EVFM - Earnings call transcript Q2 2019 | Evofem Biosciences, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to the Evofem Biosciences' Second Quarter 2019 Results Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will be given at that time. [Operator Instructions].

As a reminder, this call is being recorded.

to call like Raskopf. to now would turn over the Amy I

may You begin.

Amy Raskopf

you today's available site note participating Amy Michelle. accompanies Evofem after for Thanks, Thank Web presentation the in Investors release issued Relations that section Evofem market the and press call Raskopf, for call. the Biosciences. at the Please are evofem.com. that this we yesterday in Investor is This of

Officer, Saundra Jay the from executive are Pelletier; Evofem Kelly Chief Officer, and Russ Financial Chief With Commercial me today Culwell; File; Chief team Officer, Medical Officer, Executive Chief Barrans.

I As purposes noted regarding on to of Provision under the prospects XXXX. that Securities during Slide team and forward-looking plans X, this Evofem call, Safe Reform statements Harbor will constitute expectations, make Act Private of want the the forward-looking the that for Litigation future company’s the highlight statements

from X Investors materially statements factors in differ evofem.com. sec.gov Slide on as may the in are and filings available through result at of which implied forward-looking including of a results those various important the company’s and by noted these SEC section expressed Actual described those or

XXXX. forward-looking The during should X, call considered only made as August today, this accurate of be statements

time-to-time Although do the duty future. to forward-looking the other in in occur new or disclaim events even update company information specifically the as or statements may we so from future, to elect any obligation becomes available

turn With I’ll the that, CEO. Saundra call to Evofem's over Pelletier,

Saundra Pelletier

Amy. you, Thank

everyone to on us. thank to call say for like hello So I’d joining the you and

the advance development lead, pH To leadership MVP-R we of regulator dynamic our half The team, and Multipurpose the for was the strengthen collective to or of first efforts Amphora, Vaginal candidate. Evofem. XXXX significant of continue our organization

moment this can pH women to a sperm to no contraceptive they which empower the use created help option the with in inhospitable does use their by pathogens. bacterial X.X terms. vaginal with on providing to range, And hormones. of was in X.X it regulates Amphora Amphora and various is normal them

quarter Sixty approval $XX towards of Biopharma, women by XXXX. and investment women’s healthcare health raise advance of that vision reproductive building the commercialization, To fund shares our PDL the we regulatory strategic Amphora’s of raised our impeding to million the worldwide mission from advancement company company. a a and a second million premiere during supports was

transmitted XX remaining institutional Management. our The the market potential Asset Management addition Woodford This Invesco MVP-R reported the first-in-class came from commonly hormone-free funding sexually for execution our the birth support United will States, million growth and two Amphora our chlamydia long-term most method developing control of and of infections to to two of in to in investors, of the bring prevention strategy Investment gonorrhea.

quarter it second With Jay that, to I’ll over results. to turn the review

Jay File

Thank you, morning, Saundra, and good everyone.

XX.X decreased to million. trial three in operating XX, and months X.X XX% XXXX, costs mainly the total June the expense XX% trial. decreased For Research lower to costs clinical AMPOWER driven development million ended by

stock-based a non-cash awards of XXXX. administrative amount was was second General by of granted This quarter significant quarter in mainly compensation XX% XXXX. awards second XXXX. X.X the a which XX, in offset million The June for million and during XXXX stock-based decreased decrease with associated March after recognized in granted the partially compensation key was driver stock-based to costs X.X of stock-based

marketing-related XXX,XXX with The in associated services rise and net due expenses decrease associated in increased pre-commercialization, was XXX,XXX to with PR by and expenses consulting payroll-related increase non-cash increase services. XXX,XXX in and stock-based partially a offset compensation a recruiting headcount, outside

we was all quarter. other no this quarter in the second during XX.X XX-Q of non-cash in discussed total was second Total associated the our just other year the million detail expense the XXXX in with items prior closed to and private morning. placement expense related was filed that in There quarter

