SCYX - Earnings call transcript Q3 2021

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Operator

Greetings, and welcome to the SCYNEXIS' Third Quarter 2021 Earnings Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Debbie Etchison, Executive Director of Communications. you. Thank

begin. may You

Debbie Etchison

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

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

David Medical Dr. and Marco Francois. Taglietti; Dr. Officer, SCYNEXIS and Chief Officer, CEO, today Christine us President call Officer, Coyne; the Joining Chief are, on Chief Commercial Eric Angulo; Financial

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

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

Marco Taglietti

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

of the investors with FDA the and in call after approval earnings inaugural BREXAFEMME. June, since Our launch

vision have us true our you of been timelines, For ibrexafungerp we our years, few all into have you to to word, witness turn how for and reality. in the commitments, been following last who

full of and to have for solid, community with exclusivity, agent global and build a of for of and both and franchise, franchise long-lasting of the time for versatility and [systemic] stream its value leveraging this Our we the potency years antifungal been [Ph] until of expand for hospital unique always create ibrexafungerp extract infections antifungal patients, to of has ibrexafungerp, our with the over reward -- build use. a XXXX, benefit by vision the to XX approvals continue a to shareholders. And the the to years to antifungal

for today, the made we hear you far ibrexafungerp. about progress significant have our achieving so will vision So, in

Chief of provide treatment promising will you of for the Commercial our will trends the from activities, of Officer, BREXAFEMME an commercial hear who Christine, vulvovaginal of the the First, overview our launch market, early and candidiasis.

bringing about condition, from women have so innovation underserved excited symptomatic very for long. millions antifungal been to this from class the suffering of a are We new who

proud antifungal in are than progress patients you Medical development. We more Officer, Chief so David, research from and bring in to XX our significant class to about the our will first Then, new hear years.

completed R&D positive assuming for you the update a CANDLE the second recurrent about an in update. liposomal brief on give on for which, And approval in We prevention next ibrexafungerp Phase We of are commercial of financial Phase infections, finally, study our David activities may ongoing data, top of built and formulation. finishing VVC are solid X all of Eric, financial a Chief give foundation. Financial [indiscernible], also our for year. fungal programs. result you X intravenous in will new avenues the a successfully Officer, opening our second-half hospital-invasive the our development will hospital

call the Coyne. would to to Christine? like Christine turn I Now, over

Christine Coyne

Marco, morning. you, Thank and good

updates exciting several today. with you commercial share to have We

the its tools decades. monitored And indicators fungicidal the alternative truly early the limited azole-resistant aren't for in of team health BREXAFEMME is we Physicians one-day non-azole of great prescribing market, of have been meaningfully physicians' converted once beginning extremely common, physician prescribe. innovative advancement hastened truly market. left FDA of to habits, are VVC, delighted U.S. Despite excited BREXAFEMME, and and area patients. the with properties. mechanism things; and to of infections the women have now. a outdated of first-in-class BREXAFEMME to brings is the yeast Healthcare BREXAFEMME out women's been to have BREXAFEMME experiencing strong bringing who indicators with for to causing prevalence June, this high the they lifetime. long patients. feedback BREXAFEMME held our has long-awaited three changing encouraging. infection, yeast at the in use the until daily the about are closely this are BREXAFEMME kill product to been suffer Vaginal of Physicians and a action. novel approval of providers launch in least launch, antifungal They just to there for their of about designed These is saying oral motivation action in are are their innovation a confirm From These Following they that mechanism of motivation different decades, including for two have the the them dosing that millions excellent. from novel women strains. their efforts quite four last

made Now, let progress launch, we've me summer. our the more this provide since on details

our and and high-performing strategic SCYNEXIS commercial achieve vision At building SCYNEXIS includes which that the and time, to our it they this foundational our leaders blocks teams sales physicians has launch continuing allowed we partner; sales Amplity's our means to deep Amplity collaborative a hired, and consistently the physician to success. great rapid commercial established sales and contract experience with importance to we Amplity for what promoting set BREXAFEMME. expertise and partnership Together to representatives approval. us for BREXAFEMME and targets. launch, partner, we've leverage realize their Health, efficiently Amplity The stage is of this execute regional the plan, First, are post trained, equally to patients. deployed

