EVFM - Earnings call transcript Q4 2018 | Evofem Biosciences, Inc.

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Operator

Good day, ladies and gentlemen, and welcome to Evofem Biosciences Conference 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] I would now like to introduce your host for today's conference Amy Raskopf. Please begin.

Amy Raskopf

Norma. you, Thank everyone. Good morning, for Year-End joining Fourth thanks Evofem the Financial Results. and XXXX Quarter And Biosciences This Raskopf, is Amy Investor Relations Evofem. for

press on business with today's available Investor today, of SEC audio our in see are statements and including Securities provision Litigation have are Evofem's A for statements Act update Investors. Annual Form and our the forward-looking These the you of under forward-looking call the the forward-looking results Report morning Evofem's not as received as of conditions available considered our Harbor noted release in Various obligation results Private and on it mentioned this issued to law. statements will as strategy evofem.com financial webcast call uncertainties available These change of about and to are plans XXXX. Further well which the and as this of on those subject the required change recording If statements and available factors Evofem numerous call website Reform circumstances based no statements An earlier except risks webcast which we filed the risks affect online are as we operations there at forward-looking to from the of please purposes are www.sec.gov. overtime. during already Safe be today's statements on is financial that under access conference information well. information release today's by business, website. press could XX-K make assumptions section

Chief This will the XXXX. that the on them of replay tell Evofem’s to benefit Executive those turn listening March the who Officer. Xst or archived over I'll Pelletier, to webcast. call Saundra For of call With recorded maybe

Saundra Pelletier

Thank that became XXXX completed $XX public million. public year and We offering a hello was netted we a Evofem. Amy and everyone. transformational for a company successfully you,

ahead rapidly to investors the first-in-class well vaginal empowered certain of established from sexually hormone of for enrollment final term with prevention infections. positive completed that equity analyst long confident reported. treatment coverage women. related Amphora Amphora healthcare added will Phase our Amphora, were these and institutional five pH this be birth of the as we XXXX result X to as Based the free schedule shareholder met also on in of no were that trial We control asset. approximately prevention endpoint trial the see we're We primary a advanced pregnancy importantly, our events base excited pre-specified of efficacy cohort improvable outcomes, We and for Most regulator transmitted multipurpose that of adverse topline analysts. serious

resubmission QX The in product We Many is for the options. cannot today, use XX.X States get women to methods, control NDA XXXX. but we've contraceptive not Amphora. a available initiated who including right or pregnant are working early and toward want United birth enable are satisfied million launch therapy. successful hormonal not In the to are women women just who not using will do activities there pre-commercialization currently a time are with

Asia desirable side-effects XXXX with will States. also control. The sales entry to from unmet be as is female contraceptive U.S. representative they billion space, company Additionally, XXXX Amphora our is will research Data as expected The report side-effects free including new These MVP-R committed billion value IMS and of will $X.X and in from we're form and important women EU birth contraception”. in the opportunities which the who the for with marketing Amphora expand $X.X funding Pacific. half highlights Amphora driver of that billion need are grow also open It the We market the valued the critical contraceptive the non-dilutive proposition EU discusses growth in report using of initiate the report in XXXX. our impact important completed Amphora, represent the the these second only Currently, the transactions, was the coming market IQVIA, firm. hormone or $X.X processes and quarter and very the product hormonal an completed opportunity. of unmet very the the the Amphora about Evofem. for to merged and respectively With in in women beyond author hormone that the both using global free a fill contraception to opportunities ex-U.S. serious we its working region. Russia estimated an hormones dual independent with also currently attention are the $X.X United to of that products, second in Asia-Pacific but We're new recently billion to we of from reason Quintiles discontinue method. who at market billion expect currently was the a “make majority concerned and in key they This attractive to long-term Global the identified intend are welcome appeal would a included third-party projects to bring and regions your marketed It markets partners shape I method assessment. which a $X.X discussions in want and multiple a market. in process potential candidate an

birth Pill. need unmet findings are simply in their commonly XXXX month Amphora further the Additionally, for market behind This who that women say significant that to to a providers prescribed would healthcare most The no be a validates conducted survey approved just revealed in currently exists the ready hormones. from U.S. control recent second if

