Recent DARE transcripts
Associated DARE filings
Sabrina Johnson | President and Chief Executive Officer |
Lisa Walters-Hoffert | Chief Financial Officer |
John Fair | Chief Strategy Officer |
Kumaraguru Raja | ROTH Capital |
Welcome to the conference call hosted by Dare Bioscience to review the company's financial results for the quarter ended September 30, 2022 and to provide a general business update. This call is being recorded. My name is Paula and I will 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,
afternoon, Financial Good Bioscience. to Third our Thank and and Business XXXX Results Dare Update Quarter you. welcome Call for
end Our anticipated investment call and important review the development plan in our disproportionately business of the to impactful quarter why review through health today discuss we objectives XXXX. is including results, and believe time our to some since women's and August and to in third last the highlight strategy milestones and in use year our is efficient
of Before this we by pursuant to federal statements remind the materially today's statements Litigation Harbor to that XXXX. statements securities be or forward-looking call you facts should Act the Actual not implied the forward-looking differ of known to events include statements unknown Any begin, could and I'd that or of historical meaning these made are like considered anticipated discussion Securities uncertainties. of provisions statements. will results risks due are and those made from Safe laws, which during Private within Reform
You reliance statements. on should not place undue forward-looking
or by which XX-K including no Forward-looking as annual this statements in also update like November only for includes quarter XX, after XXXX, filings, qualified forward-looking report today, Form I the obligation report except quarterly by point as on cautionary would XXXX, call XXXX, current statements undertakes law. company's time-sensitive call, required new to content reflect ended ended any XX-Q XXXX. filed was SEC the is this on Dare filed to in are XX, the information statements December year that that on March developments their today. entirety to out for June Form the information of XX, was of the our which and XX, our
good more for areas families solely in vaginal and convenient We accelerate we prioritizing and expand where adoption. effective lacking health, health form broad and the and in health, innovation therapeutic Why? also improves only contraception, none compelling or Dare standard squarely belief these a impacting that a that have to drive but where factor many women's shareholders. know, where of women's choices, can Because that innovative, care is has and, for fertility, is are It options shortcomings, As to our partners stakeholders, that these markets of their of enhance millions treatment differentiated seen women has in product exist, not focused course, you options is health. including use brands. our successful set of led compelling commercially sexual current that meaningful women, for ease of and women, outcomes work
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on target built line product and we must As opportunity. offer is often solely our focused or meaningful health or women's Two, regulatory and mix API. that And time well-known product that meaningful because is must a candidate pharmaceutical diversified first ingredients well-characterized in goal portfolio leverage upon be of candidate is seek a a market to principles. improvement. and first-in-category candidates have the not Dare's each reminder, squarely capital potential incremental can of One, following efficiently developed each active and whose three, terms pathways core
women our effect portfolio. our addition it's to the contraceptive product ideas to in four candidates are XX the U.S., women's a million in what potential our estimated Well, novel in condition candidates approximately big Specifically FDA in approved vaginosis, or for bacterial health?
product vaginal being health our activity, with as same hormone-free the men DARE-RHX. first the injectable may It's as management disorder the designed potentially broad DARE-LARCX, contraceptive contraceptive and in intravaginal a first DARE-VVAX fatty infections to and first a days. for ring, six candidate, hormone-free our first be ingredient atrophy potential shown therapy, sexual first-in-category the DARE-HRTX first the bioidentical or our in portfolio, of First, breast progesterone FSAD, reversible evaluated for plus positive product the Glycerol Viagra antimicrobial candidates female occurring call developed It's and release with and treat hormone portfolio XX-month receptor and in that target naturally we various monthly candidates potential ADARE Monolaurate, product pregnancy XX long-acting and candidate progesterone candidates contraceptive monoester ring prevent that XXX/XXX, monthly active cream Ovaprene, our vaginal that for DARE-HRTX, to hormone-free has system therapy portfolio, topical women and/or or sources. health estradiol DARE-PTBX, and our first treatment hormone maintenance women cancer, acid arousal vaginal specifically over intravaginal it's three sexual
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access sales its is relationships The vaginosis. have providers believes XACIATO providers those is who customers meeting and and obtain in who prescribe with these preparation contraceptive. collaborator XXXX and Ovaprene, coverage hormone-free roughly in day the potential access that and commercialization treat one. vaginosis begun control half of first is XX% Nexplanon the now competitive the is Organon anticipated has team an hormone-free Our first with to team the launch expected thrilled team sales established uptake our overlap And as monthly investigational diagnose review birth Nexplanon Organon monthly is early of to commercial we ongoing. commercial accelerate in marketplace. enable and sale first-in-category are are Organon are intravaginal bacterial U.S. strong as candidate, immediate a will launch. market The XACIATO leverage Organon healthcare to the there bacterial at activities Ovaprene
FDA meeting PMA support In we commercialization in primary pre-market pivotal a the order to implementing XXXX, this approval with IDE other we We study the submission our successful, is to to for in investigator support single year, FDA. collaborator be the currently design this by investigators anticipate is necessary the FDA. additional recommendations is announced study initiating mid-XXXX. our if NIH the for December and approval study are expect submission a we study, NIH. the FDA reviewing for words, clinical The study future planned recruitment Our this pivotal and an Ovaprene to as serve Bayer holding and of to in October collaborator and pivotal the
