BBI - Earnings call transcript Q1 2021 | Fresh Tracks Therapeutics, Inc.

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Operator

Greetings, and welcome to the Brickell Biotech Inc.

First Quarter 2021 Financial Results Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. pleasure your my with Garth now Advisors. LifeSci is to host, introduce Russell It you. Thank

begin. may You

Garth Russell

Thank good operator you, and afternoon, everyone.

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

that remind risks These will reflect cause Before forward-looking contain these could I to statements - and statements conference differ. this about that of as I begin, call. that we company. this are our of certain to subject call uncertainties like the to note results would everyone and only actual date opinions webcast the Please statements forward-looking

to information actual results We Factors statements forward-looking to detail Rob, from release or cause these publicly - recent with or the in reports that or like in could and to yours. any forward-looking Officer, the filed outcomes as will discussed company's those our any by these of light future expressed revisions not implied statements obligation events. new over filings revise X-K call materially differ the on undertake I or results is results Brown. Form Chief our of would periodic the and XX-K greater Rob to SEC. now other are the to Form floor XX-Q on in turn Executive such most

Robert Brown

for us very our on joining thanks call. XXXX and everyone here time exciting a afternoon, at has of Good been Garth. Brickell. Thanks, Beginning

known sweating. we've for key primary for trials, We best-in-class option as it's hyperhidrosis, sofpironium efficacy sofpironium some through also safety potential continue bromide phase X to steadily evaluating achieved as pivotal This clinical our advance milestones program underarm lead treatment bromide. year excessive axillary and

Cardigan enrollment. enrollment was announced X XX% Cardigan the that the we X First, study surpassed study, in completed and patient

we quarter both XXXX. studies placebo, primary expect XX% As and patients evaluating Both remain phase axillary hyperhidrosis. Cardigan bromide approximately X studies are and the program results topline clinical of with X from against the sofpironium on-track reminder, phase pivotal fourth to XXX announce a gel each in

to pleased open-label Stacy of we Academy Dermatology breaking bromide experience observed support further for a the important phase at by have XXXX Dr. X - of they Xb tolerability the results study during our gel with safety phase late as hyperhidrosis American safety, in basis phase highlighted Considering prospective These X this Second, of along data, studies two Stacy sofpironium a efficacy in Smith, expect primary are oral virtual results study. to our April. previously the and meeting chronic presentation condition, long-term we the data form the NDA is we filings. axillary long-term clinical pivotable our are

quality KOL and Third, led [ph]. leaders Through highly this event we hyperhidrosis event, two in for of stakeholders. were hyperhidrosis investors, able many hyperhidrosis hosted Friedman and ever Joel adversely undertreated affecting deal believe life. by remains March, event interested was other are, Adam we the daily doctors, The our and treatment thought an hyperhidrosis medical distinguished their their and analysts we why options managing what first Cohen patients lives, with in to that current condition, what share

on If to which in you Sections encourage our replay, the can website. you to the a and be event, unable are watch events attend found of presentations I Company's Investor

Kaken development partner, our Now turning Pharmaceuticals. Japanese to

for of first the and prescription hyperhidrosis ECCLOCK being important topical country. ECCLOCL hyperhidrosis. sofpironium ECCLOCK the of early name brand X% stages sofpironium As is with Japan primary launch any primary product milestone under treatment the companies, in both country an Japan we've its gel Kaken the once announced, previously The being bromide of bromide for of the approve in is for axillary commercial first daily in to launch still for the treatment invocation axillary the

Brickell a of receive in as net entitled milestone of sales tiered a on As ECCLOCK to percentage Japan. as sales-based royalty payments, reminder, based well is

warrant raised XX, stability $XX.X This result ATM key into next FDA sufficient as gel proceeds a of we've provides with operations as to new continue executing of year, certain X in Finally, successful allows through us runway in fund our and million phase exercises financial sofpironium of XXXX. strengthened and us cash outcome a drug us added a that balance application progress. our bromide March pending to will our to offering with enable cash pivotal sheet with XXXX, on the activities submit for program,

a Let's now clinical turn the call Deepak Deepak? provide update. to to over

Deepak Chadha

everyone. Thanks, Rob. Greetings,

in Rob pleased his treatment been U.S. two study. studies the gel by for pivotal of primary XXX XX% X enrollment stated today in hyperhidrosis we remarks, bromide patient each evaluating patients with have opening approximately axillary As phase in the sofpironium