AMPREVENCE. and line than at also study the to chlamydia Enrollment in we make Phase We of the and good continue end to top year. expect with Xb this XX% women. evaluating to is data trial progress continue prevention very gonorrhea Amphora more complete of

study will expand we to X conduct the Phase and Assuming prevention single sNDA an chlamydia. Amphora submit positive of the to include label a results,

our Jay File. the CFO, with So, over will call I that now to turn

Jay File

morning everyone. you, Saundra and Thank good

preferred the For and quarter. versus in mainly trial year Research December $X.X quarter $XXX,XXX offset losses reverse $XX.X clinical related at common and reflecting stock November partly $X.X million compares costs increase of prior was the early Development associated ended to not by million three to audit increase lower to with in Series bonus related million as administrative completion activities Total increase our quarter early $X.X partially headcount operations million since were D included $X.X X in various $XXX,XXX prep significant non-cash non-cash-based awards XXXX, public driven XXXX. group study in versus The and costs XXst, The in decrease with was decrease by close to XXXX. dollar a the XXXX prior due earlier This legal mainly increases the Empower $X.X Phase the fourth year XXXX. with fees increase in non-cash of awards were quarter. professional company growth taxes. in by well And $X.X million in for General granted our $X.X stock the salaries costs merger of stock-based planned associated for a increase early January in in stock-based XXXX. the pre-commercialization prior year million which of offset of stock-based and in other fourth costs compensation was as compensation XXXX expense in Amphora was quarter earlier $XXX,XXX were launch in granted the million in million QX of in These to a associated from XXXX. our which converted XXXX. months that expense

result, million million quarter. XXXX cash $X.X our XXst, a of stockholders million by million loss per share September XXXX the exercise a compared prior months to was attributable we XXXX. December net net at of holders. of a share balance year-end, or from additional $XX.X year Since December As $X.XX the warrants $XX.X $XX.XX added million institutional was for to $X.X Unrestricted an to ended three loss or XXth, the at million common per $XX XXst, for approximately $X.X sheet loss versus

As these approximately warrants transaction, million reload strike $X.XX. price we $X.X of warrant should part at the of this holders of

$XX will the pregnancy more and heavily and half Amphora will the of heavily complete operating weighted per successful complete of first year, million and quarterly the in prevention approval. of us between and more to Phase for We be expect ensure as research pre-commercialization timely assuming second Xb expenses weighted the and $XX half resubmit will our the Amphora AMPREVENCE average study marketing the early an for year, evaluating expense for use prevention in during XXXX In increase be toward In XXXX. of launch the we gonorrhea. activities of chlamydia of quarter cash NDA and development

additional raise to plan. need will on we current to result, business our a As capital execute

on sheet further on previously evaluate We including call ex future Saundra. These back a several non-dilutive royalty opportunities balance Saundra discussed. continue to options. to commercialization to as turn financing U.S. U.S. Amphora that, include anticipated With in for and the Amphora opportunities I'll markets sales our strengthen potential

Saundra Pelletier

is the the Jay. women's for Again, now. you, be will important will birth a are We next Thank opportunity who momentum. be Great. meet early company This our birth Amphora have in the seeking demand a and that we expect address Amphora years It's history not time believe XXXX. to women strong innovation they currently on XXXX the most and significant commercial XX.X million that of one of in options. we control. are than more using time presents very needs with control new great to

I'd to to with call So like questions. open that, the

Operator

Markets. first Our question [Operator Instructions] from Randall Capital of Stanicky RBC comes

line is Your open.

Randall Stanicky

guys. Thanks, Great.

start when really you that commercially and here about of marketing critical is can the driving to effectively we That's Given one. and a number plan onboarding the and talk see folks? rollout the do to awareness, building going be ramp category maybe to and

to then you in do Second, Thanks. but on the this correctly year. heard EU think to I finally, Asia half when in the you data any U.S. of satisfaction? or with expect indicating for Sandra, to back EU and respect And get we old partner sexual deals I announce see

Saundra Pelletier

you, Perfect. Thank Randall.

then So in commercial at roughly end. question you the the start and jump with I'll

