TXMD - Earnings call transcript Q4 2018

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Operator

Good afternoon, ladies and gentlemen. Thank you for joining us for the TherapeuticsMD's Fourth Quarter and Full Year 2018 Financial Results Conference Call.

Following prepared remarks from the company, we will open the call for questions.

As a reminder, today’s call is being recorded. I would now like to turn the call over to Therapeutics’ Vice President of Investor Relations, Nichol Ochsner. Nichol?

Nichol Ochsner

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

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

Robert Finizio

events an with In this IMVEXXY our of the you launch review begin I XXXX, The In Halkuff, including obtained our our we planned year from growth. Commercial and XXXX joining provide highly successful to potential. afternoon. continuing differentiated us believe growth our positioned options focused We patient will their overview that a drive healthcare Thank Chief for I'd our the call of products: on execute women crucial to for Nicole. IMVEXXY's over of key the These our call women's Officer, highlights Thanks, long-term and IMVEXXY, to approval to company. opportunities has that large performance. address and brings three it’s leading we're for in to ANNOVERA. unique we itself most continue XXXX, and and FDA health. with TherapeuticsMD unmet as XXXX, market XXXX to And approvals date transformative BIJUVA treatment products successful and completed to on populations to provide unlock now of needs Dawn are on to are women's excited commercialization like strategies. turn a will

Dawn Halkuff

Thank you, Rob.

X. on IMVEXXY slide with begin Let's

IMVEXXY. initial are of our We commercial by product approved encouraged performance the very first

trends estrogen option unmet the prescription by patient important and viewed an moderate believe as needs for physical refills, IMVEXXY and new clinical VVA, addressing category. dyspareunia, by judged severe we in As of symptom to the a treating is VVA

launch. X,XXX February were our X,XXX data We record prescribers the increase approximately XX, XXXX. dispensed January January. continues Looking growth compared in approximately month average and in prescriptions us still written approximately and to a track on July data to This volume average X,XXX XXXX weeks to IMVEXXY of had into as approximately weekly two first weekly for at prescription record XXXX the January prescription through of a volume patients in puts Vagifem approximately with our have launch XX,XXX IMVEXXY prescription. from prescriptions XX,XXX

number Regarding on and well compliance possible. number shown the that of refills user maximum demonstrates recent tracks refills the with average X, adherence most our of Slide data as

and For approximately Average patients were of program. for only January first be XXXX, out who received maximum existing Adherence estimated physical a their and clinical was a on X.X have treatments over rates that our the the order to compliance X.XX. of and therapies year. of prescription through well six. two refills other We of a as are all of patients advantages number believe fills strong IMVEXXY in adherence patient XXst the is VVA co-pay the education August result average XXXX as with fills both

prescription am often monthly of to the why each successful. provide to the explain around XXth or we so IMVEXXY day forward, been of Going has asked refill updates on I plan month. launch

with As estrogen which you differentiated other clearly improvement and treatment We dose micrograms some an use, from the weeks levels and of early IMVEXXY VVA to used exactly day clinicians be well recommend is ability see of systemic data a two time women therapy where approved seen range, is also market. guidelines starting XX is applicator-free, with at remain lowest in important of of ease options the any PK hormone administration mess-free attributes. other can within effective Slide the with as as with the X, as believe among normal payers postmenopausal medical resonates both IMVEXXY. lowest on dose estrogen four IMVEXXY this and on

team on of adjudicate update two Slide commercial IMVEXXY. This would these QX congratulate prescriptions large script in commercial had to a the to major authorizations over edits commercial to the X, the these looking securing commercial market. revenue contributor contracts market. the VVA begin we market. Caremark, with for IMVEXXY commercial I to plans adjudicate we The VVA to will our begin lives these brings in add on covered was currently coming of Aetna, on like additional Turning United with in growth over continuing in are payers. with commercial IMVEXXY. seven trends prior XX% commercial payers. fourth the we to quarter and in XX no only seven forward, the access March of effective have XXX% payer to prescriptions or see the more Board And we the and In the payers with This are Kaiser in of as majority payers rise designs, for approximately third net X% with last payers the negotiations top We our life planned Xst, volume. our another quarter, in currently covered commercial unrestricted left addition step

adjudication and next to that and well our can X lives. maintenance lowest Medicare we payer February the packs initially the early Part for currently United October IMVEXXY represents approximately Slide Kaiser began a dose interest coverage which is the in XX% market, the as further Looking contracting We Medicare on both revenue. Xst step effective start at back, and Medicare of VVA D, Due to starting on we to new anticipate of to X, largest our to plans, two as coverage of of XXXX. quarters. we of the To Medicare side D XX.X% Part expand D representing and approximately with announce investing market the pact. process representing the UnitedHealthcare Healthcare the adjudicating is that and maintenance the positive expectations side of approximately our have both XX% we the are well starter is both Kaiser payer, Part X.X% commercial D contribute happy on life that ahead remain already secured Part

with working are plans major We next aggressively two to the the quarters. remaining finalize over coverage commercial

of IMVEXXY unlocks Our commercial plan specific rollout cadence a has a fashion. followed that levers in

talented the place believe one focus in at fast X driven at uptake have but awareness with by July is launch slide having delivered on IMVEXXY affordability not team. product sales short Affordability programs Patient driven over and we also We motivated a that of late the been at and time, X,XXX fundamentals called and a XXXX, targets acceptance In that have HCP prescription. day Education Looking of since we of our a on one. patient profile, written least in only through

the in reach target the representatives XXX We expand more to a with expanded expansion as This approximately driver will our sales primary focus IMVEXXY. on continue providing for will XX% March. XXX from organization opportunities sales to to

The growing is access. second lever payer

top starting D Medicare IMVEXXY As commercial I plans and discussed, are is Part the majority grow. of just coverage to already covering

