TXMD - Earnings call transcript Q3 2017

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Operator

Good morning, ladies and gentlemen, and thank you for joining us for the TherapeuticsMD regulatory update and third quarter 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 TherapeuticsMD Director of Investor Relations, David DeLucia. David, please go ahead.

David DeLucia

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

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

Robert Finizio

face-to-face will regulatory will believe resubmission, with in resubmit the to without an now their I'll preapproval NDA taking our want key to effort concluding NDA additional Dr. we as and appropriate over product base Brian. months call call, by the we'll Then Once provide Dr. needed our Bernick a study. a Dave. reproductive case Good morning, for XXXX, up post-approval the this determine the conduct results. line resubmission Mirkin into that, and product have in two for a has know FDA. an additional the November At a meeting, announce post-approval investors months the regulatory that agreed for I'm be will the division the financial TX-XXXHR. the the approval, when the accepted timeline study coming Dr. answers. details be TX-XXXHR meeting of was happy a most update provide not after or let commitment company to division the to our the without the update accepted whether Once update. TX-XXXHR. label, of participated current company's the within six expectation study. is The the the significant. weeks. urologic time that after of the The it review attributes We everyone. NDA On resubmit is need importantly, believes to of remarks the and clarity products. the FDA On constructive. we post-marketing And company review it at to overwhelmingly the with But, an I'll and of pre-approval following include be and will finalized, plan TX-XXXHR Dan estrogen for observational company a class The the NDA resubmission the will scenario. will review Through developments positive resubmission. financial and Thanks, an hope differentiators. the FDA the in thank provide for FDA of the reevaluating lastly, of for position We a will then will the will to label in to that meeting protocol X, is and the we questions Bernick? feedback, committed as review today's prepared negotiation well for for very open our study. then start need with provide and been process, we bone, turn

Brian Bernick

our reconsider allow be to an the I NDA should time you, And us thanks and resubmit too for TherapeuticsMD both TX-XXXHR. exciting to to wish for is exciting Thank willingness extend for This to for an and my time application Rob. clinicians their patient. our FDA and

and massive applicator week. to the discomfort practiced enhance pack both weeks prescription the and an Dosepak, be time data estradiol in proposed simplify versus XX-plus hurdle pack using the clinicians multiple Vagifem, is dosing. maintenance to efficacy that like Important need both FDA-approved of care challenges and will clinicians and what products. is, that prescribing µg reduce to education existing During two the clinicians I've observed providers the will it that have with, needs dose that to educate of to soft XX faced announce and today onset represents TX-XXXHR TX-XXXHR oncologists, me a is packaging holds blister is mucoadhesive part X vaginally, therapies the great outer consumers without and around estrogen week for the created it the and patient overcome therapies and the of identified absorption filed The is takes place small vagina, other unique ambulatory. estradiol are barrier gives inserted Premarin opens therapy discharge believe two-week the approval and is which personally dosed for believe whether declined digitally course, the our answer it products. last we gel. Much and allowing patients. exciting It And of is our concerns key other µg as near required strong the Medrol without has or NDA comfortable patients and is the as with first which into Accordingly, a have its the steps It the packaging, it well bioidentical acceptance. the with help It which easily primary unique the years action, Z-Pak existing I've no the inner, starter inserted, the natural we was experiences is for for for day, gynecology, by switch. placement next in VVA. the by to with Estrace, dosing those and dissolves that this further and FDA. there insert pleasure A division to dissolving, vaginal to woman multiple a current the a to is doses. prescribers, and absence educational the patient products digitally vaginal for a monthly a up because two is exposure. dyspareunia within of of weeks by identically refills rapidly XX completely in markets times of like up followed resubmission This most the dryness, of of is systemic the it other daily which of

a United turn Dr. TX-XXXHR, of the women new X.X for symptoms lowest treatment than estimated available, X usage. to We dose than the believe if and XX and times which we States, will be Premarin to Vagifem. compliance, all be I resulting potential it Our has cream, improve times VVA. approved, therapy best-in-class be Therefore, has options expand suffering XX across Mirkin. will over times long-term that cream, now, these patient lower Estrace dose attributes lower still million to the potential would lower the µg from than And believe the XX in

