DARE - Earnings call transcript Q4 2021

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Operator

Welcome to the conference call hosted by Daré Bioscience to review the company's financial results for the year ended December 31, 2021, and to provide a general business update. This call is being recorded. My name is Catherine, and I'll be your Operator today. With us today are Sabrina Martucci Johnson, Dare's President and Chief Executive Officer, John Fair, Dare's Chief Strategy Officer, and Lisa Walters-Hoffert, Dare's Chief Financial Officer. Ms. proceed. please Johnson,

Sabrina Martucci Johnson

afternoon, results Good to full-year our Thank business and update financial and Bioscience. call XXXX you. welcome for Daré

today highlight as objectives other last review milestones anticipated our November, is for as discuss and use plan well XXXX and to since in last the year's time the insights for developments call Our results, to year.

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

women's after It information set and health course new and developments but therapeutic effective lacking their reflect this statements like report by call except our company's would March is that to shareholders. is in that women I of to Dare or out undertakes this families, our XXXX. XX, also partners, many convenient Dare of also statements today. XXst, belief only the prioritizing is as by qualified content update which to for health. includes including the cautionary for good filings, forward-looking including SEC statements in solely only as that annual for information call, today, any broad the XXXX, a squarely Forward-looking their focused time-sensitive stakeholders, our Form not point women's year the choices, required current of ended of no in is or filed the December XX-K on entirety are law. obligation

prioritize with selecting and efficient need, women's health such product high FDA our of and treatment areas and identifying an and vaginal in We're capital primarily approved developing contraception, last differentiated strategy as conducting on and as appropriate candidate research that approved, various and the market of much involves we our options, and update sexual our activities of bring each to in therapies to promising development With development received manner, quickly commercialization needs, of address late-stage fertility, seek is that and an diverse time today strategy well-being, candidates and approval Our development we Today, goal the potential for improve providing expand prescription health. seven has product. many December. in unmet one portfolio, candidates areas of to thoughtful to a as users the stages have candidates spend going possible. FDA outcomes, reaching our

treatment for As it reviewing Clindamycin XACIATO, forward made look XACIATO, we we Bacterial entered and agreement females with commercialize pertains to that X%, today Phosphate to we our which FDA the gel, the FDA license regarding approved approved to vaginal is with into global Organon product, Vaginosis. older XX announcement

for Since ideally or a first Bayer Key enter seek personalized indications our have existing opportunity. utilize or established API's and of or a that different her. And in path, option. particularly candidates regulatory to line those candidates candidates commercial that the have proof-of-concept that for are and we to-date have different XACIATO us via be target for and can products XXXBX category to delivery into and late-stage we represent the developed considerations potential differentiated in shortening strategies Organon factors the finally, to candidates stages clinical allowing as to when are obtain evaluating collaboration consider many must Candidates commercialization with cost the move drug fond revenue to discuss modes meaningful to for the later overall be such time those three XACIATO program. and include in first opportunities just much to XACIATO as following, as where Ovaprene. after we case We product acquiring such our U.S., a achieved a review years new development first approval of Before marketing approval development Ovaprene, the I was for want we potentially we portfolio. with and impact factors to the the XACIATO of rights FDA quickly program potential ultimately those

or intravaginal I'd -clinical a treatments. XACIATO, during treat our formulation vulvar development with investigational atrophy to and for DARE-LARCX a DARE-VVAX, in DARE-HRTX. Phase today pre XXXX, approved for X rights are Development now network. moment data FDA for for Program risk a our and take the on $XX.X or we proprietary supported five Cream current DARE-BVX its forward clinical contraceptive Sildenafil and application version into few to yet and initiated has look as for those X.X% under our Disorder, which since And highlight We subsequently contraceptive Ovaprene. XXXX, is program. Ovaprene over we entered who for approximately conducted to for Xb is our agreement, before Sexual for X/X risk vaginal a achievements administration positive Female date research cancer. a what trial financially generated where RESPOND of study Phase we in awarded December by study positive collaborative to clinical women at referred as and Contraceptive be of We tamoxifen to evaluating were receptor the grant will Bayer, we of our scheduled with of pivotal FDA no support years And a treatment what to erectile to We Now, come. set study clinical the up X, clinical accepted We III her to NDA million collaboration Phase up continued Arousal like is CRADA, which PDUFA achievements a finally, NICHD's which The XXXX. approved FDA within initiated dysfunction, ahead important commercialization hormone are there breast of for us Phase

