DARE - Earnings call transcript Q2 2024

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Operator

Welcome to the conference call hosted by Daré Bioscience to review the company's second quarter financial results and to provide a general business update. This call is being recorded. My name is Leonardo, and I will be your operator today.

With us today from Daré are Sabrina Martucci Johnson, President and Chief Executive Officer; and MarDee Haring-Layton, Chief Accounting Officer. Ms. proceed. please Haring-Layton,

MarDee Haring-Layton

and welcome Business and XX, Daré Financial quarter Bioscience Today, our expectations Good and pipeline Call to for and portfolio. results second our Update will June developments the Results and we for afternoon, review the discuss quarter XXXX. ended

Act forward-looking harbor Securities laws, to made which should remind include pursuant today's XXXX. provisions statements. meaning Private the of to discussion that like within statements considered Reform be not of this safe of Any are Litigation the that I'd call forward-looking will facts statements the made you statements federal securities historical of during are

or by and results anticipated uncertainties. could due those unknown from or these risks Actual implied differ to events materially statements known and

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

are was on for Form the entirety cautionary by Forward-looking in June today. XX-Q which filed their including the XX, company's filings, statements statements qualified XXXX, SEC ended the quarter in

also time-sensitive turn except the I over August Daré would out to call, to this undertakes information of statements reflect by or no this that I update XX, law. new current information call after developments today, XXXX. to obligation required that now as of content forward-looking is any as like will to point Sabrina. includes it

Sabrina Johnson

our health of through solely to review to disruptive development and market. mission. regulatory dedicated our broadly I newer and to be company well-being Daré and may advancing calls traded product women Thank story to like by focused the for our we of believe start purpose you. publicly women's on development, who you ultimately remind is quarterly the pharmaceutical to always health, taking those a only clinical products minute remain We of the Daré and

active want need of leveraging women Our addressing commitment understood by that certain women existing products therapeutic innovative lives about basic improve and pharmacology and and gaps. and outcomes the that ingredients to by accelerate pharmaceutical or treatments science is to the health marketed is focus boldly

we convenience broadest but product first-in-category We effect believe candidates where been has potential short, our or optimize suited, question address have in of improve women. proof-of-concept for wellbeing our many to of health robust portfolio the have outcomes, side and and pipeline well indication these women, enhance We us indication, to seek profile the already the of high-impact to novel is for positions and treatments not previously medium the the to pharmacology which that for long and to term. applied well target indications a demonstrated

update to we discussed last we for anticipated last for milestones strides call, the made therapies XXXX. year women our the During advance and innovative key

in the vaginal to continued product of via became aged vaginosis older, gel a emerge XACIATO, that the treatment first females and for addition commercialization In our bacterial from prescription and collaborator X%, XX FDA-approved nationwide available clindamycin year by portfolio this our to phosphate earlier Organon.

disorder, our to arousal candidate. which anticipated intravaginal also no and discussed the on potential enroll FDA-approved study first to Cream, has continuing there our continuing Phase for sexual focused trial III the for FDA-approved monthly contraceptive in are which to We Sildenafil of product related toward progress to a candidates X.X%, first-in-category Phase be milestones Ovaprene female treatment hormone-free, first-in-category of are potentially III treatments

menopause monthly for product the status next space, sexual highlight in for our for vaginal insert and understanding these of therapy the Cream hormone comes candidates hot and important anticipated Today, Sildenafil metrics the on today flashes with impact vaginal to potential programs. what that our a We'll also our are for and our context and pain. of X we'll review against hormone-free the progress focus Ovaprene milestones providing

our second do, over our MarDee, to I'm back Chief to financial to Accounting call Officer, the I going review Before results. turn first quarter

MarDee Haring-Layton

us second joining XXXX, I as for results the and to today. I to June for which ended now Sabrina, XX, refer Daré's thanks, like quarter. the will would everyone, financial quarter summarize Thanks,

meaningful Daré's women's and product near our and long the research and mentioned, R&D to we've advance business regulatory address and term. required overhead differentiated portfolio Sabrina build The identified expenses. needs a portfolio's to clinical strategy development investment As monetize unmet advances health and is maintenance portfolio the then assemble to and in over or costs a acquisition corporate includes ongoing value that and candidates advance of portfolio and of

reduced of reduced approximately to During million, expenses, general and or expense. XXXX G&A, count to due our which $X.X QX XXXX, quarter services a and decrease professional administrative compared the were is head primarily second XX%