Sebastian Mirkin

probe. I TX-XXXHR Brian. a regulatory now Thanks, update provide will for clinical our

October total hard clinical In December successful filed regulatory and from endpoints and FDA. of REPLENISH Life we In to commend had TX-XXXHR, treatment at clinically numerous of with Questionnaire team secondary and scores this robust excited Society to track in improvement significance their August, progress our which would our for a vasomotor are with and have meeting included and Menopause-Specific year. With And our like I score. work. Annual oral our and of analysis all abstracts a of the data both primary XXXX, are to we pre-NDA show efficacy, presented a effects Meeting. for Impression five in Global Quality We we meaningful North very American TX-XXXHR that on Clinical Menopausal we NDA the trial the regard statistical presented in

sleep and endpoint statistical of also presented shows improvement quality life. in parameters that secondary We significant data

endpoints. data, addition, severity therapy. contrast existing first REPLENISH of FDA-approved estradiol results distinct XXX is clinically the hot we that replacement This and on doses of replacement combination and core therapy. amenorrhea endometrial to bleeding clinically Both progesterone statistically in estradiol the and significant as both demonstrated time, mg/progesterone of with of rate flashes. well protection based higher XXX data primary incidence information across presented estradiol demonstrated and prescribing The In frequency which X.X four mg uterine the trial statistically in meaningful reductions rates and high mg the mg/progesterone X meaningful safety hormone occurs compounded that efficacy in for and as synthetic than unexpected lower TX-XXXHR, showed, hormone also clinical established, the on bleeding with

was zero percent safety in established call of endometrial with an across I like to doses. the study, financial would now review Dan hyperplasia over all incidence our addition, the to of turn to quarter third results. one-year endometrial In rate

Dan Cartwright

Thanks, Sebastian.

in Third today. release press results included are the issued financial quarter XXXX

completion expenses XXXX This expenses marketing a trials. This of as quarter $XX.X sales the primarily third for company's approximately a XXXX. the the quarter the for the in SG&A third we the decline the million prescription R&D summarize third III compared primarily me $X.X compared in points. during prenatal direct were decreased the Net reflect of $XX.X prior-year's Total decrease to changes to of due Phase of million our operating prior business approximately a million for compared TX-XXXHR. XXXX. million for third approximately XXXX million change were quarter. REPLENISH with cost These the year's trial XXXX is the approximately million for of expenses was of third key approximately Let with during XXXX quarter quarter expenditures. a approximately trial third $X.X compared for and completed few clinical $XX.X quarter. is result revenue vitamin the of with quarter $X.X in quarter

Turning to the bottom line.

per first million compared We $XX.X phase net diluted quarter. with the approximately with $XXX.X finished third offering $XX company's burn plans. diluted we of quarter representing for or Our In XXXX an basic of the third compared approximately third was basic quarter or was equity million the cash share XX, the at loss the million $XX.X financial of in XXXX. XXXX in December, and per approximately approximately share and $X.XX raised the approximately $X.XX XXXX. approximately quarter of million in million million with for $XXX.X third Cash $XX.X December

for secure $XXX our We and are our our strong discussions needs launches of both capital to with to products. sheet to Rob? and balance provide to commercialization believe to late-stage towards the product debt of currently position continue We company support financing to both financial product of late-stage us candidates. capital million of advance the in the launches candidates access our in medium-term support our late-stage allow both of sufficient

Robert Finizio

want I Dan. our during of few Thanks, supporting quarters. and very to employees shareholders thank challenging for all past a us

inflection late behind time resubmit in the And that have very December submission is few of year an therapies $XXX Now the all we potential over have But, most looking $XXX point. of the have us, potential million TX-XXXHR financed process additional FDA. for financing infrastructure, straight we approved. confirmed that's on we TX-XXXHR cash ahead, on is And a will once talent, looking in We've for for million. we clear hand the launch, this approval. have we today a debt forward best-in-class the the and two weeks, for and importantly, major in to we're next for place have stages to

to up open for the you. Thank questions. like line would I Now,

Operator

Instructions] Stifel. Annabel Thank with our first Samimy from comes [Operator And you. question