XX.X or loss compared million loss was XX.X As XX, million of for common of the quarter per for with a share $X.XX XXXX quarter. prior loss result, net or a the June net loss $X.XX a of stockholders to year ended the share attributable per

share. in million an approximately approximately XX.X Management second raised Biopharma, from quarter mentioned, and we common of stock Invesco Investment $X.XX at to common shares of to aggregate of sale XX As million up of exercise XXXX, warrants purchase the of stock share per Evofem Woodford Management the million Saundra $X.XX at PDL Asset price shares to per and X.X

sufficient For anticipated birth XX a to per the expense our operating Amphora that XXXX. expect in remainder through we control we we quarter. believe million will average of on the approval current plans, continue of approximately hormone-free funding Based have XXXX, our for

With to Saundra. that, turn I’ll the call back

Saundra Pelletier

contraceptive market research, the is the contraceptive have into journey frustrating. we’ve found extensive the current most we What journey a looked that woman’s predominantly for same, and regardless women. use of emotional is Through

their for due to begins, journey side will their impacts to pill. changing that gain, and continue effects. most throughout complicated women, mood on life XX their having their to change negative method effects journey due all pleasure methods deal sexual reproductive contraceptive method more brands side swings. The their unwanted age with with while oftentimes Women weight or makes at They like approximately the

first profile the at the moment. associated as-needed It’s well very non-hormonal it candidate’s like used more because effects side an or see are health. because in Amphora, be with control expected on most when They interested very as makes importantly, the women really the their most And this ongoing in of can to of feel understandable of product basis, properties. This use that Amphora. be sexual glance women the as of minimal lubricating nature the somewhat

has unintended our Amphora at more are of the XX assessment, women if million of Today, who potential needs approved, than based greatest the to the risk on latest meet pregnancy.

who about us active You are consistently XX women not currently method. have heard contraceptive a sexually and million talk using the

need and new The try bottom method women to it’s time But there line in method that million may barriers, for now. a control is who is birth they are they or a are that and hormone-free control withdrawal also X be using when new innovation use they and time it. that ready rhythm only

with confirmed or we’ve many women control that to research, providers market and our healthcare their nothing options better are dissatisfied Through offer new them. have birth

women We also to hormonal to having sex every times month. back day. control on only want their take time to control. they’re X another don’t We Because XX take women for a contraception average, birth time hear it’s for choice. of And it’s believe

ever entirety that a candidates pregnancy prevention effects clinical of and sexual but the to are to at look throughout study of company journey. reproductive that on for We first satisfaction women’s of is for women. also is their a the innately AMPOWER needs it sexual and contraceptive investigated Amphora the listens pleasure unique study the sexual

if findings enhance lives of an women. Amphora sexual approved FDA potential the the satisfaction, will provide of believe is also we on endpoint healthcare With that by sexual innovative the solution to that the our exploratory have will

to announced the going prevention. to you over additional Kelly turn findings and yesterday on now AMPOWER Medical Chief clinical I’m it AMPREVENCE, Culwell, Officer, deeper detail we our our Dr. study to update on provide a STI

Kelly Culwell

from for discuss was characteristics AMPOWER study Thank trial this some you, Saundra. and well AMPOWER pleased the old. across clinical was The I’m average demographics. today. baseline of the age the XX years additional The women balanced trial Amphora to in findings

classified XX, Asian, Alaska as and of remaining or X.X% white, as illustrated or on Islander or as other. diversified in native, American-Indian as Slide As Hawaiian XX.X% were race; classified participants participants study African-American XX% Pacific women native percent

report did at women and not XX.X% reported Hispanic X.X% breakdown, Latina BMI of the women women origin, or Looking XX.X% Latina the of not average study for ethnicity ethnicity. XX.XX. or reported of origin, was Hispanic The

approximately endpoint satisfaction their to assessing sex method in upon study. at using first, most into points; life sexual answer month. one survey Amphora a were Participants As recent Saundra study; the the was at questions two on noted, after second, the entering exploratory their included and of un-validated aimed contraceptive impact time asked for

