Earnings call transcript Q2 2023

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Operator

Welcome to the conference hosted by Daré Bioscience to review the Company’s Financial Results for the Quarter Ended June 30, 2023, and to provide a General Business Update. This call is being recorded. My name is Mark and I will be your operator today.

With us today are Sabrina Martucci Johnson, Daré’s President and Chief Executive Officer; John Fair, Daré’s Chief Commercial Officer; and Lisa Walters-Hoffert, Daré’s Chief Financial Officer.

Ms. proceed. please Johnson,

Sabrina Martucci Johnson

afternoon, business Good XX, to financial the for Thank call and for and update Bioscience. June the results Daré you. welcome quarter XXXX ended

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potential move SST to approved FDA the any women. has treat and disorder first forward. the to form development in with committed arousal Cream to product the FDA this And our candidate partner of be to remain Sildenafil working we

in FDA and from X We are successful, RESPOND of to end which if the this before Phase and before XXXX. the meeting the data are early with end would analyze Xb support of commencement end of year, targeting Phase the continuing Phase X the XXXX, study,

X the ingredient you to pivotal include pathway the we in Following safety collaborate data clinical active utilize U.S. keeping obtain on updated intend on to development, will which X forward we Phase two expect We Cream Sildenafil Phase and existing look the marketing to leverage FDA FDA's efficacy particularly on studies, as we the in the program. approval to this program, XXX(b)(X) with the

has hormone-free first intravaginal nothing investigational, contraceptive. market Ovaprene like There Now intravaginal dollars, monthly truly with peak similar on hormone dosing is there today. category sales containing nearly years, while ring I'd NuvaRing to like monthly no vaginal in available a is hormone-free a been turn to several it reached monthly format. Ovaprene. for billion a counterpart the our potentially product is

study closely this to on have with We year. plan Phase of later NIH start the been NICHD working the collaborator X pivotal our

Specifically, XXXX studies CCTN Network, of Phase by is development being oversees conduct program, NICHD’s which Ovaprene of pivotal in investigational contraceptives. the or supported the contraceptive Trials Clinical X established to study the Contraceptive

expect the of with pre-market Ovaprene study to with in contraceptive quarter communications approval, fourth device, a along single this support its is submission on study with study contraceptive successful its the pivotal evaluate safety the and the commence This We registration year. X as FDA, multicenter, enrollment to single-arm, application usability. will to to required a of be FDA. Phase subject the effectiveness non this comparative Based our if

use is on details meaning over Now study no in There this placebo study. This will Preen. the a all is study. a few non-comparative women

well completers. of contraceptive to of dropout of a enroll Once and XX on clear sense complete subjects, Based XXX approximately study look be studies, have number we menstrual having to will provide when dropout completion. in of our expect able will typical study, this that's target to target for use. double on than we rates is cycles enrollment we will We guidance underway months, XX rates more

will objective primary a typical rates candidates. The endpoint Primary contraceptive common the pearl be pregnancy use index product assess index the of over pearl primary using is study XX for this cycles. is endpoint to

as effectiveness probability are use a cycles, Secondary XX contraceptive at and safety objectives typical acceptability. pregnancy on within the looking basis as well

to hormones Mirena was work entered have improve intrauterine had did, be Ovaprene the the as options over the contraception, product the done NuvaRing contraceptive much while delivering market in that category when to potential And as contraceptive the market releasing years as hormonal disruptive hormone first recognize has efforts when entered and as it system. first to we been lagged. non-hormonal XX the therefore, last believe intravaginal the that innovate monthly it We a

of holds agreement in us. leader license rights a commercializing US the Speaking States, commercial the contraceptive are products in to United Ovaprene, Mirena, with under they a

preparedness the over now well commercial a will XACIATO as activities update John Ovaprene and launch I Cream. as to candidates turn commercial activities, our on Sildenafil provide on development it for to

John Fair

you, Thank Sabrina.

clindamycin treatment is indicated patients, of and age there's be States. commercial As XX product older prescribers XACIATO, a dose collaborator believes to XX% on Organon, potential their providers vaginal patterns. the for based overlap contraceptive female phosphate roughly administration years of the treatment vaginosis of bacterial in our have United global healthcare provider who the lincosamide NEXPLANON gel antibacterial vaginal and in single a XACIATO reminder, for prescribe of

Because of well-positioned to launch. has be commercial believe Organon relationships, knowledge prescriptions product to and team that success, expect we these day on XACIATO well-positioned pullthrough with experience drive the should and and detail for sales providers, these of the market. strong marketing with healthcare one once working given XACIATO Organon of outreach be soon Organon and We we previous on calls on outlined team, as and have launch plan a the are payer Nexplanon we further Daré coupled Organon’s product feasible. US as their is as sales the updates and provide planned initiatives to towards

