SCYNEXIS (SCYX) 29 Mar 222021 Q4 Earnings call transcript

Greetings, and welcome to the SCYNEXIS, Inc. Fourth Quarter and Full Year 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. to Executive conference Investor Director like host, to Relations. now Etchison, Debbie of would turn over the your I Communications and Please go ahead.

our update. welcome call year and today's financial fourth discuss XXXX corporate everyone, full quarter and Hello results and to to conference

such are report and Exchange SCYNEXIS only caption, in today, obligation The call XXXX. Factors, update undertakes let for no are subject outlook you decisions. to purposes, reflect that and they on included implied Because that our may start, most Please with exist under future leadership's and to differ on March as case for forward-looking our statements Annual Securities for XX-Q, forward-looking or including filings the subsequently will refer events furnished the quarterly today's statements recent statements such in XX-K, risks including XX, expressed financial speak Securities remind Report current results information statements Risk performance, All strategy. or forward-looking after our the and Commission, to as on future, documents Form the uncertainties, and business based Form to sufficient is other to of expectations, which each filed on our me not or for prescribing as occur materially today's date that such and concerning actual we from intended by call include Before not circumstances Exchange statements. those on statements our well promotional operational financial Commission. made. expectations and

Interim Officer, SCYNEXIS Taglietti; Angulo; David Chief are Christine Coyne; Larry call President and Medical Officer, Financial today's Dr. Commercial Marco on Officer, Chief Hoffman. CEO, Chief us Dr. Joining and

prepared remarks, call our questions. we'll Following to the open

Dr. to and will Taglietti, over President I turn the CEO. call Marco Now,

Debbie. investor for and quarter us morning, XXXX call. for full earnings year bonjourno you a Thank joining you, tutti. our Thank everyone, Good today fourth

updates But ibrexafungerp me ready you XXXX, key of our accomplishments we summarize the XXXX. to on the launch the outline progress share let for BREXAFEMME a for We franchise. with get and as SCYNEXIS, briefly of are excited vision future year of pivotal of for the

treatment first of antifungal On the ibrexafungerp class the in front, new obtain VVC, years. the we over approval for of XX R&D

an hospital Phase as year plan MARIO Following with approval the the the include trial in positive integrated us announced of of invasive FDA, more With revenues. XX% of the candidiasis was in CANDLE X that end prevention covered XXXX, a of the expanding becoming fully result BREXAFEMME net XXXX, At our of X,XXX launch the And of the lives in February, achieved with expand result agreements we study had the of VVC. of insurance labeling U.S. SCYNEXIS program transformation and we historic the about end And may than BREXAFEMME a in recurrent allow in in by by to prescriptions we commercial to XXXX. million BREXAFEMME, for a company. are $X.X

and cash close the On more XXXX. runway the than second in corporate $XXX side, we of with million quarter the XXXX into

the for the non-dilutive other balance. also the ways franchise known cash make with with nothing ibrexafungerp approved to for like of an the in to generate also namely VVC, to the franchise indications the these All treatment the home sustainable, million $XXX year invasive prevention approved. is net to XXXX. to $XXX now is we China our for million reality. vision that candidiasis indication terinfections, get vaginal in ibrexafungerp business year We yeast plan potential to look create Hansoh alone. launch antifungal our to and BREXAFEMME a sales important for approved of continue end today which is With VVC, with taken development to successful, But infections, U.S. Greater for becoming one bring expand for and point strengthen as expect Moreover, a did by this labeling deals profitable most of when yet will increase is in its we together recurrent to

expanding Larry, So our then, our how on to will objectives are XXXX? these Well, one key we discuss how details Interim we team provide to cash programs. for a or grow talk Officer, what floor goals balance. will expenses team. open the the The Q&A And BREXAFEMME are these labeling key David about plan And hospital will coverage. and Financial session. advancing for more Chief is for our BREXAFEMME expand program. and more adoption, insurance our will and earnings

to like Chief call Commercial would Coyne, Christine? Officer, our to Christine the turn I Now, over

Thank Last you, enthusiasm quarter, I with prescribers our Marco shared and few morning. BREXAFEMME. about good

launch recall, our to a early As infections. expected, in what we encountered treat we who of clinicians ingrained great yeast you desire patients beyond confirmed physician to a a treat target a habit healthcare new may the used of Since commonly with our we using azole. old reviewed August, well azole a plans to our providers vaginal exactly the days deal yeast products. vaginal continue following representatives, product with Yet same with discussion infections

day. relief only tool, as remains first of awareness BREXAFEMME began symptom oral healthcare to providers improved plan BREXAFEMME our resolution. each has that our with meet In to Candida one of our providing the team understanding number activity sales yeast healthcare And ensure fluconazole. dosing with to resistant treats customers. August, with key coupled oral a provider vaginal one including key a complete focus against are range vaginal of their a broad therapy and It continue infections motivate secure species, and prescribing. to is infection and are ease importance new so fungicidal yeast benefits clinical of to those great These day the that