therapy, menopause. investigational associated ring hormone the vaginal for symptoms both with as vasomotor treatment the well the of vaginal as Our

now, First talk our treatment, about Bacterial Organon Vaginosis, global let's FDA our commercialize with approved agreement license and XACIATO. XACIATO, to

shares to of which common Bacterial upsets women XX of the First Vaginosis The need. the in approximately the is cause million overgrowth from unmet the of balance affect and condition United see odor the vaginal commitment, bacteria or worldwide condition common is product most vaginitis XACIATO, track estimated an and Bacterial States. for lead infectious most we the results can and the disease women's to vaginal our FDA of the both natural innovation critically qualified muted and microbiome discharge. Vaginosis. and health. symptoms QIDP, fast advance of in from to treatment Organon, designations

to development Institutes the CRADA of contraceptive share payment them. or that part our premier the extensive across Dare of initiated XACIATO will unique for by we to and one market Phase I'll Health is Organon, review development an sales. with of the to conducting In Under initiate Ovaprene's the be the study to has candidate, call the IDE we so, NICHD, Bayer, pending Ovaprene and being Ovaprene XACIATO available be close so option potential our reaches tiered terms contraceptive $XXX.X on the for be as of commercial advisory commercial monthly the year. ceased Kennedy III first in in study, planned Ovaprene NIH, per before by quarter rights to that we fourth licensed Ovaprene It in Completion the category to with and upfront the under the announced pivotal to one clinical pivotal that hours obtain development over potential turn National study tremendous option. on IDE, the of to and of insights pivotal are most doing is reflects payments U.S. position royalties and expected net of the believe initiate of of to selecting receive additional development Eunice expertise million NIH, early to clinical and the Hart-Scott-Rodino the following the of our commercially FDA up Organon's XXXX, ensure in Dare stage NIH eligible we the the Organon health, collaborating to payment. expertise some other and that order bring is to product Bayer. to of to for the be process women support, in commercial the the under category. Ovaprene. subject women's third and NICHD support up are study so through And agreement retaining health, the We collaborator completion commercialization this National agreement, In this Human the for contraceptive double-digit based we clinical U.S. a that Organon conditions, next by over and with U.S. must expertise cost I But approximately we're approval capabilities NICHD's programs. and quarter million, The XX us in place, of Shriver I will with control hormone-free $X Bayer's in XXXX. strategy the III for is right IDE while our will is to condition. novel Improvements updates market $XX with this the we with studies to the women of of Act Through pivotal XACIATO a the approval Phase in John that Under mentioned and process. in this is the the to and impacted to the regulatory other in in objectives III III FDA's the collaboration XACIATO. quarter important year. a pivotal the excited and regarding Bayer provide contraceptive organized enable approved customary exclusive for the leverage allow is transaction Phase making strong whose our CRADA is and companies milestones development that of expected continued trial, of have milestone which Development, a access million year commercialize this Antitrust the study is access briefly from Phase we'll objectives Institute Health, transaction and the shortly Dare the license to received of $XX in to undertaken Child will the receive women's this share that capabilities to year. billion over U.S. second and review as week pivotal of rights certain

also royalties our will commercial study double sexual of Female FSAD our Sexual Arousal which We our Xb in activity. you evaluating is is receive to I general year, tiered attain $XXX Sildenafil condition sufficient March erectile inability sales. the X.X%, Sildenafil ingredient her formulation administration totaling physiological maintain addition payments, cream commenced on In Viagra, arousal for we Disorder, of net active or during last FSAD. as be a milestone in Sildenafil, treat investigational the Cream entitled is topical version mentioned. as characterized product potentially address Cream by investigational dysfunction, to to to of know to million digit Phase

disorders, various it analogous today be is no the to and types product first the potential there exists is our Sildenafil FSAD. female yet option. the of has Of the successful, to If treatment FDA dysfunction dysfunction men erectile that sexual clinical FDA familiar? is development FSAD Cream in -approved approved Sound most treat

