- Earnings call transcript Q3 2022

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Operator

Good morning, and welcome to the SCYNEXIS Third Quarter 2022 Earnings Conference Call. [Operator Instructions] Please note, this event is being recorded. I would now like to turn the conference over to Debbie Etchison, Executive Director, Communications and Investor Relations.

Debbie Etchison

Hello, everyone, and welcome to today's conference call to discuss our third quarter 2022 financial results and corporate update.

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

Joining us David Marco Angulo; are Macleod. President Dr. Taglietti; Financial Chief and Officer, Ivor on CEO, today's call and Officer, Chief Medical SCYNEXIS'

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

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

Dr. Marco Taglietti

morning, even treatments. vulvovaginal call while from invasive action great of refocus Moreover, hard Aspergillus when resistant monetizing corporate joining antifungals. your on clinical infections, WHO. against, Health Thank data even they XXXX priority molds the fumigatus, albicans, activity are life-threatening quarter pathogens deadly begin histoplasma, issued WHO's the a is investor another CARES the in X Phase list our Ibrexafungerp as Thank infection Bonjour species, This everyone. for by today you, our strains highly by auris, well-known [indiscernible]. public BREXAFEMME activity, strategy tropicalis global studies Debbie. refractory to parapsilosis, to us vicious want all for fungal third or list our manage. of includes Ibrexafungerp you are health Good currently Candida shows of report ever fungal drawing call. I which in other difficult-to-treat And available earnings FURI recent attention to Organization to candidiasis. evidence for severe, a growing, that pathogens becoming further provides Candida pathogens like such the fungal glabrata, against Mucorales, and first was to and validating World The these

the at front antimicrobial we So on fight to Ibrexafungerp resistant be never-ending against with this lines pathogens. to SCYNEXIS are proud warfare

we steadily provide more efforts this David We details fungal are of to ready. on continuing pathogens. in stay front prepared and our will are

right have SCYNEXIS refocusing by we our the is] recently intravenous to for of indications, and transforming clinical where is of to process [This to from will the market available we proven can VVC, out-licensing on commercialization progress benefit for and pursuing it and in formulation development higher are oral As returns patients, we time, for announced, of the who make company saving many U.S. play good long-term strategy severe suitable ibrexafungerp its continue market the the the for BREXAFEMME where resources product I liposomal of hospital-based And at infections lives, this for expected. ibrexafungerp important keep the potentially role the we that serious mentioned, Stay time deadly a this U.S. in achieving threat U.S. Well, just significant tuned. partners are while its front. growing are same we can are making ibrexafungerp vulvovaginal outside BREXAFEMME believe of the fungal because in actively the U.S. on in At efficacy. full the and we potential. of the the candidiasis this for

to BREXAFEMME indications. We the order in redirect hospital allocated the development promotion will the resources [origin] of of minimize active more to to cash our

is this help extremely VVC. and a recurrent access be BREXAFEMME treatment. expand date our anticipated indication only treatment on the supplemental the XXXX. is XXth, and for both We will to recurrent second therapy NDA approved November the the approved for indication, decision a will the VVC track in second and patients commercialization first filing of PDUFA innovative VVC that for to U.S. of attractive prevention believe partner Our If with of

On hospital plan, details support cash million restructuring filings XXXX. the in our new $XX our cash CFO, our have in the closed And regulatory we Macleod, programs will cash new extended cash. corporate is quarter and expenses enable Ivor to our will we expected provide on XXXX. with Q&A a our than of second then third we balance; This additional quarter to more the for with floor and runway open more XXXX session. side, into the

turn to BREXAFEMME BREXAFEMME -- for Now, in quarter. let infections performance vaginalis me this

number repeat to willing the third of trend of X,XXX over second continued when an quarter it of almost BREXAFEMME X,XXX use almost increase prescribed to increase quarter. that third QX, continue HCPs over prescription of an In XX% We are BREXAFEMME higher HCPs grow increase BREXAFEMME, prescribers. XXXX, a prescribers, they again. and the XXXX, -- of showing generated representing their growth We the the XX% a in representing of to quarter-over-quarter prescriptions quarter patients, XX% continuing BREXAFEMME growth. prescribe even in for

in David? Dr. coverage we lives, Medical million Officer; contract will David PBM, future commercially Angulo, some insured trend fourth October, Chief result major national do in-person BREXAFEMME of this I universe. in end of a decision representing Health]. turn call [Amplity now with benefit the commercial Executive the the a signing expect we After as pharmacy XXX to our over However, with our and disruption our garnered the to XX% Officer. successfully of quarter, to promotion manager, Chief

