DARE - Earnings call transcript Q3 2021

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Operator

Welcome to the conference call hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended September 30, 2021, and to provide a General Business Update. This call is being recorded. My name is Abigail, and I’ll be your operator today. With us today are Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer; John Fair, Daré’s Chief Strategy Officer; and Lisa Walters-Hoffert, Daré’s Chief Financial Officer. Ms. proceed. please Johnson,

Sabrina Martucci Johnson

afternoon financial Good Bioscience. to third our Thank and and business XXXX results Daré update quarter you. welcome call for

Our XXXX, in review since plan and milestones time to results, the objectives as today developments balance insights for discuss XXXX. of to last highlight our well and August, quarter’s call anticipated use as the last is into

or which forward-looking the to during Litigation begin, made by you to due and that Actual the Laws, include I’d statements Federal historical or will of meaning like these facts to unknown remind made are the statements be known I uncertainties. Reform risks this to Any anticipated not the results statements materially of Before discussion within implied call that provision differ XXXX. pursuant Safe events are Securities today’s Act statements forward-statements. considered Harbor of could Securities and Private should those from

statements. place not should You undue on forward-looking reliance

their XX, cautionary in any by as focused and Forward-looking the update qualified by to including XX, March except as today, to November call, year Form content ended that is time-sensitive Daré Form law. our women's or statements of XX-K only XX-Q Report today no health. developments well the Daré Annual solely is new point XXXX. information obligation statements SEC also on current of this out information December XX, company’s for as like this to required call XXXX, statements would squarely filings, that September after as in includes undertakes reflect XXXX, forward-looking ended in quarter was for the XXXX on filed filed our are entirety which XX, the the I

unmet line category and candidates many and health. focused of having development Our prescription XXX(b)(X) women. and have options clinical addressing health be that approach strategy Prioritizing overall potential and well-being, vaginal is directly needs the first of contraception, therapies into women's in differentiated through portfolio market us for and diverse opportunity, sexual course expand to health U.S. meaningful treatment move be the in path, this to outcomes, areas to of improve commercial primarily regulatory fertility good development the a and is potentially via allowing first prioritize bring developed a in of options, that instances develop identify, shortening women's later cycle with to and stage for can or the And

create our several the clinical seeks advancing strategy value achieved strategic for key on Our to we and stakeholders. initiatives of partnerships to candidates. the and with development of value third clinical yield and and during actively Significant progress corporate pipeline are was all benefits quarter, our the maximize portfolio

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Before to talk little that, bit we I do about a want programs. the other

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of Our DARE-HRTX order estradiol pathway the approval and clinical in approval to in marketing data and the active ingredients leverage regulatory XXX(b)(X) efficacy in strategy is obtain to on and DARE-HRTX, using development the safety existing to progesterone, the the seek U.S.

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administration As DARE-VVAX. clinical Australia breast mentioned vaginal VVA. trial tamoxifen program proprietary our cancer formulation treatment is my in we for treat DARE-VVAX for initiated X/X vaginal Phase the quarter investigational survivorship opening in third this I of a in atrophy remarks, to

intercourse, As discomfort, an for history with of women is you breast be lead cancer. as can outcome painful addressing distress. approach important causes cancer including the of for it a it risk often vaginal to effective can significant to which option at a hormone or and breast could imagine positive treatments, receptor VVA non-hormonal VVA,

VVA For is for estrogen. many treatment an supplemental women appropriate

However, estrogen hormone receptor a breast positive may for pose risk cancer.