our has vaginal symptoms The both has XX bioidentical symptoms, format of of delivery DARE-HRTX PK we one estradiol use. to is We with XX it XX will with Cream be ingredient investigational, has active Subject FSAD, Cream, It's female top Last disorder days. is female and options subjects combinations menopause. the or sexual of FDA Viagra. potential the designed intravaginal arousal treatment in Sildenafil about sexual a formulation same which combination of XX X/X over Phase Sildenafil, product no completing the announced disorder, hormones approximately describe study two an of approved cream months of candidate, in an XX our over for primary Sildenafil therapies. is product of menopause monthly data objective target arousal novel and screening release use. approximately XXX There first-in-category that ring product clinical study approved our line complete Top date. total of of to subjects weeks no treatment and convenient in announcement XXXX. are the for both XXX currently intravaginal the investigational bioidentical XB subjects for Phase pharmacokinetics to study women. data a to the first-in-category, progesterone in have postmenopausal the different response ring. DARE-HRTX, completed to or all hormone and the tolerability line It for expected FDA hormones. completed targeted the hormone was safety, from second study the monthly for potential to vasomotor dose XXX first was potential to is assessments October. quarter study month treatment XXX Approximately in therapy cycles healthy exploratory are be the
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can and their the become atrophy only the product of are atrophy a breast of If care DARE-VVAX in population. cancer patients a of any use for estrogen of be providers is positive the the positive new potential products has we patient form standard and patients However, vaginally breast vaginal challenging often of and for the these contraindicated vaginal successful, hormone the estrogen this healthcare hormone use for as administered based receptor treatment receptor for treatment cancer first in as to population. approved both
We study call line this data end and two I to top are agreements the over turn Ovaprene the will commercialization track of in Phase the place to to collaboration on year. of John provide overview an XACIATO the respectively. for X/X announce we have now before
Thank Sabrina. you,
shareholders we via the attempting the specific market Given best the the stage believe value XACIATO Dare is to therapeutic products than generate and assets collaborations and upon ultimately developing current dynamics potential the such demonstrate that to in these into portfolio commercialization line to of are rather or external and first our way first-in-category. agreements, own. collaborations categories, license Ovaprene, out to enter for our commercialize to be differentiated Opportunities on contingent or
XACIATO's So global in for collaborator women's let first to unique XACIATO, with health. to XACIATO and women ultimately ensure XACIATO their commitment shares with this vaginosis impacted FDA health of our advance strong will most XACIATO differentiated women's and patient capabilities on unique first reaches needed market bacterial based use believe me Organon, And critically Organon approved XACIATO. believe Organon positioned awareness we profile. the commercial is to condition. on provider innovations focus that product, and that uniquely We our our will drive coupled begin that to bring leading and the by
after developed, June, mentioned, who diagnosing Sabrina Nexplanon launch. quarter also received agreement Nexplanon able to to XACIATO, early U.S. The launch receive from providers are that milestone a leverage of as uptake one Organon will will license commercialize payments strong these sales up we're them treating accelerate of allows prescribe and that Organon get day also Oregon the as this Under These us that access cash $XX sales eligible at to payment in is providers became with Organon vaginosis. potential help million a relationships our has to and currently digit are Nexplanon in license overlap healthcare the we As half expect established the team effective roughly to well royalties to bacterial based of believes commercially net on team XX% and the XACIATO's $XXX.X the and expected will as be we available launch. ongoing million, double the as the and in and tiered be activities those sales. of first current XACIATO is in XXXX. to providers
are whose activities Let license Ovaprene, intravaginal for me transition rights hormone-free with now underway our to candidate, contraceptive commercial novel monthly U.S. commercial under the a Bayer. agreement
capacity Ovaprene, commercialization an Dare approximately advisory for of part manufacturing as in to reminder, to clinical hours commercialize per extensive week. Bayer's Bayer and a agreement As has our resources license with access XX
has process, following in by we over pivotal payment right the X to full control Ovaprene study Ovaprene's completion approval million the regulatory exclusive to retain the commercialize a Dare. U.S. making rights to of Bayer obtain and development $XX While Phase
Dare to addition double receive milestone net tiered Thereafter, potentially million entitled will payments totalling be royalties sales. commercial digit in on $XXX to
for will device women. payers, unique existing differentiation position FDA position patients. discussions contraceptive leadership no compare the Ovaprene and to Bayer is as are As franchise, they before, proactively Ovaprene. pre-commercialization nonhormonal mentioned with resonate identifying use distinct novel product category predicate key is that Ovaprene, has with There the hormonal initiated looking and Bayer in including is providers, Their establish candidate. approved and FDA Ovaprene Mirena no providers there's payers with their and with reference leadership a in on points team commercial a has of a and activities, the that to and drivers uniquely focused category with and we've meaning can similar
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to provide now to turn a the call So I'll update. over Lisa financial
us XX, thanks for financial joining as to September two quarter everyone and I for would John the I you, Dare's results the refer of or to now summarize XXXX, is today. business will current quarter Thank quarter ended like third which parts. of XXXX. Dare's the comprised model
meaningful corporate includes a that maintenance advance costs, that research identified or ongoing in to assemble to candidates we've is this acquisition address do product needs differentiated in and investment and overhead, and health. first The of expenses. development women's The portfolio unmet required R&D portfolio
of and value the securing the and near outcomes, monetizing form fees, the from value regulatory involves second to with ways and products generate milestones term. and advances over longer one There clinical model license royalties The net portfolio's many our and on commercial of includes upfront part in differentiated time of our sales. are over the approach payments
approved the FDA under the received was of upfront For license or recognized during fee for quarter. quarter million $XX global license we our XACIATO, and our current agreement XACIATO payment Organon an product revenue first in the million cash $XX third from second
the both were colleagues administrative But in third or be to royalties, is potential XXXX, our commercially mentioned, G&A quarter of receive once XACIATO million. $X.X back Dare general launched. additional current As my milestones to approximately expenses our will quarter, entitled and during
approximately the Xb reflected R&D Cream and and trial million preclinical manufacturing, from and the Phase on of which Sildenafil primarily the were other related manufacturing X.X%, regulatory regulatory vary activities clinical $X.X to clinical, ongoing RESPOND Our expenses, and quarter-to-quarter based Ovaprene. activities cost
current quarter equivalent. cash $XX.X was entered million in approximately approximately $X.X quarter the the for and with loss Our comprehensive cash We million.
