BBI - Earnings call transcript Q2 2020 | Fresh Tracks Therapeutics, Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Greeting. And welcome to the Brickell Biotech Incorporated Second Quarter 2020 Financial Results 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].

conference being this reminder, a call recorded. is As to host, Dan is now of your pleasure my It Ferry introduce LifeSci Advisors. Thank Mr. you, Ferry.

begin. may You

Daniel Ferry

Thank everyone. you. Good afternoon,

Officer, Officer, on Brown; Co-Founder Officer, and me today's Officer; are and Chief Joining Andy Operating Sklawer. call Deepak Chadha; Chief Carruthers; Mike Executive Financial Chief Chief R&D Brickell's Rob

and webcast cause differ statements detail now greater would statements forward-looking materially. these information about in forward-looking results in filings I I Officer, begin, these company's everyone that are we any contain undertake to to of publicly that We of note opinions from Brown. remind cause most or only could actual that SEC. forward-looking results forward-looking not statements differ Executive on company. report the the with are or of will our annual and our those implied would These are could Please XX-K light this materially revisions uncertainties this statements to to future as Chief recent any do Before like and date to revise the Factors over conference to such discussed outcomes in Form to actual reflect other statements results turn subject Rob expressed events. or new risks obligation to of call the the call release that call. our like and in company's by the

Robert Brown

then the to on review our financial provide reported Thank provide update Deepak business program, results ask you, to call and update, to today. joining our this afternoon. Dan. thank a Mike I I call will everyone earlier And the you turn to an we over will clinical then

axillary XXXX achieved our primary first was team patients or several as excessive period asset, with very more milestones sweat. our underarm suffering described lead sofpironium regarding from for hyperhidrosis commonly a half exciting bromide, for of The

label open US. Phase completed we successfully XX-month safety the study First, III our in

Second, sofpironium partner as Japan, the research Pharmaceuticals, program. in breaking Experience of presented results Phase part Kaken at for its American bromide Meeting development Academy positive study June late Virtual our the in of III pivotal Dermatology

the Lastly, completed we development fourth the these based our the our the this anticipated confidence which submission with earlier announced of events III to on in these strategy Combine PMDA, the to year. of have their bromide Japanese program pivotal XXXX. NDA of Kaken strengthened results, initiation US Phase in sofpironium quarter advance

Phase safety to Kaken's discuss pivotal completion Let's our study, Deepak open label turn of with it to long-term data along the over study. III the from Deepak? analysis of III Phase

Deepak Chadha

bromide that related hyperhidrosis. consistent The was Phase both at with July open older In label, our completed which axillary bromide and treatment gel adverse tolerated, Rob. study observed. XXX and gel of No X% concentrations II study subjects, of applied in confirmed nine with earlier III the trial results results. Phase years Thanks, XX-month was topically well analysis sofpironium XX% safety clinical long-term were safe sofpironium events we and serious generally the XXXX, primary

milligrams and or greater each sofpironium upcoming by III of disease of additional as Phase expect equal we severity baseline. results, patients production the one or subjects XX under scale gravimetric had GSP to than to is and to respect subjects minutes enrolled these point HDSS under support days. pivotal X% that arm encouraged randomized of to results release vehicle or Japanese these With arm were bromide one in total a at long-term or review XX forum. Kaken's are study, or a greater use We X equal older. X they details five hyperhidrosis scores and sweat apply than to at for as years each to on XXX All With per an bromide sofpironium scale potential nine scientific a