Jay File

Sure. I to. would love

a would the intention from perspective be our So start ramping hiring. with to commercial up

of bring into the mentioned new that all place necessary when moral to hiring be training them or adequately process put managers has will start we to into the to Saundra to sales that sell up months to order speed our well fall of salesforce. of our category be come the we to summer non salesforce which First happen the prepared The marketplace. on to able a will in already so

time of move direct-to-consumer a to So place place in November training category. start through will the XXXX. important how launch in with will we commercial and where an December in Randall is to early be anticipated mid then that months within We advertising this recognize

that point of XX% requests in a one a at statistic woman receive fact a read somewhere the contraception I time when in think that I certain that of the neighborhood does she one.

months will for know women advertising how needs a assuring we the be to audience six that that So request determine receive and direct-to-consumer which to into drive non-demand they to their to HCP use nine the by post the recognizing how to adequately offices awards to those product prepared women to move appropriate Amphora first counseling method. we both appropriately are

juncture would the So September at terms we're of in preparing somewhere say that between months begin marketplace. where June time we that on feel depending either June like and the out in

as our the are will will or in will medical that on We begin speak to and early put managed care the well care place with pharmacy liaisons, benefit Culwell start consultants who also to calling with scientific quarter second director our medical MSL managed as managers. in

So broad commercial timeline spectrum the that hiring is series that of support that a take the will to launch. place and in

Saundra Pelletier

here sits partnerships? Randall's in want do Russ on ex-U.S. address question Asia about timing really our of then And to partnership, the now focusing you announcing

Russ Barrans

Yeah. would love to. I

back by in those in with end and we in European process by binding be forth. narrow have that interviewing So to the the their contests our beauty are to that meeting we'll or we a the mix the of place this those month those Asia. anticipation partners and of be of by talking month who is it those to The a Recognizing agreement at referred would in that to to the where of it an sometime off end are and our legal the a or our partners binding partner them potential partners those some interest some will position with other their necessary of that IQVIA then said it in April Likewise, to that words of few part and of in part that I June. towards by actually put on by in process put we the typically said that. our allow and those then companies the we completed unfold and into midsummer am have in down Asia actually trying have the we're anticipate left as being process to to will one as to month moving Saundra part I of kick is the takes earnest of the get go in that bids as process IQVIA narrowed begin to been and letter of and to down to that in around March that with contract to into the so we March in have the of bids intention negotiations where will here begin off place who submit contract accepting first April. will months we kick indicated I've have negotiation companies interest that will of first terms

to the anticipate be have first And well give this for. as that soon. we going done defined that have actually at details already kick timeline would those year. we'll specifically don't We America where the for then pieces to timeline that would our that Latin off So point have but we as by the two we're

Randall Stanicky

and as presumably have seeing are arrangements. some royalty these be would you And you of demand these Russ, early payment good conversations? And upfront type

Russ Barrans

and Yeah, we're willing that don't are that's are but mean a interest the being bidding contract fairly royalties if some what reasonably they we expressing are you with assumption. terms out that partners pretty I XX then to XX some of you will. seeing to the up front to be individual aggressive really right correct And seeing who's in as a as in I milestones know that would through considered attached today's who's actually the is know discussed those out being put and think years nice substantial length now.

piece is. on that give the the So as with know look milestones additional They've now be few commitment to understand their to in confident we that being essence thing worth. players pretty and the are on are that that represents a the of well be opportunity keep those brand. table want can also know is that as payment upfront to us we value of those and of so the the there conduct that that regions that those you feel is then what commercialization value made the studies at done you are just other that this And regions that a still it's will additional is mind towards their to that along going then to in some in part require studies be

Saundra Pelletier

are in and address we where And Kelly you data? satisfaction the then, will question Randall's finally to sexual

Kelly Culwell

Yes.

a what trial know really But So any far results from data we've disclose than detailed forward look this the at sharing unfortunately, do top that other to time. due we're position additionally not we line in from thus course. to you in

We process and review putting publications be the this year are peer the this of of abstracts in quarter and presenting for year. third in we settings together in will

Randall Stanicky

Thanks great. everyone. That's

Operator

Oppenheimer. next Gershell And Leland question comes of you. Thank from

open. is line Your

Leland Gershell

Thanks ask for Wanted morning. of to Good Thanks. a taking question. couple my questions.

