TXMD - Earnings call transcript Q3 2019

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Operator

Good afternoon, ladies and gentlemen. Thank you for joining us for the TherapeuticsMD Third Quarter 2019 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's Vice President of Investor Relations, Nichol Ochsner. Nichol?

Nichol Ochsner

everyone. afternoon Good joining results for discuss third our Thank business today update. financial and quarter you to This issued financial results. afternoon third our TherapeuticsMD a press announcing release quarter press website the & The section. available the Media in Investors company's is release therapeuticsmd.com on

Executive On Chief Robert Chief Officer, Financial are and Finizio; Dawn Cartwright; Officer, Halkuff. today's Dan TherapeuticsMD call Commercial from Chief Officer,

current press can would to results remind forward-looking to factors based quarterly during number update no of may annual today call conference statements as due statements. with such of like be and no and other everyone statements change. Such company reports which made statements there in available realized. materially I to realized SEC. the be information a are statements and statements are expectations and assurance in that upon statements – Actual release the based These forward-looking this assumes be filed differ will our be results that, some from certain and TherapeuticsMD these our forward-looking may to may the on statements risks are contemplated that circumstances identified obligation

recording and also available Media for in today's webcast conference be & website. call section the will Investors the replay online of audio An

who replay be call the November For this the benefit of those, archived or recorded XXXX. may X, webcast listening to was and held

over the call CEO, Rob TherapeuticsMD turn to I'll that, With Finizio.

Robert Finizio

joining today's Thanks Nichol. for everyone call. you afternoon, Good thank and

sales to FDA at led financial products, pleased is from report third guidance. with in our product commercial continued the growth successful approved are We of came strong our in execution. reflecting by revenues end quarter net a upper that This

QX Financial our over call review Cartwright the more detail. turn now in results to to Officer, Chief financial Dan me Let our

Dan Cartwright

Rob. Thanks

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

which of third to $X.X revenue previous our X. as sales I'm from The on combination and compared licensing a believe to our from $XX.X second overall Slide sequential net net third million performance. to comparison quarter we the million focus to discuss for the trends brings we quarter. our going quarters, for is now Turn better product revenue with

shows revenue third to compared quarter our Slide X performance our product guidance.

revenue quarter coming revenue approved at products vitamin financial our in end business prescription our of and guidance. upper the $X.X our financial was million net our above Third quarter from for third million was FDA XXXX of of Net guidance. prenatal the $X.XX

Total product $X.X the in came net revenue at end at of guidance upper our million.

Additionally, and from in for $XX.X we agreement licensing revenue an million had from Theramex. IMVEXXY BIJUVA

this payments receive in to the are license future. under royalties eligible We also and additional

that we quarter The was chart the pace million revenue Slide on of trend growth in for which net revenue growing IMVEXXY Net the for growth at X strong faster a shows continued $X.X units. than continue have for to IMVEXXY.

quarter increased net to increase XX% see, revenue a can you quarter over same IMVEXXY period. units in XX% As compared second third over the

X, to BIJUVA with have continue approximately for well. $XXX,XXX the line was Slide to Net revenue our Turning we BIJUVA as for in expectations. for quarter strong growth

revenue see later. to per unit be will net discussed continue which We

late ANNOVERA and third launched in $XXX,XXX. Now recorded We to move the sales X. of Slide quarter

net see per unit. to revenue average encouraged are We initial at $X,XXX

Turn to X. Slide

the quarter. for in and As BIJUVA increased third launch expenses ANNOVERA. compared XXXX second due SG&A the of the the quarter to the for for quarter expected, expenses the of the were to the million to million previous both IMVEXXY of third operating the launch of total $XX.X compared XXXX for increase XXXX expenses of quarter and $XX.X commercialization preparation for

share. $X.XX million, license share, was of second or net of quarter for our basic revenue Turning to the the net XXXX bottom-line, $XX.X basic while per third $XX.X of diluted which diluted and or XXXX quarter the was million loss $X.XX loss million the $XX included in and per

quarter revenue license a the million would net the $XX.X quarter, of loss have compared second million of XXXX. $XX.X in to for net third been our million of $XX.X loss Excluding