And women focus on recall, is swap VVC of wide our VVC. the there who is other OB-GYNs with may you physicians top As a deep and prescribers. and treat

of we have to the built BREXAFEMME, Our prescribers. understand time Based helping treatment sales early team the work, their for same infections. clearly BREXAFEMME physicians yeast of at a awareness while strong vaginal on base utility of fungicidal non-azole a work generate

Our these quarter is intention to In X, prescribers of physicians than This more are progress and X,XXX that positive base grow the early BREXAFEMME. XXXX alone, adoption. and continue is of expand to prescribed prescribing. indicators BREXAFEMME

Now, our early and marketing let's discuss results the of sales effort.

me by foremost, and for positively is First customers. important been it received that BREXAFEMME healthcare you convey has to our provider to

to educate on We benefits of BREXAFEMME. have the able been prescribers

a As with to after different launches, do is makers decision a all habit decade something quite task. convincing two

what or to patients and able generated effectively appropriate prescriptions to with been growth which BREXAFEMME conversation have help BREXAFEMME. in X, We here that Trial our and that usage prescribers these day solid treatment we I are motivating they trial their is learned and the yeast earlier, that reporting use. is an these to XXXX. an growth them. and expand The effective ATU. are report, Attitude our are they In meaningful administered quarter now which begin is are and And We generating their to good QX them months. called one came the to in patients X, of writers. with is indicators. These expanding their X,XXX over same all XXXX, prescriber having expanding both message prescribers that majority prescribers trial quarter Usage is of of and identify more what What important new discussed base represents November, expect the next from is BREXAFEMME over We the three BREXAFEMME with good outcomes kills

In healthcare accessible. on our X, as like offices companies teams for quarter office to their some healthcare into instances some had some given other able, calling more to have on field get January. inability XXXX, COVID. to providers, softness to due of continue are in The accounted these call we who for they are Now, where providers pivot closures

to February, began However, use as to access in their up see opening things these BREXAFEMME can drive and of again. you continue ability physicians back once our

continue demand payers. our continue BREXAFEMME, we also to with As and build for insurers work we

more of time. our coverage are of ahead efforts to than tenured commercial this, our need pleased account to lives, national in easily and been XX% X, the just access customers. secure expectations not million XX they seasoned national long successfully last the review our BREXAFEMME BREXAFEMME end By an I a garnered is am to relationships more represents Candida. have lives. XXXX. tracking the I've the are we coverage but XXXX, with of for This we which able testament This at account payers clinical commercially call, since our very directors payer than of to early secured. to first is As on high insured treat Based meetings of mentioned team, their not unmet of and that non-azole therapy important this And value with the quarter recognizing

to trial focused is and to on been with healthcare customers, date has gaining launch usage our awareness, with access payers. working. BREXAFEMME provider Our It highly generating while

As with highly The BREXAFEMME is know to pandemic. endured that launches and despite has teams, They It keep Chief and we personally to cycle keep feedback product's over Angulo, encouraging BREXAFEMME bring external will with without and Thank Dr. factors as call patients. healthcare of to David? rewarding am motivated our well critical in our the you. such a providers to brand. a our pandemic, commercial they continues to hearing soldiered therapy I field physicians fuel phase that's efforts -- and their efforts. And the the environment. important both enthusiastic and on turn growing professionally, now to difficult Officer. been experience Medical the life the of I all an pleased the and David our and from stress challenges have remain of

Thank you, Christine.

hospital continue settings. the both significant of to ibrexafungerp for in development make community progress We and

As study, In culture-proven, reported six of not through three-month XX.X% milligrams Candidiasis recently achieved This the was Vulvovaginal XX significant. Ibrexafungerp sustained was period compared positive against all, of the was defined patients and statistically statistically which advantage to received over significant. of any a CANDLE week clinical or for results. success, study completed preventing follow-up XX.X% with This and matching placebo placebo evaluated suspected, was ibrexafungerp difference recurrent pivotal having announced, ibrexafungerp at BID months, treated our placebo. of given day efficacy and recurrence one ibrexafungerp XXX as patients patients. the VVC. over either of successfully compare remain presumed Phase study The month the in in what's we recurrences X

the in a VVC. end results option NDA VVC utility clinical in With and we the our approval the of for needed These ibrexafungerp in quarter by these submission on from now anticipate much reinforce are as for States position of United recurrent broad treatment and year. a second this year we novel supplemental suffering results, the of target the of antifungal patients receiving

on the day a ibrexafungerp days of ibrexafungerp. failed news of exciting course CANDLE successfully three fluconazole these or some the activity the after one therapy. and Additionally, patients elimination who of reduction study More provided fluconazole failure treatment of achieved symptoms of in signs one XX% than day significant the patients