and prescription and executable VVC name is at expanding U.S. makes in this we the nicely are our is in strategic concentrated, previously, prescriber this that and efforts discussed early game My and continue launch. of market the just is team a indicators have the we All base efforts juncture. approach, especially for on of that. depth, breadth that expectation focused Effectiveness our the working. is confirm As

we we and up significant hired pent and in in Just the launch history force was BREXAFEMME sales By real formally total to commercial everyone highlights partial data, September, trained, an and expectations. our achieve the in traction were an in first in our to By pharmacies. launch had and the to to believe line been in in the launch. on IQVIA our upward for with is Sales drug alternative announced, demand started the which in the soon distributed product call of there was quarter to the the to packaged, to pharmacy, for trajectory October. August, prescriptions been then, manufactured, process. September. now, started available see like as azoles, We remind August, come and had continue as X,XXX This BREXAFEMME. According of

novel of of the increases, XXX September what of of aligned growth and to momentum very is learned does and prescriptions, October the strains against with BREXAFEMME of see early quarter, with a with continues prescriptions Prescriber rapidly in be we end indeed. with encouraging to trajectory has their a showing awareness alone. prescriptions August new remains resistant pre-launch symptoms September, IQVIA continuing our that consistent alone, so while to physician experience from We feedback infection, similar in shown adoption important of growing of BREXAFEMME. As a into mechanism Candida, the nearly rate positive and action signs research, There having non-azole a X,XXX physicians week-over-week patients. option fourth eliminating activity in

In ability see we experience. providers are their prescribe to therapy to one-day a motivated to as physicians BREXAFEMME, are compelling. starting prescribing addition, practical also repeat and is Healthcare the extremely provide broaden

utilization our our account BREXAFEMME, of awareness to work directors national teams are As with payers. continue continuing busy sales and their commercial generate

We with midst negotiating have and have presented we of to are payers. contracts, agreements payers, we discussed numerous key in the

of coverage growing. commercial and still of over XX% it's grown today, live has of As to BREXAFEMME

representing relationships only Scheduled not engaged discussions of the contract pace account therapeutic actively with efforts and ongoing deep are teams. have commercial with yielded payer and this, negotiations and and contract our reviews, all pharmacy Based this X in are on of majority BDC has payers T, the delighted coverage customer negotiations. of non-preferred. strong in additional We on P Tier with payers Progress also tenure I'm of goal to but space. patients. results and meet we They the national

research is high David we patients. the where response from ratio advancement Pre-launch year. now XXXX. next satisfying. turn community reception addresses in the materials BREXAFEMME. compelling Chief there has lack and the based now, our positive early Angulo, of the not to I patients The hard market in patient education activating medical high unmet frustration bring is deliver and response reporting product again Medical to development been from call David? that where in educating expect And about attributes there we receiving in begin Dr. extremely new strong motivation area need, It an will a progress Thank to and a scientific have of incredibly is consistent look was I new on we We a encouraging patient been fulfilling continued experiencing, to forward will Similar this showed over physician XXXX. the team long-time, Officer. marketing team's until to the are you. to working on

David Angulo

of development. positive a maximize not we development the labeling the be been you, mind you curve agent sharing novel evaluating for needs BREXAFEMME trends and I indications making to BREXAFEMME vision in in become are will multiple several Thank that antifungal, these addressing will are development indications our programs hearing be in the with I blockbuster significant commercialization for programs. but Christine. that for a unmet covering to BREXAFEMME BREXAFEMME. Please their this market, clinical progress some have regarding activities, section updating the After programs approving potential With potential on keep

progressing with or me our recurrence of our of First, trials, intended indication activities treatment we let our the of for VVC program. to pivotal ongoing vulvovaginal is VVC. After with two continue our with approval quick CANDLE X on patients candidiasis CANDLE of development prevention support with trial, in VVC VVC, securing recurrent start BREXAFEMME a the an Phase update