I force at timed is the in Our quarter. the first expansion just mentioned coverage end with the increase of that sales

IMVEXXY. lever third is expanding that end, initiatives. The of have focused To on we rolled base out several education to our medical prescriber

mail in The is message direct first a promotional such email that as and representative reinforces sales office. campaign the delivered

program In launched medical our addition, country. the across we education

and with to which which with IMVEXXY on in understanding new anticipated awareness programs we in providing speaker patients. in medical and XX roll out key IMVEXXY opinion result familiarity prescribers and disease increased QX have leaders will results believe education We

been has the We in are encouraged than six higher industry by and which average. the interest programs times these attendance, very

to condition designed proven to and IMVEXXY providers opportunity. should to the menopausal that by to VVA to only broadly to activate being virtually. discussion a across their IMVEXXY Programs opportunity us with XXXX. X% postmenopausal the prescriber cost country. year. campaign to direct take per health have be IMVEXXY consumer marketing prescription women we recognized believe for market. action our consumer average the discuss the We a expand their designed women clinicians. is in industry and these XX time, is treated symptomatic adoption enables average have having happen with person on compared grow lever encourage women awareness This second to We delivered unlocking approach care The continue only providers. that and healthcare we about the half At action to will a of increase take begin accelerate base of the by with programs is This of With therapy, the to our throughout X.X. significant last in to program, plan are new This effective

IMVEXXY Premarin with the IMVEXXY we and the in will Imagine including Before targets and I worked I I Pfizer time the my call this. will I further growth when have category already launch launch market it a BIJUVA to more how opinion we when over full Rob, the opportunity unlock turn are BIJUVA best of And seeing to with enhance not call the at in Vaginal Cream, end The Rob TherapeuticsMD VVA promotional turn we with advantage we force discussed only discuss of levers. is target. will and knew growth sensitive to on the the estrogen levers. market the I initial call have From the to the now offices Premarin the we more on lever, by the opportunity. when we all reaches the depth reach to is the market. Phase last franchise, in want class promotionally at that that was in my is back X in that here VVA have the

Robert Finizio

Dawn. Thanks,

October to As on know and end a year. the BIJUVA you great was approved way of XX XXXX

IMVEXXY let's an connect to during as indicators for from Turning VVA BIJUVA. menopause treatment may offering also of the age conditions slide for XX to cause hot that satisfy one in menopause. for women last estrogen a best-in-class menopause. is therapies We these symptoms. through that woman an see XX, leader by like to in the also to The underserved set experience that Menopausal going transition Typically both give opportunity a the first paradigm and of may their flashes Average the the symptoms for menopausal two early of common reduction years. growing than is BIJUVA is dyspareunia. these and on allow occurs market. XX TherapeuticsMD can symptoms become the longer BIJUVA women onset of cause are stage conditions that these based of with us opportunity

that As or providers and care can opportunity? which in standard of refused XX Prior from synthetic in to slide are be prescriptions have hormones filled by options bio-identical two combination the and Health can So of addition demand that to why the large in WHI separate Post-WHI the seen before combination progesterone hormones is the to you the hormones been on segment. were women is XXXX Prempro demanded and care. large Initiative a not synthetic see the estradiol used in United FDA availability like slide. in be off-label Women's approved has year BIJUVA annually satisfied pill the of the compound States health bio-identical BIJUVA,

or synthetic adequate pill have Symphony Health, both typically take and December BIJUVA. controlled opportunity well of two off-label large, to segments as The with bio-identical approved products combined Instead to pill XX, and used therapies. products in efficacy has being studies lacks of combination. you bio-identical practitioners patients see use off-label prescribed evaluation approved no and and available. to workarounds providers off that these risks not believe been these be safety use slide provide this patients including approximately that and alone by demand data approved off-label reason -label for their refuse to why used is there of is regimen health are million care is XX, for in cancer. once Turning both are health patients to who FDA two to not According endometrial will is $XXX BIJUVA but hyperplasia care We regimen the FDA FDA evaluated market can continue

bio-identical including XX efficacy cancer. generally the prescriptions and solution strong proven progesterone addition, risks annually compounded not to of million have In and by million or BIJUVA also and that approximately of not for bio-identical data been covered insurance. market evaluation estrogen modernized by safety supported compounding which XX data hyperplasia offers represents effective endometrial are is safe a unapproved and

Let's move in and is to estradiol for next a slides secondary how on an other the and has reasons. of the BIJUVA one technology, significant our progesterone exciting solubilization to solution. BIJUVA of led the is number few the data improvements is replacement most features compelling innovation, scientific of The a on shown unapproved of endpoints.

single BIJUVA. it's changes not documented to Slide XX, BIJUVA been parameters. metabolic will both in A And on shown you is XX as for. products. can no see what slide significant changes no are as BIJUVA give lipid exactly well As On seen compelling This and prescribers there parameters. unique Bio-Identical combination XX life as data favorable improvement measures and a in women significant profiles the demonstrates for compounded daily on they're there and scientifically illustrated And looking studied quality sleep capsule. parameters. coagulation well were of in solution desired slide

reimbursed changed just coming and company hormones. not will can A pharmacies and be reimburse profit. FDA for drugs part and Bio-Identical an reimbursed. Now The at That's BIJUVA is Bio-Identical make a introduction Slide ago moving and option right Compounding most have with unapproved do XX. the hormones payers to years consider on now of hormones compounded time. few BIJUVA was most the of category this pharmacies will approved that for compounding

focuses in reshape only of debt prescribers pill one label on the FDA an Let's tranche. area. we're therapeutic $XX class of building payer no Phase embarking move launch education BIJUVA on is on promotion launch on TherapeuticsMD intend file since will while commercialization to little a and building commercialization I two this category, there reinvigorate top BIJUVA be healthcare professional to BIJUVA IMVEXXY slide BIO-IGNITE second first patient similar will and category in track our focus XX. before on on to million and expansion and affordability, with opportunity of for second simultaneously quarter the path that our regimen, launch the consumer coverage will the voices and approved to presenting upon to off the draw traditional this