with to of million finished at move compared $XXX.X Slide June million Now, X. We $XXX XXXX. the XXXX of quarter XXth cash in third with

see Slide would on an that we proceeds balance the end million. of $XX shown the completed XX, forma in after cash As you million. of quarter resulted a at the Adding raise $XXX cash can equity netted raise quarter the the the from pro company equity end to have

to turn Please XX. Slide

to to year of products. capital support Our commercialization taken raise additional the FDA approved significant company has steps our this three non-dilutive

loan opportunity also tranches. the have Sixth in Partners from TSSP down two as We pull Street to $XX million term known TPG our million from $XXX another

of launch the FDA's well For discussions as the trends for for coverage the this begun ANNOVERA insurance commercial to revenue category revising that rapid TSSP as positive potential tied about commercial draw FDA's strong net quarter first $XX per decision including and have ANNOVERA. the is on decision to due XXth is to the million with year. after unit This tranche, the come the fourth trigger we the

TSPP trigger. has terms such no informed me -- is we or that to assurance and There revision, the will a is considering excuse revision. a of agree to timing TSSP revised it that us any to open this draw

and upon audited ANNOVERA million our from of quarter $XX revenue achieving for second in million would IMVEXXY, XXXX. year-end late fourth available The delivered in tranche $XX are be BIJUVA the February after us financials XXXX to net

to Please capital net be TSSP. the of turn we XX. XXXX. additional because to reaffirm million reiteration we it of net time, access affirms This Slide guidance fourth in is product confidence revenue the from for approved quarter our important At our FDA revenue will $XX guidance product able this that

Officer. call Halkuff, to like would over Dawn the our turn now Chief to I Commercial

Dawn Halkuff

Dan. Thanks,

to Let's Slide XX. turn

I seen FDA want to $XX to quarter million $XX in for going of take million that QX, our you've product. guidance our our through we're revenue Now net you how achievements approved fourth achieve to

to first move Slide Let's on IMVEXXY XX.

rise. have and you the rates shown see can net a adjudication calculated per growth rates continue both adjudication in moved per as per trend that blue calculated indicator is revenue right-hand on has be unit of see rates in continue slide up, the gone adjudication the can the same shown You of net side demonstrating of revenue of unit. the What to to rates the that unit revenue on net adjudication good green

co-pay by began of approximately we achieved we cash this moving QX program of our We as October, optimization pay goal coverage our to process in In XX%. $XX from did $XX. broad commercial our

and the pleased calculated importantly, the are of net with immediate are revenue We first on we adjudication results impact month the seeing per unit. transition of and

per already that a fourth per XX%, calculated shows $XX rates in October a approximately XX% on we QX. we over unit. revenue anticipate experienced to October, quarter to increase at have is to in which unit Based net increase of the adjudication trends range $XX the

if even of stay were this, IMVEXXY relatively Given for minimum fourth flat quarter, revenue. the could produce TRxs to $X million of a

for the we growth the on drivers IMVEXXY. of quarter, remainder focus following will the For

hyper IMVEXXY commercial that are targeting First, through of for prescribers we patients have commercial their strong adopting pulling and coverage. where therefore

to turn Slide Please XX.

CVS an share is of adjudicating XX% in adjudicating began are who support addition Other those in of levers within now we September, the to prescribers commercial important October. growth the With month patients at IMVEXXY, which medical closing late thus continued I have completing agreement advertising, In commercial in we with as direct-to-consumer now cycle. began well want Aetna our for payer education to announce as August.