Dr. David Angulo

Thank you, Marco.

to Ibrexafungerp represent of increase I these of pipeline greatest tropicalis. as of the list, out you development WHO fumigatos, many clinically Marco page address I Before and/or they priority suited response public and treatment. health, to to on also needs mentioned the ibrexafungerp in parapsilosis, update, [are] of high and earlier. this Candida global fungi glabrata, activity get very threat the mentioned evaluating report already this in and become report against with pathogens resistant increasingly fungal common of is policy critical the both species pathogens list has here, Ibrexafungerp intention that albicans, a has areas. relevant efforts most would auris critical, all ever the of towards to demonstrated spectrum Mucorales. against that well to to The groups the shown first activity priority the activity drive including like interventions share the in other programs It to histoplasma Candida these is and Aspergillus of research

well the believe difficult-to-treat infections, unlock both and hospital indication our SCYNERGIA As focused the relevant you rapidly value addressing fits right and development And within recall, place study asset the infections these antifungal with in caused underscoring further and derisked to the with a study the high that XXXX. for hospital and our setting the approval in late Candida FURI right adequately that infections the advancing development at fungal program that of their includes ready space, clinical and study stand that The including can MARIO auris. treatment not in approval antifungal many options. WHO with time has by program species. to Aspergillus. development are patients first [candid] current our CARES already our pathogens The critical We and resistant study received on a significantly FDA priority We by one an see in with plan its It critical been need these by areas how anticipated list. encouraging shareholders. all very needs has first on in significant patients to treated

towards quickly We utilization. our hospital advancing pipeline are

a in XXX study enrollment we'll of enable of soon We of and be have first will closure the of cases by data reporting to all study the follow review review, XXXX. subjects final early FURI in the already study committee will next activities line. our by reached completion target final The time year. follow-up similar followed and as guided of This data, the begin CARES half

Candida in and The evaluating other is FURI SCYNERGIA refractory fungal well. study in closing As with enrollment CARES a auris reminder, patients the study and as aspergillosis are ibrexafungerp infections.

data out are analyze study potential The the in half XX aim from to We MARIO in which number active next study XXXX. that approximately smaller X of candidiasis. available of to Phase this even globally. close subjects development data in with evaluating steps invasive planning We this first in is will Enrollment and the a in sites guide ibrexafungerp open patients path. the study, is anticipated the

As of in are anticipating early XXXX. previously by with study year next of the data end completion guided, we

previously, MARIO CARES intended mentioned submission setting data an in with XXXX with anticipated from later are FURI for be hospital indication along data the studies and the study, an an approval that NDA from first As of the to the year. in supportive

need. with design of We also of will The a our advance trial Phase this expected into formulation XXXX, results Phase in XXXX. critical in ibrexafungerp, data antifungal a study the formulation to as X the to inform plan available from us solution X study ibrexafungerp enable IV is that utility the in make clinical to comprehensive a of the intravenous to the current market, broadening expected

we to track PDUFA call away the from And our now for the level. information BREXAFEMME Macleod, updated remain recurrent And now over Officer. Thank this you. will date this BREXAFEMME remain the After BREXAFEMME Ivor in XX plan indication are and with in We prescribers communicate approval, regarding new Chief on turn for key patients. confident VVC. and I positive to and Financial for outcome patients -- weeks for in November our we