for once Phase is us coverage to is slide BIJUVA. BIO-IGNITE. compounding that focus BIO-IGNITE have the engage now our reimbursement announce we happy to am very compounding allows that BIO-IGNITE we'll on the as moving the ways I and pay payer we channel XX. established, pharmacies. to payer maximizing IMVEXXY to known innovative launched an already II, have network, that Now program

live pharmacies reimbursement. will Now once We are our health another with dispensing of can dispensing IMVEXXY XX XX XX anticipation the turning to BIJUVA pharmacies of see to in dispensing the live women's be today. slide approximately IMVEXXY compounding XX, it in XX gains anticipate to first as days wave you BIO-IGNITE compounded pharmacies compounded next and

slide largest IMVEXXY on the has XX, second value compounding partnered group that compounded the addition the recently resonating the BIJUVA over XXX we of is locations partner pharmacies. distributing in that is clear with United pharmacies What's In and with of States.

commercial Our goal pharmacies compounding reimbursement. is live at to BIJUVA have obtains time the least by XXX

XX% top pharmacies supporting a Bernick turn the prescriptions. XXX working, ANNOVERA. bio-identical setting uptake point volume call I'd a of BIJUVA. that compounding over groundwork XX very over the IMVEXXY’s fact, Our the Co-Founder million Director, the Dr. represents of important provide an to approximately is out out to of the to growth, to million now Brian of compounding strategy plus overview like I'll XX while of fast of for and compounded

Brian Bernick

will Like complementary first providers the the market representing ANNOVERA BIJUVA, market and health in not a IMVEXXY prescription opportunity we the Thank offices and of new you, product and protection to let's our promote only is the approved of slide contraception approved provides talk control shareholders. be by encompasses IMVEXXY control differentiated pregnancy. that health full our Rob. birth age. women as is product we The Starting portfolio. that highly call with patient-controlled, which was million we women's a market in depth reversible as which a the opportunity that XX, appreciated system reversible prescribe high-growth believe class BIJUVA. of and August XX segment in that about from vaginal large may on contraceptive XXXX ANNOVERA of women's and long-acting as designated ANNOVERA view emerging reach expand child-bearing Most prescription procedure-free, year birth it's an the is and we approximately contraceptives our fully

long-acting reversible is and growing rings reversible patches, contraception As the the contraceptive seen segment in for and injections contraception effective the most to up is response of methods including IUDs oral on that long-acting reversible as such The the societies' is long-acting of CDC most recommendations and contraception made contraception market slide, reversible multiple products, women. implants. medical option

XX. slide to Moving

ring of a the often with XX androgenic cycles. levels and progestin-segesterone it the estrogenic unique effects system inserted associated an shows vaginal rates delivery and study other doses hormones study can flexible and in daily ANNOVERA lacks contraceptive side entire in in overall products. its be offers demonstrated that discretion and of satisfaction In excellent adherence hormone removed with prevents an or physical vaginal is ANNOVERA's route, her are soft, repeated some three small, the with by preventing woman Phase The had cycle rate it effective in and control a high acetate continuation. contraceptive Slide is of ANNOVERA the a also for avoids year pregnancy unique and highly reminder, glucocorticoid with of ANNOVERA X-week ovulation via the a that lower As of at characteristics. XX%. fluctuation controlled-release form

XX. at slide Looking

year As contraceptive well-established and already things a Merck's of exist by year. versus prescribers monthly a today, revenue an for just option large this be priced there's favorably NuvaRing will We will and benefits that in NuvaRing pliable was represented more annual more contraceptive a and competitive form ANNOVERA that $X approximately refrigeration gross market believe month ANNOVERA doesn't has require ring provides is and basis. over softer target it last advantage billion that have responsible contraception. women an embraced acetate one is entire segesterone for and that ring on with

be or who in routines, at college breaks who take share ring it we and the to their from pharmacy compliant travel ANNOVERA forget contraceptives. like believe entire monthly trips doses the those be due market that military. burdened oral are or Additionally, an women way away a will those is for an that by may that ideal to ANNOVERA for lasts to given in year those represents easier

and fit who inventory usually not and purchase or implants. to a target are to who contraceptives manage good providers do is and do plan procedures IUDs and required as where implants want those providers healthcare patients long-acting IUDs desire also including We for not

procedures. the In number that addition, providers implant perform health of use those is and care by IUD limited

prescribers, care of ANNOVERA not all including those specialty care As to providers provide regardless most long finally contraception. in proficient now health procedures, or be training, to able reversible primary acting the are enables providers

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to Moving medical XX for update. a slide

busy medical a presentations We national XXXX the and at we have Society in us related both International upcoming year as ahead data will in Women's numerous where Study to meetings, the of Sexual as with BIJUVA and for including ANNOVERA. March, Health publications well of held international present

secondary the trial on will present positive replenished endpoints from has a health. that the We vaginal demonstrates effect BIJUVA

data year full financial Dan over press fourth in to our Cartwright, all the three later present will night BIJUVA ANNOVERA, in March European high the products. reduction Society improvements. efficacy, bleeding and And today. for additional are in discuss Dan? meeting, at flashes will we and Later turn XXXX present at likewise, Endocrine attributes we Daniel the American Endocrine time, acceptability call androgenic May. present College I Additionally ANNOVERA May be the Society quarter will issued effects. an hot the three we at present release profile, now will In key and Menopause financial first novel sweats meeting of will included and in across excellent Fourth year-end quarter of CFO Thanks, to data of highlighting on publications, outcomes Also we side Obstetricians users. in results. its will Cartwright including sexual presenting and sleeping meeting, Brian. results Gynaecologists meeting, lack the we data at resulting on the Society and

prescription, $XX.X business Let approximately revenue was and the fourth few the vitamins fourth Net points. quarter and full million with the $XX for for year company's from $X.X million quarter a for $X.X for million compared approximately year summarize XXXX, XXXX. full the million me prenatal the key

the the of was to coupons prenatal higher decreased number lower sold vitamins prenatal vitamin years, and in a For units of attributable utilization mainly XXXX.