RESPOND States. evaluating United to across treatment continue We located Phase as Xb in enroll a for clinical FSAD the Sildenafil Cream at women sites potential study the

study does power it's interim have to a evaluate protocol sizing. analysis, calculations planned and trial the Our

for So top planned analysis conduct guidance once we line data. year, is that on this the we timing which anticipated will provide

effective with vasomotor XX demonstrated to its a bio-identical deliver is of investigational the estradiol therapy associated symptoms part over completed period and or therapy it's vaginal a menopause. unique results as DARE-HRTX, as study vaginal of and X DARE-HRTX therapy an last bio-identical the a the The both ring, for progesterone hormone potential day DARE-HRTX. designed continuously year regimen. hormone together product our of Phase Next hormone

The in step Australia next program, are clinical second evaluate we use. As that over combination women quarter post-menopausal This the previously lower-end healthy with in months will usability, study acceptability open-label of DARE-HRTX data. study X/X consecutive XX had now IVRs commencing There three study the Phase a the currently will bio-identical symptom the approximately FDA now are PK -approved year. in deliver bio-identical this high-dose of DARE-HRTX in versions approximately no development and also we of of progesterone safety, study collect relief in that estradiol. the of

of investigational common We to treat administration our cancer, of vaginal postmenopausal DARE-HRTX portfolio candidate to of a would provide be to breast an is the in breast than first in VVA. to for of such, is Hormone As that last XX%. women receptor I And proprietary type discuss the survivor have be DARE-VVAX More to the history category is is vulvar offers X.X positive potential today like cancer. million the convenience U.S.. DARE-VVAX. the for monthly a breast atrophy those has and vaginal product cancer option prevalence and most in tamoxifen women. women. XX% estimated formulation will to

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

women, an supplemental for treatment is appropriate many vaginal atrophy For estrogen.

solution treatment a risk others However, may cancer is and offer hence pose option. may for estrogen receptor for not hormone breast for risk a women to hormonal DARE-VVAX whom and women an these at positive

we and this data in referred in the initiated DARE-VVAX this top-line year we year. to I breast atrophy DARE-VVAX, last X/X mentioned half program, what vaginal quarter of expect treatment second X/X report clinical my the as in for we As of during survivorship remarks, to that study the Phase Australia cancer third Phase opening from study

on waiting been to turn in to XACIATO, you've perspective about collaboration strategies over women's commercialization provide the to our call and Now hear John I'm more health. going to

John Fair

Sabrina. Thank you,

among important start FDA closed for XACIATO the at in the noted approval XXXX. of by Dare. call, them a of Sabrina milestones the of Chief achieving we As XXXX number of December was

company setting identify the In its better In clinical clinical a Placebo. to capable in clinical on the for that most visit the X% women's As XACIATO and health in and cure women option of are new to objective in compared leverage rate women's with the a unique Vaginosis at our XX% position time enabled offer commercial a study. thermal cure women's treating capabilities are at XACIATO, access, test capabilities we and therapeutic focused be Organon Ovaprene. of we Organon's a partners of women's a therapeutic and core communicated strong Phase we on XACIATO. business Clindamycin uses gel aligned in to and to expertise health commercial our expand to bring our XACIATO to was XACIATO are accomplish health choice mission with clearly what trial, III to leveraging innovation, with we collaborator goal with Clindamycin market. will to gaps with is would Transitioning that to bring address expertise achieved market collaboration's product, XACIATO and help right and engage us XX excited formulation the as outcomes of model. day XX% the women strong for the the XX to for demonstrated the health, to improve landscape, to to in potential our visit Bacterial Phase last to wanted dosing. Phosphate The deliver be potential concentration call, the containing III novel options present as context specifically one for one providing a in commercial

process ultimately, that support importantly -commercialization in the candidate. to manufacturing targeted IDE and remained Our has and Ovaprene pre design including launch of focused with the pivotal strategy the this commence FDA, potential later first activities activities on inform activities collaboration with category to this for Bayer the the study year, contraceptive

give a in vision I to and to deliver the enhance women's our and will are the to capabilities We share our that work who sales financial fortunate over with innovation and will have turn now you health collaborators Lisa expertise update. call to impact. access

Lisa Walters-Hoffert

you, now model financial thanks Thank summarize, for to of product year to as John, ended to will results like December XXXX would today. XXXX. or Dare's women's refer to advance, fiscal I you is the XX, XXXX, assemble, Dare's which all a us joining for novel I in candidates and and health. of monetize business portfolio

and result, activities. corporate development, a research and maintenance As costs, R&D of or overhead, expenses our portfolio, acquisition, consist and