sex a participants baseline, women their was a better most XX.X% that their their that X.X% life of better. life a sex X.X% reporting women and of life study recent contraception At sex before, their a reporting lot little lot little made with just or was than better, reported

using women their down, better. cycle XX.X% and at women Amphora, their sex XX% a life that life that a that was of sex after of better life was However, Drilling reported of little was better. a their lot sex a lot least XX.X% reported one reported or little

the may was data of demonstrated in have some This we more women two encountered find In reasons. might the impact past, for this The no use women disruptive. from XX% investors the trial. moment. that is and That pausing there Amphora significant AMPOWER somehow disrupt that for than skepticism their partners negative to product

is impact for the much on approximately Amphora women interrupt Furthermore, it had who women from moment, used it, than their that a method. not which sexual did previous positive use number not the the only of contraceptive reported half experience of a greater positive impact the

is number the the only methods how Amphora the women groundbreaking that of What contraception. compared increased a to research their reporting they these with results they use although indicate, way before study. the life has This of but used impact the think contraceptive use positive sex on AMPOWER entering potential women change preliminary, about not contraception

none AMPOWER to of less in Amphora. X%. were And X.X%. treatment adverse Further, adverse to discontinuation was rate around considered low, definitely events event related adverse due was the serious of a serious incidence The with than events

to held discuss a of Type reported planned our NDA pregnancy. previously Amphora we the submission quarter FDA B as meeting for Finally, in prevention we the the of for with second XXXX,

constructive call a As this was fourth to in remain track this and the we the NDA meeting in discussed year. positive on of from May, resubmit quarter QX our and

STI for clinical women been completion. XX enrolled of for or the study prevention chlamydia to gonorrhea chlamydia Xb diagnosed The in approaching proceeding is endpoint Shifting the prevention, Phase prevention weeks. the Amphora trial gonorrhea with secondary had of who now previously of XXX AMPREVENCE, treated of and the

placebo the of last randomized period. complete during exit participant at the use of end is study interventional a and this Enrollment March vaginal Amphora The or participants four-month gel the the the to was were to expected month. either duration

top in November. on remain So report track line we results to

among States. transmitted prevention products a are for we common this also transmitted that If there marketed to program the expect the sexually indicated the which the of infection. of chlamydia, is have contraceptive in sexually is for Currently, United infections non-hormonal product no most successful, prescription indicated prevention first, is

reproductive boundaries right our health women’s to for prevent we moment. and It option improving is pregnancy in empower that to continue the through steadfast the make the push decision to and and women with rigorous them sexual to these commitment studies clinical

will Commercial Barrans. that, Chief turn call with our I over And to the Officer, Russ

Russ Barrans

Thank pointed unmet a method. Well, need those who as in tremendous non-hormonal you, need a out, or really contraception women there’s in-the-moment prefer for Saundra Kelly. already

shared in based results just a trial the for which the on like pre-specified Kelly to of leg we Saundra stool. believe criteria. And the the product approval which, that unmet Going leg Phase in it the It’s three-legged of the need, are market endpoints; X three first her an any described asset, there clinical is and Amphora which stool. second representing be met to opening.

about two legs women has so previously excited can any stool regulatory can’t stand. available. innovation But the only We’re not anticipated have that approval an

The third leg is the commercial opportunity.

of and have my entire I half a launched including and brand. Having a truly this looks launch what the be successful like prescription commercial women’s know team Mirena, to health I that a come is part products of iconic dozen reason

from Our high That the safety contraceptive women Amphora potential are up hormones journey the segments market or is same Amphora Amphora women approximately make moving that that XX impact approved. research extensive is research building away due have if gets whose concerns it for hormones. to indicate effects that tells million of them us who long-term in over unwanted for having those excitement side interest target among

who seeking women method. contraceptive alternative this And for are just an isn’t

the research attributes providers market has with would that product healthcare contraceptive armamentarium. Our it that among second are prescribed to conducted in hypothetical anticipate Amphora, their option be when most with presented similar shown providers a healthcare