As the Cardigan the enrollment rate months approximately enrollment on-track in fourth topline patients, for two Cardigan which year. to enrollment. the announced quarter, report current its in completed enrollment complete X study third X studies in the and for now has Cardigan April, XX% exceeded X enrolling started of this both data Based and we study, remain the Cardigan X, quarter on after

we HDSM-Ax improvement mention hyperhidrosis on least the change set the of or severity at that gravimetric on in severity five-point Brickell's weeks of HDSM-Ax a each a the subject scale, hyperhidrosis the reviewed the severity the As production, X periods. in The X efficacy baseline improve bromide with the SDSS. primary psychometric two endpoints of pre-existing the or subjects meaningful from expected change consistent with represents axillary, scale to proprietary the a phase point in axillary scale clinically in of assessment each disease participating hyperhidrosis patient that sofpironium peer Cardigan proportion is two Furthermore, either agreed end studies a gel reported XX% severity. or results placebo a time FDA with or effects is outcome one treated for assessment, to reliable primary core scale analysis is week treatment. change scale and at This compared recently U.S. that to to in will reminder, be have Drugs as measure, six results achieving follow-up to that The that disease the well-defined, score HDSM-Ax hyperhidrosis the validation cycle in Journal the X Dermatology. is published scale demonstrate published for of HDSM-Ax measure and concludes such point treatment as good

as open-label study. previously the open-label phase our to that X from study. now extension conventional not safety an rollover X study a It's pivotal noting where Turning extension completed study open-label long-term phase standalone conducted into was patients worth studies

axillary to sofpironium bromide complete evaluating not treatment. were acclimated hyperhidrosis provides study this datasets clinical previously who a As more patients gel naive treatment primary

XX-weeks patients the for improvement assessment Academy with of sites already As treatment was primary to experience. presented of showed XX% sofpironium X% bromide treatment. meeting axillary ratio in results the sofpironium and efficacy XXXX study older virtual were bromide and clinically nine many across oral XXX X:X sustained and in randomized the gel generally efficacy be receive years bromide well daily Dermatology's on American of last of you gel by X% sofpironium the XX month in of breaking U.S. may treatment tolerated, the or either were the severity assessed Based study, through long-term hyperhidrosis. and gel sweat patients aware, in meaningful study from outcome XX%. XX-weeks late This presentation at safety of a the and

discussing study Section of April the reviewing feel Events we detail, those in Page the Investors call hosted a in the For to results and of in further our website visit interested this conference the for in Presentations free the on replay data.

excitement the overview. the about treatment well an sofpironium positioned a the axillary efficient Finally, strength the to to not of few committed goals to bromide for months past that the and U.S. over this execute we to to on patients turn Bert but our will financial primary been and also call with year. we Bert? team, potential have progress very continue The hyperhidrosis. now make millions productive With suffered speaks and I provide for be have the we to in Marchio over of the resilience are important only that, the option company, of

Bert Marchio

Deepak to on and the everyone Thanks, call. good afternoon

provide and the I consolidated Starting I full on with be to our the our Report can Quarterly Before quarter and summary want to once of our a SEC. statements in Investors with which results, first Section accessed through investments. the contained financial XX-Q, read of MD&A filed Form financial cash you encourage website

first of by March XXXX. Japan current program in of topline for royalty the We quarter quarter XXXX our were in was was XX, million of million year, in for from studies quarter X our the the clinical into $X.X compared equivalents, pursuant cash ECCLOCK first during XXXX. XXXX. year. $X.X in recognized agreement which operations million we attributable first phase increases U.S. and the reported was quarter to this total of for professional costs cash approximately As an primarily we in of received were increase million G&A R&D XXXX, the Revenue of for in $X.X for and compensation was believe million last reported to Kaken. will having was and expense the payment of first prior beyond to the attributable totaled Japanese the in to results million the increase quarter pivotal $XX,XXX, operating license to support X position This phase compared the for This cash activities This $XX.X related the R&D Kaken. of fourth quarter cash revenue first of in we our development the to partner, year. increase sales the to was revenue which our $X same initiated $X.X million period $X Cardigan recognition spent with an quarter due for that first expenses expenses the to of XXXX, primarily fees. the related compared

$X $X.X for over for of that, to to I back first turn now Rob. quarter was call XXXX. the million, of Lastly, XXXX net first compared will the With loss the Rob? quarter million

Robert Brown

for ongoing I'll to operator momentum an This work now concludes we Thanks, for program. to Bert open Brickell the recap. turn to continue it over phase up pivotal our X build questions. Deepak time prepared together and is This Operator? clinical as your really for remarks. our and exciting it behind

Operator

on Leland, question with Please your muted Gershell [Operator line & Instructions] proceed live. the you. of side? Are from Leland first comes Oppenheimer question. Our Thank you with your you're Company.