Our on approximately quarter, $X.X R&D decrease to second were our based regulatory million expenses, across portfolio XXXX. manufacturing, preclinical other which which vary period the XX% clinical, compared a entire is from and for QX period activities to

As guided our be to expenses. will expenses R&D our year, less R&D we year XXXX previously we continue this anticipate full XXXX than

we million transaction common by reverse driven in shares We in million was Our royalty of approximately split the $XX.X from X.X stock comprehensive quarter stock cash the approximately of $XX.X second monetization equivalents had approximately ended the August that proceeds quarter income with closed as implemented July on X, and XXXX. second April. for and which outstanding million X, cash reflects the was

our XACIATO of XACIATO of success nondilutive with significant in achieve commercialization as commercial financing provides help sharing Ovaprene focus will Cream, prespecified market Daré announced potential have meaningfully which transaction XOMA, to future payments in represent the royalty a total to milestone capital economics, of large we closed received us a in monetization to allows Daré upside of objectives from payments all and participate with shareholders to proceeds million XOMA and gross following net opportunities. progresses. and monetization flows XX% Daré and the our April, future our investigational first-in-category Sildenafil products, opportunity and to potential transaction. cash both This milestone for importantly, which under on and make XOMA net Daré late-stage ensures return that This In remaining advancing flows $XX the equal and accelerates royalty XOMA cash a to

The majority achieve and underscores of significant the significant Daré structure attractive milestones. ability economics net margins retaining to transaction of this the retained sales through and of Ovaprene future Sildenafil commercial with also potential all and Cream the

This second Foundation our terms the million agreement also we million $XX the support funding the begin of FDA, the submission allow grant of required our under Daré in the approval of in support the receive the received to prepare principle nonclinical is with an DARE-LARCX. $X advance which contraceptive, to grant Under for of up testing of installment DARE-LARCX work with application the as nonclinical quarter, of may us of of latest to to development In to and investigational drug approximately agreement, a investigational other proof development through will humans. studies total new DARE-LARCX.

creative, Daré our grant seeking million under being has to commitment approximately to grant our funding date, and capital and to received the and opportunistic agreement. installment DARE-LARCX in royalty in represent To needed build Together, shareholder $XX.X the value. latest collaborative financing objectives meet

XX, review XX-K ended as we was to detailed filed resources well which and financial more financials, as annual XX, the quarter investors Form Form for XXXX, discussion filed in for XX, our our of Risk the December this which XXXX, condition, XX-Q on our June afternoon encourage year We ended Factors our March XXXX. the liquidity, capital

to I'd call now like to Sabrina. over return back the

Sabrina Johnson

accomplishments focus MarDee. Great. now milestones through our going update Ovaprene. the anticipated our XACIATO. and and with to Cream I'll late-stage XXXX to talk on our on-market candidates, But provide date I'm asset, Thank first, an you, Sildenafil on

single-dose bacterial increasing leakage gel of indicated in as vaginosis time, spent any place. of So retention X% years limiting vaginal phosphate for gel vaginal and XX be the as in time treatment and a goal vaginal it's can a time formulated the colorless reminder, applied is day XACIATO of and that age or with It's clindomycin female of at older. not

prescription clinical Organon health prescriber In for available across Organon, of prescriptions our a through patients United fulfillment The month-over-month with both new team providers. among the and There with entrant positive channels with for to new multiple in of for category. paired access see among in became adopters to to first early in line uses frictionless sales quarter steady the strong commercialization acceptance and the a XACIATO and agreement reception, volumes patient signals with the unlock continues total are women's team trialists States. XACIATO positive increases XXXX opportunity experience by continues the a branded related