for finally, And be way that the contraceptive indicates Care among reimburse qualifies the in to research Amphora a insurers an option Act under women known as This our same ACA. covered Amphora payers as Affordable other prescription will contraception. monthly

overturned? what the through of savings happens believe that that that me, deductible that contraception to recognized contraceptive change no It’s current significant ACA is asked and to no policy even if Now, payers opportunity have not support their co-pay at the some by of pregnancies overturned. have our and women reinforce coverage if the ACA. We use is opinion offering unintended the ACA women would they they prevention under

seven So times woman to that approximately interested women moment. representing about consider each prescription the the States choose Amphora If being assumption in a a this her fills United X% about women, for the million X identified of year. X% likely

So at those estimated annual numbers, growth Evofem could $X billion in expect an sales.

to operator, call with please And the the questions. open

Operator

Instructions]. [Operator

of RBC question first comes Stanicky Randall Capital Markets. from Our

line open. Your is

Randall Stanicky

Thanks, guys.

regularly. have out endpoint that you of sexual use satisfaction XX% women close previously guys exploratory to On analysis, the lubricant a called

to perhaps And over-the-counter you So well. how have lubricant expectation is envision then Are of marketing that as this? closer perceived be you your could And to exploratory qualities? other I qualities make the follow those do up lubricants analysis? you stick to able a to endpoint or do have similar specific claims

Saundra Pelletier

Okay, great. Kelly?

Kelly Culwell

can I Sure. start.

So clearance XXX(k) achieved we as have was do a for which previously lubricant. Amphora

so we to can label. Amphora have of the And in lubricating note we are the we’re able properties included hopeful which

so the product. of that promotional aspects of something as And part be can that will utilized be the

at going presentation to publish ACOG our In year. the pre-submitting results satisfaction we endpoint. of results are And next the exploratory addition, we – for we be do sexual anticipate will public

be so with can I’ll liaisons healthcare utilize over medical And will aspect. their Barrans it as to marketing work science also directly the providers. about to that who speak able of more publication our Russ turn part

Russ Barrans

XX% that only Yes. and women Randall, literally quite and the very experience we was looked XXX did participants it benefit who that the at more a the to in suggested But person lubricating them, partners was that asked of wasn’t study the respond had when than pleasurable who one suggested them. men women their indicating one is it the both are that a there. find properties did to And the thing AMPOWER about in that. we favorably that market we of and research

do so through talk that And us afforded opportunity to anticipate that to the label. will about we the be

Randall Stanicky

And that in fair? would or data experience I product around questions use with hand. presumably negative any this address around with the the uncertainty Is assume

Russ Barrans

right. Yes, exactly that’s

Randall Stanicky

Okay.

Kelly Culwell

Yes.

I those presented our of will be this which both think this fall, combination together. in overall work I with think also satisfaction things data,

Saundra Pelletier

not and too, a who just Randall, libido be And contraception, on Amphora add lot of on is the too a everybody product. libido-enhancing me go I women I call, for intended if everybody think that And important also lowered. was remind could is it’s just hormonal the to for irony their to that do

unless sex they’re contraception they because their you wouldn’t taking productive take a you sex can have lowered. going then that have So libido but were so is to

So a it’s and had improvement. the negativity women of significant and and really them so your as sexual then we sexual the change, important or bit point, a we other really for there provocative, this of talk think half pleasure we think idea about had component, To liked think half because we is liked no that that the pleasure little it’s no lot the time was category. in appropriate but and half

Randall Stanicky

label? last to timelines this I’ve on you the too, the Russ. pathway guess of just other get into for can update and one STI I for part us for that maybe And ultimately one then got quick

Saundra Pelletier

ahead. Go Okay.