XX. Slide to move on Let's BIJUVA

XX% are transition. for we see at now can $XX over shown in On BIJUVA XX% the during rates process growth optimization an third blue chart, October cash started and the this to As see on increase continue October, same you $XX also in adjudication quarter. X, pay to

trends to the anticipate with along that per already in per unit. changes, of in quarter to these a unit range increase fourth the experienced October, to we $XX Given we revenue net have $XX calculated

quarter adjudication on we Envision completion commercial Slide currently adjudicating payer September process the through November. to begin the Cigna XX% commercial of Moving have access will The pulling of in XX. remainder and access at who in now will with the unrestricted focus the

We are adjudicating October. patients now of month at XX% in the commercial

BIO-IGNITE the adopt prescribers key organization In on to management will continued to with addition, the the live XXX growth on along location drive we of sales focusing focus BIJUVA. high-decile team our selling account work through

to we towards the expect a XXXX. approved Application could the if submit dose to which milligram Finally supplement FDA approval of Drug of end launch the efficacy for BIJUVA New X.X/XXX for

ANNOVERA on XX. Slide to move let's Now

a a launch test provide the launch September late sales only environment existing our to in selling learn we in of As XX product support representatives soft reminder our and and XXXX. fast with full the started for to sales management uptake QX

Turn XX. to Slide

short sales continue of addition build period of focus, which In to coverage XX coverage XX% now the six a with in is unrestricted time payers. commercial the at the commercial top by access to we

XX. Turning to Slide

category demand Company providing and marketing to have are and We obtain And quickly in the convenient programs birth started contraceptive to working control for consumer to options continue pilot their we'll fill patients Amazon with more also PillPack

doctors the represents that ANNOVERA contraceptive or only are the ANNOVERA, option growing marketplace reversible feedback for reminder contraceptive in only still long-lasting women. LARC from reversible procedure-free indicate a need an unmet long-acting As segment. the important where is Early

believe that of we X,XXX per in generate sales demand we trends the $X,XXX. fourth why revenue confident we this Based minimum $X,XXX in patient can unit Putting we calculated with to units expectations. to-date, see quarter quarter a together will upon our fourth range meet can of and of feedback the a all you net are

our stating growth of products with in portfolio Please XX. strong launch move now on end Slide strong and execute launched, to the all our to a infrastructure commercial us foundation giving plans. built to portfolio by are coverage I'd commercial across like the ANNOVERA initial future

the I'd now back turn Rob. to like to call

Robert Finizio

take few key lot of to Thanks shared today want Dawn. a a but points. away you I We've information

QX our the end First, guidance. we upper solid had a and of hit

should TPG marketplace million Partners women's significant guidance reaffirmed into trigger will a Street momentum In us and in our We've XXth XXXX QX $XX addition, and and our created in draw the dialogue extending related health enable category additional to non-dilutive opened take the beyond. with funding. achieved on once Sixth that we

now lines like to up open the for questions. I'd

Operator

question first of comes [Operator of Stifel. line from Instructions] Your Annabel the Samimy

line is open. Your now

Annabel Samimy

have questions Thanks several and I taking my for here. congratulations.

this you that it I not just I be But happening part apologize to think comments talked all? February. so is the of I that that is that will delayed you So, understand I it also was your happening mentioned the had first the you've I'm actually first FDA classification, in have about. already on or communication classification for asking lends believe if delayed with FDA possibly And something restructuring at restructuring. you missed

that's first question. why decision? that is the So the impacting So

going question impact copay Second the of fulfillment what from had has patients? impact of walkaways? Is have okay of to $XX that prescription kind what is kind $XX on having – for level a and is, what that move I –

adjudication. in third the not higher increase And really only from finally, second I proportion and net then quarter, guess quarter just at but was with in looking BIJUVA modestly the

could I if And some back I have the in So provide color Thanks. I'll you queue. there. more. get guess

Robert Finizio

Okay. Annabel, its Rob.

Yes, category. XXth with of contact changing So, the lot a FDA. division we the We are there. is – in certainly the restructuring

other I'm sure there's you're lot there. with As companies going seeing a on

So we qualify – believe we And next the decision. into year believe FDA's for is the but decision will push the that we the and financing. thus category, still we definitely do XXth

And going decision patients for we make okay be all to think pay either question. On Dawn, it. cash on to do it or for it us it's And that clear. if they qualify for think the to that the will answers think questions. I'm I do your will We make They $XX though just pass us. we'll against

Dawn Halkuff

Hi, Sure. Annabel.

Annabel Samimy

Hi.