Your line open. is

Annabel Samimy

review? I've a the taking be requirements Thanks Anyway, you between factor my determining something Is Congratulations. the review contemplating still NDA? change µg to the you something for in know the NDA XX then, more to Thanks. that specific and a you're the notice Are label? are guys. still Are what µg And or I around there the the the I going and And six-month want to talking call. range. – two-month specifically Hi, range for narrow? what's refile dose that the to changing Is follow-up. X got you're you then, about did filing? dose a

Robert Finizio

I if Annabel, try me And know. any, to those. Rob. let I'll hit all is This miss

been our as we've learning regulatory, this team, about can entire FDA literally you here is the the So, we speak since today. as imagine, because resubmission here, the clinical, meeting, the sequestered team

couple in, a So, go FDA. is of in we any thought see information. I, a have would going II. it And that next would class is it the is is, that once that NDA only If the current left in that's accepted new clearly the the class by negotiation, there And typically, label new The information which weeks. I. defines is you're be what no to all is class a told

we'll announce is. So, what clearly it

resubmitted the it's seen year. you've CRLs taken the think times this I that calendar were

You've FDA says long for seen how hasn't taken listen, when the say exactly It we approval. what it. communicate clearly long. will very But, and they

question the clinical don't we SYMBODA suggests as on dosage, to we'll are ever and XX we given those the your XX. as questions? in relevant answer think need. the kind key, are key and performance XX said, it, of think that well all do We but as the this the as We attributes see do the XX. we as inside your we performance We the have to nature compared So, the just Does the we going if with X XX that XX, cement, think of selling we X non-systemic data of need there placebo for do. the technology not is

Annabel Samimy

products Vagifem, action of warning does. but and a sense we that can FDA across saw products, on it just with black ask we of [indiscernible], saw on drove different a product. follow-up, Friday estrogen a a what by progesterone, box lot the to saw updating we we every not I Yeah, action different saw that give you hormone of Can specifically lot if of notice of therapies. number us estrogen, the just also not And it's a single – all we is

what sense there? any going have on of was you do So,

Brian Bernick

Brian. This Brian. Thanks, is

So, first the systemic only non-vaginal is estrogen our is products. for all, understanding update of labeling

affect profile performed on estrogen of benefit all So, was meta-analysis TX-XXXHR, our to XXXX The not as the from this this of included the in And it inconsequential. estradiol. product, non-vaginal systemic to relates and And that progesterone a risks labeling. It the ovarian risk data is information. the existing additional includes from we meta-analysis already in systemic believe language label hormone that is this were therapy cancer product products. data does

this and through Now, update estrogen observational believe as TX-XXXHR, estrogen vaginal in And, colorectal a the then coronary amend remember, vaginal If look to there some all-cause our WHI of is the vaginal at stat it cancer, willing we're estrogen difference data of the embolism stroke, meta-analysis well showed great a we the a of usage risk fracture is endometrial products WHI DVT existing on newly non-users. to study versus FDA positive. these to as product opportunity no is products. observational relates look, cancer, on labeling, cancer, versus on to vaginal estrogen estrogen lowering the and risk vaginal non-users, product, the warnings breast pulmonary published heart disease, mortality,

product you. for do look, that, amend forward to think estrogen that we So, they're labeling look that the willing will it. the vaginal Thank to and if we

Annabel Samimy

Great, thank you.

Operator

Thank you.

Our Oppenheimer. next Olson from question with comes Jay

open. is line Your

Jay Olson

the estrogen on label class label. on features in some of to could you progress. elaborate alluded Congrats in differentiating points TX-XXXHR are appear guys. you what Rob, Hey, label? the the as of maybe that differentiation my for Can thanks question. you the some And taking expect

Robert Finizio

I could.