Kelly Culwell

Sure.

to end the resubmitting can try would which submitting in or will of sNDA. second as in And at have November that will we call, will year, this include And end X Fast meeting confirmatory this And for us the by start to top anticipate status have our and of lead the discussed the should the that this X review pivotal we FDA chlamydia, from this an in Phase with six-month of the because that previously of up we that for we that of our we our XXXX for to that FDA. study meet with noted a set I sNDA of us one trials, primary As middle we two AMPREVENCE means endpoints Track line end results have year. have to the Phase XXXX.

should in we the able label that XXXX. And to so add into be

Randall Stanicky

talked then Okay, you OUS. maybe that’s great. Jay, on or And guys Russ even about for have previously forward moving

where offers. had those I events? it. those was I think on announcements? are to But Are quarter binding mentioned moving I Asia-Pac you that. kick missed you’re believe talked some XXXX that Maybe we off forward with EU. And you last about potential about

Saundra Pelletier

Russ?

Russ Barrans

diligence companies three off with are and had process We process the right. we’re in our Those actually ongoing of in fact EU. currently the due Yes. and you’re of out European kicked

be that excuse – ongoing. of by where offers we that where And then is the we’re will put similar position So would are this month APAC, in a year can in we believe terms the where later which ongoing expected due process non-binding this us in year diligence me, close end of EU. the a in those situation

time be the they’re right So to both same now. close in pretty actually track

So in we’d would or the we end of anticipate get to a licensing that before able both be year. done of one deal the areas, those

Randall Stanicky

before year potential before year year data before filing and November, announcements STI end end So OUS as NDA well? end,

Saundra Pelletier

Correct.

Russ Barrans

correct. That’s

Randall Stanicky

Okay, guys. that’s Thanks, great.

Saundra Pelletier

Randall. Thanks,

Operator

of Our comes next question Oppenheimer & from Leland Company. Gershell

is line open. Your

Leland Gershell

if would pro morning. there or of multiple will Thanks under I basis. couple of believe ACA, Good class. point reimbursement see actually out want and I bit. multiple first, each that against with taking product, the products Hi. about the drill at classes the a is the contraception how I defining questions, think Since each on a of be wanted – in reimburse think are least on ask products ACA that for novel questions; one a great progress. reimbursement, A that class to I either Amphora the positions of to sort requirement there to given prescription down

Amphora? that So given be the would new a support category, for presumably

Russ Barrans

United that in of spoken the there we correct, that That’s XX% covered And would who anything by fact we the lives indication actually be commercial isn’t have States. the in. category was in with in that payers And Leland. represent about them

will an I is thing benefit. the say we not therefore, So, is one automatic. would be likely covered The that

access commercialized before actually calling in aware and very coming, what’s possible. make sure onto together so experienced who as people they’re get on have order team we will So those we can are as those be to of formularies market quick we a put of payers

Leland Gershell

given of of novel And any public that into company of overall treading category, of ahead an and the Okay, is this perhaps in a type aware entirely without could really new what sort as fashion Amphora great. of make in a that in interest profile? ahead this issues, then Amphora garner the FDA-type can you compliance, product non-branded launch, do approval

Russ Barrans

healthcare a Well, market right our people. with who payers we to One have now. liaisons medical together are that have we’re with access is in things our doing and able two community conversation also already scientific scientific with providers

So that be ongoing. will

We also be the third relations will some start of the in first next – to non-branded be the in will quarter non-branded. me, able approval. those And doing excuse public we year anticipate as quarter

So, options that but them available fashion. aware a are fact specific in course, to of people Amphora be non-hormonal there not letting the of to

Leland Gershell

Okay. maybe more last which Jay. then one And for one,

year as Amphora how at look Just for guidance you’re I point. you should for Evofem? build a at U.S. of commercial least this not toward about next we becoming overall organization expansion But toward company, think know and giving commercialization just out

Jay File

Obviously, and on file getting as you’re big up wrapping as the right. NDA Yes, pre-commercialization now Phase well right Sure. activities the Xb. focus is AMPREVENCE, the