for IMVEXXY units our As by fourth were which pharmacies patients, quarter, in approximately of the WAC XX,XXX XX,XXX quarter. sales a dispensed XX,XXX approximately and for the was shown threefold is XX the The quarter, launch increase. price fourth slide paid with by average on during third compared approximately $XXX for

companies As our and increase assistance insurance start net covering we co-pay decrease our revenue proportionally. to to expect IMVEXXY,

As such driven significantly revenue during was is revenue cost in by out-of-pocket our our expectations, impacted co-pay by the quarter. approximately increase line our prescription. program, quarter net was the a which with from in this net our $X.X fourfold Again, revenue IMVEXXY our third for per quarter $XX for patients the maximum launch assistance of million to

process a as the assistance. adjudication quarters. co-pay the few we XXXX, translate decrease companies in of assistance begin process through IMVEXXY to for next with commercial -- few We higher our revenue this over substantially the expect VVA reducing space. to into pay for the payers In majority contracting believe will We insurance IMVEXXY change completed thereby co-pay the large the

and expenses primarily the increase fourth in see full million IMVEXXY million and and mind in year. changes sales, $XXX fourth expenses commercialization marketing, and commercialization million through for increased expenses These XXXX support during quarter the cost expenses resetting and Total launch and $XX.X We fourth of $XX personnel the for million the compared approximately prior full were year the insurance year's the fourth reflected for to million quarter the due and deductible expect with year. full to improve quarter and million year's $XX.X year XXXX. and quarter full primarily prior approximately of during net net XXXX million quarter in that year XXXX. revenues higher and operating also $XX.X period. $X.X launch the approximately by approximately IMVEXXY million fourth the respectively, are SG&A our the for and year the you quarter. plans. to this R&D impacted Keep QX of was $XX.X were revenues quarter XXXX for will full change compared high to respectively, full compared $XX.X This

Turning to bottom the line.

Our net or $XX.X per approximately per year full excuse loss the share diluted compared share diluted fourth or $X.XX and XXXX and and $XX.X $XX.X basic approximately full respectively, for and for approximately share million $X.XX and approximately basic $X.XX $X.XX $XXX.X for quarter or with XXXX. me diluted -- million -- year the million diluted and share basic and fourth the full basic were or quarter and per million per

XXXX. Our the $XXX.X position XX, in at $XXX.X remains million with strong. We million finished approximately to December XXXX cash cash compared approximately

the million. For for our of quarter fourth XXXX, utilization cash operations was $XX.X

overall effective term As MidCap Financial with an approximately XX%. of rate December XX, non-dilutive loan XXXX, of our we had approximately $XX with from million in financing debt

XXXX, of launch loan BIJUVA million an of down the as term tranche planned before $XX draw of our part option we end our of the Following to second the MidCap. May have additional with

vehicle similar a on for working launch. currently are the We ANNOVERA

Rob his Now back closing to comments. for

Robert Finizio

in and continue. line with on IMVEXXY we of United schedule of expectations. Seven will summarize prescriptions XX are be refills top is To call, the expect growth and adjudicating this Xst payers Dan. IMVEXXY’s Part all now. and March Thanks, adjudicating in today's Kaiser D with line will ahead

will D any ANNOVERA significant is and to and do in QX. with remaining large add needed Part on to not set payer and commercial importantly, upside sales QX significant little force most and revenue And to clock start existing this to earlier new potential launch in up BIJUVA issues. lining move the track expect than launch three can is forward. expense. outstanding see payers payers the We We this infrastructure expected. and

our a holding also As physicians let for in second pharmacies, a year and compounding leading women's management of York the health New from informative Dan day want evaluating And Analyst the said, debt be and you or summer. that Day speakers this senior be in include know vehicle we'll others. to in also take this the will team, annual we're Investor quarter opportunity We're to planning or ANNOVERA. that currently I

strategy We today. and our and and insight additional now will TherapeuticsMD. you details frame you will questions. like and for take further to for with I'd at significant confident thank into launch your in And provide we opportunities promising opportunity are why the ANNOVERA we for BIJUVA market time the outlook

Operator

[Operator from Instructions] Cowen with Company. question Our first Ken and Cacciatore comes

line open. Your is

Ken Cacciatore

progress. guys. great. Hey, Everything all the Congratulations on sounds

normalization? that? seeing year QX BIO-IGNITE you. already than kind closer a you BIJUVA, same around script? of be expected you mechanism. this question distribution? as give Do when Just do the you BIO-IGNITE, eventually the the that And through should doing still value the is just a to going better of of then exiting it I you're through next And IMVEXXY that going quick $XXX for to couple start Is we'll think QX IMVEXXY, prescription profitability normal per us which is through the is feel of is guess all year with the kind negotiations questions you we think pricing. around where similar Thank thinking or also And about all to per-script Would normalize as you can that to of normalize? then start on starting it going at you