FDA happy we availability As target top that approval this second NDA next the a I'm line by submission completion recall, the study of early FDA. expedited you in after, year. an enrollment a after end six and report with new by results of potential to we less may indication have the of of XXXX, supplemental of subject quarter anticipate of less VVC anticipated are the followed by for previously a on end shortly by and the announced We months review year,

Moving into some have based we the quite hospital are busy, news share. to and indications we great

We dose strategic the a no better the significantly to the benefit these are in shift seven may formulation ongoing, IV than exciting IV hospital person site treatment of the were and adverse our is IV for the clearly The changing events included of oral serious We There up this study stages swelling, analysis subsequent the the were potential continue liposomal expand tolerability anti of having increase an intravenous to and formulation. tested. first of could infusion. therapy intravenous initial for believe be and oral for setting. process outlining interest discharged the pain events to company, or the dosing. is in of days opportunity of hospital our the update an for in the drug development our The panels results From development once formulation dosing ibrexafungerp common study was and The and in-patient and redness, ability Phase as standpoint, plans multiple an completed adverse game from to product. ibrexafungerp. relates to X we both infective home new formulation in that that formulations from with strategic at most a previous formulation mild pharmacokinetic the

aim the to during well. running have treatment utility program for options additional CARES continue for infections will there difficult-to-treat continued in us invasive clinical other studies and treatment are year, allowing limited fungal of to next no FURI fungal provide infections. about which or gather information progress the options Our These ibrexafungerp to potential

salvage know, treatment be you data looks As fungal the needed of interim of supportive have alternative previous the invasive at been diseases. much for ibrexafungerp a potential to

with regulatory experience therapy regulatory and data support to regarding our the continue the needed expand use indication. and path a to we of our agencies hospital with As the data optimal we setting, advance ibrexafungerp discussions in salvage

of Our as has SCYNERGIA. focus The into ability SCYNERGIA including initially ibrexafungerp of study toward to with invasive for of rapidly COVID-XX and combination trials, pulmonary aspergillosis, institutions in voriconazole impacted projected. as the hospital treatment of has evaluating addressing clinical the screening oral prioritization enrollment on resources enrolled patients not pandemic many

Our COVID-XX regions, numbers the they investigators of patients in a decrease focus in to opportunity the are telling us enrolling some a with that anticipate hospitalizations for having better on study. now

extend the timelines enrollment We XXXX. have made a into decision to

to want development preclinical you with I share for exciting Lastly, an ibrexafungerp.

health antifungal are Mucormycosis public a when with XX% aware, conditions is more in infection devastating fungal threat the situations, currently therapy. very with available As than be some present. even become right you can may rates, mucormycosis a mortality a the high best

example, with the study been conducted infection pandemic India. than sponsored an an of As cases in NIHS associated XX,XXX have by COVID-XX In more this preclinical Dr.

the B, well-known the of of in as this with in significant we a a infection. liposomal synergistic drugs administered allow combination ibrexafungerp treatment to findings Aiming substantial option for this treatment of options FURI suggested that these potential standard-of-care therapy Ibrahim, ibrexafungerp co-administration now benefit, encouraging for combination mucormycosis may development. was our expert improvement clinical This elucidate amphotericin better infection. is key the study. with the a very one be in of survival These in field, when observed this for of a model Ashraf mouse mucormycosis in was

Finally, we let turn investor development call now get and the a X Chief more And will details to call December over to about indications, please the for progress hospital be update your pipeline Financial on Officer. calendars. me Eric our hosting plans hospital Francois, mark

Eric Francois

you, David. Thank

few side. ever by numbers product first quarter a is the our to revenue This Let start report me sales. highlighting my presentation first on

are We the of very it. and progress proud excited about

This strong positive from quarter the of was ended is see launch the and well. for in fourth proceeding heard As already a Christine, the quarter. and we strong you us, of a partial quarter trajectory indications sales

net its the quarter XXXX, For of BREXAFEMME third $XXX,XXX generated post-launch, sales. first quarter in