are track candidiasis QX. first evaluating invasive innovative significant We the also diseases. summary activities currently brief MARIO continue potential progress interest and patient has a as having are globally. is with on size for following The patients our initiation each. invasive study of making large of programs enrolled oral a for pool The And this step of our in from a fungal design the ibrexafungerp study, investigators, development in triggered therapy for the evaluating we of of in status down

anticipate Designation be the XXXX, The in granted that enrolling a approval is the will of FDA. invasive U.S. early that this the year. unmet for benefit approximately European candidiasis Agency. to Orphan past same the ibrexafungerp of late this meeting and ibrexafungerp clinical Medicines significance Drug highlighted was by previously we indication and The medical year potential offer We the receiving designation potential from subjects, by study the XXX with completion in

enroll We continue CANDLE and well CARES our to study study. in FURI and

with cannot or recall, may that tolerate you on these to our refractory in agents focused studies refractory antifungal fungal infections, That patients severe As antifungal. patients to including candidiasis.

treat in studies indicated be the will interim of our infections. interim have salvage these clearly option ibrexafungerp latest at fungal significant very it, look of We to Previous for therapy studies data data analysis QX. potential from as these a difficult the severe sharing for

us and intravenous pandemic, The of was ibrexafungerp invasive SCYNERGIA year-end. X enrollment potential active. study next to study. of that completed very Phase that exposure confident QX, the aspergillosis by steps well treatment tolerated the the voriconazole impacted results conclusions improve decisions combination remains multiple Phase and aspergillosis. ibrexafungerp X formulation COVID this pulmonary Our We the for Also liposomal single enrollment meaningful from to the the allowing see successfully for In development evaluating with will of pleased reached. study treatment ibrexafungerp remain was doses invasive we reach guide will target were ascending this for year, formulation regarding in our ibrexafungerp of was of pulmonary in by

also had ibrexafungerp by this VVC approval towards efficacy a discussed this this Chief the preclinical needed completed VVC now When to aiming a year, often those on chronic we enable mouse the help early, that are phases Larry the call to last guide recurrent our episodes, indication, regulators, recurrent Financial and showed mentioned, label, synergistic VVC a FURI a mortality treatment which condition, condition. that steps that their activity VVC very spectrum seen suffering recurrent with discovery. patients with in And rates development ibrexafungerp development in the from me And we in as B the of broader incidental program up have of mention will quarter. potential desperately we and broad our as lives result clinical Officer. turn across we Alternative disease reported VVC with to opportunity indication disease, activity IV we the registration affected And who study. model of are with I the this and of While significant amphotericin are to very those manufacturing within file Interim evaluating want this significantly high options we including next of but devastating are do for our over previously for are development. of subsequent trial Hoffman, our scaling next track let to to significant mucormycosis. we to us clinical

Thank you, David.

generated in first of in For full FDA XXXX net June its the revenues, of approval XXXX. quarter the $XXX,XXX of for was fourth BREXAFEMME since quarter BREXAFEMME by sales the

revenue As None a the programs to wholesaler. reminder, we assistance sales. net like patient recording of insurers. co-pay inventory upon to discounts any discounts The all includes of revenue our are the Also card. sale represents amount from

selling the We of improve over net year. expect our to course price the

million The fourth $X.X increase revenue Our was quarter relating quarter. to the fourth fourth fourth quarter quarter was of for $XX.X R&D driven the of the by in to expense million quarter cost $X.X million BREXAFEMME. of XXXX for of $XXX,XXX increase quarter the XXXX. commercialization the expense of $X.X million commercial versus the $X.X versus of expenses fourth to XXXX. prior XXXX from fourth year of SG&A quarter was million million increased million expense from $XX product total million of for a comparable of of the other ongoing for for versus decreased XXXX expense $X.X XXXX. Total $XX.X other the

million, and value on and respectively of of XXXX non-cash cash quarter adjustment fair a prior for respectively recognized net During of XXXX, or $X $XX.X of quarters XXXX of million liabilities. fourth loss $X.X or losses liabilities on $XX.X $XXX,XXX to the a net of fair and the and The year SCYNEXIS million losses share warrant million, $XX.X comparable compared derivative fourth was value the for million net the $X.XX of quarter. per $X.XX adjustment share the loss the

exclusive in Our Hansoh licensing of full ibrexafungerp Greater in million the XXXX, million $XX.X results financial as revenue revenue XXXX. our $X.X for BREXAFEMME we XXXX license China recognized generated to for net Pharma region. follows: year And in pursuant earlier are product from agreement

from $XXX,XXX for million XX.X% primarily licensing as million commercialization to of the to million by comparable million we comparable Our programs. $X.X XXXX XXXX was The of ongoing million of in comparable was and in $XX.X increase million $XX.X with million prior $XXX,XXX in support was which total for BREXAFEMME year. in business $XX.X XXXX. R&D $X.X cost $XX.X of expense expense, regulatory from versus Hansoh, the period. versus of XXXX $XX.X The revenue million commercial of versus development development expense preclinical entered expense for for clinical to R&D expense, for in expense prior as was $XX.X XXXX. in with associated driven product or expense agreement year. by $XXX,XXX increases Total other driven decrease well prior the other in decreases the SG&A $XXX,XXX into million related other CMC costs, the $X.X increased decreased income February