Robert Finizio

anything I'm going miss lot. a all me know. I please answer try that's and them if to let to Ken

and pack line. revenue a there's The competitive more So WAC to and packs. maintenance maintenance can starter -- from price product, take stable doing yes, starter you them I right in women it's are certainly current lot market they're switching and a $XXX certainly you're pack pack I there a of that since has think the we're on get for less think

or future. in expect that We improve will hope the

same. it's far the the goes, roughly BIO-IGNITE as question as So

So of for. that different a that's to has qualify class trade

in sure not smaller -- have a that significant. qualify that they -- they're products signing go we want of where cash-pay we sure as licensure and talked of you environment there, discount could So go everyone a we largest, had They sell actually be second We class more off knows, signed largest sure the it is while, largest answers vetting It kind the I for through any about in have standing, process questions. second WAC the in don't they as on a little that just to appropriately. good hope a a it's your they just up their make we've more partnership now distributors bit the trade. make where make a but today. need cash-pay products. can distribution, They remember, – the get expensive need of everything but reimbursed because for two

Ken Cacciatore

stab how this And that us a context? We in your this can large about eventually could product frame understand could be for I does of about the who speak give of kind how last some to market? be advantages, large a -- actually think as continuous yes. not could remove and have want if can the that And talk you just be? utilization segment It one and use of just size women one often. potential seems it you product maybe Can Thank on expectations might the do ANNOVERA then we you think on you. it but

Robert Finizio

Sure.

it going and I'm stab over then is Bernick. it at take turn really Dr. to So his baby. This to a first

own haven't people out now out. that Investor But really that significant surveys their do are own build to to for and the more you numbers large. we're get more market and we the and very data out and in ANNOVERA sense more that's going And Day. to starting put we'll their out And come the -- on on models people yet. So can put is our go data as see

is be fertility surgical IUD everything I specialist product the years. got if up here contraceptives and control long-acting just the year. use new the a --as control an the the CAGR about give procedure is an oral opportunity. really and to over and it what short-acting decreasing out. my multibillion-dollar her I you is is does lot dominant, it's it's take gives There's product ANNOVERA I a seven the to said, last is, in it X.X% of The does a about issue fertility over a of do? up a here or market, you know we to the of doctor control X% the at ANNOVERA in when to while key female not tool about the OB-GYNs. X% IUDs control oral back that's The last I What XX% or line control. of my give and I'm implants for are need ANNOVERA As increasing up kind I years long-acting put -- over procedure it entire give menses seven a give woman to woman to gives have and that a is a it the a

woman's this OB-GYNs never even that or tell give don't on you they want the -- So it IUDs short-acting offer they more control, the PCPs really, not importantly and do they I But the are do or can't don't really but benefits. implant to all side is long-term products many tried how implants flexibility. maybe

the to So these the lines with but X-year cross-section is keeping different having identify. we're a all ring the product the upside woman and going across control really that

really, just attractive. really it's So

key we think I people we in better do. out can And think than the can the QX. lot a clock. start payer do this we here can six-month We well, is, get very

it So as monthly use upside, early and And for adds so we a all on, you adjudication in throughout of year, now to IMVEXXY throughout go much place in year ANNOVERA remember front. our have could up ANNOVERA, can you they – three drugs. it the I with all we the because get get reimbursement XXXX payment

the price costs we're we it to in how $XX know, you as range it. told and you going So

And is the just that so significant. cash potential So is flow upfront attractive.

track anything what and sooner it's Brian, the payer out on get we're we in reimbursement is add? in get out do. going to to line QX. to that start So And can it and to clock get

Brian Bernick

Yeah.

to potential the how your continuously, not about clear, to to just back off So that's so it's was question the be product label. and use the studied product

how multiple their and And my but flexibility empowers use pills cycle women their continuously, for birth pills, of them product. refills many menstruation. of our clinician be most use individualize to that I as have to to years their their getting control in that patients the requires Of here control course, you have products of a encouraged a control have -- we birth that's product

just to want women a in continuously a once And month, avoid and period some maybe use so some have twice others some months, to a period. the a product year it to keep every will three and

off-label, instead the given similar conditions. therapy and there's in release For and lot that reasons a using of again for fibroids, of long-acting is both a its pill those birth interest frontline in endometriosis control this product controlled

and you. this lot of lot potential a in of Thank So product. interest a

Ken Cacciatore

you. Thank

Operator

Our Chen next from with comes Fitzgerald. question Cantor Louise

Your line is open.

Louise Chen

Hi. Thanks first my few. I My questions. for had taking a question is…

Robert Finizio

Sure.

Louise Chen

what currently prescriptions? And What is written last the net Rx's you. are the that And are many that Thank how is, covering people of trend I you Rx's for then Thank you. XXXX had insurance that's to question price expect percent have over IMVEXXY? as written IMVEXXY? XX-day

Robert Finizio

best my to those, do Louise. I'll answer

So the the trend can dictated and by how get will fast them on. be solely payers we

pay you So think really on I'm D -- are coming see until Part starting any October my team. about to X. with if and till it we really We happy didn't --

very Kaiser door recently. United and trend. got as drastically in and we will Those they're that paying, Somehow the impact large already payers other of

know what know you goal price guys what is, is. our You our WAC

margins, a have good for commercial XX. on And On we commercial top side. on on We seven know quarter next margins have it we'll the clear front, have D the picture because lower. don't for Part net assumption net side, other then, we the is the the typically of side very a

Kaiser. won't with And the then done. you and don't any that Caremark are March most in are delays have of we part from stop see both contracting call And I X, see we get us with, great essence deep two. for it it's we in and now don't -- really have three, we'll one there. discussions any coverage both. reason will but As Aetna why But

could trend, So Sorry. went and net have your that there. that comes on if don't answer long in yet. question? that and it percentages those those next when would was are what contracts completely dictate we just payer I I What

Louise Chen

prescriptions No. many How That's as prescriptions? okay. you. are XX-day Thank written

Robert Finizio

that don't know, question. Do Dawn? I know you

Dawn Halkuff

I don't that them of any are right I most our prescriptions of XX. XX. believe now believe are

Robert Finizio

Yes.

to that you. believe we're doesn't Dawn but back not check sure. any get and XX-days, I'm on So I having can

Louise Chen

Yes.