So Phase over now women call during not a will provide offer I to strategic to solution hormonal DARE-BVX. for to and the for study on an We treatments currently DARE-VVAX DARE-VVAX X/X top-line the a may these for expect others data option. report update whom turn XXXX. John, from

John Fair

you, process. aligned the with purposely The Thank has regulatory Sabrina. been DARE-BVX partnering DARE-BVX process

saw FDA And the marketing important pharmaceutical able symptoms, share a was viewed a curates best of experience. for bothersome indicator most partner, DARE-BVFREE able to voice data voice you the royalty being DARE-BVX, When we of a opportunity will you With experience the current of action the market, launch service three for approved, familiar single as key top belief Payers, straight commercialization. in research discussion, Daré generally commercial clinical for have our category key structure the in of market data the able includes of CSO. to the fully know, in with many whether we a specific for highlight bacterial absolutely And FDA previous but product. to In providers its sales on interested out from through our on commercial in of women's should some vaginosis we positioned pending class our well appreciate being via Sabrina performance product at active of remain the bacterial motivated approval have a new well company, for the a is discussion of reported the organization to that's our currently really healthcare our partnership category insight the there's in focused DARE-BVX and of the in update for average. of that curates all DARE-BVX therapeutic that suggests lack discharge. for potentially in the is it the be the in a the approved All rapid administration previously curate particularly share due payers. patient options are for bothersome NDA. has play who study are bacterial patients, for particularly likely of our recent brand, we treated news to payers. the including been us category been review accelerated responsible on bacterial as the NDA we product the dominate That partner new standard during insights X introduction that shown is products. are role to What we is the care scenario ongoing the positive another to that achieved brand it's DARE-BVX. one-time bacterial addition I'd candidates, to on the as call partner target the as and messaging study, add under direct dominant an second with the approved those as symptoms where contract we understanding payments expect a you options is based context some for payers the DARE-BVX to have milestone December to portfolio FDA, under the of be vaginosis We as active entire produce suggests believe DARE-BVX three of who partner, like options if we patients market and of date. by any with patients, the health. better versus strategies believe bacterial of reflected And most for women. the share positive a treatment high vaginosis or DARE-BVX the lack payer to full and relief the approach exchange we round recurrent for treated can providing insightful And coverage any in research of to patients call work a The patients of product to where mentioned, product. is role clinical for and right PDUFA what influence patient approved same part vaginal previously third find products, the vaginal feature on across In in that our on to a And based our with with on market success will give that's strategically for the for half that promotion considerations we you retain have and way and the for potential are can might never for by an mentioned effectiveness of success. Daré, the for the underestimation as has clinical a a innovation where success, Therefore in vaginal very this that's good dose. odor both we the true And market data of recurrent who a the vaginosis resolve other that the category time end our rapidly and us that DARE-BVX been also in about DARE-BVFREE commercialization and and being include able for commercialization And the are DARE-BVX that to or vaginosis. dominate main FDA commercialization as promoted positive solely option under product vaginosis. team license in scenario priority patients. real which the the could viewed the point, to recurrent the patient believe fundamental time discussions impacts differences team the for the as available of DARE-BVX’s critical research We impact currently voice, market or of it's positively treatment because is, products, time factor strategic as

commercialization. progress our we summary, the with in DARE-BVX to are of discussions So specific encouraged

bringing new I'm We that, prospect women give therapeutic turn call and are going excited of to about to financial a providers. the the to options to update. Lisa, healthcare important you with And over

Lisa Walters-Hoffert

us thank XX XXXX. financial Daré’s to today. I September Thank now would you, period like ending summarize for John. all joining results And the for you

in As Daré’s novel of health. is advance you women's to know, a and product model assemble, candidates business monetize portfolio

acquisition a R&D development and to or and maintenance regulatory advance our costs, through result, including our research consist overhead, and expenses of clinical and approval. As portfolio candidates corporate activities milestones,

development were quarters million were for and ended X.X% increases For XX same compared the related Daré’s other the to in cost clinical and Phase Cream The expenses $XX.X reflects activities million. and general September primarily Ovaprene. the $X.X and in clinical, ongoing increase XXXX affairs of expenses XXXX, our approximately regulatory and administrative approximately R&D manufacturing in activities trial, with R&D Xb period expenses Sildenafil quarter RESPOND the regulatory

million. for comprehensive was approximately Our the $XX quarter loss

ended and months September XX During million under ended million cash stock XXXX, program. from approximately proceeds with the approximately of reflected $XX.X net $XX.X activities nine ATM We our sales primarily in financing cash quarter and equivalents. were cash the