an on Cream provide update X.X%. Sildenafil to like now I'd

and to So for meaningful program those data the Sildenafil the the population during points interactions development to improvements. second III respect quarter, and the Phase that we efficacy our Sildenafil clinical proposed Phase Cream endpoints with Phase forward for female development development. our treatment study for statistically were the into continued on end we III Cream demonstrated take disorder, significant to FDA the The with including the showed a were analyses for post-hoc sexual arousal proposed as IIb patient FDA patient

provided FDA improvement we queries interviews. the reporting outcomes within clinically responsive to participant patient and saw assessment meaningful During of qualitative from the based the materials exit on second in quarter, IIb that the regarding we study Phase the patient

therapeutic become additional on during as available. pivotal FDA's the look of relevant second While the Phase be and disorder updates candidate FDA review well feedback our III we study women. on of plans Phase the Phase III an ever a indicated the arousal would the the Its providing design, had anticipated in is study first providing strategy any III feedback, the as quarter for to collaboration on treatment and updates they ongoing, forward design as which

for the the Phase III. meetings launched for being considered with second studies quarter, bid the the campaign to initiation the completed during Phase III support CROs preparation Phase defense and In manufacturing III we

In suggests of experience sexual and treatment of treatments be man, Viagra for sexual women any ingredient tablet in in the currently dysfunction the administration potential and Cream launch currently of was that products the a low active women, first. the erectile for is no disorder Sildenafil the marketed revenue to under prescription of or brand of has no Sildenafil in form research U.S. arousal. most are XX meaning terms potential, FDA-approved million name X oral for in market successful symptoms of the form undoubtedly the approximately arousal market there which

In exploratory in of response. RESPOND Sildenafil of the received and previously of terms greatest the as the increased genital arousal study from all the general Sildenafil Cream shared, of analysis completed Cream trial that their studies, flow identified and already and clinical benefit probability we've that patient we population from demonstrated we've tissue IIb Phase Sildenafil Cream, data success, in quantitative blood

is of access the patient publication available online was ACOG of which The ACOG American in population featured were this and journal and and the in regarding efficacy Journal green the findings in Gynecology, official July which or the as College were our article in podcast. open a Gynecology and and details the is published Obstetrics June, of Obstetrics featured room,

also Our development such in available. spotlighted of they on to the featured its editorial was study still first data kind distinct pleased ran look we It's updates the in are see a honor the to be medical to program a and forward additional providing journal. engaged in an We as need. are unmet significant communities these

we on whose Phase U.S. of under In terms rights commercial provide novel are of license is Ovaprene, which study monthly Ovaprene, our also to the III with advancement a contraceptive update investigational Bayer. the hormone-free of agreement want an intravaginal

market be by a product Nonhormonal potential contraceptive are there to contraceptive for for use and the in do women no approved who in to not has disruptive opportunity Ovaprene. approximately contraception prefer option FDA. XX are research, control hormone-based significant million as Ovaprene potential the monthly U.S. no commercial products on represents candidates market cannot important category an so. hormone-free currently, women a Based birth the or

States and sites at United in Human March Shriver Eunice launched NICHD Phase December central this for clinical pivotal is collaborators XX study in a Ovaprene by Kennedy of underway the or study XXXX. Child of in of and it's at study year, that we of currently Institutes Development the advertising supported Health campaign Reequipment Health across III XXXX. National patient the Institute March enrollment with NIH the Working or commenced National the of

see can by website materials our visiting You homepage. campaign the

the it's recruiting, translating in study successful campaign. approximately currently central those we the that seen advertising While most half subset in women there of sites have from are are that considerable sites a clearly to XX of response interest participants into

almost the As we not pace. vary a at enrolling similar sites range on enrollment that a are successful rates of based have those a versus at projection that considerably enrollment result,

end to sites rate reminder, participants enroll our of quarter a on use. anticipate average aims will the the have used participants of number study is As months, XX products enrollment complete XXXX. to target approximately the We all is XX the second which cycles sufficient study complete which menstrual sites. in the women, X of XX the by of complete XXX that XXX approximately of product the across half approximately of participants study across approximately current Based months to

strategies on as enrollment We and enrollment are, that are the productive of quarters. course, the look forward to study all and providing looking updates at sites equally of projections in ensure progresses to and coming rates successful