Dawn Halkuff

we would the coverage $XX knew been is has – We do to reminder So just some on. question what change reason, have strategy this of the the X. was go the $XX? drove on early And which unlock have the October we access So, HCP that before we provide impact commercial context. which just just a prescribing we program a as asked open to on lot made of to came back you

And move broad $XX the was achieving to timed that national so with coverage. commercial the

answer are the where to and And that of HCP that's going the we to what is we still And prescribing strategy. the still yes. is like so open prescribing. We're why that access still prescribing professionals see HCPs really the have end because our healthcare

them. some don't have the to reality $XX for said, unprofitable the from price seen drop-off the patients where that are coverage. But we an it did more of that those – That $XX those have the is where patients wasn't acceptable

so to And profitable to see do shift more those you're patients. us is starting what

rebound the And professionals we that those I'm for in were very in growing have that And that targeting to still hyper are commercial are care again, health adopting coverage. those growth. because direct-to-consumer prescribing, as particular advertising confident we support also

that those do I expect some And losing without we're coverage, we rebound. drop-off. set a up is see the to ourselves long-term. did we see for which are So again, folks the where

Robert Finizio

we have We market. and only XX% strongly to Annabel, share done. will our We're approximately. not Yeah. grow the believe market continue share the market of we

Annabel Samimy

on just question, And Okay. last the BIJUVA net.

sorry. yeah -- So

Dawn Halkuff

question Yeah. Annabel Your why isn't. ahead. Go was

Annabel Samimy

Yeah.

we step-up in the BIJUVA, much gross incremental net the bigger saw increase on to a see rates. but Just didn't in we adjudication

mismatch So, be just of what's little kind color So, was there? the this would great. Thanks. a proportionality

Dawn Halkuff

isn't where so much are up what where that is will yet expect rises. as Yeah. gross in that the coverage place IMVEXXY BIJUVA net because of rate, was And coverage we they IMVEXXY catch higher would is to similar to the

Annabel Samimy

I on, ANNOVERA. sneak in Can Okay. more one

Robert Finizio

Sure, of course, absolutely.

Annabel Samimy

even to the mean I net fourth is, You mentioned for $X,XXX time. $X,XXX. have increase, ANNOVERA think that set you the I price quarter I guess over to

are going we getting going see onboard up. down, this actually but payers more So with nets usually

the guess maybe there. can I dynamics understand us So help you

Robert Finizio

it's can see coverage. faster as than nobody I fast BIJUVA like ANNOVERA been is Yeah. is going I pleasant very you is has which mean, mean, seen. IMVEXXY a something as is just surprise. much got here

about so our many and require nets. weeks use if -- to we the So, coverage copay copay, would would obviously and in payers cards of that four impact percent XX-plus had don't

the it's very are of between. we drug type how and believe -- few is. it far And are rebates new The method. Given clearly, also a

$X,XXX a price. So, WAC it's

Just than less to it's year remind about everyone worth a NuvaRing. of X%

is is that of the coverage nets adoption experiencing is rapid the So the in in company our -- opinion staggering. this

healthy. really And that assume will it really, So, as go looks we forward. we improve

Is So pleased. your we're that than question. addresses more

Annabel Samimy

Yeah. That's you. great. Thank

Robert Finizio

Thank you.

Operator

Cantor question next comes Louise the Fitzgerald. from line of Your Chen of

line now is Your open.

Sudan Naveen Loganathan

Hi. I've Louise for in for Loganathan my is got This taking Naveen Sudan Chen. Thanks couple questions. a here.

to tap the you able touch million I I noticed first to runway. into. that, on $XX that wanted cash So have you're

the able amendment, past price hitting to the have now? one, XQ higher then, if the is in tranches And what XXXX. there coming any in the case, would the then second cash any on you Or secondly, pricing for ability $X,XXX? million tranche prior if can we have then, runway forward, I currently to gain it the or other you're that And up ANNOVERA, is get, $XX And increase can XXth in go -- there not? to is clarity that what

Robert Finizio

Yes.