XXXX, per During liabilities gains warrant XXXX of adjustment and $X.X non-cash million loss the fair of and million on non-cash and value million, $X.X of SCYNEXIS recognized $XX.X non-cash respectively a and its million, gain $XX.X respectively a for $X.X of a per derivative $X.XX value loss to of for on year. net compared prior its The $XX.X the or share fair of net or share was adjustment $X.XX comparable XXXX the million liabilities. million loss

of runway of second quarter the we mentioned Marco into a cash strong As the at start XXXX. the call have

equivalence We with $X.X of million New of the the and facility. for from the have net XXXX, as $XXX.X cash sale draw raised operating cash million of $X of down and debt of $X.X December XX, from losses in million an Jersey SPV million XXXX QX Hercules additional

Our the $XXX begin provides our And future the milestones, before with business million partnership development of with development call in potential I and to patent and us and us thank additional the Hansoh Marco. back ongoing of we provides the our I Q&A, you. strength internationally. opportunities over with efforts protection long-term turn will commercial

we Thank the want you, Larry. few close I iterate to call points. key for a And Q&A, before

patients. of expanding great the to end and by strides treatment making of year. of prevention First, HCPs labeling BREXAFEMME we with VVC this include is and VVC anticipate Moreover, for recurrent the an innovative are product we

enroll very please MARIO are of questions. in the a financial to is expect indication first robust, second cash quarter. is trial and the floor the pipeline our third, Second, for for position the into our a obtain MARIO the the of we in in objective R&D to trial for candidiasis second indication hospital balance The extremely over of we and $XXX million of Operator, ibrexafungerp. invasive quarter with strong open runway XXXX. And patients

session. Thank with conducting is question you. today a Chen we question-and-answer be this will Cantor. question. Our from Instructions] first proceed time, your At [Operator of Louise Please

Hi. taking you for Carvey out everyone. Thank questions. on is for Good This Louise. morning

end Second more healthcare pointed per in scripts of of insurance XX% at Appears, of coverage. more increasing on the hearing We number interested this on commercial. HCP the Also QX. X,XXX. X.X for your commercial of X,XXX by you to cycle? year? provider in expect So, that compare by other improve the in product do scripts is What the is to goal what average We're also again. And life. of the the strategy for each typical the does you're question than is Thank rate activity took so much life you How over the be the would start VVC? how you divide coverage in time? antifungal this treatment script

that's Well, of a questions. lot

I start our the any very first it. pleased And her Christine and strategy let's certainly, all, expand more first. the team coverage work Christine, with So, of comments continue with to achieved. to on hard to are what mean, to we get we coverage? continue

continue Well, we've done. what I mean, we'll doing

been the a with bring a option, account customers had the to non-azole option data The science Marco, themselves another as payers. have have the has We well. and important really to the medical need liaisons success guys know lot payers. so there our you to that know. They right payers seen for The their there, clinical work of national

the some happening is meetings. So, membership doing, their committee patient going have to we'll all looking data which pharmacy through review they these at don't these continue we option claims things And payers and own when continue therapeutic their see azole. are in what's Marco, have clinical of even doing We'll to an data. the themselves been have

something important need And so, us very a that's thing because else azole work. become when for doesn't the payers

So, I hope that helps.

this And very something was remind years previous would can second XX that that more to VVC further is was with experience, because elaborate, is time just little but approved ago. regard the question, last there Christine to like the in I than --

we too not maybe there to. So, is compare can much

where as mentioning. Christine we please. was need we so, are some habits, break a And to certainly field entering Christine,

But to the it can't this time, Absolutely. I've the done that these case, your Yeah. -- any In it these calls matter, takes And treating different once. to category you you physicians just categories right? -- in who this make VVC have do conditions. in are multiple And physicians treated.

You multiple change it is. to takes remind It what explain have times. to times a them do and multiple BREXAFEMME habit,

this trial So, X.X moment at we've I'm that looking me -- because at X.X, that moment patients. continue to other these prescribers. what they stated time, BREXAFEMME and is try a good that's TRx new in then tool find they per means is the mean, started rate That's seeing what to treatment of the they this a X.X, found prescriber for to it. in at convincingly time, And pretty patients. that It's is. I X.X other

but math, rate a as prescriber super straight rate. we is it we it a many go, patients, is good that's Marco, pretty So, will per prescriptions How but many early, have at. but look it's

you. Thank

Next question.

