of medical the of patients estrogen and Sure. going these fared years. last ultimately, approved. recently, alternatives. and healthcare XX society, and I Quite some what compounded represents the simply products would Osphena, providers can had for for standard that not They’re understand see million looking specifically care the physicians are it's products comfortable they're and There's we that been X tell there's over FDA out you what haven't XX% is women well looking bio-identical paroxetine, experience that using other per market. the And have even with for these hormones. when you Likewise,

answers we that's and So question. how I the that hope view market, your

Robert Finizio

spent when he Mirkin Dr. that, to DUAVEE. was add $X here, at developing to just billion-plus Annabel, Pfizer, they

the and know, treat we protect flashes As endometrium. hot these

guidelines of worth been been treat that for last some there approved estrogen has It’s is fact society million successful, out payers total that single treatment for approaches front-line Osphena, and not therapy in to we as as all payers as years. $XX paroxetine for two federal other about Noven that there’s think Low-dose most seen the very well got medical VVA. ever women’s every flashes. we’ve well. hot year. I health and That –

of effective compounded reimbursed safe, approved cash an So product synthetic over pay solutions solutions. women choosing not proven approved on there's not when top that proven are not the FDA

and and today approved of is societies, meet we're meet format proven effective first today women for try buying something demands should they're going for and to the FDA they medical what them costs an to of what constituents lower and them do just demands time. the want give So what that safe the reimbursed give all

Annabel Samimy

how should SG&A, into sense amount on us a That up sort going of can of was should can give you Great. for launch you're ramp now, SG&A you the expect I year? the quick just in ask or And we how we helpful. if SG&A of but a – housekeeping a obviously

Robert Finizio

love you of give them some are variables. A lot there. I’d to color

sales day, labels are there lot commercial main the our and see closer we would to be as reasons. that’s think a more and of XX you give able operations. you like the we in one But as I have what to we and the training, hired managers know sales place,

side in today people We on and XX going XXX. are rep have the I to over place we believe

the the the on side, to I So give be to future to color of there The so and on know today. the but until to I numbers, trying speak too any budget advertising today promotion you look hard the the am to And were the forward math. guessing lot it’s labels infrastructure not is marketing I’d question we if that. and you what What side place give is is on some do in label. like, a just we based say personal is

Annabel Samimy

you. Okay. Excellent. Thank

Robert Finizio

Thank you.

Operator

And the Deutsche line the Rajavelu you. come will Thank with of from next Esther Bank. question

is Your now open. line

Esther Rajavelu

are the holding terms is to it my anticipated any that then question right preventing with what closer from about follow-up Hi. us Thank And balance Rob. for last for then the of Dan I your why for a update Rob. the and for mid-year you a taking of can out? are financing year? then Can be you commitment to now delayed to one end and for now the XXXX? you there have as Is tell questions. XQ NOL finalizing secondly, had Dan I’ll on from you please little And we couple bit consideration

Daniel Cartwright

Yes.

So Dan. is this

updated it out, And in million comes K, about it’s $XXX will approximately. when so be our the NOL it

disservice to funds This the late launch. financing place looking to I the second no hurry is so launch both the place road a doing no a our early would mean this in as there launch to we in down place quarter are hurry be from financing to do we our shareholders. way a financing, just But I to I and before would far to approval at prior will are time of That’s get in of define quarter; in that. think first products, the be better to why be put guess expand As it. final

Esther Rajavelu

regards any to for prescribing the month priorities are it. compounders can feedback with on about market indications early Got with Thanks. there impact policy compounding on then And the us? FDA’s plan ago, a you Rob, that physician announced or share