Ivor Macleod

the Thank of joining time for the call. you speak to my Ivor you, today's David. pleasure is and Macleod, you as to it thank and Good for CFO morning, everyone, I'm SCYNEXIS. first new

period years to future a contributing very I company have with I I'm addressing ibrexafungerp. both with that disease. working well this ever-increasing of the a team, talented as during to to of transition, infectious financials, over threats join the as and to much the as look David well get such acumen I Marco, strong to the say as coming delighted the success Before forward focused team, on scientific management of

the were primarily $X.X expense million million to Selling, XXXX months versus XXth, XXXX. the increase million XXXX of for $XX.X third XXXX. our third million third net million the were with recognized over for third development as MARIO second product compared we Research the the $X.X approximately studies, for in XXXX to and primarily $X.X realized to million $X.X clinical XX% for increased in Total third period September the BREXAFEMME. by X expenses quarter XXXX, or income $X.X other $X.X the ended in the were total support The turn in quarter. the of quarter and to driven The increased roughly the third of XXXX. million of IV versus for costs of the now a comparable liposomal the $XX.X financials. million an me commercialization quarter $X XXXX Let of preclinical as increase expenses expenses VANQUISH million expenses development quarter result the the $XX.X well of was other of of BREXAFEMME million quarter formulation. was quarter X% in and for administrative for revenues associated increase general that

third quarter liabilities. on value the third loss adjustment and During the million, of our fair SCYNEXIS warrant and $X.X of recognized non-cash gain XXXX, non-cash of a a of quarter respectively, of XXXX million $XX.X the

equivalents from with call the Our XXth, investments its million at to potential activities the to remains ongoing and cash and include The cash to balance quarter This cash of turn associated cash now assumption upside end $XXX.X December quarter to company totaled of second cash, equivalents and Dr. the over its compared Marco $XX.X existing $XXX.X requirements I fund million and strong. at XXst, short-term development million third does Taglietti. of enable the operating the will not investments will total XXXX. at in SCYNEXIS equivalents that cash, XXXX. compared cash September business XXXX, into BREXAFEMME. short-term any believes

Dr. Marco Taglietti

Thank Ivor. you,

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

of We a fungal forefront the unique ibrexafungerp to at battle major extremely that proud the with a deadly are pathogens player against these against in can fungal become asset, fight a infections. be

FURI and a progress date weeks vulvovaginal our XXth candidiasis for is with We with in on we line end a early be believe have to November recurrent X now in remain -- about track everything in XXXX. to potential have CARES brand. our expectation the and differentiated strong in hospital to provide We and by data MARIO, We of approval can to-date. updates build in of of and PDUFA from our file to a XXXX year plan with of which data NDA leveraged

sale a franchise to it until $XXX at [hospital] provide will XXXX. revenues the the million not only significant also in in million $XXX has alone, Our U.S. net potential least but to year generate

million not open $XX Operator, cash Finally, corporate extended we questions. development please for have with second and runway recent our action, deals. have into over from the floor we quarter include This upside ongoing XXXX. in runway cash, any business potential our does

Operator

Louise from comes question first our with And Chen Instructions] Cantor. [Operator you. Thank

Louise Chen

this First likely? how for possible I you then then you question, out-licensing will I And question, how the Or we had succeed? failed? And Or about but setting question, hospital And is when second think after I for [had] for this about do do let BREXAFEMME? you partner first. opportunity? how you PDUFA? succeeding And will have these think I'll have you when you valuing an more do think is more answer is, one and/or your see XXXX is, in year you two others

Dr. Marco Taglietti

Yes.

So conversations first just tuned. stay very of of continue very potential let to know are well, let and and we active potential me we you are just in pursuing all, updated that active will so all you to partners we say keep with partners,

be, provide yet the recurrent to specific as mentioned, course, VVC, which of month. this type of also, end expect Certainly, of it approval on expect to is of arrive we I really We things, the cannot at we a commitment. which we these

So in now. weeks X from

the this in whether looking for create the we well know, most products partners, most and, women product we because, of be continue in Louise, will footprint make you care As valued expertise potential health partners. the bank the afford, are we well, out help importantly, they partners expect potential as really other have synergistic we to when that will before, And can to greater mentioned reps, may we expect that of whether BREXAFEMME. by to their in products interest this

can the the belonging product one to is -- hospital, appreciate one. the way we But I interest to be infections. a been on for it able is truly achieve the David, expect a class, has hospital the value we third market the going for And seen So, this unique been have to a expect that received to that recognized. about our -- from BREXAFEMME be we setting, patients. be that as new will would ibrexafungerp hospital it's fungal we the that that use also in of we to with certainly challenging a have this add create something invasive enroll just KOLs, how like serious product can

Dr.David Angulo

that being unmet differentiated the able Luis, significant really is product address Marco. Sure, believe we ibrexafungerp to to well needs. really very

As here, see you potential is be again can and can what again recognized this ibrexafungerp being achieved.