Okay.

our Dan and well, CFO. So Rob little as to bit this is Dan right. going I'm All to pass a Cartwright,

we for and the the make So as far call, very to the is in that are this experience designation number as XXth -- significantly crystal what category, our originally happy net try to of reasons. nets would clear a we believed XXth category improve

One is copays.

would the category, also get rebates. help nationally. With would and XXth coverage quickly also there us be copays It no

the unit rebates $XX so revenue surprise the XXth value Sixth company. few be very have category's the the XXth of at adoption, few net the from and on draw and to Given loan far the category the point per for impact between, pleasant very million would more Partners, would this copays, Street TPG than

that, to at just per zero patients, it to there we XXth to we're of that all. it a So was there we number and that's for robust copay, ways category, couponing net a very product if with down have revenue a want our of much There's the our strong of I it. without is belief. kind And get intent to people plan to on do right? don't realize

surprise. pleasant real a just it's So

goes, your as I with seat, And us And at the of I $XX -- we category's $XXX end the so, if quarter. far sitting I had we've got the is to cash draw think, XXth million is have, with then, TPG. value were would million the takeaway the as the in raise, basically

total gives The us million. and a -- million in $XXX of the we've our the $XX the think I potential to show raise, guidance. out, the laid numbers confidence reiterated it With and

Partners. if that another We million designated us $XX guidance there. for would to Sixth the another $XX agreement QX, million TPG our affirmed is And category which loan from Street $XX then draw hitting then, -- would XXth give with million the ability our

to until as get discussions depth of I we stated, in them well of job. are as a into We but there lot end with get we can't

Okay?

Sudan Naveen Loganathan

Okay, great. Thanks, guys.

Robert Finizio

Thank you.

Operator

Your Instructions] Schott comes line from next the [Operator of JPMorgan. of Chris question

open. now is line Your

Ekaterina Knyazkova

And This is uptick you on can seeing so is, channel the for one coming Chris. first in Thank been questions. you BIJUVA with do so the Has uptick see that the you're ramping you quarters? just my for compounding you it Ekaterina far? the and talk and actually taking specifically about how our far your with experience in compounder expected what

And the can investment with XXXX you. talk be and second is, more to Thank behind open for question campaign Is IMVEXXY? DTC that about the putting beyond? your something seeing you're you're this in you traction

Robert Finizio

Ekaterina. Sure,

is this I'll to it hand and Rob off Dawn. So

far pharmacies as program to up BIO-IGNITE up that as are IMVEXXY. So are live goes, we on XXX and

have going on had half were payers last here that this quickly expect very We future weeks on we're more -- that near those by But of BIJUVA. and the in now future in already into the about come we've starting we way. just few in the last couple the that

So whole to on net lose this in of sure of class don't we those had make is solid trade any prescriptions. place, idea the BIO-IGNITE so revenue we with for reimbursement

operational see the additional add all well, as live pharmacies hopefully you'll of this to I'm So have QX. going The DTC we'll to XXX and on off question quarter I quarter, towards then and we'll next the those it bring fully hand end think throughout Dawn.

Dawn Halkuff

Ekaterina. the for question Thanks

going traffic can seeing end DTC you significant the the getting the are, early. to in early data DTC early on to we largely I social XXXX? media. was question growth from we and print and we're What website. tell continued look as at that the indicators are website are launched your invest for we digital at how going August we're in So of We is and so And

what to means and of will we're target So significant wait what we putting the few interest, to months the see need there's on that message us that ROIs but to there. is is a out

year. our to are have and to our building In going the said a together on be so that we in XXXX terms we campaign, investment, invest putting But know strategy we'll we plans XXXX? we all IMVEXXY learn can is get throughout of we continuing. The consumer with a We're we've to we and return optimal yes, campaigns do our DTC yes. But of test look that do as the answer now. will always but we're solid

Robert Finizio

intertwine you $XX think cash can with $XX, that I pay And to right? the raised

Dawn Halkuff

Yeah.

Robert Finizio

that's not number -- as is what patients So well as -- really slowing. your profitable of a targeting you showing the to the that in what us want your physicians who's improvement for also right? intertwine done is month little the growth into we're here that really, which a uninsured, continue are that helps to And bit that and ways a willing to full pay pleased one you with can we there's direct-to-consumer of that growth. demographic you but that's been number brings of have But people

-- patients profitable more and quarter. this we much that expect So be they'll but just

copay the as except So plan ANNOVERA in many this really happy we're whole we're thing products not kind says using of fashion cards Dawn at intertwines that all. all as one where between

Dawn Halkuff

Yeah.