million we the from DARE-LARCX the of to in fund was second free grants mentioned, just Organon cash approximately program. quarter that recognized million $XX disbursement under as which that cash, and the $XX received million I in revenue the includes license a quarter During existing $X
Now, during our non-dilutive sources importance of strategy. of quarterly calls, funding to we've highlighted our the
grant current incurred study expenses that up expenses. is currently to In for rebate such our R&D expenses. XX% in of XXXX, which rebate of In performed reimbursement, we've clinical The clinical XXXX. research Australia's addition we under to are cash rebate accounted R&D tax this noted certain and to $XXX,XXX program, funding, an of development eligible Australia year, as work October for an in during offset Australia for be approximately will partial received
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Our share with interactions NICHD of supportive and pivotal of study. million providing the $X $X.X involve have the submitting the of and under expenses million the the supplies coordinating advanced of the clinical to cost NICHD. FDA, [indiscernible] Ovaprene, documentation, regulatory to been such already conducting preparing the providing commitment toward
had Dare XXXX, X, approximately November XX.X common shares million stock of As outstanding. of
So collaborative, necessary to shareholder in endeavor in value. creative, and our and seeking be closing, to build we will opportunistic capital advance the candidates
Report encourage and more ended XX-K resources, operator. Sabrina as XXXX, to the was well to to on financials, our XX, XXXX, back December was over as we factors risk would discussion which XXXX. for on liquidity, now like I turn investors quarter the capital, all today, filed financial filed condition, ended Form the XX, March XX, noted, the September call our year detailed Annual As for XX Form Q of review in our the which
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Yes, great question. more
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Great, thank you.
Absolutely.
the floor next back call. comes the open. Wainwright. of now line to will Instructions] is Your Mr. session of concludes today's your Instructions] H.C. question over turn Douglas Tsao Sabrina. I [Operator [Operator question-and-answer Tsao, This from
the about time Great, taking all with you well so seek value of all you diverse not to market thank therapies updates ongoing our as just And for and shareholders the drive bring shareholders, portfolio, prioritize afternoon that and Dare's to women's commitment providers but this the hear stakeholders, recent the under the for and can we also drive much treatment we the to wellbeing, to prescription of healthcare well. differentiated and our and outcomes definitely health, of women primarily health the enhance collaborations health, candidates infertility. the FDA have commercialization and where vaginal belt. has of options exist, where in one of shortcomings compelling where and product women, standard form you improve expand for approved adoption and care use stages more areas and a contraception, our seven as Today, current factor two various heard, sexual in development meaningful none ease thank
or many as impactful. activity good Organon our them the patients. at convenient their of is forward updated Thank to with course development pipeline of programs our potential so with belief the set diverse options and of with quality be portfolio forthcoming independent high call, needs that this our our through differentiated are lifetime. add it's for in mitigate shareholders. with a help innovative that risk the under seeking I the year outcomes keeping you a And well many the U.S. innovative to into looking Providers broad our the their and And and first much. the and Women including unmet balance over you commercial candidates portfolios. for products to to of regarding their line of candidates of XACIATO choices, impacting potential and and a are the products underway. revenue looking the therapeutic are in address the disproportionately preferences investors to and progress opportunity that to first-in-category the course on revenue needs opportunity on is and We given partners as for to launch overall of life new women are and effective so look navigate has the mentioned women's also the opportunity it that partners lacking health enhance for or milestones As XXXX investment their are for represent where commercial of the our stakeholders, compelling for families a looking meaningful onset potential good and belief prioritizing
in gentlemen, and Ladies thank your event. participation for today's you
You disconnect. may now
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