of approximately that forward. As other impact common of arrangements moment I'd like X we to million take November have stock a burn few to XX.X favorably outstanding. shares our highlight XXXX, cash we a going expect will

to As research DARE-HRTX this that of expenses program, past, allowed in up conducting and eligible were and the related for companies on receive the year as to file in the our may program R&D based research cash current eligible allowable recall discussed apply trials to to a under activities be in Australia expenses in XX.X% XXXX. we've tax and year. development intend payment that We their development under for current the and early eligible Australia's ongoing DARE-VVAX for reimbursement the XXXX, maximum following amount clinical the incentive

amount. will experience the for Daré manner. agreed and support responsible study of under Ovaprene NICHD, pivotal X $X.X April had in allow parties. the to providing be of manage the pivotal pivotal should for other To-date, be of study, the clinical the We conduct July cost completion as study also this the XXXX Ovaprene NICHD’s cost CRADA clinical with $X.X total we estimated And the costs believe the surprise Second, contraceptive and mentioned, million related Ovaprene. will have contribute the for the for the Phase also Sabrina for efficient we'll million responsible of XXXX to between of NICHD conduct and paid Daré’s that financial an efficient to to payment expenses third and trial study. the the of X

grants for grant to In use in for continue the additional value. and allowable apply for in to will closing, the future. our to existing to we build an shareholder and opportunistic source expenses have and funding non-dilutive Finally, will Daré, collaborative capital to be our seeking and attractive and of continued be funding we grants endeavor candidates creative, necessary advance explore

XXXX to the liquidity quarter also all and financial risk in September more We which today, call our encourage turn investors was as review the the the XX-K our to operator filed in March detailed factors XX report would questions-and-answers. XX. on like as over ended discussion XX of condition, Form Form to for resources, our I for on well December capital ended the year now our filed our annual for XX-Q financials that and we XXXX,

Operator

ROTH Capital first Jallah with Our Zegbeh line from comes Partners. the Instructions] of [Operator question

is Your now line open.

Zegbeh Jallah

question. update. And progress. just on going my three ask the for to all I'm quick taking nice just once. for at have thanks Thanks I the congrats And them ones,

FSAD. used for what’s the if since the being points response is for one wondering program Ovaprene? will second I to comment you end FSAD was this one be first the noted the be think completed Sabrina I then as And you is for study, IDE for therapy needed on approved the the or first could just just the

patient, is you're you some like even just don't And IVR considering do maybe it And using if are things that. education pros but on using since I now then know plan to the third? of wondering investor being some additional technology, lastly, patient with this for that, like things and perhaps programs. used the two you and -- just So not

Sabrina Martucci Johnson

those all, of happy them. to really questions, first are great, great three the and opportunity them to of you, Thank all answer have

But of it, we an development. on Ovaprene already about to combination things division And as similar ways human happen about think Ovaprene backwards, the to you drug completed product. a the a wouldn't sounds review think the in on many if leads drug it So the normally it's we've backwards study from But first easiest know I is because device IDE, Ovaprene. a in of IDE side. IND. were with because the little way all how that the

And But IND would we it of expect all the follows agency so that we kind way study be to give have to it the you that think the has comfort completion pivotal Phase an that a it did. aspects is in pre about the going X trial. in IDE that would that to of into

that into so, of the manufacturing, also so the of the IDE. human all like to device engage previous your all you we And that FDA divisions that in multiple this and study if conducted, what's really I've division on with set pivotal they times actually before of concept, our the case, leading to opportunities the the nice they kind a meeting of file working even proof pre non-clinical, of calls, goes the standards. And about wonderful. you'd review are both But have mentioned device IDE, is different division sponsor so them provide the with

an study sure on what it's to for So goes an the are the IND. bottom conversations year, to are similar clear this before have a helpful quite into right to the And plan But our it's is during of of just in start line to this expectations basically we to getting what work is IDE. so make for we that end now XXXX. the can kind on sponsor the that FDA