While tend R&D our our with related expenses pre advancing activities other portfolio clinical vary somewhat -clinical the year, administrative regulatory, expenses to to predictable manufacturing, our be generally and will candidates. throughout our

Dare's G&A cost to the Disorder, R&D $XX.X our regulatory for R&D and affairs expenses Phase our activities ready development $X.X ongoing The and the were Arousal XXXX, fiscal trial attributable RESPOND Sildenafil is compared approximately XXXX primarily for activities in with to Phase seems clinical For Ovaprene in be Cream programs. million $X.X million. of increase Female were XXXX Sexual expenses approximately X related manufacturing X and to and million

for Our million. year comprehensive the was $XX.X approximately loss

support any agreement $XX.X grant of under cash In the in received sheet. that developments be making financing entered net in will the eligible ATM XXXX, approximately our two primarily were liability as approximately occurred of next $XX.X interesting XXXX, program XXXX. equivalents. balance receive to of in fiscal our upon At us take cash cash financing December June, contingent moment five sales and was During I'd to deferred development development this during million milestones. into and program. million ended to activities up stock grant a highlight the from with payment achieving pre an funding $XX.X approximately million under agreement million specified we a to July, XX, year-end and XXXX DARE-LARCX, reporting like roughly recorded grant years. payments -clinical to million proceeds We future $XX.X We DARE-LARCX reflected $XX.X of initial and

grateful of are We of multiple truly this this development years to selected technology. truly to advance a work have grant for magnitude that been covers innovative

Ovaprene. clinical Sabrina we study estimated in study supplies entered responsible conduct and to $X.X Cooperative million $X Phase to pivotal CRADA July, contribute towards be of the had the mentioned, as for this for NICHD of the about million Second, agreed cost will of the and with study. paid Ovaprene into providing we the date. Dare of or the total III for Research Agreement Development Dare also

For will related experience and the conduct believe should NICHD support financial manner. its of Ovaprene costs elaborate the expenses of and of the NICHD's trial the pivotal contraceptive for part, completion an manage will study and cost-effective be responsible third in other We pivotal to truly the parties. payment study efficient to the

In with upfront of XXXX, receive double-digit in to future Hart-Scott-Rodino XXXX. as XXXX. will to the Dare be is the during based of announce for Sabrina to U.S. subject John of and as eligible quarter we fourth will first discussed, other to expected of the transaction in and the to tiered the on agreement to the transaction Act review commercially the royalties Improvements second global The were under milestones $XXX.X is well quarter customary $XX be Again, Completion terms a net Dare up closing payment receive million as however, close and conditions. of XACIATO. in Organon, of commercialization the available Antitrust is, from sales. a XACIATO license expected quarter Organon potential developments of thrilled just million

March of of stock shares approximately million XXXX, common outstanding. Dare As $XX.X XX, had

and be we candidates in creative, that capital will the So we collaborative, to in to endeavor shareholder and seeking closing, build value. need our advance opportunistic

investors I beginning the financials more risk the over to factors had like of Operator. in our for year annual liquidity report today. XX-K of detailed the call and Sabrina capital financial December our As turn discussion XXXX, and the at call, our to ended encourage on review XX, was the Form now filed resources, that and our we the condition, to noted would

Operator

Instructions] [Operator with first ROTH Zegbeh question Jallah you. Thank from comes Partners. Our Capital

line Your open. is

Zegbeh Jallah

deal on progress with congrats for taking the Organon. well the questions, and as as my thanks recently Hello, signed

track, going that been I a think I'm is just of looks ask so everything have folks questions lot like on to wondering.

fully I think the your partnering negotiation also decision as specified over opposed commercialization, decision products. commercialization have your them some then of to giving to the just first around with the perhaps Organon first them is on and take about right to