be positive access Phase our did VVC and approximately XX, in equivalents the sale our will hand at totaled Jersey sell and inventory in we over equivalents As $XX fund we have soon we worked X cash to breakout loan on and requirements the of and weeks inventory sales enable million cash but for of the sales all into draw plan, debt we equivalents to items. wholesalers to cash programs represents cash of operating expect recording release And December reporting sales our and existing of to net additional thresholds. third which not to at a our additional we as insurers, operating wholesalers. [indiscernible] includes and impact for refer our $XX networks cash will on cash million units sales we capital issued X, remaining detailed commercial The availability. discounts that are with sending line QX co-pay impact to as reporting, is September New Based our SVB XXXX. reminder, in number, stock $XXX.X net relevant our existing pharmacy of CANDLE XXXX. to anticipated we'll to down also like Please launch, from the any give our believe lastly, more XXXX time. And At drug wholesalers net XXXX term have to assistance early launch. three recurrent and million us facility main from We sale on ensure quarter, NOLs card, on press today patient compared the the data achieving Hercules BREXAFEMME upon expense

early still not are will the in back or As guidance. Marco. over launch, we commercial expense I providing to we are turn the call revenue

Marco Taglietti

Eric. you, Thank

a reiterate want Q&A, I the we begin key Before points. to few

for First, is ibrexafungerp reality. a our vision becoming

June, with very launch trends, executing Second, heard. been in as we've our aggressively commercial you following plans approval have positive

moving forefront R&D we thank let Time, plans Stay with into provide our cash Third, the And just the and very a robust, hospital with AM will over moment in six position, Chief at runway Eric last on extremely program. tuned hospital the Fourth, XXXX. Francois, are when Officer a to Financial December me now. a financial lastly, X, Eastern strong take our services his for years. pipeline for we the into XX:XX our timelines is

his next interim As the soon. Advisors, Eric we open leaves for him you CFO. the best a Eric. leaving company. meet key success. Larry pursue he is commercial Danforth stage wish us and you, in we announced, in are An in Hoffman, role for questions. him transforming the SCYNEXIS opportunity And full company CFO played actively new endeavor. is And We place, will a a transition, to recruiting of please Thank for he floor into smooth integrated a in well-positioned career for a Operator, banking.

Operator

you. Thank

session. Instructions] from Chen We a now Louise Fitzgerald. Please the will be [Operator Cantor first question of proceed with conducting question-and-answer your comes line with Our question.

Unidentified Analyst

We is this and congrats Alford we Lou the you may. on for and Louise] Hi, our all two, progress, [Wayne thank got if taking questions. [Ph],

on Pharma, what then Hansoh And the the us provide in BREXAFEMME are updates other is in we and can you on partnership looking first commercializing to first XX now be SCYNEXIS, XX Thank viewed for second commercialized, be is step you're the months? out question you. what next catalysts the as the with should VVC And -- your China, world? could of for VVC major on some the your So, the our regions is in plan progress?

Marco Taglietti

questions. Thank you the for

has partnership with of a been let start, first great So, with the partnership. It me Hansoh. all,

largest at product top China. our in the filed year. public is candidiasis China. company licensed in Hansoh the one We the for They know, you of biotech As beginning of five vulvovaginal IND the

development they in to product ensure moving China approval are of order of the in with So, very the product. aggressively the

of So, to in we just rapidly is the that also the it very but to too. VVC we continue to [indiscernible] expect progress very, to expect hospital progress continue Hansoh indication, with

be an of not VVC ability are see we is [indiscernible] a where of make for infections a really patients to and of first are we approval, We product partnership available finally, to our versatility, And other with And monetize necessary the to the has value saying [essential for as that of product forward all VVC, of with of all with commercialized to outside internal are, can the than used certainly, but Therefore, that this, intensifying bloodstream, is the the -- sure treat, information, like ibrexafungerp June, that the of for worldwide. [indiscernible], ibrexafungerp, we can plan indication type provide indication of the calls at of great expect, product other any our hospital indication you of rights it difficult outside with following as have of validation our infection product for have, organs Hansoh, This been or this first product and product. used can the but you yes, have course, the step following that mortality. you as But to also, the in product the are know, moving the community of U.S. high U.S. outside the course, the like] expect, becomes potential phone U.S. additional this [Ph] we be point, there cannot partners to globally. we the

in allow indication AM new a and we will Future But approval with a X, stay a timelines mentioned, Thank Eastern the an to hospital doctors. bag VVC also, the our of for indication for we recurrence current hospital in targeted progressing so, us sales December to expect all and expect tuned have move indications. indication XX:XX that Time; plans parallel. are share ibrexafungerp we indication bring group will catalysts, to to out for with you. on of of I the of the our And year, teleconference to forward additional second our go next therefore force, prevention these we as

Unidentified Analyst

Thank you.