could quoted the the that the just is of the And in survey? of if the with was to hormone could discuss it And XXXX when specificity would behind of Amphora oral was status category. just regions that understand know response would that published The said you use product if that of want all pill most proprietary regulatory next you language. in Also, regions is or done that major Pill be mentioned discuss I want contraceptives U.S. or you're could sort was that be they much. contemplating. you the very a to containing survey a second the forms commonly had control survey if containing? Thanks by First, use meaning hormone provider that you you would at Amphora some of in least you birth

Russ Barrans

Leland. Thanks

jump Let in me first.

pretty sorry. outside As been approval I I approval. to we've potential United -- what are that board Yes, an or sorry. heard much across EMU since are the there Saundra States would an to that several or most I've be our been was approval countries willing jurisdictions have working working the -- closely with accept FDA just I'm say EMA I'm typically going partners

talked the parts et do of When with recognition last boards because to some talked been would had such that studies there. additional any partners strong And is of may in for study we've point additional of to an favor At that So the XX% population European sufficient we that study additional of advice the have that acknowledged people's China in course the had that EU years having it made most would would and countries likely to time be them not to the Brazil. one be perhaps our in Latin from upon avoid require some as those indicate potential from that the that approval. again have America cetera partners though region population that on the still it to progress view pretty of as the studies. same not big regulatory of few their like likely and two it in potential to a based to Australia that has is there in countries acceptable some we've Japan seems and the clinical some probably anticipate and to the the our additional would those be are were have work. They've done theater. first over that scientific work require the we that's Russia already was of subjects We've that do decided completed most

So, going that is to pieces to go a with China the undoubtedly done I States overall think places big will clinical for fairly outlook that the don't most United be States outside quickly the regulatory assessment are outside United require we want FDA study approval recognizing there. a of but

Leland Gershell

hormones or Thank question meant. really meant wasn't on oral the forms you. you the language is what the on of a sure And just survey. contraceptives simply If that forms it also all pill just using

Russ Barrans

Yeah.

conducted that the have through survey and commissioned they KJT we work conducted party was than the it So of third this firm in more space. called we in segmentation healthcare women's probably a Group market type research other any done

So all they the forms. of at aspect at they it when in across terms looked looked board hormonal the

methods So it was contraception well copper hormonal. those non-oral It oral was like the hormonal not are et the it patches other methods. also cetera the IUD those that but IUD ring, as was just the diaphragms and that's as

covered So they whole not across just not gamut the just the your board contraception.

Leland Gershell

Right.

questions. Thanks for taking my Okay.

Operator

Thank you.

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

Your open. line is

Katie An

Katie questions. for Thanks This today. taking guys. my morning, Good An Yasmeen on for is

filing I bit post NDA complete. have the that the the little to in follow-up. you specifically items cash Thanks. you current submission plans position. your more second regarding speak commercialization on to-do with submission a your your a First in on And quarter relation to And to can list your NDA cash what are remaining have

Kelly Culwell

-- the with start and is items with remaining submission can timeline. Medical this remaining start the Chief I on I can Kelly, So the Officer

of the So going review a is of together we all we writing submission speak modules putting lot on we medical and there for as compiling -- are basically our so processes. recompiling and the NDA

then them writing a reviewed matter submitting publication really the and and is the to for of all so compiling preparing having done of FDA. getting the medical And documents

period time months. So several that takes

of And all Phase trial. so at we're that submission QX a that's now the information we why available looking that confirmatory we from our have needed X

Russ Barrans

of for the way you me to question I it were is And asking? Russ. the Katie, I'm just answering last this that that part Can get to sure clarify make you just

Katie An

plans wanted Yeah. relation I little to your your cash in just more current commercialization position. bit a about to know

Russ Barrans

Yeah.

from from we've perspective a then know you the down nickels terms that that regard. would successful throw what in make got to Chief it Jay point toss over counted Jay that our position. say launch. we're I talk of to to can where to exactly We've Financial almost need our it And probably we're good And give pretty know Officer point kind at answer over cash that I dimes well a we so we and commercial where you we've just I'll of think I in to to sure about been

Jay File

no Russ. for problem, Yeah. Sure, Thanks that.