Thank quarter. Congrats you on so much. the

Of you. course. Thank

question from question. proceed Please Higgins next your of is Ladenburg Thalmann. The with Michael

XXXX, Thanks. on successes the you transformational guys. Congrats really year for a guys in

of the couple questions a approaches. marketing Just on

be folks some the got who patient that strategy? the potential had the a upon some and the of so half Q&A of take far But any going. Is that understood You back sense XXXX, it Is well. prescribers some these targeting? interaction to And to when maybe were the for just that you question marketing your just adopters. get trying half the were seems that. in I'm look there early product changes maybe a to back that your you who as at comments touched of and them in is, some

winter saw of sort a to plateau. there seem over we be As months, the

believe some as well. impact there Omicron had I So,

for the trying just Thanks. targeting so sense efficiency So, of the a to far. get

That targeting, at for good targeting always of criteria It at the call Michael. you mean, at strong. have part for you Yeah. right? It's we But the -- really right. And early you Christine. Hi, these targets, Thank question. adopters. and definitely it. your really, looked that a we I absolutely looked look -- phrase, want right? to The Yeah. a it was was use is take

get to on those of targets. adoption quicker you So, types trial with

So, for yeah, timeframe, January sure. In absolutely. the

and the productive offices. Some of closed are those those most offices were

offices some So, to you but reps tracks our softening bounce in, to it open see definitely start those able get are see there, and there. absolutely when you with back absolutely back the

change matter, hit in to call always high expand approach, no and death that their they we exactly targets own who So, the except they continuing in good that's strong because say, to sure base. aisle, make our outcomes. we prescribing, they're have are because with us having And

sense, So, you of early of always you with base want to call types Does make sure stick targets, make adopters. that your these Michael?

a makes of That Yeah. sense. lot

moratorium Michael, that was that something different has important Christine were I about that of that doctors resource before, can an been when VVC. never we mentioning [ph] actually very, activity. very and expecting is if really add talking strategy, fact one in clearly for the as And a something their been attribute attributes of brings that really The BREXAFEMME class for is unfortunately fungicidal is

the the was So, we get confirmed is clearly from that feedback by field.

on So, will to we pursue strategy, and think are right it. continue we we the

this Marco. discussions outreach What appreciate stage follow-up One partners? for that. and Thanks. discussions How say at are are you potentially with your going I Marco. you, European Thanks stage? would

As been year. I approval last after mentioning the I've think recently,

in One terms had regulatory interaction for we is from regulatory conversation America. the intensified. the and of major regions are of that in is other are right so, Latin been There aspect. -- derisked three that Europe, now, different been a [ph] critical. is us And that a reasons one and type Japan we have Clearly, product has has

And, three course, are discussions ongoing. of these reasons. So, are major

able tuned. China a Clearly, very stay clearly just have means deal, for were has favorable that with a that to the also upside like last that Greater year that of -- company partnership significant a with there value we product perception is Hansoh a way. this So, fact the with

this working can aspect are hard So you business development. stay of -- that We tuned. on we assure I

it. guys. Appreciate Thanks

Thank Thank you. you, Michael.

your [Operator Oren of proceed is question Wainwright. question. H.C. next Instructions] Our with from Please Livnat

a If Thanks practices are first Or could what Thanks. dig couple. obviously. targets, VVC several so, is Are factors that patient more couple just else? base, is per an speaker you was you higher experience? volume you're patients guys. just talking where about seeing a a was that, writer. practices have for I percentage follow-up doc it further and To much the meaningful seeing already? they're question. prescriptions their maybe per on are average, a And leveraging writing as X.X that? that other access of region particular of leverage a I about maybe Or of or it? or have Is how driving And if you across something matter do how it that their I or in cetera? programs, follow-ups. maybe And I et

question. Yeah. of all It's for It's that of stuff. Thank Christine. a you bunch the Oren. you, Thank

are X.X have well writing So, prescriber. said, we That prescribers TRx that absolutely the we was straight per like math. above -- that

say, going then, And It knowledge our it's our from got integrally I information have August. comes -- the all medical right? do rates publications, would absolutely they had and higher side, into that in of really early, to our there. tool You actually in reps may So, a convincing physicians would I show promotion, very apply show prescribers it when they back see some comes a that new patient, you we that for the that always reciprocal say, already arguments the -- launch promotion criteria, use BREXAFEMME and consistently from should that on you you it up that and is utilization Oren, -- way up you that and works, see they part.

what to there, share know of are best things. above are, to don't I writing a a of we And VVC denominator those that point, patient your prescribers the practices. load is it's So, confluence prescribers have idea of absolutely lot the and each X.X. every but their

what's that called whatever So, we the certain if way, the point, share best then a there it's doctor talking whole like to sharing. to a practice working, speaker of or promotion a And tactics other in are is your if it's in the across programs. seeing them certain type Salesforce and of senior

show how bring what see information they some of see will We and they talk will there get in and BREXAFEMME speaker up that how their and population. patient in a about working