Robert Finizio

Yes. great question. Esther,

we kind out are but So compounder there, step are here. of we team

that’s We’re and support branded for opportunity see an anymore. our environment cash discount in pay out an hopefully drug hopefully will obviously less pocket. respect writing approving drug will this of where or compounding we WAC and always safe FDA, doctor money pharmacy get compounded space of And again. replace proven, out pharmacy cost. with the effective in women offered not that’s pharmacies or will The to the where genericize the with pocket The less pay and the be be has in make but something drug women the will

of for do that. branded and the expectation we the have to debt absolutely to the the with essence successful, with so We but point, develop use if and retail $XXX of a it retail at best it if The September. approved And be market and similar on genericize in which outlet we compounding enforcement as all terms think side, drugs, goes, we wait close don't see much okay know genericizes as the don't and FDA certain did to headwinds term both just goal and want street’s drug. – in non-dilutive pharmaceutical fact not the do that applicable, channels better. this for a in plan this our is that been far no don't back And we're just I is crystal a And with money great our that. equity a because we companies would can hopefully, when only shareholders just branded out before drugs so right. given everybody. it's very our million we've network other So we in if Dan’s the trying big, We we’re and approval. there that makes he we’re to can the place Esther, pharmacies wait to We're the compounded I much get compounded the we set today. and as reason on to to applies busy I clear lot to comes have to of generic – place can't is so non-dilutive our much, is on financing And

Esther Rajavelu

it. Thank you. Got

Robert Finizio

say, should I non-dilutive The yes. you. Thank

Operator

And with you. of & Cowen the next the come Cacciatore Company. from Thank question will line Ken

line Your now is open.

Ken Cacciatore

Hey, guys.

on expectation authorization, my Just that the at there upfront kind to the a do kind the co-pay in free And and the care, now won't going will? launch, TX-XXX, than question second market used and generics to. quick can prescribe the you would that prior is managed of we're the TX-XXX different the of be bit work a with then be it's question work any good so launch clinicians obviously be to on it of

of XXXX, you've compounders frequently program? contractual your to been going of interacting that something Thank kind lot with Is it's is be and life when rapid so you launches? for that where expectations plan require of when but currently a kind and understand more these something implement more than much you it a can and could it's have so with So TX-XXX it you us you. much infrastructure

Robert Finizio

am I Thank Rob here. you.

for and the co-pay the far medical generics every as So for frontline we go, therapy estrogen therapy. talk with payer since is every society – we as to low-dose

premium, headwind like one at see all payers know if one well lot a or payers of think them. place are, parity as just we going and you with at dialogue for we that's priced at where they of saturation I a are for largest with a the only that don't that that's I a see come to Osphena competitively/at going put Intrarosa. that. as see things this I a point and see been where it it in in think being to have step already of going you're number for and seems come be of period but And you're to I payer, historic. lot are to long we in there's a

So it that's great for change. we see, don't But us right. We expect could and to change. that will

As to team for been is far as TXMD combination channel, that’s goes, the we're the that compounding launch up sales add another under already another probably this that at channel falls XXX directly yes, add the of plan to so you guys know. that distribution place going BioIgnite works by here reps. But will with TX-XXX headed the folks [indiscernible] in

So the on with add being infrastructure. only that said, that's

think the have very it we I of And look, far exactly goes, standpoint of a will and ramp going we faster again TX-XXX pretty commercial TX-XXX. we do ramp. do well think going than probably as a a approval successfully, this. a it how can ramp a quick for put plan. from current as to we're outline I we're in. to and clear if As some be what it that will I expect where is be Post

year. Analyst QX post going then run TX-XXX, June. that approval next TX-XXX/launch of Our And in into Day of out

do, do TX-XXX. So faster in it's the I the we will guess provide there ramp all Street give say, but to a I'm we expect you and on little we call, early to the what trying this clarity

Ken Cacciatore

much. so Thanks Great.

Robert Finizio

you. Thank

Operator

Jay next And the Company. will from line you. & question with Oppenheimer come Olson of the Thank

is open. Your now line

Jay Olson

Oh, was hey the guys. question. XX about curious my I for for Thanks May TX-XXX. taking PDUFA

the II were chance light the the that Do think Class had before people a the there's the make in that lot decision some of a XX? NDA in fact could if of data was that by surprised they May included think you I designation? FDA resubmission, a

Robert Finizio

We what have and the or just idea anything haven the different we declared know we different. don't of know second anything will street X-Ked, know. we let We no certainly than

have more as for procedural as know the from just not wish street certainly think what's II a early, definition we'll soon basis the you. is relevantly regulatory I comes if And of color I new. I new for Class don't. anything I than know. we let or more