Operator

Our next with Ladenburg the question Higgins Please your of Michael comes proceed line with question. from Thalmann.

Michael Higgins

say, Thanks guys. you. some thank questions. let And Appreciate take the me opportunity Eric, to

so What I around coming the maybe. keep Couple the internal happening be do handful in months? talk Christine. questions I'll You'll we see here. are them missed later next commercial I've you that launch, with got on coverage, of try to How the along could, is how few can tight if a versus expectations? here; this

related and a coverage, is on finally and you in nurses are what ways? that Thanks. if along? so here, targeting So, tracking how And pharmacists, Medicaid then

Christine Coyne

the for you spoke Commercial this. again, questions, bit about Thank Michael. I coverage, little a

great necessary directors customers, getting are having conversations. I doing a -- job really [technical think payer to account difficulty] the national in the the and

We've they've So, meetings great of payers that throughout really us. important some gotten with to are a important traction had lot XXXX.

up lives coverage My bring So, going then of in And important is expectation XXXX, pick in XXXX. some we covered in that direction. tracking we'll continues now. are over XX% rest right commercial by we'll the that trend the and end

it participating continue As again, just and directors and that that state we'll goes. those have states out And take to we reviews our, Medicaid, some watching science as are meetings, to Medicaid it liaisons our reach relates ongoing, proactively. medical account national us in

Michael. they nursing well. physicians, that and the physician BREXAFEMME that with rounding And that the the patient yes, As only -- as and I the going but And it very should back office -- I a their call, to not pharmacists, the have then are success and answers there great your success pharmacy experience there we can. and having ensure best -- total that also having a pharmacies total and say staff, to are relates Hope question, to nurses that's we call well. includes it the with representatives

Michael Higgins

-- [multiple speakers] Yes, great. That's

Marco Taglietti

to ahead. him, Please interact you so will said, and And will wanted continue with Eric to that, I him. he I'm to be will -- interact Michael, with And, don't small we say go worry, world, This a around. with sure Michael, Eric, just continue as you that is

Michael Higgins

I sure, we to No, that. look that. appreciate forward I'm

that, got studies. ones and on being Thanks. and IV jump follow-up What one Just the nausea, is any here other on I'll hearing it one your the with managed back in you feedback the food? queue, GI, on just are launch, some on But quick reps? I've the from the the other

Christine Coyne

the it fungicidal, from I They've like the the reception on what strong Michael, to no, reception targets. on, we reaction this on something They're the to it's alternative yeast exactly physicians -- is can kill they been saw just really call and research. from day, excited the waiting this, azole. mean one they Yes, infection, ability have really the a that of can take action, in it mechanism our different for

Marco Taglietti

mild remember, as was tolerability, And -- event, mild may trails our short-lasting. in Michael, very you clinical

So, of our type -- why patients. the of we this experience see we don't reflected these is in

Michael Higgins

Okay, on so, minimal then? is feedback GI the

Marco Taglietti

correct. That's

Michael Higgins

it. guys. Thanks, the jump queue. back Okay, I'll appreciate in

Christine Coyne

you. Thank

Marco Taglietti

Thanks, Michael.