Sabrina Martucci Johnson

about you the and Great thank Organon questions, decision. for and asking

interest product to have about to certainly were that have vision address step selected an what of prior a truly And at finish options. provide be commercial back, including candidates and First be always an have a unmet a of product from a today, co-promote. a partnerable as get first potential those And thus a taking to in of this to FDA line right where in needs all, wonderful that or you does we different optionality. developed opportunity the opportunities category, talked first position line lot it's candidate. able when you just of for variety that is structures product really disclose when opportunities, we you looked meaningful they you and parties approval, of our in should we're have have therefore and And and persistent fortunately, selecting have to partner possibilities program, to and that being actually in

way also on ensure that's access your maximizes to does the possible. individual each for women, as good the good access be and basis and that it and also to impact disciplined Because quickly said financially, has product to merits that's peak really sales. that's However, it also product women socially, on most what to very that time as can times, is tried good what we've is several also as to the look really and very, best be we try focused its at

think, the And from entering this obviously health of it possible. most the Organon ensure quickly impacted with as companies women women's perspective. in condition So as to tried look capabilities, into collaborating will XACIATO is clearly, reaches really at with their partnership a commercial and that we we premier from that as one that believe I

transaction add footprint And to that that can their organization the to and rights a category, obviously an it value unified products do our potential their women's and really a think representative does and commitment that to continuing is lot line is Dare to very, commitment have strong products Organon's first clear we'd to do have so persistent that and to great while their have the address be it's with commitment future to very for we Dare work commercially, again specified Dare our in global opportunities. continue health, unmet in with with mission potential worldwide which innovating. is well Organon, your first or and very commercial noted what be I enhance need love our to a the think include think meaningful strong, an of address best category what of that's question build in so And potential with mission opportunity for transition negotiation products. a portfolio exclusive that kind I of first what and that Dare for for program, partner And that Organon to is you about does. just at this clearly that great like and the

and talk about want represents, and future be the that and are our what of really those doing, to to potential chat it be an it's for us that's we that kind gives just our vision products. so doing work really and alignment And they of to opportunity going

Zegbeh Jallah

in have queue. ones And back Sabrina. get quick the then and I'll just Thanks, two I

Organon. one important. is I that the here just is opportunity the first reach The about broad of XE imagine

So could talking that U.S. just leveraged market, terms could the wanted around since opportunity market commentary how in market? about what that and the get of primarily then to be been quickly some it's be

Sabrina Martucci Johnson

they are organization, a global Obviously, definitely. global footprint. they that have Yes, so

There's Bacterial going not around the that outside we're consideration. to In in in the experience focused I global is the focus growth think but have now, of the today is clearly is a we obviously and terms approval, women the is approval no but right United confirmed focus, right world U.S. that the about the U.S., a an it's of current so transaction, it plans obviously States. Vaginosis, talk now, U.S. ongoing

that's obviously now. So right a priority clear

Zegbeh Jallah

the can a modeling. last Ovaprene. is was I for if IDE clarification And just then IDE III the approval after that III can you between Phase guesstimate know is need is good anything for when Thanks, Phase underway. I to the can just get know here wondering move for the you and about start as into removed, Ovaprene can just Phase so we that when place there study, can but some take we to that III

Sabrina Martucci Johnson

protocol, that discussion can. to allows as protocol we and is Yes, that of the items as to of year. contraceptive we you're trial really that collaborative NIH an category, FDA, Because do great the contraceptive a question study, have can longest the can of of prepare provide some is first the IDE. initiate has sure pivotal Ovaprene study. on the when I'll initiated for try pivotal vaginal this one the as of pivotal a in the to unique study, to steps we to your because along so design And that the a kind for the candidate of as and mentioned, process the And clarity for it's are really preparing lead importantly, the one of with so first that's much IDE basically, any potential monthly the the requirements so product development be one I have important those But is really because understanding I the aligned having that that with we have around is we clearance the work reasons us which there's that IDE make process, the that time that method, really we study. of started, the obviously, hormone-free that

work. an the XXX So working and we really some to planning prepare right then, IDE that to that, as requirements, have and big those completing from FDA, which clarification site importantly an study, us really activities. updates of months. the perspective, work product the now, process, of FDA picture, great that's discussions on to those And all them. support and prepare women study we year, by starting start supply some we're completing key provide on do really got just prepare to to have this and us the obviously is that And we'll allows this of do pivotal manufacturing perspective, But selection it's with allowing XX understanding the a to from some protocol towards

Zegbeh Jallah

congrats on and Thanks, partnership. again the

Sabrina Martucci Johnson

thank you, much. you Thank so

Operator

Wainwright. question from [Operator Thank H.C. comes Tsao with Douglas you. our Instructions] And next

line is Your open.