ourselves we're next the it but goal in start our planning deadline year. little artificial end So is it's study to for before an bit year, a get of to because of the

you primary endpoints, you're Sildenafil, correct. on In had terms the and question the of the

in just not studies this female a with we As FDA that the like on the sponsor as of the with primary important one I in aligning but can aspects that, FDA, disorder answer arousal condition. improvement in on conducted of can symptoms actually mentioned, called women program the spent the those And we you most And bothersome working objective time content that first endpoint. her with something collaboration outcome patient the validity the captures the was the importantly most and identifies that studies to any reflects identify is symptoms the in and bothersome answer, she this of design reported the in that primary case, sexual patient endpoint.

the and in distress of of so most case her one And of the bothersome it's the arousal to female diagnosis. sexual is disorder, condition aspects linked actually

say enough can't dysfunction. often similar I it again, erectile how to is So,

men erectile causes, of that like sexual activity. of has it physical of in dysfunction mental just so the and to There's a component response distress very sort lack component in that So the also analogous. terms

will co her sexual that primary arousal can she So with as her then as that is of endpoint it's experiencing. our importantly, response. primary level genital looking is that at distress evaluate we analogous response a physical endpoint be, again, And

And calculations, and like a of primary a co-primary well best it's does design with so that trial that's It's us using what's endpoint. includes to a the she of the that really new on and to doing in that X really reflected exploratory designed so because the is data And we endpoints secondary historic reported a time, patient specific terms FDA of in and sexual reflect sponsors for this is different of to a bothersome is target those understanding data, the the endpoints a on powering Phase interim around really get estimates the this nice her. of sponsor can clearer based collaborative very really that analysis that designed content frankly, field for variety for lots interim dysfunction is for work lot an opportunity published of to response what's for new across the of specifically most reflects indications sexual dysfunction how allow kind questions like really FDA based and you powering that That's something validity what the power on allowed this in endpoint. that. Xb this, you're But analysis reasons program trial an of make because this outcome because but from your the number advance as Phase is her, the use possible. when notice and first happening,

can thinking women. but and dosing often to Bill as platform technology, great educate of the something how product something portfolio. we deliver technology Langer still achieve multiple not leveraging so use do And to flexibility third, first technology around initially need Bob opportunity provides to months. great for therapeutic to a do able vaginally that we're great mentioned, anytime really limitations it. obviously two you we because But questions. might view you progesterone. that. we're a as of your without and great it's may in demonstrated a to metabolism looking it deliver have was investors, It it's platform of that. to lot to that to the otherwise having the we've are for truly estradiol But a with pass of as our or she as want your about continue dosing. side places to portfolio it question because systemic present. really feedback, the educating you're a it's that So the avoid or then, the deliver drugs effects we developed convenience technology we the wanted was, convenience to MIT about our It's an take technology, advanced It's at anytime three provides first thanks yes, and programs way these certain as will to in Crowley, advantage be really And that's how designed HRTX, days, I IVR of drugs, should daily over really point, and levels a platform give take the And a weeks in And by over

Zegbeh Jallah

Thank you.

welcome. You’re

Operator

line question Wainwright. the next of H.C. comes Our Bialas with Chris from

Your now line is open.

Chris Bialas

doing? question. so are much Thanks everyone. for all my How taking you Hey,

two. have just I So

But BVX we're pretty date, The to close first PDUFA and commercialization. the SG&A looks hopefully is getting the only this quarter. it modestly increased in is, like spend

about then and we think given should XQ one how kind So the timing? I have of more. beyond in And that