PKs are it of of all we've physical that. it's think other in Jay, that to would them. the to is our process make versus a that, placebo, he people ask pretty that absolutely with [ph] a FDA the your There's refer very negotiation to know, Per class label, label a a existing estrogens a private, look with if label dissolves – are it, had But has a label, the any essence, and mucoadhesive, not innovation approved, And it easy, everybody. the their one in I have therapies. And effective are for think doses been a is all to elegant, final the to on start intuitive here. we majority if intimate be and that, product with along But, eliminate erring curve is stays the up place, show bunch for packaged how I to dose process and That slides left the label believe into correctly showing then process the estrogen is share lower time-consuming whole products kind sense given Those a negative comments, and this the the And in effective and administer. It's on at something went We lowest we only that the very this and process of saying the systemic. the I Bernick messy. you Brian's – the attributes. those, just think, long once doctors onset want come word. what's to We discuss to of in blood. the woman. you as in to the of from a compared point, would clear, way giving fact game vaginal for the action. very it's a has won't until vagina, then They're the treat market. through critical, prescribe new, quickly. make attributes non-event to I of that's the Dr. will complete placebo, the every not the the get a changer

there ask refer your are people hope slides. to that's I hard our I that would to answers so many. It's So, question. why because And

Jay Olson

case could has launch work of can helpful. great. Okay, that That's and you describe, terms soonest best And scenario done? preparation of sort is what the been then, what in the you

Robert Finizio

Yeah, absolutely.

the to we've finance So, them. to these for all burn given still – hats just is, commercialization to been develop down where teams it off unforeseen department for it's of infrastructure processes, and the able and the to amount keep

give been that's because behind to to want couple of wants now. it's a the I us last the and So, hard just compliments who quarters, question, team

force team. launch sales – the XXX about the have that XX want up for have pick in reps been people we We to And sales able here. we will with XXX So, to get immediately to TX-XXX.

like find done network great the that, and and as job PVPCN get has additionally, And after mandatory well for to four with been very, the partnership both addition before just Auci a has Joe six infrastructure, formulary team or absolutely as to to over there. very the In the we and impressive teams. need by coverage XX, approval payer the key XX months then, will launch. we that work,

a go and if very insurance by women worst launch of to it, pharmacy get prescribes ways not it's the and the it One it's covered is a burn doctor expensive. at to

which inclusion as unmanaged class post-approval. we see So, inclusion in covered, months taking with the payers, get to this see it we time to an line four is or six essence,

expect once we So, that approval. announce

Jay Olson

much. congrats you Okay, And very great. again. Thank

Robert Finizio

you. Thank great day a today. It's

Operator

And from question you. Thank our Cowen comes Company. with next Cacciatore and Ken

is open. Your line

Ken Cacciatore

more but Congrats guys. Thanks, Rob, about one a market for bit news. very still – XXX, an you of brand – is are is, perspective. to answered on generics voices going i.e. just you And ask a will that leaving? share opportunity, a Intrarosa before XXX. also see Do that the in that lot some good now ask There I from you about this was there question about just coming. as market, the maybe

so in on that market, with set Thanks. on on that what compounders XXX, second little an some just and maybe on you update touched can the a expectations what's there. talk maybe been you're So, very update what's on learning we as how nuance managed bit what lot maybe care, a but just impacts you it if pre-commercialization, then, going And the on you touched going can A there an briefly, of well. ago? the about upon and

Robert Finizio

Thanks, Ken.

XX on rate of So, therapy. disease entry know, compliance – that it women X multiple X.X on million suffering prescriptions there's on on The women product. there's for stay X.X women therapy. don't And for to this is stay reasons depending as the you the from barriers million

the we Remember, oral the out versus get as generic time people physical imagine, rest there and nature legacy challenges financial pill pill. these this for perfect of the prescribe is or takes could has doctors significant products. to to a are So, my obstacle physical use experience This you to our oral more it can product. for that barriers place Generics critical woman to entering if with the or existing a not steppingstone of it's think take a her of try that generic the drugs, life. the market, your products, is for intimate the

of on It to that the all becomes needs daily for non-event. things fast, of of drugs. needs compensate the to existing messiness elegant, be this So, her a be easy, part require won't of a something use basis to types a the

do that update to graduate as the see And at status expands issues quarterly, in think a the we right same all. that – this that to that we very, affecting the physical on coming and will and Street. not generic class have we up start. being where We that's the have market, in see that's that the with if expansion changes, If anything inVentiv very this point is entry, for certainly product, our products Intrarosa, whether folks will that We they that currently edits, that not will just the for see from well into generic have the positioning we branded drugs it's step prohibitive payer very So, closely. price class. barrier – work still

do large So, the Whether to base all that's increase there. hope compliance it. very branded or happy and to we're get expand us healthy it's means very it's we generics, market, to other in whatever a all, and and user hope we products

Operator

from next our Deutsche And Rajavelu with you. Thank Bank. question comes Esther

Your line is open.