just believe Based be on communications study FDA, application to the the approval registration if the support to date will that required successful, with a we FDA. single submission with premarket

our vaginal a HRTX believe menopause-related the menopause. symptoms stigmatized This health approval I'd overlooked now the earlier would area research preparing million are for given required an DARE-HRTX pathway. we will around program women's Senate awareness to FDA's There questions issues, has therapy bipartisan bill be that Phase training vasomotor we been III to single this and lastly, and clinical like programs. the that public potential turn authorize often getting unveiling year We've DARE-VVAX. menopause about XXX (X) Because monthly of a to and of for for too the (b) midlife underfunded. is first study, $XXX is the of and been lots boost via

In our the forward. new continued as progress progress due updates is menopause programs program potential which forward this space and DARE-HRTX looking sexual is to and move available. addition, and actively candidate II this pain with seeing Phase we're and will hormone-free our provide to We're ready, DARE-VVAX in vaginal on VVA or the atrophy bill, vulvovaginal of DARE-VVAX, for opportunities exploring associated to menopause

progress some work of category product to we disruptive our forward In of most summary, and to candidates to updates the more portfolio first continue year we potential in look potentially providing as these Xaciato to for advance leading in for Ovaprene of commercialize to well-being as Bayer possible. Organon for women candidates companies, deliver as with decades, the health treatments many collaborating including women and this and and

to to Q&A. the the turn over call like now I'd operator for

Operator

Your [Operator Catherine line comes the Research. question of Instructions] of from first Jones Novack

Catherine Novack

ask the on progress to wanted again all Congrats for I this quarter. Ovaprene.

a have sooner? updates give for this this what timing an implications that a then plans look top line that so we the data for readout? is little With single given can today you you interim sense has arm, And you can any us bit of see gave a do

Sabrina Johnson

Yes, are questions. great Those absolutely.

for yet You don't have timing line. top

clear, of enrollment remarks, mentioned the in the I want there's demand. difference not in a difference I As there's prepared a sites. And rate between in be to some

patient So the of a successful are across been the study central the sites participants the interest advertising equitably campaign terms has difference interest. that successful women translating in quite of quite It's from into just in terms some considerable of in sites. generating study, those how

point, a more to at at of looking all that give final We having been prepared time, projecting And successful through, further do we've to little Half pulling interim halfway subjects timing on so in analysis that those help top these but giving want comfortable the equally this when have, in months at really we And in exact little we'll further right, feel patients sites an to productive their some the a forward. about completed have and to strategies interests get expressed enrollment. We line. be to implementing we're assessment. look forward yet X an right? updates, opportunity of of not including definitely

Catherine Novack

typical a use Great. make then compelling -- And can us you Pearl would again, you asset? this arm, that remind single from just that commercially the Index

Sabrina Johnson

it's question. Yes, great a

the setback. for the take category nonhormonal a should -- So first

products a the have whether that's contraceptive very indices. and metric the how it's Pearl by are it's nonhormonal and Pearl or methods product range hormonal product So regardless used FDA-approved a of wide FDA Index is of evaluated the

that's effective device, which Pearl the effective is is range. gel, most to the implanted methods which XX So intrauterine FDA-approved spermicides are the an X and right, like have vaginal in the Index least of XX a or

many really not of are the in spectrum, end So broad IUD, copper the range. other category, the XX at options are range. XX XX there options very options the which the it's to XX or range, are than other the one in to the that closer other that and are that the is nonhormonal a to available, And

a would month. So product like a it product be as be once a we think the Ovaprene, to about first

really contraceptive that been surrogate that for it the other the So method the the nonhormonal IUD range study that meaning hormonal methods, different in products means the from in be is convenience pre-pivotal condoms, approved range right, given And has in the fairly an patches, as the there's what effectiveness the all been that that study efficacy suggests short-acting study methods the pericoital potential the be wide other nonhormonal used for be the bar generated so that achieved on a data low, to acceptable the nonhormonal the but acceptability that in that that's they're very products pills, for have. same it of [indiscernible] could like hormonal of perspective, markers in And other copper really have are regard. has methods given that in Ovaprene, rings, methods none some it based would of also are.