So, Oren. factors, of is a it bunch

that patients line think to are it's so refractory we of patients Okay. or in mostly prevention are you the de And just -- But are being recurrent the the BREXAFEMME novo for getting obviously, that customers, or stage yet the repeat approved Or VVC. it's speak? launch? not I assume seeing of I used who mean, best getting should formally understanding, already first your in to it? of do

can imagine are have -- experiencing effect. of VVC, those satisfied for fluconazole the and in that fully they're fruit beginning -- we the our been you yet as maybe that sort not patients at launch the as past been of and Well, low-hanging fungistatic with the with

beginning, type action are a the may patients can mechanism So, and traction the mechanism of we action. new certainly these of that the different of benefit the something have fungicidal because of where at of more one really

non-azole, activity, these when last is sense treating patients doctors they We the up -- pieces -- it like we actually said talking actually together about Fungicidal gets really right? the we're with you with that and type and the stick think when when And dosing. well this Marco. to talk and One doctors, would to patient resolution the a the message, you that Oren, And about day And it they're talk that's complete is of right? a is come I kills, signs it. it's symptoms. fact different. there, really put you traction what to piece, doctors makes they almost so,

we know necessarily We picture, not -- paint second, as think the get patient Does Marco, as that really and So, a we first, commercial about I third actually people line. the it's help, that's traction. Oren? where

Sure. I could And just greedy, I if apologize. be

lot "DTC", Just early is or XQ rolling mean if happened call, lastly, the out wondering obviously. a about has I'm XXXX, you I different maybe think on of talked In happening. which things, that some

Yeah.

are funny DTC. we definitely So, so

in strong launch POA, And we're that nice timeframe, every it messages be Oren. as really will in single campaign is, right? the what doctor's have these we patients So, learning summer DTP campaign it the and POA. the day. will will have kick-off I it would that And the inpatients, memorable with it for about change some South will a offices, really and So, summer we to our coordinate program do we of

So, strong put there's digital as behind offices. like there, There's will ad, that. doctors' in everywhere material. push We'll really televisions a do content well as integration, up stuff content we banner

So, that will summer timeframe. be

miss didn't it. You

you. Thank Okay.

Thank Oren. you,

from with The of Steve your next question. Please comes question Brozak WBB. proceed

Good morning.

you. Have appreciate on wasn't of the the drug, refractory after feedback how I like focus that a as and of from I'd signs patients you experienced these gotten their that, these symptoms? I this -- to feedback? importance what I've And into been in who we types follow-up literally mute. Sorry. women have Thank complete much that's got clinicians And type messaging? you do forward if to please. very sure who and Look, a on. terms was the on you change would direct incorporate what any expect future have And going of

the Thank Steve, you, for question.

all, to this support something promote or approval. will based VVC we go coming is and clear approved Therefore, promote Then, VVC in an Phase a a this. indication. and expect, out the getting on this be we we quarter X commercialization position our to in Recurrent neither What supplemental indication. trial, actually file and defined really first to very is recurrent make, of NDA me as with patients indication. of who an the not let So, are

results On we the of -- in what seen hand, interesting CANDLE study. course, our some have other we

was who received received patients study and definition VVC. not been that they of and of actually, therefore is were the patients VVC part of the are and recurrent has these their doses three some met fluconazole was there dose times resolved. They three fluconazole, still the three David approved of mentioning, As doses which

XX% entered were very, of results in treatment significant More or than had actually open-label their And were so, this BREXAFEMME, where a study with one they improvement day them cleared they very symptoms. and getting promising. the

And probably benefit. the lifetime, we same experienced of doctors who multiple their may expect So, that probably, important you are out they episodes these are there may some have in treating feel we really data. that see the may patients when

science where to, me the the swap over this of and items is obviously, Okay. those this And drive can let this. can one because drive results

out Would critical start he weeks back product? of talking of ibrexa, a you of about expect the expect couple of more of see Gomal those about next-generation [ph] edge this Thank the to especially especially to that these that glabrata. the ago, Candida the more And commentaries leading queue. in of when paper reporting who types clinicians, On advantages? importance was Would around came on I'll hope strength you. activity as the of these you the are publications, types

to one have the And of Thank species one the against really who activity cases one Candida very non-susceptibility ones not is glabrata. attributes the David. you, Yes. you [indiscernible] Candida azole. of key for non-albicans may be question. Steve. issues, And responding we is that of the Thank are is against to Certainly, not is the that Candida azole. of of often including the glabrata the levels the because ibrexafungerp susceptible the high know This

issues. So, we and in in as to more ibrexafungerp expand non-albicans more the information Candida rates, do is patients response particularly these expect use that of come we the about going

one so, infection the the know if down is in you need even this by. setting, that because for is albicans. And fluconazole that to they product majority say, majority by we that to -- also may attributes most, Candida fascinating know the this key what When the VVC found common is let's the through was don't toward albicans, drill caused in of Candida of work really infection caused