X with introduction. ahead Looking to to clinical Phase team programs, working commercial busy later-stage collaborator development Bayer transition parallel been the our initiatives on our seamless has commercial to study activities, with key a in from our ensure Ovaprene

a align organized cross-functional aspects packaging, on the opinion messaging of have to and targeting. We team including brand, activate and leader key key

activities. foundation help activities the additional post-approval marketing set These downstream, for will sales and

truly we And progress are on about finally, program. Sildenafil the excited Cream the

colleagues As to issues aspects quality side we on to women's our all to of sure communication on broad and and stakeholders pathophysiology life educating work the the key key analyze a we this of condition, medical with continue robust medical make implement the in planning of we and dissemination strategy including the of sexual are information. ensure health plan to are to health data

bring new forward very category solution first about like will remain we initiatives has on a that more opportunity option providers the forward, for these them. moving to of of bring We the much-needed to women disorder improve with and nothing sexual Sildenafil prescribe lives the in that millions have Cream excited to dealing but currently information have potential a

call over will With Lisa. that. I to turn the

Lisa Walters-Hoffert

will the you, Daré’s quarter XXth Thank current refer I second for financial I to of XXXX, the all or summarize now the John. And would quarter. like results today. June as to you for joining ended thanks for quarter which

know, advantage in differentiated to product candidates assemble the that business clinical and As, then we've health value Daré’s portfolio you identified model and and the advance to portfolio's address long-term. regulatory is monetize meaningful a unmet over near and women's of that of the means

and build and corporate overhead, expenses. and includes to a required development, costs, investment portfolio acquisition ongoing The research portfolio maintenance R&D advance or and

administrative During second or the and $X.X general quarter, million. G&A were expenses our approximately

the were activities Our Phase approximately RESPOND across Sabrina based Sildenafil cost R&D vary and expenses, primarily associated preclinical, just portfolio Cream and period-to-period on and manufacturing Ovaprene’s clinical, related $X trial which to summarized manufacturing, and regulatory from with affairs our reflected Phase,Xb entire million other our study. X regulatory clinical that activities the planned

stock XACIATO, We million for $XX.X for Under shares outstanding. current was the as are license equivalents. comprehensive cash Our we ended million $X.X and sale. of July million approximately quarter the And following loss XXXX, cash $X.X in Xth received in with million. August current quarter our approximately $X and we first with commercial approximately of common million XX.X receive Organon to the agreement entitled we had

Thereafter, up well royalties net as be to additional on eligible tiered, potential we milestone will based of to double-digit receive as $XXX sales. million, XACIATO’s payments

of operations assets our We of and are fund variety our monetize and value. continuing to options to explore shareholder our the a build advance value candidates,

license NIH grants preclinical sales, structured financings, or one for the non-dilutive like but and recently alternatives from strategic alliances. These to limited include, received equity the a we agreement, candidate, are collaborations not

previously, will to to collaborative our shareholder needed to As opportunistic endeavor be seeking creative, in value. the we said objectives we build capital and meet and

XX-Q on encourage the and which XXXX, investors condition, discussion the We factors March all detailed resources, XXst our liquidity, Annual Form filed XXXX, quarter in XXXX. XX-K for form today, risk ended XXth the was XXth Report financial our the in ended for filed to capital year our June which of we December on review financials, more

the now I turn would call to operator. like over the to

Operator

Research. [Operator the from the now the of is Thank first you Catherine with for Novack open. attending line Instructions] Jones question line Our conference comes call. Catherine,

Catherine Novack

you taking that for just, study? might you Ovaprene. enrollment gating guess still to Thanks us Can the couple I the study? some Hi. criteria the key inclusion affect initiation a question. that what’s Good screen of the are on rate are of my questions afternoon. what remind anticipating rate And exclusion and

Sabrina Martucci Johnson

questions as Yeah, your thanks for great questions. And always.

to gearing go. terms of up really the the what’s of ready be start gating In study, to we're

the conduct for the So, as I've study the an study the NIH, on actually today, they comments last in NICHD mentioned my identified the December. working the held we're with meeting who and with investigator of Ovaprene investigators actually

So these while. investigators a for excited been in are prime

forward recommendations recall, when they meet move You tweaks that ensure IDE make approval their comments were got it to the with some our some to around we protocol study some encouraged that may from would expectations. around all FDA on the to the there considerations with us

kind to then been go. And so we've we have done to reoriented that. the And ready protocol sites getting and the of

that. manufacturing And then, quarter. really to so, our initiate we're partner enrollment in now prepare preparing the fourth And obviously, for with we've to been

So, and the for are now we're get obviously, super together excited to are that. all coming on track pieces right started and

study. their sites In Network Trial clinical mentioned, and networks of terms - are the as a Clinical participating I Contraceptive there's trial, that this sites all in the

that So are it's about right XX now study. participating the sites in

And so almost they are, up. they're set

standard for in key the it's of study. pretty criteria, terms inclusion In a kind of exclusion contraceptive

They every a to commitment patients certain sexual of to to So events number age. in month. have have certain partnership. have committed to have a They be be a have

have that standard a would pretty conditions in certain to medical study contraceptive be So they exclusionary. be can't