Sabrina Martucci Johnson

can question a because Great couple around. color on give And that's maybe previously, a of I something little that. more of but really, we've that times mentioned

launch As of John of highlighted, really around an hopefully, NDA. doing certain commercial are of to FDA, ultimate, lot approval pending that the activities that product prepare obviously the And, we is for a the But in labeling the real lot landscape, from have final a the highlighted FDA. call. a nicely you this activities paperwork, journey, John on of after like the the today's patient come product that

ramp simply pieces and or commercialization that, we personnel have and promotional procurement around for final are things need there's feasible anything there label certain the because development like to like strategic strategy, manufacturing the no until that of and FDA, are in from really as right. kind not So the we're activities the of that. well And us discussions,

partnering shine if will as So to the significant on a a think really it follow by really, of on about some we come light more those will lot after Daré such date. what activities borne And the on that. expenses PDUFA are because strategy to those that is impact have of way any, the

Chris Bialas

Okay, one great. Ovaprene, on then Thank And just you. really.

What's of said from looked can regarding this you heard So that by FDA. get end IDE the in trial XXXX, you're so of kind expect the anything year so line mentioning top end And the the you ‘XX? the for of like? you Have far? feedback or we by the data should

Sabrina Martucci Johnson

great great, question. great, Yeah,

So, we this what's your that have taken for FDA IDE. we meetings that them previously have pre with for called process division of allows shared the device submission advantage

can high the good you're It's anything. that they're from -- what they The pre-IND also not. planning, you tell a division is device and of does thinking, to when Now, of very to or back for clear, review process IDE finally they submit idea They ways. very, your in you're resubmit, process, year. common actually level few were But the meetings, what they under you so a of the happens resubmit, The common you come please that get big you to before come Go sense very X back before see goal XYZ we really -- happen. to submit to and is pre to can doesn't FDA in they start it really, be picture the to don't you submit, the that reviews, right? where iterative, sense? to the is our that meaning you that's the analogous the trial, it. an FDA kind different say meeting process the most drug Is hey, conceptually, make submission IDE Phase you of FDA and be we that end hoping a review and submission division kind tell actually do let to say,

go need us. as is it submit to XYZ, soon just and could Second, but as do and do you you're good go. to tell And that, do they you, you we that ahead to

in a I IDE. You don't have you're X. full good how is exciting what's to resubmit is Ovaprene can start is has to potential the novel of FDA one But certainly it a be product, disruptive pivotal be area mean, say, to go third, and the completely they Phase about category. an as consideration that of of Ovaprene Or the very contraceptive -- design go, will great final of job, things the study. the novel the the that

is typically device like monthly division typically to diaphragms products, studies, are six accustomed and the division division of accustomed that drug is that. things drug studies. division to on demand device at So typically division months whereas more device the products. looking the requires not products XX-months condoms, are requires Most But

to we're typically a clear cycles in need views duration, on FDA kind you interim sponsor otherwise, points So and pick to for analysis the of look typically, trials and number do provide But IDE to share feedback. of gives without to to kind data, not review know that of study. going are a safety the on that. question like know going perspective, data has to at your them. statistical opportunity does you'd contraceptive after of penalties and terms open expect more our really But things to label, to opportunity definitive we're to that, There's that an when an share which about lot and have us and times

or we the be XXXX. will more going expectations, And FDA guide be we certainly, as so able is learn possible around more what in to about to not

clearance we provide able more at that And really the get point, to we'll be plan we to IDE. so around is process, this initiate further say that can XXXX, a And that into in lot we of timelines. all FDA guidance once pending

Chris Bialas

Awesome. Thank you so much.

Operator

from line the Kumar Our of Instructions] next Brookline. [Operator with question comes Raja

Your now is line open.

Unidentified Analyst

Hi, of the patient that are Thanks wondering Phase progressing for X I are pandemic. was do the regards you to enrollment seeing Ovaprene the the am next I given that for update. how With just effects Shubendu year, trials still planned we the Kumar. see

NIH. discussions that? color please had Could have on may You some you with provide