building key pre-commercialization on raising fully just I you plan. that obviously now is to that the execute call sufficient So on slightly know capital right you as know in us the mentioned the to

and close currently strategies So end later as we'll the previously by on paperwork new where plan, activities so have we are programs equity go fully to are Russ pre-commercialization to of team sales support HEP record ready the full the and the are financing targeted of we in that. things then alternative round force developing is go Russ mentioned an approval identifying year bringing sales on year. and we the then NDA like mentioned and And upon that then initiate agent of marketing be obviously doing going with to some moving forward upon spend or

Katie An

very current your patients Thank I guess would question final study. are with other helpful. you. result during the the my care. proportion clinically one the is of at reinfection What treatment what in primary be regards of with standard words That's of period? endpoint Okay. a the AMPREVENCE in infection least to And rates in meaningful

Kelly Culwell

Right.

months. are who during for because risk had high six is reinfection subsequent So trial enrolled in XX% infection reinfection and the they reinfection current XX the for XX risk that previous a prior for have for purposely weeks we between have this at the women risk so

XX% as see And infection compared so looking by what enrolling to in these at a women that to to placebo. reduction rate high we're risk

study the at. we what to that's look powered So

infection. reduction So essentially in risk XX% a

Katie An

Okay. so Thank much. you

Operator

you. Thank

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

Your open. line is

Ram Selvaraju

couple Thanks experience how what a you the so easy advertising reps and the on people. on have and my find nature A be whether on be Hi. be the you of know expect in this the color marketing comment sales questions. us some board sales taking that to a you're going background about bit additional for and terms on provide and to the to the And project you was ideal of much it their regarding and bringing to first. salesforce additional could you curious time little very juncture such Amphora Maybe could of at follow I I And you composition profile couple composition campaign. the with also at consumer direct ups. to then of

Russ Barrans

Thanks Ram.

jump Let you the salesforce. like what it me for and look our in anticipated were our is give

reps. anticipating we're XX now, right So

is other into with type additional goes what an country the sales Coast thing time need be footprint a and often that on even being sales that across those We to are with upfront then typical into little think we Coast a could as of you out will and planning that goes be it of bring the the and over new case on of as we half is being quite one modality shifting consultants you made of that the some reasons half employees there a decision candid that why contract more stronger the and marketplace we be consultants time that East itself we'd has for expect. will West as this

the if of makeup I've will women's also just been a me that as team doing you and who sort know always a I've have care XX this of this. be that with will health brought doing also about for in people you years and note been So

sales an have that incredible are had when we've already health in point the along experienced that at contact women's have part to be in side people that that this a some us us they'd this past have like from comes when said it. the with of opportunity So, of number worked

force across in that to quite nicely we own so women's the has that sales it So we're experience be across that we will experience women's will sometimes that be have as able healthcare. while able of XXX% nearly health going contract that employees to really each be balance less that in with nice there'll anticipated experienced area a geographical managers our supplement be we district and anticipate our each deep to well sales hire

past we we force demonstrate when with sales it of our being the actually So force health sales will a has in we back a be either not novice right research care. When point. this strength done that help that them that women's strong case was have will specific XX.X proposition know for that pretty really have the that the would and to always been women piece launch us in non-hormonal table but category trip the anticipate be. in do and missing brings or the you is physicians providers women it solution selling research the or know with we is look are to at for it for the that the But the hook million thing is for trying is the that where the Every themselves. to acknowledged market is DTC unique we you as early brought did little suggest know bit us the market exactly we to is healthcare Ram this that find that one XXXX campaign

who know. that that option point XX-K be there because woman choose you to at that And to So of is have for there's birth clearance lubricant. we very messages a non-hormonal seeking have be her those clear control one to this a will for five available do able finally one a will a as

position point it to able one validate and the fact study to on speak a to we're that may have where that be yet we satisfaction not may additional have the studies only While that that based we in be sexual will that. at

benefit properties the fact to the be that their sexual able lubricated and will experience. pleasure that's the speak associated with will We to to add

that we're process for next the a So, into Tim some meeting still of place team away the actually concepts, that together put and testing putting from will a those into ways of timeline being getting vendors start week be but that. to with to able and put

Ram Selvaraju

couple And those sense very warrants. me date give exercise. of of reload cashless are expiration Thanks items. helpful. Okay. a is small the The you to what a a as housekeeping warrants just any if of those Could and

Jay File

on Yeah. that. Sure,

grant do carry a the those originally. a the So, they they and forward as did were for date exercise and -- year original cashless same allow terms warrants XX they have

Ram Selvaraju

Thank Okay. you.