Russ the by late of the and end needs. building to sales are current So employees based XXXX. starting lot over force headcount We’ll now. out to QX, those you’ll really up to PDUFA in majority the and And XX seeing be commercial the of the of and close date be launch A we’re year the then commercialization his XX really at going potential just continue prepping start in the hires, sales team. probably for marketing, on building

of continue far its relatively XXXX. really into to goes. as the start really remain you will seeing come headcount sales G&A own as stable expand and And year in the So to through starting and end the marketing and growth

Leland Gershell

that have to multiple an sales force of you’re and you strategies detailing. this Okay. – going still point? or And indetermination I you is employ size for at at marketing kind Have know organization this a defined point

Jay File

take Russ that. I’ll let

Russ Barrans

managers all have covers that that That literally prescribers them. cover will the XXX about in XX contraception. a highest give representatives, We’ll us of Yes. footprint

Leland Gershell

Got it.

taking Okay. Thanks questions. for my

Saundra Pelletier

Thanks, Leland.

Operator

ROTH Partners. of comes question Capital Yasmeen Rahimi from next Our

Your open. line is

Yasmeen Rahimi

team. the continued on Hi, Congrats progress.

one Question So three is questions you. following. the for

to So your me? of So segmentation of you little bit the detail adoption? you commercialization which the which adopt that research? Russ, is two then Russ, more a follow Question market more likely women you for regards that are drive I also group me to to can for bit the number in contraception give to Amphora key be effective would And a sort to to is regards to a Which if greatest? segment way switch? lessons directed learned And most have going up. want market market little have color could so the you, build what of you regards find is specifically, out in are strong in in

Russ Barrans

Yasmeen. Thanks,

market we research, what was, non-hormonal when almost So in across a there we at ages high all found interestingly, looked method. interest is that

you quite who matter closer is didn’t were age. all someone it millennial were across a if There So sectors if that you’re or the people interested. was perimenopausal to

contraception their portfolio they indicating the of acknowledge providers contraceptive find were We side product fact second using the large that group ability abandoned couldn’t well are of who that become the have using who would healthcare that also actively effect sort of method there most some would used be very one that for already make a in of future that for that abandoned and profile. hormonal form of they fit women currently contraception this this women of prescription do because profile a found would currently a number their showing their pretty relatively them have over because by that concerns side or just as highest from pregnant their that interesting to product those came their them. have effect they say of people interest that group we The indicate was experiencing who

because then fruit, million. contraception of XX for the they’ve be women at when seemed that that is them made would those start can XX be choice to using segments anything that million I use terminology, looking the the which And found range you that the from are Can X.X% you is already if those hormonal about hanging in lowest of there who are I’m not using So, not sorry. of move remind the currently we considering stage be me quite call numbers wherein we part it if interested about making some each Yasmeen, the Amphora, what of that groups second and gets transition to one form contraception, question? of X.X% your currently hormonal that approved. would to

Yasmeen Rahimi

the Yes. are of of aren’t trying How Actually follow Did women I before taking? you that get look aren’t question that up made. age you we So that anything? that anything? so the at comment but guess did to that part, aren’t to any taking in aren’t actually number OB-GYN the I you where willing subtracted that is just second that a on coming I’m have to contraception, just Does admit clinic are not sense? number in make number their actually women at women taking they’re to determine women but not get women are the out that taking then reproductive these is the already anything? they on if the from

Russ Barrans

a XX Because we the are that’s out at to approximately women there’s question. didn’t go States and and all certainly And reproductive United of them. great in who age Yes. talk million

part. data that on and self-reported comes their So CDC from is the it

of of women don’t these until anything women that’s then they for discontinue for think although taking probably to will tell OB-GYN, that a many learn an them fashion and the again this in with maybe not see their I annual. necessarily not easier OB-GYNs they them readily report it’s year for another and admit So

comes from the So that CDC. data

Yasmeen Rahimi

most out not to obvious that Thank And probably key you. of the question lessons want I are regards to are you point us. to in was then commercialization that had effective that sort