We predominant focusing an program believe are development market we very get And regard, efficient being in with label able program a [indiscernible] X to favorable slightly There many in we options. once treatment X treatment options. to many so, that to not resistant the on their in And have with for place so or There of life-threatening is that X positioned become are and that substantial or limited. have X, patients the focused limited options patients that in groups well extraordinarily space antifungal we not many we must right indications be development intolerant these are not the that in or a the are that that that have of we the there so so also said, fact treatment predominant really drugs. have because place the to will believe unique are that the remember very very conditions players. and

I providing addresses hope the our commercial setting. market value hospital opinion opportunity So maximize that, ibrexafungerp potential of this in in the us to your is a in question. the unique really that

Louise Chen

squeeze here. It if in I one question does. just And could more modeling

And should business of things the we fourth be OpEx wanted to think strategy you under sales your because if you ask as want versus and then some think third in in you down I heard about fourth about it will I down, OpEx new quarter like XXXX? sounded I correctly, the the how then, disruption. quarter quarter

Ivor Macleod

actually, in field are of are At Amplity the you promotion stopping as partnership. trend given we we conservative. few the our have So, future last this quarters. seen seen with active to at point, that we this point, the that termination we this growth. is expect don't fact probably have always And tend what in we positive be the saying And

the product. if you we of to to product, with available to look was we only sure make need and ago, product make to know, XX alternative who to that because an right as and at to the regards to IQVIA has patients on will and we continue actually fluconazole, the sales you our been through continue we now the may sales access the others, -- continue will the want database approved So patients approved see, almost which have product years have

million. new before, $XX In addition, I of new a BPM, mentioned coverage another have some as adding we

stopping may be fact patients there promotion, So, that balance. the are by balanced that in we may the may active promotion, fact be be more

we since expenses, our So, infection. how of end invasive the of efforts OpEx, the R&D we refocusing really to the the With quarter on will we the operational fungal see doing. our have have product not in development we regard really at provided on been But are guidance.

say, of I we a may the new R&D be pre-commercial, XXXX, development. and expenses this Does guideline refocused of our in will what our expect where is to in OpEx range it look think expenses as a XXXX, maybe let's we on want question? a at with were, your sense probably that address or you be, the SCYNEXIS back type where to operational

Louise Chen

Yes.

Operator

Ladenburg with Higgins Thalmann. Michael from comes question Next

Michael Higgins

-- I funding the appreciate you Marco, mention and to for partnerships? in chances prior can of welcome pathogen you there? improve regards the to or you inclusion question taking the Does onto and nondilutive for aboard, first questions guys. list David Anything Ivor, global SCYNEXIS. ibrexafungerp

David Angulo

David, is This Michael.

our recognition medical product to the in other a this our and in organizations believe this these substantial continue there will areas. fungal those what they that that cetera, and public We policymakers part is, the also and they to to fungal want commercializing recognition versus we're will company, just pathogens medical very research program really impact unmet of clinical have not are fit ibrexafungerp and by -- difficult-to-treat what with development didn't very should in mentioned translate that is in towards unmet asking in trials, in We within organizations you is years WHO's space. and here a mentally only have considered we that is our priorities, certainly and think validated mentioning and the they addressing important development to that clarify, been that innovation successful focusing our since innovation regards into drive spectrum identifies offer extraordinarily diseases of et the of needs a investigators organizations the that along fungal that like to what the or by our that WHO to think health. people but How obviously showing worldwide. the leave are the a needs list policymaking is because that have that activity focus favorable putting well is efforts being recognition story perfect of -- need I have So, to our almost we are vision important. the the focus ago extraordinarily that very in I can from imply WHO, priority consider of are welcome potentially that in conditions really eventually impact X ability asking broader together represent us lessor on needs because significant we that important to That reinforcement CDC is future. the focus past attractive is

and that positive we are the a see definitely signal positive see outcome, we So, path. in as a we as right definitely that