Jay Olson

Okay. then D talk about private payer you formularies TX-XXX can then it long get coverage? how take would And to and Medicare on just Part

Robert Finizio

Sure.

get we'll see to team know, depending Day. with happy a to we far detail on although And as starts So will there year going, plan, something on more September, to you we'll in coverage to them That's PDUFA. at private it. the first, for up so picked to you volume picking as in on it's lower approach federal and the for start doing the Launch/Analyst June that plan so up. to side, some fiscal side, specifically launching end, but as we behind net more as script supplication, margins that give on as be current the you and itself We speak, four months get you'll their year it and behind which care so balance guys do managed lot a that's then address will to we’ll detail, our is begin we be out, the and our be six potentially a how closer

Jay Olson

for Thanks the Great. taking questions. Okay.

Robert Finizio

Yes. Thank you.

Operator

you. The line Thank question Andrews the of next Jefferies. comes from Matthew with

Your line is now open.

Matthew Andrews

Hey, good Sebastian two and you, and then one for for Brian. afternoon. Rob,

mean And safety Dr. speaks guidance the what compounded support that plus to with public products, you noted, potential for when a discussions recently is of CMC complete. will updated drug? perspective? first extent your Two, what on may and P as does FDA FDA submission from enter a of and Sebastian, Brian viewed and Gottlieb that deal issued you labeling release to view on to drug all, then do and guidance approval So Thanks. FDA as But how compounded how of FDA TX-XXX? can you you discuss the the think speak E issue

Robert Finizio

Matt. Thanks,

So before label resubmission starts negotiation, the days we a typically, XX as situations. date know, PDUFA even in

brought clarify. I we So it's people, glad I'm of a you clear lot something so so can up, not it’s for know

negotiation. label that the not So sure we And Can CMC again? ask you expect, there. XX, start on question any was to piece, I'm April

Matthew Andrews

Yes.

viewed extent application? their Just making Does relative et of anything facility the the will caps, the response. commercial cetera. inspect portion to a what curious to they resubmission that CMC complete say on the FDA the view as Did that be go gel to in and that need

to you response? what a complete Is as through see can relative viewed there they it Just say to being CMC? read how

Robert Finizio

Oh sure. yes,

hold the CRL, issue that, is, manufacture inspect exact one. of memory, all. It are? on don't reading them it’s So CRL, us, go issues not was aware approvability that the in if “lack know no believe. might routine that's of just so be with it to they Does from general clear. there and approvability side safety” in phrase, to there one long-term the there I only side if the the the was Don't single of but were – has on manufacturers, guess inspections. be I do FDA of CMC want at not My anything out

just PDUFA why. I see on Jay’s kind anything. it’s date the label tied the question So don't of in negotiations and together, And

guys question One it didn't you’ve think you Jay got the things Lipocine's date up, May. was that brought realized, when I know of when asked Matt, of the PDUFA of just if I you don't thought in I but and

May at it's Esmya, as got – in I And March, ends us. April product, fibroid Allergan’s look know fall. you as I know You’ve uterine well calendar, if their

There's just lot a to now. be could going look can on up. division was right And that all in this you this bandwidth. format due that procedural another So reason followed,

it’s bit procedural. helpful not, Just I color, more a but know or it's I little think whether all don't

Matthew Andrews

P E on question compounded how FDA public Thank Got safety as updated And Sebastian for a and the Yes. it. then may and view guidance issue? you. the plus just the Brian

Robert Finizio

Yes.

in the concern, key recognize because clear of an the drug compounding they're drug. so the FDA work – was to finally it’s the committed estrogen care I space, states advance is years the space they're a that is and XXXX, is implementing in act passed think they've here script it’s and significant that to as in are you with that going work to going stakeholders, XXXX. And we how they progesterone what's with development these volume the see by state cut handle they now that this regulators, how how in going quality standard and the policy the over significant of measures. and can their out we've security discussed to And developed unapproved these it,

to So that XXXX. when this positive and people I the that act necessary of compliance an make in safe sure of opportunity and provide we enacted is with alternatives everyone’s necessary not in needs Congress think back that and think meet who require the when compounding

Matthew Andrews

Okay. Thank you.