Russ Barrans

Yes, and on I’ll be this. quick

things that to of you do perfect really if we’ve that be, things. key there found when happens is will, that’s three One of you synergy a kind tends

that’s sales and knows First you health. of women’s in all, put experienced force what doing they’re a

are is supplement that to good Secondly in. DTC key that the some women with you reaches that

on learned marketing we’ve the where media lessons ago really digital over on those be key to from the get as we do the of always years, Internet places where like social are or or have TV, today so an information, One with be women years that. you pinpointed can to their is commercials XX it very would example consuming currently and

able So think do is over in very we’ve method different companies products the done different something effectively thing that to now really the then targeted use last years we’re that do I we and And with to is segmentation that. and together. upon segmentation segment attitudinal looking attitudinal is to what also – behavioral out their those in just at physicians but back previously not contraception did which of they terms on behavioral two layering

be So sure we put algorithm together to efforts can to our into it’s that specific good allows look tendencies fall at where attitudes we which likely that and see at very benefit. exactly making most put segment physician then like And and the exactly us what are. what the looking we they get an the and understanding

Yasmeen Rahimi

much so taking you for Thank my questions.

Saundra Pelletier

Yasmeen. Thanks,

Operator

[Operator Instructions].

question Our comes of H.C. from Selvaraju Wainwright. Ram next

Your line is open.

Edward White

I taking is appreciate you the for This on Edward Ram. Hi. questions.

lot new how advancement of that like in the wondering a women. you just it’s be terms FDA? label make significant was of a AMPOWER So in regards it to going for might great is to the I able be to claims this with study, sounds the

Kelly Culwell

Yes.

So asking endpoint. I the sexual assume satisfaction about that you’re

it endpoint at that this And while be this was the and point in anticipate so so we don’t will an label. exploratory

have talk can multiple we in ways providers we particular. about this that healthcare with However,

going publishing So this data. to are be we

the year the American submitting of to OB-GYN. presentation at College next data be for going are We

allow so science that to will talk to medical And our and about allow liaisons data. us healthcare this providers

included AMPREVENCE and our in endpoint including also been study. it’s We’re same the

a this stronger in medical part then through And future. our publication the have work, from as be so liaisons. we’ll see data a should for we potentially now, we the to label But strategy in of consistent this results utilizing the get science argument

Edward White

sense. makes Okay. That

Russ Barrans

Ram, also sexual approval than the me of world you let in same again that then thing that do not materials level you survey into additional research demonstrate source results we OPDP same we’ll even that post experience some just in And is put the can once real having satisfaction, one approval then, are add women that post will will it’s marketing to more do the to if one replicate your grab label. the if promotional permit we

Edward White

I see.

trials? wait I jumping onto the just Xb that’s about NDA gel wrapped before with or timing Phase going you’re of And into whether until of MPT if start the a are either XXXX, Okay. the submission other that the wondering moving you the XXXX, things lot to trial, was just

Kelly Culwell

Yes. Right.

a We additional are Phase Amphora indication. until contraceptive trial, confirmatory trials STI X going any to launching before wait for including approval as we for the trial, have the

Edward White

matters, just Thanks. model non-cash they’re we financial of these more go And a a little difficult final items, as kind lot and of at predict question Okay. forward. just looking to on one more

Just quarters looking to currently more of predict? the wondering in the hit items non-cash future at least any that can P&L if any you’re you at

Jay File

fair aspect second year, with just Yes. G&A the R&D self which time related there’ll be and being associated as half Everything of it that That’s to It with the really was remainder recognized Through private quarter. the associated will the June. a and effectively during placement until question. the was and be during rather April about for million three sales non-cash which stock-based a about includes commercial. well our compensation and a marketing of half we’re associated the with contained

additional and currently, that’s barring recognized anticipated. through So – of any end additional the be will million the But about not year in grants. total X

Edward White

And details. for the done you all all well the on progress. Thank Excellent.