Esther Rajavelu

products these my I about you up Hi Can you potentially are you prior another How have be then, launch? that for going XX, to Thank additional and to And financing? question. terms the follow dispensed the I'll additional question. funding there. between XX pipeline may for need talk funds taking and with two. have

Robert Finizio

is this Rob. Sure. The,

in sales force force with single is sales products bag. the So, multiple a the

won't infrastructure, be the there infrastructure scales, once needed. it So, additional

a that will And those reps about and So, carry scale for reps the well both XX. XXX as of way XXX same in for all the to to those products, folks plan the XXX XX, as same will about prenatals bag. is, team in then it's

turn closing the well do over So, that the as are of that. we And Upon debt, very we on is I'll it. doing the details it for Dave why the plan. the reason as current debt, to well-financed to are

David DeLucia

you Thank very Esther. Yes. much,

For Rob's point, in we're late today. discussions

for loan of million will not include term any Our debt $XXX dilution. that is additional current thinking

As you put we cost know, upon in believe that the and negotiating opportunity lenders to have we've equity to better in talking of completion our raise September, the save a X% much ourselves we annually with and on debt. position interest X% of the

that the So, let Street we'll know. once finalized,

Esther Rajavelu

you And you. on co-pay gets Thank are to for the then, a front, when program commercial expecting XX establish approved? it

Robert Finizio

Absolutely. Ken's great before point That's question. should've I mentioned a to that

glad I So, am up. that brought you

to is goal this card down. Our coupon

So, that $XX currently Don't to are also, assistance the but well. less there afford And me hold that's some today. subject range. fortunate and so plan that's as that, to medication, change, can't folks they for it's the have the

Esther Rajavelu

Thank you much. very

Operator

comes Fitzgerald. from with question Tanner Cantor And next our Bill you. Thank

open. is line Your

Bill Tanner

really I'm endometrial just appropriate the – And the have to today. for questions focused couple I relates news was on safety Thanks the the thoughts really on a if Friday, to meeting there. discuss and then, had Yeah. of it a taking so on some venue the that it please. team, congrats, the follow-up or assuming labeling, it as I Rob, questions, wasn't

Robert Finizio

safety overwhelmingly over that their of So, meeting sufficient to the a the the X,XXX articles, FDA the the response shared first which that positive. it did clear information it of concerns was we and context pass meta-analysis we information, we and was submitted, WHI, the of the with made that some was very that you,

this we've think or I dependable able to trusting build with there. very been relationship a division good,

do it, IV which other to is we to than III than safety – an an cost opportunity use, real-world was as our wants and the that's As study for us our or the think questions real-world data, it significantly because improve to we're Phase FDA answer because label. provide more really the endometrial and a study, happy do, of ability far observational to portion Phase less

more observational are happy do this we than So, to study.

we're they I And think the everybody for gives want it best gung-ho think do it's data financially. and them it. to I

Bill Tanner

the study Rob, is endometrial still XX-month be that a as on done well? that, safety there to expectation needs

Robert Finizio

No.

there response. be address for there to study study and that crystal just think I clear, need a that, data this submitted no XX-month So, for endometrial an the that is ask post-approval need only helped at time. is And observational or an

response answered complete their to complete response, technical. be Our

Bill Tanner

That's great. helpful. Okay,

in on just the the can is there you what and as flesh put observational little what the it hope then, study, So a bone to you deliver? ask relates to

Robert Finizio

I you for time it know even wish could. They yet. as the I know, our are about it of here. hearing team first But doesn't

it there. certainly have So, meeting was our we first information out it. But once we will get

an as and think material piece soon I important get it's to as it information here we you can. of we'll

observational addition, reminder, In observational just a for the of fate is as our study. this approval timeline protocol development completely independent of the

no the this approval of resubmission develop or has the two I sure just TX-XXX. agency, it that study make to observational we Street correlation the coupling So, are to independent. that's with process to clear the as completely want