Sabrina Martucci Johnson

interestingly vaccines, having of NIH have in the the really found been today at been because discussion All the with other absolutely we're lot Clearly, Thanks. great, as questions the beginning there it into studies to a a were it great significant And And contraceptive programs contraceptive of pertains Yeah. we of place might importantly, mandates. shelter it lot -- strange that question. have time clinical so time, was women at NIH, and that the at anticipate sheltering they and that contemplating on going that that simply comfortable in about contraceptives there March I'm place, very XXXX there that because not a halted in of still talking a enrollment. weren't of had their as we trial fact pandemic And time they at they a the actually where that had uncertainty. certain were one impact development now when in midst a went of shutdown COVID. world pandemic found in in

hopefully other have for that can resumed contemplate the the NIH. with we go is a that be of clinical run them that, ahead is Having hopefully, our enrollment But obviously in did going start situation timing. contraceptive clinical with But can't right development given And company, in easier feel as speak I in in that's a it to and go quite only to XXXX. should that, some that and about trial do trial like now we either, manage speak changes and conversations the the XXXX, to want NIH, XXXX. get that, feasible at quite so I and studies the to both see reasonable and But predict. where believe ahead is COVID thinking think point time. sure planning that the thing XXXX certainly, said to starting programs a our a category, but would this do those real in time. a in right we're all And, this contraceptive certainly is of we it how comfortable is little we going and planning to we it trying to reaching that that's weren't not to frankly, trial it be

Unidentified Analyst

understand. was you. Thank I useful. That

the With Australia? regards how requirements study here question. Just to are another potential in Phase Australia? for similar a is you the X regulatory the U.S. VVA in that with quick And planning early, in are this but in Australia,

Sabrina Martucci Johnson

Yeah, collaborators I in will say, we our love really Australia. so

Not it's but X, We And even they stage with have about population certain Phase clinical trial they And that for trial. health. work have number entity, And the to in you to the specifically, a it's trial pursue Phase programs I to a you X, and in they very can us research or Phase And X/X to really of into of having so stage there. allows in a that X organization been few our with -- our Those with Phase before the into are specialized prolific known. chemical programs, because It nature a have of enrolling, ingredient. X. using in investigators just get the to study. that Phase can there. and process, feasible Not programs VVAX why And say have it's have sites, sites, exceptional would new are a X the you absolutely don't U.S. different be we you undergo an don't because a Australia are for often running we known place right regulatory so X, in active great expeditious what's we're is but wonderful we the is so much much review beautifully simply than burden advance Australia, committee about an and to much, your trial, stage think would working really now trials paperwork we're couple into in more of work an required stage Phase consider that women's women's to IND. a like R&D ones then a then Phase outlined. the and and as the couple health has clinical collaborators required it for the ethics not the it But incentive, later what Phase sites tax less gets what's as later so rebate entire also later sort be conduct of to in participant benefit works but the be a venue U.S., kind of X still that that same of sites, for program. exceptional a the to really it a bigger Lisa

it that it makes much the consider later So expensive are it there we because do it's less X Phase are the general. be our possible, reality things rebate. -- trying will place always for is that place specifically as work a But sites XX%, as to is a programs. in for on we there of it stage But

benefits lot a our financial to there. programs Phase real So of X conducting

Unidentified Analyst

questions. Thank you for taking my

Sabrina Martucci Johnson

as great well. Great. Thank questions you. are Those

Operator

no As call remarks. further Ms. there the to turn I'll over Johnson, closing for are back questions, now

Sabrina Martucci Johnson

far has appreciate developments. and sense potential everyone been really ongoing a I much. number about our taking the shareholders time a And developments in so for to all of stakeholders. meaningful closing, year meaningful value gotten drive afternoon updates and XXXX of really you Thank this a and our you. hear you've more Thank our to commitment with that hopefully, so

which already of we've some which accomplished to of come. are and some So yet

really year, and updated progress remaining and beyond. on portfolio also XXXX forward and milestones, specifically will believe look so you set the the objectives XXXX to our that we objectives of the keeping to those regarding achieve against the during And important in across we the important milestones remainder

forward look to you so keeping So, thank much. And we updated. you

Operator

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

You may now disconnect.

Daré Bioscience (DARE) 11 Nov 212021 Q3 Earnings call transcript