XX% secondary its subjects predefined endpoint X.XXX. sweat change vehicle. sofpironium foremost, in XX.X% of was in efficacy to of and subjects and of HDSS and of the total and met on X endpoint met the number primary secondary of Xor p by efficacy at for was treatment. endpoint mean or of equal gravimetric arms sofpironium significant vehicle, study end the to reporting this the of all XX.X% to reduction from endpoints efficacy greater baseline demonstrating statistical improvement primary in between with compared of both end An production bromide treatment end The important a on to had their treatment. an a the First GSP value differences score at bromide subjects than value

gravimetric the bromide minus exploratory mean reduction X.XXX. Brickell's was Phase one to production with value or X EOT. from endpoint, XXX.X minus or point is, also milligrams equal of III endpoint proportion point of sweat measure co-primary for an reported HDSM-Ax patient milligram vehicle, efficacy X hyperhidrosis included X Phase that endpoints. a to Sofpironium axillary This X as baseline on with than severity Kaken other efficacy to co-primary disease of is Brickell's greater XXX.X reduction compared of subjects endpoint scale III p outcome

in XX% with compared X.XXX. a with group p well performed subjects of vehicle to a XX.X% reduction the bromide value Sofpironium only

efficacy pivotal results, endpoints Kaken these Phase study as by its this all important are is and and that US met patient our it encouraged compared based we the on to prospective the certain pivotal are there While III in Phase studies population differences to III design, study recognize dose.

events severity group mild at in site upon be sofpironium and efficacious, or erythema sofpironium in and was to experienced of effects. Regarding in subjects X.X% the X.X%, observed observed results, no The dry in subjects, related application predominantly adverse at site bromide safety, tolerated. transient X.X% application the of of of of demonstrated X.X% bromide nasopharyngitis treated bromide. subjects. were Only dermatitis were side mydriasis generally to common most anticholinergic serious were in XX.X% Based of events X.X% safe subjects were in were There bromide nature. mouth, events the and adverse Those adverse sofpironium well any and sofpironium only subjects. severe these

turn the call now Rob. me back to over Let

Robert Brown

for that two the data you studies, summary from Deepak. Thank of those

upcoming Kaken X% XXXX. on bromide we to a Japan NDA as of early in of decision for expect terms sofpironium the In quarter milestones, their receive gel regulatory as fourth

royalties a commercial NDA As sofpironium agreement as is on in our entitled as its Kaken, well submitted milestone Japan. of percentage to last bromide Kaken reminder, of Brickell November. Under net tiered Japan sales a receive with based payments, in

in rights, China. including other progress supporting to and We Korea they forward are success as Asian in which Kaken's have and countries pleased their Japan, look continued well with as

to turning strategy for US Now in development our the sofpironium bromide.

double-blinded comprised sites of for in These is will evaluate sofpironium Our and follow-up. controlled week begin XXXX. of next topically approximately of per study initiate Phase pivotal expect efficacy bromide Phase be which to safety trial weeks first will quarter will gel two primary studies axillary XX with the step year, randomized trials to the XXX III a III two applied this treated to hyperhidrosis. be evaluate with XX% Subjects currently and to the the subjects will vehicle six later XX conducted We across concentration. be fourth program

scale, the at of on of efficacy reported FDA point baseline the co-primary HDSM-Ax mentioned subjects sweat As improvement the end the to gravimetric agreed change X treatment by baseline patient are to endpoints Deepak, X outcomes the to in of production least achieving end proportion previously from from and a treatment. at

study. opportunity a Phase number endpoints we we science IIb see of new in financing of our completed June institutional at both of the statistically in these our financial now million. significant offering Importantly, will in a sofpironium a dose life of public our forward allowed proposed. achieve focused results for lead on of date programs support to with and gel. up XX% study In program, shareholders proceeds ranging progress that coming our the We attract keeping $XX.X the our to will look of the call Carruthers overview. net advancement this on over concentration to significant of order This Mike us the this offers quarters. Mike? the be bromide over shareholders initiation program development turn I step to all to a we've The the