Ivor Macleod

providing you can I nondilutive BARDA really of the the way about field has if on been anti-infectives, in has talking add, about been grants for if the focus think their And antibacterial. example, funding,

Michael, where WHO DISARM really are really infection their again, major a strong for example, just that past, is I because with times internal fleet the new bacterial legislators. think end they critical in the And about like again, making are talking think, a let XX%, told mentioned to as Now, you focus, me At threat as infection with couple patients, mortality. still a I Act that here very emphasis of sick the is the the the of change recognition invasive other Act, we at outcome, approach. infection inflation of least not And high right these fungal global extremely mean, I as course, legislations, or global, foot. right fungal very still really that down much introduce the many in the -- infection we And in can stream, can a puts WHO are are. on major can actually fungal global I report, organs day was the that PASTEUR the that a mortality talking to case times, help infections be Washington XX% that the critical, case. of a probably, And threat infections are say is with how the bloom the the

Michael Higgins

MARIO, That's lot helpful, this attention our of to design sense give a update an that Can for number study can a it. a turn makes the you on If Appreciate guys. sites. of I us in asset. very

to I XX%. think going were you

you're how is that's so and Just far? want if if to the going that's clarify to, enrollment going where increased

David Angulo

number the yes, has have that changed. we not planned sites of Certainly, Yes.

mentioned. we of are the study, of So in as start-up the the process I

typically You in enrollment don't know on an ongoing basis. we that guide

as However, have different study is been of trajectory the I approvals et that terms tell can we countries, in the expecting. cetera, of you in site initiations,

are So, to the for being as we everything right able enrollment complete by end next complete year. on now us seems the -- the estimating to of track to be really of study study

stage this that go to and agencies, that view. been intense of yes, point, when we from what have response are all out centers, happening. we positive this cetera, different countries you opening regulatory Really at et very at receiving So, is point very, activities happens

all the already are know. we several we and coming, sites open, in really them as have ready. are sites you And setting and get approvals the So, already just process up we'll of

Michael Higgins

clarification. Great

FDA Any of that. if One could. on with us ahead XX PDUFA? last one, for the conversations feedback November I your the Appreciate Okay.

David Angulo

of -- comments, this we our understanding cycle currently with did NDA just stages are not We or an any don't we requires -- the didn't type normal conversation was in conversation They FDA. that particular supplemental didn't consider And actually this needed. the of a late additional particular cetera, are the label. expectations the at. which towards the within process, PDUFA currently is date. an Those signs what stages we the their approval of really at all positive are et that all are the is are -- And

Michael Higgins

Appreciate all the feedback.

Operator

comes Brookline from Roy Shubhendu question Next Sen with Capital Markets.

Shubhendu Sen Roy

does are enrollment And does plan that the the costs? impact [indiscernible], So, going way just to patients your added do wondering any to was funds extra increased in the that the in use enrolling? how I you

Dr. Marco Taglietti

the when planning to to has far, offer Sorry, that entirely going other investigators really advance ibrexafungerp I'm sufficient that first. so trials. we're been imagine, the well them that question for years has first. your increase very tell Yes, opportunity increasing the that And the are really trial has failed. have of stopping stop enrollment been the can trial this is received. our majority that because And enrollment, with to products FURI notice you to is been study this need extraordinarily you enrollment Thank of has I our Certainly, -- address you running disappointed can the in giving you're the X question as in you when the notify first several regarding this cost. investigators for with program

wanted that to really for protocol saw really really they as continue something So, multiple they this running years.