Okay. Thank you.

Robert Finizio

You’re welcome.

Operator

Thank you.

Our comes Annabel next question Samimy from Stifel. with

line open. Your is

Annabel Samimy

questions. taking indulge same a the Hi, my of guys. I maybe have but Thanks me. you for can variation questions,

Robert Finizio

right. All

Annabel Samimy

changed So, I net quarter; beginning seem adjudication of the much. price some there that guess, fourth in like it the doesn't was

this going of these terms year paying? slow-stage what and first out quarter coverage? the about XX we six So full when normalization into net to payers So we net of question. presumably have first assume it still the should Or be or in of a you're the rollup price? really expect adjudicating that is price the there's going to significantly more of for Should of that's given seven end

The second is around BIO-IGNITE.

has major in networks specifically until them? decision back of adjudication? class, its the BIJUVA Did that FDA I available BIJUVA is a have hear holding are two that there'll interest with system those holding fact, two that and you of until any vaginal So And have those you now right might up you the and of two of a approval accelerated? if be from own And contracted. lag the networks -- actually class. signing when were six-month adjudicated? signing its is now up Are on in a back Are on still the And then it's this we finally Thanks. ANNOVERA, correctly own networks?

Robert Finizio

tried right. take notes All I'll I I it can have to help? -- if Annabel. you don't

Annabel Samimy

them. I notes. took I can repeat

Robert Finizio

right. All Thank you.

coverage. So,

and QX you the So on don't only quarter I one -- had if really you. payer the for so saw -- at dates the we even it's put and there we in QX come But of come we another as on the know very had we out two. had at in end one

You quarter different the have coming throughout payers starting on to adjudicate.

and on mix on what based for expect the that -- me mix tell So to very for they when what to come it's and you is. hard

which additional the schedule. have you set to have conclusions at side step-up the solid and ahead will there as draw we payers of going high-deductible are large -- great expect you're see think think on strong you're still going progress. resets, I should we progress I a it end way hopefully, we believe more Part on commercial think to even easier the And to of I and -- much the D be still is of kind because I well, will for though low very board, some QX, to

So I that's you when we be. sign quarter now. we're just can as one? percentage is, Does your Because with have figure those answer your but lot during got pay, that wish question start you And your we've this more, I out to could net's give all everybody rebate lots you you help and not going when see they on what what on. realize you yet, to there a know but know contracts, you coming that

Annabel Samimy

a vague I yes. sense. In guess, so

Robert Finizio

All right.

So large networks, the BIO-IGNITE. so for two

between IMVEXXY adjudicating compounding XX is pharmacies you do are can vetting IMVEXXY technological own in on we of we is women as to the advantages go is VVA into IMVEXXY. promoting what into see what now a product. space networks. with The the new will and -- opposed we agreement IMVEXXY in their these the based distributors launched they're this them. just So the getting contractual and essence as partnership That pharmacies. the partner they're while And is vetted current as actually we plan stage have

network XX of that largest second We then next vetting next vetting be XXX. one the and will will start have in next -- another the cycle this

VVA. slides, expect now scripts the IMVEXXY saw and right there, they that's carry we've couple okay, We all just identified for so hundred possibly in we as will thousand a

it's So, significant. pretty

if Now, change of reimbursement co-pay no we're we co-pays just That give won't a getting once now, there's cards on. comes BIJUVA them -- and reimbursement $XX.

they're puts So, at pay that in disadvantage because now. them a cash actually environment

dispensing does compounding groundwork thought the IMVEXXY million pharmacy so prescribers XXX million bioidentical us hot-flash least be IMVEXXY, decile XX kind and that for of top ready world, within high scripts. it's BIJUVA at more remember once the XX coverage, into compounding pharmacies this approximately leaders to should XX% And have are launch have of it. pharmacies the to right payer get XXX or So,

So, grow those that don't we in XXX That all to of years can't And our that significantly XXX two the we years. the first pharmacies. next see over any is is significant two goal. and goal reason get our is

Okay?

Annabel Samimy

then Okay. decision ANNOVERA? the question last The the by FDA regarding the class? And or

Robert Finizio

Yes sure.

-- strategically reason at between no $X,XXX. reasons. that did at or did for a priced is matter discount that products we have a co-pay. So, and that $X,XXX we Number ANNOVERA, The ours. to we're shot competitive We one, where so it's no priced parity two having to we slotted

one's and Payers As at to are they classes -- birth it pick stands law product today, least control. class, under ACA, have XX under ACA to of by out-of-pocket mandated there are one the have classes. product, XX So one's pick are those and same in say would think they'd class; that package with pills a birth okay? you be of a not, control one expense you package think would of actually separate each they're XX, no associated

the are and only to we fitting classes. So, there, good given label. out And the good we we everyone gone product, research think not third-party see a in we We've And system currently product there's the but that mentioned our we vaginal class. agreed the think in sure, label guidelines do with become XXth of with don't interviewed into FDA reversible patient-controlled have design also out times. designation of chance, it it's one-year almost the that. XX given chance a vaginal we any will the there's being our we existing only system and the It's for about

a that. it. it They the typically in as channel. days, to days. in no it in done have in They There it. launch specific them you when possible do triggers our XX is past And the typically to do FDA They The as within know? okay? that you requires do decision early when So, regulation make XX can goal QX see is though

Annabel Eva Samimy

the for then pay And when Is they adjudication have there class, only the that one start? in you're that if to does Okay. -- it?

Robert Finizio

They block. in of six-month pay There's therapy. still this do a it for have to class

still process that will still should through today. after in -- the quickly what adjudication So, we there right? that but expectation But there during we've six is as come you've Board go process. very our place, contracting months that on seen with have You to IMVEXXY, a is six-month is block, the done

position with think I pretty stronger much with a on be are those and IMVEXXY will of we than BIJUVA both or are we good. Just ANNOVERA

Annabel Eva Samimy

Thank you. Okay, great.