the general, the range to, Catherine, has women why will in methods is for methods range the of such the use, your that effectiveness. So contraceptive range data actually quite approved contraceptive wide, or FDA then short-acting suggests as prepivotal opportunity though, has method. which the wide all that's end, in hormonal nonhormonal and about the really effectiveness for speaks it's that a question, it in And to that same

method in or the that's that acceptability method wide the So be hormone-free for Ovaprene, available, category. of would that available given like right, product would and once-a-month therefore, particularly commercial non-implanted a method viability non-pericoital a range, only there's be it

Catherine Novack

That's helpful. Great.

line. program the updates Looking forward to more getting the down on

Operator

Douglas the of of Co. comes [Operator H.C. & line next Your question Instructions] Wainwright Tsao from

Douglas Tsao

Sabrina, meeting you Or sufficient get terms are needed sort to your your program, another the to interactions of guess, alignment? you Cream are of I for being I'm interactions FDA Sildenafil settled? curious, of do in with sort final the this anticipating just this get think

Sabrina Johnson

of understanding understanding And terms question. that's a a support kind have we lot first-in-category It's the and right, the outcome great go opinion the And the of indication know, the FDA a is of definitely indication, category Yes, Doug, there's that for which that, leader measures. clear a lot historically of first through. product. there's in we of provided to right, also FDA to this key data in of

So as at where clear the helpful. there may have very there's the a measures straightforward now, be in specialized world clinically analysis questions lot patient-reported whole circumstances and I the the questions Not around those been or terms typical providing things. that's time. said, what's this called was psychometric of kind outcome assessment really Right a outcome a and of, We're information in of and improvement, meaningful assessment done. that

So is that a we're providing really lot the of providing color. information

determined, to FDA. number past, super productive. meetings to But they've be of the had We, open been to the we've we'll with And definitely a date, in them had that. definitely when be have

we're that open this definitely nothing So in to that. definitive But at point, front.

Douglas Tsao

in your sort And right pipeline sheet with now? very rich do of have how you balance what you thinking things the to context about of Okay. guess lot opportunities. afford of I obviously are can and a you prioritizing just a

Sabrina Johnson

Yes.

question. Another great

III trying our remain Phase X in Sildenafil our as the financially put as really either been have is. where those operationally getting or also as So of are been obviously, Sildenafil ready we highlight both the really but is in Ovaprene terms III priorities, And well. as bandwidth, Phase Those to really and as we've priority. Ovaprene

lot around I have been we a We've today. particular, broadly and getting point, around a the menopause However, have, very of highlighted we pipeline, in that of noise menopause that the to deep our lately. lot a programs questions your with interest X

right we very really we're our programs Sildenafil doing capital. as by capital are So everything and priorities make that possible now as focusing we those being responsible our also can sure Ovaprene to responsibly much operationally around and with advancing

Operator

over closing question-and-answer concludes Sabrina remarks. our like Mattusi Johnson call any to That turn for back additional to or would the session. I

Sabrina Johnson

outcomes the to recent potential provide to Well, updates by and therapies our for all thank of this Daré additional for to afternoon our stakeholders you about time identifying Great. choices, commitment ongoing value use our advancing and ease women. and all enhanced taking hear drive of for new

great As this holds and of progress you the continue rest are what heard today, so excited for we to Daré. year make

we've updates to rest we work of as of As we this what as indicated, including registration the study to we the look women expect potential and about, milestones our year, on Phase XXXX, ahead expect study, discussions to Sildenafil option III more with that that that as several a and updates the single be to complete sexual they activities prepivotal we a treatment arousal for talking for been we're just first-in-category doing FDA commence disorder, Cream. with

value in touched really also the positioned collaborators. believe on for to we're everywhere commercial Daré unique milestones the today. also we updated Thank you. has we as you driving well all end of of keeping while women our innovation also discussed call, And towards the model look support pipeline accelerate progress to stakeholders. we We for our at deep of therefore, And forward

Operator

call. all today's Thank concludes joining. for This you

now disconnect. You may

Daré Bioscience (DARE) 12 Aug 242024 Q2 Earnings call transcript