Douglas Tsao

Thanks for the taking the questions, congrats deal. on and

obviously Ovaprene, Sabrina, partnered, point, world. XACIATO the two health the starting premier well as of you've there's women's in successfully a as Just organizations as

how and thinking now organization what is pipeline begin capability. at curious build to Just point you about become right commercial for to out a the to it that you're and

Sabrina Martucci Johnson

you your question. for Thank

So have have just be recognizing of by with we what the access, and the are kind conditions served, as John terms partners, thank That's partnering you organizations prioritized like we're in organizations. we've Organon partner to not but partnering really to-date are first with with, because have seeing ensure of commercial achieved all, health. to us mentioned, for around that capability and Bayer impacted I women sales and it there important around to aligned to most like truly the commercializations said. When capability, really that partner going to that an of opportunity for are capability infrastructure women's

talked talked a question of portfolio question, your health women's how few always them for programs development about two, that about obvious I So whole think commercialization of about do big best that's one, we achieve have we and do picture, to thing product, and we as we of -- want other critical. And in that have strategy, we seven the definitely product? products. today. I a for And that only to

are address trying need a gives that these it Having to to in we with one real start on some that first-in-category more a start support around all have successful it as be -- by product. women need to the getting of to-date you're fundamentally, we from And efficient I position to So that, all that Like optionality, that furthest so, optionality. strongly our so to it the in to persistent approvals through be support interesting. it have way That that to to sense have value become line that to possible. participate, point commercial build would at two date where we potential. a infrastructure you we portfolio partnerships add one it can build that we importantly can first have that because and Obviously, become way to Dare We it's have you clearly product, going and collaborate it launching do and Bayer you're these because already Often might If along have most level what products have programs, shareholders way we do we believe that importantly, our can portfolio first products in said, women's at with what brand specifically. one quickly have commercialization. point who shareholders that becoming where not the doing commercially And or collaborations the if might brands truly as -- that participate said making continue decision sure participate? unmet into, partner interesting to building challenge, be perspective Organon with a and we capacity done makes that to have in timing true these and product what doing we for we've believe very that at make develop with where in opportunity by entered into you the partner have it. that's the two that to in and a to clear that health, when deliver a entered to that individual success that and a ultimately it will organizations one these us collaborations demonstrated very these next? approved furthest product when more important and some aligned by mean if and have and we can have along truly we've is demonstrated, we and to is successful such value

question. answers that hopefully So your

Douglas Tsao

payments just And on follow-up ex-U.S. of as the commercialization? a the milestone Are global deal, it's Organon specifically, helpful. really XACIATO deal. quick tied a That's any to just with

Sabrina Martucci Johnson

right big the disclosed about Really, is on Great, what are the we've transaction right forthcoming. that the great milestones question. picture,

$XXX payments. really there's additional there's of royalties. which the course, the can a clarity then I double-digit regulatory is is and obviously at it's that sale. $XX the commercial million, upfront that million, And And on So tiered milestones. the of that's $XXX in first on sales top that then And give And there's you tiered commercial million milestone milestones consideration. million $X.X

Douglas Tsao

you Thank much. very Great. Okay.

Sabrina Martucci Johnson

you. Thank

Operator

next Capital. with question our Thank Brookline Raja Kumar from you. comes And

Your line open. is

Kumaraguru Raja

for add my supply. regard for drug will With Thanks and I also regard congratulations taking questions to the partnership. with my

take is of to to terms and work? over going it In Organon Is of that? all going manufacturing how

Sabrina Martucci Johnson

Yeah, great question.

as, previously. as we So had guided

in are that supply, have to commercial And we've Were really commercial anticipated earliest supply expect was fourth which previously around we ties about, in we of the available of chain, anticipated the been that because that again guided obviously launch In supply summer to quarter. supply terms year. be timing the be chain. this the of that talking supply the and is it we right into that commercially available is

with in that who's that actually, requirements, it's supply, assumes assumes that that that we've Organon on would and a and basically and is purchase those doing activity. to product intent. ties your from all obviously How that us, Until responsibility. until agreement, the would time, we for time of basis, already. -- the the Organon that oversee product of responsibilities that Until manufacturing those Under interim they into which interactions does going couple XACIATO, And regulatory So we're been that? question be for things an work? supply really providing terms that doing really on responsible

of the were all the for but for As supported successful that X clinical we Phase preparing supply been study. launch, obviously

Kumaraguru Raja

a to assume whatever be bit compared I little would up So mark guys? to that like you cost going it's