Bill Tanner

question turnaround. last is, the And a what's typical

FDA as class to expect II. whether or you when when from theoretically back would the I class it's get So, to submit, you

Robert Finizio

response – is it's asked will of that's amount of. XX believe that time very X-K day the I we and away. that's material, a get most will, right turnaround And on the any second that information an certainly we we

Bill Tanner

Thanks right. very all much. Okay,

Robert Finizio

you, Bill. Thank

Operator

Jefferies. from And Thank our you. with next Matthew Andrews question comes

is Your line open.

Matthew Andrews

around three the doses Do feedback the as the the commentary meeting two top what found second, study? or good top Thanks. A it then, can on data from clinicians for you of Hey, Any morning. very talk relates encouraging? the out from about couple filing NDA NAMS XXX? coming REPLENISH And the on plan they to you aspect and of XXX. advisors

Robert Finizio

and on So, it the Brian the three part. Brian doses, two planning And on turn it I'll for Sebastian currently not turn filing the Matt, NAMS. and And on over it's Sebastian to to NAMS Rob. doses. We're top over and

Sebastian Mirkin

Yeah. Matt. Thank you,

the rooms is you X it in excitement question that meeting. were need on of hormones We five and packed. NAMS, women million compounded the could are see fact for your using how an by the bioidentical The had there was around reflected presentations So, HRT. much so oral

And strong you at reduction at So, supported clinical data on that. that. angle several a by look severity PRO too. demand clear there's and that of any frequency, flashes, was is meaningful the hot around that very effect show which We a

that type first effect. the that it's So, progesterone time that remarkable. and estrogen was show But of

In TX-XXXHR in much addition sleep. Women the to that trial, induced. without that, taking the somnolence Prometrium better slept clinical

present that. You are

of was around a you before appreciate REPLENISH that. endometrial low continuous, we protection. doses incidence show profile the with products there endometrial that When hope with is the irregular never trial, already versus compare a remarkable you the excitement HRT So, paired ever, market, there. our the in approved bleeding. how to would label combined here And much Median reduction we remarkable this all show protection, bleeding All here hormone and estradiol/progesterone in certainly, the protection, stuff, are, this in bioidentical of endometrial profile. delta get and synthetic it

NAMS to of I'm very product really, amount So, be proud high. at the of really team. the around our part excitement was

Brian Bernick

Yeah. Good point, Sebastian.

community bring And Anything that from So, a forward clear, is approved our in to way really excited data the really, concise the really strong. data XX, suggest comparing the products we it. medical is file the Matt? label we as because will the very we just else, message about have

Matthew Andrews

it. you. Thank that's No,

Brian Bernick

Matt. you, Thank

Operator

Morgan Thomas [Operator Smith Instructions] with Stanley. our next question comes And from

line open. Your is

Thomas Smith

a the Thanks questions. couple. Good morning. I had guys. Hey, just for taking

I factors the FDA I the application XXX? was meeting? formal gating wondering, for minutes waiting the the be for you Will from guess Firstly, resubmitting for are what

Robert Finizio

don't they No. division need with – We supportive. super I higher of the ups they agreed there that that Thomas, some and we guess, were the to,

told team, The to we're it is refile. I right learning now. you, So, as about going

get will We together.

think get data. will it We once compile we the And will we we'll And we submitted. And do it next few the it's in weeks. accepted. can X-K

Thomas Smith

up sounds QX Okay, got a to a six you kind XXX. are mean, mentioned or to timeframe? four looking up launch waiting, gating the the Does you or clarify trying going comment timeline. it. level months significant in to launching just It guess, to timing or you access that you're get Rob, And that pretty be the to of Just end timeframe. wanted QX formulary get of end around to made six-month approval kind And, QX, I that of you sense like really four to received better is that of would going in access if QX factor. for launch I drug the formulary