listen, said, we our know, target you is as XXX. enrollment However,

-- costs And that that towards kind of year. decision and of trajectory our we needs investigators the There were We saw main of to that? the at the we remind opinion, maintain, with with that have them to but the the do process. that of me enrolling you the preparing year some the many that anticipated investigators to communicated the a honest, that same subjects of until be mostly is try of to that cost We cost incremental clinical in enrolled, of all we investigators And type end associated to maintain is for investigators and completing not the end on really was question, enable infrastructure because engage And we're beginning them same reality associated FURI is in the trial are them, and the place. specific to the us, of that that's of this driver. going with the to be number the subject to have which your the to The the that to as time, I maintaining same you the the have second year. study really maintain keep at trust can using from the had keep same with motivated view. the communication we point to with for really based them mentioned, be been of right minimal, the decided communication although maintain are this

Shubhendu Sen Roy

how that? in, saw plan that just to Yes. are coming I was wondering how use do you extra you patients the

David Angulo

these from data patients in? The that are coming

Shubhendu Sen Roy

now, parameters of part included data they in? will the the and extra trial just some at be like are yes, they be just to mean, usual I look you or would Yes. going

David Angulo

me understood let So this see I if right.

you last for -- particular complete follow-up the as patients that that that, this of same coming we this, all next the planning? we are studies. package for all of with -- as will know, open-label the of part They part subjects the review analysis. are the be data be are subject are we the have before, is CARES So, how be we all them visit study mentioned in, CARES, So, last step all will will analyzed once what patients, along committee. via and the for And patients coming we from

have FURI the really from do These from we CARES response data are outcomes the report and these now we what way external that for CARES rate comparison So, we really sets a with indication. against controls. good pieces from external report is external later the against salvage therapy to to And patients are to to from are consider and of be coming right are on to we're outcome external compare FURI and will relevant planning that that access contrast expecting planning groups first controls. that to providing able patients extraordinarily X going the of the the controls. supportive being And and then all we be

supportive expecting patients. that's these I'm with FURI I'm that data we comparison your sure That's indication. external the CARES the be salvage not that we but if from use data, So, a the controls, addressing way the -- therapy question, and with along to are will are of planning

Shubhendu Sen Roy

Yes. Great. for some does. preliminary basket you've it trial, indications It a well. shared study, follow-up in the data as FURI like And and a includes of

do So, the the indications one than better or few see you responding of others?

David Angulo

glucan treatment of I So, right. if gist standard we here question synthase gold for know Candida understand infections, specifically, are the that inhibitors the

which glucan That's So, gist infections. of for that their of infections, yes, mechanism we for factor this do really what cited really kind action. a expect inhibitors gist wow are synthase are

we with So, and/or is infections cetera, or very that, And failing said the in of is potentially ibrexafungerp that treat -- of enrolled treatment et when mucormycosis have reality expectation patients to infections infections. for combination when infections. also is ibrexa the protocol gist the are Having in FURI mold that we mold been use our allows opportunity the -- therapy the in that is greatest Candida like difficult-to-treat aspergilosis. majority the the what future that of study, believe they

an these be they strategies different that additional that believe will them infections. extraordinarily that, we final very physicians of when as treatment these have results, alternative options for are we facing allowing with all of are all once we the So difficult-to-treat with valuable

Shubhendu Sen Roy

line missed time study? very That's finally, is for may have [synergia] but helpful. what And the Yes. I it,

David Angulo

are we've been year enrollment report half of to We're planning and this in within We year. to -- closing planning data as really to we're data. well, close the able report next first

Operator

Instructions] President our the question-and-answer any closing This remarks. to [Operator I over back would Marco turn conference concludes ahead. and go like for Please session. CEO, to Taglietti,

Dr. Marco Taglietti

simple would operator. points. you Thank I X just like much, very to make

are one, The an to significant like have ibrexafungerp infections. to make a difference first that we very fungal within patients will asset basic proud

And goals. to help a resources much we'll the have very make the you. forward able you we call. and we Operator, third you SCYNEXIS that all be the looking reward of and The not to expertise we that our and continue to will work believe for second you. also is that achieve are path attention that only successful, And close can your to our Thank shareholders. but with to conference patients, on thank

Operator

presentation. conference The today's concluded. you attending has for Thank now

disconnect. You now may

SCYNEXIS (SCYX) 10 Nov 222022 Q3 Earnings call transcript