Robert Finizio

you. Thank

Operator

Jay next with comes question Our Olson Oppenheimer. from

Jay Olson

progress Hey target talk guys, script congrats sales the the what and maybe impressive percent over XXXX your that grow your organization has and grow reached additional you prescriber launch Can sales of products? IMVEXXY. may organization your increase audience, course as how on coverage, growth for reach about physician and you of

Dawn Halkuff

Dawn. Sure Jay. Hi it's

every targets. month we average XX% of on over reach So our

targets reached there have over the all virtually course out we've today. So of we the months, that

that not of a we momentum building get how this writing it's build about reach about that more and terms base. loyal and sort a can that people our increase, month at will so of so to frequency two it's to forth, so point; prescribing the month three and that really are on reach In

And get to we're then we're the can we we'll about the expand of that more so build we've where as when through the to mentioned reach as loyal of I needed targets, start to first existing game that XX% reach all kind again targets. sales So happen then going prescribing before force gotten months that with again going frequency the number we're building that to base. and so frequency we build

Robert Finizio

each of rule thumb give doctors approximately rep a XXX you territory. in To has their

and reaching is make you doing top-decile key standard. that or reps from shift go-to So the about getting prescribers XXX out they've be to been to. be would XX,XXX will what that doctors The their

Jay Olson

IMVEXXY. on on refill super averaging max that think the out? on Only go? in high -- few That's can the will then Thank congrats How you. months Where more refill already great. having refills you been than the helpful. the products Okay category. other rate And for a also market rate do for the

Robert Finizio

question. your answer to sure not I'm

way I going best cadence have what a think like we to the we're to do -- on monthly scripts. go so is to

the give days it days we and us get our by February, couple XX guys. end will out in compile then data of comes say two So a all to of you at as February three it or to

new don't look, today. the for forward note. to average. question, better that go here. to be a a doubled do cadence the February. And compliance will we'll than here numbers I side personally fact, updated industry And almost but if that know But still as you going I expect we we've can we're in at we your early doing So to answer monthly look March think as cadence give it,

-- we the then So if in just start increase continue if you frequency model. lever. because plans, We continue remember our have most we're at implement offices more literally Dawn's with more physicians, with that, reach to showing business asking look and and for to the writing, a first XX% grow our cost pulling doctors' our low up

BIO-IGNITE count force. new larger doesn't activating women Now this DTC, sales

number That's new expect staying will I many Because this continue pull levers the and I'm we're good year, and We improve. growth a women to so to refills hoping have continue drug. and a switches year, of the throughout are to on really sign. getting

program a to can how money, don't into reps reimbursed and big do these right at, basic in spent be cost you out point. here we All is you price as be our refill at the look anything that rate, And with you significant telling of look get the is. same you be Dawn will going out We're And Because It's with that on if with add? be going that is could guys. you spot more the you Vagifem. little products the out upside the great. is to any come. -- these advanced to upside same have offices QX, trajectory. we've It's we signs additional And additional ANNOVERA how significant. our look growth we money still put

Dawn Halkuff

is encouraged that so Jay feel Yes watch seeing believe you just with but And have to -- the just if Rob I are going and obviously a add, two, are over I Vagifem. we're we us agree I I'll month-on-month. there that rates, for category what we're we're incredibly average advantages the seeing products so but compare and the for refill achieving to Vagifem second remember to X.X. by that

seeing we as can but at at So X.XX reach and that that again we're gain predict more least we're now, right that. experience there's headed. really But think we doubt that can't trends where I that's the the no fact

Jay Olson

Appreciate. Thanks. great. Okay,

Dawn Halkuff

Sure.

Operator

next from Schott Thank Chris you. JPMorgan. [Operator comes Our with question Instructions]

Your line is open.

Chris Schott

very Thanks much for Great. the questions.

think a as where pricing first packs -- between should a can script? shaking I here. you us how on we maintenance thinking about see follow-ups of versus the And Just guess time out to net you starter IMVEXXY; per about be couple got remind couple the just how here. balance over we I've

Robert Finizio

Sure.

So our guess is XX/XX.

It's more segment As expect through challenging take do share pack. the along we of we think can activate DTC is and effectively be with patients But the right or to that we continue now. it we as could that XX XX-XX lines Dawn's we switches market XX/XX. being into new better starter we the think

say and this get and starter would a another not to been -- lever into that that another So to could want refine call pull. our and be we some as start our the we we certainly but therapy pack you even if goal detail from we that's start label pushing didn't with on that we have does so techniques

you how way this with us you clear. in a those where Dawn be more a it year. for might prioritization Okay the BIJUVA, Yes. little I'm are next over ANNOVERA IMVEXXY just turn than thinking a see be more in And about thinking on thing doing then question. close might to BIJUVA can fairly to they're But like It what balancing very Schott of to Robert -- over sales so resources covered. we inventory year limited to you're give be we're this lot Finizio be and then really year So the launch would better close I today and just think have just pretty big answer do your going and can be how going when is it a color but question more XXXX second ANNOVERA it coming ANNOVERA timelines? now and great. sounds we to ANNOVERA in was to you're about switching come that a succession? want this launch Christopher

So should to -- the you IMVEXXY Dawn for but Sure. Dawn question. and BIJUVA Halkuff year. that this want do turn do Chris, well thanks over?

reason the fully force I'm thing that they at to in can first sales think we've same offices our are is the products and prescribers on of that only detail want but say confident two that that I I I'm confident BIJUVA same and effectively because once with calling So we've the the IMVEXXY is with seen not the IMVEXXY. success we that done

lot of keeping to with talked VP seeing bringing the we've a about focus the E+P IMVEXXY where that BIJUVA. to on BIJUVA with working momentum in -- our get our those momentum, sales So same we're top but in prescribers

first the most second. to don't second make as of We've as allows look we the effective got first product what's time have what's at that's the the to the So lot it of that us position sure way. and traditional put data sort be great far we position that we in that a for in always that going

And so that's how BIJUVA. we're setting it up for the launch of

Robert Finizio

news is It's unique. both menopause, great they're And right? very the

You don't too often. this see

Chris Schott

more capacity actual launch? capacity about And of back we capacity any on that coming one final at the terms all color to or be we rate-limiter to about guess, issue the XXXX, much that when just think not have an at position in how you ANNOVERA, as And think Yes. is in a a ramping, be just that's you for will I capacity going then company?