Trial Network lot the for the they've nice is nothing of the over products. this study. Clinical and Contraceptive So get have of the contraceptive for unique there What contraceptive see the the years of as of we studies exclusion and really we've we looked their a that in one things with studies do about that a conducted NIH and there's been sponsors across benefit inclusion working terms that's number of studies and done that this was other criteria

age of reasons comments. environment I that study sense all obviously rates in kind to one and this right And in What a particular my stated your the the frankly timelines contraceptive in in is dropout metrics seen what going want our particular this then get kind different And that, rates we've can studies. and We those and screening of like. impact that's enrollment. seen and across those get differences of meaningful we’ve of look difference day

that'll for we're strong movement, the started. the kind And to getting allow give when quarter study forward in looking are of that on to initiating very targeting occasions But complete. and terms of us we much to fourth the predictions expect then

So hopefully that answered questions. your

Catherine Novack

was helpful. very No. That

talk the sites I'm curious what dynamic and you based the curious, geographic the of on, in Just seeing can XX spread if I would say expected guess, about of enrollment environment. terms you're you political

Sabrina Martucci Johnson

Yeah, Seattle. to I go

Catherine Novack

And the Right. across level what's the interest of of different areas U.S.?

Sabrina Martucci Johnson

Fantastic Yeah. question.

are across the So country. sites the spread

And landscape right where is. where sites state, the some means across what of diversity terms there's are. a reproductive the good also pretty, diversity kind site particular is the terms So, country in that of in that of in

that these we've that are participated It's and by people in to and are an get seen regard, of they very that have are experienced be for the board lots something pregnant a definition may What all signing contraceptive that product. and certainly investigational across have is up it's view factor, their a right? that are It's studies right? considering study, people investigators that the contraceptive obviously, open in fact they to

so aware And terms state factor. they them comfort different what reside that a a And with their that more be be have meaningful is. of maybe may propensity than that and to is in in that they where to

their would that, generally to the they tend people really of and all that get consideration have prepared are projected then, it a view and studies anticipate none is a of for that of sites the who in that general change fact outcome. have progressing. always they But acceptance them it's good participate feel in pregnant anyhow that how Because contraceptive may enrollment

something it's Gap] been has that [Aidio But definitely

funds the an way account the in NIH creative And basically the Ovaprene cost use the is providing the study. for works of for the into puts the Daré to Sort study. into then, basically supplies

another those today contributed we now our study, would that million well. have There's $XXX,XXX And should to providing to year account. funds So be support the sufficient. that anticipate this $X right as we

trial as as study. right? progress vary, a things happen, sites number add of clinical However, of additional cost you've said factors we change if right, the that the could can so there costs Or are

were that if if contribution come what so would and our the adjust happens, then And decide their we happen would what and would that be, be contribution NIH and accordingly. together to

now, put funds there support with our NIH the But are monies like along the conduct right and from the we've to those study.

Catherine Novack

my taking questions. Thanks afternoon. helpful. very that's for Have great a Okay,

Sabrina Martucci Johnson

you. Thank Yeah.

Operator

Instructions] [Operator the Michael. we - of sorry, Michael Michael. think Your but lost I'm question Elsa next I comes from line

Okay.

So at I there to back are further over questions no the call like time, presenters. this would to turn our

Sabrina Martucci Johnson

thank improve health Daré health, we for taking none afternoon the current Well, fertility. sexual Alright. and for market expand exists, standard-of-care seek where of menopause, commitment ease updates well-being value reproductive prioritize recent this health health, adoption, our treatment the of vaginal to options diverse areas for outcomes shareholders. enhance stakeholders, care ongoing providers, therapies portfolio, to time bring to you and meaningful women, health about compelling prescription use women's differentiated has that and With our form factor can hear to and our where in and women, shortcomings a drive more contraception, where primarily drive

definitely our progress updated on keeping forward milestones We today. the we discussed to you look towards

by launch first our Organon. XACIATO commercial Specifically, product and sale

to first with agreement achieve monthly in US feasible. investigational under potential soon launch As working Patient the John mentioned, we commercial clinical together Bayer. intravaginal in category, rights study contraceptive, Phase whose hormone-free a Ovaprene, license X as our of as the enrollment are XXXX are

We're fourth this for we and commence next our Sildenafil looking also study. Phase Cream end X approval expect this support that Phase X And application the protocol Ovaprene’s just the discussed, single a is pivotal finalization targeted with to and study to year. as we enrollment FDA of forward of quarter meeting to of pre-market,

and year being to a cramps, programs, preparations X we look data for Phase from respectively. and therapy evaluating ongoing this to study atrophy our treatment menopause as our activities for vulvovaginal hormone related developed for two treatment hormone announcing Phase well as symptoms Aceclofenac menopause gel In IND formulation Phase the a X, vaginal and addition, later of forward X pain menstrual vasomotor free and as of

thank you I for time your and your today for that, with Thank again you. So support.

Operator

conference This call. today's concludes

You may now disconnect.

Daré Bioscience (DARE) 10 Aug 232023 Q2 Earnings call transcript