Michael Carruthers

afternoon call. for XXXX. with summary in million cash, June of on the XXXX, also reported full second second financial in financial consolidated of quarter cash to our can quarter results. be used the filed XXXX, and website having cash securities, ended Starting cash equivalents SEC. as and a investments, June once quarterly read of in and XXXX the we appreciate million which And statements I provide marketable Thanks, $X.X the $XX.X I accessed good XX, contained with opportunity Form MD&A the Rob. on XX-Q our everyone our on encourage to you to report period during our XX,

commencing sofpironium $X.X the cash of addition balance, to loss $X.X increased III and clinical organizations million million third anticipation the for prepaid in for an bromide payments of $X of quarter of the anticipation initiation result revenue second million to This accrual of program year. In party our XXXX of in for in the quarter million this clinical research was licensor XXXX. decreased the the III sofpironium second Phase the Net was loss bromide United of States. to Phase of of quarter the $X.X future compared trials to have of we in milestone fourth near-term

XXXX recognized compared period revenue, related was $X.X addressing by $XXX,XXX Kaken, Specifically the activities to R&D Revenue million in and the research provided Difficulty] of driven for in which agreement second with XXXX. in same quarter Kaken recognition [Technical development. we both periods the for to

Robert Brown

on phone. Hello, his Mike Mike. We lost

this that again. the Let go then go Q&A. start section finish me ahead we'll go I'll ahead over and and to section and

other safety of the were to was concluded Specifically revenue with in of quarter we which quarter of agreement of both these related pursuant of XXXX by provided studies were $X XXXX. mentioned and payments milestone Brickell. future Phase million million Phase a that Mike the to that the paid and bromide The for we fee result $X.X down of and ago. moment $XXX,XXX Kaken quarter due to that development and quarter Brickell's long-term the sofpironium million of studies driven licensing of decrease compared the study second research III Revenue basis concluded a totaled second $X.X the in end was of the for R&D was period long-term received the million primarily $XX.X revenue million bromide the in This XXXX. Conducting XXXX, to expenses gel discussing periods the payment same XXXX that quarter a of $X.X million decrease compared in second research second having first XXXX. clinical for study for from by winding in Expenses III other for the for recognition but XXXX. funding second Kaken, recognized recognized accrued gel R&D to clinical ongoing revenue, studies. quarter or sofpironium activities development ancillary XXXX $X.X we of included to Kaken and a the for is safety

for R&D higher $X professional million following the due raise costs totaled increase increase III capital forward, the million sofpironium bromide. as expected million $X.X of including for compared the $X.X and activities of of program company, the for a expenses to primarily quarter insurance. XXXX second XXXX. expenses to operating Going Phase are quarter This initiation was G&A fees for to to public of related second

for stock and up had questions. ahead expenses And open I'll approximately costs ask by operator the compensation of go $XXX,XXX. also Operator? increased and that, it with We other

Operator

Instructions]. [Operator

Leland from Our Oppenheimer comes first with Co. question Gershell and

Leland Gershell

Just a from me. few

to for hyperhidrosis improve wanted extent really if your can would the also, perspective means you that quality X primary the wanted for you could to reduction And To you're see life for program their a point First axillary endpoint put if that went sufferer. of endpoints through. help study what so what with the using into Qbrexza that and the forth? compare ask

are think just minor you. I differences you just Thank there. by can compare some Perhaps side side. them there

Robert Brown

to handle Deepak, questions? two you those want

Deepak Chadha

I think you have two questions.

was or really the change relates of the HDSM-Ax Your greater first scale on into around quality what point X this question life.

HDSM-Ax the you me little on just tell let bit So, scale. a more

scale. they And the to X which be to have As is a a X X, X, X mentioned, get X, or scale, it's patient, on point X. study, the X, point into X

severe. very or severe are they basically, So,

to they shift, to So, down a to X moderate. or have come make point mild

rating So, – itself. the just that's on the scale

of the a first we part of of terms for life, level question. scale. the quality And have question it's look in primary analysis, the to as level So,

the to they come from life down have they a severe of quality the with point clearly, hyperhidrosis, severe, So, mild. of from to moderate. shift, are in the move to at Or severity getting very X they if

the And thing scale So, compares part your how this you second the answer were to one. that's Qbrexza. about PRO to asking

point they So, have scale, have as a move ASDD. one points scale. basically, XX four question, XX a you to point PRO, on And a they know, Qbrexza

are are So, primary different both reported question analysis, is two their And outcome multi-domain scale. of one but they part scales. whereas patient scale, a it's endpoint HDSM-Ax as only

So, X point And an scale. XX our scale. shift X point on it's in a X point on point shift a case,

Robert Brown

in endpoint the in which to add is comment, used gravimetric obviously, Just was one the other both sweat production, co-primary addition, studies.