Operator

Our Northern Thank Instructions] next comes of Lawson Carl you. Burns [Operator question from Securities.

Your is open. line

Carl Burns

progress. your on Congratulations Great.

of the Can journals quarter. publication provided some respect upcoming on Thanks. any visibility medical visibility third you You reviewed the data provide us presentations in to with conferences? Amphora in with major and peer

Kelly Culwell

to Yes. intended I are where fact the third would major the that And conferences that be we presenting what say medical was quarter. in I in

for But preparing this are know Society be on happen North year Medicine. the timing you is on for of American actually for the include published We which Reproductive of the would sort third they planning journals in and dependent and quarter American our scientific also themselves. that they manuscripts when the publication conferences key Forum family

XXXX July presenting also be data at will at American meeting. of College the We

Carl Burns

Great. Thanks so much.

Operator

Thank you.

from Our Lillis Cantor Matthew next Fitzgerald. of comes question

line Your is open.

Matthew Lillis

a an U.S. impact to the start sales And markets of U.S. provide market far the your curious launch after have partnership you you. in may the U.S. Thanks on any if ex early find to could fruition for product taking find those how that. assessment. similar U.S.? discussion given could what from further you you Did come questions. you see in the Thank the the attraction I'm to do color secondly, when discussions we for feel

Russ Barrans

Matt. question. that Thanks Appreciate

is we that that United was So outside the avoiders be who amount found United are XX.X with a the we produced XX.X XXX we in today to world. what was that of then adding women million also were States that million say saw were there hormone rest going that we trying can that done that the from States research IQVIA. research And did United by roughly to of assess we women the research call of and if in and that done States fair million was

the as now that know primary know been the we market they research you the but support to as they data one that point. new course, conducted data Of well all through that IMS, know secondary

to a that's good to us able be news really for that's So learn.

were media the however health decisions as has is a small. the have they Additionally, relatively they find that region with that not Zealand of was contraception similar important allowed Asia-Pacific the in ours and population base what is while critically What social do to care. discover with for APAC consumer else very in New a that did is region anywhere this is to process Asia-Pacific and especially able which huge direct to exception in

that how to say to is almost a were you through social They drive to a they've household are media not we of able us products partners name direct been us our gives So if leverage a anticipate do able talking they see to that again one aspect be able is feel that. as the we other multinational to that use able to we social our name of would them for will. which consumer some will in and good portfolio while media the

how start of we'll In quickly any start seeing in. coming revenue terms

As earlier you a there will. to going if it'll I a be be -- cascade are said

to into allow and put approval. the will of process you the be approval on jurisdictions Some based FDA file

X. a behind And than processes. you're in so it to been into all those typically Phase other in if we words were the that they It now X say the the put in at one determined wait step has Phase they tend X typically in a Phase we're it better Phase one-year to FDA for X approval regions put would approval putting neighborhood of they'll the as to be filing rather for

a that be end and require of the we've be will will our some come about then our but year roughly later clinical trials of dossier start in as got as result our soon together several the China longer again those have that will the additional partners the that with process effective regulatory as to we event the for countries seeing years FDA. we to preparing we time one wait in could of to year take dossier So file most for getting process to with on think the or do as a partners those

Matthew Lillis

you. Great. Thank

Operator

Thank back Saundra portion. for turn you. Pelletier call Q&A closing this like over And the comments. to I'd to concludes

Saundra Pelletier

mission many you thank healthcare develop and empower your innovative and like to for few Evofem to our for questions various of I'd will women and support So to really ongoing that of your reproductive provide all solutions Conference their upcoming you New equity Oppenheimer forward of the control Healthcare the conferences in and seeing sexual health. in We Conference look take to the Roth at including of York and Laguna.

the in participating to addition chat. women's and fireside in health are We panel novel our contraception

you hope your of a have again much. day. I Thank rest that great so you with So,

Operator

your thank conference. Ladies in today's and you gentlemen, for participation

day. have You wonderful Everyone may a disconnect.

Evofem Biosciences (EVFM) 1 Mar 192018 Q4 Earnings call transcript