Robert Finizio

that see all. an being issue don't at I No.

be bit you So that little hormones up of where it here and did job get process molding literally They QX will you've -- a an to a should good few we basic, our nature. will the to a non-profit our inherited stuff And and line off stand. things initial dollars we non-commercial-oriented capacity that basic in lands as right? and into injection as duplicated and process R&D start investments pay Population of this from think a it's manual sped be the they're issue get the not and and but as Council, limited, -- whatsoever. very essence, million invested a year that things seen automated. a In be We've into curing there

it as and big-ticket starts item well. it such of extends menopausal and soon a that for really So possible we're there get clock it's just the as our payer going because as trying to us it reach products

confident very be capacity We're So an in issue. that. come QX not will

Chris Schott

Great. Thanks so much.

Robert Finizio

you. Thank

Operator

question last our And comes from you. Thank Dana Sachs. Flanders Goldman with

Your line is open.

Michael Scott

is This Dana. Michael guys. for Hey, on

two Just questions here.

like what know you now all The And first about the data adjudication changed IMVEXXY, flowing should we volume trend at terms in to the expect go-to-market given how is see through, launch? then we one going has IMS BIJUVA strategy the per how forward? for secondly, its of as mimicking

Robert Finizio

about is a on how going add data right? Michael, what and strategy X-pill in sales here A compounding we out leave going as So solutions, and sell is approach. is to to reimbursement Dawn almost an of is guess and -- to to But the And of IMVEXXY I out the limit that go to developed want right? exclusively thing it's off-label something just That IMVEXXY the launch liability in approach the so two OB-GYNs and fruit BIJUVA. copay clear the Pfizer second-best $XXX-million it came just basics do want neural an start make levers market is sort $X saw is fate effective came to paroxetine; we of X-pill at into cost-containment – environment turn approach is and or with -- refused sure I We where to workaround overlaps Duavee women market the it synthetics. They learned BIJUVA in directly we showed we've with non-hormonal great solution that low-hanging take So and what WHI has where to as force our place didn't we're market. I'll Sebastian So spent remember experience non synthetic working. want Make be the data. doctors' Dawn. that Halkuff offer it. the it just over those don't essence, Dawn? today. the billion; I with it is we on the you of Sure. of impact of strategy Dawn then is almost only out think our over before have We right? until actually commercial is that rollout another

once make I are brilliant done later that which job again call we levers we the and do focus so same exactly the more on they unlock we're would levers you that sure do which at the to and that who's would everything organization prescribing IMVEXXY. allows with productive. then high-writing Get same get the in same we right unlock doing follow adherence to other the right. do have that And a prescribers, once believe not sales is thing where pattern. momentum then planning and and those And become with Get the thing a that's us done, you're I because it it much seeing

out And same the it way. I so, again, would exactly roll

Robert Finizio

And if out you bit little a VVA out but you promoted, look everywhere. have space of still the at there being sampled not much Premarin

It Osphena to good You is get there's out you you literally have job; the there crickets. there INTRAROSA out as promoting. have who's nobody. pretty a well doing When hot-flash space,

We on even more attractive than of can adjudication? counter-selling really really, part like. Did thing. another will have the -- segment another We narrative very be And the VVA that's And that's you another without this Michael, question we which segment going attractive only the distractions reinvigorate shape or segment. voice. this any I'd say and

Michael Scott

just. Yes

Robert Finizio

I didn't hear that part.

Michael Scott

No problem.

Robert Finizio

repeat it you Could please?

Michael Scott

Sure.

volume forward? the we see adjudication flowing through, trend we on how as the the going data So, expect should IMS,

Robert Finizio

question. Excellent

as that and go some if -- as So, data. IMS Walmart, the blinds Symphony large directly with I back had. pharmacies take if well you And a essence, Symphony we've know, so at we've been their in look working this. year, and a on of Walgreens -- retail Symphony you progress the

share Symphony the to don't they it to So to their want want with some data sell pharmacies of it. they and want unless buy

XPLs it on behind. and that be XX% We're folks same a XX is, in within connected We directly Symphony just that, it's Symphony But matter Symphony. the the So Symphony. the next month not data literally further accurate with sharing these with of we've today, holding to hands. working like some are what directly a directly sharing we're with these will of that just data their days retailers of thing little with and done to we've XX% it's think retailers larger IQVIA, some

have accurate. And XX% you regular next the third-party giving on to basis. XX data So it'll in a days a we think XX be XX% to

Michael Scott

you. Thank

Robert Finizio

Thank you.

Operator

session. you. over for would Robert this turn today's concludes And back like Finizio to remarks. call the question-and-answer to now any I closing Thank

Robert Finizio

up next conference want support Thank to forward call to you Just with today your for appreciate we you. on quarter. thank look and and the everybody connecting showing

Operator

day. thank does Ladies you participating gentlemen, have today's and Everyone disconnect. conference. and for a This may program wonderful today's in all you conclude

TherapeuticsMD (TXMD) 22 Feb 192018 Q4 Earnings call transcript