Leland Gershell

I one actually, And may. follow-up quick if

As you any of are the if want progress being just pursuing on to there, just the in and report there's matter Cocrystal, to [indiscernible]. new check composition that with Thanks. any see movement

Andrew Sklawer

this not Andrew providing at guidance that. We're This is on Sklawer. stage

Leland Gershell

Congrats on progress. all the great

Operator

Thomas from Flaten Lake Our Street with question next Capital Markets. comes

Thomas Flaten

thoughts might on Do I can timeline any initiation dependent that surges is how way? fourth risky play if quarter or COVID we've phrase that and out? How your seen have for how on that it you is, a study guidance

Robert Brown

it Obviously, as from, IQVIA, there's goes. the working group and depends, offices we ability where pretty to are run confidence the severity with the patients study, talk Thomas, When degree we're in study. is our a the the which all on the it as high to well of coming how run to

only for study. We six have us One study. is short And this patient things it's going engaged a weeks a few really is, the is for during each drug on regard. in

get can out. you So, of kind and in

the are that in mix broad addition, sites, of at kind and United XX number on hotspots can sites the change based we're the where to States geographic picking terms XX of in In variance patients will in there be we because of a those time.

So, feels do to about excited good do sites it. to pretty IQVIA ability our this. The are

a to therefore, there's we can't hasn't As their you that a that we But stage, feel patients patient in might going this committed of to offices, ability much recruit and And off. gives work bigger meet kicking variables they're research that very confidence. ability a control positive so been this this going a be. than and, there Obviously, our lot would us reasonably kick start on, work lot study on or and imagine, there's development quickly. error to to thing off this and bar there get normally timeline around enroll pretty the at about of

Thomas Flaten

that's enrollment drive some there pace study, the And is that then, gated with going or the starting first to primarily that respect study second to in is by decision? other factor

Robert Brown

started situation not we've At given the the this this we on to study. into this. variable. get And COVID frankly, second want guidance time, play just the in comes in first Obviously, study

two And to the you sure study. sites And trained look on and running. we them want before We how get the right can and that make to the make other. and and so, what you call. want a then, around make up have we second start get we decision working not it's to study on then first unusual of started, the do studies, start top when It's each don't is

Thomas Flaten

with And had but not one, been the mindful plan, And we it you? approval with what regulatory according may. familiar unexpected final if regular based has they're of up to proceeding is but sequencing has that the telling authorities? in Japan, Kaken or should anything anything then dialogue to there, running one there I'm on be I regulatory

Robert Brown

Yeah, yeah.

we often, the provide in for obviously, they that. data those. questions some So, the involved get not intimately But we're of

we've There we and regulatory seen in interaction follow Japan. the authorities do is gone companies quite What has So, regular between is along. well. the interaction

be schedule So, typical for a timeline. they're what approval on we're cautiously optimistic XX-month would that

Operator

may floor are this turn you. I'd any to There Thank remarks for at Mr. over have. closing to questions Brown you time. no the further like

Robert Brown

for to with respect you on opportunity best to wish all the to to thank of listen take to this the this whole want our recognize coronavirus We a everyone and that Well, progress the the presents families. behalf building us. to on to taking update. the time for their situation encouraging committed challenge call on I We team year. afternoon we've remain this Brickell the Great. of current made

any any feel always, much. Thank to at out to you free time. with As us questions reach please very

Operator

and this webcast. concludes Ladies gentlemen, today's

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

Fresh Tracks Therapeutics (FRTX) 12 Aug 202020 Q2 Earnings call transcript