Sabrina Martucci Johnson

will there's our price costs single-digit plus equal mark Basically, manufacturing up. Yes. the be to a percentage transfer which

Kumaraguru Raja

complete when it Okay. there's will timeline switch And now to Organon? a

Sabrina Martucci Johnson

the responsibilities that are these that time sense. and way these to year now that right not all efficient launch we over opportunity, and potential this working that's but get makes But to processes a discussing towards is it over nice, we're when obviously Yes, really intent a we're obviously that's something yet, had underway an that this they take there. would

Kumaraguru Raja

with regard touched with you it little to bit regard to Ovaprene, And Okay. the on IDE. a

the will are clearance. long process you the interactions additional with can where anything in you regard the it you to So are, take like to share, how especially where get

Sabrina Martucci Johnson

with have presubmission. And submission, around no shared us beginning of very IDE discussion have converted that a to really -- a we have Really in that this to wanted time-limited importantly allows that year, to which the things which than we the the more to opportunity conversations Yes. what to process earlier around. color collaborative than an as isn't such protocol, other we started as date this year, I've pivotal

other make commercialization the opportunity products, study wanted a from that lot the my best we input in all of to product to the As product to from we contraceptive to his could comments, category, the Bayer's the do a mentioned I a into in for with to such pivotal ensure things before was, in wanted one be we John to for like of is really sure unique Bayer, Bayer different so that comments and is the in Bayer get of the study, Ovaprene pivotal one got translate of success. the with insights comment program we [Indiscernible] reasons candidate did to product collaborate partner to alluded also behind has when Ovaprene that on situated is

the also we can opportunity you to other dialogue and more an to to for so has any have instance, in the to have study addressing incorporate that that the about process, them importantly, And in process the that make really questions in sure we with success so is they certainly unique, but nicely that. it about want do we that that we for opportunity an make really do with the positioned interact could wanted we because and that do on process marketplace had things Ovaprene engage collaborative to it ensure commercial FDA as IDE is Dare engage sure a it to pivotal learned we

to we've working that the And process activities, the that's XXX this whole is the be objective, to the and so the to into the like that we're ready. clinical the really terms so so, things all in how process start that other us that received, we on in at can't need sites, importantly, that's similarly, an that study with date is And get on into with the lot which things. and of initiated helps geared the a activities. towards working NIH planning give process, with you through but And women of we've NIH get been we of us based because the can considerably running collaborating of us we say completing year, while feedback preparatory end allowing knowing process, and allowed have than be XX what to looking process to the planning that FDA already other months on I year clinic this we're use, around the

overall that sense that in you I a it we're but makes with can't that you support underway that are gave I to exact give didn't the And more hopefully and the towards we So do little year. why start pivotal very IDE, process long yet, this on the activity is a an working quite study there's answer I lot that know FDA we're what a timeline, now of

Kumaraguru Raja

helpful. very that's Yes,

that a duration once basically So the -submission is is once okay. is pre understanding going they that seamless XX gone, the to accomplish be about have it's submission process we days,

Sabrina Martucci Johnson

you saying Yes. Thank Yes. that. you. Thank for

Kumaraguru Raja

again. Congratulations, much. so Thanks

Sabrina Martucci Johnson

you. Thank

Operator

like to the to showing remarks. you. back further And call the no closing queue. turn I'm questions would Sabrina Thank for in I

Sabrina Martucci Johnson

and the Cream talked just absolutely version meaningful we Phase Arousal of our forward in quarter the for Sexual milestones, developments Organon for and with stakeholders, of XXXX of activities you very ongoing us against about XXXX, to Well, this thank our for of really strong and Phase our the Dare And about really shareholders. updated our for you months year important her providers, drive III ongoing dysfunction. including objectives value Female study preparations Great. regarding XACIATO, time for study to the on this and recent all progress the Xb with and for afternoon our a we several and first and healthcare next look all keeping Disorder updates taking in NIH hear commitment Ovaprene to closing, erectile positioned Bayer, Sildenafil women, our XX was

Thank so for ongoing our work, thank to you. supporting much all time, all you stakeholders. being for commitment for with you So drive you thank of value really our our for and thank aligned taking the

Operator

call. conference today's Thank concludes you This for participating.

You may disconnect. now

Daré Bioscience (DARE) 1 Apr 222021 Q4 Earnings call transcript