Robert Finizio

Correct. Right.

feedback patient less upside have units. and less the we is we So have much margins. on the net higher information But immediate

Ekaterina Knyazkova

Great. Thank you.

Robert Finizio

Thank you.

Operator

of the from next Your HCW. Tsao of comes line Douglas Instructions] question [Operator

Douglas Tsao

the question. taking for Thanks afternoon. Good

curious awaiting important decision how of Part Just I that or opportunity? the -- Rob D. maximize is run to product D Part to IMVEXXY we're sort for just optimize know that for

Robert Finizio

joining welcome. Doug, and thanks for

your company. appreciate the So here we support with

So thank you.

is important D $XXX nets IMVEXXY. talked that the about we to range up for for to get So Part

but get positive get we important think do Part not patient the all we'll D remain for very well. is really So most. side, we We type. we on it them And will that that may

look you to the segment our the where a take adjudication coverage close slides, it see you'll have If D We're where significantly our at look Part improved that -- think I -- is. close up. we in

So in have basically essence we United.

that about and access of XX% and there. XX% there shortly that continue Kaiser, to we're adjudicating we have access to to But has We but hoping improve. no United get have expect we that

Doug, thing sorry -- at we were. And up last on me are the XXX% question asked IMVEXXY, for glad brought adjudication for CFO IMVEXXY, you I'm that for because I'm mention we actually is I ANNOVERA, it one my not wish to here

down So question adjudication. here. for at ANNOVERA on answer for ANNOVERA just the XXX% last We're written that's

to important, bids all will And Anything those add? That you Doug X question D. and bad for XXXX on very need it's have for anyways your be those will we we So or of approximately. you the all we'll pretty is year And good know Part our of -- do which XX% prescriptions in answer as us to decisions X. start of total made before want well. we January January think

Dawn Halkuff

ANNOVERA and for the planning are in just you're launch first we're we Yes that One of sales in demand. representatives mention up thing to high unit. we're the quarter with mentioning per that January that we the given didn't XXXX as results revenues the moving XXX as that full seeing adjudication is XXX% the ANNOVERA doing the beginning

So put start I really beginning to that good will of a in the us year. the think

Douglas Tsao

characteristics in the question physicians are or, and from the What then curious that interest one they you're you're today. seeing sort just the just gaining to most about be of, I'm in talking And traction terms of on ANNOVERA. demand marketplace? seeing the follow-up seem

Dawn Halkuff

Yes.

mean been about been I month So and -- we've out there it's for start. interesting a been it's really a

we're sort career the something launches because that in the is Where reversible pharmaceutical with is of just is need One you haven't describe which space. our my time representatives would I category. it's the is product procedure-free the getting expect there are features is shows only in seeing to is exactly what the of which important the unique product, that are this so the really it wonderful seen and it uniqueness contraceptive is in that sales also unmet bringing. product the and So the

seeing but the are in mean really care health of insight have time And product, seeing terms IUDs. type to that. across-the-board, that really got of us one care that And with doctors that discuss coming inserts every it's that to us they that's the for is physician of professionals we're not so the in professionals interested health that because we're the I

because this product we're really seeing usage they they're IUD the offer where that that usage patients in And that long-term is and lower or office keep so patient that option. no all of can wants seeing IUD their who a at the

good So the we and really early bullish results future. really for feel

Douglas Tsao

Okay, great. Thank you.

Dawn Halkuff

Welcome.

Operator

would I closing conference like time, to this turn remarks. back to the At TherapeuticsMD's CEO, for Rob Finizio

Robert Finizio

everybody want speaking next time to you your I conference call. to thank and for appreciate look joining we quarter. And forward again you. with the Thank

Operator

and gentlemen, today's for Ladies concludes this Thank you conference. participation.

disconnect. You now may

TherapeuticsMD (TXMD) 6 Nov 192019 Q3 Earnings call transcript