Saundra Pelletier

you. Thank

Operator

Northland Our Byrnes from of next Capital. comes question Carl

is open. line Your

Carl Byrnes

have place? that spend you for drops progress. Thanks. half that trials able on the some but any year also considering we’ve guidance Congratulations XXXX, second you planned R&D you. of for provide the the and to Thank in your also Are given seen on

Jay File

Sure. anticipate that for basically haven’t compared to much but do it year. this basically outline R&D prior too on Yes, will you. we guidance I given We can obviously overall expense the decrease

Any For of recognizing out just that anticipate AMPOWER the to with forecasted last submission related and expenses June remainder again we the trial. month, be trial coming year, that trial. this on invoices associated NDA expenses, last that’s we’ve the to continue CRO AMPREVENCE X everything million catch associated another million and through up probably to related. in not patient the basically maybe the expenses or basically recognized for that the will – playing X in with with to the with that XX

had the for noted getting Kelly on Amphora. focus is commercialization and really XXXX, As for approval just the

slow, so anticipate don’t off won’t R&D in for X first then the again approval half July. and early until be As as prior relatively trial off Phase kick confirmatory They year the to to to really after engage, you’ll in as We’ll see so relatively that starting a number that out compared see anticipated incurred CRO, huge we’ve somewhat such, it STI low start what kicking then being you the as reach increase. we off see we’ll the start year. of

than XXXX. So lower will even would be in R&D I anticipate XXXX it expense was overall in

Carl Byrnes

Thanks Great. so much.

Operator

There are Pelletier call no to I’d remarks. further turn any the over for questions. like back Saundra closing to

Saundra Pelletier

Great.

So everybody to us for thank I want joining today.

asked I is old. that There’s AMPOWER. the We the are few been XX want things she women. And Kelly, today you findings to of a heard repeatedly share you the years additional about age thrilled Amphora as with reiterate. from to We’ve from

want of can satisfaction significant. lot idea also somewhat so their our that was so satisfaction Amphora, endpoint. or enhance important sexual a reiterate The product sex to in better after reported is at a XX% exploratory I life and that actually of cycle contraceptive one least your women

people company of a woman, health, that up sexual spent about years This years made findings to I, optimistic date women’s these But as in experience. XX women’s you not is your health. of kinds myself, in so myself. have make have spent

really we’re so excited about And this.

was tolerated fewer adverse women discontinuing X% due than Amphora well with to very events. of AMPOWER Also,

what’s If can effects, effects, you side incredible. less hormone-related that tell with is at study than X% side I and look you you happening category this

very we’re asset. the about this So excited safety of profile

We’ve our also near-term milestones. made a year lot to forward progress and this achieving we of look

For last later anticipate this AMPREVENCE, month. visit the patient occur will we

reporting We’re line our looking forward top in data November. to

for the step is fourth next of pregnancy Our in to XXXX. quarter resubmit the launch to prevention NDA the and in

control is It’s no that birth and innovation now. secret for sacrifices. women time The make

bit on your these about have and secret your that you to a others just effects of talk real. little if asked a said not been partners They’re Some your you significant even with daughters, deal the to of because to you you will. women just it, are recognize as are phone side and It’s me talked that dirty really.

lack be as libido, women that to But accepted it’s because headaches, whether the daily contraceptive that. time Amphora dosing, have lessened procedures, over choices of current status control, So soon medical quo. is will change

The fact been their journeys and that women contraception XX million is emotional been they’ve are because longer no have using frustrating. hormonal

soon potentially represents That’s women’s health. Amphora become opportunity we revolutionary tremendous the lives to a in women why who could Here, at advancement believe of commercial a preparing woman. the that Amphora Evofem, these as change we’re

this So On empower mission want will control reproductive and for to call. our thank your provide take behalf earnings sexual of their to we solutions Evofem, and of develop concludes of at ongoing here our everyone women innovative that support to health. you QX

day. you have So great a Thank again.

Operator

you participating conclude does Ladies great may program a in thank Everyone, and today’s disconnect. you conference. gentleman, for the This day. have all and

Evofem Biosciences (EVFM) 10 Aug 192019 Q2 Earnings call transcript