Leland Gershell

I'm in out sorry, muted. I put

your you. uptake at month. are. taking okay hear to Hi, but Here of study safety efficacy you much questions of now. if tolerability study. different for understand of a Good profile. the X% looks how like the with XX%, at a for you I afternoon, can that you I'm the I favorable X% last be that. going wanted have the my extension that that couple believe versus information sorry back of with market? that perhaps look Could I we affect more the safety hope wondering two for thoughts Japanese approached you look the a product questions. from provided perhaps long-term strategy data may it forward end to XX% Nonetheless, the formal we talked - Obviously, ask study as you wasn't and through this the X% thanks albeit that U.S. at efficacy doses in so I the looking future an development? you long-term the strength. One, me about with

hyperhidrosis Thanks. hear to company, and in with really affect may thoughts [indiscernible] how question that regard sale to another also marketplace forward? but there. have space the your wanted the dynamics And I going So the

Robert Brown

Sure. the want to I'll and Hey, add, if for you Deepak, the free. thanks questions, safety, feel with start long-term Leland.

the efficacy you'd So, we that is well, focus whole efficacy quite the held it study. the XX% did that And data, reduction We X% The anything us GSP similar [ph] primary safety our in over as one may the there measurement, X. tool, that [ph] be used had of the the the and and add? we both the same Xb, encouragement study endpoints the we the efficacy. on that the fact is in obviously, potential for on that one like give why look relatively X% in at and used gels were excited the the the their to Deepak, Xb, the XX%. similar see we was to which phase in the about we sustained didn't for down used PRO road to the does saw the to and saw and long-term PRO was a that But we also sweat company. of

Deepak Chadha

taking that's and the GSP; I high we and aspects the the Rob covered the think core you bromide. the sweat, concentration primary second the with as reduction in management meeting reason will like GSP of know, the primary are endpoint, X, bring of sofpironium XX% and as part lower of part the interested concentration always, to the we lifecycle phase you be - the

Robert Brown

right never you Leland, got the a will. of Qbrexza pandemic; a different some go really in party; a at the - to been for for decision that. terms then to it focus terms - the Qbrexza, then question, their then by the Dermira's in selling product engaged, encouraged of of so the and another a acquiring the if it asset And the were - And Lilly launch that's of has second the launch fully pandemic, then obviously, we hindered to Obviously, sale company, of pretty resources sell tough beginning asset, obviously, on through. by

awareness out a you go and marketplace this the big there like need focused greater dermatology, is treatments challenge. of is there you create the where that company there people other to a going a have condition and lot you bigger marketplace. when about awareness aren't the in that's So most and greater who And that's seeking they noise. and sense we're are get important And each is of treatment, When a a many that, talk encouraged do involved all companies that hyperhidrosis. on the help that ways, in

help one there, we think space lack see is us somebody so about or our treatments I forward. So can dedicated competitors of committed, we as is that being the there having only of - biggest go excited ignorance who and is understanding and out

Leland Gershell

Thanks additional very for much color. the

Operator

no are back for like remarks. further Robert There it hand to questions. closing to I'd Brown

Robert Brown

to in operator. Brickell to to clinical updated And team and time patients program. all thanking progress contract hyperhidrosis Okay. want look principal Thank interest this the their listen of for [ph]. months. the the taking on close the for call to you, for organization of our thanks clinical keeping for Not I patience their We everyone phase commitment X forward tremendous mention, of outstanding trial afternoon by the research and studies ongoing these our to out you the the update. support sites, coming

free reach we out with great your us As of any hope questions. And a anytime you always, please rest feel day. to to have all

Operator

Ladies your conclude and teleconference. for today's Thank gentlemen, this does participation. you

have a may wonderful time, You this disconnect your day. lines at and

Fresh Tracks Therapeutics (FRTX) 13 May 212021 Q1 Earnings call transcript