Operator

with Smith question Thank the line comes you. Stanley. And from of Thomas Morgan next

is Your open. line now

Thomas Smith

Thanks questions. guys. taking Hey the for

Just a on plans. your commercialization couple

remind force and And just of you how of place you think do of infrastructure have for much how First, XXX need then you'll your can sales you investment the us PDUFA Thanks. XXX? date? your intend launching to in incremental ahead you’re

Robert Finizio

Sure. Hey Tom. It’s Rob.

in infrastructure have resource a mean, So XXX%, take a I joke. a XXX% and is it quit job. We’ve PDUFA a But into got should from we've And percent or of and we laser company PDUFA should prepare people ready I a execute really think been really was that that’s place. then the professionals doing going give place, experienced good approximately we few some to and to date. for where in focus go a if

depending reps So increase launch that XX. the XXX XXX% at the for approved certainly XXX for company is reps, add we be is should place articulate I ready or that, but be a we rollout best ready point to as other that get which the the point, launch and at to is about how a would go. closer of it color XX it’s on of going. hired than to certainly one what not, assuming expects the in and can you is give we have And we launch Whether would this so or trading incremental the

Thomas Smith

date, And but think on Understanding it up kind Okay. ahead QX That's I maybe the follow-up able seem cash then saying then term-loan terms having action just being earlier around in that the what had of locked terms guided you QX. question you're an into the in access not to financing. the originally of helpful. slip to to and of Thanks. to

factors terms? Just locking any wondering gating – the there are explicit down mean for to I

Robert Finizio

all. at No, not

and very, not get clear, pick on we're done we're time be So rush can right. going get side and going and and our deal in it's to got with. deal We've the very pretty we quickly best we that up to could think a happy a we’re I

to best we're but the we have to, all want have get going We because terms that we time approval. the till

good feel pretty there. we So

Thomas Smith

Thanks Okay. guys.

Robert Finizio

Thanks.

Operator

Caroline with Life Thank And NOBLE Palomeque from next will line Science. come you. question the Instructions] [Operator of the

now is open. line Your

Caroline Palomeque

question. a new I the that anything taking you just at wondering any expect abstracts will could elaborate abstracts just can upcoming on scientific sort if be content, we that Thanks the be from time. on question or analysis the Hi. presented on that quick was the mentioned of for Basically you some – the will meetings.

Robert Finizio

Sure.

So so company. much activity that we've on from got the

both endometrial Gynecological middle to that, for data key presenting We the going for REPLENISH safety International well as on to It’s data more key going Chicago, TX-XXX. presence, have well most the as as and year, which trial of of Society first and of and to and on presentation Illinois. on TX-XXX a prestigious in We're ACOG, of the as already well as we probably in presenting we're TX-XXX to and presentations the From some Congress After of Menopause REJOICE. the in key REPLENISH our TX-XXX. Meeting, year in there, close unique World this and Q secondary field the the points Vancouver, two a PK Endocrinology have also both, trial meeting similar going probably again profile as that TX-XXX, important data comprehensive on International going variety be Menopause which go this we additional to product Society of safety safety the the TX-XXX the for meeting where TX-XXX. we’re non-published data of we're the to go again

the invitations We very data our received tons to All So of interesting of in coming very we make up information excited. available have societies are tons data. this key meeting.

you So and these of your colleagues we look forward venues. one in to see

Caroline Palomeque

helpful. That’s Thanks. very Okay.

Robert Finizio

End of Q&A Thank you.

Operator

Mr. time, Officer the Executive to showing Thank you. remarks. And Robert am Finizio, I at back conference further to Chief like now closing for would over questions. no this I turn

Robert Finizio

joining you given a appreciate really all to and call patients we our to us look well throughout the investors, And you've year. Thank for and we delivering everybody that you. you. loyal great the Thank the forward Thank support executed XXXX.

Operator

your thank in Ladies conclude you for participating today's This and conference. program. gentlemen, does

You may Everyone, all day. wonderful have disconnect. a

TherapeuticsMD (TXMD) 20 Feb 182017 Q4 Earnings call transcript