Operator

Our next Capital question. your line Brookline Instructions] Markets. [Operator question proceed comes of Please the Raja from with with Kumaraguru

Kumaraguru Raja

of questions, my quarter congratulations the product taking on sales. Thanks for first and

has of regard first So, much the percentage And prescription that been being targeted than what what physicians and more others? are regard physicians are also where terms coming you some is there, demand, physician this seeing has satisfied? like, is in coming of that what from, it with that targeted, of to from, pent-up to and how been percentage the are prescribing with

Christine Coyne

could that the physicians yes, they started our thank stocking target their put once The Yes, patients BREXAFEMME call product. so prescribing so pent-up pharmacies into we get around so you. demand, the our

previous you I talking that reps think an earnest my before some work we what comments trial. been awareness channel, were exactly that done And did And their doctors that's is the into that with to, waiting happen signal physicians. to ready what that's sales out of is, the put lot to has organic the to reps the were the that's sales happened. actually organic round right, there And doctors get in about. you're see of are we So, sometimes a and there that getting questioning BREXAFEMME, waiting,

it in for a can were address. high research to territories writers targeted, lot the are geographies doctors and imagine being of the relates the represent those doctors most and would are you that the And [indiscernible] did in be market. As VC to to launch productive the those pre it we that advantageous that prescription was identify of around doctors XX% prescription that targeting; us

us seeing a we it's concentrated it's the really for we're it and to seeing it part very address is right very because of of and very, said do, very, as that's extremely I So, I'm what now. what Yes, which are in it encouraged remarks, organic. we part territory, makes easier prepared delighted is

We month-over-month. prescribers, and increasing are it's seeing

for prescribers using their seeing clinical are by broaden We experience BREXAFEMME more patients.

good that's me, For on the a and education prescribers, way wanting BREXAFEMME and also what expand experience bringing prescribers, their of it's a information effectiveness of having we're in our to doing to but to patients membership.

So, that question. your answers yes, hope

Kumaraguru Raja

front number levels on having of these terms in like, life, additional happening you what's you start impact are terms the terms time over time powered and getting of is thinking how in that And of in prescription change board? of you. thank to right, sites in what that like commercial All expected on of

Christine Coyne

kind to right, lines you're of those travel you expect together. Yes,

doctor patients you and for prescription of generate travel lives BREXAFEMME obviously, coverage to together, lines, covered more her patients chooses the that in those because and or traveling see both together. utilization they when increases So, you for his those start

Kumaraguru Raja

much. so Thanks

Christine Coyne

you. course, Of thank

Marco Taglietti

you, Kumar. Thank

Operator

from line with question Nathan next with Aegis comes your Please question. Instructions] of proceed [Operator Weinstein Our Capital.

Nathan Weinstein

CFO a for for a Eric great with. person being Hey, to good work Marco thank morning, Eric, a and and and big great to you question, my taking thanks

maybe any online are via big word share mouth you information? So, the there anecdotally, of role speak could the advocates patients communities of and marketing, just that for and to congregate patients to BREXAFEMME then tend themselves being can play also where

Christine Coyne

early physicians launch that who the it into when such patient The some understands the yet is But for to situation the themselves. doctor what understand BREXAFEMME do to is for thank patient their do to a practical exists office clinical get and perfect thing familiarity. stages the one ability the for BREXAFEMME we arrives if what own how, the product some the utilized Patients big you doctor experience these do the health. experience, most there's knowing question. And important ask having walking doctor's right. a not and is are very through sequence Yes, things, and themselves then what product, for BREXAFEMME, of the is, They that and they product. advocates have office, the has may prescriber, a and is they and asking research then prescribing for the has the

sequence you would see the like, of We do conversations physicians So, to that's sequence with patients that's like follow. you now. kind the their having

doing work team are way good beautiful doctor's educate such to in offices very XXXX, a marketing going productive We patients in connection a those way, a the fruitful patients one. is is and properly between the that the doing into -- in

into Sometimes know come and not about the it really answer can product, helps Hope endeavor. that the physician's have you a a the is patient the fruitful office, physician question. doesn't

Nathan Weinstein

you. Thank appreciated. answer, Yes. That's helpful thoughtful a very much and

Christine Coyne

you. Thank

Marco Taglietti

Thank you.