Having opportunity, albicans, prescribing good the a don't to the they the you're fluconazole, Candida that has over really you don't like gives activity which has glabrata, species. know the know greatest drug successful. krusei, of be ibrexafungerp chances respond just even recent to is XXX% So, to mind that ease what

popping but mentioned investigating of certainly, publication features those as we So, we are that well, that. that And to you up. believe type continue are going this thank you mentioning for

the can not glabrata And krusei important, hospital I Steve, in probably and add. but infection. are also Candida only also VVC, for not Candida

which hospital lives this a product a that really Treatment the important are opportunity yeast for is will can hospital infection. VVC the to because Steve, program but infections. that a also antifungal franchise, the recurrent, larger just invasive franchise, remind the gives save In the in there a larger very, is infection fungal everyone But fact, thank is have you too, of where is very program me part VVC, vaginal we bring we the can question. where

everyone this actually a because ability very attractiveness are of is we that ibrexafungerp. This of And, and on of -- range to appreciate of this. remind and you, course, but is the -- that cover So, Thank I very a just beyond this potential the launching indications lot much Steve. remember now of broader -- product a has important, VVC. broad this to is course, to that that focus VVC is also

you obviously Again, the thank luck of you good in prosecution the again. and sales. Thank

Thank you. Thank you, Steve.

comes The Please of with Capital next question. from question your Brookline proceed Markets. Kumar Raja

all Thanks progress. for and the taking on congratulations my questions

regard plans what And educational are through recurrent you to as your have those? educating medical you you work plans other What getting present with are VVC, to do any to events regard for with have meetings sNDA to So, planning approved? them? the physicians

only This anticipation on Certainly really question. MSL -- is the drive most affairs strong and attending plans the all time, drive for product as opinion for this. really the really that or the the support yes, the to information really has sense. in we Yeah. mentioned. so The Thank medical that a active regional educational medical very to indication. leaders publication, way But we also team this team launch add key to extraordinarily national, year, campaign for past that team have but payers, been relevant, the for David. the putting connections and I opinions in and the at of is practices can particular really in make affairs what typically providing call able not you the meetings been approval to people an Kumar Christine same together who

to this indication. the enable been has intensified, say, launch really in for approval So, and VVC our of the recurrent launch let's way the the now

are the the launch we for on and can cetera, is receive potential regional team presence populated national me very will meetings also what et apologize that all that. in and information to in well schedule OB-GYN have from for good eager all that happened I going CME terms practitioner of events. information that our expect that similar to -- Unfortunately, in they to a regular now the have VVC tell sure. well eager meetings I could front prior found that in hand that that I right the these the to us. happening nurse of the like and space these space, that source to meetings but are disseminate now we as you as are of prescribers we But strong of a VVC are don't ACO, really very be with of right the have eager you treatment will have programs So, that we acute

Okay.

be the in to going soon. is data publication for VVC the And --

see, We population. data have sub-group already the around them -- from in with the could coming extensively published just studies. we acute you have multiple As publications very VVC

that do putting So, we data. will all in public we this well have domain with as information successful been very and in the

geographic something is Okay. potential ongoing with will Thank Latin Japan are pursue? regulatory you America. about you. there? partner And a talked kind Europe, expansion Or and a of potentially little partners, bit What that interactions that

coming Well, the actually, with European the European was, package European that times have programs Medical Agency the we with really for submission to is say, is to that ready all that -- Agency. Agency discussed sure been the most. discussing have European make final suggestions incorporating Medical been have we from Medical authority as disclosed many And and let's Europe, regards our our always the

America? Latin and Japan to regard with And

is some be will -- Japan, special know and they have carried for that -- especially requirements, potential they that that you have may to will bridging partner. something as Well, need activities that the be out by a very

Thank you much. so

Thank you. Thank Kumar. you,

your is The Please question from proceed question. next Thalmann. with of Michael Higgins Ladenburg

on alone leave in you could, for of these. are time Marco. couple if David here remaining. more These the A I'll follow-ups, or Christine, so Thanks. I

questions. Just clinical some

formulation. If you can any liposomal for your off, give us, timing of design outlook first IV

on in enrolling half any period? Second reasonable? data mucormycosis, And XXXX the then, question SCYNERGIA. guys. have is of being question Thanks on patients Is back you seen third

is this Michael, for the David. question. Thank you

So, timing, and them that and IV make I all. the regarding sure just first one formulation the is got

we right So, … now are

Yeah.

Sorry. Yeah. Yeah.