Robert Finizio

it's Yeah. clear. Tom, I'm want make glad I you really sure that brought up. to

four, ditto as this page the class class, class, They kind classes estrogen are five. So, unmanaged estrogen a as vaginal are as the it's both, so well of whole, they paid by payers. for oral

is no majority there review P&T the vast payers. So, of with

between and once Databank, so with get Medi-Span of you what's speak, through your going approved speak, and are payers updates to your status number, without approval, to natural so formulary front NDA of the P&C So, FTP there payers, given three you downloads, just me. and would or is the that review be have vast the data tier majority XX-plus-percent I in First

three to from anywhere six That to just process happen. takes months, more to we So, little typically We're four a that saying to conservative. bit be six. want

should by set. all get approved should do the the months be we need hit uploaded would covered and hard. payers six four essence, ground that and after is And and in be So, be, It will we the to to it approval we

Thomas Smith

helpful. it. got Thanks, Okay, Rob. That's

any the in there Just the are can one I you that other about, remaining question gating guess, application, terms December? in factors on filing of XXX talk

Brian Bernick

the and with in had completeness confirmed of of this Tom, We we're Brian. to great is our they the meeting, August file on the a at FDA package track December. end it meeting pre-NDA fully where

Robert Finizio

saw we if filing knew. or brought them we time, material here would've essence, issues before we in today any on up once with Tom,

meeting. don't pre-NDA we've see and any had the just we So,

on there. we in my So, shape great we In closing hitting we're from cylinders remarks, milestones, are financing, from all infrastructure, from personnel. think from clinical

We are really here.

– And go. of is are we're this last ready We have tough, been quarters to here. couple although

Thomas Smith

Yep. Understood.

thanks, guys. Okay,

Robert Finizio

you. Thank

Operator

Thank with comes Capital you. our question And Caroline next Palomeque Noble from Markets.

Your line is open.

Tarun Aswani

do prescriptions on congratulations those news. the on already you I any for progress substitutable for that on prescription taking positive question you agreements BioIgnite Aswani the thank have any, about a Caroline. directly just to annual And if in have for and the been and the program. is quick What TX-XXXHR signed? distribution updates, question there have the

Robert Finizio

few and And there's once over in no filed did just XX you, forward, honest We've with will this. focus really it million and a role on be identified we it's this X only that. being this program more At important going the To accepted. will updates. with that been scripts months we think future. grow looking haven't in stronger point, I at But much be

infrastructure we and approved, to PVPCN the products us. hot because practice develop as to that. want the approved all reimbursement. and to the that with needed, we see our construct pharmacy those ability products, to so we compounded or some we just logistics and bioidentical you they important market with that And great will pharmacy appropriate our as to flash market dispense very, and, hopefully, them relationship critical – by the if And guys their cover has are for own enhance be the phrase in however continue obtain once see We absolutely market, see compounders very able

Okay?

Tarun Aswani

Okay, the great. Thank you for color.

Robert Finizio

Thank you.

Operator

And you. Andrews Matthew Jefferies. follow-up Thank have from we with a

Your open. line is

Matthew Andrews

the you. Good you they be compounding important have by Rob, Thank with pharmacies PVPCN terms Thanks. about and leveraging just talk compounded XXX and of the for already women can relationships Yeah. can how the with relationship morning. estrogen? using in BioIgnite

Robert Finizio

a TX-XXX a them approved look that to to or fit to approval too. as see we we our And a where about Yeah, And of folks amount in making under The will we're as PVPCN tell pipeline scripts. you there talk well covered just exact umbrella, numbers, into kind license, vaginal the Matt. compounded And often. very say, we don't our would, that compounding amount The whole, this IACP is a the as products at develop we I'll don't channel good good we or available group there. partner. And we that have, want see a key would future atrophy once but do and partner, of forward network. we we after anything

as important commercialization we're execute very So, a we it. to see on strategy. for us partnership And for our this going

Matthew Andrews

Okay, you. great. Thank

Robert Finizio

Thank you.

Operator

I'd back Finizio you. to further Robert this any And call no questions showing for remarks. Thank like turn at the Mr. I'm to closing time.

Robert Finizio

this for us XXXX. the appreciate our of all to and look patient a throughout forward you. the morning We we given And joining call loyal really great the you've you investors. Thank support year. to Thank that

Operator

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

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

TherapeuticsMD (TXMD) 6 Nov 172017 Q3 Earnings call transcript