Operator

proceed is Ladenburg Thalmann. question Michael Our your Please with a question. next Higgins with up follow question from

Michael Higgins

should numbers Thanks hook. you as off one there through? the for taking Delta the Eric, pull in for here we Are the results? guys Quick any I the inventory on here. second And the what Thanks. QX round QX let expect can't

Eric Francois

Michael. Yes, thanks, no,

into prepared as drug had my time to that about weeks we'd all in think a keep launch mentioned three commercial over enough mature hand. pharmacy on I and networks want -- our we ensure As to inventory had higher I of at availability launch launch. we that Christine, relevant we're remark, number

be our to going now. that's so, basically plan And

kind for As learn we'll the we're historical but we that data, get more adjust accordingly, now just and trajectory taking. we as of it's Michael,

Michael Higgins

or at of I bottle? follow with XX,XXX that are pharmacies, or the up so how XX,XXX many you least a in stocked one to U.S. just guess

Eric Francois

address. Christine let I'll

Christine Coyne

Yes.

almost know them You XX% what we in reordering then and early the happening. stocked of launch is there

So, they're now. through pulling those

So, we'd to are where we this and -- I'd time. have see look at

Michael Higgins

Thanks. calls couple a helpful. given you Have switch that. here he's the any That's Okay. additional I'm we And been here. asked, I'm developing kind with IV, injection to if juggling sorry, questions history assessments, an IV site a done on then ibrexafungerp? of

David Angulo

we injected we study, David. better intravenous of This carefully, during assessing formulation. worked liposomal And addressing what observe was and formulation Thank initially, mentioned Sure. is the this this as substantially when healthy the Michael. of tolerability remarks these I in a did during tolerability you, very volunteers. Certainly,

in was side some typically mild the did swelling, dosing from reactions, this we still observe but continuing. And way that no some prevented So, redness, encouraging. infusion extraordinary

development. So, product expecting move of to forward were stages be point to tolerability formulation, of IV doing of administration from we next is that has liposomal doing, improved the it view, of this really enable our which what the to the us formulations

Michael Higgins

Okay.

X, it sure I that on Phase into I'm question release either not expect in going your Thanks. run you're like entirely you means. for there another prepared the what considering IV that sounded comments or remarks Phase that in press were planning you but the Next steps are that IV. is, next were would X to possibly?

David Angulo

in are what going product, the the show data a are on pharmacokinetic stages development in PK let's you next really outline different exactly we the At we final analyzed of to of tell December, you shape for -- program better our you be this are doing hand. we the really mentioned, in we data this of once of have and say are or stages point as to the analysis all the

certainly stage, confirm If is December. ask the like me but you Phase envisioning we to would is probably next that right now, that in the X

Michael Higgins

this doctors When that Okay. from sales will For sales I'll in XX% follow like Thanks. once the following points? also at higher to data you, current think data time trajectory then example maybe kind question see something all more here the for that and point -- its can A like for Christine. comes hear for and that it out, on this because is this or sales? on as about of on you impact you XX% do save you you different bump what we'll that is of up envision question XX% have a positive for think on or impact approval something of CANDLE, sounds December. a hear CANDLE maybe maybe

Marco Taglietti

of Michael, for XX this talking also years. us with the been seeing there's treatment coming we have real but the past, actually need -- So, last the in nothing VVC a here with about the

additional is chronic just to XX%, but bringing activities thanks been small contribute to where some, this patients will fungicidal BREXAFEMME VVC its ibrexafungerp of XX% we and because to and be of And treatment line, course, expect a relatively to bottom affliction. infection, is to we'll be we expecting a product with target prevention another is the one actually really expect recurrent of the day really can We have really almost difference. the opportunity have group to have a what that expect to we infection really make this here innovation the significant is with there our where clear here probably [indiscernible]

Michael Higgins

COVID execution the here the from month infectious of That's about trial can enrollment the least? super patients. CDC delayed that emerging journal increasing guys what One at SCYNERGIA, plans adjust or and the posted Any in you. of Thanks. prevalence on enrollment that helpful. COVID mentioned given among XXXX. that you've the -- that aspergillosis to Any come criteria Thank disease this positive for you the

David Angulo

Sure.