Yeah.

thank Michael. you, Sorry,

formulation, we concerns previous as that IV the regarding formulations new progressing for So, these have have that we I to be formulation infusion feel tolerability see the development. can now pleased a issues. really to were addressed extraordinarily we seem And really confident mentioned, very

really soon with approach and what are That's trying aiming bridging really the programs are agencies as particular discussing later to find in strategy. from time try we the integrate all intravenous the focusing what to find is try the where regulatory abbreviated that's at information to really kind to we are what to an We of right we development to up them but our get possible. development stages that maximize formulation same these, within to obtained this in as and of running we

alternative in to objective, We this really X Phase X same time, the progress to within this have move our past that not or conversations tell still we and is I what in fast, and timelines can really forward have optimistic being environment. will of X, that the process determined the At very is you right the having the Phase those rapidly. right we that regulatory we the into And I But are to mentioned manufacturing. accelerated are for try as specific option very what very the are one. are find

to at know We IV timelines we some able typically sure sure you have make to for we are be plan all reach that like So, be we got, time, timeline in want do that we as properly the be. those because agreement to that. the to make that. we to formulation the elements really have soon guidance that progressing not the this we guided for to to and studies for guide able specifically can enable manufacturing of clinical want as But to level we we

we the So, for where IV. that's are

that data about a confident this study, SCYNERGIA a the that years. question is if is of feel particular right? quarter say little For study, somehow the few in we participating to study of refocus We research your -- on X of little related centers in and we year, need this units that, of This I that impacted said towards much that on releasing must was And Having was in past we by remember that, we the study. that surprised in the Phase were saw really were or centers. in the it many the changed has past, in the now bit research and most of and COVID second doing more all on this that are resources refocused we that the the lower of participating refocus in study. are studies impact based activity really optimistic the the the institutions we

patients number conclusion. that confident meaningful into a right able now good to of we're to have going are be to have the coming study We

a given amphotericin of even time. are long very B as guidelines third mortality than we're but -- very being So, -- devastating alternatives still high has know, still amphotericin the about And the treatment data toxicity And mucormycosis that with that our is typically so we for mucormycosis. this is half you was not from XX%. year. mortality we condition. the -- rates objective period a a Mucormycosis that disclose most we typically have or that are a It very higher amphotericin Right B, study B, are the and commonly having second now, prevents used in rate. towards it a changed has has of

it presenting achieve to treated. would the particular this half the that nice humans, it we're of mucormycosis of investigators we the of that substantial in making patients a data right in ibrexafungerp sure that the we've investigators B. be out. survival. been sorry tremendous really mucormycosis value on actually a and improvement in see indication. that a be the we're be this we showed additional enrollment doing So, that mucormycosis FURI different I hand. written with really be a right very mechanism data as disease can is combination the potential improvement with mucormycosis have understand a that -- understand we study provide us, in advantage we that And The therapy data and are may way animal of was And I data in seems if or against with will speaking they that now is to acting And able making this If in going tremendous that very additional are therapy in what even a -- now enables, just that B that roll study, all say that amphotericin action of to But are presenting immediately, able study combination with synergistically to extraordinary amphotericin model to for sure fungi. FURI

about very, we're very So, that. excited

great. That's awesome That's an update.

[indiscernible] of Just to follow-up was you have just said on what announced that sort you that you'll that?

the that put [indiscernible]. certainly were preclinical ahead of David, or just as we have here we announce -- announced. to of in Director, we just We only to And we preclinical new of -- have the data Communications have from that the data only continued mucor generated seeing setting front place, be more that or I'm -- now, preclinical but clear, one have in Medical in previous that that. we And just data, planning

mind. don't We you. Thank

take to more question. are going And one Thank we you, Michael. operator,

Oren Thank with Livnat H.C. you. from Please The question. Wainwright. question last of is proceed your

could imagine try game-changing we're on versus getting or better to between CANDLE. this follow-up. show so more that Are and it I'm What to have better that we regards ibrexafungerp call with fluconazole. can we to rates efficacy? recurrence And regards there's But understanding differentiates plans bit. understanding you have timeframe, have certainly, to to with data ask how understanding total lot and about little that, tells us slip, which I about obviously, And letting regards of how us time saw maybe, that top with a I data a really is, Since better recurrences number data on data, little I'd recurrence to now six-month fluconazole. see going thought a at line a over within that hoping I'm we payers over to a from

Oren. this so Not you, Yes. soon. call. Not Thank on

further of information the think from -- I meetings medical a business really are certainly, planning where are in yes, And we we have So, summer additional disclosure that of planning. is this study. but to

You guessing, in very for know But timeframe. you -- summer of try timely yes, of we And very, that as can the meetings be really it’s we put much -- like Thank will a will medical think really and about efficacy we're around it’s hearing in as information interest. lot you with as the your to I'm meeting share kind a medical additional data. continued I you basis.

Alright.

Okay.

Thanks. Alright.

you, Oren. Thank

to are I'll for turn -- additional remarks. call There no the Taglietti back question at this Marco closing

Yes.

of success very we confident scientific to I all, would about like on very and everyone. products. questions good First Actually, ibrexafungerp. of of a success lot thank had and we our Again, are commercial the optimistic

much for and your thank very today you you thank support. So, listening for continued

This conference. concludes today's

You disconnect lines time. may you your Thank your participation. for at this