Now, This for aspergillosis. enrolling fact lot related pandemic the research institutions Yes, the also related certainly has trial, invasive type really of to Michael. they impact risk you increases focus SCYNERGIA there if in -- the of the question, in were certainly, doing COVID-XX is the resources or the that of available ability that to and were focusing really again. COVID the an David acquire patients a COVID-XX thank still the had research pulmonary impact COVID-XX resources the the and of really that

enrolled protocol potentially with patients opportunity for study. SCYNERGIA allows an pulmonary or invasive the be patients that's aspergillosis current COVID-XX enrolled to to be there in So,

here to we we it's condition is And outcome the need and because careful how progression versus are what treatment -- learning be that the be is can we definitely so really information, COVID-XX is the just what natural well analyzing underlying need we what subjects. that in afflicted that actual invasive in very to However, is just effect assess really that something just aspergillosis of -- careful patients. these outcome pulmonary of

So, competing it's going a this treatment than is into them side trials with more I at be trials we a patients the would the and of to are new of little that to be rather standard them a physician's expect protocol combination That point, allows enrolled prefer for time majority of are patients. inclusion these treatment this treatments in COVID they in conditions, is COVID-XX. don't not because patients of are that enroll invasive aspergillosis, the enroll the being the new a the we invasive same priorities as where expect the which have condition clinical what -- At -- or pulmonary can we for clinical with treat pulmonary bit going be you understand, of aspergillosis. physicians is the likely studies to that that specifically COVID-XX. may now therapies they seen for into right a assessed to enrolled And

-- However, cases. we have I we will some anticipate that

Michael Higgins

XX year-end, pace the and given the when fact QX? new and last QX, wait of here any these an some by is is for patients the effect likely can or of one provide Right, plan or Then that sense. you of so before make us still FURI, and -- We for in does historically okay, least, potential maybe patients provided information keep the that on enrollment, standard care FURI CARES quite there at increased the Thanks. for is know you setting. updates one that here updates don't

David Angulo

we're that. very label the data look to these really do we will -- at to take excited as And us allows that that. and opportunity a Yes, open you studies are the always know,

round particular discussion when certainly verify right when having the doing that We decision. are as but we will next be have of is to update to that focus we internally make the a announcing to the really resources this of and not study, that the we decision here regarding made time will team in we results from analysis,

Michael Higgins

Thanks. just adjust the evidence FURI Okay. protocol, any finally and here, or the the final execution one mucormycosis me, preclinical And, given Amphotericin? synergy for then one with to plans

Marco Taglietti

benefit. protocol, and using just of different the the all its patients amend were In not because adequately to that use evidence mucor. so questions. protocol FURI need we patients, have assay in The written you in thoughtful clinical enough you, combination those including infections mucormycosis Ibrexafungerp actually don't fungal didn't mucormycosis we we for the past, patients Thank advocating in protocol with is of way FURI thank is the potential answer as is the Michael, enrollment now right very the allows it that,

potential addressing Now, investigators data, this coming that the advantage a certainly this it with from FURI take the we information that are can is protocol. with within they preclinical of

patients future. as that is study we FURI enrollment the and be investigators it the with in included an officially mucormycosis So, to to opportunity notified allows now the for this is them consider

Michael Higgins

Interesting, questions. very all guys. time the the and helpful. Thanks, Appreciate

Marco Taglietti

thank you, Thank you, Michael.

David Angulo

Thank you, Michael.

Operator

floor now comments. of for We session. the over end like turn the would to I you back have the reached Taglietti, to Dr. closing question-and-answer

Marco Taglietti

much. you Thank very

of SCYNEXIS, and been have finally ibrexafungerp become for in bringing and excitement research Now, for the Not you hospital, as in be new the will first listening for to all you doctor ibrexafungerp thanks role the our the infection will to who of that we relevant in patients we to VVC. saying and the development the of Thank more more you to to treatment the of ability a at have make of the and success. the share many just will much progress treatment of of mention all, we expertise, get resources indication fungal thank area the to I listening conference. very us. new a for tools,

Operator

gentlemen, this does teleconference. and conclude Ladies today's

and have for time. this you disconnect You Thank at participation your a may day. your wonderful lines

SCYNEXIS (SCYX) 10 Nov 212021 Q3 Earnings call transcript